0001 1 IN THE CIRCUIT COURT OF MONTGOMERY COUNTY 2 IN AND FOR THE STATE OF MARYLAND 3 --------------------------------x : 4 MARY K. MANOOGIAN, et al. : 5 Plaintiffs : : 6 v. : CASE NO. 263814 : 7 JAMES L. COCKRELL, M.D., : : 8 et al. : : 9 Defendants : : 10 --------------------------------x 11 DEPOSITION OF JOHN M. MILLER, M.D., FACC 12 Indianapolis, Indiana 13 Wednesday, July 19, 2006 14 2:13 p.m. 15 Job No: 24-82606 16 Pages 1 - 129 17 Reported by: Victoria S. Stuart, RPR 18 19 20 21 22 23 24 25 0002 1 Deposition of JOHN M. MILLER, M.D., held at 2 the offices of: 3 4 INDIANA UNIVERSITY SCHOOL OF MEDICINE 5 KRANNERT INSTITUTE OF CARDIOLOGY 6 1801 North Senate Boulevard 7 Indianapolis, Indiana 46202-1228 8 (317)962-0500 9 10 11 Pursuant to notice, before Victoria S. Stuart, Registered Professional Reporter and 12 Notary Public of the State of Indiana. 13 14 15 16 17 18 19 20 21 22 23 24 25 0003 1 A P P E A R A N C E S 2 3 ON BEHALF OF THE PLAINTIFFS: 4 SCOTT PERRY, ESQUIRE 5 BRUCE J. KLORES & ASSOCIATES, P.C. 6 1735 20th Street, Northwest 7 Washington, D.C. 20009 8 (202)628-8100 9 10 11 12 ON BEHALF OF DEFENDANTS COCKRELL, LEE AND 13 CARDIOVASCULAR CONSULTANTS, PA: 14 MARIANNE D. PLANT, ESQUIRE 15 GOODELL, DEVRIES, LEECH & DANN, LLP 16 One South Street, 20th Floor 17 Baltimore, MD 21202 18 (410)783-4000 19 20 21 22 23 24 25 0004 1 A P P E A R A N C E S C O N T I N U E D 2 ON BEHALF OF DEFENDANT WASHINGTON ADVENTIST 3 HOSPITAL: (Telephonically) 4 SUSAN B. BOYCE, ESQUIRE 5 ARMSTRONG, DONOHUE, CEPPOS & VAUGHAN 6 204 Monroe Street 7 Suite 101 8 Rockville, MD 20850 9 (301)251-0440 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0005 1 C O N T E N T S 2 EXAMINATION OF JOHN M. MILLER, M.D. By Ms. Plant 6 3 By Ms. Boyce 113 By Ms. Plant 114 4 5 6 7 E X H I B I T S 8 9 (Attached to the Transcript) 10 MILLER DEPOSITION EXHIBIT PAGE 11 1 Dr. Miller's handwritten notes 7 12 2 Certificate of Merit 69 3 "Atrioventricular Groove From 13 Above" Netter diagram 77 4 "Atrial Septal Puncture Sites" 77 14 Netter diagram 15 QUESTIONS WITNESS INSTRUCTED NOT TO ANSWER 16 Page 70 line 9 Page 70, line 23 17 18 19 20 21 22 23 24 25 0006 1 JOHN M. MILLER, M.D. FACC, 2 having been duly sworn to tell the truth, the whole 3 truth, and nothing but the truth relating to said 4 matter was examined and testified as follows: 5 6 DIRECT EXAMINATION, 7 QUESTIONS BY MS. MARIANNE D. PLANT: 8 Q Good afternoon, Dr. Miller. My name is Marianne 9 Plant. We had an opportunity to meet already 10 off the record. I represent Dr. Cockrell, 11 Dr. Lee, and Cardiovascular Consultants in this 12 case that was brought by the estate of 13 Mr. Manoogian. I understand that you're going 14 to be testifying in this case on standard of 15 care issues? 16 A Yes, ma'am. 17 Q Are you also going to be testifying on causation 18 issues? 19 A I believe so. 20 Q Have you given a deposition before? 21 A Yes, ma'am. 22 Q Just go over what you probably already know as 23 ground rules. If I ask a question and it is 24 unclear for any reason, you don't understand 25 what I'm asking, feel free to ask me to rephrase 0007 1 it, and I will. 2 If you need to take a break at any time, 3 let me know. If you do answer a question that 4 I've asked, I'll presume that you have 5 understood my question; is that fair? 6 A Fair enough. 7 Q Okay. Let's see, what other ground rules do we 8 have? We need to try and not speak over one 9 another. And I think that will probably be 10 reasonably easy to do, if you let me finish my 11 question and I'll let you finish your answer; 12 okay? 13 A Yes. 14 Q Great. I have -- the first thing I want to make 15 as an exhibit is notes that you took. 16 A Yes, ma'am. 17 Q Is that what you did? 18 MS. PLANT: Let's mark that Exhibit 1. 19 (Defendants' Deposition Exhibit No. 1 20 marked for identification.) 21 Q So what I've been provided before we started the 22 deposition today is this Exhibit 1, which is a 23 page of your notes. I've also been provided two 24 Netter diagrams with some markings on them? 25 A Yes, ma'am. 0008 1 Q Did you create those? 2 A Well, they're adapted from Netter -- 3 Q Right. 4 A -- but the labels and so forth are mine, yes. 5 Q There's also a number of articles, are these -- 6 some of them appear to be book chapters? 7 A Yes. Some are original manuscripts from the 8 medical literature. 9 Q Okay. And then I have a new CV that is June 15, 10 2006? 11 A Yes, relatively new, yes. 12 Q Is there anything else that you have that is 13 responsive to the deposition notice that was 14 sent, any other notes or correspondence that you 15 have had in this case? 16 A I don't believe so. 17 Q Okay. Did you ever, apart from a certificate of 18 merit, did you ever write down your opinions in 19 this case, apart from Exhibit 1? 20 A No, ma'am. 21 Q Can I impose on you to read Exhibit 1 for us? 22 A You may. You may. Now, some of this is in a 23 little bit of shorthand, so I'll give you the 24 longhand version of it. 25 Q Sure. 0009 1 A These are just kind of bullet points. So it 2 starts off with, aortic perforation site 3 difficult to see at sternotomy, unless the right 4 atrial appendage is peeled back -- and I'm 5 interpolating here a little bit -- 6 intentionally. 7 So right atrial appendage peeled back 8 intentionally, and inspect back there; by then, 9 by that time, during his procedure, the aortic 10 pressure was very, very low, therefore less 11 leakage, and because of volume depletion, in 12 parens, volume depletion in parenthesis. 13 Second point, question mark, disseminated 14 intravascular coagulation, or continued ICU 15 bleeding, question mark, due to heparin for 16 attempted cardiopulmonary bypass, question mark, 17 parenthesis, although clotted venous line at 18 attempt in the laboratory, close parenthesis. 19 Next point, question mark, Dr. Lee 20 inadvertently dislodged the second sheath from 21 plugging its own hole in the aorta, leading to 22 the start of bleeding. 23 And another point, the mapping catheter 24 really -- question, was the mapping catheter 25 really ever placed in the second sheath. 0010 1 And a subpoint from that, it clearly was in 2 the aorta. In order to record left atrial 3 activity, it would have to exit the aorta, and 4 probably enter the left atrium, but there was no 5 reentry hole at post mortem. And I'm 6 embellishing this just a little bit, for sense. 7 Q I understand. You're providing us not just the 8 shorthand, but what you meant by it? 9 A Yes. 10 Q That's fine. 11 A This is a second subpoint after that clearly was 12 in the aorta. The tear in the aorta goes 13 through the intima, I-N-T-I-M-A, not just the 14 adventitial media, adventitial/media. 15 Another subpoint here: Cannot reconcile 16 autopsy findings with recording of left atrial 17 electrograms, therefore not done. 18 Another bullet point, this is the fourth 19 one underneath here. And anyway, left atrial 20 electrograms are a nonspecific indicator of, 21 quote, good position, close quote. They can be 22 from inside of the left atrial cavity or outside 23 the left atrium, parenthesis, over the dome, et 24 cetera, close parenthesis. 25 And then indent back out. So pulled map 0011 1 catheter out of the second sheath to put back 2 into the first. Why would someone do that. 3 Another point, pressure can be misleading. 4 This is kind of an allusion to something in 5 Dr. Cockrell's deposition, looks like page 163, 6 line 18, to 164, line 4. I think that's what it 7 means. 8 And the last point, the tip lodged in aorta 9 or trapped in the septum can't have a catheter 10 through it to record left atrium bend, as far as 11 electrograms. This is, again, from 12 Dr. Cockrell's deposition, page 168, I think 13 lines 7 through 15. And that's it. 14 Q Okay. Thank you very much. 15 A Uh-huh. 16 Q So we've got this marked already. 17 But to, you know, instead of going straight 18 into the issues, what I want to do before we do 19 that is just make sure we do housekeeping first. 20 We have got your CV. Is there anything 21 that is not reflected in your CV, as far as 22 publications, society memberships, or 23 presentations that would have anything to do 24 with ablation for atrial fibrillation? 25 A I've given many, many lectures, just in-house, 0012 1 that don't appear on there, but -- 2 Q Okay. 3 A -- otherwise, no. 4 Q Have you published at all on the technical issue 5 of transseptal placement? 6 A Not as a central issue. That is not the central 7 point of a publication. 8 Q Okay. In some of your publications or any of 9 your publications, has it been an ancillary 10 issue? 11 A Yes. 12 Q And in those, you discuss techniques? 13 A Not in depth. 14 Q Okay. Do you know which of your publications 15 might involve transseptal placement as an 16 ancillary issue? 17 A Let me look. Page 20: Publications 32 and 33, 18 39, 41, 44. 19 54, page 21, 56. 20 61 on page 22. 21 I have to go back. Back on page 10, number 22 69. I'm jumping around a little bit here. I'm 23 sorry. 24 Q Okay. 25 A There are probably a couple of others in here, 0013 1 but those are the main ones. 2 Q Okay. When did you first, in your career, start 3 to perform ablations for atrial fibrillation? 4 A My first one, I think, in 1997, maybe '96, '97. 5 Q And where was that? 6 A Temple University School of Medicine. 7 Q Who taught you how to do an ablation for atrial 8 fibrillation? 9 A Well, it's been an evolving process. The 10 techniques we used back then are not the 11 techniques we use most of the time nowadays, and 12 so the techniques that we have established over 13 the years in building slight modifications along 14 the way, and so I don't know that I could say 15 who taught me to do it. 16 Q Do you remember working with any -- well, let me 17 ask it this way. 18 Were you an attending cardiologist at the 19 time when you did your first ablation for atrial 20 fibrillation? 21 A Yes, ma'am. 22 Q Did you first do the procedure as scrubbing in, 23 but not doing the procedure, i.e., watching the 24 procedure once? 25 A No. Just did it. Now, I should, by way of 0014 1 explanation, in those days, we were looking for 2 a single source, a single focus that was leading 3 to fibrillation, eventually, we would do with 4 other types of arrhythmias, then as now. And in 5 those days, that's what we were searching for. 6 I found some in a handful of cases, and ablated 7 those accordingly. 8 Q Do you recall who taught you how to place a 9 catheter that would terminate in the heart and 10 perform an ablation? 11 A Oh, yes, Mark Josephson. 12 Q Okay. And I take it that the earlier ablations, 13 the ones that you would have been doing in '96 14 or '97 were not ablations that would require a 15 transseptal puncture? 16 A That's correct. 17 Q Okay. Do you recall when you first did a 18 transseptal puncture? 19 A I think 1992 or -3, -3 at the latest. 20 Q And who was your teacher in learning that 21 technique? 22 A One of our catheterization doctors, William G. 23 Combs, C-O-M-B-S. 24 Q Do you recall what the technique was that you 25 were taught? 0015 1 A As far as the actual mechanics of it? 2 Q Yes. 3 A Yes, yes. Very much so. 4 Q Okay. Can you tell me what you recall about the 5 technique that you were taught by Dr. Combs? 6 A In what detail do you want? 7 Q Physically, what do you do to place the 8 catheter? 9 A Okay. Well, we will start a little bit further 10 back than that. One has to get some landmarks 11 within the heart. There are a couple of ways of 12 doing that. One is to have a catheter in the 13 aortic root, to avoid puncturing the aorta 14 inadvertently. Another is to have a catheter 15 recording the His bundle electrogram, because 16 that is right across the aortic wall from the 17 non-coronary cusp of the aortic root. Either of 18 those will suffice. 19 In those days, we used a catheter in the 20 aorta, a pressure catheter we had to flush every 21 few minutes to make sure clots didn't form on it 22 so we could see it fluoroscopically. Setting up 23 the fluoroscopic views, you need a couple of 24 different angulations. That's the way I was 25 taught, and that's the way many people do it. 0016 1 And then sliding a long, stainless steel 2 guidewire with a curve on the end of it, a J 3 curve, that's about maybe four millimeters in 4 diameter across it, up the -- from the right 5 femoral vein is the way I do it, up to the 6 superior vena cava, right on past -- in the 7 cavity of the right atrium, right on past it, up 8 into the superior vena cava, and then sliding 9 the transseptal dilator and sheath assembly -- 10 those are two concentric plastic tubes -- from 11 the femoral vein, over that wire, all of the way 12 up to the superior vena cava. 13 And then that wire is pulled back, and you 14 have two plastic tubes in the superior vena 15 cava. Then the Brockenbrough needle, a hollow, 16 stainless steel needle with a stopcock on the 17 end of it, is attached to a pressure monitor, 18 and it's balanced and calibrated, so we jiggle 19 it to make sure we are recording pressure from 20 it. And flushing on the way in to make sure 21 there is no air in the tubing, and no air in the 22 plastic catheter, all of the way up to within 23 about a centimeter from the end of the plastic 24 tube. That's inspected, both fluoroscopically, 25 as well as having measured beforehand, and I'll 0017 1 go ahead and insert it outside of the body and 2 say, okay, when the hub is within a centimeter 3 of the end of the catheter, the butt end or the 4 proximal end of the catheter, then I know I'm a 5 centimeter from the tip of the sheath. 6 And then, in a couple of different 7 fluoroscopic views, these are all orthogonal 8 so-called views, right anterior oblique and left 9 anterior oblique. Some will use just the 10 anterior or posterior view. I was taught, and I 11 still maintained, in these oblique views, to get 12 the septum in profile and then on fossa, so you 13 can see exactly what you're doing. 14 Gradually, pull down that assembly with it 15 tipped a little bit over towards the septum. 16 This is viewed, again, in both views to know 17 that you're not too far forward, not too far 18 back, not too high, and not too low. 19 And then, in the left anterior, 20 particularly in the left anterior oblique 21 projection, the last small movement downwards, 22 withdrawing the whole assembly. Gradually it 23 jumps over, falls over towards the left atrium. 24 That is its engagement into the recess of the 25 fossa ovalis. And then I confirm, in both 0018 1 views, fluoroscopic views that it is really 2 where it is, and it has not moved since the last 3 time I looked at it a few seconds ago. 4 And then, when I'm confident that I'm in 5 the right location, in the left anterior oblique 6 view on fluoroscopy, I advance the needle and I 7 look at the pressure tracing, and see the 8 characteristic signature of the left atrial wave 9 form. I give a flush, sometimes, of the 10 catheters to -- if there is any question, as to 11 whether it is a dampened pressure wave form. 12 You need a good wave form there. 13 And then, holding the needle against the 14 patient's thigh, just pressing down on it, 15 sliding the plastic tube assembly over the 16 needle and once on fluoroscopy, the dilator is 17 about a centimeter and a half, two centimeters 18 into the left atrium. Again, still monitoring 19 my pressure to make sure I haven't exited the 20 left atrium somehow, having done that. 21 Holding the inner dilator and the needle 22 against the patient's thigh, and then sliding 23 the plastic outer sheath over those, and again, 24 monitoring left atrial pressure. You should 25 have a nice, smooth arc into the left atrium. 0019 1 And then slowly withdrawing the needle and 2 dilator, aspirate back to make sure I have no 3 air in my side port and sheath that's now 4 situated in the left atrium. And if I do, in 5 many procedures, we have just one catheter in 6 the left atrium. And then we're there; we have 7 heparin immediately to make sure clots don't 8 form on our catheters or the sheath or the areas 9 where we do the ablations. 