0001
 1                   CUYAHOGA COUNTY, OHIO
                     COURT OF COMMON PLEAS
 2   
 3   SHANNON SULLIVAN, et al.  º
                               º
 4   vs.                       º     CASE NO.
                               º     CV-09-697617
 5   CLEVELAND CLINIC          º
     FOUNDATION                º
 6   
 7   
 8   
 9   
10           *************************************
11             ORAL AND VIDEOTAPED DEPOSITION OF
12              JOHN DAVID BURKHARDT, JR., M.D.
13                   Monday, MAY 17, 2010
14           *************************************
15   
16   
17   
18               ORAL AND VIDEOTAPED DEPOSITION OF JOHN
19   DAVID BURKHARDT, JR., M.D., produced at the instance
20   of the Plaintiffs, in the above-styled and numbered
21   cause on the 17th day of May, 2010, at 8:43 a.m.,
22   before Tomi S. Johnson, Certified Shorthand Reporter
23   in and for the State of Texas, reported by machine
24   shorthand, at the Austin Suites, 700 Lavaca,
25   Suite 1400, Austin, Texas.
0002
 1                   A P P E A R A N C E S
 2   
 3   ON BEHALF OF PLAINTIFFS:
 4          BECKER & MISHKIND CO., L.P.A.
            1660 West Second Street
 5          Suite 660
            Cleveland, Ohio 44113
 6          216-241-2600
 7          BY:  DAVID A. KULWICKI, ESQUIRE
                 dkulwicki@beckermishkind.com
 8   
                 RONALD A. MARGOLIS, ESQUIRE
 9               rmargolis@beckermishkind.com
10   
11   ON BEHALF OF DEFENDANT and THE WITNESS:
12          ROETZEL & ANDRESS
            1375 East Ninth Street
13          Ninth Floor
            Cleveland, Ohio 44114
14          216-615-7401
15          BY:  ANNA MOORE CARULAS, ESQUIRE
                 acarulas@ralaw.com
16   
17   
18   VIDEOGRAPHER:
19          SAM SWAIN,
            Rennillo Deposition & Discovery
20   
21   
22   
23   
24   
25   
0003
 1                   INDEX OF PROCEEDINGS
 2   
                                                   PAGE
 3   
 4   APPEARANCES                                      2
 5   EXAMINATION OF JOHN DAVID BURKHARDT, JR., M.D.,
 6          BY MR. KULWICKI                           5
 7   CORRECTIONS AND SIGNATURE                      191
 8   REPORTER'S CERTIFICATION                       192
 9   
10   
11   
12   
13   
14   
15   
16   
17   
18   
19   
20   
21   
22   
23   
24   
25   
0004
 1                     INDEX OF EXHIBITS
 2   
     EXHIBIT          DESCRIPTION OF EXHIBIT         PAGE
 3   
     NO.  1      Curriculum Vitae of John David
 4               Burkhardt, M.D. --------------------  06
 5   NO.  2      The Cleveland Clinic Foundation
                 Procedural Log of Mr. Sullivan -----  37
 6   
     NO.  3      Heart Rhythm Society Expert
 7               Consensus Statement ----------------  49
 8   NO.  4      8/17/06 Correspondence to Dr. Makino
                 From Dr. Burkhardt with Attachment -  84
 9   
     NO.  5      ACC/AHA/ESC 2006 Guideline For the
10               Management of Patients with Atrial
                 Fibrillation ----------------------- 117
11   
     NO.  6      The Cleveland Clinic Foundation
12               Procedure Notes of Mr. Sullivan ---- 160
13   NO.  7      Electroanatomic Image -------------- 162
14   NO.  8      11/8/06 Procedural Notes of
                 Mr. Sullivan ----------------------- 178
15   
     NO.  9      Heart Rhythm Journal Abstract ------ 184
16   
     NO. 10      4/13/2010 Correspondence to
17               Mr. Kulwicki From Ms. Carulas with
                 Attachment ------------------------- 186
18   
19                          ù ù ù
20               ORIGINAL EXHIBITS RETAINED BY
21           COUNSEL FOR PLAINTIFFS - NOT ATTACHED
22                          ù ù ù
23   
24   
25   
0005
 1                   P R O C E E D I N G S
 2                   THE VIDEOGRAPHER:  We're on the
 3   record, May 17, 2010.  The time is 8:43 a.m.  This
 4   begins Videotape No. 1.
 5                   Will counsel identify themselves for
 6   the record.
 7                   MR. KULWICKI:  David A. Kulwicki on
 8   behalf of the plaintiffs.
 9                   MR. MARGOLIS:  Ron Margolis on
10   behalf of the plaintiffs.
11                   MS. CARULAS:  Anna Carulas on behalf
12   of The Cleveland Clinic and Dr. Burkhardt.
13                   THE VIDEOGRAPHER:  Will the court
14   reporter please swear in the witness.
15              JOHN DAVID BURKHARDT, JR., M.D.,
16   having been first duly sworn, testified as follows:
17                        EXAMINATION
18   BY MR. KULWICKI:
19        Q.     Dr. Burkhardt, if you would kindly state
20   your full name and spell your last name for the
21   record.
22        A.     John David Burkhardt, Jr.,
23   B-U-R-K-H-A-R-D-T.
24        Q.     Doctor, I'm going to hand you what I'll
25   mark as Exhibit 1.  It is a copy of your curriculum
0006
 1   vitae.
 2                   (Deposition Exhibit No. 1 marked.)
 3   BY MR. KULWICKI:
 4        Q.     Is the address on there current?
 5        A.     Yes, it is.
 6        Q.     And is the CV current, accurate, and
 7   complete?
 8        A.     I believe I may have an update to this
 9   one.
10        Q.     Okay.  And can you tell me from the time
11   this was published what's been added or what we'd
12   need to add to this to make it complete?
13        A.     I'm also staff and director of Complex
14   Ablation at Scripps Clinic in La Jolla, and I'm also
15   staff at California Pacific Medical Center in San
16   Francisco.
17        Q.     Any publications that would need to be
18   added to this to make it complete?
19        A.     So, yes, there may be I think two or
20   three that are -- that have been published since
21   2009.
22        Q.     And do any of those involve ablation of
23   atrial fibrillation?
24        A.     I believe so, yes.
25        Q.     Can you tell me where those were
0007
 1   published or do you have --
 2        A.     I don't have those on me right now.
 3        Q.     Okay.  In your CV it lists you on the
 4   advisory board for Biosense Webster Emerging
 5   Leaders.  How long have you been on that advisory
 6   board?
 7        A.     That advisory board no longer exists.
 8   It was --
 9        Q.     What were the time periods that you were
10   on that?
11        A.     I believe that was two thousand and --
12   it was one -- one meeting, 2008, I believe.
13        Q.     Okay.  You're also listed on here as
14   principal investigator for "Lesion Formation Using
15   Remote Magnetic Navigation Versus Manual
16   Navigation."  Can you give me when you were first
17   identified as a principal investigator for that
18   study?
19        A.     Let's see.  That was in also I believe
20   2008.  It was after I left Cleveland.
21        Q.     At the time you were at The Cleveland
22   Clinic, were you principal investigator for any
23   devices, procedures, or equipment used in atrial
24   fibrillation ablation?
25        A.     Let's see.  I -- I did some evaluation
0008
 1   of rotational fluoroscopy.  That was an x-ray.  And
 2   I believe that's it.
 3        Q.     And whose -- was that for a particular
 4   device manufacturer or was that a clinical trial?
 5        A.     That was a clinical evaluation of using
 6   a -- using a Siemens x-ray system to obtain images.
 7        Q.     And were the results of that study
 8   published anywhere?
 9        A.     Actually, no.
10        Q.     Who are you currently employed by?
11        A.     Currently employed by Texas Cardiac
12   Arrhythmia.
13        Q.     And --
14        A.     And Scripps and Golden Gate Cardiology.
15        Q.     Scripps is a university?
16        A.     No, it's a clinic.
17        Q.     Is Dr. Natale employed by any of those
18   three entities?
19        A.     He is employed by Texas Cardiac
20   Arrhythmia, by Scripps, and he is employed by Sutter
21   Health, but not by Golden Gate.
22        Q.     Does he currently work in Austin or
23   Houston for Texas Cardiac Arrhythmia?
24        A.     Austin.  I think he also has privileges
25   in Houston, but the -- the actual business entity is
0009
 1   in Austin.
 2        Q.     You were employed by The Cleveland
 3   Clinic exclusively in August of 2006; is that
 4   correct?
 5        A.     That is correct.
 6        Q.     And your CV lists you as chief medical
 7   advisor to Stereotaxis --
 8        A.     Yes.
 9        Q.     -- from January of 2008 to the present.
10        A.     Yes.
11        Q.     What -- did you have any affiliation
12   with Stereotaxis back in August of 2006?
13        A.     I may have had a minor consulting
14   agreement.
15        Q.     Okay.  And where would you have to look
16   to see if you had a consulting agreement with them
17   at that time?
18        A.     The Cleveland Clinic would likely have
19   some record of that.
20        Q.     When you have consulting agreements with
21   companies like Stereotaxis while employed by The
22   Cleveland Clinic, does income generated by virtue of
23   that position go to The Cleveland Clinic or does it
24   come to you personally?
25                   MS. CARULAS:  Objection.  Go ahead.
0010
 1        A.     It depends on the -- on the nature of
 2   the business.
 3   BY MR. KULWICKI:
 4        Q.     And what's your recollection as to any
 5   relationship you had with Stereotaxis?  Did you
 6   receive income directly from that or did it go to
 7   the clinic?
 8                   MS. CARULAS:  Same objection.  Go
 9   ahead.
10        A.     I believe that in -- it may have been
11   after given the -- this time period, but I did -- I
12   said a -- I did a talk for them and I think I got an
13   honorarium for that talk.
14   BY MR. KULWICKI:
15        Q.     Did you have any research or consulting
16   agreements with any device manufacturer while you
17   were employed at The Cleveland Clinic, such as
18   Biosense Webster, Stereotaxis, NAVISTAR, any -- any
19   of those companies?
20        A.     Yes.  I had consulting agreements with
21   St. Jude, Biosense Webster, the one we talked about
22   with Stereotaxis, Siemens Medical, and probably -- I
23   guess it was called Guidant at the time and
24   Medtronic.
25        Q.     And would those have involved more than
0011
 1   just giving a talk from time to time?
 2        A.     Most of them would have been giving a
 3   talk, and once I may have done a -- experiments --
 4   in-house experiments for them.
 5        Q.     And by in-house, do you mean outside of
 6   The Cleveland Clinic?
 7        A.     Yes.
 8        Q.     With respect to any of these talks that
 9   you gave, would there be publications associated
10   with those handouts or otherwise?
11        A.     In general, no.
12        Q.     And would these -- again, these
13   consulting agreements be something that The
14   Cleveland Clinic would have copies of?
15        A.     Not the physical agreements, but the --
16   the involvement of the agreements and the -- the
17   monies.
18        Q.     Okay.  Your CV lists you as being on
19   staff at Akron General Medical Center.  Is that
20   current?
21        A.     I am still on staff there.  I do not --
22   haven't practiced there in a year and a half or
23   two years.
24        Q.     And when you were practicing at Akron
25   General Medical Center, were you full time at any
0012
 1   point in time?
 2        A.     No.
 3        Q.     It's my understanding that you were
 4   involved with fellowship training at The Cleveland
 5   Clinic while you were -- while you were there,
 6   assistant fellowship -- assistant director of the EP
 7   fellowship or something of the sort; is that
 8   correct?
 9        A.     That is correct.
10        Q.     Okay.  And what were your role -- what
11   was your role and duties in that capacity?
12        A.     They were evaluating the education
13   portion of the program mainly, and so I -- I came up
14   with a curriculum, weekly lecture series, and
15   assigned other positions for the -- for the lectures
16   at that, also involved in the evaluation of the
17   fellows, and we usually had meetings every quarter
18   for the evaluations, and I would go to the meetings
19   with the graduate and medical education department
20   and the -- and the national graduate medical
21   education meetings also.
22        Q.     Was the EP fellowship a one-year program
23   at the clinic back in 2006?
24        A.     It was two years.
25        Q.     And in terms of doing AF ablations,
0013
 1   would that be done by fellows during both years or
 2   would that be sort of part of the second-year
 3   curriculum?
 4        A.     That would be both years.  It was more
 5   heavily weighted towards the second year, but both
 6   years.
 7        Q.     This process that we're involved in here
 8   is called a deposition.  Have you had a deposition
 9   prior to today?
10        A.     Yes.
11                   MS. CARULAS:  Objection.  I'll have
12   a continuing line, but go ahead.
13                   MR. KULWICKI:  Sure.
14   BY MR. KULWICKI:
15        Q.     How many times?
16        A.     Once.
17        Q.     And was that in a case that was brought
18   against you personally or against some entity other
19   than you?
20        A.     It was an entity other than me.
21        Q.     Was it the clinic?
22        A.     Yes.
23        Q.     And did that deposition take place in
24   Cleveland?
25        A.     Yes.
0014
 1        Q.     Do you remember the plaintiff's name in
 2   that particular case?
 3        A.     I do not.
 4        Q.     Did you provide care to the patient who
 5   was the subject of that lawsuit?
 6        A.     Yes.
 7        Q.     Do you remember the name of the
 8   plaintiff's lawyer who filed that?
 9        A.     I do not.
10        Q.     What did -- what was the subject matter
11   of that case?  What sort of procedure was that issue
12   or what were the allegations of malpractice?
13        A.     It was an extraction case.
14        Q.     I'm not familiar with that term.  What
15   does --
16        A.     It's a --
17        Q.     -- that mean?
18        A.     -- removal of a -- an implanted device.
19        Q.     Are you aware of any prior lawsuits
20   arising out of complications of AF ablation against
21   the clinic --
22                   MS. CARULAS:  Objection.
23   BY MR. KULWICKI:
24        Q.     -- other than this one?
25                   MS. CARULAS:  Objection.
0015
 1        A.     No.
 2   BY MR. KULWICKI:
 3        Q.     Throughout the course of this deposition
 4   if you don't understand one of my questions, please
 5   tell me that and I'll restate it to your
 6   satisfaction.
 7        A.     Okay.
 8        Q.     Likewise, as you've been doing, please
 9   wait until I finish my question before you answer so
10   that our court reporter can accurately take down one
11   question and your answer and so that you get my
12   complete question.
13                   If you need to take a break for any
14   reason, if you'd like to consult with Attorney
15   Carulas or take a break, take a page, whatever,
16   we'll accommodate that.  And kindly continue to
17   answer verbally as opposed to an uh-huh or a huh-uh
18   so that, again, our court reporter can take
19   everything down accurately.  Okay?
20        A.     Okay.
21        Q.     Have you ever acted as an expert
22   witness?
23        A.     No.
24        Q.     Have your privileges to practice
25   medicine at any hospital been revoked, suspended, or
0016
 1   called into question?
 2        A.     No.
 3        Q.     Has your licensed to practice medicine
 4   in any state been revoked, suspended, or called into
 5   question?
 6        A.     No.
 7        Q.     Have you ever been the subject of any
 8   disciplinary proceedings by any board or hospital?
 9                   MS. CARULAS:  Objection.
10        A.     No.
11   BY MR. KULWICKI:
12        Q.     You hesitated.  Have you had issues with
13   respect to signing charts timely or the like?
14        A.     Oh, yes, that's definitely -- I've had
15   the usual nonsuspension for -- for late charts, yes.
16        Q.     Okay.  Is that why you --
17                   MS. CARULAS:  Just interject an
18   objection there, but go ahead.
19   BY MR. KULWICKI:
20        Q.     Is that why you hesitated?
21                   THE WITNESS:  Can I confer with my
22   counsel?
23                   MR. KULWICKI:  Sure.
24                   THE VIDEOGRAPHER:  Go off the
25   record?  Off the record at 8:57.
0017
 1                   (Recess taken, 8:57 a.m. to
 2   8:58 a.m.)
 3                   THE VIDEOGRAPHER:  Back on the
 4   record at 8:58.
 5   BY MR. KULWICKI:
 6        Q.     Doctor, during the break you had an
 7   opportunity to confer with your counsel.  It's my
 8   understanding that you have a pending investigation
 9   before a state medical board; is that correct?
10                   MS. CARULAS:  Same objection.
11        A.     Yes, a nonpatient-related complaint.
12   BY MR. KULWICKI:
13        Q.     Is that -- is that with the Ohio State
14   Medical Board?
15        A.     No.
16        Q.     Is it with the Texas State Medical
17   Board?
18                   MS. CARULAS:  I'll have a continuing
19   objection, please.
20        A.     Yes.
21   BY MR. KULWICKI:
22        Q.     Your counsel has stated off the record
23   that the -- because no formal charges have been
24   brought, that it's confidential.  Do you have any
25   understanding that that investigation or the facts
0018
 1   underlying that investigation are confidential?
 2        A.     Yes, it is listed -- it's listed to be
 3   confidential by the board.
 4        Q.     Well, tell me what is the subject matter
 5   of that investigation.
 6                   MS. CARULAS:  So I'm going to
 7   instruct him not to answer that.
 8                   MR. KULWICKI:  We'll take it up with
 9   the court.  Do you have a specific privilege that
10   you're going to base your objection on?
11                   MS. CARULAS:  And it's a -- it's a
12   confidential matter.  It's an invest -- a current
13   investigation, so we're not going to get into it.
14                   MR. KULWICKI:  Well, we reserve the
15   right to inquire and we can take it up with the
16   court.
17   BY MR. KULWICKI:
18        Q.     Doctor, what was your reason for leaving
19   The Cleveland Clinic?
20                   MS. CARULAS:  Objection.  Go ahead.
21        A.     My wife didn't like Cleveland.
22   BY MR. KULWICKI:
23        Q.     Okay.  And is she a doctor as well?
24        A.     Yes.
25        Q.     And where does she currently practice?
0019
 1        A.     She's --
 2                   MS. CARULAS:  Objection, but go
 3   ahead.
 4        A.     Here in Austin.
 5   BY MR. KULWICKI:
 6        Q.     Okay.  After you left Cleveland, you
 7   started practicing in Akron General; is that
 8   correct?
 9        A.     I filled in at Akron General from time
10   to time.  It was not immediately after.  It was only
11   after Dr. Schweikert joined Akron General.
12        Q.     So what did you do between terminating
13   your employment at The Cleveland Clinic and your
14   part-time work at Akron General?
15        A.     I was a consultant for Stereotaxis.
16        Q.     How long did that period last between
17   gigs at The Cleveland Clinic and Akron General?
18                   MS. CARULAS:  Objection.
19        A.     Between Cleveland Clinic and Akron
20   General?
21   BY MR. KULWICKI:
22        Q.     Yes.
23        A.     That time was -- I believe
24   Dr. Schweikert started sometime in April, so it may
25   have been four or five months.
0020
 1        Q.     Why did your wife not like Cleveland?
 2                   MS. CARULAS:  Objection.
 3        A.     Mostly the weather.
 4   BY MR. KULWICKI:
 5        Q.     And did she move somewhere to practice
 6   elsewhere?
 7        A.     Yes.  So she originally moved to
 8   Henderson, Nevada.
 9        Q.     Okay.  And did you ever take a position
10   out in Henderson, Nevada?
11        A.     No.
12        Q.     How long was she in Henderson, Nevada,
13   for?
14                   MS. CARULAS:  A continuing line of
15   objection to Dr. Burkhardt's wife, but go ahead.
16        A.     She was -- let's see.  She moved before
17   I left Cleveland, so I was commuting actually for a
18   while.  So she was -- probably around two years she
19   was there.
20   BY MR. KULWICKI:
21        Q.     And when you took the position at Texas
22   Cardiac, did she then take employment in Austin?
23        A.     Yes.
24        Q.     What kind of physician is she?
25        A.     She's an oncologist.
0021
 1        Q.     And what's her name?
 2        A.     Vivian Jean Mikao Cline-Burkhardt.
 3        Q.     What's her maiden name, Mikao?
 4        A.     Maiden name is Cline.
 5        Q.     Okay.  C-L-I-N-E?
 6        A.     Yes.
 7        Q.     Do you know why Dr. Natale left The
 8   Cleveland Clinic?
 9                   MS. CARULAS:  Objection.
10        A.     His contract was not renewed.
11   BY MR. KULWICKI:
12        Q.     Do you know why?
13                   MS. CARULAS:  Objection.
14        A.     I do not.
15   BY MR. KULWICKI:
16        Q.     Was your contract not renewed at the
17   clinic?
18        A.     No, my contract was renewed.  I
19   resigned.
20        Q.     When you resigned, did you publish a --
21   or did you prepare a termination notice or some kind
22   of letter setting forth the reasons for resignation?
23        A.     Yes.
24        Q.     And do you have a copy of that?
25        A.     No.
0022
 1        Q.     Who did you author the resignation
 2   letter to?
 3                   MS. CARULAS:  Objection.
 4        A.     I believe it was Dr. Nissen.
 5   BY MR. KULWICKI:
 6        Q.     And was he the director of the a-fib
 7   center at the time?
 8        A.     No.  He was director of cardiovascular
 9   medicine.
10        Q.     When you wrote the letter to Dr. Nissen,
11   what reasons did you set forth in there for
12   resignation?
13                   MS. CARULAS:  Objection.
14        A.     Only that I wanted to rejoin my family.
15   BY MR. KULWICKI:
16        Q.     Did you seek employment in Nevada?
17        A.     I did.
18        Q.     And you weren't able to find anything?
19                   MS. CARULAS:  So a continuing
20   objection.
21        A.     I didn't find anything acceptable.
22   BY MR. KULWICKI:
23        Q.     Do you know why Dr. Natale's contract
24   was not renewed?
25                   MS. CARULAS:  Objection.
0023
 1        A.     I do not.
 2   BY MR. KULWICKI:
 3        Q.     And did you resign after Dr. Natale --
 4   after you learned that Dr. Natale's contract was not
 5   renewed?
 6                   MS. CARULAS:  Same objection.
 7        A.     It was after the time of year, but it
 8   was two or three months later.
 9   BY MR. KULWICKI:
10        Q.     Were you upset when his contract was not
11   renewed?
12                   MS. CARULAS:  Objection.
13        A.     I enjoyed working with him, so, yes, I
14   regretted that he -- wouldn't be working with him at
15   the clinic any longer.
16                   (Comments off the record.)
17                   THE VIDEOGRAPHER:  Off the record at
18   9:04.
19                   (Recess taken, 9:04 a.m. to 9:06 a.m.)
20                   THE VIDEOGRAPHER:  Back on the
21   record at 9:06.
22                   MR. KULWICKI:  All right.  To double
23   back, Doctor, to the assertion of privilege with
24   respect to my question asking about the subject
25   matter of the investigation before the Texas State
0024
 1   Medical Board, I'd like to ask the court reporter to
 2   instruct the doctor to answer the question.
 3                   THE REPORTER:  Do you want me to --
 4                   MR. KULWICKI:  What we do in Ohio --
 5   unless you want to waive --
 6                   MS. CARULAS:  Yeah.  I mean, we
 7   don't have to go through the formal --
 8                   MR. KULWICKI:  Okay.  If we have a
 9   stip --
10                   MS. CARULAS:  -- the formal stuff.
11   I've instructed him not to answer; you want him to
12   answer.  We're going to have to go talk to the Judge
13   about it.
14                   MR. KULWICKI:  Okay.
15                   MS. CARULAS:  Okay?
16                   MR. KULWICKI:  So you're not going
17   to raise any objection based on --
18                   MS. CARULAS:  I will not.
19                   MR. KULWICKI:  -- failure to go
20   through any extra judicial steps that we may need to
21   go through --
22                   MS. CARULAS:  Right.
23                   MR. KULWICKI:  -- in order to raise
24   this before the court?
25                   MS. CARULAS:  Right.
0025
 1                   MR. KULWICKI:  Fair enough.  Okay.
 2   BY MR. KULWICKI:
 3        Q.     Doctor, with respect to your departure
 4   from The Cleveland Clinic -- well, Dr. Natale's
 5   departure from The Cleveland Clinic, have you talked
 6   to him about why his contract wasn't renewed?
