Hey, it Could Happen to Anyone

Repeat after me: “I was performing the most critical aspect of the procedure.” I can see a tense session in a conference room between Calkins and his lawyer just before his deposition. He’s not used to being grilled and he’s nervous.

“I was performing the most critical aspect of the procedure…”

Hopkins is very determined to keep Dr. Wu out of the picture. They do not want people to get the idea that they are running some kind of research mill up there and letting rookies pinch-hit for the big names that pull in the customers. It could be a money thing. They’ve already made the Federal Contractor Misconduct Database for doing just that:

“According to the allegations, Johns Hopkins submitted or caused the submission of false claims to the Medicare program on behalf of certain faculty physicians employed by the university without documentation to show that these physicians were personally involved in providing the services claimed by JHU. Instead, the government contends these services were actually delivered by an intern or resident of the teaching hospital.”

Aside from defrauding the government, Hopkins is like other businesses in this way. Johnny Cochrane makes the pitch to you, but once you sign on the dotted line, your case is handled by lesser lights.

So Calkins haltingly recites the company line:

“The most critical aspects of the procedure I was performing. At the time of the… I was performing the critical aspect of the procedure, the most critical aspect of the procedure, deciding where to give the energy, how much to give, when to stop burning, and that was the aspect of of the procedure that I, as the attending physician, was doing… I was performing the most critical aspect of the procedure.”

A lawyer asks if maybe corkscrewing a catheter into the left ventricle might be considered a critical aspect of the procedure.

“Same complication could’ve happened if I was going to play with the catheter. I have no reason to believe that was something attributable to Dr. Wu versus myself manipulating the catheter. It’s something inherent in having the catheter in the heart.” This from a guy who professed quite a bit of surprise when it did happen.

Whether or not Hugh Calkins had any reason to believe that he, a twenty year veteran, would not have made the rookie mistake of turning the catheter knob the wrong way, he had no right to deceive my wife about who was going to be playing with the catheter that day.

Limits of Government Intervention in Technological Assessment

(Tuesday, July 10, 2007)

The Case of Catheter Ablation for Atrial Fibrillation

In 1976 Dr. Howard Hiatt, dean of the Harvard School of Public Health, give a speech advocating a U.S. technological assessment center before any medical product went to market.

Joseph Califano, secretary of Health and Human Services, chimed in. He whined more CAT scanners existed in Los Angeles than in Canada, as if that was a bad thing.

The rest is history. Neurosurgeons recognized CAT scans as a superior technology. Immediately they deployed CAT scans to spot brain tumors. MRIs followed CAT scans. The scans received the same warm reception as CAT scans among physicians. In 2001 a survey of 225 general internists published in Health Affairs ranked the top 30 major medical innovations, and MRI and CAT scans came out number one.

Government can’t control technology markets once doctors and patients spot a superior device, even if the device costs more than government thinks it can afford and even studies of safety and effectiveness have yet to be published..

Take the case of catheter ablation of heart atria sites that spark fibrillation. Atrial fibrillation afflicts 2.2 million Americans. It’s a leading cause of strokes and heart failure. Doctors think ablation is more effective than open heart surgery and multiple drug treatments. Consequently, thousands of ablations have been performed since 2000 – even though federal regulators haven’t approved the procedure and don’t pay for it.

Where there’s a will, there’s a way. Catheter ablation is moving faster than the federal approval process. Doctors and patients are saying, in effect, “To hell with the clinical trials. This ablation procedure works.” And “We” the patients, will demand it, and you, the doctor, had better provide it, or we’ll go elsewhere.

Doctors and hospitals are inventive. They know they can bill Medicare and insurers by using codes for similar cardiac procedures to partially pay for atrial ablations. Doctors perform ablations in major hospitals or teaching centers, where doctors are on salary and not compensated for procedures, but who wish to distinguish and differentiate themselves from the competition. The American Heart Association and the American College of Cardiology have recommended the procedure, and many established and start-companies are marketing ablation devices. Major ablation centers are trumpeting ablation success stories and marketing services to atrial fibrillation victims..

When patients want something done, and doctors and hospitals want to do it, and mounting anecdotal evidence shows it works, it will be done, and there is little government can do to stop it.

Market forces often move so fast they overwhelm government assessment and resistance. There are limits to federal intervention in health care, and catheter-ablation to remove or neutralize the cause of atrial fibrillation is the latest, but not the last example of those limits.

*******

http://www.kevinmd.com/blog/2010/02/treating-atrial-fibrillation-catheter-ablation-tv-ethical.html

*****

http://www.healthnewsreview.org/blog/2010/02/whats-wrong-with-nbc-today-show.html

Hugh Calkins 2007 : ” …it’s also by far the most dangerous procedure that electrophysiologists (EPs) perform. All of us have heard of terrible outcomes following AF ablation, partly due to lack of physician awareness. We wanted to get the physician community up to a standard level of practice as quickly as possible to reduce the painful learning curve and the risk of patient complications… You can put a patient on an anti-arrhythmic drug, and they may do well for two, three, five or ten years on anti-arrhythmic drugs… The point is that the physician needs to explain to the patient what the standard of care is, and if the patient wants other than the standard of care — that is if they want to do catheter ablation as a first-line therapy — they need to be aware that they’re taking an aggressive approach. They need to understand that approach may not be wrong, but it’s not considered standard for most patients, it’s the exception, not the rule…. Dr. Calkins: I think many physicians are very frustrated because they read in the literature that catheter ablation has an 85% cure rate and yet all the patients they refer for the procedure seem to have AF after the procedure. This document is partly for them, saying first of all that we shouldn’t use the term ‘cure’ anymore for treating AF and also telling the physician community that when we publish our results, we need to report results in a standardized fashion. You can’t report an 85% success rate when 38% of the patients had three procedures. You need to report single-procedure outcomes.” http://cme.medscape.com/viewarticle/558137_4

*****

Justice Department Charges Guidant:http://online.wsj.com/article/BT-CO-20100225-717543.html?mod=WSJ_latestheadlines

Have we overestimated the health benfits of ICD therapy: “Stacking the deck: antiarrhythmic drugs as “control” arm and beta-blocker inequity.” http://content.onlinejacc.org/cgi/content/full/52/14/1111 “With modern medicine, less emphasis has been placed on the physician-patient dialogue where concerns and expectations are freely exchanged. Physicians should understand that choosing longevity with potential tradeoffs in device-related complications and quality of life is a personal decision that must be individually tailored to patient preference. The process of obtaining informed consent from patients mandates and pre-supposes that physicians, first, are fully informed of the risks and benefits of the therapy that they are offering. It is ethically imperative that we are honest with the data, so that we can be honest with our patients.”

*****

A new system for catheter ablation of atrial fibrillation

Hugh Calkins 1999

http://www.ajconline.org/article/S0002-9149%2898%2901034-0/abstract

FDA Trial Design 198 1A (Ablation for V Tac) PreMarket Approval for Chilli Catheter Brinker/Calkins

FDA Trial Design 1998 1C

Dr. Cynthia Tracy: “To me, it doesn’t make any sense to compare the risk of anti-arrhythmic drug therapy with the risk of catheter ablation… you are comparing apples and oranges. A patient is at a heck of a lot more risk on the day they are having their ablation done than on the day they are just taking Amiodarone.”

Dr. Simmons: “trying to randomize them to drugs is just not going to work, right? We all agree to that. There is certainly enough historical data on drug therapy for atrial fibrillation to establish criteria on drug therapy, plus it is not a comparable control. So doing a randomized study comparing some ablation technique to drug therapy for atrial fibrillation is kind of a meaningless study.”

Dr. Anne Curtis: “I agree… It is comparing apples to oranges. I’m not sure you can compare ablation in patient A, whose got their own pattern of afib, to how patient B does with drug therapy.

Dr. Tracy: “I agree with all those comments.”

Dr. Vetrovec: “I just don’t want you stopping the drug and then ablating them and then starting the drug again and calling it a success…” (p33)

FDA Trial Design 1998 2A (Atrial Flutter – AFib starts p.99)

FDA Trial Design 1998 2B (Afib ablation)

FDA 1997 (Public Hearing File out and File back in)

***

FDA clinical trial design transcript 2007 Part One

FDA Clinical Trial Design 2007 Part Two

FDA Clinical Trial Design 2007 Part Three

FDA Clinical Trial Design 2007 Part Four

FDA Clinical Design Trial 2007 Part Five

FDA Clinical Design Trial 2007 Part six

$500,000 to Hopkins from Philip Morris: http://legacy.library.ucsf.edu/tid/ziw10c00/pdf;jsessionid=4035E6F05B21CF88E3B49C98B14EB3A6

Panel votes down proposal for non-RCTs for AF ablation use:http://www.accessmylibrary.com/article-1G1-169074616/panel-votes-down-proposal.html

Off label use — http://www.eplabdigest.com/articles/Letter-Editor-%E2%80%9COff-label%E2%80%9D-Use-Ablation-Catheters-Atrial-Fibrillation

Off label use: http://www.fredlaw.com/bios/attorneys/klepinskirobert/Klepinski_JMDRMay2009.pdf

Atricure to Pay US $3.76 Million to Resolve Charges

Medtronic defibrillator wires: http://online.wsj.com/article/SB10001424052748704259304575043300593884216.html?mod=WSJ_hps_LEFTWhatsNews

http://tinyurl.com/theidealcandidate

Trial Design 2007 2/pp140: ” …we sought input from a significant number of  E.P.s. We were told by many of them that a  study comparing A.F. ablation and medication did not make for strong clinical science because patients that failed a drug are being randomized to additional drug therapy as the control.”….. Burke Barett,  vice president of regulatory and clinical affairs for CardioFocus.

For the argument that too many patients fail drug therapy and that it is ineffective long-term, Prystowsky said that he has longitudinal follow-up on patients in his practice for an average of six years, with some patients managed on drug therapy for more than 10 years. Overall, more than two thirds of his patients have remained in sinus rhythm, he said, noting that this follow-up is three or four years longer than any existing ablation follow-up. – Prystowsky 2005 http://www.theheart.org/article/546039.do

ic drug, the use of catheter ablation compared with ADT resulted in a longer time to treatment failure during the 9-month follow-up period.”

Brodsky: Calkins Meta Analysis Flawed: http://circep.ahajournals.org/cgi/content/extract/2/6/e44

When J&J had less heartening news to report, it didn’t do the full court press. This from a Reuters dispatch in 2005:

Johnson & Johnson has revised the label of its Natrecor heart failure medicine to include data that suggest it may increase the risk of death, following two widely publicized medical journal articles that questioned its safety.

J&J did not issue a press release to announce the label change.

Instead, a company Web site, Sciosinc.com, published the lengthy label without pointing out which section of it had been added. “The label was quietly changed by Johnson & Johnson, which apparently doesn’t want to attract much attention to the new mortality language,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who in 2001 advised U.S. regulators not to approve Natrecor.

***

Exec in Risperdal Kickback Case: “I Wasn’t Going to Jail for J&J”

Jim Edwards has been covering the

writes in PharmaAnalysis

According to data appearing today in JAMA, patients with a common heart rhythm disorder, called Atrial Fibrillation, who were treated with catheter ablation using the NAVISTAR^® THERMOCOOL^® Catheter, demonstrated significantly better outcomes at one year compared to those receiving drug therapy. In addition, the patients treated with catheter ablation reported markedly fewer symptoms and substantially improved quality of life. http://news.moneycentral.msn.com/ticker/article.aspx?Feed=BW&Date=20100126&ID=11060705&Symbol=JNJ

****

In 2007, with his patient recruitment piece still up on the Hopkins site, he wrote an opinion piece for the journal Nature in 2007, in which he recommended that catheter ablation for Afib should not be considered as a first line therapy. He begins by repeating what he told the FDA four years earlier, that “The true efficacy of Afib ablation remains unknown.”