10 If we had -- in those days, if we had this 11 pigtail catheter in the aortic root, we would 12 pull it out, it's no longer necessary, it was 13 just a fluoroscopic landmark at that time. And 14 the His bundle catheter nowadays that we use 15 stays there. 16 If we are doing a second puncture, as I 17 often do, most characteristically beside the 18 first, I use exactly the same technique. I know 19 pretty much where to go, fluoroscopically, 20 because I already have a sheath in there. 21 Now, I typically will put a catheter 22 through that first sheath, for a couple of 23 reasons. It stabilizes it. I can get a 24 catheter out a little bit further into the left 25 atrium or into the one with the pulmonary veins, 0020 1 such that if something should happen in the 2 groin and I accidentally pull back that sheath, 3 I don't lose the atrial access for the first 4 one. 5 It also prevents me from accidentally 6 puncturing the sheath, that I just had in there, 7 with my second needle. I have never seen that 8 happen. I don't want to see that happen, so I 9 have a safeguard against that. And then, just 10 use exactly the same technique for the second 11 one as the first. Pressure monitoring, 12 fluoroscopic imaging in both views. And it 13 usually goes just like the first one does. 14 Q Is a procedure where you do two transseptals 15 more difficult or twice as difficult as a 16 procedure where you do one transseptal 17 puncture -- 18 A No. 19 Q -- apart from the fact that you're doing two of 20 them? 21 A No, I don't think it is anymore difficult. In 22 some, it is different. For instance, when I'm 23 doing two, I have both of my sheaths already 24 situated in the superior vena cava, such that 25 once I get the first one into the left atrium, I 0021 1 have as little time as -- the minimum amount of 2 time between getting that first one in there and 3 when I can give heparin safely. I don't want to 4 give heparin before. Some people do. I don't 5 do that. So I try to minimize the time that I 6 have something in the left atrium, but not 7 anticoagulated. 8 So there is a little bit of time pressure 9 with that, perhaps, but you've got to still do 10 things properly, because there is nothing worse 11 than rushing through something and making a 12 mistake when it is not necessary. 13 There, in a sense, it is a little bit 14 easier, because that first sheath that's already 15 across and stably situated is something of a 16 landmark. You might go a little bit behind 17 that, a tiny bit in front of it, but no more 18 than a couple of millimeters. 19 Q You have alluded to the fact that there is -- 20 that you use a slightly different technique now 21 from the first technique that you were taught. 22 I think you said that, at that point, you were 23 using a pigtail catheter -- 24 A Yes. 25 Q -- in the aorta, but now you would instead use a 0022 1 catheter, an electrocatheter? 2 A Electrocatheter -- 3 THE WITNESS: I'm sorry. 4 MR. PERRY: I'm just going to object to the 5 characterization, but you can answer. 6 A The difference in technique is solely on how we 7 note where the aorta position is. 8 Q Otherwise, it is the same procedure as how you 9 first learned it? 10 A Yes. I should say that back then, it was a 11 single plane of fluoroscopy that we had to move 12 the camera back and forth for different 13 angulations. Now, in one of my rooms, I have 14 biplane, as was present in Mr. Manoogian's case, 15 as well. 16 Q Okay. Is there any variability in how -- in 17 your technique, from one case to another? 18 A There can be. For instance, would you like 19 elaboration? 20 Q Yes, please. 21 A If I know that someone has a rather large right 22 atrium, I sometimes will put an additional 23 slight bend on the stainless steel needle, so it 24 has a little bit better so-called reach; it is 25 able to get over to the septum more easily. 0023 1 Almost never is that necessary, even in 2 relatively large atria. I don't do that up 3 front, only if it is nearly impossible to reach 4 the septum, and then I just pull out and start 5 over. 6 Q Do you know what point in time it was, 7 approximately, that you switched from using the 8 pigtail catheter to using an electrocatheter in 9 the bundle of His? 10 A About 1997 or so. 11 Q Okay. And what prompted the change? 12 A Well, the more stuff you have in the arterial 13 circulation, the left heart and so forth, that 14 needs to have attention, flushing and so forth, 15 the less time you can spend on -- the less 16 attention you can spend on the business at hand, 17 of getting across the septum. 18 So if we had difficulty coming down, 19 engaging the fossa ovalis, time is still going 20 by, and we have to stop and flush the pigtail. 21 And I noticed that we had a His bundle catheter 22 there all of the time, and it's marking -- they 23 are always overlying each other. What do I need 24 the aortic catheter for? So we dispensed with 25 using that. 0024 1 Q Do you place an electrocatheter in the coronary 2 sinus? 3 A I do. 4 Q Any other electrocatheters you place? 5 A For an atrial fibrillation case, no. 6 Q Okay. 7 A I should say, I do have a plastic tube now, not 8 an electrocatheter, but a plastic tube in the 9 femoral artery to monitor continuous blood 10 pressure. 11 Q Okay. I'm trying to be organized. 12 I want to try and go through this in a 13 little bit of an organized fashion. The first 14 thing I was hoping we could talk about, as far 15 as background, is Mr. Manoogian's health. Is 16 that something that you're going to be rendering 17 any opinions on? Do you have any opinions on 18 Mr. Manoogian's health prior to his treatment 19 with Cardiovascular Consultants? 20 A My understanding was, he was working -- 21 Q Okay. 22 A -- full-time, and a rather vigorous gentleman, 23 but I don't know specifics of the type of 24 activities. 25 Q What's your understanding of what, if any, heart 0025 1 problems Mr. Manoogian had, prior to coming to 2 see Cardiovascular Consultants? 3 A I know that he had atrial fibrillation, of 4 course, and there was some mention of a mild 5 dilated cardiomyopathy, mild diminution in left 6 ventricular systolic performance -- 7 THE REPORTER: I'm sorry? 8 A -- I'm sorry. Mild diminution in the left 9 ventricular systolic performance. 10 Q Did Mr. Manoogian have a low ejection fraction? 11 A That's what I'm -- that's the proper term, yes, 12 it was slightly diminished. 13 Q What is a normal ejection fraction? 14 A Depends on the laboratory, but certainly 15 anything over 50 or 55 percent, up to about 16 70 percent is in the normal range. 17 Q Okay. Do you have an opinion as to the reason 18 for Mr. Manoogian's lower ejection fraction? 19 A I don't have any specific way of knowing what it 20 was -- why it was somewhat diminished. 21 Q Do you have any opinions with respect to the 22 cause of Mr. Manoogian's atrial fibrillation? 23 A No. 24 Q Is it important in treating a patient's atrial 25 fibrillation, to determine a cause? 0026 1 A If one can identify a precipitant, that's a 2 wonderful thing. It is quite uncommon to be 3 able to define a reversible precipitant, I 4 should say. Most individuals, it is idiopathic 5 atrial fibrillation, sometimes related to some 6 structural heart disease, but most of the time 7 we can't nail down a specific cause. 8 Q Okay. Do you have any criticisms of 9 Dr. Cockrell or Dr. Lee, with respect to the 10 indication for atrial fibrillation ablation for 11 Mr. Manoogian? 12 A No, ma'am. 13 Q Okay. Would you agree that atrial fibrillation 14 ablation is a generally good and safe technique 15 for treating atrial fibrillation? 16 A In properly selected patients, I believe so, 17 yes. 18 Q Have you ever done an AV junction ablation? 19 A Yes, ma'am. 20 Q And what are the benefits and risks of an AV 21 junction ablation, as compared to an atrial 22 fibrillation? 23 A Well, it's apples and oranges. It simply 24 controls the ventricular rate. The atrial 25 fibrillation is allowed to go on in the atria, 0027 1 as it would just by course of nature. So if an 2 individual is encumbered by a decrease in 3 cardiac output, cardiac performance by virtue of 4 not having an effective atrial contraction that 5 contributes, through optimal left ventricular 6 filling, AV junction ablation does nothing for 7 that; it simply prevents the ventricular rate 8 from going excessively fast. 9 The part and parcel of the AV junctional 10 ablation is, in almost all cases, insertion of a 11 ventricular pacemaker. By its nature, this 12 engenders some decrease in left ventricular 13 contractile efficiency. In many cases, that's 14 not important for the individual, but in some 15 cases, it can be. 16 Atrial fibrillation ablation, by contrast, 17 when it works well, does restore mechanical 18 function of the atrium. So not only do you have 19 de facto rate control during -- with atrial 20 fibrillation, because atrial fibrillation is 21 absent, but the systolic performance of the left 22 ventricle, if dependent on an effective atrial 23 contraction, is preserved. 24 Q Do you -- are there any particular rates that 25 you know of, either for yourself or generally 0028 1 speaking, for A-Fib ablation of recurrence 2 following the procedure? 3 A Well, this is a difficult thing to know. Many 4 individuals will have asymptomatic recurrences. 5 And only when one looks very carefully or finds 6 one serendipitously might one be aware of that, 7 either the patient or the physician. In 8 general, individuals with the more readily cured 9 forms of atrial fibrillation, paroxysmal atrial 10 fibrillation -- Mr. Manoogian was not paroxysmal 11 at this point -- those more readily treated 12 individuals might have as high as a 30 percent 13 recurrence rate within a year or two. 14 We don't have large numbers of individuals 15 who have been followed for five years, say, to 16 know what their recurrence rate is. In chronic 17 or permanent atrial fibrillation, such as 18 Mr. Manoogian had, the recurrence rates are 19 slightly higher, perhaps 40 percent or more, 20 even after what appeared to have been an 21 effective procedure. 22 Q Are you going to be rendering any criticism of 23 Dr. Lee, relative to the performance of the 24 May 2004 ablation procedure? 25 A No, ma'am. 0029 1 Q Okay. Would you agree that there are, in 2 addition to recurrence, other known risks for 3 atrial fibrillation ablation? There is a 4 certain set of known risks that you would advise 5 your patient about? 6 A Procedural risks? 7 Q Yes. 8 A Yes, ma'am. 9 Q And what would those risks be? 10 A A variety of things, including most commonly 11 perforation of the heart, with blood leaking 12 around the outside of it, resulting in a 13 pericardial effusion, or even if the pressure 14 rises enough in the pericardial space, cardiac 15 tamponade, requiring closed drainage, or even 16 open drainage by a surgeon and repair of the 17 hole. Vein stenosis, pulmonary vein stenosis. 18 Damage to the normal conduction system requiring 19 a permanent pacemaker. Damage to one of the 20 cardiac valves. Damage to the esophagus through 21 the back of the left atrium, resulting in a 22 fistula or communication between the left atrium 23 and esophagus. Stroke, heart attack, even death 24 resulting from the procedure. Damage to the 25 phrenic nerve, P-H-R-E-N-I-C, nerve that 0030 1 controls diaphragmatic contractions. Just 2 pericardial inflammation, pericarditis, 3 discomfort that way. 4 And aside from those that are relatively 5 more specific for left atrial in extended 6 ablation procedures, groin complications, atrial 7 ven- -- arterial ventric- -- venous fistulas and 8 pseudoaneurysms and hematomas and distal emboli, 9 and things like that. 10 Q And those are the risks that you would tell any 11 patient that you were giving informed consent 12 to, prior to doing an A-Fib ablation? 13 A Yes, ma'am. 14 Q Okay. Is it fair to say that those 15 complications can occur in the best of hands? 16 A Yes, ma'am. 17 Q Including death? 18 A Yes, ma'am. 19 Q Do you know what the national rate is for death 20 as a complication of A-Fib ablation? 21 A I don't. I know that overall, it is about a 22 two percent risk of any of these complications 23 occurring, with death being a very, very small 24 slice of that, but it does occur. 25 Q Have you ever had a complication from an A-Fib 0031 1 ablation case? 2 A Yes, ma'am. 3 Q What kind of complication have you encountered? 4 A Cardiac tamponade; pulmonary vein stenosis; 5 transient ischemic attack, TIA, of a neurologic 6 nature; phrenic nerve palsy; pericarditis; 7 hematomas in the groin. That's all I can think 8 of right now. 9 Q Have you ever needed the assistance of a cardiac 10 surgeon to handle a patient you had tamponade or 11 other kind of complication during an A-Fib 12 procedure? 13 MR. PERRY: Just object to what you mean by 14 assistance. Could you make that -- 15 Q Is that -- do you understand my question? 16 A Have I needed to consult a surgeon? Yes. 17 Q Okay. How many times? 18 A I've consulted them more than they have needed 19 to do anything, fortunately. Which answer would 20 you like, or both? 21 Q Both would be great. 22 A Well, it is easier to try to count up the number 23 of times I've actually needed them, and it would 24 probably be myself, personally, once. We here 25 have had, I think, two other instances in which 0032 1 a surgeon intervened. I have summoned a surgeon 2 or spoken with one by telephone probably half a 3 dozen other times. 4 Q And in those half dozen times you spoke with a 5 surgeon and, ultimately, realized that you 6 didn't need them to come and treat the patient? 7 A Yes, ma'am. 8 Q Okay. We were talking about all of these 9 various risks of the procedure. Did you review 10 the medical records in this case relating to 11 Mr. Manoogian's treatment at Washington 12 Adventist Hospital? 13 A I did. 14 Q And did you see his informed consent forms, 15 relative to his A-Fib procedures? 16 A I bet I did. I don't recall them specifically. 17 Q Okay. Can we agree that Mr. Manoogian was aware 18 of the risks that you articulated with respect 19 to atrial fibrillation ablation? 20 MR. PERRY: I'm going to object. Calls for 21 speculation. 22 A I don't recall specifically that these were 23 enumerated in that statement there. 24 Q Okay. So you don't know, one way or the other? 25 A No, ma'am. 0033 1 Q Okay. 2 MR. PERRY: (Coughs.) Excuse me, I'm 3 sorry. I don't want to interrupt you. 4 Q Okay. Did you see, in the medical records, 5 references to Mr. Manoogian's being a 6 well-educated patient, a well-informed patient 7 about his condition and treatment? 8 MR. PERRY: Same objection. You can 9 answer. 10 A I know that he was a well-educated gentleman, 11 and -- but I don't know to what extent he 12 explored his options and the nature of the 13 procedure, as well as the potential 14 complications. 15 Q If Mr. Manoogian had come to you for treatment, 16 prior to -- let's see, let's get a date -- in 17 May of 2004, having already tried a medication 18 regimen, what would you have recommended for 19 him, if anything? 20 A I would have counseled him that this was 21 definitely an option for him. I would have gone 22 through exactly the list of potential 23 complications, and also quoted those types of 24 percentage risk and percentage beneficial 25 outcome. 0034 1 Q Can we agree that Dr. Cockrell and Dr. Lee are 2 and were in 2004 experienced 3 electrophysiologists with ablation procedures? 4 MR. PERRY: Objection. 5 A Well, I can agree that they had done a large 6 number of procedures. 7 Q Well, okay. Is that different from experienced, 8 in some way? 9 A Well, there are connotations about -- there is 10 good experience and bad experience, I suppose. 11 Expert, I can't attest to that. Have they had a 12 large number of procedures? Yes. 13 Q Is an atrial fibrillation ablation a difficult 14 procedure, technically speaking? 15 A Yes, ma'am. 16 Q What aspects of the procedure are the 17 technically challenging portions? 18 A Many are technically challenging. One is 19 getting the coronary sinus catheter, in some 20 cases. That's almost always -- that can be 21 overcome. Getting safely into the left atrium 22 with one or two catheters is another. 