 7                   MS. CARULAS:  Objection.
 8        A.     Yes.
 9   BY MR. KULWICKI:
10        Q.     And what did he tell you?
11                   MS. CARULAS:  Objection.
12        A.     He was not given particular reason from
13   the clinic, only that his contract was not renewed.
14   BY MR. KULWICKI:
15        Q.     During the time that your employment at
16   The Cleveland Clinic overlapped with Dr. Natale's
17   time at The Cleveland Clinic, were you aware of
18   issues from administration where they were upset
19   with things that Dr. Natale was doing or not doing?
20                   MS. CARULAS:  Objection.
21        A.     I did hear of some things that they were
22   not happy about.
23   BY MR. KULWICKI:
24        Q.     And what sort of things did you hear
25   about?
0026
 1                   MS. CARULAS:  Objection.
 2        A.     That he was travelling and doing
 3   procedures at other institutions.
 4   BY MR. KULWICKI:
 5        Q.     Okay.  Anything else?
 6        A.     No.
 7        Q.     Did you travel with Dr. Natale and do
 8   procedures at any other facility?
 9        A.     No.
10        Q.     Doctor, in preparation for today's
11   deposition, what materials did you review?
12        A.     The prepared medical records.
13        Q.     Did you review any depositions?
14        A.     Yes, and two depositions.
15        Q.     What did you review?
16        A.     Dr. Kanj's and Dr. Cummings'.
17        Q.     Do you know why Dr. Cummings left The
18   Cleveland Clinic?
19                   MS. CARULAS:  Objection.
20        A.     She accepted a job at Akron.
21   BY MR. KULWICKI:
22        Q.     Did you look at any films or any -- any
23   digitalized information like images from the
24   procedure in preparation for today's deposition?
25        A.     I saw a CARTO disk from before and I saw
0027
 1   a -- an x-ray loop.
 2        Q.     Did you prepare any notes that are not
 3   part of the medical record?
 4        A.     No.
 5        Q.     Relative to this patient obviously.
 6        A.     No.
 7        Q.     In terms of communicating with regard to
 8   patients back in 2006 while you were at The
 9   Cleveland Clinic, would you communicate with other
10   physicians via e-mail regarding patient matters?
11        A.     Rarely.
12        Q.     Do you know if you communicated with
13   anybody regarding Shannon Sullivan or his
14   complication with anyone via e-mail?
15        A.     I don't recall.
16        Q.     Was Mr. Sullivan's complication the
17   subject of an M&M conference?
18                   MS. CARULAS:  Objection.
19        A.     It was --
20                   MS. CARULAS:  You can answer yes or
21   no.
22        A.     Yes.
23   BY MR. KULWICKI:
24        Q.     And would you have prepared anything in
25   writing for purposes of that M&M conference?
0028
 1        A.     No.
 2        Q.     Would someone else have prepared
 3   something in writing regarding that?
 4                   MS. CARULAS:  Continuing objection.
 5   If you know.
 6        A.     Not other than a list of subjects for
 7   the M&M.
 8   BY MR. KULWICKI:
 9        Q.     And, again, without talking about the
10   substance of the writing, can you tell me what you
11   mean by a list of substance?
12        A.     List of subjects.
13        Q.     Subjects.  Tell me -- tell me what that
14   would be.
15        A.     So it would just basically include the
16   patient's name.
17        Q.     Okay.  And would you have made an oral
18   presentation or would someone else like Dr. Kanj
19   have made an oral presentation at the M&M
20   conference?
21                   MS. CARULAS:  Objection.
22        A.     Yes, someone else would have presented
23   that.
24   BY MR. KULWICKI:
25        Q.     Who -- who would have presented that?
0029
 1        A.     Likely the --
 2                   MS. CARULAS:  Just know --
 3        A.     -- fellow.
 4                   MS. CARULAS:  Yeah.  Okay.
 5   Objection.  We're not going to get into any of the
 6   M&M discussion --
 7                   MR. KULWICKI:  Okay.
 8                   MS. CARULAS:  -- who said what, what
 9   was said.
10                   MR. KULWICKI:  Understood.
11   BY MR. KULWICKI:
12        Q.     Who would have been present at the M&M
13   conference?
14        A.     It would have been fellows and staff.
15        Q.     Okay.  Anybody not employed by The
16   Cleveland Clinic present at that M&M conference?
17        A.     No.
18        Q.     Any device representatives --
19        A.     No.
20        Q.     -- that would be present?  Did you
21   review any notes regarding the M&M conference,
22   minutes or otherwise, in preparation for today's
23   deposition?
24        A.     I do not believe there were any notes
25   from that conference taken.
0030
 1        Q.     Back in August of 2006, was Dr. Natale
 2   the lead investigator for the ThermoCool catheter?
 3        A.     Could you be more specific?
 4        Q.     Well, was he designated as a principal
 5   investigator for the NAVISTAR CELSIUS ThermoCool
 6   catheter relative to the study for paroxysmal -- its
 7   use in ablating patients with paroxysmal a-fib?
 8        A.     I'm not sure at that time.
 9        Q.     Do you know if the a-fib center at The
10   Cleveland Clinic was funded in part by device
11   manufacturers?
12                   MS. CARULAS:  Objection.
13        A.     I don't know anything about the funding
14   of the a-fib center.
15   BY MR. KULWICKI:
16        Q.     Do you know if any equipment or devices
17   were donated by device manufacturers for use at the
18   a-fib center?
19                   MS. CARULAS:  Objection.
20        A.     I'm unsure about any funding at the
21   a-fib center.
22   BY MR. KULWICKI:
23        Q.     Who would know about that?
24                   MS. CARULAS:  Objection.
25        A.     Likely be the administrator --
0031
 1   BY MR. KULWICKI:
 2        Q.     And who was that --
 3        A.     -- at the time --
 4        Q.     -- back in August of '06?
 5        A.     The administrator for cardiology was
 6   Frank Petrovic.
 7        Q.     And is that a doctor?
 8        A.     No.
 9        Q.     What is Frank Petrovic's position or
10   title back in August of '06?
11        A.     I don't know the official title, but
12   head administrator for cardiovascular medicine.
13        Q.     And what was his background?  Was he a
14   businessman or was he a hospital administrator?
15   What -- what kind of back --
16        A.     I would call him a hospital
17   administrator.
18        Q.     In terms of the a-fib center back in
19   August of 2006, is that what you called it, the
20   Center for Atrial Fibrillation?
21        A.     Yes.
22        Q.     And was Dr. Natale the head of that
23   department?
24        A.     He was co-head.
25        Q.     And who was the other head?
0032
 1        A.     Mark Gillinov.
 2        Q.     How do you spell Martin's last name?
 3        A.     Mark is his first name.
 4        Q.     Mark.
 5        A.     G-I-L-L-I-N-O-V.
 6   And do you know if Dr. Gillinov is still at The
 7   Cleveland Clinic?
 8        A.     I believe he is.
 9        Q.     Did you hold any position in the a-fib
10   center?
11        A.     No.
12        Q.     In one of -- you'll note in Dr. Kanj's
13   deposition that there was a discussion about the
14   a-fib center registry.  Are you familiar with that?
15        A.     Yes.
16        Q.     And what was the a-fib center registry?
17        A.     It was a database of patients who
18   underwent atrial fibrillation ablation.
19        Q.     Would it contain all patients who
20   underwent atrial fibrillation ablation?
21        A.     I don't know the exact contents of the
22   database.  I was not the administrator of it.
23        Q.     Would you report cases to it yourself?
24        A.     Yes.
25        Q.     And would you report all of your cases?
0033
 1        A.     Well, I didn't personally report the
 2   cases.  It would be gathered.
 3        Q.     By who?
 4        A.     By someone from the a-fib center and
 5   from the -- from the medical records.
 6        Q.     And would they gather all of your cases
 7   for purposes of entering them into the a-fib center
 8   registry?
 9                   MS. CARULAS:  Objection.
10        A.     I can't tell you what they gathered.
11   I'd assume they would gather them all.
12   BY MR. KULWICKI:
13        Q.     And would Frank Petrovic know about how
14   the a-fib center registry was ran back in August of
15   2006 or would there be somebody else that would have
16   better information about that?
17        A.     It would likely be someone else.
18        Q.     And who would that someone else be, if
19   you know?
20        A.     I don't know the exact person.
21        Q.     What title would they have?
22        A.     They would have some -- I don't know.
23   They would have some title in the a-fib center, so
24   there was...
25                   MS. CARULAS:  Do you want some
0034
 1   water?
 2                   THE WITNESS:  Sure.
 3                   MS. CARULAS:  Could we just take a
 4   quick break?
 5                   MR. KULWICKI:  Sure.
 6                   THE VIDEOGRAPHER:  Off the record at
 7   9:16.
 8                   (Recess taken, 9:16 a.m. to 9:18 a.m.)
 9                   THE VIDEOGRAPHER:  We're back on the
10   record at 9:18.
11   BY MR. KULWICKI:
12        Q.     Doctor, would you have used the a-fib
13   center registry for any purpose in the course of
14   your research, studies, or patient care?
15                   MS. CARULAS:  Objection.
16        A.     They would have provided data for
17   publication and the study.
18        Q.     Okay.  So you would have referenced that
19   database?
20        A.     I would have asked them for the data.  I
21   was not -- I didn't administer or do anything with
22   the database.  I would had to have asked them for
23   that data.
24        Q.     Who would you ask?  Who would you
25   approach?
0035
 1        A.     Either Dr. Natale or -- there was a
 2   nurse manager of it, Michelle Williams, I think is
 3   her name.
 4        Q.     And can you recall for us any specific
 5   instances where you approached either Nurse
 6   Williams, Dr. Natale or some other person associated
 7   with the a-fib center registry to collect
 8   information for a particular publication or study
 9   that you were working on?
10        A.     Don't recall specific instances, no.
11        Q.     During Dr. Kanj's deposition there was a
12   discussion about a Prucka System, and I wrote down a
13   spelling of it of P-R-U-C-A.  The court reporter
14   took down P-R-O-C-K-A.  Either way.  Are you
15   familiar with something called a Prucka System?
16        A.     Yes.
17        Q.     What is that?
18        A.     I believe it's P-R-U-C-K-A.  It's -- it
19   records electrical signals.  It's a -- we just call
20   it a recording system, electrical recording system.
21        Q.     Do you know what the acronym stands for?
22        A.     I believe it's a name.
23        Q.     Name of a physician maybe that came up
24   with it?
25        A.     Or the German company.  I think it's
0036
 1   just ...
 2        Q.     And was the Prucka System in operation
 3   or use at The Cleveland Clinic back in August of
 4   '06?
 5        A.     Yes.
 6        Q.     And what kind of information did it
 7   record?
 8        A.     Electrical signals.
 9        Q.     Electrical signals from electroanatomic
10   mapping or some other resource?
11        A.     No, from electrodes in catheters.  So --
12   so voltage measurements, things like that.
13        Q.     Okay.  Would it be something that would
14   be used while you're doing ablations to tell you
15   what the -- the wattage was at the electrode
16   surface?
17        A.     It displays it, but the generator does
18   that.
19        Q.     Okay.  Well, without me trying to play
20   20 questions here, tell me how the Prucka System was
21   used by in the clinic back in August of '06.  What
22   information was important for that system or how was
23   it useful to you?
24        A.     It displayed and recorded electrical
25   signals.  And in case of ablation, it would display
0037
 1   ablation parameters, so temperature, impedance,
 2   time.
 3                   MR. KULWICKI:  I was going to get to
 4   this later, but why don't I jump ahead to it.  I'm
 5   going to mark as Exhibit 2 what was marked as
 6   Exhibit 8 for Dr. Kanj's deposition.
 7                   (Deposition Exhibit No. 2 marked.)
 8   BY MR. KULWICKI:
 9        Q.     And it is portions of the procedural log
10   from Mr. Sullivan's August 17, 2006, procedure.
11   Several pages in there's something called an
12   ablation summary and it lists the time of the
13   ablation, the temperature, the power, and impedance.
14                   Would this be information, Doctor,
15   that would be provided by the Prucka System?
16        A.     That would be -- it would be input into
17   the Prucka System.
18        Q.     Okay.  And would the information that
19   the Prucka System records be kept anywhere?
20        A.     I believe it's backed up on a digital
21   disk or an optical disk or --
22        Q.     And if I were to look at that
23   information, what kind of information would it give
24   to me?
25        A.     It would give you something like this, I
0038
 1   think in a different format.  And it would give the
 2   electrical signals that we saw, or at least the ones
 3   that were recorded.
 4        Q.     The electrical symbol -- the
 5   electrical -- what did you say, symbols or --
 6        A.     Signals.  Signals.
 7        Q.     Signals.  I'm sorry.  The electrical
 8   signals from the heart?
 9        A.     Well, from -- there would be EKG leads,
10   so from the surface of the body, and then the
11   electrical signals from inside.
12        Q.     Do you think the clinic keeps that
13   information?
14        A.     I believe so, but I'm not positive.
15        Q.     Dr. Kanj told us that device
16   manufacturers' representatives would attend
17   procedures 20 to 30% of the time.  Was that your
18   experience as well?
19        A.     Overall procedures, yes.  For atrial
20   fibrillation, probably more.
21        Q.     Okay.  And back in August of 2006, was
22   there a particular device representative from any
23   particular catheter manufacturer or mapping system
24   manufacturer that would attend your procedures?
25        A.     I believe there was one in that
0039
 1   procedure.
 2        Q.     And he identified a Susan.  Is that the
 3   person?
 4        A.     Wouldn't have been a Susan.
 5        Q.     Okay.  Tell me who.
 6        A.     It would have been one of the St. Jude
 7   medical representatives.
 8        Q.     And what was his or her name?
 9        A.     I don't remember which one in
10   particular, but there were usually three.
11        Q.     And were they based out of the Cleveland
12   office for St. Jude or would they fly in from
13   somewhere else?
14        A.     They were usually from Cleveland.
15        Q.     And do you know if one was in attendance
16   during Mr. Sullivan's procedure?
17        A.     I believe one was, yes.
18        Q.     And how do you recall that?
19        A.     Can you clarify that statement?
20        Q.     Well, I didn't see it documented
21   anywhere.  Is it documented anywhere?
22        A.     No.
23        Q.     And how would you know that one was in
24   attendance at Mr. Sullivan's procedure?
25        A.     Most of my cases like that in which I
0040
 1   use the NavX mapping system, usually they would
 2   provide a person to operate the system.
 3        Q.     What part of the system would the device
 4   rep manufacturer -- or the device manufacturer rep
 5   operate?
 6        A.     The mapping system.
 7        Q.     Would they actually hold the mapping
 8   catheter?
 9        A.     No.  They're at a separate computer
10   console.
11        Q.     This person is not an M.D.; is that
12   correct?
13        A.     That's correct.
14        Q.     And would that be for the remote
15   navigation?
16        A.     No.
17        Q.     Would that be for the manual navigation?
18        A.     Yes.
19        Q.     And would that be using a particular
20   type of catheter, ThermoCool catheter?
21        A.     A particular type of ThermoCool.  It's
22   only -- only with the CELSIUS-type.
23        Q.     And in terms of that person, their
24   involvement, would they be at a monitor reviewing
25   3-D images of the procedure as it proceeds?
0041
 1        A.     Yes.  They would be at a separate
 2   computer console that displays their mapping system.
 3        Q.     And how would they be involved in the
 4   procedure?  What would they be doing?
 5        A.     They would be assisting in the
 6   generation of the geometry.  And so sort of turning
 7   the system on, when we move the catheter about, it
 8   records the locations where the catheters were, and
 9   so they determine when the catheter -- they push the
10   button that tells you when the catheter collects
11   this, and then they push the button that -- when it
12   stops collecting.  And during the case, they would
13   rotate the image based on where you -- which -- the
14   way you tell them to rotate it.
15        Q.     Would there then be a monitor that you
16   would be looking at that would display the image
17   that they were --
18        A.     Yes.  It's --
19        Q.     -- changing?
20        A.     It's enslaved from that system to -- to
21   one of our monitors on the bedside.
22        Q.     Would part of the role be to correlate
23   images from different sources with one another; in
24   other words, using a CT image and then overlaying
25   some sort of electroanatomical image over the CT
0042
 1   during the course of the procedure?
 2        A.     I'm not sure that was available on their
 3   system at the time.
 4        Q.     Okay.  What sort of images would they be
 5   correlating during the procedure?
 6        A.     Only the -- the map.
 7        Q.     Okay.  And tell me, again, the name of
 8   the map that they would be --
 9        A.     Their --
10        Q.     -- looking at.
11        A.     Their system is called NavX.
12        Q.     And is NavX a -- an ultrasonographic
13   image or --
14        A.     No.  It's --
15        Q.     How --
16        A.     Electroanatomic is what we call it.
17        Q.     Is there any documentation that would
18   tell us who that individual was during
19   Mr. Sullivan's procedure?
20        A.     Not from our records.
21        Q.     Are the NavX images kept by the clinic
22   or by St. Jude?
23        A.     Only if requested.
24        Q.     And under what circumstances would you
25   request that they be kept?
0043
 1        A.     If the physician wanted that image for
 2   any reason.
 3        Q.     Besides you, the NavX rep, or the St.
 4   Jude rep, and Dr. Kanj, I understand there would be
 5   a number of nurses in the EP lab during a procedure
 6   like Mr. Sullivan's, correct?
 7        A.     Yes, usually two or three.
 8        Q.     Okay.  And besides the nurses and you
 9   and the fellow and the representative, any other
10   people that would usually be present?
11        A.     Not routinely.  Occasionally an engineer
12   would come in.
13        Q.     And do you have any recollection of an
14   engineer being present during Mr. Sullivan's
15   procedure?
16        A.     Not specifically, no.
17        Q.     In terms of your practices back in
18   August of 2006, was it your practice to report
19   complications from devices to MAUDE?
20                   MS. CARULAS:  Objection.
21        A.     If I thought it was device related.
22   BY MR. KULWICKI:
23        Q.     Okay.  And that's a voluntary reporting
24   requirement?
25                   MS. CARULAS:  A continuing line of
0044
 1   objection.  Go ahead.
 2        A.     I'm actually not sure.
 3   BY MR. KULWICKI:
 4        Q.     Okay.  Would you -- was it your practice
 5   in August of 2006 to report complications to JCAHO?
 6                   MS. CARULAS:  Objection.
 7        A.     My practice would to be report them to
 8   the clinic.
 9   BY MR. KULWICKI:
10        Q.     And who would you report to at the
11   clinic?
12                   MS. CARULAS:  Objection.
13        A.     Usually the nurse lab manager and the
14   director of electrophysiology, if it was a
15   lab-related complication.
16                   MR. MARGOLIS:  If it was what?  I'm
17   sorry.
18                   THE WITNESS:  A lab-related
19   complication.
20                   MR. MARGOLIS:  Thank you.
21   BY MR. KULWICKI:
22        Q.     And who was the director of EP back in
23   August of 2006?
24        A.     I believe it was Dr. Natale at that
25   time.
0045
 1        Q.     And who was the nurse lab manager back
 2   in August 2006?
 3        A.     I believe Barb Thomas.
 4        Q.     And in what format would you report a
 5   complication to Dr. Natale and Barb Thomas?
 6        A.     Verbally.
 7        Q.     And what kind of information would you
 8   give them?
 9        A.     Well, they would have all the medical
10   record type of information.  I would just tell them
11   what the complication was, what actions were taken.
12        Q.     Would they keep records of those
13   complications?
14        A.     I don't believe Dr. Natale did.  I
15   believe the lab puts it in some sort database, but
16   I'm not sure on that.
17        Q.     And this is outside the context of an
18   M&M conference, correct?
19                   MS. CARULAS:  Objection.
20        A.     I believe so.  I'm not sure how they do
21   it.
22   BY MR. KULWICKI:
23        Q.     What would be the purpose of reporting
24   to the lab nurse manager?
25        A.     So they can have it for their data
0046
 1   for -- and -- for whatever purposes they use it for.
 2        Q.     Do you know what purpose they use it
 3   for?
 4        A.     I suppose for reporting to
 5   administration and if other entities come by and
 6   need to know that information.
 7        Q.     When you reported -- oh, strike that.
 8   Would you also -- strike that.
 9                   When you would report a complication
10   to, say, the nurse manager or Dr. Natale as the head
11   of the EP lab, would you typically do that as soon
12   as reasonably possible after learning of the
13   complication?
14        A.     Yes.
15        Q.     And do you think you likely did that
16   relative to Mr. Sullivan?
17        A.     Yes.
18        Q.     Do you -- did you report complications
19   to device manufacturers back in August of '06?
20                   MS. CARULAS:  Objection, asked and
21   answered.  Go ahead.
22        A.     Only if I thought it was related to the
23   device.
24   BY MR. KULWICKI:
25        Q.     And do you recall making any reports
0047
 1   relative to Mr. Sullivan's complication to MAUDE or
 2   to any device manufacturer?
 3                   MS. CARULAS:  Objection.
 4        A.     No.
 5   BY MR. KULWICKI:
 6        Q.     I take you didn't feel that it was
 7   device related?
 8        A.     Correct.
 9        Q.     Okay.  What do you think the cause of
10   his complication was?
11        A.     Can't say for certain other than he had
12   atrial fibrillation and developed a stroke
13   afterwards.
14        Q.     And why would you conclude that it was
15   not device related?
16        A.     The timing would be one.  In that sense
17   it wasn't during the physical procedure itself is
18   one -- would be one of the main ones, and we didn't
19   see any gross device malfunction during the case.
20        Q.     Was it your understanding in August of
21   2006 that in order for something to be reported to
22   MAUDE or to be reported to a device manufacturer a
23   complication that it would have to be deemed device
24   related, and by that, it would mean that the device
25   had malfunctioned in some respect?
0048
 1                   MS. CARULAS:  Objection.
 2        A.     Well, in general, I would report all
 3   complications to The Cleveland Clinic and -- and
 4   they would report it as they thought necessary.
 5   BY MR. KULWICKI:
 6        Q.     Would you ever directly report
 7   complications from procedures to MAUDE or to the
 8   device manufacturer or would that be something that
 9   would be done by the clinic after you reported the
10   complication to, say, the nurse manager or the EP
11   lab director?
12        A.     Yes.
13                   MS. CARULAS:  Objection.
14        A.     I've never reported to MAUDE directly.
15   BY MR. KULWICKI:
16        Q.     In August of 2006, were you aware of the
17   Innovative Practices Committee?
18        A.     No.
19        Q.     And so I take it that you never
20   registered any off-label uses of ablation catheters
21   with the Innovation -- Innovative Practice
22   Committee, correct?
23        A.     I personally did not.
24        Q.     I'm going to hand you what I'll mark as
25   Exhibit 3.
0049
 1                   (Deposition Exhibit No. 3 marked.)
 2   BY MR. KULWICKI:
 3        Q.     And this is the Heart and Rhythm Society
 4   Expert Consensus Statement on Catheter and Surgical
 5   Ablation of Atrial Fibrillation.  It is a, roughly,
 6   34-page document.
 7                   Are you familiar with this consensus
 8   statement, Doctor?
 9        A.     I've seen it before.
10        Q.     One of the task force members on that
11   statement was Dr. Natale, correct?
12        A.     Yes.
13        Q.     And in terms of you have seen that
14   before, tell me in what context you would have seen
15   that publication.
16        A.     I've seen it presented at conferences
17   and -- and in publication before.
18        Q.     Can we agree that the consensus
19   statement is endorsed and approved by the American
20   College of Cardiology and the American Heart
21   Association and the Heart Rhythm Society?
22        A.     Well, at least the Heart Rhythm Society
23   on this document.
24        Q.     I think if you'll flip through you'll
25   see where it says it's endorsed and approved by the
0050
 1   others, pretty much highlighted that in there.
 2                   Are you a member of the American
 3   College of Cardiology, American Heart Association,
 4   and the Heart and Rhythm Society?