****

There is no question that Hopkins is fighting this lawsuit not about money, they have already spent enough to demonstrate that. It’s about about their business model, which requires a burnished reputation by which to gain the confidence of those searching for medical help. The trainees get paid by device manufacturers. Hopkins contends that the term trainee carries a negative connotation, and points out that these are full Medical Doctors on fellowships. The Fellowships are paid for by medical device manufacturers. Richard Wu, for example, might have been the BioSense Webster Fellow at Hopkins in 2002.

When Barbara Bean sent Pam’s records to her new cardiologist, she included this note: “She has a lawsuit pending against Johns Hopkins.”

The catheter that Richard Wu took out of its wrapper that morning was of a kind he had never seen before.

The catheter  was a Biosense Webster LASSO™ Deflectable Circular Mapping Catheter, which Hugh Calkins would later declare to be a dangerous instrument.

It was was manufactured by a division of  Johnson & Johnson, and the version Richard Wu snaked into to wrong chamber of  my wife’s  heart was approved by the FDA in 2000.  Biosense Webster got approval for the catheter by telling the FDA that, except for a few minor improvements,  it was essentially the same as the one that came before it, the T20 Diagnostic Deflectable Tip Catheter, which the FDA had already approved.  Thus there was  no need for studies on safety and effectiveness. The T20 was designed and manufactured by Webster Laboratories, before it was bought by the Cordis Corporation, before Cordis Corporation was bought by the Biosense Corporation, which was bought by Johnson & Johnson.

As was the case with the Lasso catheter, Cordis Webster got approval for the T20 catheter in 1995 by telling the FDA that, except for a few minor improvements,  it was essentially the same as its predicate device, the Cordis Webster Deflectable Tip Catheter — and there the trail goes cold. One would have to write to the Johnson & Johnson to further pursue the provenance of the  Lasso catheter.

I imagine that the original catheter from which all subsequent versions were designed and approved must have looked like the business end of a coat hanger, which probably wouldn’t recognize itself in the year 2000. As Johnson & Johnson proudly points out in their 2000 application for approval, “The Lasso Mapping Catheter is substantially equivalent to the predicate devices — with the addition of the Nitinol formed ‘Lasso’ assembly. The platinum ring electrodes are located on the lasso assembly rather than on the catheter tip…”

So, it’s pretty much the same, but it’s different. Like the last one, and the one before that …

But Hugh Calkins later laid the blame for what happened to Pam on the the Nitinol formed “Lasso” assembly:  “… the circular spine of our catheter became entangled in the chordae tendineae. The design, relative stiffness, and entrapment of the preformed circular spine in the mitral apparatus prevented complete straightening or relaxation of the circular tip. We suspect that the abrasive nature of the 20 electrodes caused resistance, which contributed to the inability of the catheter to slide off the mitral valve apparatus …”

In fact, the very “Lasso” assembly which was spared regulatory scrutiny — on the manufacturer’s say so — has gotten tangled in so many mitral valves since Dr. Richard Wu pioneered  the technique that  doctors at Harvard published a paper about how to deal with such a “complication” in 2004.

So Hugh Calkins, who was among the pioneers boldly and blindly exploring of the left atrium of the heart in the search for a cure for Afib, laid claim to being the first EP to have lost a mapping catheter in a mitral valve. Dr. Keane may have outdone his old Harvard pal by figuring out how to get Lasso catheters untangled without killing the patient, but it was Hugh Calkins who laid the foundation for all the great works that followed.

In 2006, a few Swedes, named Englund, Jensen, and Jensen-Urstad, got into the weeds with Lasso catheters and mitral valves. Their paper, Entrapment of Circular Mapping Catheter in the Mitral Valve,  describes “three patients with entrapment during ablations for atrial fibrillation. The entrapments occurred with three different operators at three different electrophysiological laboratories within 2 years. The complication described here may be more common than is widely appreciated.  From our figures, we estimate the incidence of the complication to 0.9%”

The irony is that the design of the catheter was not the primary cause for what happened to Pam.

Whatever the design of the catheter, it had no business in the mitral valve muscles of Pam’s heart. It got there because Hugh Calkins let a trainee do the job. He knew it was a tricky operation which should have been performed by someone of considerable skill and experience, and he knew that his patient believed that would be the case.

BioSense Webster Lasso Catheter Recalled

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69666
Recall Number: Z-1703-2008 and Z-1704-2008. See FDA weekly enforcement report for more details about the recall.

This recall was initiated on March 25, 2008 by Biosense Webster for the Lasso 2515 Variable Circular Mapping Catheter, US Catalog Number D7L202515RT.

This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and separation of the distal end of the catheter may occur. Also, the firm determined that when the catheter is fully deflected and the variable loop is fully contracted, it is possible that the catheter mechanism can become “locked” in position and cannot return to the un-contracted, un-deflected state. This could lead to damage to the device or limit the ability to withdraw the catheter safely. Call Diana M. Thorson 909-839-8604

A History of GI Bleeding

Mallory Weiss

Richard Wu

So that’s why he was all shaken up when he stood next to Hugh Calkins that afternoon in 2002.  By the time we found that out, litigation was under way. I thought, I’ll just get hold of Dr. Wu and have him write a statement about how he had never met my wife. This would prove that Hugh Calkins had tricked and misled us.

Wu was working at the University of Texas Southwest Medical

Texans like their heart centers and it is a big deal to be the Dallas Heart Ball Chair in Cardiac Arrhythmia Research at The University  Texas Southwestern Medical Center.

America’s Best Hospital

The experience begins when you drive up to the front of the hospital, a large and impressive structure built on a hill. There is a professional valet staff; crisp, cordial and efficient like at a swanky hotel. The doors slide open as you walk into a large atrium. Before you have a chance to feel lost, you are met by a smiling greeter who sorts you and sets you on the right path.

Before you know it, you have surrendered your autonomy and are sitting in a wheel chair while  a uniformed staffer is pushing you down a long corridor paneled on both sides with posters of  Johns Hopkins Medicine on the cover of US News and World Report.

You have put your life into the hands of the institution.

” She was a Nurse”

DR. MORRISON:  Well, I would just like to ask the other members of the panel if any of them are as shocked as I am to hear the FDA say we’re designing trials where the sample size is based on safety rather than efficacy.

****

******

Sanjeev Saksena, M.D.

“… the first survey, worldwide survey, on atrial fibrillation demonstrated that percent of the patients who were deemed effectively treated with atrial — for atrial fibrillation by ablation had that success associated with the need for anti-arrhythmic drug therapy.

The protocol is designed so that if a retreatment is within two months, it’s considered not a treatment failure.  And yet clinical practice is typically to delay retreatments beyond two months because we all know about delayed healing, and there’s certainly an inflammatory phase that can go on for three months or longer. So this, obviously, is a difference between how the study was designed and what is considered best clinical practice to date.” Calkins FDA2007#2p27

” … we all know that once you’ve failed your first anti-arrhythmic drug, that almost guarantees you you’re going to fail your second or third anti-arrhythmic drug.

So the current way drugs are mandated, I think, is very cumbersome.

“And I think the entire field would benefit tremendously from saying if you failed a beta blocker or calcium blocker, you could be randomized to ablation or an anti-arrhythmic agent, and that would give you a more effective comparator and, I think, help enrollment a great deal in all of these trials.” Calkins FDA 2007#2 p 29

As a practicing electrophysiologist who does these procedures, I’m very eager to have objective evidence demonstrating particularly the safety and efficacy. Dr. Slotwiner DAF 2007 # 2 page 60

***

Cindy Tracy FDA Hearing 1998:

“I think you always have to bear in mind that just because you can do something, it doesn’t mean that you should do something. I think we have to exercise some judgment about whether to do something. Maybe we shouldn’t consider doing the procedure on this patient, maybe we consider another try with anti-arrhythmics. Should we be putting a catheter in this person? There has to be some sense to the doing of it…

Tracy:  “…it is too risky up front[sans aad] and we don’t know the risks to the patients.”

Tariq Aiz, 98 FDA:Dr. Aziz:  “Basically you are going to have a learning curve of people who are using the catheters. I think it is a point where you are gathering data and if the patients are willing to take that chance…”

DR. SIMMONS: Let’s say you have a patient referred in for this study. A typical patient is going to come in– they have probably already had a couple of episodes. They have probably already been on beta blockers or calcium channel blockers and dig. They have probably already failed at least one
antiarrhythmic drug. Whether or not they have truly failed it is, again, a question.

****

Dr. David Eddy proved again and again that the emperor had no clothes. “The intellectual foundation of medical care is based on the assumption that whatever a physician decides is, by definition, correct. While many decisions are, no doubt, correct, many are not, and elaborate mechanisms are needed to determine which are which.”

****

Hugh Calkins could not have explained the risks and benefits of catheter ablation for atrial fibrillation to Pam because he did not know what the risks and benefits were. In fact, performing the procedure on Pam was how he was hoping to find out what the risk/benefit ratio was.

****

Lawsuit Challenges Marketing of Stents

By BARRY MEIER

A former medical device executive claimed in a potential whistle-blower lawsuit that was unsealed this week that the makers of stents approved to treat digestive tract cancers had illegally marketed them for years to treat blocked blood vessels in other parts of the body.

In the lawsuit, Kevin N. Colquitt, a former regional sales director for Guidant, stated that he had been trained to market the devices, which are known as biliary stents, to doctors for off-label uses not approved by the Food and Drug Administration.

****

*****

“We commonly saw what looks like a gunshot blast where you have one lesion here, one lesion here, one lesion here, one lesion here, nothing continuous or linear about it. Whether these lesions are in fact pro-rhythmic, anti-arrhythmic, who really knows… (emphasis added) this new catheter would be more doing what we are trying to do which is not ablate the atrium but put road blocks up to ablate atrial fibrillation.”

So it appears that at least one interventional cardiologist performing the procedure was fully aware of “the level of destruction created in a patient’s left atria.” In 2003, Hugh Calkins was trying to sell the FDA on Cardima’s new catheter on the grounds that it would help cardiologists not obliterate the inside of the left atrium. Imprecise, blundering obliteration may have been what he was practicing, but it’s not what he was selling. It’s not the picture he presented for public consumption. It’s not what the David Erdmans of the world were told – because, how else would you learn?

One has to wonder about the motivation for the duality in Calkins’ portrayals of the procedure to his different audiences. Two of his public pronouncements in 2006 illustrate the contrast between selling to perspective research subjects (patients) and reporting to colleagues. In “The Arrival of A-FIB Ablation” on the Hopkins website, the good news is delivered to AFIB suffers that their worries are practically over: Dr. Calkins “delivers radiofrequency energy around the outside of the pulmonary vessels to knock out the source of the aberrant electrical signal. A-fib episodes may still occur for a few weeks, but most patients are free of them within a month.”

Free at last! Thanks Doc!