23 Perhaps the most difficult aspects are the 24 actual ablation portion, and knowing when one 25 has done the type of damage and the degree of 0035 1 damage in the location desired, in order to 2 effect the desired outcome, and knowing when you 3 shouldn't do any more ablation in the particular 4 location. And knowing what the end points are 5 of the procedure is also somewhat difficult in 6 many circumstances; when have you done enough. 7 Q Going back to the risks issue, have you in your 8 experience ever passed a Brockenbrough needle 9 through the intra-atrial septal wall? 10 A Yes. 11 Q And have you ever advanced a catheter through 12 the intra-atrial septal wall? 13 A You mean, through the fossa ovalis. 14 Q Outside of the fossa ovalis is my question. 15 A Oh, well, those -- 16 MR. PERRY: Can I just -- can we clarify 17 that the prior answer, then, is -- I think, 18 based on your question, I think it was unclear 19 what you were asking. 20 MS. PLANT: Let me -- I'll withdraw. 21 A To me -- 22 MR. PERRY: Doctor, just let her reask the 23 question. 24 THE WITNESS: I'm sorry. 25 Q Have you ever, in your experience, passed a 0036 1 transseptal catheter through an intra-atrial 2 septal wall outside of the fossa ovalis? 3 A No. 4 Q And how do you know that? 5 A Well, to me, these are almost identical, to say 6 that one is in the fossa ovalis, but outside of 7 the -- or in the atrial septum, but outside of 8 the fossa ovalis are almost contradictory 9 statements, because the fossa ovalis is pretty 10 much the limit of the junction between the two 11 atria. There is very little around the outside 12 of that that's -- that one could traverse and 13 not be outside of the right atrium. 14 Q So in other words, it is hard to find a point of 15 entry that would land in the left atrium that is 16 not the fossa ovalis? 17 A Yes. There is a little rim around that, the 18 limbus of the fossa ovalis, but more than a 19 millimeter or two in any direction from there, 20 leaving the right atrium, you do not enter the 21 left atrium directly. 22 Q Okay. So when we're talking about -- when 23 you're saying the term limbus, you're talking 24 about a small, several-millimeter area around 25 the fossa ovalis? 0037 1 A Yeah, just a rim around it. 2 Q Okay. Is that also called the ridge, a ridge? 3 A Don't usually call it a ridge. 4 Q Okay. Limbus. We'll call it limbus. 5 A Okay. 6 Q Have you, in your experience ever punctured 7 through the limbus in passing from the left to 8 right -- right to left atrium? 9 MR. PERRY: Just object. When you say 10 "passing through," with what are you referring 11 to? 12 MS. PLANT: With the transseptal catheter. 13 A Through that actual rim around there? I don't 14 know. 15 Q Okay. Why are two transseptal punctures often 16 used? 17 A For purposes of having two catheters 18 simultaneously in the left atrium. 19 Q And what do the two catheters do, typically? 20 A One catheter is used for ablation, delivery of 21 typically a radio frequency current to actually 22 do the ablation, one moves that around and 23 ablates in various locations. It is also a 24 mapping catheter that can record signals and 25 determine timing and quality of signals. 0038 1 Another catheter can sometimes be used to 2 determine where that ablation catheter should be 3 targeting, and that would be solely a mapping 4 catheter of a variety of configurations. 5 Q Has the standard of care applicable to atrial 6 fibrillation ablation procedures changed in the 7 past five years? 8 MR. PERRY: I'm going to object, just sort 9 of a broad question, but you can answer it if 10 you -- 11 A I'm -- I would ask for a clarification, as to 12 what you mean. It seems rather broad to me. 13 Q Okay. What is your understanding of what the 14 term standard of care means? 15 A It means what a reasonable and prudent 16 practitioner would do under certain 17 circumstances. 18 Q Is there any aspect of an atrial fibrillation 19 ablation procedure that has changed, as far as 20 what is expected of a reasonably prudent 21 physician, within the past five years? 22 A I think so. 23 Q Okay. What part has changed? 24 A Well, the indications have gotten a little bit 25 more liberal. As the safety and efficacy of the 0039 1 procedure have improved somewhat, we are opening 2 it up to more individuals who we would like to 3 cure of atrial fibrillation, but whose 4 likelihood of success seemed lower, or their 5 procedural risk seemed higher five years ago. 6 Five years ago, we were ablating more 7 towards the vein than towards the atrium, and 8 thus, there was a higher incidence of pulmonary 9 vein stenosis. 10 I think in many settings, the prevailing 11 thought was, let's use as much energy and do as 12 much ablation as we can. And some complications 13 have come to light that suggest that there is 14 such a thing as too much ablation. 15 But as far as the techniques of getting 16 into the left atrium and manipulating catheters 17 in the left atrium, I don't think those have 18 changed substantially. 19 Q Can you tell me at what point in time there came 20 this paradigm shift, there was a change in the 21 standard of care for the items that you 22 mentioned? 23 A I don't know that there was a point in time. 24 Probably it's been about five years, about 25 the -- or more, five years, as to how far out 0040 1 towards the vein from the atrial venous or 2 veno-atrial junction one could safely ablate. 3 It's been perhaps the last three years 4 about avoidance of very high energy delivered to 5 the posterior left atrium to try to avoid left 6 atrial esophageal fistula formation. I think in 7 just the last year or so, there's been a greater 8 awareness of wanting to try to avoid damage to 9 the phrenic nerve. 10 Q I limited my last question or series of 11 questions to the past five years. And you said 12 in that time frame, the technique of getting 13 into the left atrium has been static, as I 14 understand it; is that correct? 15 A The techniques that are available nowadays were 16 available in that five years ago, yes. 17 Q Okay. Going back further, at any point in time, 18 is it your view that there has been a shift in 19 what the standard of care requires, as far as 20 the technique of getting into the left atrium? 21 A Not as far as what the standard of care 22 requires. The techniques for assuring that 23 safety and efficacy of getting into the left 24 atrium have changed a little. 25 Q Okay. What has changed, and when? 0041 1 A In the last 10 years, did you say? 2 Q I said at any point, but -- 3 A At any point? Okay. Well, as originally 4 described, the technique used pressure 5 monitoring. Additional means of confirming 6 one's location of the needle in the left atrium 7 would be aspiration of blood back through the 8 needle, to assure that it had a left atrial 9 oxygen content. That has a potential confuting 10 factor that, if you're in the aorta, you get the 11 same oxygen content, so that's not perfect. 12 Injection of dye through the needle, either 13 right before intending to puncture through the 14 septum, to stain the atrial septum and say yes, 15 I'm in the atrial septum, I'm not outside of the 16 atrial septum, I'm not in the aortic wall is one 17 method. Injection of dye immediately after one 18 thinks one's in the left atrium, to make sure 19 that it is in the left atrium, not outside the 20 left atrium, not in the aorta. Each has their 21 own characteristic findings on fluoroscopy after 22 injection of dye. 23 Passage of a very thin angioplasty 24 guidewire on the left upper pulmonary vein, or 25 into the left atrial appendage, to serve as a 0042 1 rail to track the entire apparatus over, so the 2 needle doesn't inadvertently puncture the dome 3 of the left atrium; once it is safely in, it 4 should not go out again. Use of intra-cardiac 5 echocardiography, either the rotating transducer 6 or the phased array, in order to image both the 7 fossa ovalis and the actual puncture across the 8 septum and other structures to avoid the aorta 9 and coronary sinus. 10 So just in the last, you know, since the 11 inception of the technique, the angioplasty 12 guidewire, for instance, has been an innovation. 13 The use of intra-cardiac echocardiography has 14 become available and widely used. Injection of 15 dye, I think, was a pretty early technique; and 16 some use it, some don't. 17 The fundamental, what all of these 18 techniques feed into is assuring that the needle 19 is safely situated in the left atrium before 20 passage of the dilator and sheath assembly, and 21 that the whole thing remains in the left atrium 22 and doesn't -- it is in there in the first 23 place, and not some other location, and remains 24 in the left atrium. 25 Q Is it fair to say the purpose of each of the 0043 1 types of precautions that you have been talking 2 about are to reassure the operator about where 3 he or she is, anatomically? 4 A Correct. 5 Q Okay. And for example, the item you mentioned 6 with using dye before passing the needle, that's 7 a reassurance that's given to the operator prior 8 to passing the needle? 9 A Correct. 10 Q So reassurances about anatomical location can 11 happen before or after the needle puncture? 12 A It can happen before, but need to happen 13 afterwards. 14 Q Okay. When is it your opinion that that became 15 the standard of care? 16 A Oh, I don't think that that has ever not been 17 the standard of care. 18 Q Okay. What are the techniques, in your opinion, 19 that would comply with the standard of care in 20 reassuring an operator as to their anatomical 21 location? 22 A Those that I have enumerated, plus fluoroscopic 23 imaging that your assembly is situated in both 24 fluoroscopic angulations and center of the left 25 atrial shadow. That's not quite as good as some 0044 1 of these other techniques, because there are 2 some overlying shadows, so I wouldn't rely on 3 that alone. 4 Q Do you know whether there are physicians who 5 practice in relying on a biplane fluoroscopy 6 with anatomical landmarks as their guidance and 7 their reassurance as to where they are 8 anatomically? 9 MR. PERRY: Objection, but you can answer. 10 A I don't know. I hope not. As their sole 11 method? Is that what you're asking, ma'am? 12 Q Well, I'm not characterizing it as a sole 13 method, but using both anatomical landmarks with 14 electrocatheters, and having biplane 15 fluoroscopy. 16 A What do you mean by electrocatheters and where? 17 Q Well, I think you had discussed previously 18 placing an electrocatheter in the bundle of His 19 as a good landmark to tell you where, at least 20 in part, where the edge of the aorta -- aortic 21 root is? 22 A Correct. 23 Q And an electrocatheter in the coronary sinus -- 24 A Correct. 25 Q -- which tells you -- what does that tell you? 0045 1 A It is another landmark. It says that's the 2 bottom of the left atrium, at least, in both of 3 the views. An electrocatheter actually in the 4 left atrium is a nonspecific indicator, as I 5 suggested from my handwritten notes there, 6 because one can record an atrial electrogram 7 from the right atrium, from inside of the left 8 atrium, from inside of the coronary sinus, from 9 outside of the left atrium. 10 So the mere presence of the left atrial 11 electrical recording doesn't assure that the 12 apparatus is in the correct location. 13 Q Would it reassure an operator that one was not 14 in the aorta? 15 A I don't know that I could answer that. I'm not 16 used to trying record atrial signals from the 17 aorta. 18 Q Or to record any signals from the aorta? 19 A Usually, the aorta is a conduit, and not 20 something we are trying to record in itself. 21 Q Do you have an opinion as to what would be found 22 if an operator tried to record electrogram 23 signals from a catheter that had been placed in 24 the aorta? 25 A Actually, in reflecting on this, I do have some 0046 1 insight into that. And we have had -- we have 2 tried to record a His bundle recording, for 3 instance, from the aortic root. It is difficult 4 to see an atrial signal from there. And in 5 other circumstances, we can recognize, if for 6 instance, we are doing a left ventricular, 7 mapping an ablation procedure, so the catheter 8 has gone through the -- traversed around the 9 aortic arch, and through the aortic valve and 10 into the left ventricle. We can recognize when 11 we have come out of the left ventricle 12 inadvertently because we can't record any 13 signals of any sort, atrial or ventricular, even 14 in the aortic root. 15 So I would say it would be unlikely to be 16 able to record atrial signals from the aortic 17 root. 18 Q So is it fair to say that recording of 19 electrical signals, after placing the 20 Brockenbrough needle across the -- into what you 21 believe is the left atrium -- right atrium -- 22 left atrium, that a operator would be reasonably 23 reassured that they were in -- that they were 24 not in the aorta, if they got a wave form that 25 represented the left atrium; does that make any 0047 1 sense? 2 MR. PERRY: Object, just because I didn't 3 understand the question, but if you did, Doctor, 4 you can answer. 5 A Well, I wouldn't want to record that with a 6 Brockenbrough needle. I would want to record 7 that with a electrocatheter. 8 Q Thanks. 9 A If I had good, so-called sharp, so-called near 10 field recordings, I could be, I think, confident 11 that I was not in the aorta. 12 Q Okay. We may have -- we talked about this a 13 little bit, but do you have any source of 14 information or familiarity with what of these 15 different kinds of systems and precautions are 16 being used across the country? 17 A I think all of them are, in various 18 laboratories. And in our laboratory, we have 19 different operators using different techniques. 20 One develops a familiarity and a confidence with 21 one or a variety of techniques, and uses them. 22 Q And so is it fair to say that the 23 electrophysiologist performing a transseptal 24 puncture should utilize the system that he or 25 she is most comfortable with, and gives them the 0048 1 best reassurance about their anatomical location 2 of the catheters they are placing? 3 MR. PERRY: Objection. You can answer. 4 A That gives them true reassurance that they're in 5 the right location. 6 Q Is that yes? 7 A It is a qualified yes -- 8 Q Okay. 9 A -- because one needs to confirm that they are 10 uniquely in the left atrium, and no other 11 structure. And methods that someone might rely 12 on that seems to be a reassurance to them, but 13 is not confirmation of left atrial location, 14 would not be adequate. 15 Q Have you ever seen or are you aware of any 16 surveys or any studies that have tried to 17 articulate what the various different types of 18 precautions and systems being used across the 19 country are? 20 A Nothing formal, no. 21 Q Have you ever seen that for any other country? 22 A Not that I'm aware. 23 Q Okay. Are there any other countries that are on 24 a par with the United States, as far as ablation 25 for atrial fibrillation technology -- 0049 1 A Certainly. 2 Q -- and procedures? 3 MR. PERRY: Just object, but go ahead. 4 A Certainly. 5 Q And what countries are on a par or even better 6 than the United States, if any? 7 A Better than the United States? (Laughter.) 8 On a par with the United States, a variety 9 of laboratories in France, in Italy, in Germany, 10 in Japan, in Taiwan, Canada. 11 Q Okay. 12 A I don't want to be too exclusive, but these are 13 the ones that are very much at the forefront. 14 Q And in particular, what role have physicians 15 from Italy played in the evolution of techniques 16 for atrial fibrillation ablation? 17 MR. PERRY: Objection. You can answer. 18 A The so-called Pappone, P-A-P-P-O-N-E, capital P, 19 method, devised by Carlo Pappone, C-A-R-L-O, in 20 Milan, has been an innovation in the way that 21 atrial fibrillation ablation is performed. 22 Q Have you ever seen Dr. Pappone perform an 23 ablation for atrial fibrillation? 