0001 1 IN THE COURT OF COMMON PLEAS CUYAHOGA COUNTY, OHIO 2 - - - - - 3 4 Shannon Sullivan, et al, ) Judge Brendan ) J. Sheehan 5 Plaintiffs, ) ) 6 vs. ) ) Case No. 7 The Cleveland Clinic ) CV-09-697617 Foundation, ) 8 ) Defendant. ) 9 - - - - - 10 11 Videotaped Deposition of: MOHAMED H. KANJ, M.D. 12 13 14 May 10, 2010 1:57 p.m. 15 16 17 Location: The Cleveland Clinic Foundation 18 Lerner Research Institute, Room NA2-17 9500 Euclid Avenue 19 Cleveland, Ohio 20 21 Reporter: Michelle A. Bishilany, RDR, CRR 22 23 24 25 0002 1 APPEARANCES: 2 3 On behalf of the Plaintiffs: DAVID A. KULWICKI, ESQ. 4 Becker & Mishkind Co., LPA 660 Skylight Office Tower 5 1660 West Second Street Cleveland, OH 44113 6 216.241.2600 dkulwicki@beckermishkind.com 7 8 On behalf of the Defendant: 9 ANNA MOORE CARULAS, ESQ. Roetzel & Andress 10 1375 East Ninth Street One Cleveland Center, Ninth Floor 11 Cleveland, OH 44114 216.615.7401 12 acarulas@ralaw.com 13 14 - - - - - 15 ALSO PRESENT: 16 Brad Simpson (Videographer) 17 Michelle Mahon 18 19 - - - - - 20 21 22 23 24 25 0003 1 I N D E X 2 EXAMINATION OF MOHAMED H. KANJ, M.D. 3 Page Line 4 BY MR. KULWICKI...................6 8 5 6 EXHIBITS MARKED 7 Deposition Exhibit 1 .............6 23 8 Deposition Exhibit 2 .............36 14 Deposition Exhibit 3 .............37 1 9 Deposition Exhibit 4 .............53 23 Deposition Exhibit 5 .............60 11 10 Deposition Exhibit 6 .............66 24 Deposition Exhibit 7 .............71 3 11 Deposition Exhibit 8 .............75 24 Deposition Exhibit 9 .............86 3 12 Deposition Exhibit 10 ............156 21 Deposition Exhibit 11 ............165 5 13 Deposition Exhibit 12 ............166 19 14 15 OBJECTIONS 16 objection.........................9 10 objection.........................12 25 17 objection.........................15 8 objection.........................16 15 18 objection.........................16 24 objection.........................17 5 19 objection.........................17 16 objection.........................17 20 20 objection.........................18 4 objection.........................18 9 21 objection.........................18 13 objection.........................18 18 22 objection.........................19 2 objection.........................20 18 23 objection.........................21 5 objection.........................23 16 24 objection.........................25 7 objection.........................30 14 25 objection.........................32 4 0004 1 2 3 objection.........................33 13 objection.........................33 19 4 objection.........................34 6 objection.........................35 6 5 objection.........................35 7 objection.........................35 11 6 objection.........................40 6 objection.........................43 4 7 objection.........................56 16 objection.........................56 25 8 objection.........................57 6 objection.........................57 12 9 objection.........................57 17 objection.........................61 6 10 objection.........................61 14 objection.........................73 3 11 objection.........................74 15 objection.........................74 19 12 objection.........................77 10 objection.........................82 1 13 objection.........................82 18 objection.........................86 12 14 objection.........................86 24 objection.........................87 7 15 objection.........................88 9 objection.........................88 17 16 objection.........................89 14 objection.........................90 25 17 objection.........................94 12 objection.........................94 19 18 objection.........................104 17 objection.........................105 14 19 objection.........................126 14 objection.........................135 14 20 objection.........................139 11 objection.........................143 25 21 objection.........................146 24 objection.........................151 3 22 objection.........................159 15 objection.........................159 20 23 objection.........................160 3 objection.........................160 17 24 objection.........................162 1 objection.........................163 23 25 objection.........................164 13 0005 1 2 3 objection.........................164 17 objection.........................167 21 4 objection.........................169 9 objection.........................169 15 5 objection.........................171 17 objection.........................172 25 6 objection.........................174 17 7 - - - - - 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0006 1 VIDEOGRAPHER: We're on the record. 2 - - - - - 3 MOHAMED H. KANJ, M.D., of lawful age, 4 called for examination, being by me first duly 5 sworn, as hereinafter certified, deposed and said 6 as follows: 7 EXAMINATION OF MOHAMED H. KANJ, M.D. 8 BY MR. KULWICKI: 9 Q. Doctor, would you please state your full 10 name and spell -- probably spell your first and 11 last name for us. 12 A. Sure. Mohamed Hani Kanj. 13 M-O-H-A-M-E-D, K-A-N-J. 14 Q. And, Doctor, are you currently employed 15 by the Cleveland Clinic? 16 A. Yes. 17 Q. And how long have you been so employed, 18 as of your most recent engagement with them? 19 A. 2007. 20 Q. And I'm going to hand you what I'll mark 21 as exhibit 1. Is this a current, accurate and 22 complete copy of your curriculum vitae? 23 (Deposition Exhibit 1 was marked for 24 purposes of identification.) 25 A. It is a curriculum vitae, but I don't 0007 1 know if it's current. I think there are newer 2 things, newer publications changed in some of the 3 first page, I think. And publications, probably 4 there are new publications. 5 Q. And do you have a copy of your CV that 6 would be up-to-date somewhere? 7 A. No. 8 Q. Do you know what you've published 9 recently that would make this version more 10 complete? 11 A. Abstracts in the new Heart Rhythm 12 Society meeting. 13 Q. Okay. Do any of those have to do with 14 atrial fibrillation ablation procedures? 15 A. I don't think so. 16 Q. It's my understanding that back in 17 August of '06 you were also an employee of the 18 Cleveland Clinic; is that true? 19 A. Yes. 20 Q. And I understand from your CV that you 21 were an electrophysiology fellow at the Cleveland 22 Clinic from March of 2005 through March of 2006, 23 correct? 24 A. Yes. 25 Q. And during that timeframe, Doctor, can 0008 1 you tell us what procedures and techniques you 2 were being trained to perform? 3 A. We're trained to perform defibrillator 4 implantations, pacemaker implantations, 5 electrophysiology study, ablation techniques, 6 temporary pacemakers. All different ablations. 7 Q. Okay. Even during that first year of 8 fellowship, EP fellowship, you would be trained 9 in ablation techniques? 10 A. Absolutely, yes. 11 Q. Okay. And then the second year of your 12 ablation -- or of your EP fellowship, from March 13 of '06 through February of '07, what additional 14 training or is it just more of the same? 15 A. More of the same. 16 Q. With respect to performing atrial 17 fibrillation ablation procedures, were you 18 trained by any particular physician or did you 19 train under various physicians here? 20 A. Various physicians, you get to work with 21 all. 22 Q. Can we agree that you're not considered 23 an expert in atrial fibrillation ablation until 24 you have completed your fellowship and training 25 in that particular specialty? 0009 1 A. Yes. 2 Q. Doctor, this process that we've just 3 started here is called a deposition. Have you 4 had a deposition taken previously? 5 A. Yes. 6 Q. How many times? 7 A. Once. 8 Q. And what kind of case was that? 9 MS. CARULAS: Just note a continuing 10 line of objection, but go ahead. 11 MR. KULWICKI: Sure. 12 A. Business. 13 Q. Okay. Had nothing to do with your care 14 or treatment of patients? 15 A. No. 16 Q. Was that deposition taken in a case 17 pending in Cuyahoga County, Ohio? 18 A. No. 19 Q. Where was that case filed at? 20 A. Summit County. 21 Q. Is that a case that you filed? 22 A. No. 23 Q. Who filed that case? 24 A. The title is Physician -- I think it's 25 called NPH. 0010 1 Q. And what does that stand for? 2 A. It's a physician group in Akron. 3 Q. Okay. And can you just give me in very 4 brief broad strokes, brush strokes, what that 5 case was about? 6 A. I'm sorry, I signed a confidentiality 7 agreement, I can't discuss this case further. 8 Q. Okay. Who would have been the 9 defendants in that case besides yourself? Well, 10 strike that. 11 Were you a plaintiff bringing the suit 12 or were you a defendant who the suit was brought 13 against? 14 A. I was a defendant. 15 Q. Okay. And who were the other 16 defendants, if anybody? 17 A. To my knowledge it's only me. 18 Q. And in terms of NPH, did that 19 physicians' practice, was that -- did that 20 include Dr. Schweikert or Dr. Cummings? 21 A. I don't know if they worked for NPH. 22 Sorry. 23 Q. All right. Anyhow, probably like your 24 last deposition, this deposition will involve me 25 asking you questions, you answering. 0011 1 As you've done so far, please be patient 2 with me, let me finish my question before you 3 answer. And, likewise, as you've done so far, 4 kindly answer verbally as opposed to an uh-huh or 5 huh-uh or a nod of your head so our court 6 reporter can take down your response accurately, 7 okay? 8 A. Yes. 9 Q. And, finally, if you want to take a 10 break for any reason, you want to confer with 11 your counsel, please let us know and we'll 12 accommodate that; fair enough? 13 A. Thank you. 14 Q. Do you have any time requirements today 15 in terms of do you have to be somewhere at any 16 particular time? 17 A. No. But I appreciate it if you can -- 18 for patient care I have my pager on, in case 19 there's a page or something I'm going to disrupt 20 this deposition to answer my pages. 21 Q. Fair enough. Not a problem. 22 A. Thank you. 23 Q. Now, are you familiar with the American 24 College of Cardiology, the American Heart 25 Association's statement on clinical competence? 0012 1 A. Yes. 2 Q. And can we agree that it requires 3 trainees' experience to be documented in writing 4 and confirmed by a lab supervisor? 5 A. Yes. 6 Q. Who was your lab supervisor during the 7 first year of your fellowship, March of 2005 8 through March of 2006? 9 A. Dr. Schweikert and Dr. Saliba. 10 Q. And who was your lab supervisor between 11 March of 2006 and February of 2007? 12 A. Drs. Schweikert and Saliba. 13 Schweikert is S-H -- 14 S-C-H-W-E-I-K-E-R-T. Saliba is S-A-L-I-B-A. 15 Q. Thank you. 16 And in terms of the information that is 17 required to be documented showing your experience 18 and competence in particular procedures, can we 19 agree that you have to document the date of the 20 procedure, the patient identification number, the 21 patient's age, the indication for the procedure, 22 the type of procedure, findings from the 23 procedure and complications, if any, associated 24 with the procedure? 25 MS. CARULAS: Note an objection. 0013 1 Go ahead. 2 A. We documented patient's number, type of 3 the procedure, date of the procedure and the 4 complications. 5 Q. Did you also record the patient's age 6 and the type of procedure? 7 A. We recorded under subcategory, you can 8 later find this one out, but the category is 9 ablation or ICD or pacemaker. 10 Q. Okay. Did you maintain such a log of 11 your procedures? 12 A. It's automatically maintained through 13 our computer system. 14 Q. Do you have a copy of that in your 15 possession? 16 A. No. 17 Q. Have you seen a copy of that log showing 18 your procedures as a fellow? 19 A. I routinely look at my log and to see 20 how many procedures I performed every month, up 21 to -- so how many procedures I've performed, I do 22 it every month to check how many procedures I've 23 performed up to that date. 24 Q. And in terms of getting your board 25 certification with the -- in cardiac 0014 1 electrophysiology, would you have forwarded that 2 log of procedures from your fellowship to the 3 certifying board for that, that specialty group? 4 A. I believe the board would contact the 5 fellowship program or the fellowship program 6 would respond and sign off. 7 Q. What is the board for the board 8 certification in cardiac electrophysiology? 9 A. To certify that you have been trained in 10 cardiac electrophysiology. 11 Q. I'm sorry, I didn't make myself clear. 12 What's the name of the board? Is it called the 13 American Board of Cardiac Electrophysiology? 14 A. Yes. 15 Q. Okay. And do you know where it's 16 located, what city? 17 A. No. 18 Q. In addition to this log that's 19 automatically created that we've been talking 20 about, do you keep any separate log of your 21 surgeries that list, you know, types of 22 procedures that you've performed and the outcomes 23 from those procedures? 24 A. No. 25 Q. Relative to Shannon Sullivan, the 0015 1 patient that we're here about today, do you have 2 any notes regarding this patient that are not 3 part of the medical chart that you prepared? 4 A. No. 5 Q. Did you leave the Cleveland Clinic at 6 the conclusion of your EP fellowship in 2007? 7 A. No. 8 MS. CARULAS: Note an objection, a 9 continuing line, but go ahead. 10 A. No. 11 Q. I thought that you went from the 12 Cleveland Clinic to Akron General and then back 13 to Cleveland Clinic. Clarify your work history, 14 if you would, after your fellowship. 15 A. I worked at the Cleveland Clinic, then 16 we started our program in conjunction with -- 17 it's Cleveland Clinic physicians going there one 18 day a week to perform procedures and coming back 19 to the Clinic. 20 Q. Going to Akron General? 21 A. Yes, sir. 22 Q. And were you still an employee of the 23 Cleveland Clinic when you were performing 24 procedures at Akron General? 25 A. Actually we've always been an employee 0016 1 at the Cleveland Clinic. We were not employees 2 at Akron General, it's part of the Cleveland 3 Clinic program, outreach program. 4 Q. Was Dr. Burkhardt an employee of the 5 Cleveland Clinic through the conclusion of your 6 fellowship in February of 2007? 7 A. Yes. 8 Q. And then after your fellowship it's my 9 understanding that he left the Cleveland Clinic; 10 is that correct? 11 A. He left -- I was a staff when he left. 12 Q. Okay. Have you maintained contact with 13 Dr. Burkhardt since he's departed in the sense of 14 staying in touch professionally or personally? 15 MS. CARULAS: Objection. 16 Go ahead. 17 A. No. 18 Q. Did Dr. Natale leave the Cleveland 19 Clinic after you were -- after you became staff? 20 A. Yes. 21 Q. And have you maintained professional or 22 personal contact with Dr. Natale since his 23 departure from the Clinic? 24 MS. CARULAS: Note an objection. 25 Go ahead. 0017 1 A. I saw him once at one of the national 2 meetings. 3 Q. Do you have any understanding of why Dr. 4 Burkhardt left the Cleveland Clinic? 5 MS. CARULAS: Note an objection. 6 Go ahead. 7 A. My understanding is the last few months 8 before he departed the Cleveland Clinic he was 9 working semi part time, meaning working a week 10 here and going to see his family in Las Vegas 11 because his wife got a job there. So it was a 12 transitional mood -- transitional mode until he 13 finds a job south. 14 Q. And do you know why Dr. Natale left the 15 Cleveland Clinic? 16 MS. CARULAS: Objection. 17 A. No, I don't. 18 Q. Did you hear any explanation of why he 19 left the Cleveland Clinic? 20 MS. CARULAS: Objection. 21 A. No. 22 Q. Have you ever acted as an expert witness 23 regarding medicolegal matters where you've been 24 consulted by a lawyer about a pending legal case? 25 A. No. 0018 1 Q. And, Doctor, have your privileges to 2 practice medicine at any hospital been revoked, 3 suspended or called into question in any manner? 4 MS. CARULAS: Objection. 5 A. No. 6 Q. Has your license to practice medicine in 7 any state been revoked, suspended or called into 8 question in any manner? 9 MS. CARULAS: Objection. 10 A. No. 11 Q. And have you ever been the subject of 12 any disciplinary proceedings? 13 MS. CARULAS: Objection. 14 A. No. 15 Q. Do you have any relationships, 16 contractual or otherwise, with any device 17 manufacturer? 18 MS. CARULAS: Note an objection. 19 Go ahead. 20 A. We have -- when I give sometimes talks, 21 I have to sign a contract to give that talk at a 22 national meeting or a local meeting. 23 Q. Okay. In addition to that situation, 24 have you ever been an investigator, a medical 25 director, a consultant or a researcher for any 0019 1 device manufacturer? 2 MS. CARULAS: Note an objection. 3 Go ahead. 4 A. We are involved in more than one 5 investigational studies that are going on at the 6 Cleveland Clinic. 7 Q. And when you act as an investigator for 8 a particular device manufacturer, do you enter 9 into -- personally do you enter into a contract 10 or a letter of understanding or some other 11 agreement with the device manufacturer that sets 12 forth the details of your duties? 13 MS. CARULAS: Just give me a continuing 14 line to this. 15 MR. KULWICKI: Sure. Oh, absolutely. 16 A. We -- it actually -- the trial comes 17 through the Cleveland Clinic C5 and then we look 18 at the inclusion and inclusion criteria and we'll 19 see if it's a viable trial or not, or if it's a 20 doable trial and then we'll -- if we like it 21 we'll participate. 22 But person, no, I don't have any 23 contractual agreements with them. 24 Q. Okay. And by C5 what are you referring 25 to? 0020 1 A. It's the cardiology research -- I'm 2 sorry, they're in charge of cardiology research 3 at the Cleveland Clinic. 4 Q. Okay. Who heads up that department 5 currently? 6 A. Mike Lincoff. 7 Q. And is that a Dr. Lincoff? 8 A. Yes, Dr. Michael Lincoff. 9 I believe it's L-I-N-C-O-F-F. 10 Q. Have you ever had a position in the 11 cardiology research unit known as C5? 12 A. No. 13 Q. When you act as an investigator for a 14 device manufacturer relative to a particular 15 device, does the Clinic receive any compensation 16 or do you receive any compensation for acting in 17 that capacity? 18 MS. CARULAS: Objection. 19 A. I don't receive any compensation. 20 Q. Did you ever act as an investigator 21 prior to becoming staff in 2007? 22 A. No. 23 Q. Do you know if in August of 2006 if, 24 when the Clinic was acting as an investigator for 25 ablation catheters, whether the terms of the 0021 1 investigation required the Clinic to report 2 complications from the procedure to the device 3 manufacturer? 4 A. I don't -- 5 MS. CARULAS: Objection. 6 A. I don't know. 7 Q. As a fellow back in 2006 and 2007 did 8 you ever have to make a report to a device 9 manufacturer about a complication associated with 10 a device that was under investigation? 11 A. I do not. 12 Q. Did you ever communicate with device 13 manufacturers for any reason back in 2006 or 14 2007? 15 A. Please, sir, define communicate. 16 Q. Yeah. Well, would you be talking to any 17 representative of any device manufacturer like 18 Biosense Webster or any representative of the 19 equipment manufacturers for any aspect of the 20 ablation process? 21 A. If they're assisting with the procedure 22 that we're performing, I would definitely be 23 talking with them if -- during the case. 24 Q. Okay. And let me ask you about that. 25 When device manufacturers' representatives attend 0022 1 a particular -- did you get a page? 2 A. I'm sorry, sir. I just might need be. 3 MR. KULWICKI: Off the record, please. 4 THE WITNESS: Off the record, please. 5 (Discussion had off record.) 6 VIDEOGRAPHER: We're back on the record. 7 BY MR. KULWICKI: 8 Q. Okay. Doctor, we were talking about -- 9 or I was about to ask you about when device 10 manufacturer representatives attend procedures, 11 are they typically listed in the procedure note? 12 A. No. 13 Q. How often -- how would you know if a 14 particular device representative was in 15 attendance at a procedure? 16 A. We don't keep a log, so it would be 17 really hard to know. 18 Q. What is the purpose in having device 19 manufacturers' representatives attend procedures? 20 A. To solve technical issues during the 21 case. 22 Q. Are these representatives typically 23 physicians? 24 A. No. 25 Q. Just to give me some sense about how 0023 1 common it is to have a device manufacturer rep 2 attend a procedure, on a percentage basis, what 3 percentage of procedures are they in attendance 4 at? 5 A. It depend on the case, but probably on 6 average probably 20 to 30 percent you'll ask them 7 to fix something, you're not seeing a good 8 signal, you're not seeing a good picture, you're 9 not -- there's a problem with the connections, so 10 all the technical aspects that we physicians 11 cannot solve. 12 Q. In situations where you have multiple 13 newer technologies being used, would it be common 14 to have more than one device manufacturer's 15 representative present during a procedure? 16 MS. CARULAS: Just note an objection. 17 Go ahead. 18 A. Not usually. 19 Q. Do they keep records of their 20 attendance, to your knowledge? 21 A. I don't know. 22 Q. Would you happen to know back in August 23 of 2006 who the device representative or 24 representatives were that would attend procedures 25 at the Cleveland Clinic from the company that 0024 1 manufactures the NaviStar ThermoCool irrigated 2 tip catheter? 