But he has more sobering news for fellow researchers in a Cardiosource journal article that came out at the same time: “Hugh Calkins, MD, FACC, recently co-authored a worldwide survey on the methods, efficacy, and safety of catheter ablation procedures for AF… (Only) 52.0% of catheter ablations proved “curative”… Also, it should be noted, 24.3% of patients required a second ablation procedure… The overall incidence of major complications was 6.0%, which the authors noted “is not trivial.” Complications included …death, tamponade, aortic dissection, stroke, and PV stenosis. Further, Calkins says, “We really do not have a true handle on the long-term efficacy of this procedure. Also, I personally have a problem with physicians who make the statement that their patient’s atrial fibrillation is cured by catheter ablation. We really don’t have data to support that claim.”

In another illustration of the difference in the two faces put on the procedure is that generally, when Hugh Calkins talks about having to repeat the entire process because it failed the first time, he’ll tell his peers that the patient needs a second procedure, a third procedure. When Hugh Calkins talks to prospective patients, uses the phrase “touch-up.”

Why does he do this?

In 2007, with his patient recruitment piece still up on the Hopkins site, he wrote an opinion piece for the journal Nature in 2007, in which he recommended that catheter ablation for Afib should not be considered as a first line therapy. He begins by repeating what he told the FDA four years earlier, that “The true efficacy of Afib ablation remains unknown.”

I don’t know about the rest of the hundreds, perhaps thousands of other patients that Hugh Calkins “steered toward” what he called “the most dangerous procedure that electrophysiologists do,” but he most definitely did not tell Pam and me that he had no idea whether the procedure actually worked. (I would have distinctly remembered if a doctor recommended a procedure, told me that it would be the most risky and dangerous thing he ever did, that the complication rate is unprecedentedly high — and then said that he didn’t even know if it worked.)

Calkins goes on to say that “serious complications continue to occur even in the most experienced hands… New, devastating complications are emerging. Perhaps the most frightening of these is esophageal perforation, which is often lethal — and atrioesophageal fistulas, which are perhaps the most feared and most lethal of the many complications that have been associated with this procedure – with mortality in excess of 75 percent… and new complications are being ‘discovered’ on a regular basis…”

“Some doctors are pretty enthusiastic about ablation as a primary therapy,” Calkins says, “but they’re only enthusiastic until a patient has a stroke or some type of devastating consequence. Then the enthusiasm tends to go down a little bit.”

Ah, the learning curve.

****

hopefully by then we’ll know what tools are the best to do it with and we’ll have a little more information so we can do it more safely.”

Hugh Calkins would occasionally make an appearance when a new family member arrived.  When Pam’s sister Laura flew in from Seattle, he told her the story that he told to Jackie and Kristi me: that he’d turned away momentarily and the catheter got caught in the mitral valve muscles. He told that same story to Pam’s sister Lisa. We were all clear on that fact.

Sorry, he says, again and again, but now it was starting to have a ring of tough luck to it. Sorry. Oops. Oh, well. And as the days wore on, we began to see less and less of Hugh Calkins.

editing editing editing editing editing editing

We demanded to see the doc in charge.

He was a hard man to get a hold of, and this issue of The American Medical News explains why:

“Johns Hopkins Penalized for Resident Hour Violations”

“The Accreditation Council for Graduate Medical Education has disciplined its first resident program for work-hour violations since new rules went into effect for all programs July 1. Johns Hopkins Hospital’s internal medicine program was cited for exceeding the 80-hour work week and requiring call more than every third night in the intensive care, counter to ACGME work hour standards.”

Johns Hopkins Magazine dutifully reports that “Nine days into the new enforcement period, a new Hopkins intern sent an e-mail to ACGME officials stating that some Internal Medicine residents were working more than 100 hours per week.”

The person upon whom Pam’s life depended was working about 90 hours a week, maybe a hundred. I tracked him for days and finally snagged him at a nurse’s station. The man was obviously exhausted, but so was I, and I pressed him about why she wasn’t coming around. He had reached the point of exasperation and he told me more or less that he was a very busy guy with lots of patients and they all had families who wanted answers and he had a family of his own to worry about.

I decided to call Dr. Yuh, the surgeon who installed Pam’s mechanical heart valve. I was told that he was on vacation – in Hawaii.

****

******

The Heart.org: Is more conflict of interest disclosure getting us closer to the truth? http://www.theheart.org/article/963203.do

******

BusinessWeek Medical Guesswork: http://www.businessweek.com/magazine/content/06_22/b3986001.htm

Calkins “So anyhow I went ahead and started doing the procedure and these are the results we saw in our first 75 patients….”

[ In addition to the destruction of my wife's heart valve, the procedure caused three people to have holes poked in their hearts,  three other people to have strokes, and six people developed pulmonary vein stenosis.  Out of 75 people who underwent the procedure, 11 people had it done twice. Twenty six people experienced no benefit whatsoever. The 39 people for whom the procedure was counted as successful were only followed for eights months, and it was becoming clear that Afib returned more and more often as time went by.]

The longer you follow the patient, the more Afib recurs. . for persistent or permanent Afib this procedure is just awful – a 20% success rate.

Complications, they were memorable  two strokes, [not counting Pam's] three tamponades, the mitral valve Lassoed, Pulmonary Vein stenosis, some vascular complications.

… this was not the answer, at least for the patients that I had to deal with and deal with the aftermath.

Circumferential ablation (worked a lot better, very impressive, breeze through the complications,

Let’s take a harsh look at our numbers and see how we really did, and it was somewhat appalling, I think our success rate was about 35% — our success rate for single procedure outcomes with 12-moth follow up — with a 7% complication rate. And my colleague Ron Berger says, you can’t publish these data, we’ll never see another patient again at Hopkins. Can you find a silver lining? So we did identify a subset of patients with paroxysmal afib that were young that had small left atrium that had blue eyes that had a 70% success rate, but for the rest, the success rate was  much worse…

****

Jeff Brinker was called at xxxpm, arrived at 2xx pm yanked on the catheter at # pm.

What had he been doing when Calkins called. Was he in the middle of training the other fellow?

Wu says he discussed alternatives like drug therapy and doing nothing.

Calkins had already falsely declared that Pam had failed three anti-arrhythmic drugs. Why would Yuh be offering her the option?

******************

“Staffing for ablations should consist of at least three team members in addition
to the attending physician. It is “recommended that staff utilized for ablative
procedures have experience with at least 30 catheter ablations before working
independently in the EP lab, and that they continue to assist on 30 cases per
year.” -  Hugh Calkins, NASPE Policy Statement on catheter ablation: Personnel, policy, procedures, and therapeutic recommendations. PACE 2003;26:789–799

It is likely that Richard Wu’s salary was being paid by a medical device manufacturer…

http://www.mddtransparency.com/sites/default/files/file/Biosense_Webster/BWI_%20Q109Grants%20090617.pdf

Boisense Webster Largess to Johns Hopkins…
EP Fellowship Program ‐Jan‐ 09 JOHNS HOPKINS UNIVERSITY BaltimoreMD $50,000.00 ****

*****

http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3442t2b.pdf

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Masking Malpractice Claims

Doctors can be removed as defendants as a case evolves. Paul Bekman of the firm Salsbury, Clements, Bekman, Marder and Atkins said Hopkins has asked him to drop doctors as defendants. He said he is “more than willing” to agree, because doing so speeds up settlements.

In a claim filed in 2003, Bekman named Johns Hopkins Hospital and Dr. Mark A. Talamini as defendants, accusing the surgeon of accidentally cutting a hole in John T. Adrian’s stomach during a nearly six-hour procedure to relieve acid reflux.

According to the claim, as Adrian was being wheeled into the operating room, Talamini said he planned to use a new robotic device for a “safer operation with fewer risks of complications.” The claim contends that Adrian would not have consented had he known that Talamini had “limited experience” with the device.

Adrian, 53, of Arlington, Va., spent more than a month in the hospital recovering after the operation, according to the claim.

Bekman said he agreed to drop Talamini from the claim in the early stages, at the request of Hopkins’ lawyers. That left the hospital as the sole defendant. The case is pending in Baltimore City Circuit Court. Hopkins has denied any negligence.

****

Ten days before Pam and I pulled up to valet parking at Hopkins for the big event, officials from the organization were down in the state capital fighting like hell against a bill that would tighten oversight of research studies with human beings as subjects.

Medical research bill opposed at hearing Biotech industry, universities against adding state oversight
By Tom Pelton, The Baltimore Sun (Sun Staff) Originally published March 15, 2002

http://www.circare.org/media/31502BS.pdf

***

FDA Warning Letter Hints at Crackdown on Unregulated Research, IND Enforcement
By M. Alexander Otto
BNA’s Medical Research Law & Policy Report
May 7, 2003
A recent letter from the Food and Drug Administration to Johns Hopkins University in Baltimore contains what may prove to be the start of agency efforts to bring unregulated human experimentation under federal oversight, according to BNA interviews with key FDA personnel

http://www.circare.org/bna05072003.pdf

*****

“The process of atrial fibrillation ablation is really exploding out there regardless of whether it’s approved, simply because it works,” Hugh Calkins, M.D., of John Hopkins, an electrophysiologist who consults for Johnson & Johnson, told the advisers. The FDA can go pound rock salt, as my old man used to say.

Working for J&J Navistar ‘08 http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/11880

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In a 1999 SEC filing Cardima writes that  “Although our microcatheter products are labeled for single use only, we are aware that some  physicians are reusing such products. Moreover, despite labeling of our microcatheters for diagnostic use only, we believe that physicians are using such mapping microcatheters for ablation.”

What would lead Cardima to believe that physicians were using mapping catheters to perform ablations, which is contrary to their approved use? It might have been this press release they sent out the year before:

Cardima Successfully Treats First Patient in United States Atrial Fibrillation Study at the Johns Hopkins Hospital

FREMONT, Calif.–(BW HealthWire)–April 3, 1998–Cardima, Inc. today announced that the first patient in its (AF) ablation feasibility study was successfully treated last week. The patient, a 38 year old male who had been suffering from almost daily episodes of AF for over five years, was treated and left the hospital in normal heart rhythm. Ronald D. Berger, M.D., Ph.D., a cardiac electrophysiologist at the Johns Hopkins Hospital, treated the patient using the Cardima Pathfinder ablation catheter. Dr. Berger said, “This was a highly symptomatic man who had been suffering from AF with no potential for a cure available in the near future. We were delighted to enroll him in Cardima’s clinical trial and treat his AF in a minimally invasive fashion. We had considered a highly invasive open heart operation called the maze procedure on this patient, but felt the minimally invasive approach would be safer in this instance. Cardima’s product offered the option of a catheter-based maze procedure and we are extremely pleased with the results.”

Dr. Berger cautioned that long-term follow-up will be required to further assess the success of the procedure…

Phillip C. Radlick, Ph.D., President and Chief Executive Officer of Cardima said, “We are pleased with the outcome of this very difficult case. It is gratifying to see a successful patient outcome, especially for a person who had suffered for as long as this gentleman did. Approximately four million people in the world suffer from this condition, with no cure currently available. We will strive to complete the U.S. ablation feasibility phase of our trial …”

“The cardiac device, The Pathfinder, was cleared for marketing by the Food and Drug Administration (FDA) in 1998: The developer is Cardima, Inc. You should know, though, one of the FDA’s device experts tells us, the intended use of the device seems to be different from what you are asking about in your e-mail. You may want to check clinicaltrials.gov to see if there are any new studies in this area.