24 A Yes. 25 Q Okay. When and how did you do that? 0050 1 A I went to Milan. 2 Q And when was that? 3 A October of last year. 4 Q Do you recall what his technique was for 5 transseptal placement? 6 A Yes. 7 Q What was it? 8 A Fluoroscopy plus pressure monitoring. 9 Q When he used fluoroscopy, did he use a single AP 10 view? 11 A He did. I should say, his laboratory did. He 12 only did one puncture, and most of the rest were 13 done by one of his associates, and that was 14 using pressure monitoring and the anterior 15 posterior view. 16 Q Is it your recollection that Dr. Pappone used 17 pressure monitoring? 18 A That is my recollection. 19 Q Okay. 20 A I know that his associate, Dr. Vicedomini, 21 V-I-C-E-D-O-M-I-N-I, recommends that. 22 Q Is it fair to say there are a number of 23 different ways to comply with the standard of 24 care in using adequate precautions for a 25 transseptal placement? 0051 1 A Yes. 2 Q Okay. How many physicians in this country do 3 atrial fibrillation ablations, as of 2006? 4 MR. PERRY: Objection. You can answer if 5 you know. 6 A It would be a very rough estimate, 200. 7 Q We had been talking about various complications. 8 In your experience, have you ever encountered -- 9 have you ever perforated an aortic root in doing 10 a transseptal puncture? 11 A My own hands have not punctured an aortic root. 12 Q Have you ever been in an EP lab when someone 13 punctured the aortic root during a transseptal 14 puncture? 15 A Yes, ma'am. 16 Q When did that happen? 17 MR. PERRY: Can I just -- I just want to 18 clarify. When you are talking about puncture, 19 what are you -- what are you referring to? 20 MS. PLANT: I was being intentionally 21 general. 22 MR. PERRY: Okay. 23 THE WITNESS: May I be specific then? 24 MS. PLANT: You may indeed. 25 MR. PERRY: Fair enough. 0052 1 A A needle has entered the aortic root to give a 2 characteristic signature aortic wave form on two 3 occasions that I can recall. 4 Q Do you recall what happened on those occasions? 5 A I certainly do. 6 Q What happened? 7 A There was a loud "Oops," and watched it for a 8 second or two to make sure this is not an 9 illusion, this is not just a catheter fling, 10 this is the real thing. Pull the needle back 11 into the right atrium, and ask for an 12 echocardiogram, ask the patient how they are 13 doing, make an assessment of their hemodynamic 14 status. And in both of those cases, I can't 15 speak to every case, but in both of these cases, 16 there was no -- no adverse sequella whatsoever. 17 The procedure was continued. 18 Q Do you recall how the puncture into the aortic 19 root was recognized in those two cases? 20 A In both cases, by the characteristic wave form, 21 pressure wave form. This was only the needle, 22 this very thin needle entering just into the 23 aorta. And we didn't even draw back blood. 24 Q Is a perforation into the aorta, such as the two 25 that you have described, in and of itself a 0053 1 deviation from the standard of care? 2 A No. 3 Q Can you tell me what your criticisms are of 4 Dr. Cockrell in this case. 5 A I believe he did not use adequate means of 6 determining that he was uniquely in the left 7 atrium with one of his puncture attempts. One 8 of those left the right atrium and entered the 9 aorta, went through the wall and into the aorta 10 itself, not just with the needle, but with the 11 actual plastic dilator and with the sheath, 12 which is then about a 3- or 4-millimeter 13 diameter, 3-millimeter diameter. And that, in 14 itself, directly contributed to Mr. Manoogian's 15 complication. 16 Q Any other criticisms? 17 A Having done it, and not recognized that he was 18 in a place where his catheter didn't belong. 19 Q And not that I'm looking for more, but any 20 others? 21 A When the blood pressure dropped and 22 pericardiocentesis was appropriately undertaken, 23 once a large amount of blood had been retrieved 24 from the pericardium, and/or the patient had not 25 stabilized, and/or CPR was necessary, under 0054 1 those circumstances, a surgeon needed to be 2 called immediately to try to rectify the 3 situation. 4 Q Let me see if I can make sure I understand what 5 point in time you're talking about. At what 6 point in time in that continuum that you have 7 described, in Mr. Manoogian's case, was the -- 8 did the standard of care require Dr. Cockrell to 9 contact a cardiothoracic surgeon? 10 A I don't know over what period of time that 1500 11 CCs to which Dr. Lee alluded was removed. I 12 know that in most cases, it is a 20- or a 50-CC 13 syringe that is used. And at some point along 14 the way, it can be connected to a bag or to a 15 bottle to suction. It takes a certain amount of 16 time to pull 50-CC after 50-CC syringe off. 17 If I may back up for a moment, the 18 pericardium is a somewhat distensible sac in 19 which the heart is situated. And it can -- 20 (A knock at the door and a discussion was 21 held off the record. Record read.) 22 A -- accommodate a certain amount of blood within 23 it that's outside of the heart, and expand to a 24 point. In individuals in whom there is a slow 25 accumulation of fluid, over a period of weeks or 0055 1 even months, that pericardium can become quite 2 enlarged and accommodate 800, a thousand CCs, 3 without any compromise of heart filling, because 4 the pericardium has a chance to stretch. 5 When blood is acutely entering the 6 pericardial space, it doesn't have a chance to 7 stretch. And so as more blood goes into there, 8 pressure increases within the space, compressing 9 the heart. And it doesn't take more than 150 or 10 200 CCs of extra cardiac blood within the 11 pericardial space to result in severe 12 cardiovascular compromise. Removing that much 13 blood, if the bleeding has stopped, at that 14 point, should suffice. Sometimes it is only 15 50-CCs removal. 16 But certainly, by the point of 2- or 3- or 17 400 CCs, there is continued leakage; that must 18 be inferred at that point. And it is not going 19 to -- it is very unlikely to stop by itself. If 20 it does, you're very fortunate, but I would not 21 want to rely on that hope at that point. And I 22 would be calling a surgeon. That would be the 23 standard of care once blood is continuing to be 24 aspirated, despite getting more and more out. 25 Fifteen hundred CCs is a very large amount 0056 1 of blood to evacuate from the pericardial space, 2 and bespeaks a continued leak. 3 Q And so if I understand you correctly, at the 4 point that the physician recognizes that there 5 was 1500 CCs of blood, that was when -- 6 A Before then. Fifteen hundred is certainly -- 7 that's the number they mention, but if a 8 physician sees 400, 500 CCs of blood still 9 coming out, it is not prudent to hope that it 10 will stop sometime along the way. And a surgeon 11 needs to be contacted. 12 Q Okay. What is your understanding or assumption 13 about when a surgeon was contacted in this case? 14 A It is difficult to get from the narrative. Both 15 Dr. Lee's and Dr. Cockrell's handwritten notes 16 say that Dr. Militano was contacted somewhere 17 along the way, but it is difficult for me to 18 piece that in to the time line very well. 19 MR. PERRY: Marianne, if I could just state 20 for the record, Dr. Militano's deposition 21 transcript is not available at this time, and 22 has not been available to Dr. Miller prior to 23 his deposition. 24 MS. PLANT: Sure. 25 MR. PERRY: Thanks. 0057 1 Q Dr. Miller, do you have any understanding of 2 what Dr. Militano has testified about, not 3 withstanding the fact that his deposition 4 transcript is not yet available? 5 A I have some information in that regard. 6 Q And what information do you have? 7 MR. PERRY: I think I'm going to object on 8 work product. 9 MS. BOYCE: On what? 10 MR. PERRY: Work product. 11 MS. BOYCE: I think it is all discoverable, 12 Scott, even in an expert. 13 MR. PERRY: Yeah, okay. I'll put my 14 objection on, but you can answer, Doctor. 15 A Well, what I remember of what I was told was 16 that Dr. Militano did not recall having 17 specifically been summoned or contacted, and 18 that when he arrived, his impression was that 19 this was a hopeless situation. His description 20 in his note of the heart being in ventricular 21 fibrillation and could not get it out of 22 ventricular fibrillation is a very, very late 23 finding. I believe CPR was ongoing for some 24 time prior to his arrival. CPR, cardiopulmonary 25 resuscitation, chest compressions, in the 0058 1 setting of extra-cardiac compression by cardiac 2 tamponade is very unlikely to support the 3 circulation. It is marginal, even when there 4 isn't extra-cardiac compression. 5 Q Is it fair to say that you have not assigned a 6 time to the point when you believe that a 7 cardiac surgeon needed to be contacted? 8 A I'm looking at the anesthesia record here, and 9 it says that -- this is page 1 of 3 of the 10 anesthesia record -- it says that at 1725, blood 11 pressure decreased. Decreased. Echocardiogram 12 cardiac tamponade. Cardiologist inserts 13 pericardial centesis drain. I'm interpreting 14 that somewhat. And that's giving a time of 15 1810. 16 Cardiac arrest and start CPR at 1820. And 17 the entry following that is, called cardiac 18 surgeon. Open chest and cardiac massage. 19 Q Does going back over that give you a time that 20 you assigned as the point when a cardiac surgeon 21 needed to be called? 22 A When he needed, I can't get too well from that. 23 If I can continue here, on page 2 of 3 of the 24 anesthesia a record, 1740 p.m., in the margin 25 there, pericardial drainage started at 1740 p.m. 0059 1 Patient's vitals unstable. 2 At 1800 or 1801, endotracheal tube number 3 eight. And then, CPR started at 1815. 4 And I don't know where in there this -- the 5 300 CCs, the 500 CCs mark of -- but when I see 6 patient unstable despite pericardial centesis, I 7 think that a surgeon certainly needs to be 8 called at that time. That's at 1740. 9 Q Okay. How long would you typically expect to 10 have to waited, after contacting a cardiac 11 surgeon, before they could enter into the 12 electrophysiology lab? 13 MR. PERRY: I'm going to object. In this 14 hospital? 15 MS. PLANT: I'm asking for his experience 16 right now. 17 A It varies widely. It might be five minutes; it 18 might be 15 minutes. It could be longer. 19 Q Do you have an understanding of what 20 Dr. Militano was doing at 1740? 21 A I have been told that he was beginning a cardiac 22 coronary bypass procedure. 23 Q Okay. Do you have an opinion that you hold 24 within reasonable medical probability as to 25 whether a different timing or different manner 0060 1 of contacting Dr. Militano would have resulted 2 in a different outcome for Mr. Manoogian? 3 A I don't know. 4 Q Okay. We went through three criticisms that you 5 had of Dr. Cockrell. Are those the three 6 criticisms that you have? Are there any others? 7 A Refresh my memory, please. 8 Q Number one was inaccurate reference about being 9 in the left atrium with one of the passes. 10 Number two was failing to recognize it, and 11 number three was -- 12 A Something about delay? 13 Q -- a discussion about talking with the -- 14 contacting the cardiac surgeon. 15 MR. PERRY: My record shows me that he also 16 said the putting in of a dilator and the sheath, 17 as opposed to just a needle was also a 18 criticism. I don't want to put words in your 19 mouth; is that correct? 20 THE WITNESS: It is correct. If I didn't 21 say that, I meant that. 22 Q Okay. In addition to those that we have just 23 articulated, however we number them, three or 24 four, is there -- are there any other criticism 25 that we need to discuss? 0061 1 A I don't believe so. 2 Q Do you have any criticisms of Dr. Lee? 3 A A similar one to the last one, with 4 Dr. Cockrell, that of recognizing the point at 5 which it was -- should have been clear that the 6 bleeding was unlikely to stop on its own, and a 7 surgeon needed to be summoned immediately. 8 Q What's your understanding of what Dr. Lee knew, 9 as far as whether contact had been made with a 10 cardiac surgeon as of 1740? 11 A I don't have any way of knowing that. 12 Q Okay. So do you have an opinion that Dr. Lee 13 breached the standard of care? 14 A If he got -- well, let me refresh my 15 recollection here. All I can go by is his 16 handwritten note here. It says emergency 17 pericardial centesis was done, and 1500 CCs of 18 bloody fluid was drained. Blood transfusion was 19 started. Pericardial drain stopped draining, 20 despite echo showing, open quote, pericardial 21 infusion, close quote. Dr. Militano was 22 consulted. 23 It seems to read that he got 1500 CCs out, 24 and only when it stopped draining, despite the 25 presence of continued extra-cardiac fluid, 0062 1 pericardial fluid on the echocardiogram on a 2 subsequent echocardiogram did he then call 3 Dr. Militano. 4 And my contention is that the mere fact 5 that he got 1500 CCs out is reason to call 6 Dr. Militano or a surgeon. 7 Q Okay. Let me just take one second, if we can 8 take a brief break. 9 (A discussion was held off the record.) 10 Q Have you had an opportunity to review Dr. Lee's 11 deposition transcript? 12 A Yes, ma'am. 13 Q Do you have it with you? 14 A I believe so. 15 Q Can you look at pages 139 to 140. 16 MR. PERRY: Let me read over your shoulder, 17 if you don't mind. 18 THE WITNESS: Sure. 19 MR. PERRY: Thanks. 20 A I have it. 21 Q Okay. I'll give you a minute. 22 A I'm ready. 23 Q Okay. Having had an opportunity to read that, 24 does that refresh your recollection about 25 Dr. Lee's testimony as to the sequence of 0063 1 events? 2 A Okay. 3 MR. PERRY: I'm going to object that he 4 needs his testimony to be refreshed, but go 5 ahead and ask your question. 6 THE WITNESS: You're talking about the -- 7 Q The sequence of events with respect to when 8 Dr. Lee indicated that a cardiac surgeon needed 9 to be contacted. 10 A Well, I don't see that he talks about contacting 11 the cardiac surgeon within these two pages. He 12 talks about in line -- page 139, line 8, the 13 question is posed: 14 QUESTION: Okay. So you have 1500 CCs come 15 out of the pericardial centesis. 16 He affirms. He affirms in line 15 that 17 that is a large amount of blood. 18 And then the question as to whether that is 19 tamponade or not is answered in lines 18 through 20 22. And we have talked about how a large 21 effusion can accumulate over time. 22 Then he says, the question is posed in page 23 140, line 1: 24 QUESTION: When you got 1500 CCs, did you 25 recognize that, hey, there is an issue here? 0064 1 His answer: 2 ANSWER: When we saw blood pressure drop to 3 70, and when I saw the cardiac fluid not 4 moving -- 5 I presume he means the cardiac shadow. 6 ANSWER: -- and when I saw the 7 echocardiogram that there was pericardial 8 effusion, I knew I was in trouble. We knew 9 there was a bleeding that was causing a drop in 10 blood pressure. But this -- 11 I'm sorry. 12 ANSWER: -- I asked Dr. Cockrell to call 13 Militano, just in case -- 14 On line 12 of page 140. 15 ANSWER: -- as I was drawing a lot of blood 16 out. 17 But it doesn't say to me when, in this 18 narrative -- it seems to indicate that he's 19 already got 1500 CCs out. And then he said 20 okay, I asked Dr. Cockrell to call Dr. Militano 21 just in case. 22 Q Well, let's -- just to be -- just to make sure 23 we read the whole thing on the record, starting 24 at line 10, Dr. Lee says -- after having been 25 asked to decide to call in the surgeon, he says: 0065 1 ANSWER: As I was draining a lot of blood 2 out, then Dr. Cockrell was actually talking to 3 the family, and I asked Dr. Cockrell to call 4 Dr. Militano, just in case. 5 That sounds -- correct me if I'm wrong, but 6 that was what you said should be a trigger to 7 call the cardiac surgeon, when you're getting a 8 lot of blood out. 9 MR. PERRY: Object to the characterization. 