3 A. There are more than one, but one person 4 would be Susan, but I don't know her last name. 5 Q. I think I called that the wrong thing. 6 I meant to say the Biosense Webster Celsius 7 ThermoCool irrigated tip catheter. Is that Susan 8 the same person or somebody else? 9 A. Susan. 10 Q. Then how about with respect to the 11 NaviStar RMT magnetic tip catheter, is there a 12 different person? 13 A. Susan. 14 Q. All right. It's my understanding that 15 back in August of '06 that Dr. Natale was the 16 lead investigator relative to the Biosense 17 Webster Celsius ThermoCool irrigated tip 18 catheter; is that correct? 19 A. I don't know. 20 Q. Would you request, and harkening back to 21 August of 2006, would you or one of the staff at 22 the Cleveland Clinic request a device 23 representative to be present at procedures, or 24 would they schedule themselves to be available 25 pursuant to their own scheduling? 0025 1 A. It could be done both ways. 2 Q. Doctor, are you aware of any other 3 lawsuits brought against the Cleveland Clinic or 4 any of its physicians arising out of 5 complications from atrial fibrillation ablation 6 procedures? 7 MS. CARULAS: Objection. 8 A. No. 9 Q. I'm going to hand you what I'll mark as 10 exhibit 2. 11 And this is a seven-page document that 12 has a cover letter from your attorney. And just 13 take a look at that -- 14 A. Thank you. 15 Q. -- and I want to ask you some questions 16 about that. 17 Tell me when you're ready. 18 A. Yes, sir. 19 Yes, sir. 20 Q. Okay. The cover letter is more of a 21 summary sheet, but looking at the procedure logs 22 that are attached to it. Do you know where this 23 information comes from? 24 A. All the procedures performed at the 25 Cleveland Clinic electrophysiology suite. 0026 1 Q. Okay. And going to the last page, it 2 looks to be a search of your name for procedures 3 involving SVT and VT ablation procedures, and I 4 want to ask you some questions about that. 5 A. Yes, sir. 6 Q. From my reading, it appears that SVT and 7 VT ablation procedures can include atrial 8 ventricular nodal reentrant tachycardia ablation, 9 atrial ventricular reciprocating tachycardia, 10 atrial tachycardia, aflutter and atrial 11 fibrillation along with ventricular tachycardia 12 ablations; is that correct? 13 A. Yes. 14 Q. Are there any others that would fall 15 under the category of SVT/VT ablation as 16 indicated on the Procedure of exhibit 2? 17 A. That's it. Atrial tachycardia, AV nodal 18 reentrant tachycardia and AV nodal recip -- AV 19 reciprocating tachycardias and ventricular 20 tachycardias. And atrial fibrillation. 21 Q. Okay. And in terms of the number here 22 that shows that you performed 207 SVT/VT ablation 23 procedures as of August 17, 2006, is there any 24 way to break those down so that we could 25 determine which of them involved treatment for 0027 1 a-fib versus the other kinds of supraventricular 2 tachycardias? 3 A. It's going to be really hard because 4 you've got to go through the charts. But the 5 bulk of the procedures performed at the Cleveland 6 Clinic, probably more than 80 percent of them or 7 85 percent, 85 percent are atrial fibrillation 8 ablations. 9 Q. Okay. And how do you distinguish 10 between performing an a-fib ablation procedure 11 and an a-flutter ablation procedure? 12 A. We rarely get atrial flutter ablations. 13 A simple procedure, usually it's been taken care 14 in the -- what do you call -- satellites. 15 But during atrial fibrillation ablation 16 we do sometimes perform atrial flutter ablations 17 at the same time if the patient had atrial 18 flutter. 19 Q. And when you say it's a simple 20 procedure, what do you mean by that? 21 A. It's like expertise, it's available 22 everywhere. 23 Q. And with respect to all these various 24 types of SVT ablation procedure that we've 25 discussed, can we agree that atrial fibrillation 0028 1 ablation is less amenable to cure with catheter 2 ablation than the regular forms of SVTs? 3 A. Yes. 4 Q. And can we agree that atrial 5 fibrillation requires more technical skill than 6 these other SVTs? 7 A. Yes. 8 Q. And can we agree that atrial 9 fibrillation ablation is a more complex and 10 involved procedure than the ablation procedures 11 associated with the other types of SVTs? 12 A. It's more complex but I don't think it's 13 more involved. 14 Q. Okay. Does it carry a higher risk of 15 injury to the patient or post-procedure 16 complication than the other types of SVTs? 17 A. We don't have any data regarding that. 18 Q. Does the Cleveland Clinic have an 19 internal policy or practice with respect to 20 establishing a learning term -- a learning curve 21 for competency in performing atrial fibrillation 22 ablation? In other words, you have to do so many 23 procedures before you're considered competent to 24 do that procedure? 25 A. No, but we have a subjective evaluations 0029 1 and objective evaluations that every fellow 2 has -- we have routine evaluation forms that are 3 being filled every -- I think every month or 4 every couple month and this has to be reported to 5 the ACGME, accreditation -- it's the 6 accreditation for residency and fellowship 7 programs. Accreditation committee, we call it 8 ACGME. 9 Q. Is the ACGME involved at all in awarding 10 board certification in either cardiovascular 11 medicine or cardiac electrophysiology? 12 A. I don't believe so, but they may contact 13 each others, or they can get information from 14 each others. 15 Q. And in terms of the subjective and 16 objective evaluations, are those done by your lab 17 supervisors or someone else? 18 A. By staff, attendings. 19 Q. Okay. So whoever you did the procedure 20 with? 21 A. Yes, sir. 22 Q. And do they perform a subjective and 23 objective evaluation for each procedure you do, 24 or how is that done? 25 A. I believe it's every -- end of every 0030 1 rotation or every month this has to be filled. 2 Q. Do you know if those evaluations are 3 maintained as part of your personnel or your 4 training file at the Clinic? 5 A. I don't know. 6 Q. Do you have copies of any of those 7 evaluations? 8 A. No. 9 Q. Can we agree that when it comes to 10 atrial fibrillation ablation procedures that 11 there's an increased risk of complications 12 associated with inexperienced operators 13 performing the procedure? 14 MS. CARULAS: Objection. 15 A. It depends what you define 16 inexperienced. Definitely it's a person done one 17 or two procedures, you might be inexperienced. 18 But the COCATS, which I think it's part of the 19 American Board of Internal Medicine and Heart 20 Rhythm Society, they decide on competencies. And 21 I think the competencies they set to 75 22 procedures, 75 ablations. One year fellowship, 23 75 ablations, ten of them needs to be 24 transseptal, meaning a left-sided ablation, and 25 people who have to start atrial fibrillation have 0031 1 to done probably 20 a-fib ablations. 2 Q. We talked earlier about your -- the 3 number of procedures that you had as of August 4 2006. Are all of the atrial fibrillation 5 procedures that would be included in that number, 6 are all of those transseptal procedures or can 7 you have an a-fib ablation without puncturing the 8 septum and entering the left side of the heart? 9 A. No, sir, now we do transseptals to do -- 10 perform atrial fibrillation ablation. 11 Q. Okay. And just so I'm clear, is it the 12 case that at the Cleveland Clinic in, say, 2006 13 that if you were performing an atrial 14 fibrillation procedure, ablation procedure, that 15 as a necessary part of that procedure you would 16 puncture the septum and enter the left side of 17 the heart? 18 A. Yes, sir. 19 Q. Okay. I read something where there was 20 a transition apparently going on from doing 21 atrial fibrillation ablation by isolating the 22 ostium to doing it by isolating the antrum, and I 23 noticed in Mr. Sullivan's procedure that they 24 call it ostial/antrum isolation, and I'm 25 wondering -- I'd like to try to ask you some 0032 1 questions about that. 2 First of all, what is the difference 3 between ostial isolation and antrum isolation? 4 MS. CARULAS: Shown an objection, but go 5 ahead. 6 A. Since 2000 -- I started at the Cleveland 7 Clinic in 2005, we've not done any ostial 8 isolation, we've done only antrum isolation. 9 What the difference is is the ostium -- 10 if the vein is a tube, ostial isolation is that 11 you put it -- you burn way inside the vein. 12 Antrum isolation you burn outside. The advantage 13 of burning outside is less risk of -- more 14 success and less risk of pulmonary vein stenosis 15 requiring surgery and other complications. 16 Q. And when you use the term ostial/antrum 17 isolation, does that mean that there is ablation 18 taking place at the area where the ostium and the 19 antrum meet? 20 A. Yeah. Anteriorly the front part of 21 the -- the front part of the vein, you have to 22 burn at the ostial level and the back part of the 23 vein we burn from the antral level. 24 So there's no antral level in that front 25 part of the vein just because we're going this 0033 1 way, so we burn at the ostium, or the opening of 2 that vein. However, at the back wall, we don't 3 burn at the ostium, we try to burn outside, this 4 way we don't cause narrowing in the vein. It's 5 more of, think about it as a funnel and you cut 6 it sideways (indicating). 7 Q. Looking at exhibit 2 again. When it 8 lists 206 or 207 procedures from August 17 -- or 9 prior to August 17, 2006, does that number tell 10 you how many you were actually the primary 11 operator on; in other words, the physician who 12 was actually doing the ablations? 13 MS. CARULAS: Objection. 14 A. No, it doesn't tell me this way. 15 Q. Okay. So of those 207 cases, in some 16 you may have been doing ablations and others you 17 may have been just the second operator who was 18 maybe manipulating the mapping catheter? 19 MS. CARULAS: Objection. You're talking 20 about these when he was a fellow? 21 MR. KULWICKI: Yes. 22 Q. Okay. Exhibit 2, yeah. 23 A. Yes. 24 Q. Okay. Is there any way -- we talked 25 earlier about the log you would keep of 0034 1 procedures, would that delineate for us those in 2 which you were the primary operator actually 3 doing the ablation versus being the secondary 4 operator who was simply positioning the mapping 5 catheter? 6 MS. CARULAS: Note an objection. 7 Go ahead. 8 A. You know, the involvement, we're always 9 involved in this procedure. It's true that we 10 are assisting, but our role is we have to assist 11 during the procedure, whether it is -- holding 12 the mapping catheter's also important, keeping it 13 in place is very important, it's like -- and 14 ablating is also important, so I find no 15 difference between the two. 16 Q. Okay. 17 A. Involvement is involvement. 18 Q. Okay. But to go back to my question. 19 Is there any way to delineate when your role is 20 that of holding the, you know -- positioning the 21 mapping catheter versus when you're actually 22 doing the ablations? 23 A. I don't believe. I don't believe we can 24 do that. 25 Q. Okay. I used some terminology and let 0035 1 me make sure that I've used it correctly. When I 2 talk about the primary operator, would you 3 physicians at the Cleveland Clinic assign that 4 label to the physician who was actually doing the 5 ablations? 6 MS. CARULAS: Note an objection. I'll 7 just note an objection, I'm not sure I understand 8 that question, but maybe -- 9 Q. Well, versus holding the mapping 10 catheter. 11 MS. CARULAS: Objection. 12 A. Well, both are very important roles, so 13 sometimes you do this, sometimes you do that. 14 Q. Okay. 15 A. I find no less important mapping than 16 ablation. 17 Q. In terms of your role as a fellow, 18 earlier on in your fellowship when maybe you were 19 involved in your first couple of atrial 20 fibrillation ablation procedures, would you 21 typically be assigned to one role or the one, you 22 know, more likely to use -- to be -- having the 23 role of holding the mapping catheter or more 24 likely to be in the role of doing the ablation? 25 A. It depends on the staff, it depends on 0036 1 the complexity of the procedure, depends on the 2 comfort level that the staff have built with you, 3 different people have different comfort in doing 4 a procedure. 5 Q. In the case where there are two 6 operators and one is using the ablation catheter 7 and the other is using the mapping catheter, does 8 one involve a higher degree of skill? 9 A. No. But they're complementary to each 10 others. 11 Q. Why don't I get that back from you so I 12 can mark it. Thank you, Doctor. 13 A. You're welcome. 14 (Deposition Exhibit 2 was marked for 15 purposes of identification.) 16 Q. I'm going to hand you what I'll mark as 17 exhibit 2. 18 MS. CARULAS: Going to have to be 3. 19 MR. KULWICKI: Oh, 3. Thank you. 20 Q. And this is an article where you're the 21 lead author with Dr. Wazni and Dr. Natale 22 published in 2007 in the Heart Rhythm Society 23 journal, and it's pages 73 through 79. I'll hand 24 that to you. 25 A. Thank you. 0037 1 (Deposition Exhibit 3 was marked for 2 purposes of identification.) 3 MS. CARULAS: Do you have an extra copy 4 of this that you -- 5 MR. KULWICKI: I will send you, just 6 like I have in the past, I'll scan these and 7 e-mail them to you tomorrow, so... 8 MS. CARULAS: Okay. 9 Q. Doctor, I want to ask you some questions 10 about this article. This was published in, as I 11 said, 2007. It appears that it was prepared 12 obviously prior to that time, and I'm suspecting 13 that you prepared some of this while you were 14 still a fellow; is that correct? 15 A. Yes. 16 Q. And can you tell us how you became 17 involved in this particular article? Were you 18 assigned the project? Or how did you get to be 19 involved in putting this article together? 20 A. I believe Dr. Natale was the invited 21 author and he assigned me and Dr. Wazni to help 22 out writing this article. 23 Q. Was Dr. Wazni at the time staff? 24 A. I don't know. 25 Q. And when you say Dr. Natale was 0038 1 assigned -- 2 A. Invited, sorry. 3 Q. -- invited, who invited him? 4 A. I don't know. 5 Q. What was the purpose of this particular 6 article? 7 A. I don't know. They asked us to write 8 about pulmonary vein antrum isolation, but actual 9 purpose from the journal I don't know. 10 Q. In the article you talk about the 11 Cleveland Clinic's approach to pulmonary vein 12 antrum isolation including the approach to 13 anticoagulation, the type of power settings that 14 you use with the catheter and some of the various 15 monitoring, mapping and navigational techniques 16 that the Clinic used in that timeframe. 17 When you prepared this article, did you 18 have reference materials that you looked at? 19 A. It's mainly how Dr. Andrea Natale 20 performed this procedure. 21 Q. And where would you get the information 22 that's contained in here, just through your 23 personal experience in working with Dr. Natale or 24 talking to him, or some other resource? 25 A. It's usually from talking to Andrea 0039 1 and -- Dr. Natale, and our -- and his expertise 2 in this field and he'll write it and we'll write 3 it and then he'll edit it and become an article. 4 Q. Do you know if you were still a fellow 5 when this was published? 6 A. Honestly, I don't know. When was it 7 published? 8 Q. I'm not sure of the exact month, but, 9 anyhow -- 10 A. It was written in 2006, but then it's -- 11 definitely when I wrote it I was a fellow. 12 Q. Okay. 13 A. Or when we wrote it. 14 Q. Was part of the purpose in publishing 15 this article or preparing this article and 16 publishing this article to show doctors outside 17 of the Cleveland Clinic what Cleveland Clinic was 18 doing, how they were doing PVAI ablation 19 procedures? 20 A. This is mainly how Dr. Andrea Natale was 21 performing this procedure. Other physicians 22 might have a different approach to this atrial 23 fibrillation problem. 24 Q. On page 74, in the very last sentence on 25 that page it talks about power settings for open 0040 1 irrigation catheters. 2 Was the maximum setting of 50 watts, was 3 that something that was sort of an institutional 4 practice? In other words, not to go over 50 5 watts? 6 MS. CARULAS: Note an objection. 7 Go ahead. 8 A. It was mainly Dr. Andrea's experiences 9 to stop at 50 watts. 10 Q. Do you know of anybody else at the 11 Clinic, yourself or other staff that you worked 12 with, that would deliver energy at a temperature 13 greater than -- or a wattage greater than 50? 14 A. If the lesion is not going away, you -- 15 sometimes clinically you want to give higher 16 doses. 17 Q. In your training with Dr. Natale or 18 discussions with him, did you learn why he set a 19 maximum of 50 watts? 20 A. We were worried about pops. Pops is 21 when there's too much heating inside the heart 22 and then it will pop. 23 Q. Is that something that you can hear 24 outside of the body? 25 A. Yes. 0041 1 Q. And the risk of a pop is greater above 2 50 watts? 3 A. We don't know. 4 Q. That was a concern, though? 5 A. That was the concern. 6 Q. When there's a pop, what actually is 7 popping? Is it the skin crackling? 8 A. No, it's actually inside the heart 9 that's popping. 10 Q. I said skin. 11 A. Sorry. 12 Q. I meant the endothelium. 13 A. Yes. 14 Q. Is that actually crackling and popping 15 itself? 16 A. Yes. 17 Q. Okay. Is that something that you would 18 typically chart when a pop occurred during a 19 procedure? 20 A. No. But we look to see if anything can 21 correlate with pop and we were not successful in 22 finding anything that predicts a pop, 23 scientifically. 24 Q. Were you able to determine any risk 25 factors for pops? 0042 1 A. We couldn't. And by we, it's not me, it 2 was Dr. Andrea Natale and one of his fellows, 3 Claude Elayi. 4 Q. The section that we're reading goes on 5 to say that a lower energy setting is used for 6 the posterior wall and it says a maximum of 30 to 7 35 watts. 8 Why was a lower energy setting used for 9 the posterior wall? If you know. 10 A. Dr. Andrea Natale was worried about 11 esophagus. 12 Q. And I was interested in that because it 13 seemed to me like the left side of the heart is 14 far enough away from the esophagus, I can't 15 picture anatomically how the -- how a catheter in 16 the left side of the heart might implicate the 17 esophagus. What's going on there? How are they 18 positioned that heating within the left side of 19 the heart can possibly cause injury to the 20 esophagus? 21 A. And the left heart is posterior to the 22 right heart. 23 So they're not like this, they're like 24 this (indicating). 25 Q. Okay. Was this protocol set forth in 0043 1 your article, Dr. Natale's protocol? Was this 2 generally being used by the staff at the 3 Cleveland Clinic back during your fellowship? 4 MS. CARULAS: Objection. 5 Go ahead. 6 A. No. No, there's a lot of variability. 7 Q. Is injury to the esophagus a common 8 complication of tissue overheating and pops? 9 A. We don't know. 10 Q. Is pericardial effusion a common 11 complication of tissue overheating or pops? 12 A. Again, we don't know, but we've seen it 13 more with the open irrigated catheter. 14 Q. Seen what more? 15 A. The effusion. 16 Q. And is the pericardial effusion the 17 result of an inflammatory process within the 18 heart? 19 A. It may be. 20 Q. Have you seen more esophageal 21 involvement with the irrigated catheter, the open 22 tipped irrigated catheter? 23 A. In the trial that we did, we did see 24 increased esophageal injury. 25 Q. What's the mechanism of injury to the 0044 1 esophagus? 2 A. We don't know. 3 Q. Are there any risk factors that you've 4 identified other than the irrigated catheter for 5 esophageal involvement or pericardial effusion as 6 a result of PVAI ablation? 7 A. Would you please repeat your question? 8 Q. Sure. Are there any risk factors 9 identified for esophageal injury or pericardial 10 effusions secondary to PVAI ablation procedures? 11 A. The procedure itself. We're burning in 12 the left side of the heart, that can cause 13 perforation, inflammation that may result in 14 pericardial effusion, and you're burning in the 15 left side of the heart, that might cause injury 16 to the esophagus. 17 Q. On page 75 of this article, Doctor, at 18 the bottom of the left hand column it says: Each 19 ablation treatment has the end point of local 20 potential elimination, thus the duration of 21 energy application is not fixed and is dependent 22 on the potentials being ablated. 23 I wanted to ask you about that. Does 24 that mean that you would continue the energy 25 delivery until the potential is eliminated, 0045 1 irrespective of how long it took to do that? 2 A. No. There's a near field and a far 3 field. The near field usually goes away within 4 20 to 30 seconds. Sometimes longer, but the far 5 field you can't get away. So it's a clinical 6 decision. 7 MR. KULWICKI: Why don't we go off the 8 record. 9 VIDEOGRAPHER: This is end of tape one. 10 Off the record. 11 (Discussion had off record.) 12 VIDEOGRAPHER: This is tape two. Back 13 on the record. 14 BY MR. KULWICKI: 15 Q. Doctor, you used some terms that I 16 wasn't familiar with, and forgive me if I don't 17 restate them correctly. 18 I think you said that there is the far 19 potential and the near potential; is that right? 20 A. Yeah, the near potential is what we call 21 the local potential. And the far potential is 22 the far potential from the rest of the atria, 23 A-T-R-I-A. 24 Q. Are they called near and far by virtue 25 of their location within the heart? 