Very Respectfully,

Eugene J. Koprowski and Nancy Bruening”

Journey to the Far Side:http://www.secinfo.com/dut49.72zh.htm#aug

Currently, there is considerable clinical debate about the needfor mapping AF prior to ablation, and no mapping is performed during the openheart surgical maze procedure.  However, the Company believes that mapping priorto ablation may be useful to identify different segments of the AF population,each of which could require slightly different mapping and ablation procedures.For example, some electrophysiologists believe most AF patients will need to bemapped and ablated in both the left and right atria, while others believe onlythe right atrial intervention is warranted.  Market acceptance of this productfor mapping will depend largely on a determination that there is a clinical needfor diagnostic mapping prior to ablation of AF.  The Revelation Tx ablationprocedure may require the use of RF energy in both the right and left atria toproduce lesions.  In general, the use of RF energy in the left atrium has thepotential to create blood clots, which could travel through the vasculature tothe brain and may cause a stroke...

http://tinyurl.com/Nightmaresin-AFibAblation

"The FDA's prohibitions against promoting approved products forunapproved ("off-label") uses."

Cardima :BIG MONEY

1997 Pathfinder Berger”The company has been funded by a variety of venture capital firms, including Kleiner, Perkins, Caulfield and Byers; Goldman Sachs; Chase Venture Partners; New Enterprise Associates; Premier Health Ventures; and Atlas Ventures.http://findarticles.com/p/articles/mi_m3570/is_n10_v20/ai_20043173/pg_2/?tag=content;col1

FREMONT, Calif., Oct. 6 2000 /PRNewswire/ –Cardima, Inc., (Nasdaq: CRDM) announced today it has treated the first patient in Phase III of its atrial fibrillation (AF) clinical trial. Dr. Hugh Calkins of the Johns Hopkins Hospital treated the patient.

“The patient was a 68 year old female with a 10 year history of paroxysmal AF,” stated Dr. Calkins. “We treated her with the Revelation Tx and Cardima’s new NavAblator catheters, the patient tolerated the procedure well and she has returned to work. The evaluation of this new therapy is ongoing. I am very pleased with the outcome of this case and the performance of Cardima’s products.”

“We are very pleased to treat the first patient in Phase III of the clinical trial,” said Gabriel Vegh, President and Chief Executive Officer of Cardima. “We continue to focus our development efforts on therapies that significantly reduce or eliminate AF as opposed to supportive therapies with devices such as pacemakers.”

****************

the technology is way ahead of the science.  That’s always a problem.  I think that’s where we are now and we have made advances in this field.- Dr. Waldo

********

American Heart Association’s Annual Scientific Sessions, Dallas Dec.2001

Hugh Calkins, MD, professor of medicine and director of electrophysiology services at Johns Hopkins University (Baltimore, Maryland), reported on the current results of the U.S. right-sided linear ablation trial of the Revelation ablating catheter, a study now in its third year. His discussion encompassed the design of the catheter and the current status of right atrial linear ablation in the overall picture of catheter ablation of AF.

He noted the need for an atrial catheter, adding a call to industry to develop one that would work properly. There have been many attempts to make such a device, Calkins said, but “the only one still standing right now is the Cardima Revelation.” He noted that he was initially skeptical of the device’s ability to make decent lesions. “I told them [Cardima] that I wanted to do animal studies myself,” he said, adding that he was “pleasantly surprised” with the results.

Getting the device into the hands of his colleagues was a difficult endeavor, Calkins said, with the comment that the FDA “never makes things easy here in the U.S.”

He first did a 10-patient feasibility study, then a Phase II trial, and finally a pivotal trial, currently in progress. Calkins said that the results of the first 48 patients can be interpreted based on “what type of person you are — an optimist or a pessimist. If you’re a pessimist, you’d probably say, `47 out of 48 patients had atrial fibrillation again, and it doesn’t work.’ But if you’re an optimist, you’d say, `my goodness, look at this tremendous reduction in afib burden.’” He cited the example of a patient with more than 50 AF episodes a month, now down to just four per month.

Additionally, data from six-month follow-up demonstrated more than a 100% reduction of episodes in half the patients and a 50% reduction in episodes in 87% of the patients. The real issue here, he said, is quality of life, “since afib doesn’t kill you.”

Calkins said that he personally called some of the patients who had participated in the trial from one to three years previously, and asked about their condition. A total of 21 patients responded and said they were now minimally symptomatic.

Summarizing these preliminary results, he told his breakfast audience that radiation ablation using the Cardima system “demonstrates that it’s safe, it seems to reduce the afib burden results in long-term elimination of afib in up to half the patients and improves [their] quality of life.” Calkins Scientific Sessions, Dallas Dec.2001 http://www.accessmylibrary.com/coms2/summary_0286-27267181_ITM

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“It is not advisable to draw conclusion from these data…”  FDA statistician on PMA20039.   Equipment failures during trials pg 96 PMA20039…

IN March, 2002, a Press Release went out announcing the big date for the presentation. http://www.medscape.com/pages/editorial/pressreleases/pr-crm-cardima1

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Business Wire May 14, 2003: Dr Calkins will discuss linear ablation as a less-invasive alternative to the MAZE procedure. Smithsonian

Cardima to Host Scientific Symposium at NASPE Thursday, May 15, 2003

******************

January 7, 2003 • Cardima (Fremont, California), developer of the
Revelation Tx and Helix microcatheter systems for treating
atrial fibrillation (AF), has completed a private placement of
4.36 million shares of common stock to select accredited
investors at a price of about 75 cents per share. The private
placement also included the issuance of warrants to purchase
up to an aggregate of about 2.4 million additional
shares of common stock at an exercise price of approximately
82 cents per share. Net proceeds to the company
were about $3 million. http://www.medicaldevicedaily.com/img/mdd_sample.pdf

Calkins for Cardima at the Smithsonian: http://findarticles.com/p/articles/mi_m0EIN/is_2003_May_14/ai_101684079/

The article includes comments by Dr. Hugh Calkins, professor of medicine and Director of Electrophysiology Services at Johns Hopkins University, in Baltimore, who participated in the right-sided linear ablation trial for the Revelation Tx. According to Dr. Calkins, “Three months after ablation 38% of patients had no AF and six months after ablation 47% had no AF.”

Additionally, Dr. Calkins noted that the study group had significant episode reduction in symptomatic AF. The study group recorded an average of 10 AF episodes per month prior to ablation, an average of 3.7 AF episodes per month three months after ablation, and an average of 1.9 AF episodes per month six months after ablation. Dr. Calkins commented, “This is the first prospective, multi-center clinical trial for catheter ablation of atrial fibrillation that has reached the finish line. I think that’s the enormous hurdle that has been crossed. There were about 10 other companies that started the race, but all the rest packed it in. Cardima had the fortitude to stick with it and present us with results.” Dr. Calkins further noted that catheter ablation resulted in a significant improvement in quality of life. “I think catheter ablation will be routinely performed to cure afib — that’s clearly where we’re moving,” he commented. Cardima, Inc. developed the REVELATION(R) Tx linear ablation microcatheter system as a minimally invasive, single-use product that may have the potential for curing AF. The REVELATION(R) Tx linear ablation microcatheter system is believed by the Company to be the first device to treat AF that has completed a multi-center clinical trial and has had a pre-market approval (PMA) application submitted to the FDA.

Cardima submitted the PMA on September 20, 2002 and was granted expedited review status by the FDA on November 5, 2002. Clinical trial data from the REVELATION(R) Tx microcatheter demonstrated safety and promising efficacy. Cardima’s mission is to get better devices to treat AF in the hands of the medical community.

*************************

“The panel members noted that Cardima’s primary investigators “contaminated the data” The panel noted this clinical trial was not a prospectively defined trial from the onset, and that the primary investigators “did not play by the rules that they designed, and furthermore, should have been eliminated from the clinical trial as primary investigators” (Dr. White). The panel also noted that missing data from the clinical trial did not translate to mean that patients did not experience episodes. Therefore, there was a lack of rigor and robust data (per Dr. Waldo, Dr. White, and Dr. Norman). In addition, the panel members concurred with the Agency’s recommendation that the increase of amiodarone dosage would be considered a clinical failure. Most importantly, the panel noted in thclr final remarks that this was an “observational exercise” and not a true clinical trial. Since the data was improperly collected, there was no way to salvage any information from this study. It is the Agency’s understanding that the sponsor would hare to start again at the Pre-IDE level. Finally, the panel found very little evidence to support reasonable assurance of safety and effectiveness for the Cardma catheters (the Revelation TX and the Navablator)….Finally, the panel found very little evidence to support reasonable assurance of safety and effectiveness for the Cardima catheters…

*********

“Increased attention is now being focused on developing new technologies to cure atrial fibrillation using catheter ablation techniques…. The Guidant Heart Rhythm Technologies Linear Ablation System was developed to create long transmural linear lesions. Calkins” 1999 A new system for catheter ablation of atrial fibrillation”:

Increased attention is now being focused on developing new technologies to cure atrial fibrillation using catheter ablation techniques. The performance of a MAZE-type procedure using standard catheter ablation technologies is arduous and is associated with an unacceptable risk of complications. The Guidant Heart Rhythm Technologies Linear Ablation System was developed to create long transmural linear lesions. Unique features of this system include the availability of different preshaped multi-electrode steerable ablation catheters, the use of phased radiofrequency (RF) energy, and the control of RF output by varying the duty cycle. A prospective multicenter clinical trial to evaluate the safety and efficacy of a right atrial ablation procedure using this technology to treat atrial fibrillation is currently underway. To date, 15 patients have been enrolled and the procedure was acutely effective in 14 of 15 patients with no complications. Atrial fibrillation has recurred during short-term follow-up in 12 of 15 patients, a not surprising result, because this initial phase of testing involved only right-sided ablation. The early results of the phase I clinical trial confirm the findings of others that successful ablation of chronic atrial fibrillation is likely to require a left atrial approach. This clinical trial, as well as others that are currently underway, will be invaluable in the continuing development of catheter ablation of atrial fibrillation and, ultimately, in determining if the routine use of this therapeutic tool can become a reality.http://tinyurl.com/Guidant-NewAblationSytem-1999

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http://tinyurl.com/Cardiac-Pathways (Leveraging electrophysiologists)

FOIA

Food and Drug Administration Freedom of Information Staff (FOI) 5600 Fishers Lane , HFI-35 Rockville , MD 20851 (301) 827-6500 (voice), (301) 443-1726 (fax)

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Cardima:Medical Device Daily Features Cardima’s Technology to Treat Atrial Fibrillation.