 5        A.     I'm a fellow of the American College of
 6   Cardiology and of the Heart and Rhythm Society.
 7        Q.     Okay.  Would you agree that catheter
 8   ablation for atrial fibrillation was undergoing
 9   rapid evolution before publication of that consensus
10   statement in 2007?
11        A.     Can I have a second to review this?
12                   MR. KULWICKI:  Oh, sure.  We can go
13   off the record.
14                   THE VIDEOGRAPHER:  Off the record at
15   9:40.
16                   (Recess taken, 9:40 a.m. to 9:41 a.m.)
17                   THE VIDEOGRAPHER:  We're back on the
18   record at 9:41.
19   BY MR. KULWICKI:
20        Q.     Okay.  Doctor, you asked for the
21   opportunity to review the consensus statement that I
22   marked as Exhibit 3.  What -- what were you looking
23   for or was there some particular reason why you
24   wanted to look through it?
25        A.     I was just looking for other references
0051
 1   to the American College, and I couldn't find any
 2   other than on the first page.
 3        Q.     Okay.  In terms of the catheter ablation
 4   for atrial fibrillation in August of 2006, can we
 5   agree that the procedure required off-label use of
 6   catheters?
 7        A.     I think that's somewhat difficult to
 8   answer actually, because catheters are approved for
 9   ablation and -- and so the labelling is not always
10   clear on the utilization of the catheters.
11        Q.     Were any catheters approved by the FDA
12   in August 2006 as safe and effective for atrial
13   fibrillation ablation?
14        A.     For ablation, but not necessarily atrial
15   fibrillation as a specific entity.
16        Q.     Okay.  In terms of the ThermoCool
17   catheter, that was approved for use in an invest --
18   as an investigational device as of August 2006 for
19   treatment of paroxysmal a-fib, true?
20        A.     As an investigational device?
21        Q.     Yes.
22        A.     I'm not sure of the timeline, so that --
23   that was actually approved before that for -- yeah.
24   It was originally an investigational device for
25   ventricular tachycardia --
0052
 1        Q.     Right.
 2        A.     -- and then approved for ablation.  And
 3   I'm not sure about when it started the IDE for
 4   a-fib.
 5        Q.     Okay.  And just to sort of button it up,
 6   are you aware of any catheter that was approved for
 7   a-fib ablation by the FDA in August 2006?
 8        A.     No, I don't believe there was anything
 9   at the time approved for atrial fibrillation
10   ablation.
11        Q.     If you would, turn to page 337.  There
12   are definitions of paroxysmal and persistent a-fib.
13   Tell me if you agree with those or not.  Right-hand
14   column.
15        A.     Somewhat agree.
16        Q.     Okay.  Tell me how you disagree.
17        A.     The -- the term paroxysmal -- and so in
18   general I would use it as any self-terminating
19   episode and so not necessarily what the --
20   spontaneously within seven days.  Persistent, I
21   usually refer to as something that needs some sort
22   of intervention.  And then permanent is not used
23   very often anymore.  And in general I wouldn't call
24   something permanent which hasn't been attempted
25   cardioversion.  I would say we don't know.
0053
 1        Q.     In terms of the term long-standing,
 2   persistent --
 3        A.     Yes.
 4        Q.     -- a-fib, do you use that term?
 5        A.     On occasion, yes.
 6        Q.     And what do you use that term to mean?
 7        A.     Just someone who's been in a-fib for a
 8   longer period of time.  Somewhat nebulous, but
 9   that's basically it.
10        Q.     Okay.  Would you --
11        A.     That hasn't self-terminated.
12        Q.     Would you consider a-fib that has
13   persisted for longer than 48 hours to be
14   long-standing?
15        A.     No.  I usually would call it longer than
16   that.
17        Q.     Okay.  Can you give me some idea about
18   what you would consider to be within the realm of
19   long-standing, persistent a-fib?
20        A.     It -- it sort of depends on what has
21   been attempted in the patient.  And so if they -- if
22   nothing has been attempted, I would usually just
23   call it persistent a-fib.  And if something has been
24   attempted but not worked, then I would put it more
25   in the long-standing, persistent category.
0054
 1        Q.     In terms of Mr. Sullivan's a-fib, he had
 2   been treated with various medications and attempted
 3   cardioversion during the six-month period leading up
 4   to the surgery in August of 2006.  Would you
 5   consider his to be long-standing, persistent a-fib?
 6        A.     Yes.
 7        Q.     Okay.  On page 342 of Exhibit 3, there
 8   is a discussion in the lower left-hand corner,
 9   highlighted, and it talks about hypothetical reasons
10   for a-fib ablation.  And what -- take -- take your
11   time to familiarize yourself with it.
12                   What do you take that to mean,
13   hypothetical reasons for a-fib ablation?
14        A.     I would say that potential ben -- I
15   would try to say that it equates to potential
16   benefits.
17        Q.     And would you agree with the
18   characterization of the reasons or the potential
19   benefits as being hypothetical back in 2007?
20                   MS. CARULAS:  Objection.  Go ahead.
21        A.     No.  I wouldn't say necessarily
22   hypothetical.  I would say a potential benefit.  So
23   like you're not guaranteed --
24                   (Cell phone interruption.)
25                   THE WITNESS:  Sorry.  I'll take
0055
 1   this.
 2                   MR. KULWICKI:  We can go off the
 3   record.
 4                   THE VIDEOGRAPHER:  Off the record at
 5   9:48.
 6                   (Recess taken, 9:48 a.m. to 9:49 a.m.)
 7                   THE VIDEOGRAPHER:  We're back on the
 8   record at 9:49.
 9   BY MR. KULWICKI:
10        Q.     In that highlighted section on page 342
11   there's a discussion about a-fib ablation improving
12   quality of life for patients.  Can we agree that it
13   only improves quality of life if it is successful?
14                   MS. CARULAS:  Objection.
15        A.     No.  There are some gradations in there
16   and where it may not be completely successful and
17   yet quality of life is improved.  And there's even
18   some data where there appears to be some other
19   unknown benefit in quality of life.
20   BY MR. KULWICKI:
21        Q.     Can we agree that rate control alone is
22   effective in allowing people to live productive and
23   decent lifestyles?
24        A.     Not in every person, no.
25        Q.     Would you agree that it was unproven in
0056
 1   2007 whether a-fib ablation decreased the risk of
 2   stroke or improved survival over rate or rhythm
 3   control?
 4        A.     In 2007?
 5        Q.     Yes.
 6        A.     I would say it was unknown.  Unknown.
 7        Q.     Okay.  Back in 2007 a-fib ablation was
 8   not considered a first-line treatment, true?
 9        A.     That is true.
10        Q.     Is that the same today?
11        A.     I would say, yes.
12        Q.     And why is that?
13        A.     I would say it's based on
14   recommendations and there's some data suggesting
15   that it should be first line in some populations.
16   But I would say in general, that's just based on
17   routine.
18        Q.     And in what populations do you refer to?
19        A.     Can you be more specific?
20        Q.     Well, you said in some populations that
21   it -- there's some data to suggest that it should be
22   used as first line.  Is that paroxysmal?
23        A.     That -- it's -- I think it's best
24   studied in paroxysmal, but I think there is even
25   some other data in nonparoxysmal patients.
0057
 1        Q.     On page 343 of Exhibit 3 there is a
 2   discussion about a-fib ablation that should be used
 3   only with little or no left atrial enlargement.
 4                   Do you agree with that, first of
 5   all?
 6        A.     No.
 7        Q.     Okay.  You used it in 2007 or before in
 8   patients who had left atrial enlargement?
 9        A.     Yes.
10        Q.     And what -- is there any risk associated
11   with using it with patients who have left atrial
12   enlargement?
13                   MS. CARULAS:  Objection.
14        A.     The -- the success rate in significant
15   left atrial enlargement appears to be lower.
16   BY MR. KULWICKI:
17        Q.     And would mild left atrial enlargement
18   be enough to change the success rate associated with
19   a-fib ablation?
20        A.     Not much.  It doesn't appear to be.
21        Q.     On page 343 the task force describes the
22   procedure as being a demanding, technical procedure.
23                   Do you agree with that?
24        A.     Yes.
25        Q.     And what does that mean?
0058
 1        A.     It would mean that it's not easy to
 2   perform.
 3        Q.     And would you agree that it requires
 4   more technical skill than other ablation procedures?
 5        A.     Than some other ablation procedures, not
 6   all.
 7        Q.     And would you agree that patients with
 8   a-fib are less amenable to cure with ablation than
 9   regular forms of SVT and VT?
10        A.     I wouldn't agree with VT.  With SVTs
11   are, in general, considered higher success rates.
12        Q.     Set that aside -- set that article aside
13   for a second.  I'm going to come back to it.  But
14   let me turn to Shannon Sullivan for a moment.
15                   Do you recall Mr. Sullivan such that
16   you could describe him?
17        A.     Yes.
18        Q.     And describe him.
19        A.     Went and met him in the office.  He's a
20   handsome man.  Taller than me.  And I'd say he had a
21   sort of moderate athletic build.
22        Q.     And I assume you've done a lot of
23   in-office visits with patients.  How would you
24   remember Mr. Sullivan as opposed to many other
25   patients that you've had?
0059
 1        A.     I remember him -- you know, there were
 2   some distinctive things about him.  He was from
 3   Hawaii, in which I've only had a couple of patients
 4   who were from Hawaii.  And I remember we talked
 5   about bicycling, which is one of my interests, so...
 6        Q.     Do you remember if anyone was with him
 7   during your in-office encounter with him?
 8        A.     His wife was.
 9        Q.     And can you describe her.
10        A.     She was shorter than me and appeared to
11   be of Asian decent.
12        Q.     Back in August of 2006, let me ask about
13   your practice with respect -- respect to scheduling
14   out-of-state patients with a-fib ablation.  Let's
15   talk about that process.
16                   First of all, were you involved in
17   setting up that process in terms of, you know,
18   patient gets Cleveland Clinic's number from a
19   website or from the phone directory or from a doctor
20   and then they call in and then they talk to somebody
21   and then there's sort of a process that goes on from
22   there?  Would you be in -- would you have been
23   involved in setting up that process?
24        A.     For -- for a visit, no, I wouldn't have
25   been involved in anything.
0060
 1        Q.     Do you have an understanding, going back
 2   to August of 2006, as to how that process would go
 3   forward to the point where you have a visit with the
 4   patient?
 5        A.     So there's several methods that a
 6   patient can come in.  They can call -- sometimes
 7   they call a secretary directly.  There's several
 8   different scheduling numbers they can call.  There's
 9   like a 1-800 Cleveland Clinic number.  There's
10   numbers from the website.  There's a physician
11   referral number.  There's also -- there's several
12   methods.
13        Q.     In terms of when patients call the
14   number on the website, do you know what would happen
15   with those patients or who they'd talk to and what
16   sort of information they would be provided?
17        A.     Really depends on what number they call.
18        Q.     Once they call into the number and
19   connect with someone, what happens, generally
20   speaking, between that initial phone call and their
21   original meeting with you?
22        A.     If it's -- if it's simply for a visit,
23   they would -- sometimes over the phone and sometimes
24   via mail, they would receive a --
25                   (Cell phone interruption.)
0061
 1                   THE WITNESS:  Sorry.  Take this.
 2                   MR. KULWICKI:  Go off the record.
 3                   THE VIDEOGRAPHER:  Off the record at
 4   9:56.
 5                   (Recess taken, 9:56 a.m. to
 6   10:00 a.m.)
 7                   THE VIDEOGRAPHER:  We're back on the
 8   record at 10:00 a.m.
 9   BY MR. KULWICKI:
10        Q.     Doctor, before the break we were talking
11   about the process that takes place between a
12   patient -- an out-of-state patient's initial contact
13   with the clinic and your first visit.  And I'd like
14   to understand as much of that as I can from you,
15   understanding that you weren't involved in setting
16   that up, but can you tell us what sort of was
17   supposed to take place during that period of time.
18        A.     So if it -- if it's just for a simple
19   visit, then they would contact the clinic in one way
20   or another.  They would be contacted back or
21   responded to immediately about a potential date and
22   time of the visit.  And usually via mail, they would
23   receive a schedule of if there's any testing, things
24   like that that need to go along.
25        Q.     Okay.  Now, in terms of them getting
0062
 1   contacted back, would that be done by a nurse or
 2   some other staff other than a physician?
 3        A.     Yes.  A lot of it's in fact automated, I
 4   believe.
 5        Q.     And in terms of a situation like this
 6   where a patient has the initial visit followed by
 7   surgery --
 8        A.     Uh-huh.
 9        Q.     -- what sort of information would be
10   communicated during that same time period between
11   their initial contact and the first visit in a
12   situation like this?
13        A.     Well, that's a little different in that
14   you can't schedule surgery as an outpatient
15   without -- without a permission.  So that -- that
16   would have come to a physician.
17        Q.     Okay.  And in a situation like this
18   where you're doing a procedure for Mr. Sullivan,
19   would you be the physician who would be giving
20   permission for the outpatient procedure?
21        A.     Yes.
22        Q.     And tell me what information you would
23   have solicited from either the patient or his
24   physician prior to the office visit in order to give
25   permission to schedule an office visit plus a
0063
 1   procedure on the next day?
 2        A.     So in most cases, I wouldn't do that,
 3   only if the patient requested.  So, in general, I
 4   would have a visit first and then do the scheduling
 5   after the visit, because a lot of people actually
 6   cancel the procedure.
 7                   So in this case, Mr. Sullivan
 8   requested what we call a one-trip visit.  And so in
 9   order to do that -- and I wouldn't do that even for
10   people who were local.  So it would be for someone
11   who's from out of state, far away.
12                   And in order to do that, I would
13   have to go through several things.  And so I would
14   have to get medical records, which would include
15   things like if there have been any stress tests, any
16   procedures, what medicines they've been on before,
17   and their medical history.  And the other thing is I
18   request that my atrial fibrillation -- in this case,
19   atrial fibrillation nurse would go over things like
20   the success rate, risks and benefits of the
21   procedure before showing up.
22        Q.     Via phone?
23        A.     Yes.
24        Q.     Okay.
25        A.     And sometimes I would mail them some
0064
 1   things in addition.
 2        Q.     And who was your atrial fibrillation
 3   nurse back in August of two thousand -- or back in
 4   2006 between the time of Mr. Sullivan's first
 5   contact in January of '06 and the surgery in
 6   August of '06?
 7        A.     Stacy Poe.
 8        Q.     Okay.  Have you talked to Stacy Poe
 9   about this particular lawsuit?
10        A.     No.
11        Q.     Have you had any communication with her
12   since you left The Cleveland Clinic?
13        A.     Actually I think I called once to the --
14   to the outpatient department and she answered the
15   phone.
16        Q.     Okay.  So it was just happenstance?
17        A.     Yes.
18        Q.     Did you review her depo in preparation
19   for today's deposition?
20        A.     I did not.
21        Q.     Did you train Stacy Poe in terms of what
22   to discuss with the patient in a situation like this
23   where it's a one-trip visit where the patient is
24   going to come in for the initial visit with you,
25   followed by the procedure?
0065
 1        A.     Yes.
 2        Q.     And tell me what you would have trained
 3   her to cover.
 4        A.     In terms of the risks and benefits --
 5        Q.     You tell me.
 6        A.     -- or --
 7        Q.     What all would she be trained to do in
 8   terms of that telephone conversation?
 9        A.     That's a very exhaustive list.
10        Q.     Okay.
11        A.     Very detailed.
12        Q.     Well, let me -- let me stop you there,
13   then, before we get into it.
14                   Is there any documentation in terms
15   of -- I would call it a cheat sheet, but some sort
16   of list of information that she's supposed to cover
17   in a situation like this where the patient is
18   scheduled for a one-trip visit?
19        A.     I'm unaware of any documentation right
20   now.
21        Q.     Well, did you prepare anything to her, a
22   letter or a memo or anything?
23        A.     Not -- nothing written, no.
24        Q.     How do you know, because it's an
25   exhaustive -- as you call it, exhaustive list of
0066
 1   information covered, that she would get everything
 2   covered in something important like this where a
 3   one-trip visit is being planned?
 4        A.     Because she does it every day.  And so
 5   it's a -- most of it is the things we actually cover
 6   during the visit, and so that's something she would
 7   do 15, 20 times a day.  And so instead of covering
 8   it face-to-face, she would do it on the phone.
 9        Q.     How many one-trip visits did you have
10   back in 2006 for a-fib ablation?
11        A.     It was probably less than ten.
12        Q.     A year?
13        A.     In 2006, yeah.
14        Q.     Okay.  Then why would she be having this
15   conversation several times a day?
16        A.     Because it's the same -- the things I'd
17   asked her to cover on the phone are the same that
18   she covers in the clinic physically.
19        Q.     I see.  Is there any record, to your
20   knowledge, of this phone conversation between Nurse
21   Poe and an out-of-state patient like Mr. Sullivan
22   relative to what's covered for a one-trip visit?
23        A.     I believe there's just a notation
24   annotating the phone call.
25        Q.     And tell me, if you would, what's
0067
 1   covered by her, what she's supposed to cover in that
 2   telephone conference where she's scheduling a
 3   one-trip visit.
 4        A.     It's a lot of things.  It's -- it would
 5   include sort of the time of day you would come in,
 6   preprocedure testing, risks and benefits, how long
 7   the procedure may take, what you would expect after
 8   the procedure, anticipation of discharge, things you
 9   should bring with you, clothes, things like that,
10   and what follow-up would be.
11        Q.     Okay.  Would she discuss -- or did you
12   train her to discuss in this telephone conversation
13   anything with respect to the personnel that would be
14   involved in the procedure?
15        A.     Yes.  She would usually discuss that.
16        Q.     And tell me what kind of information she
17   would be trained to talk about.
18        A.     She would usually tell people that there
19   would be many -- or several people in the room at
20   the time of the procedure, nurses, other physicians.
21        Q.     Anything else you can think of regarding
22   personnel?
23        A.     No.
24        Q.     In terms of risk and benefits, what
25   would she be trained to cover in that respect?
0068
 1        A.     So she would cover the estimated success
 2   rate.  She would cover the most common
 3   complications, so stroke, bleeding, pulmonary vein
 4   stenosis, things like death, damage to the other
 5   structures in and around the heart, potential need
 6   for a pacemaker, things like that.
 7        Q.     Would she be trained to cover with the
 8   patient anything that discussed the experimental
 9   nature of the procedure or the fact that devices
10   involved in the procedure were the subject of
11   research studies -- ongoing research studies or the
12   fact that different aspects of the procedure
13   including mapping, anticoagulation, navigation,
14   types of catheters and the like were all -- had not
15   been established as the standard of care by virtue
16   of any long-term research studies?
17                   MS. CARULAS:  Objection.
18        A.     Can you narrow that down into a single
19   question?
20   BY MR. KULWICKI:
21        Q.     Sure.  Well, let's take it -- in terms
22   of risks and benefits of the procedure, what would
23   you train her to discuss with the patient in this
24   telephone conference that we're talking about; just
25   what you covered?
0069
 1        A.     Yes.
 2        Q.     Okay.  In terms of benefits, what would
 3   you have trained her specifically to discuss about
 4   expected benefits of the procedure in this telephone
 5   conference?
 6        A.     Mainly the anticipated -- or potential
 7   success rate.
 8        Q.     Which were in 2006?
 9        A.     It varied depending on the type of
10   patient and the risks, but, in general, we would say
11   60 to 80%.
12        Q.     And would she know what type of mapping
13   system or catheter or anticoagulation protocol would
14   be used for the procedure?
15        A.     Anticoagulation before the procedure she
16   would know.  And she would usually just say we will
17   make your blood thin during the procedure, but she
18   wouldn't go into more detail than that.
19        Q.     I didn't hear you.
20        A.     She would -- she would say we will make
21   your blood thin during the procedure, but would not
22   likely go into more detail than that.
23        Q.     And in terms of the mapping system and
24   the type of navigation system and the catheter,
25   would she know anything about that or be able to
0070
 1   relay that to the patient?
 2        A.     She would give an overview of how the
 3   procedure's done in terms of several catheters going
 4   into the body and one catheter ablates the tissue
 5   and one catheter looked -- takes pictures of the
 6   heart in that.
 7        Q.     If I hear you correctly, she would give
 8   kind of a general overview, maybe a laymen's -- a
 9   laymen's understanding of how the procedure's done,
10   but she wouldn't tell the patient specifically
11   whether it would be, say, a close-tip or open-tip
12   catheter, correct?
13        A.     Correct.
14        Q.     She wouldn't tell the patient whether it
15   was going to be remote navigation or a manual
16   navigation, true?
17        A.     Correct.
18        Q.     And she wouldn't know what kind of
19   mapping system would be used in the procedure, true?
20        A.     She may not say a specific mapping
21   system, but she may say a mapping system.
22        Q.     Now --
23                   (Comments off the record.)
24   BY MR. KULWICKI:
25        Q.     So your first meeting with Mr. Sullivan
0071
 1   was the day before the procedure, correct?
 2        A.     Correct.
 3        Q.     And you would not have had any telephone
 4   conversations with him prior to that date, true?
 5        A.     No, Stacy would.
 6        Q.     And no other physician at the clinic
 7   would have spoke within him prior to that meeting
 8   that you had with him the day before the procedure,
 9   true?
10        A.     I don't know.  I don't know if anyone
11   else talked to him, but I'm unaware.
12        Q.     At the time of your initial visit with
13   him, he was already scheduled for surgery, correct?
14        A.     He was given a potential time for
15   surgery, yes.
16        Q.     Do you recall the meeting that you had
17   with him?
18        A.     Yes.
19        Q.     And why don't you tell us what happened
20   during that meeting.
21        A.     That would be kind of a long discourse.
22   Can you --
23        Q.     Okay.  Well, it's my understanding that
24   on that particular day you had two procedures
25   scheduled, true?
0072
 1        A.     I'm unsure about that.
 2        Q.     All right.  We can go back through the
 3   records.  But would it be typical for you to
 4   schedule a couple of procedures on a day that you're
 5   meeting with a patient for a one-trip visit preop
 6   meeting?
 7        A.     Sometimes.  I'm not sure there would be
 8   a typical on that.
 9        Q.     If you had two procedures scheduled for
10   a particular day, that's -- that's a busy day for
11   you, true?
12        A.     Depends on the procedures.
13        Q.     How about two ablation -- AF ablation
14   procedures?
15        A.     Yes, that's a -- that would be a
16   moderate day.
17        Q.     Those procedures take about five hours
18   each, correct?
19        A.     The total procedure time is around
20   five hours.  The ablation time in general, two.  Can
21   be anywhere between sort of one and a half to two to
22   three.
23        Q.     As an attending, how much of the
24   five hours and how much of the two hours would you
25   typically be present?
0073
 1        A.     So for the actual ablation time, for all
 2   of it.
 3        Q.     Okay.  And how about the procedure time,
 4   the five-hour procedure time?
 5        A.     So -- so for the -- I'd usually be in
 6   when the patient gets in the room.  But while
 7   they're scrubbing and putting all the electrodes and
 8   things like that on, I wouldn't be in for any of
 9   that.  And then there's probably another hour to two
10   basically after the procedure's done where they're
11   pulling those things off and transferring, I
12   wouldn't be -- usually wouldn't be there for that.
13        Q.     Tell me what you would have discussed
14   with the patient in terms of the informed consent
15   discussion.
16        A.     So it would have been -- basically it
17   would have been done three times.  And so Stacy, in
18   this case, would have talked to -- got the informed
19   consent over the phone.  Stacy would have done
20   basically the same thing again before -- before I
21   did my final meeting, and then I would have come in
22   and gone over it yet again.
23        Q.     And tell me in as great of detail as you
24   can from your recollection of this meeting with the
25   Sullivans as to what you would have discussed with
0074
 1   them.
 2                   If you want to take it one at a time
 3   risks, benefits --
 4        A.     Okay.
 5        Q.     -- alternatives, whatever else you --
 6        A.     Sure.
 7        Q.     -- would do as part of -- I want to
 8   cover everything that you recall about informed
 9   consent.
10                   MS. CARULAS:  This is not an
11   objection, but as best as you can replicate.