10 A I just don't know when that occurred. In line 1 11 it says, "When you got 1500 CCs." And this 12 seems to be occurring after that, but I don't 13 know for sure. 14 Q Okay. Do you have an opinion that you hold 15 within reasonable medical probability that 16 Dr. Lee breached the standard of care? 17 A I don't know when along the way he called the 18 surgeon, but certainly, from reading his note 19 and the vagueness of the deposition, it seems 20 like it was after this 1500 CCs, and after 21 imaging the echocardiogram. In his handwritten 22 note, he says, then I couldn't drain anymore and 23 I know I've still have got a problem, so then 24 I'm going to call a surgeon. And that's too 25 late. 0066 1 Q Where are you getting that he said he had 2 finished draining and couldn't get any more, and 3 then decided to call? 4 A His handwritten note -- 5 MR. PERRY: Okay, just -- Doctor, I just 6 ask you to give me a chance to object. 7 THE WITNESS: I'm sorry. 8 MR. PERRY: I object. First of all, it's 9 been asked and answered three times now. We 10 have gone over various portions of the record. 11 He can go over it again, if you want him to. 12 MS. PLANT: Okay. 13 Q Which portion were you referring to? 14 A His handwritten note of -- do you have it there? 15 Q Yep. 16 A Okay. About 40 percent of the way down, 17 emergent pericardial centesis was done -- and 18 some symbol of -- maybe approximately 1500 CCs 19 of bloody fluid was drained. Blood transfusion 20 was started. 21 And then "however" is scratched out. It 22 looks like "BP" scratched out. Something, 23 something. Then "pericardial drain" scratched 24 out. Stopped draining, despite echo showing, 25 open quote, pericardial effusion, close quote. 0067 1 Dr. Militano was consulted, and emergent 2 stenotomy was performed. 3 Q And so based on the order in which it is written 4 there, you're presuming that's the order in 5 which it happened? 6 A That's all I have. 7 Q Do you have a number of minutes in mind, as to 8 how long there was a delay between when a 9 cardiac surgeon should have been contacted, and 10 when a cardiac surgeon actually reached the 11 electrophysiology lab? 12 A I don't know over what span of time that 1500 13 CCs was removed, and that he remained unstable. 14 Q So it is a period of delay of an indeterminate 15 amount of time that you're alleging? 16 MR. PERRY: Object to characterization. 17 A I don't know how long it was. 18 Q Okay. And fair to say that you don't know what, 19 if any, difference that alleged delay made? 20 MR. PERRY: Objection, asked and answered. 21 You can go ahead, Doctor. 22 A That is correct. 23 Q Do you have any criticism of anyone else in 24 Cardiovascular Consultants, PA? 25 A I don't believe so. 0068 1 Q Any other individuals at all of whom you're 2 critical in this case? 3 A No, ma'am. 4 Q Okay. 5 MR. PERRY: Object to the way that -- can 6 you just state the question back to me, if you 7 don't mind? 8 (The requested material was read by the 9 reporter.) 10 MR. PERRY: I just want to object that 11 Dr. Miller is a standard of care witness against 12 Dr. Cockrell and Cardiovascular Consultants 13 only, and that was the only people he was asked 14 to be a witness for. 15 Q Dr. Miller, did you sign a certificate of merit 16 in this case that included Washington Adventist 17 Hospital in the criticism that you rendered? 18 MR. PERRY: Objection to the 19 characterization of criticism. 20 A If one could be produced that I signed, I will 21 affirm that. 22 MR. PERRY: Can we just -- Marianne, we can 23 do this off the record or on. Do you want to go 24 off the record for a second? 25 MS. PLANT: No. 0069 1 MR. PERRY: Or do you want me to state my 2 objection on the record? 3 MS. PLANT: On the record is fine. 4 MR. PERRY: Okay. If you're going to go 5 here with the certificate of merit, I think the 6 cases are quite clear that simply because a 7 doctor has opined on a certificate of merit that 8 there have been violations of the standard of 9 care, if I don't ask him to testify with regard 10 to a specific defendant, he has no opinion as to 11 that defendant. 12 MS. PLANT: Okay. I'm going to mark this 13 as Exhibit 2. 14 (Defendants' Deposition Exhibit No. 2 15 marked for identification annoyed 16 Q And Dr. Miller, is this, that is marked 17 Exhibit 2, the certificate of merit and report 18 that you executed in this case? 19 A It is. 20 Q And as I understand it, based on representations 21 from counsel, you are not going to be rendering 22 any standard of care opinions against the 23 hospital; is that correct? 24 A That is correct. 25 Q Okay. 0070 1 MS. BOYCE: Can you just say that answer 2 again? Because I couldn't hear. 3 MR. PERRY: It is important to you. 4 A That is correct. 5 MS. BOYCE: I still didn't hear it. 6 MR. PERRY: I'll state on the record, 7 Susan, Dr. Miller will not be offering any 8 opinions with regard to the hospital. 9 Q That being said, can you specify what it is that 10 you previously thought was a violation of the 11 standard of care on the part of Washington 12 Adventist Hospital? 13 MR. PERRY: I'll object and instruct -- 14 MS. BOYCE: Object to the question. 15 MR. PERRY: -- and instruct him not to 16 answer. 17 MS. PLANT: What's the basis for 18 instructing him not to answer? 19 MR. PERRY: What I just stated on the 20 record. He's not being presented as a witness 21 to the hospital, and therefore, he does not have 22 to divulge his opinions. 23 Q So just to make sure we have a clear record, 24 Dr. Miller, you do have opinions, one way or the 25 other, with respect to Washington Adventist 0071 1 Hospital? 2 MR. PERRY: Objection, and instruct him not 3 to answer. 4 MS. PLANT: You're going to instruct him 5 not to answer whether or not he currently holds 6 an opinion? 7 MR. PERRY: Yes. He's not being put forth 8 as a witness with regard to the hospital. 9 MS. PLANT: I'm entitled to ask the doctor 10 whether or not he's changed his mind. That is 11 certainly something that is relevant. 12 MR. PERRY: You're not representing the 13 hospital, Marianne. 14 MS. PLANT: I'm not. 15 MR. PERRY: And so my objection is clear. 16 MS. PLANT: And on what basis are you 17 instructing an expert witness not to answer 18 questions? 19 MR. PERRY: He's not being presented as a 20 witness against the hospital. You're asking him 21 about his opinions as to the hospital. He has 22 no opinions. 23 MS. PLANT: Well, that's what I asked. I 24 asked whether or not he had any opinions. 25 MR. PERRY: You're asking, does he have 0072 1 a -- because you're showing the certificate of 2 merit. 3 MS. PLANT: Correct. 4 MR. PERRY: Okay. The question was, does 5 he have an opinion. And I'm telling you, he 6 does not have an opinion. If you want him to 7 say, I do not have an opinion, he can go ahead 8 and do that. But I'm telling you, the reason he 9 does not have an opinion is I have not put him 10 forth as a witness against the hospital, which 11 is different than the signing of the certificate 12 of merit. 13 MS. PLANT: Okay. As I understand it, 14 Scott, and I don't want to belabor the point, 15 you are not going to allow Dr. Miller to answer 16 any questions about any opinions he ever did or 17 does hold, with respect to Washington Adventist 18 Hospital, not withstanding the fact that, as I 19 understand, he's not going to be testifying 20 against them? Is it accurate that you're not 21 going to let him answer the question? 22 MR. PERRY: It is accurate that he has no 23 opinions that he is going to set forth with 24 regard to the hospital. 25 MS. PLANT: There was a two-part question. 0073 1 My question is: You're not going to allow me to 2 inquire of the doctor what his opinions may be, 3 not withstanding the fact that you're not going 4 to ask him to render those opinions at trial? 5 MR. PERRY: No, I'm not. 6 MS. PLANT: Okay. So you're not going to 7 permit him to answer? 8 MR. PERRY: That is correct. 9 MS. PLANT: Okay. I think we have 10 preserved my objection adequately, if that's 11 acceptable to you. We will preserve it and 12 handle it later. 13 MR. PERRY: Sure. 14 MS. PLANT: Okay. 15 Q Do you have an opinion that you hold within 16 reasonable medical probability as to the cause 17 of death for Mr. Manoogian? 18 A Exsanguination from aortic perforation 19 engendered by one of the sheaths. 20 Q Okay. Do you -- have you formed any opinions 21 with respect to when the bleeding started? 22 A I can't put -- I can put a time on it. I can 23 put a time on it. The clocks are different, but 24 if I refer to the anesthesia record, it was 25 somewhere prior to 1725, not more than a few 0074 1 minutes prior to 1725, according to the 2 anesthesiologist's record. 3 Q Okay. Do you have an opinion as to why there 4 was not bleeding at the initial time of the 5 transseptal placement? 6 A I do. 7 Q What is that opinion? 8 A I believe that the sheath was plugging the hole 9 that it had made. 10 Q Do you have an opinion as to what caused it to 11 stop plugging the hole? 12 A It became displaced from so doing, being pulled 13 back, more than likely. 14 Q As I understand it, you're not attributing any 15 adjustment or changing of the catheters, you're 16 not describing that as a breach in the standard 17 of care? 18 A No. 19 Q Okay. 20 (The doctor's cell phone rang.) 21 MR. PERRY: Do you need to answer that? 22 THE WITNESS: (Shakes head side to side.) 23 Q Have you ever heard of other cases in which a 24 patient had a perforation or a dissection of the 25 aorta that resulted in a death from -- in the 0075 1 electrophysiology lab? 2 A No. 3 Q What would you expect typically would be the 4 result of having -- let me strike the question 5 and start over. 6 Would you agree that, more likely, in your 7 assessment, what you would expect if there was a 8 perforation of the aorta with a transseptal 9 catheter, you would expect an immediate 10 catastrophic event? 11 A No. 12 Q Does the loss of 1500 CCs of blood necessarily 13 cause a patient to have their heart stop 14 beating? 15 A No, ma'am. 16 Q Did Mr. Manoogian's heart stop beating because 17 of tamponade? 18 A I believe he had a combination of cardiac 19 tamponade with inadequate -- that caused 20 inadequate cardiac output, such that his 21 coronary arteries were not adequately supplied, 22 and so the cardiac tamponade was the ultimate 23 cause of that. 24 Q Okay. Did that tamponade cause a mechanical 25 pressure on the heart that permanently damaged 0076 1 Mr. Manoogian's heart? 2 A No. 3 Q Do you have an opinion within reasonable medical 4 probability as to why Mr. Manoogian's heart 5 would not restart initially? 6 A Well, he was in ventricular fibrillation when 7 Dr. Militano encountered it. And because of 8 these phenomena, the low cardiac output from the 9 continued cardiac tamponade, the extra cardiac 10 compression preventing the heart from 11 contracting, pumping blood even to its own 12 coronary artery supply, so it was deprived of 13 oxygen for some minutes, enough so that even 14 counter shock directly applied to the heart was 15 ineffective at first. 16 MR. PERRY: Do you need to take a break to 17 make a call? 18 MS. PLANT: This is a fine time, yeah. 19 (A brief recess was taken.) 20 Q Doctor, I wanted to ask you about the two 21 medical diagrams that you provided, and ask you 22 if you could explain what these two show. One 23 is labeled, "Atrioventricular Groove From 24 Above," and the second is labeled, "Atrial 25 Septal Puncture Sites." 0077 1 So can you explain, in particular on the 2 first one, what is meant by the rectangular box 3 that says, "True Atrial Septum"? 4 A Yeah. 5 MR. PERRY: Can we just make it clear when 6 you refer to the first one, that you're 7 referring to -- 8 MS. PLANT: The "Atrioventricular Groove 9 From Above." 10 MR. PERRY: Thank you. 11 MS. BOYCE: I'm sorry, Marianne, are you 12 referring to an exhibit number? 13 MS. PLANT: We did not mark it as an 14 exhibit. It is one of the two diagrams that he 15 produced. 16 MS. BOYCE: Is it marked? 17 MS. PLANT: It is not. Do you want me to 18 mark it? 19 MS. BOYCE: That would be easier. 20 MS. PLANT: I think we can do that one as 21 3, and this one as 4. 22 (Defendants' Deposition Exhibit Nos. 3 and 23 4 marked for identification.) 24 A If I might digress, most people think of the two 25 atria as like two dodge balls somewhat 0078 1 compressible, you push them together, and 2 there's a disk of interface between them, a 3 relatively large disk. It is not that way. It 4 is more like two soccer balls, not very 5 compressible, and the interface is a very, very 6 small disk, a true atrial septum. 7 And that's what I have illustrated in this 8 dotted rectangular box. This is a little bit 9 lower than the actual septum. This is at the 10 valve level, but -- 11 Directly out of the plane here is where the 12 true atrial septum is. And you can see that if 13 you -- this is towards the back, if the catheter 14 goes -- in attempting to puncture the septum, if 15 the catheter goes too far towards the back 16 posteriorly, it exits the right atrium. And you 17 can get back into the left atrium there, but 18 you're outside of the heart in the midst. 19 And in that setting, I might say, your 20 sheath or your catheter is plugging the hole for 21 as long as it is over the left atrium. When you 22 pull it back is trouble. 23 If the catheter is too far forward, it 24 enters the aortic root, and way too far forward, 25 it is out that way. And way too far backwards, 0079 1 these are not too relevant, but it has 2 implications for being too high or low, as well. 3 Q Got it. The area that is the true atrial septum 4 in your description doesn't include any of the 5 area that has a muscular layer between the two 6 chambers? 7 A Well, this, as I say, is too low, too far down 8 towards the valves to be able to show that. 9 Q Okay. But there is an area that is not the 10 fossa ovalis that has a layer of muscle? 11 A Yes, this limbus, this rim around it. 12 Q The limbus, okay. And I think you said 13 previously that you just don't know whether or 14 not or how many times you have ever had your 15 transseptal puncture go through that limbus? 16 A Yes. 17 Q Okay. Exhibit 4, can you tell me what is 18 represented by the one and two? 19 A Okay. Number one is the proper course of a 20 transseptal assembly, traversing the atrial 21 septum and into the left atrium. Number two is 22 just ever so slightly forward of that, and it 23 goes into the aortic root. And this is my 24 representation in this projection of the autopsy 25 findings. 0080 1 Q Okay. Do you have an opinion, within reasonable 2 medical probability, what the distance is 3 between the edge of the fossa ovalis and the 4 number two puncture? 5 A The front edge of the fossa may be -- 6 MR. PERRY: Can I just clarify, do you mean 7 in this patient or generally? 8 MS. PLANT: I'm talking about for this 9 patient. 10 MR. PERRY: Okay. 11 A That would be from the pathology, and I think 12 that was four or five millimeters or so. I 13 could check that number for you. 14 Q That's okay. Do you -- going with the 15 presumption that it was four or five 16 millimeters, what are -- structurally, what is 17 before you get to the aorta, is there a 18 thickness of muscle before you get to the aorta 19 in that projection? 20 A Right atrium. Right atrial free wall is here. 21 Q Okay. 22 A And there is, technically, a space between the 23 right atrial free wall and the aorta, but it is 24 like the space between a glove and a hand; it is 25 not much. Fluid can get in there, blood can get 0081 1 in there, and a catheter traversing there 2 situated, sitting right in the aortic root, a 3 sheath, could stay there for an extended period 4 of time and not do any leaking, any appreciable 5 leaking. 6 Q Would you expect a catheter placed in the 7 direction that your number two arrow goes, for 8 that to feel different to the operator from 9 passing a transseptal through the fossa ovalis? 10 A I would have no way of knowing that. 11 Q Okay. Do you, when you do transseptal passes, 12 rely on your sense of feel as one of your 13 guides? 14 A It -- one can feel a so-called pop as the needle 15 traverses the septum. After that, I must say I 16 don't recall any tactile sensation, even though 17 a larger diameter structure, the dilator and 18 sheath, are going through. So I've not felt 19 any -- the most resistance I've felt is with 20 that initial puncture. 