Cardima: http://www.medscape.com/pages/editorial/pressreleases/pr-crm-cardima1

http://tinyurl.com/EthicalIssuesCardiology

********** CALKINS: Among these sources of outcome data, it is well recognized that data derived from large prospective randomized clinical trials most accurately reflect the outcomes that can be anticipated when a procedure is performed in clinical practice. Unfortunately, as of the time this document was prepared, there have been no large randomized multicenter clinical trials performed to determine the safety and efficacy of catheter ablation of AF. http://www.medscape.com/viewarticle/558137_3 2007

***** CALKINS Mitral valve trauma Entrapment of the mitral valve apparatus by a curvi-linear electrode mapping catheter is an uncommon complication of AF ablation.290Go,291Go It results from inadvertent positioning of the circular electrode catheter into the ventricle with counterclockwise rotation of the catheter resulting in entrapment of the circular catheter in the mitral vale apparatus. When suspected, it is important to confirm the diagnosis with echocardiography. Although successful freeing of the catheter has been reported with gentle catheter manipulation and advancing the sheath into the ventricle, great caution must be used as it is possible to tear the mitral valve apparatus. It is recommended that if gentle attempts to free the catheter fail, elective surgical removal of the catheter should be performed. http://europace.oxfordjournals.org/cgi/content/full/9/6/335?ck=nck#EUM120C51 (2007)

Cardima submitted the PMA to the FDA on Sept. 20, 2002, and was granted expedited review status by the FDA on Nov. 5, 2002. Cardima announced on March 6, 2003, that the FDA has set a May 29, 2003, Circulatory System Devices Panel date to review the REVELATION(R) Tx PMA application. Clinical trial data from the REVELATION(R) Tx microcatheter demonstrated safety and promising efficacy. http://www.allbusiness.com/legal/health-care-law-drug-medical-devices-approval-fdas/5716900-1.html

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§4–401 of the Maryland Code

A provider may not knowingly or willfully destroy, damage, alter, obliterate, or otherwise obscure a medical record, hospital report, laboratory report, X-ray report, or other information about a patient in an effort to conceal the information from use as evidence in an administrative, civil, or criminal proceeding. A provider who violates any provision of this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $5,000 or imprisonment not exceeding 1 year or both. http://mlis.state.md.us/asp/web_statutes.asp?ghg&4-401

Sharon-Lise Normand, Ph.D.; Christopher J. White, M.D.; Alberto L. Waldo, M.D.; Francis R. Gilliam III, M.D.; David S. Schwartzman, M.D.; Thomas Ferguson, M.D.; William Maisel, M.D. M.P.H.Waldo: Consultant: BioSense Webster, Inc., Reliant Pharmaceuticals, GlaxoSmithKline, ev3, Sanofi, Boehringer Ingelheim, CryoCor, Inc.; Royalties: Mosby; Speaker’s Bureau: Reliant Pharmaceuticals, Sanofi, Boehringer Ingelheim    http://www.acc.org/accel_disclosures.htm Dr. Waldo has reported that he has received grants for educational activities from Medtronic and Pfizer. He has served as an adviser or consultant for Pfizer, Solvay, Aventis, and CryoCor. He is on the Events Committee for Cardios-Webster. He has received honoraria for lectures from Medtronic and Pfizer. He is on the Speakers’ Bureau for most drug companies that market antiarrhythmics. http://cme.medscape.com/viewprogram/2338GilliamIII F.R.G.: Consultant (Boston Scientific), Speaking honoraria (Boston Scientific, Medtronic, St Jude Medical, Phillips Medical), Advisory boards (Boston Scientific), Research funding (Boston Scientific) http://europace.oxfordjournals.org/cgi/content/full/eup055Tracy: Dr. Tracy has disclosed that she has received grants for clinical research from Guidant http://cme.medscape.com/viewarticle/452817Calkins: Consulting Fees/Honoraria/Interests/Stock Options/Advisory Board/ Speaker’s Bureau/Fellowship Support: Biosense Webster (Significant), Ablation Frontiers (Significant) ProRhythm (Board of Directors), IRhythm (Equity Owner) , CryoCor, St Jude Medical, Reliant, Bard, Guidant, Medtronic, Sanofi Adventis, TASER International

Clyde W. Yancy, MD, FACC, FAHA

Disclosure: Clyde W. Yancy, MD, Professor of Medicine/Cardiology, University of Texas Southwestern Medical Center, Dallas; Director, Heart Failure/Heart Transplantation, St. Paul University Hospital, Dallas, Texas has disclosed that he has received grants and clinical research support from GlaxoSmithKline, Scios, Medtronic, and NitroMed. Dr. Yancy has also disclosed that he has served as a consultant for GlaxoSmithKline, AstraZeneca, Scios, Medtronic, and NitroMed. Dr. Yancy has also disclosed that he has served on the speaker’s bureau for GlaxoSmithKline and Novartis

Medtronic

Calkins, Waldo, Gilliam

ACC/AHA/ESC Guidelines for the Management of Patients With Atrial Fibrillation 2001: http://circ.ahajournals.org/cgi/content/full/104/17/2118“Ablation of these foci eliminates or reduces the frequency of recurrent AF in more than 60% of patients, but the risk of recurrent AF after a focal ablation procedure is still 30% to 50% over the first year and even higher when more than 1 pulmonary vein is involved. Thus, many patients continue to require antiarrhythmic drug therapy after ablative therapy of AF (¹⁵³). Potential complications of catheter ablation for AF include systemic embolism, pulmonary vein stenosis, pericardial effusion, cardiac tamponade, and phrenic nerve paralysis. Thus, although these procedures have produced promising results, they have not yet been widely applied.” Circulation November 7, 2000 “Dofetilide should be considered an important new treatment option for patients with AF”"

The treatment should not be worse than the disease itself.”http://circ.ahajournals.org/cgi/reprint/102/19/2385?ijkey=1afa008ccb8bbf6da31ae357458ca7e37315ae91 Wellens HJ. Pulmonary vein ablation in atrial fibrillation: hype or hope? Circulation. . 2000; 102: 2562–4. http://circ.ahajournals.org/cgi/ijlink?linkType=FULL&journalCode=circulationaha&resid=102/21/2562 Dofetilide is “Proven Effective for Pharmacological Cardioversion of Atrial Fibrillation.”

“Uh… You Weren’t There that Day…”

I couldn’t believe what I was hearing. I was listening on an old Bakelight telephone I’d picked up at the Goodwill years before. It sounds much more clear than any telephone manufactured today. So when Hugh Calkins told me an out and out lie, there was no mistake about it.

After months and months of research, trying to understand what went wrong, it dawned on me one evening that we were not told how risky catheter ablation for atrial fibrillation was. I had been reading medical journals

Agency’s Freedom of Information Office, Room 12A-15 of the Parklawn Building

*****

in2001: The concept of catheter ablation of focal atrial fibrillation emerging as  a first line treatment option is likely to become a reality.

in 2006:  catheter ablation of AF in general should not be considered as first line`therapy. It is important to recognize that catheter ablation of AF is a demanding technical procedure that may result in complications. Patients should only undergo AF ablation after carefully weighing the risks and benefits of the procedure…. http://www.hrsonline.org/Policy/ClinicalGuidelines/upload/HR-and-Euro-Copy-for-Print.pdf

The Internet

1999 Bad year for Cardiac Pathways. Sunnyvale’s Cardiac Pathways Corp., a maker of heart diagnostic products, was at the very bottom of the list, with its stock down 82 percent for the year. The company is still awaiting approval from the U.S. Food and Drug Administration for a system that uses ultrasound technology to treat heart abnormalities. (Year End 1999) http://www.sfgate.com/c/a/2000/01/01/BU106661.DTL

Top U.S., European Physicians Discuss Clinical Application at Pre-NASPE Symposium WASHINGTON–(BW HealthWire)–May 17, 2000 The RPM system, the only commercially available system to integrate real-time, 3D-catheternavigation with state-of-the-art ablation technology, is designed to assist physicians in accurately manipulating catheters within the heart during procedures without the aid of fluoroscopy examination by means of the fluoroscope. The Chilli Cooled Ablation System uses closed-path fluid circulation to control the catheter tip temperature during ablation. By controlling the temperature, electrophysiologists are better able to deliver energy to ablate cardiac tissue responsible for the arrhythmia arrhythmia , disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of . Design improvements to the Chilli catheters enable clinicians bi-directional steering capability in real-time and integrate the company’s ultrasound transducer transducer, device that accepts an input of energy in one form and produces an output of energy in some other form, with a known, fixed relationship between the input and output. technology. “Used together, these new, groundbreaking products provide electrophysiologists with the toolsand the technology that will deliver improved productivity for the EP lab. It is our hope toprovide a better quality of life for patients with arrhythmias by using a procedure that is safe,easy to use and cost-effective,” said Thomas M. Prescott, President and CEO of Cardiac Pathways. Hugh Calkins, M.D., an electrophysiologist with John Hopkins University of Medicine and PublicHealth, spoke to the system’s utility during a pre-NASPE symposium at the Grand Hyatt Hotel lastnight. Dr. Calkins, along with his colleague, Dr. Ronald Berger, has performed a number of procedures using the Cardiac Pathways’ RPM system and has been impressed by its ease of use and intuitive nature. “The 3D display of information enables the creation of linear lesions to within 1-2 millimeters of accuracy,” Dr. Calkins said. “I can see the entire scope and trajectory of the catheters, and it is my hope that I will be able to manipulate the catheters within the system, so I will no longer need to use fluoroscopy.”

*** Wharton 2001 It is clear from the available information that curative ablation approaches for AF are rapidly advancing, but too little is known at present to advocate widespread implementation. In particular, given the potential for serious complications, even with ablation of AF initiators in healthy individuals, it is difficult to advocate ablation as front line therapy in advance of traditional pharmacologic approaches. Furthermore, the procedures are technically difficult, arduous, time-consuming, and are not cost-effective. Given the risks of serious complications, even in experienced hands, a loud note of caution must be expressed concerning widespread application by individuals who are inexperienced in technical aspects of the procedure, such as trans-septal catheterization, pulmonary vein ablation, and linear lesion creation in the left atrium. Appropriate educational guidelines need to be established in order to ensure safe application of these approaches in the community….More importantly, rates of major complications in the prospective studies have been unacceptably high, occurring in approximately one-quarter of patients. Although symptomatic control with continued antiarrhythmic drug therapy can be achieved in the majority of patients, the high rates of serious complications significantly limit application of these procedures to only a few, heavily symptomatic patients, and hamper enrollment of patients in studies evaluating new technologies that are aimed at simplifying the procedure. Limitation of the linear lesions to the right atrium greatly simplifies the procedure and avoids the potential risks associated with creation of linear lesions in the left atrium. Right-atrium-only linear lesion sets rarely cure patients with paroxysmal AF, however, and are ineffective in chronic AF [16,19,20]. Selected patients with paroxysmal AF may have high rates of cure [20], but the criteria for selection of these patients are not well defined. http://tinyurl.com/Wharton2001

Calkins Linear lesions, 2007: However, this strategy may be counter-productive, as linear lesions may themselves be proarrhythmic, especially if incomplete.