12                   THE WITNESS:  Okay.
13        A.     So, in general, the first thing I would
14   do is enter --
15   BY MR. KULWICKI:
16        Q.     Let me -- let me just stop you for a
17   second, because you started off with in general.
18   What I want to know is if you have a specific
19   recollection of what you talked about with the
20   Sullivans or if you are going from what you
21   generally would do in terms of your custom and
22   practice.  So why don't we start with that as a
23   question.
24                   What -- do you have a specific
25   recollection or are you going from the way you
0075
 1   did --
 2        A.     Okay.
 3        Q.     -- things back then?
 4        A.     Well, I'll go specifically with the
 5   Sullivans.
 6        Q.     Okay.  Let's talk about that.
 7        A.     So I believe I actually met them in the
 8   morning originally and discussed that I had some
 9   information, laboratory and things like that, and
10   said we would need to get a census, INR was low, you
11   need to get an imaging study on him, and -- and that
12   we would talk more in detail later.  And they happen
13   to have an opening for -- for an imaging study and
14   so he went directly to that testing.
15                   Then later I saw them in the
16   afternoon and reintroduced myself.  I had reviewed
17   his history and paperwork and testing once again.
18   And this is after Stacy had been with them again.  I
19   talked about how does a-fib affect you.  And he told
20   me that -- the main thing I remember was that he
21   cycled with his friends in Hawaii and didn't feel
22   like he was keeping up as usual.  I reviewed his
23   history with him, discussed the cardioversion, the
24   medications he had been on, and then went into the
25   procedural details and said that Stacy has talked to
0076
 1   you about this.
 2                   I have a sheet of paper that's a --
 3   it's blue and it -- I think it says electrical
 4   anatomy of the heart.  And I usually -- I take that
 5   in with me.  And what I do is I say you have -- and
 6   him.  What I said was, you've done the things that
 7   you should do and so your heart rate -- you're on
 8   the medicines for heart rate, you've tried an
 9   antiarrhythmic medicine, and you're -- these haven't
10   been very successful and you still have symptoms.
11   And I said the other options include surgery.  And
12   usually surgery's recommended if you need surgery --
13   open-chest surgery for another reason, in particular
14   that would be the way to go.  I guess that he'd
15   already tried antiarrhythmic medicines, and any
16   other option would be catheter ablation procedure.
17                   After that, I would say the success
18   rate in -- and I would give him the estimated
19   success rate.  So I usually go with the good first.
20   And in him having -- I would say the good and bad
21   things going for and against you.  And I would say
22   the things going for you is that your atrium is a
23   little bit enlarged, but not massively enlarged.
24   You don't appear -- doesn't appear to have other
25   significant structural heart disease.  I said --
0077
 1   and -- but the things going against you are that
 2   you're in this more permanent type of atrial
 3   fibrillation.  These other things haven't been
 4   successful.  And so I would say, you know, in a
 5   patient like that, usually the estimated success
 6   first -- after our first ablation attempt would be
 7   around 60%.  After one or more repeated ablations,
 8   that may get up to around 80%.  And then I would say
 9   that some people don't want another -- some people
10   even though not successful are improved and don't
11   want necessarily another ablation or controlled on
12   medicines that were previously ineffective.
13                   Then I would talk about the risks.
14   And the first thing I usually talk about is stroke,
15   and that would be around 1 to 2% at the time.  I
16   would talk about the risk of bleeding, which is
17   usually the thing I say is No. 2, and I would
18   usually say it's up around 10%, and that can include
19   something as little as needing some extra pressure
20   held on the side up to getting a blood collection, a
21   hematoma, all the way up to needing a surgeon to
22   repair a hole in an artery or a vein.
23                   I would say that there's a risk of
24   damaging things in and around the heart, perforating
25   the heart, puncturing the heart, usually less than
0078
 1   1%.  Then I'd talk about using anesthesia with the
 2   procedure a little bit.  And there's a risk just
 3   with any anesthesia of heart attack, stroke, or
 4   death.  Once again, usually 1% or less.
 5                   Risk of pulmonary vein stenosis,
 6   usually around 2 to 4%.  That's the vein becoming
 7   clogged up with scar tissue.  And I would say
 8   sometimes that's potentially treatable with a
 9   balloon procedure, if that occurs, and that would be
10   part of the follow-up procedure.  And infection,
11   usually less than 1%.  And I would say there's other
12   things that we don't necessarily know that can
13   potentially happen on a regular basis.
14        Q.     Continuing with this initial meeting
15   with the patient, can you tell us -- you've talked
16   about benefits -- or expected benefits, risks.  Tell
17   us what you would have discussed with the Sullivans,
18   what else would you have discussed with them in the
19   course of this meeting.
20        A.     I would usually give them that sheet of
21   paper that had a lot of this written down.  Some
22   people keep it.  Some people throw it away whenever
23   they leave.  I would have discussed a little bit
24   about the anticoagulation.  And I talked about who
25   was following his Coumadin and that he was
0079
 1   subtherapeutic and that we would need to increase
 2   his Coumadin dose and also give him injections with
 3   that.  And -- and then I would have answered any
 4   questions he had with the procedure.
 5        Q.     In terms of scheduling this afternoon
 6   meeting where you had this more detailed
 7   discussion --
 8        A.     Yes.
 9        Q.     -- would that have typically -- or would
10   that have taken place between two -- the two
11   procedures that you had on August 16?
12        A.     Could have been between.
13        Q.     How long do you estimate that this
14   meeting took place wherein all these -- all this
15   information was discussed?
16        A.     The afternoon meeting was probably
17   around 30 minutes.
18        Q.     And was anyone present besides the
19   Sullivans and you during that meeting?
20        A.     Stacy.
21        Q.     Do you use any kind of, as I referred to
22   it before, a cheat sheet or a list of information to
23   cover with the patient?
24        A.     No.
25        Q.     In terms of this blue sheet of paper, is
0080
 1   that something that's supplied to you by The
 2   Cleveland Clinic or is it something that you had
 3   printed up on your own?
 4        A.     It was supplied by the clinic.  It's
 5   actually a patient handout that's -- was on a wall
 6   in -- in the office area.
 7        Q.     Was that blue sheet of paper still being
 8   used when you terminated your employment with the
 9   clinic?
10        A.     Yes.
11        Q.     And does it have the risks and benefits
12   laid down on it?
13        A.     No.  I use the sheet of paper as it's --
14   just -- it shows a picture of a heart and I write --
15   handwrite on the side, and then I show that it has a
16   picture of the pulmonary veins and superior vena
17   cava.  And so I physically show them what catheters
18   go in by drawing a little picture and -- and show
19   them what the pulmonary veins are and what the
20   superior vena cava is.
21        Q.     Anything else that you can recall being
22   discussed in this half-hour meeting on the afternoon
23   of August 16, 2006?
24        A.     Not specifically, but I'm sure there
25   were other things.  Bicycling, we talked about some.
0081
 1        Q.     You said not specific -- no specific
 2   recollection, but there may have been other things.
 3   What kind of other things would you likely have
 4   discussed?
 5        A.     Could have been I answered some
 6   questions.  I remember that.  I remember they asked
 7   about what -- what stroke meant.  And I said that
 8   could be anything from -- from something reversible
 9   and very small all the way up to death.  And I said
10   that 1% or 2% number includes all of that.
11        Q.     Okay.  Anything else that you can recall
12   or that you likely would have discussed in this
13   August 16 -- either August 16 meeting?
14        A.     Not that I can recall right now.  And
15   actually I would -- I thought I did -- inside --
16   always after the risks-and-benefits discussion, I
17   asked them if they have any questions, answered
18   those, and if they want to proceed or not proceed.
19   That's the other thing I do.
20        Q.     All right.  Back in August of 2006, you
21   didn't have the patients sign anything where they
22   would indicate that they did in fact receive a
23   complete list of risks, benefits, alternatives, or
24   discussion of personnel, true?
25        A.     Not from my side, no.
0082
 1        Q.     What do you mean?
 2        A.     Not from my side, no.
 3        Q.     I'm not sure I get what distinction
 4   you're trying to make.  What do you mean from your
 5   side?
 6        A.     So the patients are asked to answer
 7   multiple forms, I guess, coming into the hospital.
 8   And so from my part in particular they weren't asked
 9   to sign anything.
10        Q.     And it's my understanding that it was
11   the policy of the clinic back in 2006 to not obtain
12   or document informed consent in writing, correct?
13        A.     Only via the notation at the bottom of
14   the page.
15        Q.     Let me ask you some specifics about this
16   discussion that you had with the -- with the
17   Sullivans on the day before the procedure.
18                   You mentioned that some of the good
19   things that he had going for him, one was no
20   structural heart damage.  And I want to ask you
21   about that.  Is that specifically coronary artery
22   disease or are there other aspects that would
23   qualify as structural heart damage?
24        A.     No, there's lots of others potential.
25   He'd never had surgery on his heart, he didn't
0083
 1   appear to have major valvular abnormalities, so
 2   things like that.
 3        Q.     How about the fact that he had a prior
 4   MI?
 5        A.     It -- based on the echocardiogram, it
 6   may not have been a true MI.
 7        Q.     Okay.  Can a -- would a prior MI
 8   cause -- I mean, if it appeared on an EKG, would
 9   that cause structural -- or be equivalent of
10   structural heart damage?
11        A.     On an EKG, not necessarily.
12        Q.     Can an MI reduce the likelihood of
13   success of the procedure of a prior MI?
14        A.     A real MI, yes.
15        Q.     In terms of his medications that he was
16   on, he was on rhythm and rate control medications,
17   correct?
18        A.     He -- I'd have to look over the notes to
19   see what he was actually on at the time, but he had
20   been on them, yes.
21        Q.     And he was currently on rate control
22   medicines at the time of your meeting with him,
23   correct?
24        A.     I'd have to review the record.
25        Q.     Sure.  I think -- you know what, let me
0084
 1   hand you what I'll mark as Exhibit 4.  And this is a
 2   letter to Dr. Makino.  It's a two-page -- or
 3   four-page document.  And it appears to be pretty
 4   much a reiteration of the H&P, pre-op H&P, put it in
 5   a letter form and sent to Dr. Makino.
 6                   Tell me if that would allow you to
 7   answer the question in terms of what meds he was on
 8   currently.
 9                   (Deposition Exhibit No. 4 marked.)
10        A.     Yes.  He was on a rate-controlling agent
11   at that time.
12   BY MR. KULWICKI:
13        Q.     Okay.  And that seemed to be working in
14   the sense that his heart was being controlled, true?
15        A.     It's -- it's a tougher question to
16   answer, but at least at rest his rate was relatively
17   controlled.
18        Q.     Did you have any testing that showed
19   what his rate was like while he was on rate control
20   medicines at exercise?
21        A.     I didn't comment on it, and I don't
22   remember.
23        Q.     He complained of exercising tolerance
24   and I think you put that in terms of him not being
25   able to bicycle as well as or as much as he had in
0085
 1   the past.
 2        A.     Yes.
 3        Q.     Is that related to rate control
 4   medicines in all likelihood?
 5        A.     Not necessarily.  Could be the atrial
 6   fibrillation itself, which is -- may even be more
 7   common.  The -- he was on a beta blocker, which can
 8   cause fatigue, but it also reduces your potential
 9   VO2 max.  It's banned in Olympic trials.  It's a
10   performance -- potential performance enhancer.
11        Q.     In terms of a beta blocker, was that
12   doing anything for him?
13        A.     It would -- well, he would need to
14   certainly be on it for -- to assist in controlling
15   his rate, yes.
16        Q.     His rate or his rhythm?
17        A.     His rate.
18        Q.     Okay.  Was he on any medication -- any
19   antiarrhythmic medications?
20        A.     He had been taken off because they had
21   failed.
22        Q.     Okay.  So when they talk about him being
23   refractory to medications, that's refractory to --
24   in other words, refractory to the antiarrhythmics,
25   right?
0086
 1        A.     Yes.
 2        Q.     All right.  Let's go back to Exhibit 3,
 3   the consensus statement, on page 343 it states that
 4   "Patients should only undergo atrial fibrillation
 5   ablation after carefully weighing risks and benefits
 6   of the procedure."
 7                   Would you agree with that?
 8        A.     Correct, yes.
 9        Q.     And would you agree that the risks and
10   benefits vary from patient to patient?
11        A.     Somewhat.
12        Q.     Okay.  In other words, one size doesn't
13   all fit all in terms of the risks and benefits of
14   atrial fibrillation ablation, true?
15        A.     Well, I think that the complication
16   rates are really done over groups, so it's tough to
17   individualize, but you can -- you can try to.
18        Q.     The complication rates that you stated,
19   you mentioned stroke at 1 to 2%.
20        A.     Yes.
21        Q.     Is that for all comers?
22        A.     Yes.  I can't -- we don't give peri --
23   individualized complication rates.
24        Q.     Based on your experience, is the stroke
25   rate higher for patients in persistent a-fib versus
0087
 1   those in paroxysmal a-fib?
 2        A.     That appears to be.
 3        Q.     And what in your experience is the
 4   difference?
 5        A.     Can you clarify that?
 6        Q.     Well, percentage-wise, what -- what
 7   would you quote for persistent back in August of '06
 8   versus the paroxysmal?
 9        A.     Well, that's my point about the
10   individualization.  I don't think you can reliably
11   do that from the data.
12        Q.     Okay.  You mentioned a variety of
13   different risks and the percentages.  Is there an
14   overall complication risk for the procedure back in
15   August of 2006 that you would --
16        A.     In terms of an overall rate?
17        Q.     Yeah, rate of complications.
18        A.     So I think if you include everything, it
19   would be around 10 to 15%.
20                   THE VIDEOGRAPHER:  We have five
21   minutes remaining on the videotape.
22                   MR. KULWICKI:  Oh, why don't we take
23   a break and go ahead and switch.
24                   THE VIDEOGRAPHER:  Off the record at
25   10:34.
0088
 1                   (Recess taken, 10:34 a.m. to
 2   10:40 a.m.)
 3                   THE VIDEOGRAPHER:  We're back on the
 4   record at 10:40.  This begins Tape No. 2.
 5                   MR. KULWICKI:  Thank you.
 6   BY MR. KULWICKI:
 7        Q.     Doctor, I had before the break, I
 8   believe, re-oriented you to the consensus statement
 9   that I marked as Exhibit 3, and I'd like to just run
10   through a few statements in there and see if you
11   agree or disagree.
12                   Page 344 it states, "The catheter
13   ablation is less likely to be successful with
14   persistent atrial fibrillation."
15                   Do you agree with that?
16        A.     Yes.
17        Q.     And also on page 344 it states that as
18   of 2007, when the document was published, "Patients
19   who have the procedure are considered to be a new
20   and previously unstudied population."
21                   Do you agree with that
22   characterization?
23        A.     I think in -- in what it talks about in
24   terms of -- it says, "Patient's desire to eliminate
25   the need for long-term anticoagulation by itself
0089
 1   should not be considered an appropriate selection
 2   criteria.  So in arriving at this recommendation,
 3   the task force recognizes patients who have
 4   undergone catheter ablation of AF represent a new
 5   and previously unstudied population."
 6                   In regard to the -- the cessation of
 7   anticoagulation --
 8        Q.     You --
 9        A.     -- I would agree --
10        Q.     You --
11        A.     -- with that portion, yes.
12        Q.     I've got down on page 337, but somehow I
13   think this is wrong, that -- yeah.  I think it
14   actually is what I -- what I was going to ask you is
15   earlier in the document.  Could I see that, because
16   that's my copy with highlights on it.  Thank you,
17   Doctor.  Let me just find what I was going to ask
18   you about.  Okay.  Yeah.  Page 337.  That's right.
19   Okay.  I'm going to ask you about this.
20                   Can you agree that despite the
21   breadth of the consensus statement marked as
22   Exhibit 3, that the task force at the end did not
23   recommend or promote AF ablation?
24                   MS. CARULAS:  Note objection.
25        A.     It says this statement is not -- the
0090
 1   statement does not intend to recommend or promote.
 2   BY MR. KULWICKI:
 3        Q.     Catheter ablation, right?
 4        A.     Yes.
 5        Q.     Okay.  Can we agree that as of the
 6   publication of that consensus statement in 2007 that
 7   physician --
 8                   (Cell phone interruption.)
 9                   THE WITNESS:  Sorry.
10                   MR. KULWICKI:  That's all right.  Go
11   off the record, please.
12                   THE VIDEOGRAPHER:  Off the record at
13   10:43.
14                   (Recess taken, 10:43 a.m. to
15   10:45 a.m.)
16                   THE VIDEOGRAPHER:  Back on the
17   record at 10:45.
18   BY MR. KULWICKI:
19        Q.     Doctor, again turning back to Exhibit 3
20   on page 344, there's a statement in there that as of
21   2007, the publication of that statement, that
22   physicians were still studying other areas to ablate
23   in addition to the pulmonary veins.  And I assume
24   that includes the -- the superior vena cava, true?
25        A.     I would say at the time the superior
0091
 1   vena cava was sort of included in the -- in the
 2   pulmonary veins.  I think this would be mostly
 3   referring to the coronary sinus, the areas in the
 4   left atrium outside of the pulmonary veins.
 5        Q.     Do you currently as part of a PVAI
 6   isolation procedure ablate the superior vena cava?
 7        A.     Yes.
 8        Q.     If you would turn to page 345 and 346.
 9        A.     Okay.
10                   MR. KULWICKI:  Do you have your copy
11   of it?
12                   MR. MARGOLIS:  I do.
13   BY MR. KULWICKI:
14        Q.     Let me just see my copy again.  I
15   apologize for that.  Thank you.  Okay.
16                   So starting on page -- at the very
17   bottom of 345 it says, "Most tissues exposed to
18   temperatures of 50 degrees Celsius or higher for
19   more than several seconds will show irreversible
20   coagulation necrosis."
21                   Do you agree with that?
22        A.     And the all -- and the rest of it,
23   "evolve into the non-conducting myocardial scar."
24        Q.     Yes.
25        A.     Yes, I would say that's true.
0092
 1        Q.     And with respect to the irreversible
 2   coagulation necrosis, what is that?
 3        A.     That is the -- it's the killing of the
 4   tissue basically.
 5        Q.     What specifically is the coagulation
 6   necrosis?  What does that -- what does that refer
 7   to?
 8        A.     Well, necrosis is the death, and so
 9   that's another way of saying that.  And coagulation
10   here just means inside the cells so that the
11   proteins and everything and -- deforming.
12        Q.     Okay.  It says, "High power delivery and
13   good electrode-to-tissue contact promote the
14   formation of larger lesions and improve procedure
15   efficacy."
16                   Do you agree with that?
17        A.     Yes.
18        Q.     It says, "High power delivery can be
19   achieved with large-tip or cool-tip catheters."
20                   Do you agree with that?
21        A.     Well, potentially.
22        Q.     It says, "Optimal catheter-to-tissue
23   contact is achieved by a combination of steerable
24   catheter selection, guide sheathe manipulation, and
25   skill of the operator."
0093
 1                   Do you agree with that?
 2        A.     Those are some of the things.
 3        Q.     What else would you include in that
 4   list?
 5        A.     It can be achieved through other
 6   technologies.
 7        Q.     Such as?
 8        A.     So robotic systems, potentially magnetic
 9   systems.  There are -- and other balloon systems, so
10   other things that can -- that can improve the
11   contact.
12        Q.     It says, "Significant complications can
13   occur during the AF ablation if radio frequency
14   powers administered in an uncontrolled fashion."
15                   And do you agree with that?
16        A.     Somewhat, in that it can --
17   complications can occur even during controlled RF
18   ablation.
19        Q.     And what I was going to ask you is, what
20   do you think that means, an uncontrolled fashion?
21        A.     I'm not sure I understand what the
22   author here is saying about uncontrolled fashion.
23        Q.     Okay.  Says, "The increased risk of AF
24   ablation compared to ablation of other arrhythmias
25   may be attributable to the great surface area of
0094
 1   tissue ablated, the large cumulative energy
 2   delivery, the risk of systemic thromboembolism, and
 3   the close location of structures susceptible to
 4   collateral injury."
 5                   Do you agree with that?
 6        A.     I think that's part of it.
 7        Q.     And what else would you add to that?
 8        A.     I think, you know, things like the
 9   experience of the operator is certainly another one.
10        Q.     Okay.  It says, "Thrombus and char can
11   be minimized by limiting power and/or target
12   temperature by monitoring the production of steam
13   microbubbles at the catheter tip with ICE, and by
14   cooling the electrode-tissue interface with saline
15   irrigated tips."
16                   Do and you agree with that?
17        A.     Yes -- well, the -- it doesn't say
18   specifically, but the ICE, the intracardiac echo,
19   specifically for solid tip catheters.
20        Q.     Okay.  So the ICE doesn't help minimize
21   the risk of thrombus in char formation when
22   irrigated tip catheters are used?
23        A.     Well, the microbubbles, not the ICE.
24        Q.     Okay.  It says, "Intramural steam pops
25   can be reduced by limiting power and the
0095
 1   electrode-to-tissue contact surface, which is
 2   greater when the catheter is oriented perpendicular
 3   to atrial wall."
 4                   And do you agree with that?
 5        A.     That and time is another component.
 6        Q.     Time meaning the -- the time at which
 7   the catheter surfaces and contact and ablating the
 8   tissue surface?
 9        A.     In a single area.
10        Q.     And with respect to steam pops, what
11   does that refer to?
12        A.     That is a -- basically an explosion in
13   the tissue of the heart in which the -- the
14   temperature inside the tissue gets very high and you
15   have a steam type of explosion inside the tissue.
16        Q.     And does that increase the risk of
17   thrombus formation?
18        A.     That -- that I don't think is entirely
19   clear.  The -- it definitely increases the risk of
20   perforation.
21        Q.     Okay.  Dr. Kanj in one of his articles
22   describes when radio frequency ablation is delivered
23   at 50 watts, that in a particular study population
24   that 100% of those patients experienced steam pops.
25                   Is that your experience too, that at
0096
 1   50 watts that 100% of patients or a vast majority of
 2   patients will experience steam pops?
 3                   MS. CARULAS:  Objection.
 4        A.     No.
 5   BY MR. KULWICKI:
 6        Q.     What percentage of patients experience
 7   steam pops when radio frequency ablation is
 8   conducted at 50 watts?
 9        A.     That depends on all those factors we
10   talked about.
11        Q.     In terms of the electrode-tissue contact
12   and interface, is that better achieved based on
13   increased operator experience?
14                   MS. CARULAS:  Objection.  I don't
15   understand the question.
16                   THE WITNESS:  Yeah.  Can you
17   clarify?
18   BY MR. KULWICKI:
19        Q.     Sure.  Well, it talks about wanting to
20   improve the catheter-tissue contact and wanting the
21   catheter surface or the electrode surface to be
22   perpendicular to the tissue being ablated.
23                   Are those -- those interface issues,
24   are those the subject of operator experience?  In
25   other words, is a more experienced operator able --
0097
 1   better able to achieve an optimal catheter-tissue
 2   contact?
 3                   MS. CARULAS:  Objection.
 4        A.     I don't believe we know the answer to
 5   that question at this point.
 6   BY MR. KULWICKI:
 7        Q.     How does operator experience improve
 8   the -- or improve success and reduce risk?
 9        A.     I believe mostly through experience.
10   The -- the minor parameters, I don't think I can
11   scientifically state what exactly it is.
12        Q.     Well, is it just that after a certain
13   number of procedures, the success rate goes up and
14   the risk rate goes down, or is there something
15   objectifiable in that experience that -- or the
16   learning curve that improves from the operator
17   perspective that increases the success and decreases
18   the risk?
19                   MS. CARULAS:  Objection.
20        A.     That's the thing.  I don't think we know
21   what parameters.  We think there are parameters.
22   I'm just not sure we can quantify which ones.
23   BY MR. KULWICKI:
24        Q.     Is 50 watts considered to be a higher
25   temperature or a higher power in terms of energy
0098
 1   delivery with radio frequency ablation?
 2        A.     With radio frequency ablation, I would
 3   say no.
 4        Q.     Okay.  What would you consider to be a,
 5   you know, lower power, higher power, medium power?