21 Q Okay. 22 A And I must plead ignorance as to what it feels 23 like going through an aortic wall. 24 Q I guess my question was more geared towards what 25 your expectation would be, rather than the 0082 1 experience. 2 A I know what it feels like normally. Sometimes 3 there is no discernible pop, but that's the most 4 to which I'm accustomed. 5 Q Is there something additional that you would do, 6 if you have a case where you don't feel a 7 discernible pop that gives you, you know, a 8 concern that maybe you didn't make your pass in 9 the place that you intended it? 10 A Left atrial pressure. 11 Q So you don't do anything different from what you 12 would normally do? 13 A No. I am monitoring that pressure. And if it 14 looks like a left atrial wave form, whether I 15 felt a pop or not, I'm in the right location. 16 And if it doesn't have a right wave form, 17 whether I had a pop or not, I'm not happy with 18 it unless I get some confirmation, some 19 indisputable corroboration that I'm uniquely 20 within the cavity of the left atrium. 21 Q Okay. Have you ever used contrast dye? 22 A Yes, ma'am. 23 Q Okay. Do you still use that? 24 A On occasion. 25 Q Okay. What is the occasion that would prompt 0083 1 you to use contrast dye? 2 A I was -- a couple of weeks ago, I used it in a 3 situation in which I felt a pop, and the 4 laboratory I was in was a relatively new 5 configuration, and I was not entirely happy with 6 the left atrial wave form I was seeing, pressure 7 wave form. 8 And I asked for some dye and injected it, 9 and even though the fluoroscopic appearance 10 looked good, I wanted additional confirmation, 11 so I injected dye. And I was in the left 12 atrium. 13 Q What do you do -- or what did you see when you 14 injected contrast dye? 15 A There is a puff that appears, contained within 16 the space where I would identify the left 17 atrium. And it moves, kind of swirls around a 18 little bit. In this case, it went into the left 19 atrial appendage a tiny bit and then was 20 expelled from there, and went towards the 21 ventricle. 22 Q Could you observe the direction that it moves? 23 A That the -- that it moves, the rapidity with 24 which it moves, and the direction. 25 Q Would it be within the standard of care to use 0084 1 contrast as the sole method of confirming 2 presence in the left atrium? 3 A I think that's acceptable. 4 Q Okay. Do you have an opinion, within reasonable 5 medical probability, as to what would have been 6 shown had Dr. Cockrell utilized contrast in this 7 case? 8 A If he had the needle in the aorta and injected 9 dye, it would have had a rapid rush towards the 10 head, instead of towards the left hip, a slower 11 progression towards the left hip. 12 Q I think previously, we were discussing that your 13 view is that contrast can be used either before 14 or after the advancement of the actual needle? 15 A I should clarify that then. It can be used 16 before to stain the atrial septum to show that 17 you are there, but that is no substitute for 18 assuring that you are uniquely in the left 19 atrium with the needle before passing the rest 20 of the system over it. 21 Q Has NASPE or ACCHE or any other body promulgated 22 policies upon transseptal puncture technique? 23 A I don't believe so. And NASPE is a past entity. 24 It is now Heart Rhythm Society, HRS. 25 Q Oh, thank you. It was NASPE as of 2004; 0085 1 correct? 2 A The change occurred about then. 3 Q Okay. So fair to say that as of 2004, there was 4 not a protocol or policy issued by -- 5 A Our society. 6 Q -- any of the societies that might be taken as 7 authoritative on the transseptal puncture 8 technique, and what is required? 9 MR. PERRY: Object to the foundation. 10 MS. PLANT: Okay. 11 MR. PERRY: Go ahead. 12 A Correct. 13 Q Obviously, you're familiar with many of the 14 techniques that are utilized at your hospital; 15 are there any other facilities where you know 16 what their various techniques are that they use 17 for transseptal puncture? 18 A Yes. 19 Q What are the institutions that you're familiar 20 with? 21 A At the University of California, San Francisco, 22 intra-cardiac echo is used extensively. At 23 Brigham, in the Women's Hospital, that is used 24 plus angioplasty guidewire by some of the 25 workers. I don't know of anybody right off who 0086 1 uses only dye. 2 Q I think you mentioned Dr. Pappone previously? 3 A Uses pressure monitoring. 4 Q Oh, he does pressure monitoring, in your 5 recollection? 6 A Uh-huh. Some will use a combination of 7 techniques, pressure monitoring and 8 intra-cardiac echo, or pressure monitoring plus 9 dye injection or angioplasty guidewire. 10 Q You have produced a number of journal articles 11 for me. What were you looking for when you did 12 your medical literature search? 13 A I was not really looking for anything. I was 14 providing some background material for 15 Mr. Perry. 16 Q Okay. So this was to educate Mr. Perry in the 17 procedure? 18 A Types of procedures for treatment of atrial 19 fibrillation, as well as the transseptal 20 technique. 21 Q Are any of the articles or chapters that you 22 provided, is it your position that any of these 23 articulate a standard of care? 24 A I think, in that they are all, as they address 25 the topic, are in agreement about the 0087 1 transseptal technique, the importance of 2 affirming left atrial location, that they do set 3 that standard of care. They don't speak to one 4 unique method of affirming that. 5 Q Is the Journal of the American College of 6 Cardiology a reliable and authoritative journal? 7 A It is reliable. 8 Q Okay. 9 MR. PERRY: Journal of the American College 10 of Cardiology? 11 MS. PLANT: JACC. 12 MR. PERRY: Thanks. 13 Q Are you familiar with an article from JACC that 14 discusses a survey that was done in Italy of 15 transseptal catheterization techniques? 16 A No, I'm not. 17 Q Would that be something that would reasonably 18 speak to what reasonably prudent 19 electrophysiologists do in utilizing precautions 20 for a transseptal technique? 21 MR. PERRY: I'm going to object, that's -- 22 I'm sorry, you said an article of a study in 23 Italy? 24 MS. PLANT: Correct. 25 MR. PERRY: And you're asking if it is what 0088 1 reasonably prudent physicians in the U.S. would 2 do? 3 MS. PLANT: I was asking if it was a -- 4 what -- would it speak to what a reasonably 5 prudent physician would do. 6 MR. PERRY: I'll object to the fact that it 7 is a -- 8 A Without reading it, I can't speak to that. 9 Q Why don't I give you a second and let you look 10 at it, and share it with Mr. Perry, as well. 11 MR. PERRY: Thanks. 12 (A discussion was held off the record.) 13 Q Would the use of ICE alone be sufficient as a 14 precaution for proper placement of a transseptal 15 catheter? 16 A If one can clearly visualize where the needle is 17 at, at all times, and confirm that it is in the 18 left atrium, that should be adequate. 19 Q Would the use of a pigtail catheter in the aorta 20 alone suffice, in addition to fluoroscopy, for 21 placement of a transseptal catheter? 22 A No, it would not. 23 Q Does your interpretation of this article 24 indicate that the individuals were using a -- 25 strike that question. 0089 1 Do you take from this article that there 2 are electrophysiologists who use only that 3 approach? 4 A Yes. 5 Q Okay. 6 MR. PERRY: I'm sorry, "only that approach" 7 being the pigtail? 8 MS. PLANT: Correct. 9 Q And is it your testimony that those 10 electrophysiologists are practicing beneath the 11 standards of care? 12 A Yes. And I would note that those 13 electrophysiologists do, on average, over a 14 hundred procedures a year. And it is noted that 15 they are highly experienced centers. 16 Now, I believe Dr. Cockrell stated that he 17 was ranging up towards 12 to 15 procedures per 18 year around this time. And that is not the same 19 level of experience, in my estimation. 20 Q Okay. So my understanding was that you said, 21 yes, that is beneath the standard of care? 22 A In a very practiced, experienced operator, to 23 use the tools that they suggest in this article 24 is I don't think outside of the standards of 25 care. 0090 1 Now, they note in this article, that if 2 only the needle punctures a structure that it 3 shouldn't, it can be withdrawn without adverse 4 sequella. One has no way of knowing if the 5 needle is in -- if you have only gone through 6 with a needle unless some other method is used. 7 So for them to say that we didn't use any 8 other method to confirm where we are, but we 9 only went through into a wrong space with a 10 needle, they had to have had some other method, 11 in those cases. Otherwise, they would have put 12 the whole sheath where they shouldn't have been, 13 and would have encountered a complication. Am I 14 being unclear? 15 Q To me, which only means that I'm not 16 understanding. 17 A Okay. 18 Q You're talking about some of the complications 19 described in the article? 20 A Uh-huh, yes. 21 Q And those don't necessarily correlate with the 22 individuals who are using just a pigtail 23 catheter in the aorta? 24 A Well, if you're using a pigtail catheter in the 25 aorta, and your needle goes posterior to that, 0091 1 such that it looks like you are not in the 2 aorta, unless you have some other way of 3 confirming that that needle is not in the aorta, 4 you don't know that it is not. 5 If the needle is outside of the heart, way 6 behind the left atrium, a pigtail catheter in 7 the aorta is of no avail. You have to -- in 8 order to recognize that only the needle is in a 9 place where it shouldn't be before the entire 10 sheath, dilator and sheath are passed over it, 11 you have to have some other method of knowing 12 where that needle is. 13 Q Okay. So in your view, the individuals who are 14 described in this paper as using only that 15 precaution, only a pigtail catheter in the 16 aorta, are practicing beneath the standard of 17 care? 18 MR. PERRY: Objection, asked and answered. 19 A That is not what I said. I said these highly 20 experienced individuals, who average over a 21 hundred procedures a year, and who, when they 22 encounter a situation in which, hey, this 23 doesn't seem right, are using some additional 24 modalities. They don't say that, but they have 25 to have; otherwise, they wouldn't have pulled 0092 1 the needle back and not entered into 2 complications. 3 Q So you're assuming -- I think what you're 4 assuming is that they have not identified being 5 in the wrong place based on the location of the 6 pigtail catheter? 7 A Correct. 8 Q Because you don't think that that is enough to 9 tell someone where they are? 10 A Correct. 11 Q But that's just your supposition; correct? 12 A Well, I think it is a very good inference, 13 because if they didn't use some other method of 14 finding out where their needle was when it was 15 in a wrong location, they would have gone ahead 16 with the much larger-diameter dilator and 17 sheath, and made a large hole and ended up 18 leaking somewhere. 19 Q Wasn't the purpose of the survey that they did 20 to ask what precautions are you using? 21 MR. PERRY: I'm going to object. It is 22 argumentative. And this is a survey that the 23 doctor had about five minutes to read, sitting 24 at his deposition. Go ahead. 25 A Well, it says it is an informal, voluntary 0093 1 survey. The data may be biased with reporting 2 accuracy, one way or another. So it is a 3 survey, like any survey, as a -- it is not a 4 rigorously controlled scientific study. 5 Q So even though on the face of the article, it 6 describes people who are using only one 7 precaution, and others who are using no 8 precautions, your assessment is they actually 9 are using more than what's been reported; is 10 that correct? 11 MR. PERRY: Objection, argumentative, 12 characterization, asked and answered. Go ahead. 13 A My assessment is that if they were using no 14 method whatsoever, they could not have figured 15 out that the needle was in the wrong place. 16 Because it can look good on fluoroscopy, which 17 is the only method they would have been using, 18 if no other corroboration, and yet be in the 19 wrong place. And fortunately, they were smart 20 enough, experienced enough, having done it 21 hundreds of times, to have suspected that 22 this -- there's something wrong here. 23 MS. PLANT: May I have that for a second? 24 MR. PERRY: Sure. 25 Q You didn't mention, when we were talking about 0094 1 precautions, transesophageal echocardiogram; is 2 that another acceptable method of verifying 3 location? 4 A It can be used, yes. It is not very extensively 5 used. 6 Q Okay. I just wanted to make sure I have a 7 completed list and understanding of the various 8 ways. It sounds like there are many ways, but I 9 wanted to make sure I understand what are all of 10 the different ways that one can comply with the 11 standard of care in verifying the location, from 12 your perspective. 13 A And of course, that's a transesophageal echo 14 done at the time the needle is trying to pass 15 through the atrial septum. 16 Q Right, okay. So that contemporaneous TEE would 17 be an appropriate precaution? 18 A It is an additional useful modality. 19 Q And if you used that, you wouldn't need to use 20 anything else to comply with standards of care? 21 A If it told you that you were uniquely in the 22 left atrium with your needle, before passing the 23 dilator and the sheath, usually it should be 24 able to. But it can be difficult to get stable 25 images of the atrial septum with the beating 0095 1 heart with a transesophageal echo. 2 Q How does it tell you that you're uniquely in the 3 left atrium, visually? 4 A On a screen, yes. 5 Q Okay. And you have never tried that system? 6 A I have not. No, I'm sorry, I have once, many, 7 many years ago. 8 Q Okay. And it sounds like it didn't stick; you 9 didn't like it? Why did you abandon it? 10 A Well, it is an additional piece of equipment 11 that's difficult to fit in with all of our 12 fluoroscopy stuff. There is another person 13 there that's looking at it. Somebody has to be 14 manipulating the transesophageal probe. And 15 they don't like radiation when you're doing 16 fluoroscopy. And the images, I -- end up being 17 not quite suitable. 18 Q So in either using ICE or a contemporaneous TEE, 19 those are two systems where what you're doing is 20 visually plotting, seeing where you are with 21 respect to the patient's anatomy? 22 A Correct. 23 Q And in a system where you use electrocatheters 24 and take them as anatomical landmarks, that's 25 also a system where you're visually confirming 0096 1 where you are? 2 A It is a -- it doesn't tell you where your needle 3 is. 4 Q You can't see the needle? 5 A It tells you where your needle is in relation to 6 those structures, but it doesn't tell you, 7 you're in the left atrium. These other imaging 8 modalities, the sonographic imaging modalities 9 do say, yes, my needle is at the atrial septum, 10 it is tinting it, it is pushing it, and then it 11 pops into the left atrium. 12 Q Would you agree that the use of the electrodes 13 and the bundle of His and the coronary sinus 14 tell you, at a minimum, where you're not? In 15 other words, they tell you by landmarks, by 16 anatomical landmarks, where you are not, as far 17 as -- 18 A Well -- 19 Q Go ahead. 20 A Well, if you're adjacent to one of those 21 electrocatheters, and they're truly at this 22 bundle of His and the coronary sinus, you know 23 that you're not where you should be, in relation 24 to the atrial septum. And they are a guide, but 25 individual variations in anatomy, a so-called 0097 1 vertically related heart or a horizontally 2 related heart, a large heart, a small heart, and 3 so forth, variations in someone has had a 4 partial lung removed, so the heart has shifted 5 in the chest. 6 They are a guide, but they are not an 7 infallible guide as to where the center of -- 8 where the atrial septum is. And I have been 9 surprised on occasion, that, oh, that's where 10 the fossa ovalis really is. I would not have 11 thought it was there, but there it is. 12 Q Did Mr. Manoogian's heart have any anatomic 13 variations or abnormalities to it, to your 14 knowledge? 