CALKINS 2007 “… Over the past five years, the technique of catheter ablation for atrial fibrillation (AF) has evolved from being an experimental procedure…” http://www.medscape.com/viewarticle/558370_4

Calkins 2007: Entrapment of a catheter in the mitral valve results from inadvertant positioning of the catheter into the ventricle with counterclockwise rotation… Heart Rythym, Vol. 4 No. 6, June, 2007 http://www.i-sis.org.uk/isisnews/i-sisnews11-14.php:

####

Scientists at Johns Hopkins serve as paid consultants and scientific advisers to corporations. The university filed more patent applications in 1999 than all but two other major research centres. It helped launch 18 companies in recent years, and corporate-sponsored research at the medical school has nearly quadrupled in the past decade. Johns Hopkins is taking a permissive attitude towards its scientists researching products on which they have financial stakes. For example, a senior scientist was allowed to test an experimental vaccine developed by a company he co-founded. Tiny Magnetic Resonance Imaging devices were tested on humans by scientists who invented the devices, developed by a company that the scientists and Johns Hopkins partly own. Dr. Bart Chernow, then vice dean of research at the medical school, proposed a business partnership to Craig Venter of Celera, the private company that sequenced the human genome, back in 1998. He boasted that Johns Hopkins was “one of the biggest biotech companies in the world”, and suggested that the school could supply Venter with blood and tissue samples from some of the 100,000 patients that Johns Hopkins scientists see each year. “There is this supposed immorality in trying to patent genes and develop new medicines,” Chernow said, shaking his head. But Johns Hopkins, he said, had finally recognised that industry was not its adversary but its greatest ally. On 19 July 2001, the US government ordered a suspension of all clinical trials in Johns Hopkins following the death of a previously healthy 24 year old volunteer in an asthma experiment, for which the University accepted full responsibility. The shutdown lasted 3 days, but 2 200 research protocols will have to be reviewed by ethics board before they can recommence [6]. ______________________________________________________________________________________________ http://www.hindu.com/fline/fl1817/18170090.htm The most striking example for well-known academic-research institutions in the U.S. having such links with industry is perhaps the Johns Hopkins University (JHU) itself. Spurred by the fear of being left behind in the race for research funds and top-notch faculty and students, the institution, once dedicated to pure research, is now in the forefront of universities trying to forge partnerships with business. After the cancellation of federal funds following the death of a “healthy volunteer” participating in an asthma study at the JHU on June 2, the university has remained in media focus with regard to the growing involvement of clinical investigators and research institutions with business. According to a report in The Baltimore Sun, the university had filed more patent applications in 1999 than all but two other major research centres in the U.S. Moreover, in recent years the JHU had helped launch 18 companies, and the volume of corporate-sponsored research at its medical school had nearly quadrupled in the last 10 years, the report said. http://www.cardiosource.com/ExpertOpinions/hottopics/article.asp?paperID=228 ________________________

CALKINS: “I think all of us are aware of the fact that the published literature probably tremendously overestimates the true efficacy of catheter ablation…”http://tinyurl.com/CalkinsFDAProRhythm 2007

DR. YANCY:  This is just a generic comment, so please don’t interpret it as being directed towards you, but one does wonder if there are inducements for the investigator to more avidly enroll based on reimbursement, because we certainly have to support our clinical enterprise.

CALKINS: So we — you know, there’s a lot published on afib ablation, but if you look at how it was collected and how much monitorin was done for asymptomatic and afib, and if they did it, none of the studies tell you what the compliance was to the monitoring protocol. So I think you’re just asking fo trouble with this objective performance  criteria, unless you pick 20 percent as your target efficacy or something like that.  So I think that would be a very poor approach.  And the bigger challenge, which I think the group should comment on, which I think we struggle with is the issue of asymptomatic afib.  And the guidance document now says that the goal should be elimination of symptomatic afib.  So if you take the extreme patient, which we’ve seen in prior studies, they show up in paroxysmal afib.  You do an ablation procedure. They come back six months later in permanent afib but they’re asymptomatic.  And according to the current guidance document, that’s successful.  The patient’s asymptomatic.  They have no symptomatic afib.  It’s a success.  But hopefully everyone on the panel would say if you went in with an intention of getting rid of afib and now you have permanent afib, it’s hard to call that a success.  And yet the primary end point of all these studies says that patient’s a success. And we all know about placebo effect you know, it’s the same thing if you go into a late afib and you end up with a left atrial flutter that’s incessant, you could call that successful because afib’s gone.  Now you have an iatrogenic left atrial flutter.  And prior studies that have been published have called that patient successful.

DOUGLAS PACKER, MAYO Clinic: all studies of A.F. ablation should include a complete reporting of major complications which is actually not done currently.

DR. MORRISON:  Well, I would just like to ask the other members of the panel if any of them are as shocked as I am to hear the FDA say we’re designing trials where the sample size is based on safety rather than efficacy. I can’t think of a procedure in the history of medicine where we’ve gone to patients and say this is very expensive, it’s very dangerous, we have no idea what good it does you, but we’d like to do it, and if we can talk you into a trial we’re just going to see how many of you have serious adverse events… And to put it bluntly, as a non E.P. person, I’m just anxious to give you all enough rope to hang yourself, because I think what you’ll demonstrate — what is likely that you will demonstrate in low-risk people wh0 have lots of symptoms is that it’s very hard to demonstrate, even compared to beta blockers and calcium blockers, that ablation changes life very much.

DR. KOCHERIL: Quite frankly we don’t know.  I think the big picture here is that we got good results.  We got symptomatic AF episode reduction and I think we were doing some good.  The animal data is very helpful.  It shows that adequate transmural contiguous lesions can be delivered with this catheter system employed in the fashion we were using it in the clinical trial.  But aside from telling you that that was what was looked for, there’s no good way to confirm that it confirms an adequate lesion.

Cindy Tracy: “The cat is out of the bag …“http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3442t2a.pdf

1998 FDA meeting to set up guidelines for Afib.

FDA asks cardiologists for input on how best to design clinical trials for ablation procedures for Atrial Flutter and AFib.  Randomized trial or single arm.

*************** CALKINS

Understanding the Expert Consensus Recommendations on AF Ablation: Impact on Clinical Practice and Patient Care

this document will allow them to very quickly get through the learning curve and be able to start at a fairly high level instead of having to make mistakes trying to figure out some of these things on their own. All of us have heard of terrible outcomes following AF ablation, partly due to lack of physician awareness. We wanted to get the physician community up to a standard level of practice as quickly as possible to reduce the painful learning curve and the risk of patient complications. the field of AF ablation is relatively young, there’s not sufficient data published from large studies to develop a detailed guideline. the procedure has very significant risks, a 2%-6% major complication rate — even higher in some literature. And some of the complications are lethal. If a physician does an AF ablation as a first-line treatment in a 35-year-old patient, and an esophageal fistula develops and the patient dies, the physician is going to feel pretty bad about that. They will wonder why they didn’t try a drug first. So this is an acknowledgment that with this procedure, death and stroke are both very real complications. It’s not acceptable anymore to say ‘we had an 80% success rate’ and then only in the fine print somewhere in the document disclose that 40% of patients required two procedures. http://www.medscape.com/viewarticle/558137_3 (2007) HUGH CALKINS: “In contrast to catheter ablation of accessory pathways and atrioventricular nodal reentrant tachycardia, for which detailed mapping is necessary to identify appropriate sites for energy delivery, sites for catheter ablation of atrial flutter and atrial fibrillation, for example, are identified almost entirely on an anatomic basis. Although the feasibility of anatomybased catheter ablation has been demonstrated with standard catheter ablation techniques, these procedures are extremely time-consuming, require prolonged fluoroscopy exposure, and have been associated with a high incidence of complications.”http://circ.ahajournals.org/cgi/reprint/102/6/698.pdf

“Our goal, and [that of] everybody involved in atrial fibrillation ablation, is to develop a safe and effective procedure that can be applied broadly to patients worldwide who have paroxysmal and persistent atrial fibrillation,” said Calkins. “Our hope is that within the next five years these procedures will be associated with long-term success rates greater than 90% and complications rates less than 1%.”http://www.theheart.org/article/789667.do “Heart rhythm societies develop consensus statement on catheter and surgical ablation of AF” 2007

J Marcus Wharton Section of Clinical Cardiac Electrophysiology, Duke University Medical Center, Durham, North Carolina, US “Furthermore, the procedures are technically difficult, arduous, time-consuming, and are not cost-effective. Given the risks of serious complications, even in experienced hands, a loud note of caution must be expressed concerning widespread application by individuals who are inexperienced in technical aspects of the procedure… “ Current Controlled Trials in Cardiovascular Medicine 2001, 2:67-70 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=59627

***

Guidelines for supervisor presence at at stress test, what about ablation? http://circ.ahajournals.org/cgi/reprint/102/14/1726.pdf

COMPLICATION RATES AT HOPKINS:

All patients (n = 517) undergoing catheter ablation for AF at Johns Hopkins Hospital between February, 2001 and June, 2007 were prospectively enrolled in a database. Data from 641 consecutive procedures were analyzed and complications considered if they occurred within 30 days of ablation. Major complications were defined as those that required intervention, resulted in long-term disability, or prolonged hospitalization. Results: Thirty-two major complications occurred in 641 procedures (5%). Among the patients with major complications, seven had cerebrovascular accident (CVA), eight had tamponade, one had PV occlusion with hemoptysis, and 11 had vascular injury requiring surgical repair and/or transfusion. No periprocedural deaths occurred, and no instances of esophageal injury were seen. Complication rates were higher during the first 100 cases (9.0%) than during the subsequent 541 (4.3%).  CALKINS Journal of cardiovascular electrophysiology 19(6):627-31, 2008 Jun

Hugh Calkins told Pam and me that there had never been any complications with the procedure at Hopkins. His report above states that there were 641 procedures in 65 months. That’s roughly 10 per month. If procedures began in Feb ‘01 and Pam had her procedure in March ‘02, that means that  130 procedures were done in the 13 months before Pam’s. Calkins says the complication rate was 9% during the first 100 cases, meaning that there would have been at least 11 complications with this procedure before Pam had hers.

Who signed off on buying the biosense webster ablation system?

“Today it can take $60, $80, $100 million, or more to get a PMA-based medical device company to cashflow positive. If the public market is not available, where does that money come from? As companies look to complete large late-stage rounds of $25-40 million, CEOs increasingly are looking to privateequity for investment dollars. What is private equity and how do you access it? At what stage does acompany become an attractive investment for a private equity or hedge fund? Join a CEO and severalprivate equity investors as they discuss how to identify these important late-stage players and how tounderstand what it takes to get a funding commitment” http://www.docstoc.com/docs/3905699/TUESDAY-JUNE-p-m-WEDNESDAY-JUNE-a-m-p-m http://www.wsgr.com/WSGR/Index.aspx

www.fda.gov/ohrms/dockets/ac/07/briefing/2007-429

“I think all of us are aware of the fact that the published literature probably tremendously overestimates the true efficacy of catheter ablation…” Hugh Calkins http://www.fda.gov/OHRMS/DOCKETS/ac/07/transcripts/2007-4318t2-02.pdf

“These trials tend to be small ones, at single medical centers. They may be aimed at polishing a doctor’s résumé or making a center seem at the vanguard…   Others studies, by companies, are designed to persuade doctors to use their drugs.” NYT CANCER trials… http://www.nytimes.com/2009/08/03/health/research/03trials.html?ref=todayspaper

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I strongly suspect that David Erdman is the figment of some copywriter’s imagination – but if he does exist, I’d be curious as to his current condition, because ablation of the inside of the pulmonary veins was abandoned after practitioners ran in to an “unforeseen complication” called pulmonary vein stenosis. Basically, the veins that supply blood to the heart become occluded and start to close off. In fact Hugh Calkins was one of the earliest to sound the alarm:

He wrote this in 2001:

” … And a final obstacle was the growing appreciation that pulmonary vein stenosis may occur as a complication of catheter ablation within the pulmonary veins…”

And he told this to the FDA in 2003, the same year he was enticing patients with the Dave Erdman success story:

“What we’ve learned obviously as we look back, years ago we were ablating deep into the pulmonary veins creating all this pulmonary vein stenosis thinking we were doing good. At the end of the day, a lot of people were stepping back and saying ‘We have to be out of the pulmonary veins for that.”

Calkins may have been stepping back and telling colleagues what he really thought, but he certainly was not telling patients what he really thought.