 6        A.     Well, it -- there's a lot of different
 7   factors.  But, in general -- the highest power in
 8   general is 100 watts, I believe.  And the low power,
 9   little bit depends on where you're at in the heart,
10   but probably -- certainly less than probably 20
11   watts would be considered low.
12        Q.     What do you currently use for PVAI
13   ablation?
14                   MS. CARULAS:  Objection.
15        A.     In terms of powers --
16   BY MR. KULWICKI:
17        Q.     Yes.
18        A.     -- or --
19        Q.     Yes.
20        A.     Okay.  It usually is 40 to 50 watts.
21   Somewhat depending on the temperature and things
22   like that.  Similar protocols to them.
23        Q.     Can we agree that as of the consensus
24   statement in 2007 that no studies have been
25   performed that would -- that established what was
0099
 1   the ideal energy delivery in terms of wattage?
 2        A.     I would say there's -- I would say it's
 3   not clearly established.  I would say there's data
 4   on the low side definitely that you'd probably need
 5   a minimum wattage.
 6        Q.     Okay.  And in terms of the use of a
 7   large-tip catheter versus an open-irrigated
 8   catheter, can we agree that in 2007 as per the
 9   consensus statement as stated on page 346 that there
10   were no studies to demonstrate which -- which is the
11   safest and most effective catheter type?
12        A.     Between the 8 and the irrigated, you
13   said?
14        Q.     The large-tip and the open-irrigated
15   catheter.
16        A.     Okay.  I would say that there's probably
17   no -- at the time probably not much data in terms of
18   safety.  I believe there were some presentations in
19   terms of efficacy.
20        Q.     Can we agree that the open-irrigation
21   catheter at temperatures greater than 35 watts
22   increase -- the use of open-irrigated temperatures
23   at -- temperatures greater than 35 watts increases
24   the risk of tissue overheating and pops?
25                   MS. CARULAS:  Objection.
0100
 1        A.     I think you misstated it.
 2   BY MR. KULWICKI:
 3        Q.     Well, do -- do you disagree, then, with
 4   that?
 5                   MS. CARULAS:  Objection.
 6        A.     Well, the statement's not correct.  It's
 7   not temperatures in terms of 35 watts, so --
 8   wattage, it's a --
 9   BY MR. KULWICKI:
10        Q.     It's what -- okay.  Well, the -- okay.
11   Fair enough.  Open irrigation at temperatures in
12   excess of 35 Celsius increases the risk of tissue
13   overheating and pops.
14                   MS. CARULAS:  Objection.
15        A.     No.  I would say that number is
16   incorrect.
17   BY MR. KULWICKI:
18        Q.     Okay.  All right.  There is a statement
19   here on page 346 that "Depending upon the ablation
20   technology employed, many operators limit RF power
21   to 25 to 35 watts."
22                   Was the clinic using RF power of 50
23   watts or was that what was used with Shannon
24   Sullivan?
25                   MS. CARULAS:  Objection.
0101
 1        A.     At the time power was titrated depending
 2   on tip temperature and efficacy of diminishing the
 3   electrical signals.
 4   BY MR. KULWICKI:
 5        Q.     Looking at Exhibit 2, the ablation
 6   summary, where it says power and it has the average
 7   47 and the maximum of 50, can you tell me what that
 8   means, Doctor?
 9        A.     Sure.  The -- so the maximum, I don't
10   believe is a reliable number on this.  It's just a
11   maximum, the generator setting potential.
12        Q.     Okay.
13        A.     And the average is likely the -- the
14   average power generated over a period of time.
15        Q.     Okay.  So it might be higher, might be
16   lower, but that's the average?
17        A.     Yes.
18        Q.     And the maximum that it would be would
19   be 50?
20        A.     It's the maximum you can -- you can go
21   to, but that's just a generator setting.  You -- I
22   mean, you might not have ever actually set it to 50.
23        Q.     And in terms of the generator setting,
24   that just measures the temperature at the tip of the
25   electrode; is that correct?
0102
 1        A.     No.  That measures the -- the tip
 2   temperature measures the tip temperature.  The
 3   generator setting is what you -- the wattage you
 4   apply.  It's a -- it's a dial.
 5        Q.     Can we agree that as stated on page 346
 6   of Exhibit 3, that no study had been performed as of
 7   2007 identifying the safest and most effective
 8   energy source, whether radio frequency, cryotherapy,
 9   ultrasound, or laser?
10        A.     Can you point to where it says that?
11        Q.     In the upper right-hand corner says,
12   "Different ablative energy sources have been
13   developed and currently are being evaluated in
14   clinical trials."
15                   So as of 2007 there hadn't been any
16   clinical trials completed that compared the relative
17   efficacy and safety of radio frequency versus
18   cryotherapy versus laser versus ultrasound energy
19   delivery systems, true?
20                   MS. CARULAS:  Objection.
21        A.     There were some trials completed.  I'm
22   not sure if you can generalize their safety and
23   efficacy, but I believe there were some trials
24   completed at the time with alternative sources.
25   BY MR. KULWICKI:
0103
 1        Q.     Can you name any of those?
 2        A.     I believe there were some small studies
 3   on cryoablation.  I think there -- I think there was
 4   an earlier catheter that had been actually completed
 5   by then, but not approved.  CUBA or something like
 6   that.  It's another -- another ultrasound system.
 7   Laser had some study at the time.  There was a stint
 8   maybe at the time even that had been studied.
 9        Q.     Going further down where it says
10   Electroanatomic Mapping Systems on that same page --
11        A.     Yes.
12        Q.     -- can you agree that in terms of state
13   of the art in 2007 that the available
14   electroanatomic mapping systems had several
15   potential sources of error, including differences in
16   volume status, respiratory phase between the CT and
17   MRI image and the electroanatomic map, cardiac
18   rhythm differences, as well as the registration
19   algorithm?
20                   MS. CARULAS:  Objection.
21        A.     That's in reference to registration to
22   another image.
23   BY MR. KULWICKI:
24        Q.     Okay.
25        A.     Not in reference to the image itself.
0104
 1        Q.     All right.  And those would be
 2   limitations of electroanatomic mapping back in 2007,
 3   true?
 4        A.     If registered to another image.
 5        Q.     Okay.
 6        A.     That's --
 7        Q.     Was that done with Sullivan's images?
 8        A.     No.
 9        Q.     Were there any studies back in 2006 that
10   established what was the best, most effective and
11   safest mapping system?
12        A.     I don't think you can say that.
13        Q.     Tell me about the efficacy of monitoring
14   for tissue overheating back in 2006 -- August of
15   2006.  Is it true, as Dr. Kanj said, that there were
16   some monitoring tools available but they weren't
17   perfect in terms of being able to tell you about
18   tissue overheating or the development of char or
19   coagulum?
20                   MS. CARULAS:  Objection.
21        A.     Well, I think there is some very good
22   tools.  I think intracardiac echo is a very good
23   tool.  And then there -- there's several other
24   parameters that you can look at, including the
25   impedances on the catheter, temperature on the
0105
 1   catheter.  The electrical -- sometimes the
 2   electrical signals even give you clues.
 3   BY MR. KULWICKI:
 4        Q.     Okay.
 5        A.     So -- but I'll agree nothing's perfect,
 6   but we do have some good tools.
 7        Q.     And that in many cases you wouldn't know
 8   if you were overheating tissue or creating coagulum
 9   or char as it was occurring?
10                   MS. CARULAS:  Objection.
11   BY MR. KULWICKI:
12        Q.     True?
13        A.     Well, then -- well, I think that's a
14   more complicated question.  And so deep tissue
15   overheating is more -- is somewhat more difficult to
16   see.  Tissue interface and coagulum and char is
17   something that is easier to see on ultrasound.
18        Q.     Okay.
19        A.     In fact, something that we -- on a
20   solid-tip catheters, that's what we published.
21        Q.     On page 350 there's a discussion about
22   approaches to esophageal monitoring.  Would you
23   agree that the various approaches to esophageal
24   monitoring, listed on page 350, remained unproven as
25   of the publication of this document in 2007?
0106
 1        A.     Can you clarify that?
 2        Q.     Well, it states on 350 that these
 3   various approaches -- and above it it lists the
 4   different types of esophageal monitoring.
 5        A.     Uh-huh.
 6        Q.     It says that "It's important to note
 7   that owing to the rarity of the complication, it
 8   remains unproven whether their use lowers or
 9   eliminates the risk of esophageal perforation."
10                   Would you agree that?
11        A.     I would say in terms of technology to
12   potentially reduce it that, yes, I would say it was
13   unknown.
14        Q.     Let's talk about anticoagulation before,
15   during, and after the procedure.  Is that an
16   important aspect of AF ablation?
17        A.     Yes.
18        Q.     And in terms of the different
19   measurements and types of anticoagulation, does INR
20   measure the effect of both Heparin and Coumadin or
21   Warfarin in anticoagulating a patient?
22        A.     INR is more the effect of Warfarin than
23   not Heparin.
24        Q.     Okay.  And how about ACT, does that
25   measure the effect of Heparin and Warfarin or one or
0107
 1   the other?
 2        A.     ACT is mostly Heparin; however, it might
 3   be affected by Coumadin or Warfarin.
 4        Q.     And how about the APTT?
 5        A.     That is -- I'd call it similar to the
 6   ACT in that it's mostly a Heparin affect, but can
 7   see some differences in the value based on Warfarin.
 8        Q.     And in terms of protamine, does that
 9   reverse Coumadin or Warfarin at all?
10        A.     Really only Heparin.
11        Q.     Okay.  And in terms of Coumadin or
12   Warfarin, that is given orally, true?
13        A.     Yes.
14        Q.     And it's given once a day, is -- or
15   prescribed to be taken once a day; is that correct?
16        A.     In most cases.
17        Q.     And what is the half-life of Coumadin or
18   Warfarin taken orally?
19        A.     I wish we'd -- in half-life in terms of
20   effectiveness is a very difficult thing to predict.
21        Q.     Okay.
22        A.     But in terms of availability over --
23   over a day is reasonable dosing.
24        Q.     Okay.  And how about Heparin given via
25   injection?
0108
 1        A.     Heparin, that is a little difficult, but
 2   it can be up to several hours.
 3        Q.     And is that a measurement -- is
 4   half-life a measurement of effectiveness of the
 5   medication?
 6        A.     No.  Half-life is just sort of a
 7   bioavailability concentration in the blood.
 8        Q.     What term would you use to measure the
 9   effectiveness of anticoagulants?
10        A.     It would depend on the specific
11   anticoagulant.
12        Q.     Is there a half-life associated with
13   protamine; in other words, how long it continues to
14   reverse Heparin?
15        A.     Well, those are two different -- two
16   different things.
17        Q.     Okay.  Let me ask it this way.  How long
18   does protamine when given IV act to reduce Heparin?
19        A.     Well, it binds to the molecule, so it --
20   you get an effect from it, but it's not -- it
21   doesn't sort of continue to be effective.
22        Q.     Okay.  And from the time that you
23   administered protamine, how long would it continue
24   to drive down ACT as it binds with the Heparin?
25        A.     It doesn't really.  It's like we talked,
0109
 1   it just takes a certain amount out of pull and
 2   rhythm.  It really doesn't have a continued effect.
 3        Q.     Okay.
 4        A.     They're -- that's dependent on other
 5   factors.
 6        Q.     Let me see this real quick.  All right.
 7   I'm going to hand you Exhibit 3, again, which is the
 8   consensus statement, and I'm going to direct you to
 9   page 348, the highlighted portion there where it
10   discusses anticoagulation.
11                   And the first thing -- the first
12   sentence it says, "Careful attention to
13   anticoagulation of patients before, during, and
14   after ablation for AF is critical to avoid the
15   occurrence of a thromboembolic event, which is
16   recognized as one of the most serious complications
17   of AF and also of AF ablation procedures."
18                   Do you agree with that?
19        A.     Yes, I'd say in terms of all --
20        Q.     And --
21        A.     -- all -- everything regarding AF is
22   important.
23        Q.     Okay.  And then further down, the other
24   highlighted portion, it says, "It is for this reason
25   that the task force recommends that the
0110
 1   anticoagulation guidelines published as part of the
 2   ACC/AHA/ESC 2006 guidelines for the management of
 3   patients with atrial fibrillation be adhered to."
 4                   And do you agree with that?
 5        A.     In terms of surgical procedures, the way
 6   it's handled, yes; not in terms of cardioversion
 7   procedures.
 8        Q.     Okay.  There's no mention anywhere in
 9   this consensus report marked as Exhibit 3 of the
10   efficacy of aspirin as an anticoagulant, true?
11        A.     I would have to read through.
12        Q.     Well, let me just tell you that it
13   doesn't; just accept that for now.  Let me ask you
14   in terms of your experience and training.  The
15   concept of evidence-based medicine, are you aware of
16   any evidence-based medicine that proves that aspirin
17   is effective as a postablation device to reduce the
18   risk of stroke?
19        A.     That would be -- if -- well, in terms
20   a-fib postablation, I would say yes.
21        Q.     Okay.  Now, based on my reading, it --
22   I've --
23        A.     I would say, yes, it's proven that it's
24   a reasonable anticoagulation protocol.
25        Q.     Okay.  And thanks for clarifying.
0111
 1        A.     Okay.
 2        Q.     Where do you get that from?  Is there
 3   any study that shows that it reduces the risk of
 4   stroke?
 5        A.     In terms of AF.  And so just like the
 6   guidelines talk about in terms of their risk profile
 7   and stroke in AF that ablation doesn't necessarily
 8   change it.
 9        Q.     Okay.  Well, let me ask specifically
10   postablation.  Is there any study that shows that
11   aspirin reduces the risk of ablation-related stroke?
12        A.     I would say there's no study that shows
13   anything conclusively reduces postablation stroke.
14        Q.     Okay.  In terms of stroke related to the
15   ablation procedure itself, can we agree that damage
16   to the endothelium from the ablation itself is a
17   potential mechanism for stroke?
18                   MS. CARULAS:  Objection.  Go ahead.
19        A.     Well, depends on what you mean.  Can you
20   be more specific?
21   BY MR. KULWICKI:
22        Q.     Well, does the damage to the endothelium
23   from the ablation itself create a nidus for a
24   thrombus formation?
25                   MS. CARULAS:  Objection.
0112
 1        A.     I would say not ablation-related damage.
 2   Disruption, I would say yes.
 3   BY MR. KULWICKI:
 4        Q.     Tell me what you mean.
 5        A.     So if you have a disruption, if you
 6   expose tissue underneath the endothelium, that I
 7   think is -- is a nidus for it.  But I think just in
 8   terms of ablating if you're -- if you're -- assuming
 9   you're anticoagulated and not just getting clot on
10   the -- on the tip of the catheter, that I think
11   that -- that's not as clearly as associated with
12   thrombus.
13        Q.     Does heating of blood increase the risk
14   for thrombus formation?
15        A.     Overheating the blood, yes.
16        Q.     Okay.  And what do you call overheating
17   the blood?  What temperature?
18        A.     I don't think we have a good -- a good
19   knowledge of that, because there's differences in
20   temperature away from the catheter and at the
21   catheter interface.  So I'm not sure we know that
22   number very well.
23        Q.     How about cardioversion?  Does stunting
24   related to cardioversion increase the risk of
25   stroke?
0113
 1        A.     I think we call -- I would say that
 2   overall cardioversion itself in any situation is
 3   associated with a stroke.  We think it may be due to
 4   stunting, is how I would say it.
 5        Q.     And is there any way to measure whether
 6   a patient has had significant heart stunting as a
 7   result of cardioversion either by EKG or any other
 8   test?
 9        A.     The -- the tests that aren't routinely
10   performed but have been done in the past are
11   transesophageal echos.
12        Q.     Besides damage to the endothelium or the
13   tissue below the endothelium, heating of blood and
14   cardioversion, what other aspects of AF ablation are
15   identified as being factors in the development of
16   thrombus and/or stroke?
17                   MS. CARULAS:  Objection.
18        A.     I would treat those two a little
19   differently, but -- so factors in terms of thrombus
20   in addition to what we talked about, high pressures
21   is one, obviously the presence of thrombus
22   beforehand would be another, anticoagulation that we
23   talked about during ablation, the anticoagulation
24   whether you do that before or after the puncturing
25   to the left atrium, I think is another, the time may
0114
 1   be one.
 2                   And then in terms of stroke in
 3   addition to those, there are some patient-related
 4   factors and whether they're -- have a
 5   hypercoagulable state, certainly the longer the
 6   a-fib, if there's an atrial-esophageal fistula.
 7   That's a risk for stroke that usually occurs later,
 8   though.  You can directly damage an artery,
 9   obviously, during the procedure which could result
10   in a stroke.  Air -- air is another one.  So air
11   introduced into the catheters or through the sheaths
12   or through one of the -- one of the veins.  What we
13   call paradoxical embolus is a blood clot like coming
14   from the leg or something that -- that comes across
15   into the arterial system.  Patients can have
16   spontaneous rupture of plaque, develop a stroke.
17   There are -- you can disrupt plaques and those can
18   result in strokes.  Those are some of them.  There's
19   lots of other potentials, I guess.
20        Q.     In terms of high pressures, what do you
21   mean by that?
22        A.     So at the pressures at the catheter
23   interface or if you're -- even if it's not a
24   catheter; it's just a sheathe.  If you're -- high
25   pressure on the heart wall or occluding an area of
0115
 1   blood flow can potentially result in it.
 2        Q.     And the presence of instrumentation, is
 3   that what you mean by time, that the presence of
 4   instrumentation in the left atrium increases the
 5   risk of stroke just by virtue of being a foreign
 6   body?
 7        A.     I think both in that having anything in
 8   the left atrium is certainly a risk, and then
 9   probably the very long times may increase the risk.
10        Q.     You mentioned that patient-related
11   issues including hypercoagulable -- coagulable
12   state.
13        A.     Uh-huh.
14        Q.     In this case, were you aware that
15   Mr. Sullivan had a gene mutation that is -- puts him
16   at risk for a homocysteine anomaly -- I can't
17   remember if it's hypo or hyper -- homocysteinemia.
18   Were you aware of that?
19        A.     No.  I believe he -- in our discussion
20   we had no history of a hypercoagulable disorder.
21        Q.     Are you familiar with that disorder,
22   hyperhomocysteinanemia?
23        A.     Yes.
24        Q.     And can we agree that in a patient who
25   has the mutation for -- that puts him at risk for
0116
 1   hyperhomocysteinanemia, but who in fact does not
 2   have hyperhomocysteinanemia are not at increased
 3   risk of clotting or not in a frank hypercoagulable
 4   state?
 5        A.     I don't know the answer to that
 6   question.
 7        Q.     Okay.  And would you know what the
 8   treatment is for hyperhomocysteinanemia?
 9        A.     I believe it's folate.
10        Q.     It would be vitamins that you would get
11   with a typical multivitamin like Centric?
12        A.     I believe the doses are different.
13        Q.     Is that something that you'd be an
14   expert in or that you'd defer to someone else?
15        A.     Yeah, I would defer that to someone
16   else.
17        Q.     Okay.  In terms of anticoagulation, can
18   we agree that aspirin, Warfarin and Heparin impact
19   different parts of the clotting cascade?
20        A.     Well, I think there is some crossover,
21   but -- but overall they do act differently.
22        Q.     Okay.  I'm going to mark as Exhibit 5 --
23                   MR. MARGOLIS:  I think we're on 4.
24   I have 3 as being the consensus statement --
25                   MR. KULWICKI:  We're at 5.
0117
 1                   MR. MARGOLIS:  -- 2, the ablation
 2   log, 1, his CV.  What's 4?
 3                   MS. CARULAS:  4 was his letter to
 4   Dr. Makino.
 5                   MR. MARGOLIS:  Oh, okay.
 6                   (Deposition Exhibit No. 5 marked.)
 7   BY MR. KULWICKI:
 8        Q.     So 5 is the "ACC/AHA/ESC 2006 Guidelines
 9   for Management of Patients with Atrial
10   Fibrillation," and it's a -- roughly a 100-page
11   document.  Let me hand that to you.  I take it
12   you're familiar with that -- those guidelines?
13        A.     Yes, I've seen them before.
14        Q.     And at page 204 -- yeah.
15        A.     Okay.
16        Q.     They state that there is a 1 to 7% risk
17   of stroke without prophylactic anticoagulation in
18   patients with a-fib.  Do you see that?
19        A.     Yes, that's...
20        Q.     Did I read that right or did I quote
21   that correctly?  I don't have the copy in front of
22   me, so I would like to at least first confirm that
23   I've said that correctly and then second I'd like to
24   see if you agree with that.
25        A.     So that's referring to cardioversion.
0118
 1        Q.     Okay.  Let me take a look at that real
 2   quick so I can -- I've got questions here, but I
 3   don't have a copy of this in front of me.  Okay.
 4                   All right.  So page 204 of Exhibit 5
 5   it states, "The risks of direct-current
 6   cardioversion are mainly related to thromboembolism
 7   and arrhthymias.  Thromboembolic events have been
 8   reported in 1% to 7% of patients not given
 9   prophylactic anticoagulation before cardioversion of
10   atrial fibrillation."
11                   Do you agree with that?
12        A.     Regarding cardioversion, yes.  But
13   that's specifically talking to people who haven't
14   had some sort of imaging beforehand.
15        Q.     Right.
16        A.     That's a different population.
17        Q.     Right.  And so if you would, go to
18   page 206.  They talk about patients who have had
19   imaging beforehand.  Item No. 1 there talks about --
20   let me just look at it real quick and I'll give it
21   to you.  It says for patients with atrial
22   fibrillation of 48-hour duration or longer, or when
23   the duration of atrial fibrillation is unknown,
24   anticoagulation with an INR of 2 to 3 is recommended
25   for at least three weeks prior to and four weeks
0119
 1   after cardioversion, regardless of the method used
 2   to restore sinus rhythm.
 3                   And that would be patients where
 4   the -- there is no precardioversion imaging to see
 5   if there's thrombus in the left atrium, correct?
 6        A.     Can you repeat that?
 7        Q.     Sure.  And actually why don't I -- maybe
 8   I can help clarify what I want to ask and see if you
 9   agree.  It goes on to say, "As an alternative to
10   anticoagulation prior to cardioversion of AF, it is
11   reasonable to perform TEE in search of thrombus in
12   the left atrium or the left atrial appendage.  For
13   patients with no identifiable thrombus on imaging,
14   cardioversion is reasonable immediately after
15   anticoagulation with unfractionated Heparin as
16   evidenced by an INR equal to or greater than 3.0.
17   Thereafter, oral anticoagulation (INR 2.0 to 3.0) is
18   reasonable for a total anticoagulation period of at
19   least four weeks, as for patients undergoing
20   elective cardioversion."
21                   Let me just ask you some questions
22   about that.
23        A.     I just want to make sure we're talking
24   about cardioversion and not surgical procedures.
25        Q.     Correct.  Yeah.
0120
 1        A.     Okay.
 2        Q.     Yeah.  And so -- and I understand
 3   we're -- I'm going to ask you about that situation
 4   in a moment.  But generally speaking, would you
 5   agree with those guidelines that for electrical
 6   cardioversion in a patient who has imaging, whether
 7   cardiac CT or TEE precardioversion, that they should
 8   be anticoagulated during the procedure and for
 9   several weeks afterwards?
10                   MS. CARULAS:  Objection.
11        A.     So for cardioversion --
12   BY MR. KULWICKI:
13        Q.     Right.
14        A.     -- not during the procedure?
15        Q.     Correct.
16        A.     I would agree that you either need a
17   preimaging study or therapeutic anticoagulation
18   prior to the procedure and you try to keep it after.
19        Q.     And how do you square those guidelines
20   for cardioversion outside of a procedure with what
21   happens during AF ablation like in Mr. Sullivan's
22   case where you perform an electro -- electrical
23   cardioversion during the procedure and then the
24   patient is not anticoagulated for several hours post
25   procedure?  How do you square those guidelines with
0121
 1   what you do during his procedure?