15 A I believe his left ventricle was slightly 16 dilated, but I don't recall mention of 17 significant substantial variations in the atrial 18 anatomy. 19 Q Do you agree that a bad outcome for a patient 20 does not necessarily demonstrate medical 21 negligence? 22 MR. PERRY: Objection. You can answer. 23 A That is correct. 24 Q In other words, patients can have bad outcomes, 25 even with the very best of care? 0098 1 MR. PERRY: Same objection. 2 A That is correct. 3 Q And you have had patients suffer bad outcomes? 4 MR. PERRY: Objection as to what you mean 5 by "bad outcomes." 6 A I would characterize some outcomes as bad. 7 Q Have you ever had a patient die -- 8 A Yes. 9 Q -- consequent to care you rendered? 10 MR. PERRY: Objection. 11 A Yes. Subsequent to care I rendered. 12 Q My question was: Was it consequent to care you 13 rendered? 14 MR. PERRY: Objection as to what that 15 means. 16 A I would characterize it as in spite of care I 17 rendered. 18 Q Did the slight dilation of Mr. Manoogian's left 19 ventricle, is that something you would expect to 20 have any role or impact on proper transseptal 21 placement? 22 A No. 23 Q Can a puncture to the fossa ovalis bleed at all? 24 A Well, there is some bleeding from one atrium to 25 another, but external to the heart, no. 0099 1 Q Okay. In the cases where you have encountered 2 tamponade, were you always able to locate the 3 source of the bleeding? 4 A I would say almost never. 5 Q And why is that? 6 A Well, we have several catheters in the heart 7 simultaneously, and tamponade develops. Blood 8 pressure drops where you make a diagnosis of 9 tamponade with echocardiogram. Which catheter 10 may have done the damage is generally not 11 appreciable. In a substantial number of 12 cases -- perhaps I should back up. 13 Years ago, we did open heart surgery to 14 cure certain rhythm disturbances. These 15 patients would have electrophysiology studies 16 prior to the procedure, the open heart surgery. 17 And in some cases, there would be some blood in 18 the pericardial sac when the surgeon opened up 19 the next day or two days after our procedure, 20 and a little bruising, typically on the right 21 ventricle. Probably, that's the catheter that 22 perforates most of the time. 23 Mr. Manoogian did not have a catheter in 24 his right ventricle, so that's not applicable in 25 his case. But in the times that we see this, 0100 1 very often, it seems to be towards the end of a 2 procedure or actually at the end of the 3 procedure, and catheters are being withdrawn. 4 Presumably, they were plugging their own holes. 5 Q The occurrence of tamponade in and of itself 6 doesn't necessarily mean the physician 7 performing the procedure was negligent; right? 8 MR. PERRY: Objection, asked and answered. 9 You can go ahead. 10 A That is correct. 11 Q We talked a little bit about your experience 12 with watching other individuals have a needle 13 stick into the aorta. The question I want to 14 ask is: Do you have an opinion on whether the 15 needle stick alone can cause tamponade? 16 A My impression is that it should not. 17 Q Okay. 18 A And my very, very limited experience and hearsay 19 from others suggests that is correct. 20 Q Is that an opinion that you hold within 21 reasonable medical probability? 22 A Yes, ma'am. 23 Q Do you have an opinion as to the cause of 24 Mr. Manoogian's blood pressure drop at 1520, at 25 1615? 0101 1 A 1520, a variety of things could have occurred. 2 He has had an accumulation of several milligrams 3 of sedation, Versed, V-E-R-S-E-D, by that time. 4 There's a notation of Propofol, P-R-O-P-O-F-O-L, 5 infusion beginning about then. It can drop 6 blood pressure. 7 It could be that he had some leakage around 8 this perforation at that time, but not so much 9 that it caused tamponade. That was the 1520. 10 You asked also about -- 11 Q 1615. 12 A Well, it really didn't change dramatically from 13 1520. There is a bump upwards, but then it just 14 restabilized back where it was at 1615. 15 Q Are either of those blood pressure drops events 16 that would have caused you concern, or caused 17 you to do something to investigate, had you been 18 notified of those blood pressure drops? 19 A Going from his 140 or so that had been 20 relatively stable for about an hour or so prior 21 to the initial drop, down to the 1530, I would 22 have paused the procedure to assess as to why 23 this would be. That doesn't mean I would get an 24 echocardiogram. I would say, has he had his 25 sedation increased, is he bleeding from the 0102 1 groin, is he uncomfortable. 2 Q You would inquire of the patient? 3 A Inquire of the patient, inquire of the nurse 4 anesthetist, or whoever is monitoring and 5 providing medication for him. 6 Q Can you estimate how many ablations for atrial 7 fibrillation you have done? I'm sorry. 8 A No, that's fine. Several hundred. 9 Q Several hundred? 10 A (Nods head up and down.) 11 Q What other procedures require a transseptal 12 puncture? 13 A Ablation of left atrial tachycardia, some forms 14 of ventricular tachycardia, in which one cannot, 15 for whatever reason, use the retrograde aortic 16 approach. And those are electrophysiology 17 procedures. Left atrial flutters, those are the 18 ones. 19 Q Are there any non-electrophysiology procedures 20 that you're aware of that utilize a transseptal? 21 A That's where it started, yeah. And those would 22 be measurement of left atrial pressure, and/or 23 getting into the left ventricle to measure left 24 ventricular pressure, when the aortic valve 25 can't be crossed for whatever reason. Aortic, 0103 1 in the old days, or still mitral valvular 2 plasty, pulmonary vein dilation, some 3 hemodynamic assessments and oxymetric 4 assessments prior to characterization of 5 congenital heart disease, abnormalities. 6 Q What is Wolff-Parkinson-White syndrome -- is 7 that correct? 8 A Correct. There are two Fs in Wolff, three 9 names, Wolff-Parkinson-White, hyphenated. 10 That is a disorder in which a so-called 11 accessory pathway, or residual bundle of heart 12 muscle connects atrium and ventricle extrinsic 13 to the normal atrial-ventricular conduction 14 system. And in particular, transmits impulses 15 from atrium to ventricle such that an 16 abnormality shows up on the resting 17 electrocardiogram so-called delta wave, 18 D-E-L-T-A. 19 Wolff-Parkinson-White Syndrome is that 20 abnormality in young individuals with episodes 21 of palpitations, tachycardia. 22 Q Is there a procedure that is geared at 23 addressing Wolff-Parkinson-White Syndrome that 24 involves transseptal puncture? 25 A Yes, ma'am. I neglected to mention that, 0104 1 because it is -- I so rarely see those nowadays, 2 but yes. 3 Q Is it seen more rarely now than it used to be? 4 A Yes. 5 Q Do you know why? 6 A The individuals who have it are undergoing 7 ablation at a rate faster than the birth rate of 8 this abnormality. 9 Q In the several hundred A-Fib ablations that you 10 have done, is it accurate to say that you have 11 never punctured the aortic root, even with a 12 needle? 13 A That is correct. 14 Q Okay. So the use of fluoroscopic guidance with 15 anatomic landmarks has safely guided you to the 16 left atrium in hundreds of cases? 17 MR. PERRY: Objection. 18 A No. 19 MR. PERRY: That is not what he said. 20 MS. PLANT: Okay. 21 A I use those, and I use left atrial pressure 22 monitoring to confirm that my needle is where it 23 should be. 24 Q Does the left -- does the pressure monitor do 25 something prior to the needle stick? 0105 1 A Confirms that I'm in the right atrium, but I'm 2 not looking for that information. 3 Q Okay. So in other words, the pressure has 4 confirmed for you what you have already done in 5 those hundreds of cases, which is, effectively 6 punctured into -- 7 A The correct location. 8 Q -- the correct location? 9 A Or tells me that I have punctured into the 10 incorrect location, not necessarily the aorta. 11 Q And has that ever happened? 12 A Yes, ma'am. 13 Q And where have you punctured that was the wrong 14 location? 15 A The right atrial free wall. 16 Q Can you show me. 17 A I really can't on there. It is out of the plane 18 of -- it is above the septum. 19 Q Okay. 20 A The two atria arc, kind of like two spheres. 21 And the atrial septum, the tops of the two 22 atria, I don't know if you can see this too 23 well. 24 The tops of the two atria are like this, 25 with the septum in between there. And as the 0106 1 catheter with this type of bend on it -- I'm 2 running out of hands here -- but the catheter 3 with this type of bend on it comes up to the 4 atrial septum, if it doesn't engage there and go 5 into the left atrium, and continues going up and 6 eventually does meet a perpendicular surface, 7 the right atrial free wall, and goes in an arc 8 very similar to what one would see going into 9 the left atrium, but it is over the top of the 10 left atrium. It won't give a left atrial 11 pressure tracing, injection of dye will not 12 swirl towards the left ventricle. An 13 angioplasty guidewire will not go up the left 14 upper vein, and intra-cardiac echocardiography 15 will tell you, you're not in the left atrium. 16 Q Have you had any other occasions, apart from the 17 time that you punctured the right atrial free 18 wall, when you punctured the wrong place? 19 A No. 20 Q Do you know why, in the case that you punctured 21 the right atrial free wall, why that happened 22 apart from, I mean, you've given an anatomic 23 description, but was there something different 24 about that patient? 25 A A very large right atrium, extremely large right 0107 1 atrium. 2 Q So if your practice had been to use pressures, 3 or to use contrast in cases where there was an 4 indication, something that would make you think 5 that there was going to be difficulty in the 6 transseptal path, that would be a case where you 7 would have utilized it? 8 A Well, I do every case. 9 Q I'm using a hypothetical, the hypothetical 10 being, if you used the contrast, or -- if you 11 used contrast or if you used pressures on an 12 as-needed basis, as opposed to using it in every 13 case, this would be a case that would tell you, 14 I need to have an extra precaution because of 15 the patient's anatomy? 16 A Well, certainly. Now, I have been in locations 17 that I did not recognize where I was. I was 18 probably buried in the atrial -- the needle was 19 buried in the atrial septum, or it may have 20 actually exited, and -- exited the right atrial 21 free wall, and I pulled the needle back because 22 I was not getting the pressure tracing I needed. 23 And but in a handful, a couple of cases, I 24 recognized that I was definitely outside. In 25 the rest of the cases, I simply pulled back. 0108 1 But I knew to pull back because the monitoring I 2 was looking for, the signal I was looking for to 3 say, you're safely in the left atrium, was 4 absent. 5 Q So there was more than one occasion where you 6 have punctured a place that you didn't intend to 7 puncture? 8 A Yes, where my first pass with a needle did not 9 end me up in the left atrium. 10 Q How many times would you say that's happened? 11 A Probably 40 or 50. 12 Q Can you estimate a percentage of cases where you 13 have the needle puncture into a place that is 14 not the right place? Forty or 50 times seems 15 like it is a large portion of the several 16 hundred procedures. 17 A Well, maybe we're talking semantics. If I 18 extend the needle, attempting my puncture 19 through the septum, and I don't get the left 20 atrial recordings, or I inject dye and I see not 21 what I want to see, I don't really know -- 22 sometimes I don't know where I am, with that, 23 whether it is stuck in the -- it is a very thick 24 septum, and I'm just not through it all of the 25 way, that's probably the majority of those 0109 1 cases, or whether it is a little bit off angle 2 in the right atrial free wall, or have exited 3 the right atrial free wall. 4 Q You would not expect a transseptal catheter to 5 make an 8-millimeter puncture; correct? 6 A An 8-millimeter diameter puncture, no. 7 Q I understand you do consulting work, or maybe 8 you did in the past; you do consulting work with 9 Medtronic, Inc.? 10 A I do. 11 Q And what's your relationship with them? What do 12 you do with them? 13 A I advise them, on a very sporadic nature, as to 14 features of implantable cardiac rhythm 15 management devices that would be nice, or that 16 this feature is not very useful after all. 17 Q Do they fund research for you? 18 A Periodically. 19 Q Do they pay you a salary or a honorarium? 20 A Periodically. Honorarium, not salary. 21 Q That's what I meant. 22 A I should not say periodically. I should say 23 sporadically. 24 Q Consistent with the sporadic times that you're 25 giving them the advice? 0110 1 A Yes. 2 Q What is the significance of a person having 3 regurgitation at three of their valves? 4 A Well, that's a rather open question. It depends 5 on the degree of regurgitation, more than the 6 fact of it. There is a so-called trivial or 7 physiologic regurgitation, particularly in the 8 tricuspid and pulmonic valves, and the mitral 9 valve can have a little bit as well that is of 10 no clinical significance. 11 Q I'm not going to be able to find a page of the 12 medical records, but let me take a second and 13 see if I can. 14 Are you familiar with correlating a trivial 15 amount or a trace amount and a moderate amount 16 of regurgitation with numbers, like a number of 17 one through four? 18 A Sure. 19 Q Okay. Assume for me that Mr. Manoogian had 20 regurgitation at three valves, and he had a two 21 out of four at the tricuspid, a three out of 22 four at the mitral, and two out of four at the 23 aortic valve. What, if anything, does that tell 24 you about the condition of his heart? 25 A Doesn't really tell me a whole lot. He had some 0111 1 valvular regurgitation that could be clinically 2 significant, although individuals with just 3 those findings can run the gamut, from very 4 symptomatic, very limited exercise capacity to 5 none. 6 Q Are you going to be rendering any opinions with 7 respect to Mr. Manoogian's life expectancy, had 8 he not passed away? 9 A I don't have any reason to suspect it would have 10 been dramatically limited. 11 Q Do you have any reasons to suspect that it would 12 have been somewhat limited? 13 A Individuals with left ventricular systolic 14 dysfunction can have a decrease in life 15 expectancy, but if it was due to his atrial 16 fibrillation and that was cured, that might 17 vanish. It is speculative, either way. 18 Q Would Mr. Manoogian's smoking habit have 19 affected his life expectancy? 20 A More than likely. 21 Q In a negative way? 22 A In a negative way. 23 Q Okay. Are you able to quantify at all what 24 effect his however-many-years smoking habit 25 would have had on his life expectancy? 0112 1 A I can't quantify that. 2 Q Okay. Would a depressed ejection fraction have 3 an impact on life expectancy expectations -- 4 life expectancy? 5 A As I stated previously, it can, but to the 6 degree that that might have been reversible 7 after definitive therapy of his atrial 8 fibrillation, I can't say. 9 Q Do you agree that Mr. Manoogian had moderate 10 non-ischemic cardiomyopathy? 11 A One might say mild. One might say moderate. 12 Q Is there any reason why a prostate infection 13 would precipitate atrial fibrillation? 14 A Well, not directly. There are some nerve 15 reflexes that can indirectly provoke episodes of 16 atrial fibrillation. 17 MS. PLANT: I can take this chance to see 18 if Susan has any questions, and I'll go through 19 my notes to see if I have anything else to talk 20 about. 21 MR. PERRY: Susan, do you have any 22 questions for Dr. Miller? 23 MS. BOYCE: I have two questions. Hold on 24 one second. 25 0113 1 DIRECT EXAMINATION, 2 QUESTIONS BY MS. SUSAN BOYCE: 3 Q Dr. Miller, can you hear me okay? 4 A Perfectly. 5 Q Okay. I just want to put on the record that you 6 have no opinions that any hospital personnel 7 deviated from the standards of care at any time; 8 correct? 