Eventually, Calkins backed off his claims for a cure altogether — going so far as to suggest the word “cure” be banned in the literature

***

Catheter Ablation of Afib: Two Techniques Compared

Remarkable advances have been made recently in catheter ablation techniques for atrial fibrillation (AF). In fact, 2 techniques that specifically target the pulmonary veins (PVs) have had favorable results. Segmental ostial ablation involves electrical isolation of targeted segments of the PV ostia. With circumferential ablation (also known as left atrial ablation), the PVs are completely encircled electrically. In a randomized trial, researchers compared the 2 techniques in 80 consecutive patients (mean age, 52) with symptomatic paroxysmal AF. Patients with left atrial size >55 mm were excluded.

Segmental procedures were guided by a lasso catheter, whereas circumferential procedures were guided by an electroanatomic mapping system. Procedure duration did not differ significantly between the 2 groups; fluoroscopy duration was shorter in the circumferential group, but not significantly so.

By 6-month follow-up, significantly more patients in the circumferential group (88%) than in the segmental group (67%) were free of symptomatic paroxysmal AF without taking antiarrhythmic drugs. Repeat procedures were necessary in 18% of the segmental group and 0% of the circumferential group. The only complication was left atrial flutter in 1 patient in the circumferential group.

Comment: In this first randomized comparison of circumferential ablation with segmental ostial ablation, the circumferential technique was more effective in keeping patients free of paroxysmal atrial fibrillation for 6 months. Although the positive results bode well for the circumferential technique, we must remember that long-term success has yet to be established and that the potential for serious complications is real (in most series, 0.5% to 1% each for stroke, PV stenosis, and cardiac tamponade). For now, only patients with highly symptomatic paroxysmal AF who have failed at least 1 antiarrhythmic drug should be considered for catheter ablation using either of the 2 tested procedures.

— Hugh Calkins, MD

Published in Journal Watch Cardiology January 23, 2004

***

The catheter that Richard Wu took out of its wrapper that morning was of a kind he had never seen before.

***

The catheter  was a Biosense Webster LASSO™ Deflectable Circular Mapping Catheter, which Hugh Calkins would later declare to be a dangerous instrument.

It was was manufactured by a division of  Johnson & Johnson, and the version Richard Wu snaked into to wrong chamber of  my wife’s  heart was approved by the FDA in 2000.  Biosense Webster got approval for the catheter by telling the FDA that, except for a few minor improvements,  it was essentially the same as the one that came before it, the T20 Diagnostic Deflectable Tip Catheter, which the FDA had already approved.  Thus there was  no need for studies on safety and effectiveness. The T20 was designed and manufactured by Webster Laboratories, before it was bought by the Cordis Corporation, before Cordis Corporation was bought by the Biosense Corporation, which was bought by Johnson & Johnson.

As was the case with the Lasso catheter, Cordis Webster got approval for the T20 catheter in 1995 by telling the FDA that, except for a few minor improvements,  it was essentially the same as its predicate device, the Cordis Webster Deflectable Tip Catheter — and there the trail goes cold. One would have to write to the Johnson & Johnson to further pursue the provenance of the  Lasso catheter.

I imagine that the original catheter from which all subsequent versions were designed and approved must have looked like the business end of a coat hanger, which probably wouldn’t recognize itself in the year 2000. As Johnson & Johnson proudly points out in their 2000 application for approval, “The Lasso Mapping Catheter is substantially equivalent to the predicate devices — with the addition of the Nitinol formed ‘Lasso’ assembly. The platinum ring electrodes are located on the lasso assembly rather than on the catheter tip…”

So, it’s pretty much the same, but it’s different. Like the last one, and the one before that …

But Hugh Calkins later laid the blame for what happened to Pam on the the Nitinol formed “Lasso” assembly:  “… the circular spine of our catheter became entangled in the chordae tendineae. The design, relative stiffness, and entrapment of the preformed circular spine in the mitral apparatus prevented complete straightening or relaxation of the circular tip. We suspect that the abrasive nature of the 20 electrodes caused resistance, which contributed to the inability of the catheter to slide off the mitral valve apparatus …”

In fact, the very “Lasso” assembly which was spared regulatory scrutiny — on the manufacturer’s say so — has gotten tangled in so many mitral valves since Dr. Richard Wu pioneered  the technique that  doctors at Harvard published a paper about how to deal with such a “complication” in 2004.

So Hugh Calkins, who was among the pioneers boldly and blindly exploring of the left atrium of the heart in the search for a cure for Afib, laid claim to being the first EP to have lost a mapping catheter in a mitral valve. Dr. Keane may have outdone his old Harvard pal by figuring out how to get Lasso catheters untangled without killing the patient, but it was Hugh Calkins who laid the foundation for all the great works that followed.

In 2006, a few Swedes, named Englund, Jensen, and Jensen-Urstad, got into the weeds with Lasso catheters and mitral valves. Their paper, Entrapment of Circular Mapping Catheter in the Mitral Valve,  describes “three patients with entrapment during ablations for atrial fibrillation. The entrapments occurred with three different operators at three different electrophysiological laboratories within 2 years. The complication described here may be more common than is widely appreciated.  From our figures, we estimate the incidence of the complication to 0.9%”

The irony is that the design of the catheter was not the primary cause for what happened to Pam.

Whatever the design of the catheter, it had no business in the mitral valve muscles of Pam’s heart. It got there because Hugh Calkins let a trainee do the job. He knew it was a tricky operation which should have been performed by someone of considerable skill and experience, and he knew that his patient believed that would be the case. Cardiologist Howard Cohen, speaking of invasive procedures, said “I always like to ask, ‘Does it meet the mother test?’ That is, would you want your mother to undergo such an intervention?”

I wonder  whether Hugh Calkins asks himself that question  as he  blythely follows his custom of  showing up “to be there” to  watch a rookie sweat out the trickiest part of a difficult, high risk procedure.

***

Irvine Biomedical, Inc. Announces the Completion of Phase I Clinical Trials With the Super-4 Catheter Ablation System For the Treatment of Type I Atrial Flutter.

IRVINE, Calif., Feb. 14 2000/PRNewswire/ — Irvine Biomedical, Inc. announced today that it has successfully completed Phase I clinical trials with the Super-4(TM) Ablation System, indicated for use in the treatment of Type I Atrial Flutter. This preliminary study involved the treatment of a total of 10 patients at three separate clinical sites. The clinical sites and principal physicians are as follows: The Johns Hopkins University Medical Center, under the direction of Dr. Hugh Calkins; the University of Alabama at Birmingham, under the direction of Dr. G. Neal Kay; and the Virginia Commonwealth University/Medical College of Virginia, under the direction of Dr. Ken …

*********************************************

The American Medical Association Council on Ethical and Judicial Affairs “Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all facts necessary to ensure understanding of what has occurred….

A physician who uncovers evidence of major errors by colleagues or identifies possible flaws in medical devices faces an ethical dilemma. Such situations may arise when a physician witnesses an error or flaw directly, or when a patient is referred by a colleague or third party for corrective treatment. Physicians are ethically obliged to facilitate disclosure to individual patients; they also should report new and serious medication-related adverse events and possible medical device defects to the relevant regulatory agencies and manufacturers. But when should a physician report previously undocumented problems at professional meetings or in peer-reviewed journals? Currently, no published ethics guidelines mandate a physician to publicly disclose adverse events or device flaws.

An individual physician generally sees only a small percentage of patients treated with a specific medication or medical device. Isolated physicians often have difficulty proving a causal relationship between the adverse event and a medication because individual physicians rarely have sufficient data for meaningful statistical analysis. Publication of poorly supported suspicions or opinions may inappropriately malign valuable procedures, medications, or devices. Even vague and unsupported suspicions may have dramatic commercial repercussions for a device manufacturer or biotechnology company. Physicians may be reluctant to publish unfavorable findings because of the lack of definitive proof, fear that unsupported disclosure will lead to libel suits, and concern about undermining professional relationships with colleagues or medical companies…. Disclosure of serious medical errors to patients generally is the best ethical and clinical course. Patients have a fundamental . Furthermore, most major errors ultimately are exposed with or without physician disclosure, and patients are more likely to be aggrieved and to sue physicians who are perceived as deceitful.^… The American Medical Association Council on Ethical and Judicial Affairs states, “Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.”

The fear of damage to reputation and loss of respect from peers may also inhibit physicians from disclosing errors. Error disclosure to peers must be recognized and accepted as a fundamental part of a comprehensive error-reduction program. Guidelines should be created that describe when physicians should disclose medical errors, particularly system-wide errors. The guidelines should also describe a course of action when one identifies errors made by others (including directly notifying the physician in error) or describes an error he or she has made. In particular, physicians-in-training must be notified in such a way that helps maintain their confidence and professional development….  Similarly, institutions prize their reputations, and nonstatutory reporting of medical errors is unlikely.

http://www.chestjournal.org/content/131/3/890.full

And, and I wouldn’t be surprised that, in the future, we continue those types of efforts, where we may be coming to you a little bit more informally, asking for your good clinical, as well as pre-clinical, opinions on various issues of clinical design that we might be struggling with at the time.

I think that being able to air some of those concerns, as well as having input from industry and the public, helps to put them in the forefront, so that when we sit down and we actually do a lot of the behind-the-scenes work that’s not necessarily out in the open, we’re able to have a little bit of a more level footing when we’re dealing with the individual manufacturers. So, that’s currently where those efforts are. http://www.fda.gov/OHRMS/DOCKETS/AC/00/transcripts/3628t2.rtf

**********************

Believe it or not, today’s FDA is a vastly improved organization.

The law requires that ordinary citizens be allowed to comment  during the approval process.  Unfortunately, not many ordinary citizens exercise their rights to attend. http://www.fda.gov/OHRMS/DOCKETS/AC/00/transcripts/3628t2.rtf

*****

1999 was a busy year for Calkins. In addition to the Cardima work, we was a Principle Investigator in at least 14 other projects.  St. Jude Medical  was testing out  a new Implantable Defibrillators in nonischemic cardiomyopathy,”

the PI for “Evaluation of high density array catheters in patients with ventricular tachycardia (Cardiac Pathways)

PI for  “Low energy safety study” (LESS): Efficacy of Ventricular defibrillation with low energy margins (CPI) (P.I. H. Calkins) Guidant ICDs

Cardiac Pathways was running a study to  evaluate  catheters in

with ventricular tachycardia (Cardiac Pathways)

Co-investigator, “An evaluation of radiofrequency ablation in the right

atrium for treatment of atrial fibrillation” (P.I. H. Calkins)

Co-investigator, “Monophasic vs. biphasic waveforms for ventricular

fibrillation” (Zoll) (P.I. H. Calkins)

Co-investigator, “Monophasic vs. biphasic waveforms for atrial

fibrillation” (Zoll) (P.I. H. Calkins)

1997- 1999 Co-investigator, Co-investigator,

Co-investigator, “Feasability of using a multi-electrode catheter in the

Coronary veins for epicardial mapping of ventricular tachycardia: Implications for RF catheter ablation “ (P.I. H. Calkins)

Co-investigator, Co-investigator, “Sudden cardiac death in heart failure trial” (SCD-Heft)

(NIH and Medtronic) (P.I. H. Calkins)

Co-investigator, “ Linear-phased radio-frequency ablation system “HRT” (CPI) (P.I. H. Calkins)

Co-investigator, “Dynamic over-drive pacing for the prevention of atrial

fibrillation” (ADOPT A and B)(St. Jude Medical) (P.I. H. Calkins)

Co-investigator, “The North American Vasovagal Pacemaker Study”

(North Western University) (P. I. H. Calkins)

1998-1999 Co-investigator, “PhaseII-Evaluation of the Cardima revelation treatment

microcatheter for the treatment of atrial fibrillation” (P.I. H. Calkins)

Co-investigator, “Clinical investigation of the CPI Endotak Endurance

EZ defibrillation system” (P.I. H. Calkins)

Co-investigator, “Ventak CHF AICD Biventricular Pacing Study”

(P.I. H Calkins)

***************************

Berger Pathfinder: Cardima Successfully Treats First Patient in United States Atrial Fibrillation Study at the Johns Hopkins Hospital.