 2        A.     It's a difficult thing to answer to, but
 3   in general we treat it more like a surgical
 4   procedure, in that sense that you have a significant
 5   risk of bleeding that you do have to treat it
 6   differently just like with bypass surgery and
 7   open-chest surgeries in that -- and it's almost
 8   irrespective of cardioversion.  It's just the
 9   presence of a-fib in that at whatever time procedure
10   you think it's safe to reinitiate anticoagulation,
11   then you do.
12        Q.     You would agree with me that there is a
13   conflict between the guidelines set forth in
14   Exhibit 5 and the practice as it's developed with
15   respect to cardioversion during a-fib ablation
16   procedures, true?
17                   MS. CARULAS:  Objection.
18        A.     I would say these guidelines refer to
19   cardioversion and not to surgical procedures.
20   BY MR. KULWICKI:
21        Q.     Right.  But you are doing cardioversion
22   during a-fib ablation procedures and you're not
23   anticoagulating the patient immediately -- in the
24   period immediately after cardioversion, correct?
25        A.     Well, that's the harder question.
0122
 1        Q.     I'm sorry?
 2        A.     That's the harder question.
 3        Q.     Okay.
 4        A.     In that -- so he was anticoagulated
 5   during the procedure and still had anticoagulation
 6   after.  That's not what everyone does.  Just like
 7   with a surgical procedure wherein -- which very may
 8   well involve cardioversion, they wouldn't
 9   necessarily have any anticoagulation whatsoever.
10        Q.     Okay.  When you say --
11        A.     So that's what I'm saying.
12        Q.     -- use "he," we're talking Shannon
13   Sullivan?
14        A.     Yes.
15        Q.     What do you mean by he was
16   anticoagulated?  Are you talking about the aspirin?
17        A.     So he received -- he was on Coumadin.
18        Q.     Okay.
19        A.     He received aspirin and he received
20   Heparin during the procedure.
21        Q.     Okay.  Well, the Heparin was reversed --
22        A.     Not at the time of cardioversion.
23        Q.     Well, at the conclusion of the
24   procedure, the Heparin was reversed, true?
25        A.     At the end of the procedure, yes.
0123
 1        Q.     Okay.  How long does --
 2        A.     But it was not fully reversed.
 3        Q.     Okay.  And the ACT was not therapeutic
 4   levels at the conclusion of the procedure, true?
 5        A.     At the time of sheath pull, it was --
 6   there's -- it was not therapeutic for ablation, but
 7   we weren't ablating.
 8        Q.     Right.  Okay.
 9        A.     It was above normal, but not -- not at
10   an ablation range.
11        Q.     What would you consider to be a
12   therapeutic level of therapeutic ACT for
13   cardioversion outside of the context of an ablation
14   procedure?
15                   MS. CARULAS:  Same objection.
16        A.     Well, the number depends on the
17   laboratory, and usually 1.5 times a limit.
18   BY MR. KULWICKI:
19        Q.     Okay.
20        A.     Except actually it's ACT.  That's --
21   that's outside --
22        Q.     That's the INR?
23        A.     That's -- no, that's PTT.
24        Q.     Okay.
25        A.     ACT in general is testing in laboratory
0124
 1   measurement.
 2        Q.     It's my understanding that the ACT is
 3   sort of a rough estimate of Heparin levels; is that
 4   true?
 5        A.     Yes.
 6        Q.     And, Doctor, referring you to Exhibit 2
 7   on page 4 of that document, there are -- there's a
 8   reference range for the PT and the INR.  Is this
 9   what you were referring to?
10        A.     For the PT and INR?
11        Q.     Yeah.
12        A.     No.
13        Q.     Okay.  Are those reference ranges listed
14   there the reference ranges for PT and INR used by
15   The Cleveland Clinic in August of 2006?
16        A.     Yes, that is a reference range for PT
17   and INR at our -- at The Cleveland Clinic.  I'm not
18   sure whether that's the main lab or our local lab.
19        Q.     Okay.  And do you know what the
20   reference ranges used by The Cleveland Clinic for
21   ACT were back in 2006?
22        A.     Reference range in terms of they're
23   normal?
24        Q.     Yes.
25        A.     I do not know.
0125
 1        Q.     And do you know what the reference
 2   ranges were for the APTT at The Cleveland Clinic
 3   back in 2006?
 4        A.     I don't recall offhand, no.
 5        Q.     Referring back to Exhibit 5, if you
 6   could turn to page two thousand -- or, I'm sorry,
 7   207.  Couple more questions about that and then we
 8   can set that document aside.
 9        A.     Okay.
10        Q.     Let me just look at it real quick so I
11   can find it.
12        A.     Okay.
13        Q.     Okay.  Doctor, I've underlined a couple
14   of lines from page 207.  One of them talks about the
15   risk of thromboembolism with cardioversion being at
16   1 to 5%.
17                   Would you agree with that?
18        A.     I'd have to go back to the -- in here
19   and see what it says.  So it says randomized studies
20   are lacking but the -- in case control series the
21   risk was estimated to be between 1 and 5% for
22   cardioversion.
23        Q.     And it states that it was at the lower
24   end of that range if anticoagulation was used three
25   to four weeks before and after cardioversion,
0126
 1   correct?
 2        A.     So it appeared to be that the risk was
 3   on the lower side of that, yes, if they were given
 4   therapeutic for three to four weeks before that.
 5        Q.     Is that consistent with your experience?
 6        A.     Yes.
 7        Q.     And it says -- in the next underlined
 8   area it says, no evidence -- there's no evidence
 9   that cardioversion resulting in return to normal
10   sinus rhythm reduces the risk of thromboembolism.
11   Do you see that?
12        A.     Yes.
13        Q.     And do you agree with that?
14        A.     That's once again referring to a
15   cardioversion population.  And I think in the
16   general population that would be true.  I think
17   there is subpopulations where that may not be true.
18        Q.     And specifically those that have
19   undergone AF ablation?
20        A.     No.  Things like reversible causes of
21   atrial fibrillation.
22        Q.     How would that -- what we just read that
23   there's no evidence that cardioversion decreases the
24   risk of thromboembolism, how would that apply in a
25   patient like Shannon Sullivan, if at all, who's
0127
 1   undergone an ablation procedure?
 2                   MS. CARULAS:  Objection to form.
 3        A.     Well, this just refers to cardioversion
 4   and not a surgical procedure, so it's somewhat
 5   different.
 6   BY MR. KULWICKI:
 7        Q.     Okay.  Going back to Exhibit 3,
 8   page 349.
 9                   (Comments off the record.)
10   BY MR. KULWICKI:
11        Q.     I've underlined two portions on
12   page 349.  The first one reads, "At the conclusion
13   of the procedure, sheath removal requires withdrawal
14   of the anticoagulation for a window of time to
15   achieve adequate hemostasis."
16                   Is it your testimony that you didn't
17   do that in Shannon Sullivan's case?
18                   MS. CARULAS:  Objection.
19        A.     The -- well, it depends on what you mean
20   by "withdrawal."  You'd have to be more specific on
21   that.
22   BY MR. KULWICKI:
23        Q.     Well, you did use protamine to reverse
24   the Heparin, right?
25        A.     So the Heparin was partially reversed,
0128
 1   yes.
 2        Q.     Okay.  And --
 3        A.     And then he got aspirin and then
 4   obviously had maintained Coumadin.  So I wouldn't
 5   say that we had withdrawn.  We partially reversed is
 6   how I would say it.
 7        Q.     But in terms of his Coumadin levels
 8   during the couple of hour period of time between the
 9   procedure and his stroke, it was not at therapeutic
10   levels, true?
11        A.     That's true.
12        Q.     And with respect to the Heparin, it was
13   reduced down to an ACT of 117.  Could we agree that
14   between the withdrawal of Heparin in terms of not
15   giving -- actively giving intravenous Heparin and
16   the reversible of Heparin that was there via
17   protamine, that over the course of that period of
18   time between the procedure and the stroke, that the
19   anticoagulative effects of Heparin would have been
20   constantly in decline over that period of time?
21                   MS. CARULAS:  Objection, form.
22        A.     Can you show me the 117 you were
23   referring to?
24   BY MR. KULWICKI:
25        Q.     Let me see that exhibit.  Exhibit 2
0129
 1   at -- oh, I'm sorry, it's actually 151 --
 2        A.     Okay.
 3        Q.     -- at 1835.  Sorry, that's what I get
 4   going from recollection.
 5        A.     Okay.
 6        Q.     But that 151 you would expect that as a
 7   measurement of anticoagulative effects of Heparin to
 8   be continuously declining between the conclusion of
 9   the procedure and the stroke later that evening,
10   true?
11                   MS. CARULAS:  Objection.
12        A.     I would say that the anticoagulation
13   effects of Heparin will continue to reduce over
14   time.
15   BY MR. KULWICKI:
16        Q.     Okay.
17        A.     The 151 may or may not be an entirely
18   accurate number.
19        Q.     Okay.
20        A.     As I talked about it, it's a relatively
21   crude measurement.
22        Q.     Well, do you have an opinion sitting
23   here today as to what the level of anticoagulation
24   was from Heparin in him during the period of time
25   between the conclusion of the procedure, and
0130
 1   specifically at 1835, and the time of his stroke at
 2   roughly 9:15 p.m. on that evening?
 3                   MS. CARULAS:  Objection.
 4                   THE WITNESS:  And so -- can you
 5   repeat that?
 6   BY MR. KULWICKI:
 7        Q.     Sure.  What I'm asking is, is if you
 8   have an opinion as to what the -- what
 9   Mr. Sullivan's anticoagulatives -- anticoagulant
10   status was related to Heparin between 1835 when it's
11   noted as being ACT of 151 and the time of his stroke
12   roughly three, four or five hours later.
13                   MS. CARULAS:  Objection, form.
14        A.     Only related to Heparin I would say he
15   was partially anticoagulated.
16   BY MR. KULWICKI:
17        Q.     Do you think he would have remained
18   partially anticoagulated from 13 -- sorry.  13 --
19   I'm sorry, 1835 until the time of his stroke roughly
20   four hours later?
21        A.     With regard to the Heparin it's -- I
22   can't say for sure.  We know that it would be --
23   like I said, the effect of Heparin would continue to
24   decrease over time.  But as far as its amount of
25   effect, I can't say.
0131
 1        Q.     All right.  Now, on page 349 of
 2   Exhibit 3 there is a discussion about continuing
 3   Warfarin for the period of time leading up to the
 4   procedure, through the procedure, and then
 5   continuing it --
 6        A.     I'm sorry, you're going to have to help
 7   me here.
 8        Q.     Page 349.
 9        A.     I don't have a 349.
10        Q.     You know what?  I gave you the wrong --
11   wrong exhibit.  It's actually Exhibit 3.  I think I
12   said Exhibit 3 and handed you Exhibit 5.
13        A.     All right.
14        Q.     Sorry about that.  So page 349.  Go
15   ahead and orient yourself.
16        A.     Yes.
17        Q.     I think in the place that's starred --
18   highlighted and starred there, there's a discussion
19   about the use of Warfarin continuously before,
20   during and after ablation procedures.
21        A.     Yes.
22        Q.     Were you doing that at the clinic back
23   in 2006?
24        A.     From the 2007 documents, right.
25        Q.     Yes.
0132
 1        A.     Yes.  From 2006 there were, and as it
 2   says here, a small number of operators, and I was
 3   one of the people doing that at the clinic, yes.
 4        Q.     Did you --
 5        A.     Not everyone was.
 6        Q.     Did you do that in Shannon Sullivan's
 7   case?
 8        A.     I attempted, yes.
 9        Q.     Okay.  To do it right, it would have
10   been keeping the Warfarin at an INR of 2.0 to 3.0,
11   right?
12                   MS. CARULAS:  Objection.
13        A.     We advised him -- I was not in charge of
14   his anticoagulation therapy prior to his arrival to
15   the clinic, but we advised him that he would need to
16   be on Coumadin at least a couple of months prior to
17   the procedure and we would prefer the INRs to be
18   therapeutic.
19   BY MR. KULWICKI:
20        Q.     Did his records show that he was indeed
21   taking Coumadin prior to the procedure?
22        A.     Our records did.  And I had INR at some
23   point in the records that I looked --
24        Q.     At one point --
25        A.     No, the one from prior to him visiting
0133
 1   us that was in the therapeutic range.
 2        Q.     Okay.  And why did you maintain Coumadin
 3   throughout the procedure at therapeutic levels?
 4   What was your thought process in doing so?
 5                   MS. CARULAS:  Objection.
 6        A.     That came -- that came about from a --
 7   from experience and that obviously this was
 8   something not a lot of people were doing.  So what
 9   -- in most cases what was happening is that people
10   were getting Lovenox.  So shots at some point after
11   the procedure.  That could be eight hours, could be
12   the next day.  What was happening is that there were
13   a lot of people developing bleeding problems from
14   the Lovenox.  And in fact -- and patients also
15   particularly didn't like giving themselves
16   injections.  And so what we decided to try was to
17   maintain the Coumadin to see if it would be possible
18   to avoid the Lovenox, potentially avoid some
19   preprocedure testing in terms of TEE, and avoid the
20   postablation issues of the bleeding and the
21   self-injection.
22   BY MR. KULWICKI:
23        Q.     Okay.  And did the Coumadin serve that
24   purpose?
25        A.     In retrospect it appears to, but it's
0134
 1   only a small -- only sort of a single study out of a
 2   few centers.
 3        Q.     All right.  Not the subject of clinical
 4   trials or the like to establish it as a practice?
 5        A.     There's no randomized clinical trial
 6   supporting that.
 7        Q.     In Mr. Sullivan's case his INR
 8   preoperatively was 1.4, I believe, and then the next
 9   one taken postop was, I think, 1.3.  Can we agree
10   that in all likelihood between those two numbers it
11   remained in the 1.4 to 1.3 range?
12        A.     Let me see my -- look at the
13   laboratories.
14                   THE WITNESS:  Do you have my
15   prelabs, by chance?
16                   MS. CARULAS:  Uh-huh.
17                   (Comments off the record.)
18                   MR. KULWICKI:  You know what?  Let's
19   take a quick break.  Let's go off the record.  Okay.
20                   THE VIDEOGRAPHER:  Off the record at
21   11:51.
22                   (Recess taken, 11:51 a.m. to
23   12:01 p.m.)
24                   THE VIDEOGRAPHER:  We're back on the
25   record at 12:01.  This begins Tape No. 3.
0135
 1   BY MR. KULWICKI:
 2        Q.     Doctor, I think during the break we
 3   were -- you were looking at the preprocedure and I
 4   believe post procedure INR levels and --
 5        A.     Yes.
 6        Q.     -- I just want to confirm that
 7   preprocedure the patient's INR was 1.4, correct?
 8        A.     On the day of I believe it was reported,
 9   yes.
10        Q.     Day of.  And then post procedure I think
11   the first INR you see drawn was after the stroke,
12   and that was 1.3, correct?
13        A.     Correct.
14        Q.     And can we agree -- seems pretty very
15   obvious to me, but I just want to make sure I'm not
16   missing something.  That between the value of 1.4,
17   the value of 1.3, that during that period of time in
18   all likelihood his INR remained subtherapeutic in a
19   range of 1.3 to 1.4?
20        A.     Yes, above normal but not in the
21   therapeutic range.
22        Q.     Okay.  You were concerned about that
23   preoperatively, correct?
24        A.     In terms of the -- we would need to get
25   an imaging study now.  Whereas, if he had been
0136
 1   therapeutic, we wouldn't necessarily have needed
 2   that.  And we would -- as I said, a lot of purpose
 3   for us attempting this strategy was to avoid Lovenox
 4   and that he would have to get Lovenox.
 5        Q.     Okay.  And what is the purpose of
 6   wanting to have the patient with the therapeutic INR
 7   prior to the procedure?
 8        A.     Well, mainly to -- for us to avoid
 9   Lovenox and potentially to avoid some -- in some
10   patients you can avoid preprocedure TEEs and things
11   like that.
12        Q.     I thought every patient who underwent
13   atrial fibrillation ablation had to have a preop
14   imaging study, whether TEE or cardiac CT, in order
15   to confirm that there was no thrombus in the left
16   atrium.
17        A.     Not in every patient.  And so if they
18   had been therapeutically anticoagulated for a period
19   of time and if they were paroxysmal, they wouldn't
20   necessarily need that.
21        Q.     All right.  When we look at Exhibit 3 on
22   page 348, this portion that we read before, it says
23   that the task force recommends adherence to the ACC
24   guidelines that we have marked as Exhibit 5.  It
25   says -- it says, "In particular, the guidelines for
0137
 1   anticoagulation, both for long-term management and
 2   also those that apply to cardioversion procedures,
 3   should be followed."
 4                   And so my question is, you don't
 5   follow those guidelines from page -- or from
 6   Exhibit 5 with respect to cardioversion during an
 7   ablation procedure; is that true?
 8                   MS. CARULAS:  Objection.
 9        A.     No.  This is -- the reference here as we
10   talked about before is really a long-term
11   anticoagulation strategy and not procedure related.
12   BY MR. KULWICKI:
13        Q.     But it says for long-term management and
14   also those that apply to cardioversion --
15        A.     Procedures.
16        Q.     -- procedures, right?
17        A.     It doesn't mean procedures during the
18   ablation.
19        Q.     But this document specifically
20   references patients undergoing ablation therapy.
21        A.     Yes.  So if you've had ablation
22   procedure, the -- the success or failure of that
23   procedure should not impact your anticoagulation
24   strategy down the line.  And if you have a
25   cardioversion two months down the line, you would
0138
 1   continue to go by the guidelines.  It -- that
 2   doesn't refer to the procedure itself because, in
 3   fact, as stated in the other document as we just
 4   talked about, only a very few people were actually
 5   doing Coumadin.
 6        Q.     But in terms of cardioversion separate
 7   and apart from ablation procedures --
 8        A.     Yes.
 9        Q.     -- the standard of care back in 2006 was
10   to anticoagulate patients to a therapeutic INR of 2
11   to 3 during and after the procedure, correct?
12                   MS. CARULAS:  Objection.
13        A.     Or an imaging study and Lovenox or
14   therapeutic INR.
15   BY MR. KULWICKI:
16        Q.     Okay.
17        A.     For cardioversion.
18        Q.     Right.
19        A.     Actually, I don't think it even says
20   Lovenox, but -- Heparin is what it talks about
21   specifically, but Lovenox would be the other option.
22        Q.     Right.  So the options for a patient
23   undergoing cardioversion for a-fib back in August of
24   2006, outside of an ablation procedure, would be an
25   imaging study and a therapeutic INR during and after
0139
 1   the procedure or a therapeutic INR before, during,
 2   and after the procedure, correct?
 3                   MS. CARULAS:  Objection.
 4        A.     If you're just talking about
 5   cardioversion --
 6   BY MR. KULWICKI:
 7        Q.     Right.
 8        A.     -- in respect to nothing else --
 9        Q.     Yes.
10        A.     -- and so in -- some of this comes down
11   to judgment and that obviously there are some
12   patients who don't meet the guidelines or you have
13   other reasons you have to cardiovert them and --
14   irrespective of anticoagulation.  But for elective,
15   ambulatory, nonsurgical patients that you have a
16   choice in, that you would anticoagu- -- you would
17   anticoagulate them around the time of the procedure.
18        Q.     And the reason for that is to avoid
19   thromboembolic complications of the procedure, true?
20        A.     Of the cardioversion.
21        Q.     Correct.
22        A.     Yes.
23        Q.     Okay.
24        A.     Or of the effects of the cardioversion.
25        Q.     Let me turn you back to Exhibit 3, and
0140
 1   maybe you're there already.  Could you turn to 353
 2   and I want to talk to you about the success rate of
 3   a-fib ablation as it was understand -- as it was
 4   understood as of the publication of that document.
 5        A.     Yes.
 6        Q.     I assume success rates weren't any
 7   better before the publication of that document in
 8   2007, right?
 9        A.     It depends on what you're talking about,
10   individual or gross worldwide.
11        Q.     Well, hasn't the procedure gotten better
12   over time as opposed to worse in terms of success
13   rates?
14                   MS. CARULAS:  Objection.
15        A.     That would depend of the individual and
16   the center.
17   BY MR. KULWICKI:
18        Q.     Well, are there centers that their
19   success rate has gone down over time?
20        A.     Well, there are some that have stopped
21   doing it and -- but I'm talking -- in terms of
22   absolute numbers that the -- for example, one
23   technique may be significantly superior to another.
24   And so if you combine those numbers, it may look
25   like one went down.  So it really depends on what
0141
 1   you're talking about, if you're talking about a
 2   success rate at a certain center or a global success
 3   rate.
 4        Q.     What centers have stopped doing a-fib
 5   ablation?
 6        A.     A lot of it is sort of physician
 7   related, but I think -- there's even a place in
 8   Columbus that may have stopped doing it.  Not major
 9   academic centers, but smaller centers.  Some people,
10   you know, attempted and decided it's not for them.
11        Q.     Okay.  At page 353 of Exhibit 3 there's
12   a discussion about that success differs markedly
13   between ablation of paroxysmal a-fib and persistent.
14                   Would you agree with that?
15        A.     Yes.
16                   MS. CARULAS:  Objection.
17   BY MR. KULWICKI:
18        Q.     And the success rate for persistent
19   a-fib is noted as being 22 to 45% with most centers
20   being less than 30%.
21                   Do you agree with that?
22        A.     As a global number, yes, I would agree
23   with that.
24        Q.     Did the clinic publish its success rate
25   for persistent a-fib back in August of 2006?  Was
0142
 1   there a published success rate?
 2        A.     We had presentations and publications.
 3        Q.     And where would that success rate for
 4   persistent a-fib be published at?
 5        A.     Oh, boy.
 6        Q.     In terms of the clinic's experience.
 7        A.     I would have to look that up.
 8        Q.     What do you think the number was back in
 9   August of '06?
10        A.     My estimation for a persistent
11   population at that time first time around was
12   probably around 60%.
13        Q.     Do you think that experience is
14   published in a journal or --
15        A.     I think -- yes.  I think it's been
16   presented at different meetings and -- and as a part
17   of some journal articles.
18        Q.     Page 355 there is list of
19   complications -- or a discussion about complications
20   associated with a-fib ablation.  There's a
21   discussion I believe over here that's starred that
22   says that the complication rate is likely
23   underestimated because of reporting is voluntary and
24   people don't like to report their mistakes.
25                   Would you agree with that?
0143
 1                   MS. CARULAS:  Objection.
 2        A.     Yes.
 3   BY MR. KULWICKI:
 4        Q.     And, for instance, Shannon Sullivan's
 5   outcome was not published anywhere, was it?
 6        A.     Can you be more specific?
 7        Q.     Sure.  Was there any literature, case
 8   report or otherwise where his complication or his --
 9   outcome of his procedure was published?
10        A.     As an individual, I don't believe so.
11        Q.     How about as part of a group?
12        A.     It very well may have been included in
13   things like the Worldwide Survey, something like
14   that.
15        Q.     What's the Worldwide Survey?
16        A.     It's a -- it's just like here.  The
17   Worldwide Survey of AF Ablation, it's a publication
18   of where they send out surveys to centers who do
19   a-fib ablations and you report your complication
20   rate, success rate, things like that.
21        Q.     And would they report that for all
22   comers or just patients that are enrolled in
23   studies, to your knowledge?
24        A.     Well, the Worldwide Survey requests
25   your -- that your -- institution's or individual's
0144
 1   numbers, not a study.
 2        Q.     Who administers the Worldwide Survey?
 3        A.     I think it was HRS.  HRS/EC -- it was
 4   sort of a multiple -- multiple organization
 5   endeavor.
 6        Q.     And were the results from the Worldwide
 7   Survey survey published on an annual basis or some
 8   other periodic basis?
 9        A.     It's periodic -- it's periodic, but not
10   annual.
11        Q.     In terms of the types of complications
12   reported by -- reported in Exhibit 3, one would be
13   cardiac tamponade.  Is that a potential
14   complication?
15        A.     Yes.
16        Q.     Pulmonary vein stenosis, that would be
17   one?