0046 1 A. It's what the catheter detects locally 2 versus from the rest of the heart. 3 Q. And when you're doing the ablation, is 4 it the case that you're ablating the near 5 potential? 6 A. That's what we're after. 7 Q. Okay. And then what is the significance 8 of the far potential as you're ablating a 9 particular near potential? 10 A. There's no role for the far field. 11 Q. And then back to my question. 12 In terms of ablating a near field, is it 13 the case that you deliver energy until the 14 potential is eliminated with no fixed limit on 15 how long you apply the energy? 16 A. The signal will go away. 17 Q. Okay. 18 A. Within 20 to 30, sometimes 40 seconds, 19 but it will go away. 20 Q. Okay. Is there -- and again we're 21 talking about back in August of 2006. Was there 22 an outer limit as to how long you'd apply energy 23 when trying to eliminate a particular near 24 potential, near field? 25 A. I don't recall if there was one. 0047 1 Q. Was there any understanding back in 2 August of 2006 that the longer that energy is 3 applied, the greater the risk of tissue 4 overheating or pops? 5 A. No, we don't have any evidence. 6 Q. On that same page in exhibit 3 on the 7 right hand side it says: The procedure may 8 require two operators standing side-by-side, each 9 operating a catheter. 10 Earlier you and I talked about the use 11 of the ablation catheter and the mapping 12 catheter. The way this reads, it talks about may 13 require two operators. Is that just maybe not 14 the greatest way to explain, or are there 15 occasions where there is only one operator 16 involved with a-fib ablation procedures? 17 A. No, there are usually two operators at 18 the Cleveland Clinic. 19 Q. Okay. To the left of the sentence I 20 just read it talks about an esophogeal 21 temperature probe being used. 22 Are the readings from that esophogeal 23 temperature probe, are they typically recorded 24 either manually or by the equipment itself? 25 A. They're measured through the probe and 0048 1 then it is displayed on a monitor. 2 Q. Okay. And is the display from that 3 monitor recorded anywhere? Does the nurse in the 4 operating room write it down, or does it have a 5 readout that would be made part of the chart or 6 available? 7 A. No. But that temperature keeps going up 8 and down so there's -- I don't find the utility 9 of documenting because it keeps going up and down 10 (indicating). 11 It's like a fluoroscopy, it's there to 12 assist us at that moment at that particular time. 13 Q. And, Doctor, I want to look at some of 14 the pictures in this article you've written here 15 that we've marked as exhibit 3. 16 On page 74, the second page, there are 17 three dimensional CT images at the top. Is 18 that -- are those from the fluoroscopy? 19 A. 74? 20 Q. Yes. 21 A. Okay. No, this is a CAT scan image, 22 sir, which is part -- it's like fluoroscopy but 23 it's more than a fluoroscopy. It's obtained -- 24 Q. Is that -- I'm sorry. Is that done 25 preoperatively? 0049 1 A. In some cases. And it's done 2 postoperatively in most patients. 3 Q. Okay. And what's the purpose of that 4 particular image? 5 A. In the article? 6 Q. Yes. 7 A. Okay. To show the difference between a 8 ostia and an antrum. 9 Q. Okay. And then below that there is an 10 image from the intracardiac echocardiography. 11 And do you call that ICE? 12 A. Yes, sir. 13 Q. Okay. And so the ICE recording, is that 14 something that is done throughout the ablation 15 procedure? 16 A. Yes, but it's displayed on TV, but it's 17 not recorded. 18 Q. Okay. 19 A. Because it's continuously changing. 20 Q. And how did you get these images on that 21 page and the next page from the ICE recording? 22 A. Yeah, sometimes if we see something 23 really good that might help other people or we 24 can ask the nurse to click on Save and it can be 25 saved. It's a -- I think it's a still image. 0050 1 The machine would allow us to save a still image, 2 and that's what is on the still images, and these 3 are all still images. 4 Q. And then on page 76 there's another 5 image, it looks like from the circular mapping 6 catheter. 7 It talks about this being a cartoon and 8 I wasn't sure if the cartoon is the colored 9 dots -- 10 A. Sir, all of it is cartoon, all except -- 11 except the shell of the left atrium. The rest is 12 all cartoon. 13 Q. And is the shell from a CT image? 14 A. Yes. 15 Q. And then on page 77 there are some other 16 images at the top, it's called a Circular Mapping 17 Catheter Recording. Is that something that's 18 performed throughout the procedure? 19 A. Yes. 20 Q. And are those images kept? 21 A. Yes, during ablation. 22 Q. Okay. And then below that there's an 23 electroanatomic image. And are those images 24 recorded throughout the procedure? 25 A. No. 0051 1 Q. When are they recorded? 2 A. You know what? You can accumulate these 3 points during the procedure, but whether we 4 record them on a physical data, it depends on the 5 case and the physician and the technician. 6 But they don't carry much of a clinical 7 use after the procedure, it's mainly during the 8 procedure to assist us with the catheter location 9 with respect to the heart. 10 Q. In terms of detecting thrombus formation 11 or char formation during a procedure, is it 12 typically the ICE recording that gives you 13 evidence of that during the procedure? 14 A. It is very hard, but this is what we -- 15 this is what we use. 16 Q. Okay. Tell me -- 17 A. It's very hard to detect. 18 Q. Okay. So you can have thrombus 19 formation and/or char formation and not know it 20 based on the ICE recording? 21 A. Yes. 22 Q. Do you have statistics for the 23 sensitivity and specificity of ICE recordings for 24 a thrombus or char formation? 25 A. No, sir. 0052 1 Q. In your experience is it useful in 2 detecting char or thrombus formation more than 50 3 percent of the time? 4 A. Would you please rephrase? Like the ICE 5 is it? 6 Q. Yes. 7 A. The ICE, we don't have that denominator. 8 Q. Tell me what that means. 9 A. Meaning that we don't know how many 10 patients really have a thrombus. 11 Q. Okay. 12 A. And if you don't have the denominator, 13 you can't come up with this number. 14 Q. And obviously before these procedures 15 you look with imaging to see if the patient has a 16 thrombus in the left side of their heart, 17 correct? 18 A. Yes. 19 Q. So you're talking about you don't have 20 the denominator of how many patients develop char 21 formation or thrombus in the left side of the 22 heart during the procedure? 23 A. Yes. 24 Q. Okay. How come you don't do a post-op 25 echocardiography, like a transthoracic 0053 1 echocardiogram, to look for thrombus formation 2 after the procedure as a matter of routine? 3 A. We don't find it of clinical utility 4 because the left atrium -- you can't see the left 5 atrium with a transthoracic echo. 6 Q. How about with a TEE? 7 A. I would be very worried about the risk 8 of sticking a tube in somebody's esophagus after 9 an ablation. I won't recommend that, especially 10 if it doesn't have any clinical utility. 11 Q. Have you read about physicians, or 12 physicians here at the Clinic, have you all 13 considered any other type of imaging modality or 14 other test to look for left heart thrombus during 15 or after ablation? 16 A. Not to my knowledge. 17 Q. Do you know if the ICE imaging is 18 typically billed for by the Cleveland Clinic? 19 A. I'm sorry, I don't know much about 20 billing. 21 Q. I'm going to hand you what I'll mark as 22 exhibit 4. 23 (Deposition Exhibit 4 was marked for 24 purposes of identification.) 25 MR. KULWICKI: Mark that, that'll be 3. 0054 1 MS. CARULAS: Uh-huh. 2 Q. This is a three-page copy of the op 3 note. And I was going to, Doctor, direct your 4 attention to -- let me just see that -- page two 5 of that document at the bottom. 6 It states: Recording Sites, Coronary 7 Sinus, HIS Bundle, Left Atrium, Right Atrium. 8 Do you know what that refers to? 9 A. Yes. We're recording signals from the 10 coronary sinus because we're putting a cath in 11 the coronary sinus, the HIS bundle, the 12 electrical system of the heart, we're recording 13 the left and right atria because we ablate there 14 so we also record signals. 15 Q. And are these, when you talk about 16 recordings, are these the circular mapping 17 catheter recordings that we see on page 77 of 18 exhibit 3? 19 A. No, any kind of recording is considered, 20 as long as it's in these. So this would be part 21 of this (indicating). 22 Q. Okay. In terms of the overall record, 23 what of those recordings that are mentioned there 24 on page two of exhibit 4 are kept as part of the 25 patient's record? 0055 1 A. I'm sorry, but what is patient record? 2 Like, these are usually recorded in the system on 3 what we call a Prucka system and this is what we 4 get. 5 Q. What kind of system? 6 A. Prucka. 7 Q. How do you spell that? 8 A. P-R-U-C-A, I think, or K, there might be 9 a K in the middle. 10 Q. Do you know what that stands for? 11 A. No. Just -- it's this (indicating). 12 Q. Okay. Have you seen Prucka imagings or 13 circular mapping catheter recordings relative to 14 Shannon Sullivan? 15 A. I don't believe I saw any. 16 Q. Do you know why they would not be part 17 of his record if they're not -- 18 A. Again, it doesn't -- it doesn't have 19 much of a value to the medical records. It's 20 like the fluoroscopy and temperature recording or 21 like a, the three-dimensional mapping, they're 22 there to help during the performance of the 23 ablation procedure. 24 Q. Let me change gears, Doctor. 25 Do you have, as a fellow here, did you 0056 1 have an e-mail account at the Clinic? 2 A. Yes. 3 Q. And would you e-mail fellow physicians, 4 staff members and other fellows regarding 5 patients' issues? 6 A. No. 7 Q. What would you use your e-mail account 8 for? 9 A. Through the Cleveland Clinic, 10 corresponding with other fellows and staff, 11 schedule-related issues, conferences, who's going 12 and who's covering for. 13 Q. You wouldn't discuss interesting cases 14 or developments or patient-related matters in the 15 e-mails at all? 16 MS. CARULAS: Objection. 17 A. Usually meeting -- no, we have meetings 18 for that. 19 Q. And what kind of meetings? 20 A. We have -- every week we have two or 21 three meetings where we sit and learn from staff. 22 Q. Okay. Do you know if Mr. Sullivan's 23 case was discussed as part of any of those 24 meetings? 25 MS. CARULAS: Note an objection. 0057 1 A. I don't recall. 2 Q. Do you recall yourself ever presenting 3 on Mr. Sullivan's case with respect to what 4 happened or your experience in this particular 5 procedure? 6 MS. CARULAS: Objection. 7 Go ahead. 8 A. I don't -- I don't recall. 9 Q. Back in August of '06 do you know if 10 complications related to any device that was 11 under investigation were reported to the FDA? 12 MS. CARULAS: Objection. 13 A. I don't know. 14 Q. Is it the case today that if there's a 15 complication associated with an investigational 16 device that you will report it to the FDA? 17 MS. CARULAS: Objection. 18 A. I don't know. 19 Q. Are you familiar with the MAUDE 20 database? 21 A. No, sir. 22 Q. Would you have -- 23 A. What -- 24 Q. Go ahead. 25 A. What is that? 0058 1 Q. MAUDE? 2 A. Yes. 3 Q. You're not familiar with it? Okay. 4 A. But what is it? If I may ask. 5 (Discussion had off record.) 6 Q. Yeah, it's for reporting adverse device 7 outcomes to the FDA. I'm not sure what the 8 acronym stands for. 9 A. Oh. 10 Q. When there were adverse outcomes with 11 investigational devices at the Cleveland Clinic 12 back in August of '06, do you know if a report 13 was made to the manufacturer? 14 A. I don't know. 15 Q. And let me just kind of open it up. Are 16 you aware if, outside of morbidity/mortality 17 conferences, if complications related to an 18 investigational device were reported in any 19 systematic fashion to anybody either in the 20 Clinic or outside the Cleveland Clinic? 21 A. I don't know. I'm sorry. 22 Q. Did fellows ever attend M&M conferences 23 in 2006? 24 A. Yes. 25 Q. Was there -- with respect to M&M 0059 1 conferences that involved complications from EP 2 procedures in 2006, would it be only EP 3 physicians involved in the conference? 4 A. The whole staff, EP staff and fellows, 5 will attend the M&M. It's usually once a month. 6 Q. Okay. Would Dr. Natale chair that 7 conference? 8 A. If he's present he will -- I don't think 9 it's a more for chair, it's a list of cases and 10 we go through them. I don't think anybody's in 11 charge. 12 Q. Would anybody attend those M&M 13 conferences besides EP physicians and fellows? 14 MS. CARULAS: Just have a continuing 15 line about M&M. 16 MR. KULWICKI: Sure. 17 A. If we invited somebody they may attend, 18 but usually it's EP staff and fellows. 19 Q. And who might be invited to it 20 besides -- 21 A. If we want to present a pathology, we 22 ask some pathologist to read a pathology. 23 Q. Okay. Are you familiar with something 24 called the Outcomes Research Database? 25 A. No. 0060 1 Q. Are you familiar with the a-fib center 2 registry? 3 A. No. A-fib center -- you mean the PVI 4 registry, or a-fib for the cases, or for the 5 center? 6 Q. Let me find a reference and I can show 7 it to you. 8 A. Yes. 9 Q. I'll hand you what I'll mark as exhibit 10 5 -- 11 (Deposition Exhibit 5 was marked for 12 purposes of identification.) 13 Q. -- which is an article published in 14 circulation in 2007. The lead author is Dr. 15 Wazni. It's pages 2,531 through 2,534. 16 And on page two of that document, you'll 17 see it says: All information collected was 18 entered into our AF center registry. 19 You know what that refers to? 20 A. Yes, now I know. It's a retrospective 21 database for patients who have had atrial 22 fibrillation ablations at the Cleveland Clinic. 23 Q. And who maintains that registry? 24 A. Through the Cleveland Clinic. Who 25 maintains it, I don't know. 0061 1 Q. Okay. Would all patients undergoing 2 a-fib ablation be included in that registry? 3 A. I don't know. 4 Q. Well what's your understanding of who 5 was included in the AF center registry? 6 MS. CARULAS: Objection. 7 A. It's a registry to collect retrospective 8 information about patients who have had procedure 9 at the Cleveland Clinic, atrial fibrillation 10 ablation. 11 Q. Okay. If I wanted to know more about 12 that registry, who would you recommend that I 13 talk to? 14 MS. CARULAS: Objection. 15 A. I don't -- 16 MS. CARULAS: If you know. 17 A. I don't know. 18 Q. Who's the current chair of the EP 19 department? 20 A. Bruce Lindsay. 21 Q. And is there a separate person who's 22 sort of identified as the head of the EP unit 23 that does a-fib ablation currently? 24 A. Walid Saliba. 25 Q. Have you ever accessed the AF center 0062 1 registry? 2 A. No. 3 Q. Okay. In preparation for today's 4 deposition, Doctor, did you review -- well, tell 5 me what you reviewed. 6 A. I reviewed the operative report and Dr. 7 Cummings' deposition. 8 Q. Did you also -- in addition to the 9 operative report did you also review any other 10 procedural reports or records? 11 A. Yes, nurses note. 12 Q. Okay. Anything else? 13 A. And I went and got the Carto, the disk. 14 Yeah, that's all. 15 Q. Okay. Do you recall Mr. Sullivan in a 16 way that you could describe his physical 17 appearance or what he looks like? 18 A. No, sir. 19 Q. Do you recall any conversations with 20 him? 21 A. No. 22 Q. Do you know if you were involved in any 23 respect in obtaining informed consent or in 24 describing the risks, benefits or alternatives to 25 this procedure to him? 0063 1 A. I -- when I meet the patients in the EP 2 lab I routinely do something called a time out. 3 Q. Okay. 4 A. Which is talking to the patient, 5 examining them, telling them who am I and who's 6 everybody else and then discuss the risks and 7 benefits of the procedures. But personally I 8 don't discuss the alternatives because I believe 9 that the patient is already on the table. But I 10 talk to them -- I examine them, I tell them who 11 am I and what's my role in the procedure. 12 Q. And in August 2006 in your time outs, 13 what would you typically -- can you just run 14 through what you would tell them in terms of 15 risks and benefits. Let's leave out who you are. 16 A. You know, we call it -- what I usual 17 say, say hi, Mr. So-and-so, we should check the 18 ID badge, now we group everything and call it a 19 time out. But we check the badge and say I'm 20 so-and-so and I'm going to be assisting, in this 21 case Dr. Burkhardt performing this procedure, do 22 you know what you're here for. If they know what 23 they're here for, that's fine. If they don't 24 know what they're here for, sometimes they joke 25 and then we tell them you're here to have atrial 0064 1 fibrillation ablations. We're going to get 2 access -- take the catheters up from the groin or 3 the neck up to the heart, to the left side of the 4 heart, burn areas inside the heart that we 5 believe they are the cause or what maintains 6 atrial fibrillation. 7 The risk of doing this procedure, the 8 risk of -- cumulative risk is around 46 percent, 9 22 percent risk of stroke, 22 percent risk of PV 10 stenosis and one to two percent risk of 11 perforation on the heart or need for a pacemaker. 12 And then they usually -- some patients 13 have more questions, some patients don't have 14 questions. 15 What I used to tell them also is the 16 worst thing -- one of the worst things that 17 they're going to feel is when we put the probe 18 from the nose up to the esophagus because I 19 really need their help in that and they're not 20 going to -- they might not like it just because 21 it might cause them some pain. But I said -- I 22 mean, I tell them that we need their cooperation 23 in doing this. 24 And then I examine them. Sometimes this 25 may take five to ten minutes, but sometimes this 0065 1 may take to an additional half an hour or rarely 2 45 minutes because some patients, sometimes they 3 have more questions and we'll go over everything. 4 Q. In terms of benefits, what do you talk 5 to a patient about in the time out? 6 A. What we talk about is that our aim and 7 our goal is to perform this procedure to suppress 8 atrial fibrillation. And this is what we insist 9 is people sometimes think that they're cured from 10 atrial fibrillation and we keep telling them, you 11 know, we're not going -- I usually refer we're 12 not going to go in and take their gallbladder or 13 their heart, we're just going in to suppress 14 areas inside the heart that we feel that they are 15 cause of atrial fibrillation. 16 Q. Okay. Anything else that you can recall 17 that you would typically talk about in terms of 18 risks or benefits during the time out? 19 A. I mean, we -- sometimes patients are 20 very -- we talk about the risks, obviously, of 21 their groin complication, but they're -- most 22 people are worried about the stroke and this is 23 what we tell them, sometimes it's like what's the 24 strokes going to be, tell them sometimes it's 25 minimal and sometimes it's, unfortunately, major. 0066 1 But I don't recall any details more than that. 2 Q. Do you have any recollection of having 3 this conversation with Mr. Sullivan? 4 A. No, sir. 5 Q. You talked about the probe being -- the 6 esophogeal probe being introduced nasally. Was 7 there a different type of probe under 8 investigation back in August of 2006, a Pill 9 Camera? 10 A. I don't recall, sir. There's a camera 11 now, but I don't recall it was available at that 12 time. 13 Q. With respect to the time out, is that 14 done immediately before the procedure? 15 A. Yes. 16 Q. And what is -- is the patient medicated 17 at all at the time the time out occurs? 18 A. No, sir. 19 MS. CARULAS: Sorry. 20 Need some water or anything? 21 THE WITNESS: No, I'm fine. Thank you. 22 Q. Okay. I'm going to hand you what I'll 23 mark as exhibit 6 -- 24 (Deposition Exhibit 6 was marked for 25 purposes of identification.) 0067 1 Q. -- which is a two-page document called 2 an Encounter Billing Record. And let me ask you, 3 Doctor: Are you familiar with this record? Have 4 you ever seen one before? 5 A. No, sir. 6 Q. About two-thirds of the way down there's 7 a reference to a St. Jude Medical Center catheter 8 EP, and it goes on to describe it as a steerable 9 EP catheter, two millimeter tip electrode. 10 Given -- go ahead. 11 A. Oh, I'm sorry, sir, where is -- 12 Q. Yes. It's where I've highlighted. 13 A. Catheter? 14 Q. Yeah. 15 A. Okay. Got AF/EP/DAIG Division, 16 Catheter, EP. 17 Q. Yes. 18 A. 20 electrodes, seven French -- yep, I 19 got it, sir. 20 Q. Does that description give you any idea 21 about what type of catheter is being identified 22 there? 23 A. Yes. Yes, sir. This is the catheter 24 that we put in the coronary sinus because it says 25 two a -- 20 volt, so when we mentioned here that 0068 1 we recorded the coronary artery sinus 2 electrograms at recording sinus, this is the 3 catheter that we place in the coronary sinus to 4 record these signals. 5 Q. Is this a mapping catheter? 6 A. It is a cath -- yeah, it's considered as 7 a mapping catheter. We don't move it, it's still 8 there, it stays there to record signals from the 9 coronary sinus. 