9 A Hospital personnel? 10 MR. PERRY: She is asking, are you offering 11 an opinion. 12 A I'm -- no. 13 Q That's correct? 14 A Correct. 15 Q Okay. And you're not acknowledging in this case 16 or contending in this case or giving any opinion 17 whatsoever that any hospital deficiency, such as 18 lack of equipment, insufficient equipment caused 19 or contributed to the injury? 20 A I can agree with that. 21 MS. BOYCE: That's all I have. 22 MR. PERRY: Did you want some time to go 23 over your notes? 24 MS. PLANT: I think I can. 25 0114 1 REDIRECT EXAMINATION, 2 QUESTIONS BY MS. MARIANNE D. PLANT: 3 Q A little bit of background, so we're doing this 4 in a little reverse order. 5 Have you ever been sued in a medical 6 malpractice suit? 7 A Yes, ma'am. 8 MR. PERRY: Just objection. Go ahead. 9 Q How many times? 10 A I have been named four times. 11 Q Are all of the cases resolved? 12 A Yes, ma'am. 13 Q Okay. What was the nature of the allegations in 14 those cases? 15 A Completely divergent. And in what detail would 16 you like this? 17 Q If you can go through them, one through four? 18 A Sure. The first was in about 1989, or '90. 19 '89, I think. It was a case in which a 20 gentleman had a disorder called ventricular 21 tachycardia, a life-threatening rhythm 22 disturbance. In those days, we did surgical 23 therapy, as I alluded to previously. I feel 24 like an old man "in those days." 25 I was in charge of the intraoperative 0115 1 mapping, the electrophysiological mapping, 2 telling the surgeon, this is the spot, or that's 3 the spot. And as such, I dealt with the 4 patient's -- a lot of the patient's management 5 before and after the procedure. The gentleman 6 came into the hospital with this disorder, 7 multiple episodes requiring shock treatment. 8 And he was scheduled for a surgical 9 procedure on a Friday morning. He came into the 10 hospital on a Thursday. We were all set to do 11 it Friday. Thursday night, he had recurrent 12 episodes and severe hemodynamic decompensation. 13 And at about 2:00 in the morning, after a 14 couple of phone calls, I said, "We have got to 15 go. We have to not wait until 6:00 in the 16 morning. We have to go now." 17 So we called in the anesthesiologist and 18 the perfusionist and the surgeons. And we were 19 doing CPR on him going down to the operating 20 room. The procedure went very smoothly. 21 When the surgeon removed, cut out the 22 section of the heart that was responsible for 23 the rhythm disturbance, it was a thinned out 24 area. And he ended up cutting too deeply. This 25 was in the septum, the partition between the two 0116 1 ventricles. You can't know how thick that is, 2 you just cut. And it ended up with a little 3 leak between the two ventricles. He patched 4 that over, and the procedure continued. 5 The man did phenomenally well. And no 6 rhythm disturbances thereafter. Through the 7 course of the next day and on Saturday, he was 8 doing so well, his blood pressure was actually 9 too high. And he was in ICU. And suddenly, he 10 dropped his blood pressure severely. 11 Could not figure out what was going on. So 12 the surgeons opened up his chest in the ICU. 13 There was no blood around the outside of the 14 heart. He had blown this patch between the two 15 ventricles. And so they rushed him down to the 16 operating room to try to repair this, but it was 17 too late, and he expired in the operating room, 18 and thence to the morgue on a Saturday. And his 19 records were lost somewhere. 20 And his wife remembered my name, because I 21 had dealt with her, trying to reassure her and 22 so forth. And I was served with a suit thereby. 23 There being no records, it was a couple of years 24 later that the suit was brought, there being no 25 records, no one could say exactly what, it was 0117 1 all recollection. And that ended up being 2 settled before deposition. Any questions with 3 that? 4 Okay. A second was in about 1997, or -8, 5 '97, in which a woman came into the hospital 6 over the July 4th holiday, and was having some 7 chest pain, and was scheduled for a cardiac 8 catheterization, I believe, the following 9 Tuesday or so. 10 Somehow, over the weekend, she had a 11 cardiac arrest and expired in the hospital. I 12 had never taken care of her, had never seen her. 13 I had never offered any opinions, but I had read 14 two of her electrocardiograms in a stack of the 15 electrocardiograms when she was hospitalized. 16 And I was named in that proceeding. I had to 17 give a deposition as a defendant, of which I was 18 dismissed. 19 The third time I was sued by a woman who I 20 did see. She was not represented. She 21 cross-sued herself. And she had come into the 22 emergency room one evening with a headache, and 23 was found to have an extremely high blood 24 pressure, was given some medication for that, 25 and had some shortness of breath or chest pain. 0118 1 And that's when they called in our team. 2 I was not in the hospital at that time, but 3 my interns and residents saw her, gave her some 4 medication. Because of her risk factors, the 5 next morning when I saw her, we recommended a 6 stress test. She declined and wanted to go 7 home. We let her go home. 8 A year or two later, she brought suit, 9 again on her own behalf, alleging that I had 10 seen her in the emergency, and all she wanted 11 was something for her headache, and I refused to 12 give something for her headache, instead ramming 13 two syringe-fulls of a medication called Lotrel, 14 L-O-T-R-E-L, into her veins, at which point she 15 had a cardiac arrest, saw God, flopped off the 16 stretcher, and somehow managed to get back on 17 the stretcher, after which she was left with a 18 rash. 19 And I had not seen her in the emergency 20 room. She did not get this medication by vein, 21 which doesn't even come by a vein. She didn't 22 get the medication at all. She didn't have the 23 cardiac arrest. She didn't flop on the floor, 24 but I couldn't dispute that she might have had a 25 rash afterwards. That case was dismissed. 0119 1 And the last one was a gentleman who 2 underwent atrial fibrillation ablation that was 3 successful. And I do not know what the nature 4 of his complaint was. He again represented 5 himself, without legal counsel, and the case was 6 dismissed. 7 Q And what was the year, approximate time of the 8 third and fourth cases? 9 A The third one was brought 2004, early 2005. The 10 last one was earlier this year, February or 11 March, sometime like that. 12 Q Okay. Have you ever worked with Mr. Perry's 13 office before? 14 MR. PERRY: Objection, you can answer. 15 A I don't believe so. 16 Q How did you first become involved in the 17 Manoogian case? 18 A I was contacted -- trying to remember how and 19 when. I don't -- I don't believe -- I believe 20 it was a different attorney, Mr. Duncan 21 or Dobson or some such, Duncan, I think. 22 Q Were you told who the electrophysiologists 23 involved were? 24 MR. PERRY: Objection. You can answer. 25 A Not, I don't think at the first blurb, I was. 0120 1 Q Do you know or know of Dr. Cockrell or Dr. Lee, 2 separate from having reviewed this case? 3 A No, ma'am, I don't. 4 Q Do you know Dr. Hugh Calkins, and is he someone 5 who is considered one of the national experts in 6 atrial fibrillation ablation? 7 A I would say -- 8 MR. PERRY: Objection. 9 A -- I would agree with that. 10 Q How often in your career have you reviewed 11 medical malpractice cases as an expert? 12 MR. PERRY: Just so I don't keep 13 interrupting, I just object to these lines of 14 questions. 15 A How often or how many? 16 Q How many, either way, whatever way you think of 17 it. 18 A Oh, over the years, probably a dozen, maybe 19 slightly more, but not dramatically more. 20 Q And do you know, of the approximately dozen, how 21 many are for the plaintiff and how many are for 22 the defendant? 23 A I would have to say it is pretty evenly 24 balanced. 25 Q Have you ever testified in Maryland before? 0121 1 A I don't think so. 2 Q Or I should say ever? 3 A Have I testified in court? 4 Q Have you testified in court, in any court? 5 A Yes. 6 Q Okay. Where have you testified? 7 A Pennsylvania and Connecticut and Florida. 8 Q Have you ever testified in either depositions or 9 trial in a case involving an allegation of 10 improper transseptal placement? 11 A I don't believe so. 12 Q What do you charge for review of medical 13 records, and what do you charge for testimony as 14 an expert? 15 A For medical records it is $500 an hour, that's 16 whatever, review, conversations, so on. For a 17 day like today, it is $2,000 for three hours and 18 I think $750 an hour thereafter. And for trial 19 testimony, I believe it is 3,500 per day and 20 travel expenses. 21 Q Do you know how much time you have spent on this 22 case, up until the time of your deposition 23 today? 24 A I keep track of that, but I don't know. I don't 25 know what the tally is right off. 0122 1 Q Have you sent a bill to Mr. Klores' office? 2 A Huh-uh. 3 Q Huh-uh? 4 A I don't believe so. Nothing recent, anyway. 5 Q How do you keep track of your time, is it in the 6 computer? 7 A Yes. 8 Q So is that something that you would be able to 9 access if you had access to your computer? 10 A Yes. 11 Q Can you provide that to Mr. Perry -- 12 A Gladly. 13 Q -- afterwards? 14 MR. PERRY: Does that mean I have to pay it 15 then? 16 MS. PLANT: And if you would provide it to 17 me, Mr. Perry, I would be appreciative. 18 MR. PERRY: Sure. 19 Q We've talked a little bit about what materials 20 you have reviewed. I see you have a pile over 21 there, medical records and deposition 22 transcripts? 23 A Dr. Lee, my CV, this scratch, Dr. Cockrell, and 24 this stuff. Oh, here's a couple of cover 25 letters for transmittal of these items here, 0123 1 which is photomicrographs of Mr. Manoogian's 2 histopathology. I think this is some -- 3 Q That is not something I have seen before. May 4 I? 5 MR. PERRY: May I see it before you? 6 A I have an event log from the electrophysiologist 7 study ablation, both the Purcka system -- it is 8 not called as such, but that is what it is, and 9 Carto, C-A-R-T-O. Purcka is P-U-R-C-K-A. And 10 autopsy findings. And much of this is 11 redundant, similar to what is in here. 12 MR. PERRY: I can represent to you that 13 these, I believe, were prepared by Dr. Hutchins. 14 I'd be happy to give you copies. 15 MS. PLANT: Off the record. 16 (A discussion was held off the record.) 17 MR. PERRY: I'll give copies if you agree 18 to give me a copy of your article. 19 MS. PLANT: You can have it. 20 MR. PERRY: Thanks. We will have to make 21 copies of those. That may be the doctor's only 22 copy. 23 Q Okay. I may have already asked you this, so I 24 apologize. 25 Do any of the journals or chapters that you 0124 1 have provided, do you assert that any of these 2 articulate the standard of care? 3 MS. PLANT: We did. 4 MR. PERRY: I object. Asked and answered. 5 MS. PLANT: We don't need to go through it 6 again. 7 Q Have you consulted any other healthcare 8 providers in reaching your opinions in this 9 case, for example, have you spoken with any 10 other electrophysiologists about what is 11 required by the standard of care? 12 A No. 13 Q I understand Mr. Perry gave you information 14 about what Dr. Militano said in deposition. 15 Were there any other communications from 16 Mr. Perry that formed the basis of your opinions 17 in this case? 18 A I don't think so. 19 Q Okay. I shouldn't limit it. Any information 20 that you were provided by any of plaintiff's 21 counsel that resulted in your rendering any 22 of -- certain of your opinions in this case? 23 A I can't think of any. 24 Q Okay. Is there any other literature that you 25 found when you did your literature search, apart 0125 1 from what you have provided today? 2 A Well, as I say, I was not doing it for 3 information for me. I was doing it for 4 information for Mr. Perry. 5 Q Okay. 6 A So the short answer is no. 7 Q Okay. 8 A I'm sorry. 9 Q That's okay. Did you know Mr. Manoogian? 10 A I did not. 11 Q Do you know any of the experts who have been 12 designated in this case? Are you aware of who 13 the experts who have been designated in this 14 case are? 15 A I've been told of some. 16 Q And who are you aware of, and who do you know? 17 A Dr. Fred Morady, M-O-R-A-D-Y. 18 Q How do you know him? 19 A Oh, we've been friends for umpteen years. He's 20 a very well-regarded electrophysiologist. And 21 Dr. Calkins, who you mentioned, Hugh, 22 C-A-L-K-I-N-S. And Dr. Laurence -- I believe, a 23 U, Laurence, starts with an L -- Epstein, 24 E-P-S-T-E-I-N, whom I've known since he was one 25 of our trainees. 0126 1 Q Do you know Dr. Platia? 2 A Yes, I'm sorry. Ed Platia, P-L-A-T-I-A. 3 Q And how do you know him? 4 A Well, we all kind of ran in the same circles for 5 years. Well, that doesn't sound right, does it? 6 Q Is it your opinion that needle of -- let me 7 strike that and start over. 8 Do you have an opinion that you hold within 9 reasonable medical probability that a puncture 10 with a needle only and not the catheter or 11 dilator, that that is essentially something that 12 can happen with relative impugnity? 13 MR. PERRY: Objection. 14 A I believe experience, and a limited experience, 15 and what limited data there are, suggests that 16 that is the case. 17 Q Have you ever done a literature search to 18 investigate whether complications arising from a 19 needle puncture have been reported? 20 A I was given a literature search just today. 21 That's my only experiences in the literature 22 that addresses that point specifically. 23 MS. PLANT: Thanks for your patience. I 24 think we're just about finished. 25 By Ms. Plant: 0127 1 Q Going back to that article just for a moment, do 2 you have any knowledge, one way or the other, as 3 to whether the breakdown that's shown in that 4 survey, or that article, of the techniques and 5 tools used, whether that would also be the same 6 if a survey was done in the United States? Do 7 you have any basis for saying it would be 8 different? 9 A Well, I think our tools are the same as theirs. 10 I can't -- I can't say what proportion might be 11 used overall. 12 MS. PLANT: Okay. I have no further 13 questions. 14 MR. PERRY: Susan, any other questions? 15 MS. BOYCE: No, I don't have any questions. 16 MR. PERRY: Okay. I think we're done then. 17 We would read it. 18 AND FURTHER DEPONENT SAITH NOT. 19 20 ___________________________ 21 JOHN M. MILLER, M.D. 22 23 24 25 0128 1 STATE OF INDIANA ) ) SS: 2 COUNTY OF MARION ) 3 4 I, Victoria S. Stuart, RPR, a Notary Public in 5 and for the County of Marion, State of Indiana, at 6 large, do hereby certify that JOHN M. MILLER, M.D., 7 the deponent herein, was by me first duly sworn to 8 tell the truth, the whole truth, and nothing but 9 the truth in the aforementioned matter; 10 That the foregoing deposition was taken on 11 behalf of the Defendants at the offices of Indiana 12 University School of Medicine, Krannert Institute 13 of Cardiology, 1801 North Senate Avenue,, 14 Indianapolis, Marion County, Indiana, on the 19th 15 day of July, 2006, at 2:00 p.m., pursuant to the 16 applicable Maryland rules; 17 That said deposition was taken down in 18 stenograph notes and afterwards reduced to 19 typewriting under my direction, and that the 20 typewritten transcript is a true record of the 21 testimony given by the said deponent; 22 And that signature was requested by the 23 deponent and all parties present; 24 That the parties were represented by their 25 counsel as aforementioned. 0129 1 I do further certify that I am a disinterested 2 person in this cause of action, that I am not a 3 relative or attorney of either party or otherwise 4 interested in the event of this action, and that I 5 am not in the employ of the attorneys for any 6 party. 7 IN WITNESS WHEREOF, I have hereunto set my 8 hand and affixed my notarial seal on this _______ 9 day of July, 2006. 10 11 12 N O T A R Y P U B L I C 13 14 My Commission Expires: 15 June 2, 2008 16 County of Residence: 17 Marion County 18 19 20 21 22 23 24 25