18        A.     Yes.
19        Q.     Esophogeal injury on atrio-esophogeal
20   fistula, true?
21        A.     Yes.
22        Q.     Phrenic nerve injury, correct?
23        A.     Yes.
24        Q.     Thromboembolism, or stroke?
25        A.     Yes.
0145
 1        Q.     Air embolism?
 2        A.     Yes.
 3        Q.     Postprocedural arrhythmias?
 4        A.     Yes.
 5        Q.     Were those new arrhythmias that the
 6   patient didn't have preprocedure?
 7        A.     They may be different arrhythmias.  So
 8   atrial fibrillation would probably still be included
 9   and then a atypical atrial flutters and atrial
10   tachycardias also.
11        Q.     Vascular complications such as groin
12   hematoma, retroperitoneal bleed, a femoral arterial
13   pseudoaneurysm or a femoral arteriovenous fistula.
14   Are those all --
15        A.     Yes.
16        Q.     -- potential complications?
17                   Acute coronary artery occlusion as a
18   potential complication?
19        A.     Yes.
20        Q.     And periesophageal vagal injury, is that
21   a potential complication?
22        A.     Yes.
23        Q.     How about mitral valve trauma?
24        A.     That is potential, yes.
25        Q.     How about pericardial effusion?
0146
 1        A.     Not necessarily a complication, but can
 2   be.
 3        Q.     On page 357 of Exhibit 3 they list the
 4   risk of thromboembolism at between 0 and 7%,
 5   correct?
 6        A.     Yes, that's what it says.
 7        Q.     And they discussed the fact that there
 8   may be silent ones that may occur.  And if that's
 9   the case, they're immeasurable making the rate of
10   thromboembolism unknown.
11                   Would you agree with that?
12        A.     Yes.
13        Q.     And specifically I think I've been told
14   that during this procedure there's a constant shower
15   of emboli from the left atrium -- small microemboli
16   during the course of the procedure; is that true?
17                   MS. CARULAS:  Objection.
18        A.     Well, there are things that have been
19   detected on an ultrasound Doppler type of monitor.
20   BY MR. KULWICKI:
21        Q.     Okay.
22        A.     We don't -- I can't say we know exactly
23   what that is, but there are detections on monitors
24   that are seen.
25        Q.     And would you agree that there is --
0147
 1   during the left atrial ablation procedure that based
 2   on whatever imaging is available, that there are
 3   literally thousands of emboli that shower during
 4   that portion of the procedure?
 5                   MS. CARULAS:  Objection.
 6        A.     Once again, I don't think I can attest
 7   to what the characterization of those things are.
 8   You see -- obviously there's saline bubbles from --
 9   from heating and things like that.  Whether they're
10   all actually emboli in terms of clots, char, things
11   like that, we can't say that.
12   BY MR. KULWICKI:
13        Q.     Okay.  The article talks about most of
14   the thromboembolic complications occurring within
15   24 hours of the procedure.  Is that your experience
16   as well?
17        A.     It appears.  They do occur up to several
18   weeks out.  Most actually appear to occur right in
19   and right around the procedure and then it sort
20   of -- it continues to trail off after the procedure.
21        Q.     And what -- why do you think that is in
22   terms of most of them happening within 24 hours of
23   the procedure?
24        A.     Well, I think the -- I think it's a
25   couple of different things.  One, during the
0148
 1   procedure, I think is the -- the instrumentation
 2   time, and so I think things may occur actually
 3   during the procedure, clots on catheters and sheaths
 4   and things like that.
 5                   After the procedure, I think is --
 6   that one's probably a little bit different and it
 7   may be more spontaneous thrombosis.
 8        Q.     Do you have an opinion as to why Shannon
 9   Sullivan had a stroke?
10                   MS. CARULAS:  I'm going to object.
11   I think you asked this at the very beginning of the
12   deposition, but go ahead.
13                   MR. KULWICKI:  I think we asked if
14   it was device related, and I remember you told us it
15   wasn't device related, so I was --
16                   MS. CARULAS:  You asked the
17   question, but go ahead.
18        A.     I think that -- yeah, in keeping with
19   what I just said, it's -- I can't say for sure.  And
20   I don't think we can, but I think it's most likely
21   spontaneous thrombosis.
22   BY MR. KULWICKI:
23        Q.     Okay.  When you say it's not device
24   related, would you agree that it was probably
25   procedure related?
0149
 1        A.     Well, I think it's more -- it's -- I
 2   can't say 100% for sure, but I think it's more to
 3   him going back into rhythm.
 4        Q.     Tell me about that, what that means.
 5        A.     So I think most likely he just happened
 6   to develop a clot afterwards, probably in the left
 7   atrial appendage, that -- that resulted in a
 8   cerebral embolism.
 9        Q.     And you don't know the reason for that?
10        A.     Well, I can't say for sure that is what
11   it is.  But the reason for it is the fact that he
12   went into rhythm, or like the stunting that we
13   talked about, that's a possibility even though we
14   don't really understand it.  But -- but if you're
15   asking me to sort of rank the possibilities, I think
16   that the clot on sheath, char, air embolism, things
17   are down on the list considering the time period
18   we're out after the procedure, because that's what
19   I'm trying to say.
20        Q.     And why would he develop a clot in the
21   left atrial appendage?
22        A.     Because that's the most common source of
23   clot.
24        Q.     But if he was anticoagulated, why would
25   he clot?
0150
 1        A.     Well, why he did it as opposed to anyone
 2   else in a similar situation, I can't say at all.
 3        Q.     Is that typically the case, that when a
 4   patient has a thromboembolic complication following
 5   AF ablation that you really don't know the reason?
 6        A.     Well, like I said, some of it depends on
 7   the timing.  And so during the procedure, the
 8   air-catheter-related thrombus and char are probably
 9   the -- the big ones, or if -- if something where you
10   damaged the carotid or something like that,
11   obviously those would be the big ones then.  But I
12   think afterward the time changes and so -- I
13   wouldn't -- I would say during the procedure where
14   there -- the chances of spontaneous thrombosis in
15   the left atrial appendage are probably lower on the
16   list.  And the other things we talked about are
17   probably higher on the list.  And as you get away
18   from the procedure, the -- it reverses quite a bit.
19        Q.     But he went into sinus rhythm during the
20   procedure, right?
21        A.     Yes.
22        Q.     So -- and just to clarify what you're
23   saying, because I don't fully understand what you're
24   saying.  But just to clarify, you would agree that
25   if he did not go through this procedure, the AF
0151
 1   ablation with the cardioversion in the middle of it,
 2   that in all likelihood he would not have had a
 3   stroke on August 17, 2006, right?
 4        A.     Well, I would say that being in AF, he's
 5   a risk factor for stroke anyway.  But as -- that
 6   particular day, anything, cardioversion, surgical
 7   procedure, AF ablation procedure certainly puts him
 8   at higher risk, anything that's restoring normal
 9   rhythm in that day.  If he touched a -- touched an
10   electrical outlet and got in a normal rhythm that
11   day, I think he would be at higher risk for stroke.
12        Q.     Okay.  But more likely than not, the
13   procedure was a contributing factor in his stroke,
14   right?
15        A.     Well, like I said, the fact that he got
16   into normal -- at that point, the fact that he got
17   into normal rhythm I think was the risk for stroke.
18        Q.     What's the risk of stroke for a patient
19   that's converted to a normal rhythm from a-fib when
20   they're therapeutically anticoagulated?
21                   MS. CARULAS:  Objection.
22        A.     Let's see.  I think we had talked about
23   before.  It's estimated to be sort of the 1 to 7%.
24   BY MR. KULWICKI:
25        Q.     Do you think that his stroke is related
0152
 1   at all to his anticoagulation status?
 2                   MS. CARULAS:  Objection.
 3        A.     I don't think I can say 100%.  It
 4   appears in populations that the -- that the risk is
 5   lower if you're therapeutically anticoagulated.  As
 6   an individual, I can't say that.
 7   BY MR. KULWICKI:
 8        Q.     Is it likely a contributing factor to
 9   his stroke?
10                   MS. CARULAS:  Objection.
11        A.     As I said, I think the risk is in that
12   population to be higher.  But for him personally, I
13   can't say.
14   BY MR. KULWICKI:
15        Q.     We could agree that he didn't have a
16   left atrial or left atrial appendage thrombus
17   preoperatively, true?
18        A.     That's correct.  Or at least at -- even
19   at the end of the procedure.
20        Q.     How would you know that at the end of
21   the procedure, via the ICE monitoring?
22        A.     Yes.
23        Q.     And what's the sensitivity and
24   specificity of ICE monitoring for detecting left
25   atrial or left atrial appendage thrombus?
0153
 1        A.     For left atrial thrombus, it's pretty
 2   good.  Left atrial appendage thrombus, it's not as
 3   well studied.  There's been one study that seems to
 4   show that it's reasonable.
 5        Q.     Okay.  What's reasonable --
 6        A.     That --
 7        Q.     -- percentage-wise?
 8        A.     It's I think well into the 90s.
 9        Q.     What is the risk of thromboembolic
10   complication of a-fib for patients who have lone
11   a-fib with no other risk factors?
12        A.     For a-fib ablation --
13        Q.     No, no, no.
14        A.     -- or --
15        Q.     Without ablation.
16        A.     Without ablation.
17        Q.     Yeah.
18        A.     So it's estimated to be sort of 1 to 2%
19   a year.
20        Q.     And isn't it the case that a patient who
21   has lone a-fib and a CHADS2 score of 0 are at such a
22   low risk of stroke that the recommendation is that
23   they not even necessarily be anticoagulated?
24        A.     No, I would say that's not true.
25        Q.     Okay.
0154
 1        A.     I would say that the recommendation is
 2   for anticoagulation with aspirin.
 3        Q.     Okay.
 4        A.     The -- and I wouldn't say that they're
 5   low risk for stroke necessarily.  What I would say
 6   is that the risk of anticoagulation with Coumadin is
 7   likely higher than the benefit of stroke reduction
 8   in that population.
 9        Q.     Okay.  And with respect to patients with
10   lone a-fib and a CHADS2 score of 0, is there --
11   what's their risk of stroke?  Is it the 1 to 2%?
12        A.     Yes.
13        Q.     Okay.  I didn't know if you were
14   referencing a treated versus untreated risk.  Does
15   that risk increase with age?
16        A.     Well, if you get up to a certain age,
17   then you're no longer a lone a-fib.
18        Q.     Okay.  Now, let's talk about magnetic
19   navigation systems.  Can we agree that the remote
20   magnetic systems were not FDA approved for atrial
21   fibrillation back in August of 2006?
22        A.     I would say at that time nothing was
23   approved --
24        Q.     Right.
25        A.     -- for atrial fibrillation.
0155
 1        Q.     Well, what was the regulatory status of
 2   the magnetic tip catheter and the monitoring, the
 3   mapping, and navigation systems like cardioversion
 4   that go along with that back in August of 2006?
 5        A.     The catheter -- the catheter's an FDA
 6   supplement to the manual catheter.
 7        Q.     And do you know when that supplement was
 8   added?
 9        A.     I don't know the exact year.  I think --
10   I'm not sure exactly when it was actually submitted
11   to the FDA.  But as a supplement, I believe it was
12   approved around 2005, something like that.
13        Q.     Okay.  And can we agree that there
14   were -- that studies were not available in August of
15   2006 to establish that the use of the magnetic tip
16   catheter or the remote-guided system improved
17   outcomes or safety?
18        A.     I would say there's no scientific
19   evidence to prove it just like with the other
20   catheters, but there were studies published with
21   some suggestion that it might be safer.
22        Q.     Okay.  Wasn't scientifically proven,
23   though, right?
24        A.     Yes.
25        Q.     Okay.  Now, let's go to Exhibit 2 again.
0156
 1   And hopefully I can get through this a little bit
 2   more -- or a little quicker.
 3                   Now, we talked to Dr. Kanj and I
 4   think he agreed that in all likelihood the left side
 5   of the heart was ablated using a manual catheter and
 6   the right side of the heart was done remotely with a
 7   magnetic catheter; is that true?
 8        A.     That is correct.
 9        Q.     Okay.  What's the purpose of the op
10   note?
11        A.     Is that the end of the question?
12        Q.     Yes.
13        A.     Just to describe what was -- what was
14   done during the procedure.
15        Q.     Okay.  And is there any mention of the
16   use of remote guidance in the op note?
17        A.     No.
18        Q.     And why would you not include that
19   information?
20        A.     I don't always include my particular
21   tools.  And just like I don't necessarily mention
22   what type of scalpel I use in a device.
23        Q.     Well -- but this is different than a
24   type of scalpel.  This is a whole sort of
25   investigational navigation and operating system,
0157
 1   correct?
 2                   MS. CARULAS:  Objection.
 3        A.     I'd consider it a tool for ablation.
 4   BY MR. KULWICKI:
 5        Q.     Was fluoroscopy used for both the
 6   left-sided ablation and the right-sided ablation?
 7        A.     Yes.
 8        Q.     And you saw the DVD showing the
 9   fluoroscopy images that we have available, correct?
10        A.     Yes.  I saw two what appear to be fluoro
11   loops.
12        Q.     And that just shows the right side?
13        A.     That's correct.
14        Q.     Why would -- why would the clinic only
15   record or -- well, first of all, whose decision is
16   it as to what portions to record and maintain?  Is
17   that your decision as the attending?
18        A.     Sometimes if I elect to save something,
19   I can.  And then I think the system may have an
20   automatic last-loop save or something.
21        Q.     Okay.  Why -- do you think that
22   following a procedure like this that -- strike that.
23                   In the op note there's a mention
24   that systemic anticoagulation was discontinued and
25   reversed with protamine.
0158
 1        A.     Yes.
 2        Q.     It doesn't say partially reversed or
 3   that it was partially continued.
 4        A.     Uh-huh.
 5        Q.     Can we agree that the intent of the
 6   protamine reversal was to stop the systemic
 7   anticoagulation in terms of Heparin?
 8        A.     I wouldn't say stop.  I would say to
 9   thicken the blood enough to safely remove the
10   sheaths.
11        Q.     How many times have you used remote
12   navigation prior to this procedure based on your
13   recollection?
14        A.     Best guess, 100 to 200.
15        Q.     Did you use remote navigation to do the
16   left side of the heart in this case?
17        A.     No.
18        Q.     And why would you use it for the right
19   side but not the left side?
20        A.     One would be entering the right
21   ventricle on the right side after anticoagulation.
22   It's a thin structure, and so it's just part of my
23   routine and practice.  I don't like putting anything
24   with a relatively stiff shaft or tip in the right
25   ventricle.  And I also think it has a little more
0159
 1   stability on the right, so potentially avoid
 2   damaging the phrenic nerve.  And it also doesn't
 3   have the power or depth of the -- of the ThermoCool
 4   catheter, and so it may be a little safer on the --
 5   in the superior vena cava area.
 6        Q.     Who did the ablations in Mr. Sullivan's
 7   case and who managed the mapping catheter?
 8        A.     So I would have done the vast majority
 9   of ablation, and the mapping catheter would have
10   likely been mostly Dr. Kanj.
11        Q.     And how do you know that?
12        A.     That's what I do.
13        Q.     And when you say the vast majority of
14   the ablations, would Dr. Kanj likely have done some
15   of them?
16        A.     Yes, he may have done some.
17        Q.     And why is that not recorded?
18        A.     Because, once again, just talking about
19   what we -- what we did in the procedure, not
20   necessarily saying who was holding what or things
21   like that.
22        Q.     Is both the positioning of the mapping
23   catheter and the ablation catheter both considered
24   critical parts of the procedure?
25        A.     I would say both are -- both are
0160
 1   important, yes.
 2                   MS. CARULAS:  Do either of you have
 3   another pad of paper?
 4                   MR. KULWICKI:  I may have.
 5                   MS. CARULAS:  I have gone through
 6   three pads.
 7                   (Comments off the record.)
 8   BY MR. KULWICKI:
 9        Q.     On Exhibit 2 -- strike that.
10                   I'm going to mark as Exhibit 6 what
11   was previously marked as Dr. Kanj's Exhibit 4, which
12   is another version of the op note.  And if I could
13   just have you tell me, generally speaking, why there
14   would be two different versions of the op note.
15                   (Deposition Exhibit No. 6 marked.)
16        A.     The reason is there are two different
17   systems, computer systems.  One is the actual
18   medical record of the patient and the other is a
19   system that gen -- that's a report generator for the
20   laboratory.
21   BY MR. KULWICKI:
22        Q.     Okay.  Now, this indicates that it was
23   prepared and approved on August 17 at 1741.  Would
24   that be the time that you dictated that, Doctor?
25        A.     Well, it's not dictated.  It's -- it's
0161
 1   typed into the computer.
 2        Q.     Is that when you would have completed
 3   your typing or what would that mean?
 4        A.     It would be around that time.
 5        Q.     Okay.  Exhibit 2 has a result date and
 6   time, which is roughly the same time.  It's about a
 7   minute off.
 8        A.     Uh-huh.
 9        Q.     What does that refer to?
10        A.     Let's see.  PAT is in the -- in the
11   other database, so that may have been when it --
12   when it came over, or the clocks are different.  I
13   don't know.
14        Q.     Okay.  And in Exhibit 4 on page 2
15   there's -- at the bottom it has recording sites and
16   there are a number of items issued there -- or
17   listed there.  What does that mean?
18        A.     Just means areas that the -- that you
19   had catheters in that record electrical signals.
20        Q.     Now, in addition to the DVD of the
21   fluoroscopy images that we talked about earlier --
22        A.     Uh-huh.
23        Q.     -- we were provided with another image,
24   which was previously marked as Kanj's Exhibit 7 and
25   I will also mark it as Burkhardt Exhibit 7.
0162
 1                   (Deposition Exhibit No. 7 marked.)
 2   BY MR. KULWICKI:
 3        Q.     It's a snapshot image, I believe, of an
 4   electroanatomic image.  Is that what that is?
 5        A.     That is correct.
 6        Q.     And typically would you record more than
 7   just this simple snapshot as part of this type of
 8   procedure?
 9        A.     Can you be more specific?
10        Q.     Yeah.  This -- this is all that was on
11   the DVD was this single snapshot.  It wasn't a
12   dynamic electroanatomic image that showed from one
13   portion of the procedure to the next.  Instead it's
14   just a single snapshot.
15                   And my question is, typically would
16   you record more than this single snapshot that we
17   have a picture here as Exhibit 7 as part of this
18   type of procedure?
19                   MS. CARULAS:  Objection.
20        A.     Well, I believe this was all that was
21   done with this.
22   BY MR. KULWICKI:
23        Q.     Okay.  And why would you have taken that
24   particular picture or why would that one have been
25   saved?
0163
 1        A.     Well, in general, we would save
 2   everything off of the CARTO system, the different
 3   electroanatomic mapping system.  Those -- most of
 4   those were saved onto a DVD type of disk and put in
 5   a file.
 6        Q.     And where would that file be?
 7        A.     It's -- they were usually put in a disk
 8   holder, which was a box, was like that, and there
 9   were several of them.  And that's likely the DVD
10   that present these images on.
11        Q.     Would they be listed by the patient
12   number or patient identification, information like
13   name or number?
14        A.     I'll say I'm not sure on that.  It may
15   be just from the -- it may be just a date range
16   even, because I think it depends on whether they
17   saved this one as a sole one or as a group.
18        Q.     And would you keep those for every
19   patient?
20        A.     For the CARTO, yes.  Almost every CARTO
21   procedure was saved if it was -- if anything was
22   generated from it.
23        Q.     Is CARTO just for the remote?
24        A.     Well, now, Carto can be used with
25   specific manual catheters, not the one used in this
0164
 1   case.  But CARTO can be used for the remote -- this
 2   remote catheter too.
 3        Q.     So that CARTO image that we have marked
 4   as Exhibit 7 would be associated with the magnetic
 5   tip catheter?
 6        A.     Yes.
 7        Q.     Would you typically save ICE images as
 8   part of a procedure like this?
 9        A.     No.  ICE is only saved sort of on
10   demand.
11        Q.     And relative to manual catheterization
12   where CARTO isn't used, are there any other
13   recordings or images that are kept that show what
14   happened during the procedure?
15        A.     Not other than the things we've talked
16   about.
17        Q.     In terms of saving these CARTO images,
18   would that be -- what would be the reason for
19   systematically collecting that information and
20   storing it by date?
21        A.     Well, this is a little different than
22   the other mapping system.  And so it -- it's a
23   little better in terms of the -- the anatomic
24   portion of the other system is good.  The electrical
25   system not as good.  And so this one we -- this
0165
 1   system we tend to use for more complex arrhythmias
 2   and things like that, and so more apt to be useful
 3   information if needed again, and so all of the
 4   CARTOs we would save.
 5        Q.     And would that be something that people
 6   other than you, other physicians, would go back and
 7   look at or reference at some point in time?
 8        A.     Well, they might if they're looking for
 9   something in particular.
10        Q.     Would you go back and look at other
11   people's CARTO images that they saved for purposes
12   of training or experience or research?
13        A.     Yes.
14        Q.     And they would all be in the same file
15   that you would put your images in -- your CARTO
16   images in?
17        A.     They -- usually they were just stored by
18   room, I think.
19        Q.     By what?
20        A.     By room.
21        Q.     Did you have a room designated to you or
22   would there be other EPs that would use the rooms
23   that you would use?
24        A.     I mostly used that one room, but several
25   other physicians also used them.
0166
 1        Q.     And in terms of -- strike that.
 2                   In terms of the sedation that was
 3   used in the procedure, let me refer to Exhibit 2, it
 4   indicates that it was commenced at 1335 with Versed
 5   and Fentanyl, correct?
 6        A.     Well, I can't actually read it, but --
 7        Q.     I think it's --
 8        A.     -- I think it is.
 9        Q.     Yeah.  It's every five minutes, so if
10   you go down --
11        A.     It's got a little hole or something
12   through it.
13        Q.     Right.
14        A.     But the next one says 1349, I think.
15        Q.     I think it's 1340 and then they go every
16   five minutes if you page forward.
17                   Anyhow, Doctor, that --
18        A.     That's --
19        Q.     -- really wasn't the point of my
20   question.  My -- the point was, would that reflect
21   sedation once the patient is in the lab?
22        A.     No, sedation -- the patient would be in
23   the lab for a while before that actually.  And so
24   during the prepping and things, it would be -- that
25   would be after the time out is confirmed.
0167
 1        Q.     Okay.  With respect to --
 2                   (Cell phone interruption.)
 3                   THE WITNESS:  Sorry.
 4                   MR. KULWICKI:  That's all right.  We
 5   can go off.
 6                   THE VIDEOGRAPHER:  Off the record at
 7   12:43.
 8                   (Recess taken, 12:43 p.m. to
 9   12:44 p.m.)
10                   THE VIDEOGRAPHER:  We're back on the
11   record at 12:44.
12   BY MR. KULWICKI:
13        Q.     All right.  Doctor, before the break we
14   were talking about sedation.  And before Fentanyl
15   and Versed are given --
16        A.     Yes.
17        Q.     -- is the patient put into a twilight
18   state with any other medication?
19        A.     No.
20        Q.     Okay.  How quickly acting are Fentanyl
21   and Versed?
22        A.     Very quickly, within a couple of minutes
23   usually.
24        Q.     Okay.  There's a note in your op note
25   that an esophageal temperature probe was used.  Are
0168
 1   there any recordings made from that particular
 2   probe?
 3        A.     They're actively recorded, but they're
 4   not saved.
 5        Q.     Okay.  And postoperatively this patient
 6   was noted to have a new esophageal stenosis and
 7   pericardial effusion.  Would those be --
 8        A.     Pardon me?
 9        Q.     I'm sorry?
10        A.     The esophageal stenosis.
11        Q.     Yeah.  You weren't aware of that?
12        A.     I'm just not sure what you're referring
13   to.  Could you show me?
14        Q.     Okay.  I don't have those records with
15   me.  But would an esophageal stenosis -- a new
16   esophageal stenosis after this procedure and a
17   pericardial -- well, let me take it one at a time.
18                   Is that evidence of tissue
19   overheating during the procedure?