10 Q. Okay. And then on page two of this 11 document, about a third of the way down, there is 12 a catheter identified as a Biosense Webster 13 catheter, the Celsius ThermoCool irrigated tip, 14 3.5 millimeter tip catheter; do you see that? 15 A. In the middle of the page? 16 Q. Yes. 17 A. Yes. 18 Q. And is that the -- 19 A. Ablation catheter, sir. 20 Q. Okay. And then below that, the next 21 line, it says, there's another catheter 22 identified there, a Lasso catheter. Is that the 23 mapping catheter? 24 A. Yes, sir. 25 Q. With respect to the irrigated tip 0069 1 catheter, is that -- was that used for manual 2 ablation procedures? 3 A. Yes, sir. 4 Q. And could it be used with a magnetic -- 5 a remote procedure? 6 A. No, sir. 7 Q. Okay. And then further down, I think 8 almost the last -- second to last entry, Biosense 9 Webster catheter ablation, and it indicates a 10 NaviStar RMT four millimeter tip thermocouple 11 catheter. And what kind of catheter is that? 12 What's that used for? 13 A. This is a four millimeter non irrigation 14 catheter that -- it's an ablation catheter used 15 inside to ablate areas inside the heart. 16 Q. Is that catheter used -- is that a 17 magnetic tip catheter? 18 A. Yes, sir. 19 Q. And that's used with remote navigation; 20 true? 21 A. Yes. 22 Q. Okay. The cardiodrive, which is the 23 next item on there, is that the navigational 24 equipment used to navigate a magnetic tip 25 catheter remotely? 0070 1 A. I don't know. 2 Q. You're not familiar with the term 3 cardiodrive? 4 A. No. I -- 5 Q. Okay. What did I mark that, 6? Is that 6 exhibit 6? 7 A. Yes. 8 Q. Thank you. 9 There's another bill in, I'm not sure I 10 can get my hands on it, but it talks about Carto 11 reference patches. Do you know what Carto 12 reference patches are? 13 A. Yes. 14 Q. What are those used for? 15 A. So they are used to, for the 3D, this -- 16 this map which is used with Carto. So they're 17 patches we put on the patients so they would find 18 the position of the catheter with respect to 19 these patches and this way we'll know where we 20 are inside the body of a patient. 21 Q. Can those be used with both remote and 22 manual or are they used with one or the other 23 type of ablations? 24 A. Honestly, I don't know. I would assume 25 they're the same, but I don't know. 0071 1 Q. All right. I'm going to hand you what 2 I'll mark as exhibit 7. 3 (Deposition Exhibit 7 was marked for 4 purposes of identification.) 5 Q. Tell me what that is, if you would, 6 Doctor. 7 A. Yeah. This is a map of part of the 8 right atrium showing us the location of the HIS 9 bundle and the location of the foramen ovale or 10 post ovale where they did a transseptal. 11 Q. You mentioned earlier that you looked at 12 a disk. Was this image included in that disk? 13 A. Yes. 14 Q. Were there more images included in the 15 disk besides that? 16 A. No, sir. 17 Q. Can you tell me, just based on your 18 experience doing this kind of procedure, why that 19 particular image would have been kept and no 20 other images from the Carto electroanatomic 21 mapping. 22 A. This is the only Carto was done in this 23 patient. 24 Q. And why would that particular picture be 25 important or relevant to keep? 0072 1 A. Because when you save, when you -- you 2 have to save -- to save this dot, you have to 3 click to save this dot and this will be saved 4 (indicating). 5 Q. Okay. But I guess why I'm asking is why 6 would you save that particular picture? 7 A. To -- here where they were interested in 8 the location between the HIS and where they 9 punctured and they're -- so that whether they 10 want to measure it today or measure it tomorrow 11 or measure it the day after or measure it when -- 12 in case they want to go back in, they have an 13 actual measurement of where's the HIS and where's 14 the area that they punctured. 15 Q. Okay. 16 A. The other 3D mapping is important when 17 you -- during the procedure, just give us where 18 are we and where's the catheter now and where's 19 the catheter in a different spot. 20 Now we do save more images, but at that 21 time obviously we didn't. 22 Q. Are all the images, the electroanatomic 23 images, are they all digital? 24 A. Yes. 25 Q. So you would have to physically delete 0073 1 them as part of the record back in August of 2 2006, right? 3 MS. CARULAS: Objection. 4 Go ahead. 5 A. They would -- 6 MS. CARULAS: I'm sorry, go ahead. 7 A. Oh, that's okay. 8 They would -- the computer rewrites on 9 top of each others. Like what we do with 10 fluoroscopy x-ray, it fluoro and then another 11 patient's would be written on top of it 12 (indicating). 13 Q. Why would it be important to have a 14 measurement of that distance in exhibit 7? 15 A. I answered this question. I said what 16 I'll -- you'll have to ask Dr. Burkhardt, but 17 what I would -- actually this to me is very 18 important because you know exactly where's the -- 19 what's the distance between the HIS and the 20 foramen ovale or where we entered the septum. 21 Q. And I guess why -- 22 A. In case patients -- 23 Q. Yep. 24 A. -- you want to bring them back later on, 25 you'd know was it where we punctured the septum, 0074 1 is it high, is it low, is it the same level as 2 the HIS. 3 Q. In repeat procedures, do you try to 4 avoid the puncture site from the previous 5 procedure or do you try to enter in the same 6 area? 7 A. We try actually to enter in the same 8 area. At least that's what I do. But different 9 physicians maybe do different things. Hopefully 10 there are not many redo's. 11 Q. Currently does the Clinic use written 12 and informed consent forms as part of every 13 atrial fibrillation ablation procedure, whether 14 the patient's part of a study or not? 15 MS. CARULAS: Objection. 16 A. Currently we have written consents. 17 Q. Okay. And do the written consents 18 currently list all of the risks of the procedure? 19 MS. CARULAS: Note an objection. 20 Go ahead. 21 A. They list that we discuss them with the 22 patient. 23 Q. I'm sorry? 24 A. They say that we've discussed the risks 25 with the patients. 0075 1 Q. Does it actually lay out the risks? 2 A. No. You can't list every single 3 complication. 4 Q. Back in August of 2006 it's my 5 understanding that written informed consent forms 6 were only used when a patient was part of a 7 study; is that correct? 8 A. Maybe. I'm not sure. 9 Q. Okay. If a patient had an informed 10 consent form that was IRB-approved because they 11 were in a study, was that kept as part of the 12 patient's chart or would it be kept somewhere 13 else? If you know. 14 A. I don't know. 15 Q. Do you recall having -- observing -- 16 well, strike that. 17 It's our understanding that Dr. 18 Burkhardt met with the patient the day before the 19 procedure or two days before the procedure, day 20 before. Were you present at that meeting? 21 A. I don't recall. 22 Q. Why don't I hand you what I'll mark as 23 exhibit 8. 24 (Deposition Exhibit 8 was marked for 25 purposes of identification.) 0076 1 Q. Which is numerous pages that include the 2 cardiac EP report, the procedural sedation 3 record, and the op note. 4 A. Thank you. 5 Q. And I'm going to ask you a number of 6 questions about that. 7 First thing I want to ask about is on 8 the front page in the upper left hand corner it 9 says, Result Date and Time, and there's a date of 10 August 17, 5:42 p.m. 11 Do you know what that time refers to? 12 A. Honestly, no. 13 Q. Under the Patient History it describes 14 the patient as having persistent a-fib. How do 15 you define persistent a-fib? 16 A. Atrial fibrillation that recurs after DC 17 cardioversion, or requiring a DC cardioversion. 18 Q. Would he also qualify as having 19 permanent a-fib? 20 A. There's no term about permanent atrial 21 fibrillation, because you can always correct it. 22 Q. And when you talk about chronic a-fib, 23 does that include both permanent and persistent 24 a-fib? 25 A. Same thing. This chronic atrial 0077 1 fibrillation and permanent atrial fibrillation 2 is -- haven't been using them anymore in the EP 3 literature. 4 Q. In the past in EP literature when they 5 refer to permanent and chronic -- well, strike 6 that. 7 In the past when they referred to 8 chronic a-fib, did that refer to both permanent 9 and persistent? 10 MS. CARULAS: Objection. 11 A. I would probably be more about permanent 12 or long-standing resistant. 13 Q. Did you review the fluoroscopy films for 14 this patient? 15 A. No, sir. 16 MR. KULWICKI: Can we boot this up? 17 Q. Let's show you what we have here. 18 A. Sure. 19 MS. CARULAS: Now what is this? 20 MR. KULWICKI: This is the fluoroscopy 21 that you provided us. You provided us with two 22 CDs, one is the HIS study that we have marked as 23 exhibit 7 and this is the -- 24 MS. CARULAS: Whoops. Sorry. 25 MR. KULWICKI: -- the one that is marked 0078 1 as August 17 Fluoroscopy. 2 MS. CARULAS: Just off the record. 3 VIDEOGRAPHER: Off the record. 4 (A recess was taken.) 5 VIDEOGRAPHER: This is tape three. 6 We're back on the record. 7 BY MR. KULWICKI: 8 Q. Okay. Doctor, during the break we 9 showed you the CD that was provided to us by the 10 Cleveland Clinic and it's our understanding that 11 it is the fluoroscopy from Mr. Sullivan's August 12 17th procedure, and I know you've had a chance to 13 review it. I want to ask you a couple questions 14 about it. 15 First of all, does it show the catheter 16 in the right side of the heart only? 17 A. Yes, sir. 18 Q. Okay. And based on your experience and 19 training back in August of '06, why would it be 20 that the fluoroscopy from, you know, only a 21 portion of the procedure would be kept? 22 A. The procedure depends on the main 23 operator, Dr. Burkhardt probably wanted to save 24 this piece. 25 Q. Okay. Going back to August of 2006. 0079 1 Was there any standard portion of the fluoroscopy 2 that was typically kept? 3 A. There are no standards. 4 Q. In this particular image that we have 5 here, does it show remote navigation occurring 6 within the right side of the heart? 7 A. Yes, sir. 8 Q. And does it show ablation occurring in 9 the right side of the heart using the remote -- 10 the magnetic tip catheter? 11 A. You can't see ablation on fluoroscopy. 12 Q. Okay. 13 A. You can only see catheter movement. 14 Q. Are the movements that we see there 15 consistent with ablation underway? 16 A. I doubt it, no, because you have to 17 position your catheter at the location and then 18 you burn. 19 Q. Do you know if -- in Mr. Sullivan's case 20 whether the right side of his heart was done 21 using remote navigation and a magnetic tip 22 catheter? 23 A. That was the -- this is what was done to 24 ablate, as I understand from this (indicating). 25 Q. Okay. And just so I clarify, is it the 0080 1 case that the right side of the heart was done, 2 was ablated using remote navigation with a 3 magnetic tip catheter? 4 A. Yes. 5 Q. Okay. And how about the left side of 6 the heart, do you know how that was performed? 7 A. As reported by the report, it's 8 performed through a 3.5 millimeter ThermoCool 9 catheter. 10 Q. Were there times back in August of 2006 11 where you'd do one side of the heart manually and 12 the other side of the heart remotely? 13 A. Yes. And that depends on -- the problem 14 with the 3.5 millimeter is that you need it on 15 the left side of the heart because it's a better 16 catheter, it's a -- can create more a transmuter 17 lesion that you need on the left side of the 18 heart. 19 Well, on the right side of the heart 20 when it comes to the superior vena cava, it's a 21 much thinner structure over there so you worry 22 about delivering high energy because the lesion 23 with a 3.5 millimeter catheters are usually 24 deeper, so it doesn't deliver a shallow lesion, 25 it's more of a deeper lesion so you'd worry about 0081 1 phrenic nerve paralysis and perforation in the 2 superior vena cava. So you rely on more of a 3 lower profile catheter, like a four millimeter 4 instead of a 3.5 ThermoCool catheter which 5 delivers much of a deeper lesion. 6 Q. Can you tell me in the op note that Dr. 7 Burkhardt dictated on August 17 where it says 8 that he performed some of this procedure using 9 remote navigation and a magnetic tip catheter? 10 A. It didn't say here, but -- 11 Q. What's the purpose of an operative note? 12 A. To explain the most -- the most of 13 everything that happened during an operating 14 room -- or operation. 15 Q. And we can agree looking at Dr. 16 Burkhardt's note that you can't tell that he 17 did -- or that a portion of this procedure was 18 performed remotely; true? 19 A. Yeah, but sometimes we perform steps 20 during the procedure that sometimes fails to come 21 to the operative report. 22 Q. Well, Doctor, when you perform an 23 ablation procedure and you do part of it manually 24 and part of it remotely, you record that in your 25 operative note, correct? 0082 1 MS. CARULAS: Just note an objection. 2 A. On most of them, yes. 3 Q. Do you do this procedure where part of 4 it is done manually and part of it's done 5 remotely? 6 A. Yes, but to less extents these days. 7 Q. And why do you do it to less extent 8 these days? 9 A. Because the issue of safety, we learned 10 a new trick that we didn't know at that time, 11 that you can lower the irrigation or turn off the 12 irrigation and the catheter would not -- you 13 could deliver energy and lower or shut off 14 irrigation. 15 Q. And how would that be more safe with the 16 irrigation shut off? 17 MS. CARULAS: Just going to -- just note 18 an objection to anything learned afterwards, but 19 go ahead. That's fine. 20 A. Okay. Because -- 21 MS. CARULAS: Just for the record, but 22 go ahead and explain, I'm sorry to interrupt. 23 A. Because when you shut off the 24 irrigation, you are limited with amount of energy 25 that you can deliver so your lesion is not that 0083 1 deep. 2 Q. And how does that improve upon safety? 3 A. Because you're not delivering deeper 4 lesions. 5 Q. How do deeper lesions lead to 6 complications? 7 A. If the structure is very thin and you 8 deliver a deeper lesion, you might actually cause 9 like a pop or -- you might injure the phrenic 10 nerve because the phrenic nerve runs close to 11 that region (indicating). 12 Q. Does the use of irrigation increase the 13 risk of thrombus formation? 14 A. No, on the opposite. Hyp -- I mean 15 theoretically this is why we went to irrigation 16 is because it theoretically has a benefit of 17 decreasing the risk of char formation on the 18 catheters. 19 Q. Okay. And yet with the irrigated tip 20 catheter, you'll agree with me that the use of 21 open irrigated catheters is often associated with 22 increased risk of tissue overheating and pops; 23 true? 24 A. Maybe. 25 Q. Well, that's what you wrote in your 0084 1 article that we've marked as an exhibit, didn't 2 you? 3 A. Yes. 4 It's all about balance. So we use the 5 irrigation, open irrigation catheter because we 6 believe that it's safer with respect to char 7 formation and decrease the risk of charring in 8 the left atrium, while on the right atrium we're 9 not that much concerned about this, we're 10 concerned more about how deep is the lesion that 11 can occur in the superior vena cava. 12 Q. In August 2006, did physicians at the 13 Cleveland Clinic appreciate that the likelihood 14 of success from a-fib ablation was lower with 15 persistent a-fib than with paroxysmal a-fib? 16 A. There was a consensus that the 17 long-standing atrial fibrillation may carry a 18 lower success rate than a paroxysmal. 19 Q. Did you have a percentage in mind in 20 terms of the success rate, meaning return to 21 sinus rhythm, what percentage of patients on a 22 single ablation would be returned to sinus rhythm 23 with persistent versus paroxysmal? 24 A. Yes. And what we usually use, we use a 25 range and that's because we usually tell the 0085 1 patients it's more than one factor. But on 2 average, for example, for paroxysmal it's 3 someplace between 75 -- 75 to low 80s and for 4 long-standing persistent it ranges between 50 to 5 around 75 to 80. And all of this depends on left 6 atrial size, whether there was scarring in the 7 left atrium and obesity, for how long the patient 8 had their atrial fibrillation. 9 Q. Any other factors? 10 A. Probably the presence of structural 11 heart disease or prior heart surgeries. 12 Q. Would a prior MI increase the risk of 13 failure? 14 A. I don't know data. 15 THE WITNESS: I'm sorry, can we go off 16 the record for just a second? 17 MR. KULWICKI: Oh, sure. 18 VIDEOGRAPHER: Off the record. 19 (Discussion had off record.) 20 VIDEOGRAPHER: Back on the record. 21 MR. KULWICKI: 22 Q. Doctor, I'm going to hand you what I'll 23 mark as exhibit 9. It's an article called Remote 24 Magnetic Navigation, lead author is Dr. DiBiase, 25 you're listed as an author as well. And it was 0086 1 published in the Journal of the American College 2 of Cardiology in 2007. 3 (Deposition Exhibit 9 was marked for 4 purposes of identification.) 5 Q. Are you familiar with that article? 6 A. It's been a while. 7 Q. The article discusses the magnetic 8 tipped catheter in the use of remote navigation 9 to perform PVAI ablation and it describes it as 10 being a novel approach in 2007. Would you agree 11 that it was a novel approach in 2007? 12 MS. CARULAS: Objection. 13 Go ahead. 14 A. Yes. 15 Q. Doctor, the article reports on 40 16 something patients that were part of the study, 17 but it also references 40 some patients that were 18 used to try the technology out on before the 19 study patients were treated. 20 Do you know if Mr. Sullivan was one of 21 the 48 patients that this technology was used on 22 prior to the commencement of the study reported 23 in that article? 24 MS. CARULAS: Objection. 25 A. No, I don't. 0087 1 Q. Given that remote navigation was used on 2 Mr. Sullivan and this article's published in 3 2007, does it stand to reason that he would have 4 been one of the patients referenced in that 48 5 patients that the remote technology was used on 6 prior to this study being commenced? 7 MS. CARULAS: Objection. 8 A. It's very unlikely because we got this 9 system, I think in -- back in 2005 and these 10 physicians were doing cases all over the country 11 using remote navigation. So I would assume that 12 this 48 probably occurred in 2005 or before that 13 time. 14 Q. Well, the article talks about the 15 experience at the Cleveland Clinic. Aren't all 16 the physicians listed in the list of physicians 17 all from the Cleveland Clinic? 18 A. There's somebody from -- Filipova, no, 19 he's not from the Clinic, from -- I think it says 20 Czech Republic, Prague, yes. We have a center 21 over there where Dr. Natale used to go sometimes 22 over there. And they've used to go also to a -- 23 different places too, because there's a center 24 here, Dr. Filipova from the Institute of Clinical 25 and Experimental Medicine in Prague, Czech 0088 1 Republic. 2 Q. Is the tech -- or was the technology in 3 August 2006 such that if there was a transseptal 4 puncture made manually with a ThermoCool 5 catheter, that you could reenter that puncture 6 with a magnetic tipped catheter just for purposes 7 of testing out the use of the magnetic 8 technology? 9 MS. CARULAS: Objection. 10 A. We've -- I don't recall I've ever done 11 that. 12 Q. Okay. Can you think of any reason why 13 Dr. Burkhardt would leave out the fact that a 14 portion of Mr. Sullivan's procedure was done 15 remotely? 16 A. No. 17 MS. CARULAS: Just note an objection. 18 Go ahead. 19 THE WITNESS: Sorry. 20 Q. Would there be a way to identify the 48 21 patients on whom magnetic navigation was used 22 prior to the 46 cases that were reported in this 23 article that we've marked as exhibit 9? 24 A. I don't know. 25 Q. Do you know who performed the 48 cases 0089 1 that were done before the cases that are reported 2 in that study? 3 A. No, but I would ask Dr. Natale. 4 Q. Okay. Back in -- well, currently, let 5 me ask currently, is there more standardization 6 in terms of how a-fib ablation is done than back 7 in 2006? In other words, is the anticoagulation 8 protocol, the type of navigation system, the type 9 of catheter, the type of energy delivery and the 10 length of energy delivery, are all those 11 parameters, have they been sort of refined to the 12 point where they are more standardized than they 13 were back in August of '06? 14 MS. CARULAS: Objection. 15 A. No, there's too many questions. I'll 16 try to answer one-by-one. 17 Performing the procedure still it 18 differs still from one institution to another and 19 from one physician to another because it's all -- 20 depends on what an individual believe is the way 21 it's going to benefit the patient. So different 22 institutions perform this procedure slightly 23 differently. 24 Energy wise, again, there's slight 25 difference between the amount of energy. We all 0090 1 know that probably in the left atrium you have to 2 deliver a lesion above 35 watts or 30 -- above 3 30, 35 watts to deliver a good transmuter lesion. 4 For areas that are really thin, I don't 5 think there's a consensus, whether how much 6 energy you can deliver, like the superior vena 7 cava. Anticoagulation, we have the Heart Rhythm 8 Society, American -- European Society of 9 Cardiology consensus to tell us about the 10 procedures and anticoagulation protocol and 11 follow-up from the ablation procedure. And what 12 else, sir? 13 Q. Okay. That's okay. Let me ask you a 14 more specific question. If you're done with your 15 answer for now I can maybe redirect the inquiry. 16 I don't want to cut you off. 17 A. No, no, no. Sure. Sure. 18 Q. Okay. Let me sort of break it down 19 by -- 20 A. Sure. 21 Q. -- different aspects of it. 22 Was there any consensus in August of 23 2006 about what was the safest catheter for left- 24 sided ablation? 25 MS. CARULAS: Just note an objection. 0091 1 Go ahead. 2 A. I would pick an irrigated catheter 3 because this is where hypothetically decreased 4 risk of char formation. 5 Q. With what? 6 A. With irrigated catheter, which is the 7 3.5 ThermoCool catheter. But, again, if somebody 8 performed it with a different catheter, with like 9 an eight millimeter catheter, there's nothing 10 wrong with that. 11 Q. Right. And that's what I'm asking is: 12 Was there -- in August of 2006 was there any 13 consensus about which type of catheter was 14 safest, setting hypotheticals aside? 15 A. I don't think there was a consensus. 16 Q. Were there any studies done that showed 17 the relative safety and effectiveness of 18 irrigated tip versus closed tip eight millimeter 19 versus closed tip four millimeter? 20 A. We reported some data from Italy, the 21 cases were done in Italy that showed that there's 22 more effective with a 3.5 but there's increased 23 risk of pericardial effusion. 24 Q. With a 3 point -- 25 A. .5 irrigation, open irrigation catheter. 0092 1 Q. Okay. 2 A. And there's slightly increased risk of 3 esophogeal erythema. 4 Q. With the irrigated tip? 5 A. Yes. 6 Q. What about with respect to the risk of 7 stroke using the various types of catheter, was 8 there any consensus or clinical study that showed 9 which was the safest in that respect? 10 A. I -- the issue when you study something 11 that doesn't occur, that is very rare, it's hard 12 to come up with a category saying that this is 13 better than this; you're going to need a lot of 14 patients to answer this question. 15 Q. Why do you think Mr. Sullivan had a 16 stroke? 17 A. We don't know. 18 Q. Did you and Dr. Burkhardt talk about it? 19 A. I don't remember I've had discussions 20 with him. 21 Q. Did you have any discussions with Dr. 22 Natale or any of the other physicians at the 23 Clinic about Mr. Sullivan's stroke? 24 A. I did not know that Mr. Sullivan had a 25 stroke until I was approached by Anna -- I'm 0093 1 sorry, my counsel -- I think a few month ago or 2 something. 3 Q. So back in August of '06 no one made you 4 aware that a patient that you were involved with 5 had a major complication like this? 6 A. I don't recall. 7 Q. Do you know what portions of the 8 procedure you did? 9 A. I was involved from the beginning of the 10 procedure until the end. 11 Q. In what way? 12 A. I was assisting Dr. Burkhardt with IV 13 access, I assist him with a transseptal. Dr. 14 Burkhardt is more of a hands-on individual so 15 he's more in the ablation side. 16 But evaluating the intracardiac 17 echocardiography, getting the images straight, 18 moving the table, getting the -- positioning the 19 Lasso catheter for him to burn. But this is 20 what's -- Burkhardt's more of a hands-on, but I 21 could have been involved in other things also. 22 To taking care of the sheets, to 23 transseptal, access, transseptal, ablation and 24 taking out the sheets. 25 Q. Can you tell from the medical record who 0094 1 did what in this procedure in terms of you and 2 Dr. Burkhardt? 3 A. No, I can't tell. But from my 4 experience with him, he's more of an obsessive 5 individual with hands-on individual. 6 Q. He was the assistant director of the 7 fellowship program in August of 2006; true? 8 A. Yes. 9 Q. So one of his goals was to make sure 10 that you, as a fellow, were getting appropriate 11 experience with doing procedures, correct? 12 MS. CARULAS: Objection. 13 A. He's -- yes. 14 Q. If Dr. Burkhardt was dictating the 15 operative report while this procedure was going 16 on, would that tell us that you were in fact 17 doing some of the ablations during this 18 procedure? 19 MS. CARULAS: Objection. 20 A. I -- if there was -- I'm pretty sure 21 that I can't be doing any ablations without him 22 and his presence inside the room. 23 Q. Can you rule out that you did any of the 24 ablations in this procedure? 25 A. No, I can't rule out. But I can rule 0095 1 out that ablations were done without him presence 2 next to me. 3 Q. When we -- oh, sorry, go ahead. Yes, 4 please. 5 A. We don't dictate, we type the procedure 6 note. 7 Q. Okay. 8 A. And it's -- the way it happens is typed 9 and then it's signed electronically. 10 Q. On occasions where you would be doing 11 the ablation portion of the procedure and the 12 attending would be in control of the mapping 13 catheter, was there any special paperwork that 14 had to be prepared for that to be done, for that 15 arrangement to take place? 16 A. No. 17 Q. If the mapping catheter comes in contact 18 with the ablation catheter, does that increase 19 the risk of thrombus formation? 20 A. We don't have any -- we don't have any 21 data suggesting that, but we try artificially to 22 avoid touching Lasso. 23 Q. Because of the risk of thrombus 24 formation? 25 A. No, because every time you touch a Lasso 0096 1 you actually make a -- drain some of the energy 2 and then put it in the Lasso and it may increase 3 the risks of char formation. 4 Q. In addition to the two EP physicians, 5 the attending and the fellow, who else is present 6 in the EP lab when a procedure like Mr. 7 Sullivan's is taking place? 8 A. Usually we have two or three nurses and 9 a technician, if we need it, from the three 10 dimensional mapping system that we use, if we 11 needed him or her. 12 Q. In cases where you were the fellow, did 13 you ever prepare the operative note, or was it 14 always the attending who prepared the operative 15 note? 16 A. I might have prepared some of it, but it 17 needs to be read and approved by the staff. 18 Q. So you may have actually prepared some 19 of Mr. Sullivan's note but Dr. Burkhardt would 20 have signed it? 21 A. Yes. 22 Q. If you would, Doctor, turn to page three 23 of exhibit 8 which is the procedural records. I 24 just want to ask you about a few things there. 25 A. Yes. 0097 1 Q. Is any of the writing on this page 2 yours? I see your signature at the bottom. 3 Anything else on here that you wrote? 4 A. Yes. The heart is irregular, and excuse 5 my handwriting, lungs is clear, resonant. And I 6 said the patient is here for a-fib and the plan 7 is to do a PVI. 8 Q. And anything else that's your 9 handwriting? 10 A. And I signed. 11 Q. Okay. Now, in the -- sorry, go ahead. 12 A. Sorry. No, that's it. 13 Q. Okay. In the upper right hand corner it 14 says: Follow-up DB. 15 A. David Burkhardt. 16 Q. I assume that's Dr. Burkhardt. What 17 does that refer to: Follow-up Dr. Burkhardt? 18 A. This means who's the physician. 19 Q. The attending assigned to the case? 20 A. This, no. This is the attending who 21 sent the patient to the lab, put a request for 22 the procedure. 23 Q. And then it says: ID verified by, and 24 then there's a check mark, RK. Do you know who 25 that individual is? 0098 1 A. No. But usually a nurse would identify 2 that ID and then I come and identify the ID also. 3 Q. And then to the right of that it says: 4 TCI/SP. Do you know what that refers to? 5 A. I know what's TCI. TCI means an 6 outpatient. 7 Q. TCI refers to the: To come in? 8 A. Maybe. 9 Q. Okay. And you don't know what the SP 10 stands for? 11 A. I'm sorry, sir. 12 Q. Okay. And then below that it says: 13 ESI -- well, first of all, when is this record 14 prepared? Is this before the procedure is 15 started? 16 A. Yes. This is usually prepared by the 17 nurse, one of our nurse schedulers. After 18 somebody initiate a request for a procedure, she 19 collect this information and write the name and 20 the procedure date and then calls the physicians 21 and they decide on what equipment they're going 22 to need. So here it says: ESI and Carto RMT. 23 So the physician requested ESI and Carto RMT and 24 then writes the indication of procedure and then 25 the procedure. 0099 1 Q. So this would be Dr. Burkhardt would 2 communicate to a nurse that he wants ESI and 3 Carto RMT? 4 A. Yes. 5 Q. Is the ESI used with remote navigation? 6 A. No. No, sir. 7 Q. What is ESI used with? 8 A. ESI is a three-dimensional mapping 9 system. So it's like -- it can build images like 10 these ones, but it uses a different technology. 11 It has its pros and cons. So these are two 12 different technologies. The Carto uses more of a 13 magnetic; the ESI use more of an impedence 14 measurement. To both, they do similar thing by 15 creating the geometry inside the heart, create a 16 left and right atrial shell. 17 Q. Can the ESI -- is the ESI a navigational 18 system or a mapping system or... 19 A. It's a mapping system. 20 Q. And can it be used with remote 21 navigation? 22 A. You know what? I don't know. 23 Q. You'll agree that Carto RMT can only be 24 used with remote navigation, right? 25 A. Yes. 0100 1 Q. Okay. When you see this ESI and Carto 2 RMT, what does that tell you about the physician 3 who was planning this procedure, what they were 4 planning to do? 5 A. This is planning that the physician 6 needs both companies' patches on the patient. So 7 he may end up using both. 8 Q. And this would be something that would 9 be communicated to the nurse by the attending, in 10 this case -- 11 A. Yes. 12 Q. -- Dr. Burkhardt? 13 A. Yes. 14 Q. Is there a pre-procedure meeting that 15 takes place between the attending and the nurse 16 to make sure the right equipment is present or 17 the scheduling is appropriate, or is that done by 18 e-mail? Or how does that take place? 19 A. Can be done by both ways, either a phone 20 call from the physician or through an electronic 21 respond -- through EPIC. EPIC is our electronic 22 medical record. So it can be done through EPIC 23 when you request a procedure or through a phone 24 call. 25 Q. There's a note below that, it says: 0101 1 Verified with patient by KB. Do you know who 2 that initial is for? 3 A. No. But we have a Kathy in the lab, I 4 don't know if that's her. 5 Q. Okay. Is there a different lab used for 6 remote -- and again going back to August of 7 '06 -- was there a different lab that was used 8 for remote procedures than with manual 9 procedures? 10 A. Yes. 11 Q. Could you do both remote and manual in 12 the lab where the remote procedures were done? 13 A. Yes. 14 Q. And in labs where the manual procedures 15 were done, could you do both remote and manual in 16 that lab? 17 A. No. 18 Q. Okay. In other words, you had to have a 19 special lab to do it remotely? 20 A. Yes. 21 Q. Where it says at the bottom: Informed 22 consent for procedure and sedation, August 16, 23 2006 in EPIC, that's not your handwriting? 24 A. No. 25 Q. And where it says: Risks, benefits and 0102 1 alternatives discussed and patient agrees to 2 proceed, the yes, yes, that's not your 3 handwriting? 4 A. No, that's most likely from before I 5 approach the patient. 6 Q. Okay. On page -- the next page, is any 7 of the handwriting on this page yours, Doctor? 8 A. No. 9 Q. There is -- about a little over halfway 10 down your signature appears there and then there 11 are a number of -- 12 A. I'm sorry, sir. 13 Q. (Indicating). 14 A. It's not my signature, sir. It just 15 said Dr. Kanj. 16 Q. I see. Somebody just wrote in -- 17 A. Yes. 18 Q. -- physician would be Dr. Kanj? 19 A. Yes. 20 Q. Kanj, sorry. 21 A. Yes. Who did the audible time out. It 22 says: Audible time out. 23 Q. And that's what you were telling us 24 about earlier, the time out? 25 A. Yeah. Yes. 0103 1 Q. Okay. And next to that it says: 2 Assistant, and there's Lopez, Maggio -- 3 A. Yes. 4 Q. -- Petro. Can you tell me who those 5 individuals were? 6 A. These are the nurses. So when I come to 7 the room, I introduce myself and I tell them, so 8 we can gather around the patient and say I'm 9 so-and-so, I'm assisting doctor and then we have 10 Mr. or Mrs. Lopez is going to be at the head of 11 the bed and going to be doing this, Mrs./Mr. or 12 Ms. Petro is going to be there doing this and 13 this, Mr., I don't know who's Maggio, but 14 explaining to the patients the role of -- so 15 these are the ones that attended the time out. 16 Q. Okay. And when it says the time, is 17 that the time that the audible time out took 18 place, at 13:45? 19 A. I would assume so, sir. 20 Q. Now the record shows that Versed was 21 given at 13:45. Is that the conscious sedation? 22 A. Where is it, sir? 23 Q. Right here (indicating). 24 A. Yep. 25 Q. 13:45, it says: Versed and then 0104 1 Fentanyl. 2 A. Yes. 3 Q. What does the Versed do? 4 A. Makes the patients relax. 5 Q. And what does the Fentanyl do? 6 A. Also takes care of the pain. 7 Q. Now, have you ever had a patient during 8 a time out when you're going through the things 9 that you're talking about as they're laying there 10 with sedation imminent or started say to you, you 11 know, Doctor, I've -- based on what you're 12 telling me, I don't think I want to go forward 13 with this procedure; have you ever had a patient 14 cancel at that point? 15 A. The procedure? 16 Q. Yes. 17 MS. CARULAS: Just note an objection. 18 A. Yes. 19 Q. You have? 20 A. Yeah. 21 Q. And have they cancelled because of 22 anxiety about the procedure -- 23 A. Yes. 24 Q. -- or cancelled -- okay. 25 In that square that's towards the bottom 0105 1 it says: Patient name, Shannon Sullivan. And 2 then below that it says: Date and time of 3 collection, it says August 17 at 10:30. Do you 4 know what that refers to? Is that when the 5 pre -- 6 A. This is the pro time, sir. 7 Q. Okay. 8 A. So it was collected at 10:30. 9 Q. And it shows his INR was 1.4 10 pre-procedure; true? 11 A. Yes, sir. 12 Q. Typically the INR would be two to three 13 pre-procedure, correct? 14 MS. CARULAS: Objection. 15 A. No, depends on the staff. Sometimes we 16 perform these procedures with low INRs but we 17 check for a TEE or a CAT scan to make sure that 18 there's no blood clot. 19 Q. Is a subtherapeutic INR pre-procedure 20 associated with an increased risk of thrombus 21 formation? 22 A. The true answer to this question is we 23 really don't know. We have data showing that 24 patients with no risk factors the risk of a blood 25 clot is zero. 0106 1 But the true -- we have, you know, now 2 that I think about the a-fib, we have a 3 registry -- now I think about the a-fib registry, 4 we have a registry for everything we do here, 5 like for -- call it quality control registries. 6 So we have a VT registry, we have I 7 think SVT registries, a-fib might be one of it. 8 We have device registries. We have CRT 9 registries. Where these only for quality control 10 to -- for complications reasons where we go 11 through them. 12 So this is where you have to -- I 13 believe in 2007 we looked at our -- looked 14 backward at our patients who had a stroke and 15 there was a trend that most patients who had a 16 stroke had a subtherapeutic INR. 17 But the truth of the matter is these 18 things can only -- they don't prove anything, 19 they're there to suggest to the medical field 20 that we need to do a good trial to look for 21 these -- to validate these things. 22 Q. In terms of that, I'm familiar with Dr. 23 Natale's article that reflects on looking back at 24 the patients within the registry and it being 25 something like 26 different strokes reported in 0107 1 that retrospective analysis, and he mentioned 2 that they all had subtherapeutic INRs. And I was 3 wondering did that, by subtherapeutic INR, was he 4 talking about pre-procedure or post-procedure, or 5 either/or? 6 A. We can look it. Do you have it? 7 Q. I don't have it. If you don't remember, 8 that's fine. 9 A. No, I don't remember. 10 Q. Doctor, on the next page, if you would, 11 flip to that. 12 Is that your signature where it says: 13 Physician Signature? 14 MS. CARULAS: Where you at? 15 MR. KULWICKI: Right here (indicating). 16 A. Yes. Yes. 17 Q. And what does that signify? 18 A. Signifies that I was in the room and I 19 signed these orders. 20 Q. On the next page, the Procedural 21 Sedation, Additional Monitoring (indicating). 22 A. Yes. Yes. 23 Q. Ask you some questions about that. 24 At 16:50 it shows that a cardioversion 25 was attempted, correct? 0108 1 A. Yes, sir. 2 Q. Which led to a sinus rhythm? 3 A. Yes, at 200 joules. 4 Q. When do you typically attempt 5 cardioversion? Or in a procedure like this with 6 Mr. Sullivan, when would you -- what would be the 7 event that would trigger attempt at 8 cardioversion? 9 A. It depends again on the physician. Some 10 physicians do it at the beginning of the 11 procedure and then they do the ablation, some 12 physicians they would do it in the middle and 13 some physicians will do it near the end. But 14 even when we do it near the end, we have to 15 recheck the veins to make sure that we have 16 gotten isolation in the pulmonary veins. So 17 because the best way to document isolation in the 18 pulmonary veins is to put the patient back in 19 normal rhythm. 20 Q. I saw you got a page, do you need to 21 grab that? 22 A. Yeah, I'm sorry, is it okay? 23 Q. That's okay. 24 MR. KULWICKI: Let's take a break. 25 VIDEOGRAPHER: Off the record. 0109 1 THE WITNESS: Thank you. It's another 2 physician. 3 (A recess was taken.) 4 VIDEOGRAPHER: We're back on the record. 5 BY MR. KULWICKI: 6 Q. Okay. Doctor, we were looking at the 7 part of exhibit 8, I believe it is, which is the 8 Procedural Sedation, Additional Monitoring 9 record. And just by way of overview, who records 10 all the information that's contained on this 11 particular record? Is it the nurse that's 12 present? 13 A. No, actually it will be recorded by the 14 nurse at the head of the bed. 15 Q. Okay. 16 A. I'm going to take you back to that time 17 out. 18 So there's three, we had three nurses 19 here. As I told you we, after we do the time 20 out, we say this is in charge of the head of the 21 bed, this is going to be -- this nurse is going 22 to be helping us with operating this machinery or 23 something like that. So the nurse who's one of 24 these nurses who's in charge of the head of the 25 bed will be the one who's responsible to chart 0110 1 this. 2 Q. Okay. Incidentally, back in August of 3 2006 when you were a fellow, did you have a 4 particular designation on your lab coat that 5 indicated that you were a fellow? 6 A. We had a badge that says Cardiology 7 Fellow and we had -- the coat that we wear is a 8 blue and it's not black. 9 Q. Okay. Going back to the Procedural 10 Sedation, Additional Monitoring record. 11 We were looking at 16:50 in a 12 cardioversion at that point in time. About 16:47 13 there's a note there, it says: DC, and it looks 14 like 120 joules. Tell me what that means to you. 15 A. This means that a direct current 16 cardioversion at 120 joules was attempted. 17 However, it was not successful because the 18 patient stayed in atrial fibrillation. 19 Q. Okay. And in terms of the nurse 20 recording this information, would this 21 information be called out by the physician or -- 22 well, obviously in the left hand column there's 23 vital sign information that she would be 24 recording based on her own observation, correct? 25 A. Yes, sir. 0111 1 Q. But in terms of the effort at 2 cardioversion resulting in -- remaining in a-fib, 3 would that be something that the physician would 4 report to her and then she would chart that? 5 A. Yes. 6 Q. Okay. With respect to cardioversion in 7 patients that are undergoing a-fib ablation, does 8 that lead to a condition called cardiac stunning? 9 A. Yes, may. 10 Q. And does cardiac stunning -- well you 11 say may; what percentage of patients have 12 stunning? 13 A. The truth is we don't know. But the 14 longer the patient's in atrial fibrillation, the 15 more the risk of stunning. 16 But to get them back -- the heart to 17 function, it's a counterproductive thing because 18 you really need to put them back in normal rhythm 19 to get the heart going again and the longer you 20 keep them in atrial fibrillation, the more the 21 risk of stunning. So the sooner you do it and 22 try to fix the problem, the better in the long 23 run. Because the longer you keep them in atrial 24 fibrillation, the higher the risk of their 25 stunning. 0112 1 Q. And let me make sure I understand that. 2 Are you talking about the length of time that 3 they're in a-fib perioperatively? 4 A. Yes, sir. 5 Q. Not going back in time over the history 6 of their a-fib, but you're talking about during 7 the procedure itself? 8 A. No. Over the time of the atrial 9 fibrillation that the patient had. 10 Q. Okay. So a patient who has a-fib for 11 two years is going to be at a greater risk of 12 stunning when they're converted to sinus rhythm 13 than a patient who's been in a-fib for 30 days? 14 A. Yes. 15 Q. Okay, got it. 16 Now with respect to stunning, is there 17 any way to measure whether a patient has cardiac 18 stunning or the extent of their stunning via EKG 19 or any other -- 20 A. No. 21 Q. Okay. When a patient has stunning are 22 they at increased risk for thrombus formation? 23 A. Depends on the duration. We haven't 24 seen that over a short period of time that 25 stunning can cause anything. 0113 1 Q. And I apologize if you've answered this, 2 but I just want to make sure. Is there any way 3 to tell in Mr. Sullivan whether he had 4 cardioversion-related stunning to his heart? 5 A. No, we don't know. 6 Q. Okay. Now at 17:05 it shows his ACT at 7 417 and ten milligrams of Protamine are given. 