20                   MS. CARULAS:  Objection.
21        A.     Well, on the esophagus, I'm still not
22   sure what you're referring to, so I would have to
23   see.
24   BY MR. KULWICKI:
25        Q.     Okay.
0169
 1        A.     The pericardial effusion, it's a very
 2   common thing after the procedures.
 3        Q.     What causes pericardial effusion?
 4        A.     Most often inflammation on the outside
 5   of the heart.
 6        Q.     Due to what?
 7        A.     Due to the burning, that it irritates
 8   the lining on the outside of the heart and produces
 9   a little fluid.
10        Q.     And lower power settings, is the risk of
11   pericardial effusion decreased?
12                   MS. CARULAS:  Objection.
13        A.     Pericardial effusion itself is seen in
14   nearly everybody.  It's a -- perforation, however,
15   is a different deal.
16   BY MR. KULWICKI:
17        Q.     Referring to Exhibit 2, again, there is
18   an indication on page 2 of that particular op note
19   that you reviewed the record on August 20th and that
20   Dr. Cummings reviewed it on August 22.  Do you know
21   what purpose there would be in those reviews?
22        A.     So August 20th and 22nd.  So these I
23   believe are computer-generated things from the
24   electric -- from the electronic medical record, and
25   so they can be -- they could be one of several
0170
 1   things.  They could be us just look -- following the
 2   patient and looking up something on the computer.
 3   The other is that anytime a report is generated,
 4   just like the -- the one that's transferred in --
 5        Q.     Uh-huh.
 6        A.     -- if you're involved in that patient,
 7   it comes to your personal site on the electronic
 8   medical record, and you have to clear it saying that
 9   you reviewed it.  You have to actually click on
10   something saying, yeah.  And so all the labs and
11   basically anything that goes into that record that
12   has any association with you comes to you.
13        Q.     So in terms of these indicating that
14   there was a review in all likelihood, you and Dr.
15   Cummings would have looked at his chart for some
16   reason on those dates, but you can't tell from that
17   fact what portion of the record --
18        A.     Well --
19        Q.     -- you would have reviewed?
20        A.     Well, may have looked at the chart or it
21   just may have come in as a thing to clear on the --
22   on the sort of electronic to-do list.
23        Q.     Later in Exhibit 2 there is some
24   handwriting about informed consent for the procedure
25   and sedation, and there's a risks, benefits, and
0171
 1   alternatives discussed, somebody handwrote in yes.
 2   Patient agrees to proceed, somebody wrote in yes.
 3   And then above that it says, August 16, 2006, in
 4   epic.
 5                   Is any of that your handwriting?
 6        A.     No.
 7        Q.     And in terms of the portion of the
 8   pre-op H&P you prepared and Nurse Poe prepared --
 9        A.     Yes.
10        Q.     -- where it says risks and benefits and
11   alternatives discussed with the patient, is that
12   something that you physically type in or is it
13   already there as part of the form when you prepare
14   that form?
15        A.     I type that in.
16        Q.     On this there's something here where it
17   says -- there's something that says POCT stickers
18   and then there's some -- a couple of mathematical
19   equations.  What do those refer to, if you know?
20        A.     POCT is point of care testing, which
21   usually refers to things like INRs, ACTs.  But what
22   the stickers are, I don't know.  I believe that the
23   V, these are drug totals --
24        Q.     Okay.
25        A.     -- is what the V and F are.  That's what
0172
 1   it looks like.
 2        Q.     And do you know what those would refer
 3   to, Versed and Fentanyl, do you think?
 4        A.     Yes.
 5        Q.     Okay.  There are three or four nurses
 6   listed at the very bottom of that page you're
 7   looking at.  Do you recognize any of those nurses'
 8   names?
 9        A.     Let's see.  I believe the top one is
10   Kathy Brogan.  The bottom one I believe is Cheryl
11   Maggio.  That one's tough to read, but that may be
12   John Lopez.  And I can't make out the one in the
13   middle on the left.
14        Q.     Do you know what role each of those
15   nurses would have played in this procedure based on
16   how they typically would be involved?
17        A.     Well, one would usually be at the head
18   of the bed and so administering anesthesia, monitor
19   and take down vital signs.  One would likely be a --
20   sort of a circulator/scrub tech, which would get
21   equipment and assist in anything else needed.  And
22   the other one would usually be at the ablation
23   panel.
24        Q.     And why would there be a fourth one as
25   it appears?
0173
 1        A.     Usually we don't have four in a room but
 2   to -- to relieve people.  So if someone needs to go
 3   to the bathroom or something like that or take a
 4   break, and then usually someone comes in to relieve.
 5        Q.     Okay.  Now, further in this document
 6   it -- on the procedural sedation, additional
 7   monitoring log at 1647 there's an indication about
 8   DCC, looks like 120 joules; and then at 1650, DCC
 9   with 200 joules.
10                   Are those two efforts at
11   cardioversion?
12        A.     Yes.
13        Q.     The one was success -- the second one
14   was successful, right?
15        A.     The second one was successful, yes.
16        Q.     And these would be electro -- obviously
17   electrical cardioversions?
18        A.     Yes.  Direct current, yes.
19        Q.     Now, at 1715 there's a note that says,
20   "Dr. Burkhardt aware."  Does that signify that you
21   wouldn't have been present at that point in time?
22                   MS. CARULAS:  Objection.
23        A.     No.  That's -- there's an arrow from the
24   ACT --
25   BY MR. KULWICKI:
0174
 1        Q.     Okay.
 2        A.     -- that says 417.
 3        Q.     Right.
 4        A.     That just means that they told me the
 5   ACT and I told them no more Heparin or anything like
 6   that since it was in the appropriate range.
 7        Q.     And why would they chart that you're
 8   aware if you're there and obviously aware?  I mean,
 9   that in my experience always signifies that they're
10   identifying for a doctor who's not present that
11   something of importance is happening.
12                   MS. CARULAS:  Objection.  Anyway --
13        A.     I don't --
14                   MS. CARULAS:  I mean, if it's -- if
15   it's not documented, it's -- you know, I mean,
16   it's -- it's -- anyway, I'm objecting to his
17   experience.  Go ahead, you can finish your answer.
18        A.     Okay.  I can say I don't know why they
19   put that on there other than to say I didn't give
20   any new Heparin orders.
21   BY MR. KULWICKI:
22        Q.     Okay.  In the margin of that document,
23   sort of cut off, but --
24        A.     Uh-huh.
25        Q.     -- there's like a star and a question
0175
 1   mark.  Is any of that your handwriting?
 2        A.     No.
 3        Q.     And I'm looking at the left margin.  Do
 4   you know what any of that signifies, the star and
 5   the question mark or any of that other marginalia?
 6        A.     That's cut off.  I'm not even sure
 7   what -- if that's a question mark or it -- or it's
 8   another star that's cut off.  I can't tell.  But I
 9   can't correlate them to anything.
10        Q.     In terms of the protamine and the
11   Heparin, Dr. Kanj gave us, I believe, a formula that
12   a certain number of milligrams of protamine reverses
13   a certain number of units of Heparin; is that right?
14        A.     It's an estimation.
15        Q.     Okay.  And can you tell me what that
16   estimation is, just to refresh, so we can talk about
17   that?
18        A.     It's sort of 1 to 10, or something like
19   that.  It's --
20        Q.     One milligram of protamine would reverse
21   10 milligrams of Heparin?
22        A.     Well, it's units of Heparin.  And so I
23   think it's -- or maybe it's 100 -- 1 to 100.  That's
24   just -- I tend to do this by guessing as opposed
25   to -- I guess on my experience as opposed to
0176
 1   mathematics.
 2        Q.     How many units of Heparin were given
 3   during this procedure?
 4        A.     Wow, let's see.  I can't tell you.
 5   It's -- it would be a complex mathematic evaluation,
 6   so...
 7        Q.     Okay.  In terms of the target ACT for
 8   sheath removal, can we agree that in August of 2006
 9   it was 200?
10        A.     In general you'd like it less than 200.
11   And if there's any bleeding, you'd like it lower
12   than that.
13        Q.     Okay.  Did he have any bleeding?
14        A.     Not that I'm aware of, but I didn't pull
15   the sheaths.
16        Q.     In a patient like this, what would you
17   consider to be in -- too low of an ACT postop?
18        A.     I don't think we have a too low level.
19        Q.     Do you have an opinion why his procedure
20   ultimately failed; in other words, he returned to
21   a-fib?
22        A.     Well, in general, the most common
23   incidence is reconduction of one of the veins.
24        Q.     Okay.  And why would that occur?
25        A.     Well, there -- everything we have is
0177
 1   imperfect, in that some things that you -- you know,
 2   you achieve isolation, not everything always remains
 3   isolated.  And so in some areas you may not -- you
 4   may damage it as opposed to -- to kill the tissue
 5   and such.  It tends -- it's the most common.  Plus
 6   there's potentially other areas that initiate atrial
 7   fibrillation that were not included in the ablation
 8   set.
 9        Q.     Now, his surgery was in August of '06.
10   And in November of '06, he was at Metro Health
11   getting rehabilitation and --
12        A.     Yes.
13        Q.     -- he had an electrocardioversion
14   November 8 of 2006.
15        A.     Yes.
16                   (Deposition Exhibit No. 8 marked.)
17   BY MR. KULWICKI:
18        Q.     It appears -- it's noted in Deposition
19   Exhibit 8, it appears that he was transferred back
20   to The Cleveland Clinic for that cardioversion.
21        A.     Yes.
22        Q.     And I'm wondering if you can tell me why
23   that would be, why Metro wouldn't just do a
24   cardioversion there.
25        A.     I can't tell you why they chose to do
0178
 1   that that way.  I can guess, but --
 2        Q.     Okay.  Was it because it's part of any
 3   sort of protocol for a patient like Mr. Sullivan?
 4        A.     Well, the -- their rehabilitation there,
 5   their unit, is more of a kind of an outpatient unit,
 6   and so it would have likely been treated as an
 7   outpatient, didn't go back to the person who did --
 8   who was taking care of their atrial fibrillation.
 9        Q.     Can we agree that Mr. Sullivan's a-fib
10   ablation was an elective procedure?
11        A.     Yes.
12        Q.     And do you think that his prior MI
13   impacted his chance of success for the procedure in
14   any respect?
15                   MS. CARULAS:  Objection.
16        A.     Once again, I'm not sure on this prior
17   MI.
18   BY MR. KULWICKI:
19        Q.     Whether he even had one.
20        A.     Right, so...
21        Q.     Now, in postop testing there were some
22   evidence of some new cardiac anomalies like
23   regurgitation and some valve issues.  Do you know
24   what the -- do you know what I'm talking about,
25   first of all?
0179
 1        A.     Could you show it to me?
 2        Q.     No, because I don't have those records
 3   with me.  You don't recall offhand?
 4        A.     I'd have to look at the record to
 5   discuss it properly.
 6        Q.     Okay.  In terms of issues like mitral
 7   valve regurge in -- well, let's go with that one.
 8                   Why would that occur following an
 9   ablation procedure?
10        A.     Can we talk specifically about the
11   patient?
12        Q.     Yeah.  Let me --  I'll tell you what,
13   I'll --
14        A.     I'm not seeing what you're doing.
15        Q.     Sure.  Let's -- let's can that question
16   for now and I'll get that information and we'll
17   follow up in a minute.
18        A.     Okay.  Because I have an echo here from
19   November that --
20        Q.     There's no evidence of --
21        A.     -- that looks essentially normal.  I'm
22   not sure what you're referring to.  It says he's got
23   some atheroma in his thoracic aorta, but otherwise
24   it's grossly normal.
25   BY MR. KULWICKI:
0180
 1        Q.     All right.  Let me follow up with that.
 2   The preop orders for postop care indicates that
 3   there should be an increased number of neuro
 4   checks -- or a number of neuro checks in the postop
 5   period.  What's the reason for that?
 6        A.     So they're a standardized order set.
 7   After the ablation procedure, it talks about neuro
 8   checks.
 9        Q.     And the reason is, is because the
10   patient's at increased risk of stroke, correct?
11        A.     To assess for neurologic deficits, yes.
12        Q.     Would you have any involvement in the
13   creation of the Cleveland Clinic's website that
14   would have been published in 2006 in terms of
15   approving the content or any of that sort of thing?
16        A.     No.
17                   (Telephone interruption.)
18                   MR. MARGOLIS:  Go off the record a
19   minute.
20                   THE VIDEOGRAPHER:  Off the record at
21   1:02.
22                   (Recess taken, 1:02 p.m. to 1:04 p.m.)
23                   THE VIDEOGRAPHER:  We're back on the
24   record at 1:04.
25   BY MR. KULWICKI:
0181
 1        Q.     To your knowledge, Dr. Burkhardt, was
 2   Shannon Sullivan in any formal clinical study?
 3        A.     No.
 4        Q.     Was there a reason why he was excluded
 5   from any of the studies that were going on with
 6   respect to atrial fibrillation ablation at the
 7   clinic at this time period?
 8                   MS. CARULAS:  Objection.
 9        A.     We'd have to go through the specific
10   studies.  The ones that I recall he wouldn't have
11   been a candidate for.
12   BY MR. KULWICKI:
13        Q.     Because of persistent a-fib?
14        A.     Yes.
15        Q.     Okay.  Any other reason?
16        A.     There would be -- there may be in
17   addition to that.  Probably follow up would be an
18   issue.
19        Q.     Okay.  Are you familiar with an article
20   by a Dr. Patel, and I think Dr. Natale's a coauthor
21   on it, that studied something in the neighborhood of
22   26 patients out of 3,000 who had undergone atrial
23   fibrillation ablation at the clinic and had a stroke
24   as a result.  Are you familiar with that?
25        A.     Yes.
0182
 1        Q.     Are you --
 2        A.     I'd be happy to look at it.
 3        Q.     I don't have it on me.  But in it the
 4   one common thing amongst all the patients was that
 5   all of the patients that had the stroke had a
 6   subtherapeutic INR.  And what I wanted to ask you is
 7   if you know -- because it's not really clear from
 8   the article -- whether that was a subtherapeutic INR
 9   before, during, or after the procedure that appeared
10   to be the contributing factor.
11        A.     I can't say I know.  And I believe that
12   may have included some patients who were even taken
13   off of Coumadin prior, back before we initiated the
14   other protocol.
15        Q.     All of those patients had recovery from
16   their stroke.  They didn't have any permanent
17   deficits from their stroke.
18        A.     I believe one actually died in the
19   following.
20        Q.     I think that's right, yeah.
21        A.     So --
22        Q.     But I don't know if it was related to
23   the stroke.
24        A.     Yeah, that -- yeah.  That's in follow
25   up, so I really -- don't really know.  I thought
0183
 1   there was another that had something.
 2        Q.     Okay.
 3        A.     Trying to remember what it was.
 4        Q.     All right.  In terms of outcomes,
 5   Mr. Sullivan's was one of the worst that you've
 6   seen, true?
 7        A.     Yes.
 8        Q.     And did he have any risk factors that
 9   you're aware of that contributed to the severity of
10   his complication?
11        A.     I don't think we have any data that --
12   that correlates with the severity very well.
13   There's some retrospective data that's sort of on
14   the stroke or no stroke.  But on the severity, I
15   don't think we're very good at.
16                   (Deposition Exhibit No. 9 marked.)
17   BY MR. KULWICKI:
18        Q.     Okay.  I'm going to hand you what I've
19   mark as Exhibit 9.  It is a portion -- or a one-page
20   segment of Heart Rhythm Journal.  It is an abstract.
21   You're listed as a coauthor along with Dr. Wazni,
22   Saliba, Cummings, Natale.  And it talks about
23   experience -- operator experience, the impact on
24   success of PVAI ablation.
25                   The conclusion is, is that
0184
 1   "High-volume operator experience results in a marked
 2   reduction in the procedure and fluoroscopy times of
 3   PVAI.  Operator experience also affects AF
 4   recurrence after PVAI."
 5                   And do you agree with that?
 6        A.     Yes.
 7        Q.     And I'll show those to you.  But in
 8   terms of what they consider to be an experienced
 9   operator, they talked about a case load of being
10   greater than 400, true?
11        A.     Yes.  And this is with the 8 millimeter,
12   though.
13        Q.     Okay.  Is the 8 millimeter harder to use
14   than the irrigated tip catheter?
15        A.     I wouldn't say harder to use.  It --
16   like we talked about before may be some efficacy
17   differences.
18        Q.     Would you think that the experience
19   level would be comparable between becoming competent
20   in an experienced operator as that term's used in
21   that article?
22        A.     I would say that it's probably easier to
23   perform isolation with the irrigated than with the 8
24   millimeter.
25        Q.     Is there any published number of
0185
 1   procedures that is used to deem someone an
 2   experienced operator when it comes to the irrigated
 3   tip catheter?
 4        A.     No.  The -- originally they -- I know
 5   they had looked at certifying programs, and they
 6   were trying to get 75 cases a year, but that
 7   actually -- that number was even too high and
 8   knocked out the majority of programs.
 9        Q.     Was there a point in time when you
10   started doing PVAI ablation with -- exclusively with
11   an irrigated tip catheter to the exclusion of the
12   8-millimeter catheter?
13        A.     Yes.
14        Q.     What time period would that have been?
15        A.     Oh, boy.  Probably somewhere in two
16   thousand and -- it may have been 2005 or early.
17        Q.     Would you have some record that you
18   could check to confirm that for you or some
19   publication or some other --
20        A.     No.
21        Q.     With respect to the -- the study of
22   a-fib ablation for treatment of paroxysmal a-fib
23   that was being done by the clinic in this time
24   frame, I read something where there was difficulty
25   getting study participants for that.  Were you
0186
 1   familiar with that problem?
 2        A.     Yes.
 3        Q.     And what was the reason why there was
 4   difficulty getting study participants?
 5        A.     Because most of the patients who came
 6   wanted an ablation, and the other arm in that study
 7   was not an ablation.
 8                   MR. KULWICKI:  Okay.  Got it.  I
 9   think I'm done.  Give me a few minutes and -- oh,
10   let me hand you what I'll mark as Exhibit 10, which
11   was previously marked as Kanj Exhibit 2.
12                   (Deposition Exhibit No. 10 marked.)
13   BY MR. KULWICKI:
14        Q.     It's a listing of procedures performed
15   by Dr. Kanj as a fellow -- or SVT/VT ablations
16   performed by Dr. Kanj, lists 207 prior to
17   Mr. Sullivan's procedure.
18                   Do you know how many of those would
19   have been performed using an irrigated tip catheter
20   versus how many were used performing -- or done
21   using an 8-millimeter?
22        A.     I can't tell you that.
23        Q.     Is there any way to find that out?
24        A.     That would be very difficult, but --
25        Q.     Is that kind of data collected as part
0187
 1   of the fellowship program?
 2        A.     No.  That -- you would literally have to
 3   go through every case he did and look through the
 4   billing records, I think.
 5                   MR. KULWICKI:  Okay.  I think I'm
 6   done.  Give me five seconds to confer with
 7   co-counsel.  Let's go off the record and --
 8                   THE VIDEOGRAPHER:  Off the record at
 9   1:12.
10                   (Recess taken, 1:12 p.m. to 1:13 p.m.)
11                   THE VIDEOGRAPHER:  Back on the
12   record at 1:13.
13   BY MR. KULWICKI:
14        Q.     Doctor, do you have a current CV that
15   would list all of your articles and abstracts?
16        A.     Not the current-current.
17        Q.     Okay.
18        A.     I have one -- one I updated last is
19   probably a couple of months old.
20        Q.     Can you get a list of articles that
21   you've published since your most recent CV and a
22   copy of your most recent CV and e-mail that to
23   Attorney Carulas.
24        A.     Okay.
25        Q.     And I'd like to look at that.  And the
0188
 1   last thing I want to ask you about, I apologize for
 2   being so thick about this, but I'm just trying to
 3   understand it.
 4                   With respect to the protamine
 5   reversal, does it bind with the Heparin instantly or
 6   relatively instantaneously?
 7        A.     We -- I'm not sure I know the answer to
 8   that question.  But I know we wait -- usually wait
 9   15 minutes or so to check after protamine's given.
10        Q.     And is the expectation that any more
11   than 15 minutes after it's given, that it won't
12   continue to reverse or it won't change the ACT
13   markedly?
14        A.     Well, that's tougher too on whether you
15   think that's a real number or not.  And --
16        Q.     The ACT number.
17        A.     Exactly.  And so you may draw -- even
18   though the level -- the actual level may be similar,
19   even though you draw another -- another number, it
20   may be different.  So -- because we talked about it
21   being a crude test.
22        Q.     Yeah.
23        A.     It's kind of like that.
24        Q.     Do you have any reason to believe that
25   the 170 listed as the -- 151, whatever that last ACT
0189
 1   was --
 2        A.     Uh-huh.
 3        Q.     -- charted there, any reason to believe
 4   that that was markedly higher or markedly lower for
 5   this particular patient?
 6        A.     Just based on experience, that seems
 7   low.
 8        Q.     Okay.
 9        A.     Because right now I give a single
10   boldness of 35 to 40 of protamine.  And in someone
11   with an ACT of -- sort of 400-ish starting, that
12   usually brings it down to sort of 270, 250.
13        Q.     With an ACT of what starting?
14        A.     417.
15        Q.     Okay.
16        A.     Or 400-ish.
17        Q.     So 400 down to what?
18        A.     So if they have an ACT of around 400, I
19   would usually give 35 to 40 of protamine, which
20   usually brings it down to that 270 to 250 range.
21                   MR. KULWICKI:  Okay.  Thank you,
22   Doctor.  That's all the questions.
23                   MS. CARULAS:  Okay.  Great.
24                   MR. MARGOLIS:  Just subject to
25   reconvening and based on type of issues that we're
0190
 1   going to take up with the court, we're -- defense
 2   counsel advised the witness not to answer questions.
 3                   THE VIDEOGRAPHER:  Off the record at
 4   1:16.
 5                   (Deposition concluded at 1:16 p.m.)
 6   
 7   
 8   
 9   
10   
11   
12   
13   
14   
15   
16   
17   
18   
19   
20   
21   
22   
23   
24   
25   
0191
 1                 CORRECTIONS AND SIGNATURE
 2   PAGE/LINE      CORRECTION          REASON FOR CHANGE
 3   ____________________________________________________
 4   ____________________________________________________
 5   ____________________________________________________
 6   ____________________________________________________
 7   ____________________________________________________
 8   ____________________________________________________
 9   ____________________________________________________
10   ____________________________________________________
11   ____________________________________________________
12   ____________________________________________________
13   ____________________________________________________
14   ____________________________________________________
15          I, JOHN DAVID BURKHARDT, JR., M.D., have read
     the foregoing deposition and hereby affix my
16   signature that same is true and correct except as
     noted herein.
17   
                          _______________________________
18                        JOHN DAVID BURKHARDT, JR., M.D.
19   STATE OF _____________  )
20   COUNTY OF ____________  )
21        Subscribed and sworn to before me by the said
     witness, JOHN DAVID BURKHARDT, JR., M.D., on this
22   the _________ day of ________________, 2010.
23   
                      _______________________________
24                    NOTARY PUBLIC IN AND FOR
                      THE STATE OF________________
25                    My Commission Expires: ____________
0192
 1                   C E R T I F I C A T E
 2   
 3          I, Tomi S. Johnson, Certified Shorthand
 4   Reporter in and for the State of Texas, certify
 5   That on the 17th day of May, 2010, I reported the
 6   Oral and Videotaped Deposition of JOHN DAVID
 7   BURKHARDT, JR., M.D. after the witness had first
 8   been duly cautioned and sworn to testify under oath;
 9   said deposition was subsequently transcribed by me
10   and under my supervision and contains a full, true
11   and complete transcription of the proceedings had at
12   said time and place.
13          I further certify that I am neither counsel
14   for nor related to any party in this cause and am
15   not financially interested in its outcome.
16          GIVEN UNDER MY HAND AND SEAL of office on
17   this 20th day of May, 2010.
18   
19   
20                        __________________________
                          TOMI S. JOHNSON, CSR
21   
22   
23   
24   
25