8 And then his ACT comes down to 308, five 9 milligrams of ACT -- or five milligrams of 10 Protamine are given. And then it shows that his 11 ACT actually went up to 420 after 15 milligrams 12 of Protamine are given. 13 Can you tell me why, despite Protamine 14 reversal, his ACT would go up? 15 A. You know, this is a crude lab test. But 16 the thing is this gentleman have had so many 17 Heparin, so if anything, the ACT at 308 is the 18 one that's, it's un -- artificially lower than 19 the usual. Because with the Protamine, he only 20 got ten milligrams of Protamine and that's only 21 able to reverse less than 1,000 units of Heparin, 22 which is a very insignificant number. Because if 23 you look, he always wanted more -- like to jump 24 from 354 to 368 he required 3,000 units. From 25 368 to 378 he required another 3,000 units. So, 0114 1 if anything, this 308 is little bit artificially 2 on the lower side. Just taking 1,000 out of the 3 way is a little bit hard to believe. And he 4 still continued on Heparin. 5 Q. At roughly 18:05 to 18:10 he's given 6 another ten milligrams of Protamine -- 7 A. Yes. 8 Q. -- per your instruction. What would be 9 the reason for giving additional Protamine at 10 that point in time? 11 A. Because we have to reverse the ACT to 12 get it below 200. This is per the consensus 13 statement of the American Heart Association and 14 Heart Rhythm Society, to get it to less than 200 15 so that we can safely transfer the patient to the 16 floor without the risk of vascular complications. 17 Q. And why would the ACT go from 420 to 151 18 at 18:35 after ten milligrams of Protamine? 19 A. Again, this is a crude test. So what we 20 usually like to do is that we usually try to 21 reverse with some place -- usually like now we do 22 25 to 30 IV push right away and then reassess the 23 ACT and then we'll go from there. 24 Q. 25 to 30 milligrams of Protamine? 25 A. Yes. This is what we currently do. But 0115 1 at that time we were worried about some 2 anaphylaxis from the Protamine so we were giving 3 it at ten, five, ten. But now we start with like 4 25 to 30 and then reassess and then we'll go from 5 there. 6 Q. By my review of the record, the ACT of 7 151 is the last one drawn before -- 8 A. Yes. 9 Q. -- his stroke, correct? 10 A. I don't know. 11 Q. Assuming that's the case, would an ACT 12 of 151 be subtherapeutic? 13 A. Actually it is very therapeutic. 14 Because if you look at patients who are on 15 Coumadin and they are taking Coumadin at INR of 16 two to three, their ACT is usually in the 130, 17 140. 18 But it's not therapeutic for putting a 19 left-sided catheter, but at that time we were 20 more worried about bleeding and there's no 21 catheters inside the left side of the heart. So 22 you want to avoid the risk of complications, 23 whether it is vascular complication or even 24 pericardial effusions and tamponade. 25 Q. Does the ACT always correlate with the 0116 1 INR? 2 A. There is -- the Coumadin actually -- 3 there is a relationship between Coumadin and INR 4 and ACT. 5 Q. Okay. There's a note next to the ACT 6 151, it says: Report call to G110, and then I 7 can't read that, but it says: Bed cancelled per 8 admitting to transfer patient to, looks like PTO 9 or DTO. Do you know what any of that means? 10 A. PTO, I'm not sure. Patient transferred. 11 MS. CARULAS: It's actually in and out 12 room. 13 THE WITNESS: In and out. I was going 14 to say that, but I didn't want to put it -- 15 MS. CARULAS: Yeah. 16 THE WITNESS: -- if I'm not sure. We 17 need to use a lot of -- 18 MS. CARULAS: Abbreviations. 19 Q. What does that mean; do you know? 20 A. PTO? 21 Q. Yeah, the -- 22 A. I believe it's -- it might be the in and 23 out room. The in and out room is where -- it's a 24 cardiac stepdown unit near the cath labs and 25 electrophysiology labs where usually our patients 0117 1 are prepped and they come to the EP lab and then 2 if they want to go to -- they're waiting for 3 their room to be cleaned they go back to this 4 cardiac stepdown unit, it's in the -- next to the 5 EP labs -- 6 Q. Okay. 7 A. -- and the cath labs, so... 8 Q. And would that cancelling of the bed 9 reflect that the patient was going to be stepped 10 down for release? Does this tell us anything 11 about the patient's condition or decisions being 12 made about the type of post-procedure monitoring 13 that would take place? 14 A. Yeah, their post-procedure monitoring 15 depends wherever -- if the patient goes to the 16 unit, that nurses' staff would take over the 17 monitoring. Or if the patient is not taken over 18 there, then the nurses, the three nurses who 19 are -- they were part of the procedure, they will 20 assume that care. 21 MR. KULWICKI: Okay. Why don't we go 22 ahead and change the tape. 23 VIDEOGRAPHER: End of tape three. Off 24 the record. 25 (Discussion had off record.) 0118 1 VIDEOGRAPHER: This is tape four. We're 2 back on record. 3 BY MR. KULWICKI: 4 Q. Doctor, looking at exhibit 8 -- and let 5 me double-check, if I could, I kind of lost 6 track. Is this exhibit 8, the front page of what 7 we've been talking about (indicating)? 8 A. Yes, sir. 9 Q. Okay, thank you. 10 If you would turn to the cardiac EP 11 report section of it. 12 A. Yes, sir. 13 Q. On the first of seven pages there is -- 14 there are a couple of fields of information, 15 Procedures, Staff, Medication, Events and Vital 16 Signs, and there's no information recorded under 17 that. Do you know if this is looked at 18 electronically if you were to, say, click on 19 Procedure or click on Staff that the information 20 would come up? Or maybe you can just help me 21 understand why there's no information under any 22 of those fields of information. 23 A. This is usually entered electronically 24 into the system, but I don't know why it's shown 25 this way. 0119 1 Q. Okay. In a record like this when you 2 look at Staff and it says Duty and the name, what 3 kind of information would be entered in there, 4 the attending who's responsible or would it be 5 some other kind of information? 6 A. Honestly, I don't know, I've never done 7 any of that. I'm a staff right now and I don't 8 know who enters this information. 9 Q. All right. And then below that where it 10 has the Event Log there are a number of ablations 11 recorded and I want to ask about that. 12 A. Sure. 13 Q. Who would enter that information, would 14 it be one of the nurses in the room? 15 A. Sir, this is automatic. So when staff, 16 say, come on, meaning ablate, then I think what 17 happens is the RF generator would send a signal 18 to the recording software and the recording 19 software would automatically record this 20 information. 21 Q. Okay. 22 A. So none of these are manual, this is all 23 automatic. So from when the staff says on, 24 information will be transferred and the event 25 would tag and you'll have this ablation start and 0120 1 ablation end. 2 Q. So when you do your first ablation at 3 3:14, it would last until 3:15? 4 A. Yes. 5 Q. Okay. And then as you go down, there's 6 another entry in there, it says: Arrhythmia 7 tachycardia. What would that reflect? 8 A. This is, again, this is -- this 9 recording software is -- so if the recording 10 software thinks that the patient in arrhythmia, 11 it will tag this. 12 Q. Okay. 13 A. But the patient -- this tells you that 14 the software should have detected the arrhythmia, 15 this says the patient is in atrial fibrillation. 16 So it detects, for example, if the patient start 17 having tachycardia, their heart rate is set -- 18 their heart rate decided to go above 100 or 19 something like that, the machine will 20 automatically mark that as a arrhythmia or -- 21 Q. Are you okay or you need to take a 22 break? 23 A. Actually, I'm sorry. 24 Q. Hey, don't worry about it. 25 A. You know what? That's fine, I think I 0121 1 can let this one slip. This is my brother. Can 2 wait. 3 Q. Okay. So then as we go through this, 4 there's -- there are a total of 52 ablations 5 between 3:14 and 5:24. So a procedure time of 6 about two hours and, what, ten minutes. 7 In terms of PVAI ablation, is that on 8 the long side or is that in the middle or is that 9 short? 10 A. Probably in the middle to kind of short. 11 But probably in the middle, it's probably a good 12 representation of -- how many hours did we say? 13 Two, 3:14 to 5:24, two hours 15. Probably a good 14 one, because we can do only two cases a day; in 15 the morning one case, in the afternoon one case. 16 Q. And in terms of the number of ablations, 17 it says 52, is that -- again, how would that fit 18 if terms of PVAI ablations, is that a lot, a 19 little or average? 20 A. You know, these ablations points is, you 21 know -- this only records when the doctors comes 22 on and when the doctors -- would you like me to 23 wait for you? 24 Q. No, that's all right. Thank you. 25 A. So it only records when the doctors 0122 1 comes on and the doctors comes off. The Doctor 2 might come on and ablate two areas next to each 3 other, so the ablation points -- so this doesn't 4 mean much. I mean, you want to go in and do the 5 job right, whether the patient is going to take, 6 you know, 100 points or 500 points -- or 50. If 7 anything, it's in the lower side. 8 Q. And as you state here with, say, one 9 ablation, that might actually be energy used to 10 deliver at two different sites? 11 A. It may be, depending on whether, again, 12 whether we were able to ablate that area or not. 13 Q. Between ablation 46 and 47 there's about 14 a half hour period of time. Is that likely when 15 there was a transition from doing the left side 16 of the heart manually and beginning to do the 17 right side of the heart remotely? 18 A. Yes, sir. 19 Q. When you switch from manual to remote, 20 do you have to remove -- well, you have to remove 21 the catheter, right? 22 A. Yes. 23 Q. Do you have to remove both the mapping 24 and the ablation catheter? 25 A. At the end of the case we have to 0123 1 take -- I mean at the end of the left side we 2 have to move the mapping and the ablation from 3 the left side. We keep the mapping on the right 4 side, we remove the ablation from the right side 5 and we put another mapping ablation on the right 6 side. But the mapping catheter stays in the 7 right. 8 Q. In terms of the ablation summary, there 9 is a reference to the power delivered, and those 10 are the watts that we talked about earlier, 11 right? 12 A. Yes, sir. 13 Q. And in terms of the -- it's my 14 understanding that that would be the measurement 15 of the heat at the tip of the electrode or at the 16 tip of the catheter, right? Or the energy, I'm 17 sorry, the energy at the tip of the catheter, 18 right? 19 A. This is, yes, the energy delivered at 20 the distal electrode. 21 Q. And the temperature to the left of that 22 would reflect the temperature at the end of the 23 electrode as opposed to the temperature at the 24 tissue interface, correct? 25 A. Yes. 0124 1 Q. Can the heat or the temperature at the 2 tissue be higher than what's recorded on the end 3 of the electrode? 4 A. Yes. 5 Q. And is there any way to monitor the 6 difference between the temperature at the end of 7 the catheter and the temperature at the tissue? 8 A. There's no way to do that. 9 (Discussion had off record.) 10 THE WITNESS: Counsel, I was going to 11 ask while you're talking is it okay to take a 12 break? 13 MR. KULWICKI: Oh, sure, no problem. 14 Take a break. 15 VIDEOGRAPHER: Off the record. 16 (Discussion had off record.) 17 VIDEOGRAPHER: We're back on the record. 18 MR. KULWICKI: 19 Q. Okay. And, Doctor, just in terms of the 20 overall procedure, I think it was roughly five to 21 six hours, the total time for the procedure; does 22 that sound about right for a PVAI ablation 23 procedure? 24 A. Yes. 25 Q. And when you have two of them, tell me 0125 1 how you would typically schedule those. Would 2 you schedule -- what time would you schedule the 3 start of each one? 4 A. We don't -- we tell the second patients 5 to come around noon, but we work until the work 6 is done. 7 Q. Okay. And when you have -- let me ask 8 you in terms of you as a fellow: Would you get 9 an assignment where you would know what cases, 10 what types of cases you'd be having on the 11 morning of the cases or the day before or the 12 week before? How would that work? 13 A. It's usually either the morning of the 14 procedure or the night before. 15 Q. And would you know from the schedule 16 that you received -- how would you receive that, 17 by e-mail or some other way? 18 A. Now we receive it by e-mail, but at that 19 time we -- there's a board and you come and see 20 who you're going to be assisting, who's the 21 doctor who you're going to be assisting with, or 22 some doctors might have more than one, mean you 23 might be responsible for this procedure and work 24 with Dr. X, then you might work with a Dr. Y or Z 25 with a different procedure. 0126 1 Q. And when you do something like this, a 2 PVAI ablation first thing in the morning, would 3 you typically be assigned to, say, Dr. Burkhardt 4 for both procedures so that you're available for 5 the second one? 6 A. Sometimes like this and sometimes not. 7 Q. And in a PVAI ablation procedure when 8 roughly two hours or so of it is spent ablating 9 and it's a five-hour long procedure, is there a 10 point in time during the procedure when only one 11 physician is needed to be available and attending 12 to the patient, leaving the other physician to 13 leave and maybe start another case? 14 MS. CARULAS: Objection. 15 Go ahead. 16 A. No. No. The only time is when they are 17 taking out the sheets. 18 Q. Okay. So let me understand that better. 19 So when, as it says here that she DC'ed per Dr. 20 Kanj at 17:55, is that when Dr. Burkhardt would 21 be free then to go attend to another case or 22 begin another case? 23 A. Usually has -- the patient has to be in 24 the room so Dr. Burkhardt can do something else, 25 like type his report or go step out and talk to 0127 1 the patient's family. But if he's going to have 2 another case, the case cannot be done without the 3 patient's getting out of the lab for another 4 patient to come into the lab. 5 Q. Okay. We were talking about the seven- 6 page cardiac EP report and I'm on page six of 7 that. 8 A. Is it -- is it -- is this six or 9 exhibits from the beginning? 10 MS. CARULAS: Yes, I think. 11 A. Sir, is it six out of seven -- 12 Q. Yes. 13 A. -- or is it six from the beginning? 14 Q. No, six out of seven. Yeah, sorry. 15 A. Okay. 16 Q. Beginning with ablation number 47, the 17 impotence levels go down. Would that likewise 18 confirm that in all likelihood the right side of 19 the heart is being done via remote -- remote 20 navigation and remote magnetic catheter? 21 A. Yeah, that tells us that he's starting 22 to use the formal (phonetic) meter because, as I 23 told you, we need to deliver lower powers so we 24 don't have to worry about the deeper lesions, and 25 that's what clearly shows here, nine and six and 0128 1 four and 17 and 25 and 50. 2 Q. And in terms of the catheter that was 3 used for ablation number 46 through number one, 4 was that a 3.5 millimeter? 5 A. The 46? From one to 46? 6 Q. Yes. 7 A. I would assume. What time -- we can 8 look at the times. 9 Yeah. Yes, sir. 10 Q. And on that same page where it says 11 Conduction Intervals and then AV Nodal 12 Conduction, Conscious Sedation and then Manual 13 Measurements, again, there are different fields 14 of information that we don't see any information 15 in the field. Is that information that's 16 typically accessible using the electronic medical 17 record from a computer terminal? 18 A. This is -- that you have to put it in 19 that system, but I think we elected not to put it 20 in that system so it's an additional step to put 21 it in the system. But it should have -- was it 22 reported? 23 Q. Well, let me ask you that: Is that the 24 kind of information that you would typically 25 report in some fashion? 0129 1 A. No, we don't do that here. But we 2 report it another database, though, this one 3 (indicating), which is -- 4 Q. Okay. Is that something that's 5 retrievable? 6 A. This (indicating)? 7 Q. The conduction intervals? Was that what 8 we just looked at? 9 A. This is what we -- this is another 10 system of recording the information. 11 Q. Okay. Well, when it says Conduction 12 Intervals -- 13 A. Yes. 14 Q. -- is that what we see on page one of 15 seven where it says ablation one starts at 3:14 16 and then ends at 3:15? 17 A. It's the same recording system. 18 Q. But just so -- I'm sorry I'm not 19 understanding -- 20 A. I'm sorry, yes. 21 Q. -- but are those conduction intervals, 22 where it says -- 23 A. No, sir. 24 Q. -- ablation one started? 25 A. The conduction intervals -- okay. These 0130 1 are conduction intervals (indicating). 2 Q. Okay. 3 A. So if like between this signal and the 4 next signal, this is what we call a conduction 5 interval between here and here, between here and 6 here (indicating). But depending what we're 7 looking for here, for example here, what's the VV 8 is the time between the one ventricular beat and 9 the other ventricular beat. 10 Q. And is this information recorded 11 somewhere else then? 12 A. It's reported -- the HV, which is the 13 most important part of this is, we reported it, 14 should have been reported in the lab 15 (indicating). 16 Q. And do you see where that's recorded in 17 the lab report? 18 A. Not this one, the lab report. This is 19 the EPIC, we should have a different one. 20 Q. Let me find that. I think we marked 21 that as an exhibit. 22 Exhibit 4. 23 A. Thank you, sir. 24 It wasn't reported. It was not 25 reported. 0131 1 Q. What is the HV? 2 A. It's the distance between the HIS bundle 3 signal and the ventricular bundle signal, 4 ventricular signal. 5 Q. And why is that important? 6 A. Because it test the electrical system on 7 the heart. 8 Q. Do you know why -- well ultimately this 9 patient returned to a-fib. Do you know why his 10 procedure likely failed? 11 A. We don't know. We don't know who 12 responds and who don't responds to these 13 procedures. If we knew, we would have saved a 14 lot of people procedures. 15 Q. And you don't know which patients stroke 16 and which patients don't stroke, right? 17 A. Yes. 18 Q. You don't know what risk factors there 19 are for procedural failure? 20 A. The best risk factor that we have is 21 the -- to have scars inside of -- scar or dead 22 tissue in the left atrium. Unfortunately, we 23 can't get that information until we perform this 24 procedure. In ten years it might be different, 25 but right now, unfortunately, the main important 0132 1 factor we don't know until we do the procedure. 2 Q. Wouldn't an EKG show you if they have -- 3 by dead tissue are you talking about a prior MI? 4 A. No. 5 Q. What are you talking about? 6 A. Left atrial scarring. 7 Q. And what causes that? 8 A. Atrial fibrillation and heart surgeries 9 or it could be genetics, bad genes inherited from 10 parents. 11 Q. Can you tell if this patient had left 12 ventricular or left atrial scarring? 13 A. Not that we -- did we -- let's see if we 14 reported it. 15 No. 16 Q. It says: Cardiac Diagnoses: No 17 structural heart disease. 18 Does that tell you that he didn't have 19 atrial scarring or would -- 20 A. No. 21 Q. -- that refer to something else? 22 A. It has to be -- it has to be mentioned 23 in the -- under Additional Comments. 24 So there's no scarring, there's no -- we 25 didn't report it so it's not present. 0133 1 Q. Where is that Comment section? 2 A. Additional Comments, sir (indicating). 3 Q. Oh, I see. 4 Is that something that would typically 5 be charted if it was present? 6 A. If it was present then we would mention 7 it. 8 Q. This was an elective procedure; true? 9 A. Yeah. 10 Q. Following the procedure, the patient's 11 anticoagulation is reversed; true? 12 A. Partly. 13 Q. I'm going to hand you what I'll mark as 14 exhibit 10. 15 A. We've got 8, 9. Yes, 10. 16 Q. This is an article, four-page article, 17 primary author is Dr. Wazni, you are listed as an 18 author on it. It's called Atrial Fibrillation 19 Ablation In Patients With Therapeutic INR. 20 A. Yes. 21 Q. I'll hand you that. 22 MR. KULWICKI: Copy of it. I had a copy 23 of it, I don't know what I did with it. 24 A. Thank you. 25 Q. Oh, I think I previously marked that 0134 1 same one as exhibit 5, that's why I couldn't find 2 my copy of it. 3 A. Would you like to see it? 4 Q. No, that's all right. We'll just have 5 two copies of it, just to keep the record 6 straight. 7 You know what? Actually, what I'm going 8 to do, Doctor, is we'll stick with the way I've 9 marked this, we'll call it exhibit 5 because we 10 talked about it as 5 earlier, and I'll use 11 exhibit 10 for something else later. 12 A. Is this my copy? 13 Q. Yes. 14 A. Okay. 15 Q. This was published in September of 2007 16 and it says: The best approach to management of 17 anticoagulation before and after atrial 18 fibrillation ablation procedure is not known; do 19 you see that? 20 A. Yes. 21 Q. And do you agree that that was the case 22 back in August of 2006 as well? 23 A. Yes. 24 Q. It goes on to state, and I'm reading the 25 portions that I underlined: The discontinuance 0135 1 of Warfarin and administration of Enoxaparin or 2 Heparin may increase the risk for bleeding and, 3 more importantly, thromboembolism especially in 4 the early post-ablation period which represents a 5 heightened period of risk due to inflammation and 6 irritation inherently associated with ablation. 7 And let me ask you a couple questions about that. 8 First of all, was that the understanding 9 of the Clinic back in August of 2006, that during 10 the early post-ablation period that there was a 11 heightened risk of thromboembolism due to 12 inflammation and irritation that occurs -- that 13 goes along with the ablation procedure itself? 14 MS. CARULAS: Objection. 15 A. I don't know back in 2006 what was their 16 thinking. 17 Q. Okay. Well this was published in -- 18 well, let's talk about it then. Doesn't it stand 19 to reason that if you are ablating inside the 20 left side of the heart, that as you destroy and 21 denature tissue in the left side of the heart 22 with an ablation catheter that there is a risk of 23 inflammation and irritation? 24 A. Yes. 25 Q. And this goes on to say: Insufficient 0136 1 levels of anticoagulation before and after 2 ablation may increase the risk for 3 thromboembolism. 4 Do you think that was appreciated back 5 in August of '06? 6 A. I don't know that's the case back in 7 2006. 8 Q. Well certainly you knew back in August 9 of 2006 that inflammation and irritation within 10 the left side of the heart increases the risk for 11 thrombus formation; true? 12 A. Yes. 13 Q. Now on page 2,533 of this article, under 14 Discussion it says that: This present study 15 shows that continuation of Warfarin throughout 16 PVAI ablation without administration of 17 Enoxaparin before and after the procedure is safe 18 and efficacious. 19 And let me just understand what that's 20 talking about. Is that talking about, unlike 21 Shannon Sullivan, continuing the patient's 22 Warfarin from before the procedure, through the 23 procedure and then after the procedure? 24 A. I can't comment on the unlike Mr. 25 Sullivan. 0137 1 But I can say that it's a clear 2 statement is that this is what, from experience 3 here, is that continuation of Warfarin throughout 4 pulmonary vein antrum isolation without 5 administration of Enoxaparin before and after 6 procedure is safe and efficacious. 7 Q. But in Mr. Sullivan's case, his Warfarin 8 was discontinued prior to the procedure; true? 9 A. I don't know. 10 Q. Okay. Well, he was bridged with Heparin 11 during the procedure; true? 12 A. Yes. 13 Q. Okay. And then his Warfarin wasn't 14 restarted after the procedure and was not started 15 up and through the time of his stroke, the 16 evening of the date of the procedure, correct? 17 A. Yes, but there was a reason why you 18 avoid anticoagulation after the procedure. The 19 reason that's what the American Heart Association 20 and the Heart Rhythm Society is that you have to 21 stop these anticoagulation around six hours or 22 so, four to six hours after the procedure to 23 prevent vascular complication because, God 24 forbid, a vascular complication happen, then 25 we're doomed, we cannot even start 0138 1 anticoagulation for even a longer period of time 2 because you're going to send the patient to 3 surgery and that's it, we can't do any 4 anticoagulation after that for a very long period 5 of time. 6 Q. By a vascular complication you're 7 talking about bleeding, right? 8 A. Whether it's a bleeding or cardiac 9 tamponade. 10 Q. Okay. 11 A. And that's -- it's a -- these are big 12 problems. Like tamponade, risk of tamponade, I 13 mean, nationally it's -- the risk of pericardial 14 effusion is like five to six percent, which is a 15 good number. 16 Q. And that's what I was trying to 17 understand with this sentence here that we just 18 talked about in exhibit 5. This seems to say 19 that you can keep the patient anticoagulated 20 using a different kind of anticoagulation, 21 Warfarin, before, during and after the 22 procedure -- 23 A. Yes. 24 Q. -- without a risk of a vascular 25 complication as you describe; true? 0139 1 A. In our experience. But still the 2 consensus statement is -- tells you that you may, 3 and actually it's more viable to interrupt and do 4 this procedure and this is -- but this is what -- 5 another way of doing it. However, there are 6 still physicians at our institutions where they 7 stop and perform and restart. 8 Q. As you do the procedure today, do you 9 continue their Warfarin before, during and after 10 the procedure? 11 MS. CARULAS: Objection. 12 Go ahead. 13 A. Okay. Actually, I don't pay much -- 14 because there's not convincing data in both ways 15 and the heart rhythm is -- say we still don't 16 know how to do this procedure, whether to stop it 17 or to continue it. So if I don't have a -- we 18 don't have evidence-based medicine to tell us 19 which way we need to go and that's -- hopefully 20 is going to change probably in five or six -- or 21 hopefully sooner when we able to group all the 22 data from all institutions. 23 Q. Is there a process underway to try to 24 study what are the evidence-based best ways of 25 doing anticoagulation perioperatively for this 0140 1 procedure? 2 A. We're pushing for that here at the 3 Cleveland Clinic. Hopefully we will get that and 4 the hope -- we're hoping in less than a year 5 where we're able to build a registry for all 6 these patients, at least through Medicare. 7 Q. With regard to evidence-based medicine, 8 was there evidence-based medicine that suggested 9 that a particular type of catheter was better 10 than other catheters back in August of 2006 in 11 terms of either the eight millimeter or four 12 millimeter closed tip or the 3.5 millimeter 13 irrigated tip catheter? 14 A. I don't believe it's a -- we had strong 15 evidence-based medicine tell us which way. I 16 will tell you the four millimeter is out of the 17 picture because it doesn't make much reasoning on 18 the left side of the heart. But the eight and 19 the 3.5 millimeter in 2006 you can go either/or. 20 Q. And was there evidence-based -- were 21 there evidence-based studies showing the efficacy 22 of using an irrigated tip catheter versus 23 treating a patient like Shannon Sullivan 24 medically back in August of 2006? 25 A. Yes. There are reports from -- is 0141 1 showing that patients after atrial fibrillation 2 ablation they have less risk of stroke, we have 3 evidence that patients, at least from that Affirm 4 data, tells us that patients who were in sinus 5 rhythm, they did much better than patients with 6 atrial fibrillation, and we have evidence -- this 7 is mainly from the Affirm data showing the 8 patients who were in sinus rhythm and they stayed 9 in normal sinus rhythm, they actually had a trend 10 of living longer. 11 Q. What study is that? 12 A. Affirm Trial. 13 Q. Affirm? 14 A. Yes. A-F-F-I-R-M. So patients who were 15 back in atrial fibrillation and sustained atrial 16 fibrillation, they did very well. And overall -- 17 and that's why we -- overall patients who were on 18 antiarrhythmic medications, they didn't do very 19 well because they had toxicity from 20 antiarrhythmic medications. 21 And so this is the beauty and effect of 22 the procedure is that if you can maintain sinus 23 rhythm without taking the risk of antiarrhythmic 24 medications, then you got the benefit of sinus 25 rhythm and you got rid of the antiarrhythmic side 0142 1 effects and complications, antiarrhythmic side 2 effect and complication. 3 Q. With respect to lone atrial 4 fibrillation, can we agree that risk of stroke is 5 very, very low? 6 A. Around 1.9 percent per year. 7 Q. Are you talking about all-comers or are 8 you talking about patients with no -- with, say, 9 a CHADS score of -- 10 A. Zero. 11 Q. -- zero, zero? 12 A. CHADS2, score of zero. 13 Q. Would you agree that the risk of 14 thromboembolic stroke in a patient with lone 15 a-fib is so low that they don't even need to be 16 on anticoagulants? 17 A. It's low but still higher than the 18 general population, it's 1.9. It does not 19 justify the risk of Coumadin. These are two 20 different things that we have to separate between 21 the risk of Coumadin and the benefit of Coumadin. 22 Still patients with lone atrial fibrillation they 23 are going to be at increased risk of stroke, it's 24 1.9 percent per year, so it's -- 25 Q. What's the risk of stroke for the same 0143 1 population without a-fib, without lone a-fib? 2 A. I don't know. 3 Q. In August of '06 were some patients at 4 the Clinic having a continuous -- continuation of 5 Warfarin throughout PVAI ablation surgery before, 6 during and after? 7 MS. CARULAS: I'm sorry, can you say 8 that again? I'm -- 9 MR. KULWICKI: Sure. 10 MS. CARULAS: I'm tired. I just want 11 you to say it again. 12 MR. KULWICKI: Sure. No problem. 13 Q. Sure. In August of '06 were some 14 patients undergoing PVAI ablation being treated 15 with a continuation of their Warfarin throughout 16 the procedure, both before, during and after the 17 procedure? 18 A. I don't know the answer of this 19 question. 20 Q. Have there been improvements in the way 21 PVAI ablation is being performed since August of 22 '06 through the present, either in terms of the 23 success rate or in terms of reducing the 24 complication rate? 25 MS. CARULAS: Objection. 0144 1 A. There's new data that some 2 investigators, not at the Cleveland Clinic, in 3 Europe and in Bordeaux (phonetic) and in 4 California recommended adding few extra steps to 5 the atrial fibrillation ablation; however, 6 there's no hard data to support that. So that's, 7 again, we have to wait and see if additional -- 8 of this series of lesion would increase the 9 success rate of this procedure. 10 Q. What kind of steps? 11 A. They recommended ablations what we call 12 in CAFE areas -- C, I think C-A-F-E -- where the 13 areas inside the left atrium which had rapid 14 fractionated electrical signals, but we don't 15 know if they -- it's only a suggestion. We don't 16 know if it has any hard data. 17 Q. Can we agree that Mr. Sullivan did not 18 have any evidence of a thrombus in his left heart 19 prior to this procedure? 20 A. Based on the CAT scan we haven't seen 21 any. 22 Q. Would you agree that his stroke is 23 procedure related? 24 A. Yes. 25 Q. Would you agree that the likely inciting 0145 1 event for the stroke was the combination of 2 ablation within the left -- well, strike that. 3 That the likely inciting event for his 4 stroke was the ablation within the left atrium? 5 A. Yes. 6 Q. After his procedure, were any 7 precautions taken to minimize clot formation in 8 the immediate post-ablation period? 9 A. We don't know if anything is -- can 10 minimize the risk of stroke after the procedure. 11 Q. Okay. So the answer would be no? 12 A. I don't know of any steps, but I 13 don't -- personally don't know of any steps you 14 can do to decrease that risk. 15 THE WITNESS: Can we go off the record 16 just a second? 17 MR. KULWICKI: Yes. 18 VIDEOGRAPHER: Off the record. 19 (A recess was taken.) 20 VIDEOGRAPHER: We're back on the record. 21 BY MR. KULWICKI: 22 Q. Okay. Doctor, we were talking about 23 anticoagulation during the procedure and I just 24 wanted to ask a fairly obvious question: What is 25 the purpose of anticoagulation during the 0146 1 procedure? 2 A. When you have foreign objects inside the 3 left side of the heart, you worry about the blood 4 sticking to these foreign objects and that might 5 form a blood clot. 6 Q. In addition to actually having a foreign 7 object in the left atrium of the heart, is there 8 anything about the ablation itself that increases 9 the risk for thrombus formation? 10 A. Yes. There -- we worry about the -- 11 when you burn inside the heart you may disrupt 12 endothelium. And that's why we give aspirin at 13 the end of the procedure. Because aspirin works 14 more in -- when you have destruction of 15 endothelium it prevents platelets from sticking, 16 while if you have a foreign object inside the 17 heart, you need more of the Coumadin/Heparin 18 anticoagulation. 19 Q. In this patient there was evidence of 20 esophageal swelling postoperatively and there was 21 evidence of pericardial effusion. Do you have an 22 opinion as to what was the likely cause of those 23 conditions? 24 MS. CARULAS: Objection. 25 A. I don't know about the esophogeal 0147 1 swelling, but most likely the result of the 2 pericardial effusion is from the atrial 3 fibrillation ablation. 4 Q. And is that evidence of -- well, that's 5 considered a complication of the procedure; true? 6 A. It's a finding at the end of the 7 procedure. It's a common finding that we saw in 8 probably 20 percent of patients. It depends how 9 you can define a complication. It's usually, 10 if -- it usually gets reabsorbed by itself 11 without causing a more aggressive bleeding, more 12 a -- if there's aggressive bleeding, it cause 13 tamponade, that would be considered a 14 complication. 15 Q. Is esophogeal swelling considered a 16 complication of the procedure? 17 A. I'm not sure if -- I've never seen a -- 18 I'll tell you I've never heard of this with 19 esophageal swelling. 20 Q. Okay. Do you need to take that? 21 A. No, it's okay. It's blinking weird 22 messages. Sorry. 23 Q. The records show that the first INR 24 drawn after the patient's stroke was reported at 25 1.3. Would what be considered subtherapeutic? 0148 1 A. Yes. 2 Q. At 02 -- so 2:40 a.m. on the 18th, the 3 day after his stroke, so his stroke happened on 4 17th on -- 2:40 a.m. on the day after his stroke, 5 an APTT was reported at 23.1 with a reference 6 range of 24.6 to 34. Is that consistent with a 7 hypercoagulable state? 8 A. No. 9 Q. Is it a hypocoagulable state? 10 A. No. 11 Q. When you have a low APTT, lower than the 12 reference range, what does that reflect? 13 A. It doesn't reflect anything. This is 14 just a reference and patients can be -- this is 15 like a standard deviation of the population that 16 you're studying. 17 Q. Well what's the reference range? 18 A. What did you say, 23? 19 Q. No, but I'm saying isn't the reference 20 range the standard deviation of normal, what's 21 considered normal? 22 A. Yes. 23 Q. So this is reported as being low at 23.1 24 and the reference range is 24.6 to 34. 25 A. APTT is not a measure of pro- 0149 1 coagulability. 2 Q. What does it measure? 3 A. It's a measure of anticoagulability. 4 Q. Does a low APTT show that the patient is 5 not anticoagulated? 6 A. Yes. 7 Q. Okay. 8 A. With Heparin. 9 Q. Can we agree that as of Mr. Sullivan's 10 procedure in August of '06 that no catheter was 11 approved by the FDA for treatment of a-fib? 12 A. Would you please re -- state one more 13 time the question. 14 Q. Sure. That as of August 17, 2006 the 15 FDA had not approved any catheter for treatment 16 of atrial fibrillation, for atrial fibrillation 17 ablation? 18 A. I don't know. 19 Q. Do you know if the ThermoCool irrigated 20 tip catheter was being used under an 21 investigational device exemption in August of 22 2006? 23 A. I don't know. 24 Q. Do you know what the FDA's role is in 25 device regulation? 0150 1 A. No. 2 Q. If I told you that the FDA's role in 3 device regulation is to establish a reasonable 4 assurance of safety and effectiveness of medical 5 devices marketed in the U.S., would you have any 6 reason to disagree with that? 7 A. No. 8 Q. I read about four different techniques 9 for catheter ablation, and I can't tell you where 10 I read this, but one was called the Cleveland 11 Clinic Approach, another was the Anatomical 12 Approach, another was called the Isolation Guided 13 By Angiography and another was called Ablation of 14 Fragmented Electrogram Approach. Are you 15 familiar with those four approaches -- 16 A. Yes. 17 Q. -- or techniques? 18 What was the CCF approach in that 19 context? 20 A. I think what they meant is the pulmonary 21 vein antrum isolation. 22 Q. Okay. Was there any standard of care in 23 August of 2006 as to which technique should be 24 used in the United States? 25 A. No. 0151 1 Q. Is there a standard of care today? 2 A. Yes, there's a standard. 3 MS. CARULAS: Just note an objection. 4 Go ahead. 5 A. Yeah, the standard of care today is 6 isolate the pulmonary veins in the antral way, 7 like what we've been doing for the past eight 8 years. 9 Q. And where is that standard of care 10 published at? 11 A. Again, I'll take you back to the Heart 12 Rhythm Society consensus statement, Heart Rhythm 13 European Cardiac Arrhythmia Society conjoined 14 consensus. 15 Q. Does that specify the, in addition to 16 specifying the technique, what we just talked 17 about, the Cleveland Clinic Approach, PVAI 18 ablation, does it also specify any other 19 parameters for the procedure? 20 A. It talks about the anticoagulation 21 protocols, it talks about pulmonary vein 22 isolation -- the need for pulmonary vein 23 isolation. 24 Q. Does it designate a preferred catheter? 25 A. No, not that -- I'm sorry, not that I 0152 1 recall. 2 Q. Is there a standard of care regarding 3 what catheter should be used back in August of 4 2006 for PVAI ablation? 5 A. I don't know back in 2006, but I can 6 tell you now standard of care, when -- for the EP 7 community is the 3.5 ThermoCool. 8 Q. The open tipped? 9 A. The open, I'm sorry, the open 10 irrigation. 11 Q. And is it the open irrigation without 12 irrigation? 13 A. I'm sorry. 14 Q. Used without saline profusion? 15 A. The open, by definition, sir, open 16 irrigation meaning the saline is exiting the 17 catheter. 18 Q. Okay. I thought you told us earlier, 19 maybe I misunderstood you, that you've learned 20 that the open tip catheter is more effective if 21 used without the saline profusing through it. 22 A. Yeah. 23 Q. Maybe I misunderstood. 24 A. No. I'm sorry, I might have miss -- 25 what did I say? 0153 1 (Discussion had off record.) 2 A. Oh, so what we do is that we turn the 3 irrigation off on the right side so we don't 4 deliver a deep lesion. 5 Q. I see. 6 A. Trick of the... 7 Q. And does the Heart Rhythm Society 8 specify what catheter type, as you've discussed, 9 do they endorse the irrigated tip catheter as 10 being the standard of care? 11 A. I don't recall if they do or not. 12 Q. Does the Heart Rhythm Society or does 13 anybody establish as a guideline or standard of 14 care the type of navigation, whether remote or 15 manual, as being the standard of care? 16 A. No, sir. 17 Q. Does the Heart Rhythm Society or any 18 other professional body establish as a standard 19 of care or guideline the type of mapping system 20 to be used? 21 A. No, sir. 22 With my personal opinion when it comes 23 to mapping is that each one has its own niche 24 over the other one. 25 Q. Has the Heart Rhythm Society or any 0154 1 other consensus body endorsed as the standard of 2 care a particular monitoring device, 3 intraoperative monitoring device for PVAI 4 ablation as a standard of care? 5 A. I'm sorry, what do you mean by 6 monitoring? 7 Q. Like ICE recording or esophogeal probe 8 or any other type of -- 9 A. No. 10 Q. -- monitoring? 11 A. I don't -- I don't recall they did. 12 Q. Same question for the type of energy 13 delivery, radiofrequency, ultrasound or 14 cryotherapy. Is there any energy delivery that 15 has been endorsed by any professional 16 organization as being the standard of care? 17 A. I think in their consensus statement 18 they discussed RF, because this is the most 19 available technology. 20 Q. Do you know if there was any -- all of 21 this consensus statement or this Heart Rhythm 22 Society that you are pointing to, this is all 23 after August of 2006, correct? 24 A. Yes, but the meetings, it's usually a 25 verbal meetings and presentations that would 0155 1 result into production of this consensus 2 statement. 3 Q. And do you think these meetings were 4 taking place prior to August of '06? 5 A. I don't know, sir. 6 Q. Does the Heart Rhythm Society or any 7 other consensus body establish the energy 8 parameters in terms of time or strength of energy 9 delivery? 10 A. I don't recall, sir. 11 Q. Does the Heart Rhythm Society establish 12 or publish, or any other consensus body endorse a 13 minimal lesion set for treatment of atrial 14 fibrillation? 15 A. Yes, to isolate the pulmonary veins. 16 Q. Does the Heart Rhythm Society or any 17 other consensus body establish a standard of care 18 for when cardioversion takes place 19 perioperatively, whether before ablation, during 20 or after ablation? 21 A. I don't recall they did, sir. 22 Q. Would you agree that in August of '06 it 23 was known that during image integration between a 24 CT scan and electroanatomical mapping that there 25 could be a shift in images? 0156 1 A. I'm not expert in that field, but there 2 may be. We looked at it one time and wasn't 3 impressive. 4 Q. Okay. It wasn't impressive? 5 A. I don't think -- it wasn't very 6 impressive. 7 Q. I'll mark as exhibit, I think we're on 8 12, an article published in August 2006, lead 9 officer -- lead author is Fahmy, Dr. Fahmy, 10 F-A-H-M-Y, ICE-Guided Image Integration. 11 A. That's for a CAT scan, sir. 12 Q. Okay. 13 A. This technology was not used. 14 Q. Let me just mark this so I can 15 understand that. 16 VIDEOGRAPHER: I've got to change tapes. 17 MR. KULWICKI: Oh, geez. Okay. Sorry. 18 VIDEOGRAPHER: This is the end of tape 19 four. Off the record. 20 (Discussion had off record.) 21 (Deposition Exhibit 10 was marked for 22 purposes of identification.) 23 VIDEOGRAPHER: This is tape five. We're 24 back on the record. 25 MR. KULWICKI: Thanks. 0157 1 BY MR. KULWICKI: 2 Q. Doctor, I've marked as exhibit 10 the 3 Fahmy article. Can you tell me why that would 4 not apply? I think you started to explain it and 5 then I marked it and we took a break, so if you 6 would please tell me. 7 A. I just want to make sure this is what 8 we -- okay. 9 They talked about CT integration, 10 meaning using the CAT scan to build the shell 11 inside the heart. However, this technology was 12 not used on Mr. Sullivan. 13 Q. Okay. I thought he had a pre-op cardiac 14 CT. Is that different? 15 A. Yes, but that -- the cardiac CT was not 16 used. 17 Q. Okay. 18 A. The image was not used for integration. 19 Q. Okay. Thank you. 20 A. It was used to look for left atrial 21 clots, I believe. 22 Q. Right. 23 Would you agree that it was known that 24 in August of 2006 that patients could live 25 productive lives with rate control -- patients 0158 1 with lone atrial fibrillation could live 2 productive lives with rate control medicines 3 only? 4 A. Yes, but still we have data showing that 5 patients, if you put them in sinus rhythm they'll 6 live longer and there's a risk of mortalities and 7 morbidities with atrial fibrillation of around 8 1.3, hazard ratio 1.3 to 1.4 times if somebody 9 has atrial fibrillation. 10 Q. Is there also literature that shows that 11 rate control medicines provide a good alternative 12 to ablation for stroke prevention? 13 A. Yes. 14 Q. Mr. Sullivan's procedure was not a 15 medical emergency; true? 16 A. Yes. 17 Q. And he was entitled to make informed 18 decisions whether to undertake the procedure; 19 true? 20 A. Yes. 21 Q. Do you know in exhibit -- strike that, 22 we didn't mark it. 23 Can I see that (indicating)? 24 I'm going to show you, I'm not going to 25 mark it because it's my copy, but this is the 0159 1 August 16, 2006 office visit with Dr. Burkhardt 2 prior to Mr. Sullivan's procedure. I assume you 3 didn't have any involvement at that office visit, 4 correct? 5 A. Yes. 6 Q. On page three of this note there's a 7 reference here to, and I'll give you this, it 8 says: IC, informed consent, RBAC, risks, 9 benefits and alternatives, were explained to 10 Shannon Patrick Sullivan. He consents to 11 pulmonary vein isolation procedure and he wishes 12 to proceed. 13 Do you have a similar form today for 14 PVAI ablation procedures? 15 MS. CARULAS: Objection. 16 A. What? I'm sorry, similar form of what? 17 Q. Like a pre-procedure office visit where 18 you would document informed consent being 19 obtained. 20 MS. CARULAS: Objection. I think we've 21 been over this, but go ahead. 22 A. We have a written consent form. 23 Q. Okay. Did you have any involvement 24 with, as a -- well, strike that. 25 Before there was the switch to a written 0160 1 informed consent, would you have been involved in 2 preparing pre-procedure notes like this one? 3 MS. CARULAS: Objection. 4 Go ahead. 5 A. On my patients? 6 Q. Yes. 7 A. Yes. 8 Q. And what I want to ask you about is 9 about that section I just read and highlighted. 10 A. Yes. 11 Q. Is that something that is present on the 12 form electronically before you prepare the form 13 or is it something that you have to type in every 14 time? 15 A. No, you have to -- 16 MS. CARULAS: Yes, go ahead. Just 17 objection, go ahead. 18 A. Okay. So the nurse practitioner you're 19 working with -- if you're working by yourself 20 then you have to type everything. If there's 21 no -- if there's a nurse practitioner with you, 22 she'll go over some of the details and put the 23 stuff and then you have to come and put the 24 history of present illness, the physical 25 examination and then assessment and plan. 0161 1 Q. Okay. And the nurse practitioner does 2 everything else? 3 A. No, you go over -- the nurse 4 practitioner will go over whatever in the 5 beginning and then go over what the nurse 6 practitioner put in, if you're working with her, 7 make sure things are okay. And then your 8 responsibility is to type -- you go over all of 9 this, you put a statement that you agree with -- 10 I agree with so-and-so and then you put a brief 11 history and physical and physical -- a brief 12 history and a physical and then assessment and 13 plan. This is what I would do. 14 Q. Right. 15 A. This is what I do. 16 Q. Sure. And when -- would you be doing 17 this process, these pre-procedure visits, as a 18 fellow back in '06? 19 A. If I'm working with an attending, so I 20 would do this work with the staff. 21 Q. Okay. And in those situations back in 22 August of '06 when you were working with a nurse 23 practitioner, who would put in -- who would 24 physically enter in the information about 25 informed consent that I highlighted there? 0162 1 MS. CARULAS: Objection. 2 Go ahead. 3 A. I -- as a fellow I don't work with a 4 nurse practitioner. 5 Q. Okay. 6 A. As a staff I work with a nurse 7 practitioner. 8 Q. All right. And did you work with a 9 nurse practitioner with these pre-procedure 10 visits before the written consent form was used? 11 A. Yep. 12 MS. CARULAS: Yes, I just want to know 13 what time, you're saying when he's a staff or 14 when he's a fellow? 15 MR. KULWICKI: Right, when he's a staff. 16 A. When I'm a staff when I work with her? 17 Q. Yeah. 18 A. Yeah, I work with her and then I 19 dictate, using Dragon, my note. 20 Q. Okay. And Dragon, the voice recognition 21 software? 22 A. Yes, sir. 23 Q. And with regard to -- and, again, 24 Doctor, we're talking about a period of time when 25 you were staff but before written consent -- 0163 1 A. Yes. 2 Q. -- was the policy. 3 Would the nurse practitioner fill in the 4 part that we have highlighted there about 5 informed consent? 6 A. No. 7 Q. Okay. That would be something that you 8 would dictate? 9 A. Yes. 10 Q. Okay. All right. 11 (Discussion had off record.) 12 Q. Getting close here, bear with me. 13 A. That's okay. 14 (Discussion had off record.) 15 VIDEOGRAPHER: Back on the record. 16 BY MR. KULWICKI: 17 Q. Doctor, earlier I asked you if you had 18 an opinion as to the likely reason why Mr. 19 Sullivan had a stroke, and I want to ask you a 20 slightly different question. 21 Can you tell us if the likely source of 22 the emboli was char or coagulum? 23 MS. CARULAS: Objection. 24 A. I can't -- we don't have any data right 25 now to tell us what's the nidas for these 0164 1 strokes, I mean, what originates them. 2 Q. Following Mr. Sullivan's procedure and 3 after his stroke, he was at MetroHealth for 4 rehabilitation in November of '06 and he had 5 reverted back to a-fib, but for some reason he 6 was transferred from MetroHealth to the Cleveland 7 Clinic for cardioversion. Do you know why that 8 would be, why -- because obviously they can 9 cardiovert him at MetroHealth -- why he would be 10 transferred, if you know, back to the Clinic for 11 cardioversion in November of 2006, three months 12 after his procedure? 13 MS. CARULAS: Objection. 14 A. I don't know why they would do that. 15 Q. Do you know if that was part of the 16 NaviStar protocol, the study protocol? 17 MS. CARULAS: Objection. 18 A. I'm sorry, what's the NaviStar study 19 protocol? 20 Q. The NaviStar RMT thermocouple catheter. 21 You know what? Never mind. I'll withdraw the 22 question. 23 Of the procedures that we looked at in 24 exhibit 2, do you know how many of the 207 SVT 25 ablations were done using an irrigated tip 0165 1 catheter versus using a closed tip catheter? 2 A. I don't know, sir. 3 Q. I'm going to hand you what I'll mark 4 exhibit 11. 5 (Deposition Exhibit 11 was marked for 6 purposes of identification.) 7 Q. This is the orders and it looks like 8 it's signed by you at the bottom there. 9 These are the post-op orders but it 10 looks like -- is this something that you would 11 typically prepare before the procedure? 12 A. After the procedure, sir. 13 Q. You do it afterwards? 14 Over in the right hand side where it 15 says Unit we see that his room assignment changed 16 multiple times. Do you have any reason -- do you 17 know why that would have occurred? 18 A. I don't know, sir. 19 Q. Under Diagnosis it says: Status post 20 PVI ablation, and then it looks like a number 21 there, number one or number seven, I can't tell, 22 or maybe number nine even. Do you know what that 23 refers to? 24 A. No, sir. 25 Q. Next to where it says Activity it says 0166 1 Number Eight. Do you know what that refers to? 2 A. Probably these are things that the 3 nurses have to go through or something, but I 4 don't know. 5 Q. Okay. Is that your handwriting? 6 A. No. No. All these numbers, they were 7 edited by somebody, probably to put the orders in 8 the computer or something like that. I'm not 9 sure. You have to ask nursing staff. Nurses 10 staff would know. 11 Tell you for sure that the orders didn't 12 have any of that. 13 Q. All right. I'm going to hand you what 14 I'll mark as exhibit 12. It's an article, you're 15 the lead author, it was published in Heart Rhythm 16 Disorders -- I'm sorry, the Journal of American 17 College of Cardiology in, I'm guessing 2006 or 18 2007. 19 (Deposition Exhibit 12 was marked for 20 purposes of identification.) 21 A. Thank you. Yep, 2006. 22 Q. Doctor, this appears to be a study where 23 there was a comparison of the eight millimeter 24 closed tip catheter with the irrigated tip 25 catheter used at a lower power and a higher 0167 1 power. 2 A. Yes. 3 Q. And it's -- the conclusion is is that 4 the irrigated tip catheter used at the higher 5 power was associated with increased 6 cardiovascular complications, correct? 7 A. Increase in pericardial effusions. 8 Q. Okay. So that's what I was going to ask 9 you. By cardiovascular complications you're 10 talking about pericardial effusions? 11 A. Yes. 12 Q. Okay. On page 1637 there's -- under 13 Complications it says: There was one TIA in the 14 group having -- using the irrigated catheter at 15 the higher power and it said that all of the 16 patients who had the irrigated catheter used at 17 the higher power had pops during their procedure. 18 Is it your experience that most patients 19 when an irrigated catheter is used at a higher 20 power have pops? 21 MS. CARULAS: Objection. 22 A. This trial was done in Europe, okay? 23 Our experience here, I do -- I rarely see pops, 24 but I move the catheter a lot. 25 Q. There's no discussion in this article 0168 1 that the pops are associated with, as you say, 2 not moving the catheter around enough. Is that 3 something that you came to understand afterwards 4 or -- I mean, are you saying that in this study 5 the catheter wasn't moved around as much as you 6 do and therefore there were more pops in the 7 study? 8 A. I don't know what's this -- what they 9 did here technically because the operators 10 were -- I mean, some of them were here, but this 11 was conducted in Europe. Exactly how are they 12 doing the procedure, I don't know. 13 But I personally now, we -- as I told 14 you, I'll take you back to when we started the 15 conversation -- is that we here stay on a lesion 16 every 30 to 40 seconds and then we move. I don't 17 know how their operators over there in Europe 18 they were doing these cases, whether they were 19 staying in a spot for a longer period of time or 20 not. 21 Q. Are you saying that when you stay in a 22 spot for a longer period of time that it 23 increases the risk of a pop? 24 A. Maybe. 25 Q. Okay. And does that increase -- does 0169 1 the risk of a pop increase with the longer that 2 you stay on a lesion? 3 A. The more you deliver energy, the more 4 the risk of pop. 5 Q. Do you, in your practice today, have an 6 outside limit on how long you'll stay on a 7 particular lesion without moving on, before 8 moving on? 9 MS. CARULAS: Note an objection. 10 Go ahead. 11 A. Probably less than 180 seconds. 12 Q. Okay. How about back in August of 2006, 13 did you deliver energy for longer than 180 14 seconds during these procedures? 15 MS. CARULAS: Objection. 16 A. During atrial fibrillation at the 17 Cleveland Clinics we rarely did this, we've never 18 done that. 19 Q. Okay. Now I just want to clarify 20 something from -- 21 A. Yes. 22 Q. -- the procedure note here. And I'll 23 refer you to exhibit 8. 24 A. Sure. 25 Q. So, for instance, on ablation number 29 0170 1 and ablation number 30 when it shows for the time 2 262 seconds and 286 seconds -- 3 A. Yes. 4 Q. -- would that be the time that energy's 5 being delivered into the tissue? 6 A. Yes, but as I told you, each one of this 7 may represent more than one ablation because we 8 move -- we move our catheter. So we burn and 9 then we move, and then move, and then we move, 10 and then we move, and then we move (indicating). 11 There's no reason for us to stop and restart. 12 It's what -- the time that you spend on 13 every spot. The ablation, the generator is on 14 and then you move, and then you move, and then 15 you move (indicating). 16 Q. Are there any operators who, when they 17 move the catheter, stop energy delivery at each 18 interval? 19 A. I'm not -- I mean, there might be, but I 20 don't know. 21 Q. So in this article, going back -- 22 A. I'm sorry. 23 Q. -- to exhibit -- was it 12? I'm on page 24 1639. 25 The very last sentence in the first 0171 1 column, it says: The use of higher powered 2 delivery settings in this area might have been 3 the reason after the increased incidence of 4 complications observed in that group, and it says 5 it's possible the use of lower energy -- 6 A. Where are you reading, sir? 7 Q. Right here (indicating). The use of -- 8 A. Okay. Yep, I got it. 9 Q. -- higher powered delivery settings in 10 this area might have been the reason after the 11 increased incidence of complications observed in 12 that particular group. 13 A. Yes. What's the question? 14 Q. Is that suggestive that the higher 15 powered delivery settings are associated with a 16 greater risk of pops? 17 MS. CARULAS: Objection. 18 Go ahead. 19 A. These are only suggestions for future 20 research. 21 Q. And we still don't know? 22 A. And we still don't know, unfortunately. 23 Q. We talked about this before, I believe, 24 and I just want to make sure. The next sentence, 25 the next paragraph, it says: The increased 0172 1 incidence of complications observed with the use 2 of the irrigated catheter higher power may be due 3 to the limited effectiveness of the ICE to 4 monitor for excessive energy delivery. 5 And I think you talked about that, we 6 asked about -- I asked about the efficacy, you 7 know, the sensitivity and specificity for ICE to 8 detect tissue overheating and the like. Is that 9 what you were talking about right there? 10 A. Yes. 11 Q. Okay. And then the last page of the 12 article, page 1641, the very last sentence, it 13 says: One could postulate that a modified 14 approach using shorter radiofrequency pulsatile 15 applications, as well as lower power and lower 16 irrigation rates, at some left and atrial 17 locations, such as the posterior wall, and 18 greater power and irrigation rates at other 19 locations might prove to be an effective 20 alternate strategy. 21 Is that the way you do it today, where 22 you use different powers and durations of 23 applications, depending on where you're at in the 24 heart? 25 MS. CARULAS: Objection. 0173 1 A. Okay. No. What I do today is that I 2 use -- I guide the duration, not the power, the 3 duration of RF depending on the esophogeal 4 temperature. So if I see a rise in the 5 esophogeal temperature, I move or I stop. 6 Q. Can you tell from the seven-page cardiac 7 electrophysiology report that's part of exhibit 8 8 at what time you are ablating the posterior wall, 9 at what time you're ablating a particular 10 pulmonary vein? 11 A. No. 12 Q. Okay. 13 MR. KULWICKI: All right. Let's go off 14 the record. I think I'm done. I want to -- 15 VIDEOGRAPHER: Off the record. 16 (A recess was taken.) 17 VIDEOGRAPHER: We're back on the record. 18 MR. KULWICKI: 19 Q. Doctor, thank you for your patience 20 today. 21 I just want to ask just as a general 22 matter and with respect to PVAI isolation 23 ablation procedures, would you agree that the 24 procedure is a procedure that is a newer 25 procedure that continues to be perfected? 0174 1 A. I think the big jump, we've already done 2 it in 2001-2002. I don't know over the past five 3 or six -- probably four to five years I don't 4 know -- we haven't seen anything materialistic. 5 And by materialistic, improvement. I think the 6 most important thing is the isolation of the 7 pulmonary veins and that was clearly established 8 I think back in 2002-2003. 9 Q. With respect to patients who the 10 procedure fails on and patients who have strokes 11 like Mr. Sullivan, would you agree that there 12 needs to be more study done to figure out why 13 some patients fail with no risk factors for 14 failure and why some patients have severe 15 outcomes like Mr. Sullivan without any particular 16 risk factors for those outcomes? 17 MS. CARULAS: Just note an objection, 18 but go ahead. 19 A. Definitely we would like to -- we would 20 like to make this procedure as successful as it 21 can be and with as least risk as it can be. 22 When and how we're going to get there is 23 a good question. 24 MR. KULWICKI: Okay. Doctor, that's all 25 the questions I have. Thank you. 0175 1 THE WITNESS: Thank you very much. 2 MS. CARULAS: Now you have the right to 3 read over this transcript. 4 THE WITNESS: Yes. 5 MS. CARULAS: I usually recommend 6 that -- 7 THE WITNESS: Okay. 8 MS. CARULAS: -- but I have no idea when 9 you'll have time to read over this, it's this 10 long. So we will not waive signature, but -- 11 THE WITNESS: Sure, that's fine. 12 MS. CARULAS: -- whether you can get to 13 it or not. 14 THE WITNESS: That's fine. Thanks 15 everybody for your time and patience with my 16 pages. 17 MR. KULWICKI: No problem. 18 19 (Deposition concluded at 6:46 p.m.) 20 ~ ~ ~ ~ ~ 21 22 23 24 25 0176 1 CERTIFICATE 2 3 The State of Ohio, ) 4 ) SS: 5 County of Cuyahoga. ) 6 7 I, Michelle A. Bishilany, a Notary Public within and for the State of Ohio, duly 8 commissioned and qualified, do hereby certify that the within named witness, MOHAMED H. KANJ, 9 M.D., was by me first duly sworn to testify the truth, the whole truth and nothing but the truth 10 in the cause aforesaid; that the testimony then given by the above-referenced witness was by me 11 reduced to stenotypy in the presence of said witness; afterwards transcribed, and that the 12 foregoing is a true and correct transcription of the testimony so given by the above-referenced 13 witness. 14 I do further certify that this deposition was taken at the time and place in the 15 foregoing caption specified and was completed without adjournment. I do further certify that I 16 am not a relative, counsel or attorney for either party, or otherwise interested in the event of 17 this action. 18 IN WITNESS WHEREOF, I have hereunto set my hand and affixed my seal of office at 19 Cleveland, Ohio, on this 11th day of May, 2010. 20 21 22 _______________________________________ 23 Michelle A. Bishilany, Notary Public within and for the State of Ohio 24 My commission expires January 18, 2011 25 0177 1 AFFIDAVIT OF NOTARY PUBLIC 2 3 The State of Ohio, ) 4 ) SS: 5 County of Cuyahoga. ) 6 7 Before me, a Notary Public in and for said 8 County and State, personally appeared MOHAMED H. 9 KANJ, M.D., who acknowledged that he did read his 10 transcript in the above-captioned matter, listed 11 any necessary corrections on the accompanying 12 errata sheet, and did sign the foregoing sworn 13 statement and that the same is his free act and 14 deed. 15 In TESTIMONY WHEREOF, I have hereunto 16 affixed my name and official seal at this______ 17 day of _____________________ A.D. 2010. 18 19 20 ________________________ 21 Notary Public 22 23 _________________________ 24 My Commission Expires: 25 0178 1 SIGNATURE PAGE 2 3 Re: Shannon Sullivan, et al. vs. The 4 Cleveland Clinic Foundation 5 Case Number: CV-09-697617 6 Deponent: MOHAMED H. KANJ, M.D. 7 Deposition Date: May 10, 2010 8 9 To the Reporter: 10 11 I have read the entire transcript of my 12 Deposition taken in the captioned matter or the 13 same has been read to me. I request that the 14 following changes be entered upon the record for 15 the reasons indicated. I have signed my name to 16 the Errata Sheet and the appropriate Certificate 17 and authorize you to attach both to the original 18 transcript. 19 20 21 22 23 _________________________________ 24 MOHAMED H. KANJ, M.D. 25 0179 1 ERRATA SHEET 2 Page Line Change 3 _____ _____ _________________________________ 4 _____ _____ _________________________________ 5 _____ _____ _________________________________ 6 _____ _____ _________________________________ 7 _____ _____ _________________________________ 8 _____ _____ _________________________________ 9 _____ _____ _________________________________ 10 _____ _____ _________________________________ 11 _____ _____ _________________________________ 12 _____ _____ _________________________________ 13 _____ _____ _________________________________ 14 _____ _____ _________________________________ 15 _____ _____ _________________________________ 16 _____ _____ _________________________________ 17 _____ _____ _________________________________ 18 _____ _____ _________________________________ 19 _____ _____ _________________________________ 20 _____ _____ _________________________________ 21 _____ _____ _________________________________ 22 _____ _____ _________________________________ 23 _____ _____ _________________________________ 24 _____ NO CHANGES 25 Signature:_________________________ Date:________