Calkins Guidant 1999 linear lesions  http://www.ncbi.nlm.nih.gov/pubmed/10089870

*****

“One thing is evident: many strategic
and practical questions need to be answered
before this approach is to be considered an established
therapy.” Editorial 2004 The European Society of Cardiology http://europace.oxfordjournals.org/cgi/reprint/6/2/79.pdf

*****

Cardima , a Fremont, Calif., medical-device company, almost doubled its market value, surging 2 13/32, or 91.7%, to 5 1/32. Cardima said it received regulatory approval to begin selling its Revelation Tx atrial fibrillation microcatheter in the European Union.http://online.wsj.com/article/SB912777708109922000.html?mod=googlewsj Dec 4, 1998

*******

Nov 18, 2004

Cardima Announces Receipt of Notice From Nasdaq Fell below $1 gets warning.

http://findarticles.com/p/articles/mi_m0EIN/is_2004_Nov_18/ai_n6366383/?tag=content;col1

**********************

December 2003

StockPickReport.Com announces stock evaluation ratings on Hecla Mining, Anheuser-Busch, Cardima Inc, Compuware Corp, Continental Airlines.http://findarticles.com/p/articles/mi_hb5243/is_200312/ai_n19961026/?tag=content;col1

M2 Presswire, December, 2003

StockPickReport.Com announces stock evaluation ratings on Hecla Mining, Anheuser-Busch, Cardima Inc, Compuware Corp, Continental Airlines(C)1994-2003 M2 COMMUNICATIONS LTD RDATE:12022003 SHREVEPORT, La. — StockPickReport.Com (IARD#119079 – makes these short-term stock recommendations: Hecla Mining Co (NYSE:HL) – WEAK BUYAnheuser-Busch Cos Inc (NYSE:BUD) – SELLCardima Inc (Nasdaq:CRDM) -

******

****************

Conclusion: Published success rates are much better than current success rates in a large single centre. It is possible that the information regarding outcome given to patients during the consent process is not accurate. EuroPace 2007

“It would be nice to know that the thousands of people that are having this procedure done every year are having it done for a good reason….  Most of the data that are out there discuss symptomatic improvement, and these are largely observational experiences, with no blinding and no randomization involved,” FDA medical officer Dr Randall Brockman told heartwire. “When you talk about improvements in quality of life or reductions in symptomatic episodes of atrial fibrillation, it’s a little hard to be sure that you’re seeing a treatment effect and not the effects of placebo. Placebo can be very powerful. We learned that from other therapeutic lines, and so we’re very sensitive to it. Catheter ablation may be very helpful and the jury is coming in, but it’s not in yet.”  2005 http://www.theheart.org/article/546039.do

“A rapidly developing therapy that relies on both recent technologies and evolving techniques…” Hugh Calkins 2002 Catheter Entrapment in the Mitral Valve Apparatus…“

Adminisphere

editing…

“This Never Happened Before”

When something bad like this happens, you naturally get pissed-off at the responsible party.  When Hugh Calkins first described the complication, I’m sure that’s the reaction he was expecting from me. He was short. He was meek.  He wore thick glasses. He was    dripping with sincerity, appalled that his own actions led to this terrible thing that happened to my wife. But it had never happened before, and the catheter was actually to blame because once in got tangled in the muscles of the mitral valve, you couldn’t get it out. It was a design flaw. He himself was a victim as well, for he would forever carry the guilt of what had happened. It was hard to get mad at the guy.  He was Piggy from Lord of the Flies.  Plus, I still had faith in the institution and its people.   I believed in him.  I’d seen no reason to change my estimation of him as a physician who cared deeply about his patients and would do his very best to protect them from harm. I wanted to believe it. I thought, OK, tragedy all around. Concentrate on getting her fixed up.

He wrote this about Pam’s procedure: “A review of the literature reveals that catheter entrapment in the mitral valve has been reported in association with catheter ablation procedures.”  He cites two cases.

I found a few more — and it wasn’t very difficult. To quote Hugh Calkins himself: “Because the nature of complications for cardiac catheterizations is similar, the same format for presenting complications is used to summarize theses articles.”

1991 “Aortic valve leaflet perforation during radiofrequency ablation.” PACE Seifert MJ, Morady F, Calkins HG, Langberg JJ. Division of Internal Medicine, University of Michigan Medical Center, Ann Arbor 48109. http://www.ncbi.nlm.nih.gov/pubmed/1721146

1992: “One patient developed valvular damage as a conse-quence of catheter trauma. The patient was noted to…other complications resulted from catheter placement and manipulation. Hugh Calkins, Circulation 1992;85;1337-1346

1993 “In such a situation, the catheter should be carefully manipulated in order to avoid entrapment into the mitral valve apparatus.” Hindricks G: (MERFS): complications of radiofrequency catheter ablation of arrhythmias. Eur Heart J 1993, 14:1644-1653.

1994 “Catheter entrapment in the mitral valve apparatus during radiofrequency ablation. Conte, Geiser, Curtis, Pacing Clin Electrophisiology  17:1681

1994 “Complications associated with radiofrequency catheter ablation… Valve damage.” Annals of Internal Medicine

1997 The following potential adverse events are applicable to all catheterization and ablation procedures in general and are not dependent on catheter type: … valvular damage. … Complications associated with cardiac catheterization have been reported in the literature… valvular damage.” http://tinyurl.com/CordisWebster-IFU

1998 “We describe a patient with Wolff-Parkinson-White syndrome in whom a catheter became entrapped in the mitral valve apparatus during radiofrequency ablation. Pacing Clin Electrophysiol.Apr;21(4 Pt 1):772-3.

1999 Calkins report of valve damage during catheter ablation : (Circulation. 1999;99:262-270.) 1999 “Certain risks are associated with RF ablation. They include the general risks of any cardiac catheterization, such as… valvular damage” Hein J. J. Wellens, MD http://circ.ahajournals.org/cgi/content/full/99/2/195 w/editorial specifically citing Calkins: http://circ.ahajournals.org/cgi/content/full/99/2/262)

1999 “Adverse events which may be associated with catheterization and ablation include …valvular damage.” Cardiac Pathways Chilli Cooled Ablation System Information for Use, 1999: http://www.fda.gov/cdrh/pdf/P980003c.pdf

2000 “… Damage to the mitral valve apparatus from catheter manipulation can occur.” http://heart.bmj.com/cgi/content/full/84/5/553 2000 “Serious complications can occur and include valvular  disruption.” American College of Cardiology http://circ.ahajournals.org/cgi/content/short/102/18/2309

2001 “Complications associated with catheter ablation… may result from catheter manipulation valvular damage…” Hugh Calkins 2001;85;594-600 Heart

2001 Cardima Evaluation Study for Revelation Catheter 2001, citing work by Hugh Calkins, who was employed by the company to work on the study. “Anticipated Adverse Effects: Valve Damage”

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4297b1_16%20-%20APPENDIX%20A%20Study%20Protocol.pdf

2001 Complications associated with catheter ablation… valvular damage… may result from catheter manipulation. Hugh Calkins: http://heart.bmj.com/cgi/content/full/85/5/594

2002 Cardima REVELATION™Tx Microcatheter System and NavAblator™ Ablation Catheter Evaluation of Radiofrequency (RF) Ablation for Atrial Fibrillation in the Right Atrium Anticipated Adverse Effects Possible adverse effects that may be anticipated in association with the investigational devices and procedure : Valve or cardiac structure damage” – Hugh Calkins

Next Chapter:

This has nothing to do with the story, but it’s interesting. A transcript synopsis of a meeting that was held on 9/11.

*****

Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation JAMA. 2010;303(4):333-340

http://jama.ama-assn.org/cgi/content/full/303/4/333

Financial Disclosures: Dr Wilber reported receiving grants from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical; consulting fees from Biosense Webster, Medtronic, and Sanofi-Aventis; honoraria from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical; and royalties from Blackwell/Futura. Dr Pappone reported receiving grants and consulting fees from St Jude Medical and Johnson & Johnson, and honorarium from Biosense Webster. Dr Neuzil reported receiving grants from Biosense Webster, Cardiofocus, Cyrocath Technologies, Hansen Medical, NIH BARI 2D, and St Jude Medical; consulting fees from Stereotaxis; and honorarium from Biosense Webster. Dr De Paola reported receiving a grant from Bristol-Myers Squibb. Dr Marchlinski reported receiving grants and honoraria from Biosense Webster, Boston Scientific, and St Jude Medical; consulting fees from Biosense Webster, Boston Scientific, GE Healthcare, Medtronic, and St Jude Medical; and speakers’ bureau fees from Biosense Webster. Dr Natale reported receiving grants from Biosense Webster and St Jude Medical, and speakers’ bureau fees from Biosense Webster, Boston Scientific, Medtronic, and St Jude Medical. Dr Macle reported receiving consulting fees and honorarium from Biosense Webster. Dr Daoud reported receiving consulting fees from BARD and Biosense Webster, and honorarium from Biosense Webster. Dr Calkins reported receiving consulting fees from Ablation Frontiers, Atricure, BARD, Biosense Webster, Boston Scientific, CryoCor, CyberHeart, Medtronic, ProRhythm, Sanofi-Aventis, and TASER International; a grant and honorarium from Biosense Webster; speakers’ bureau fees from Atricure, BARD, Biosense Webster, Boston Scientific, Medtronic, and Reliant; and fellowship fees from BARD, Boston Scientific, and Medtronic. Dr Hall reported receiving consulting fees from Biosense Webster. Dr Reddy reported receiving grants from Atritech, Boston Scientific, Biosense Webster, Cardiofocus, CryoCath Technologies, Endosense Hansen Medical, St Jude Medical, and Stereotaxis; consulting fees from Biosense Webster and St Jude Medical; and honoraria from Boston Scientific, Biosense Webster, Medtronic, and St Jude Medical. Dr Augello reported receiving honoraria from BARD, Biosense Webster, and St Jude Medical. Dr Reynolds reported receiving consulting fees from Biosense Webster, Cardiome Pharma Corp, and Sanofi-Aventis. Mr Vinekar and Ms Liu are employees of Biosense Webster. Drs S. Berry and D. Berry reported receiving consulting fees from Biosense Webster, Veridex LLC, Boston Scientific, Endologix, R.R. Bard, W.L. Gore, Medtronic, Bristol-Myers Squibb, Pfizer, and Teva Pharmaceuticals.

Funding/Support: This study was funded by Biosense Webster, who provided the catheters used.

**********

STIMSOFT:

http://www.circare.org/fdawls2/stimsoft_20031027.pdf

Two Johns Hopkins University professors are accusing the school of pressuring them to give up nearly $1 million from the sale of their company, in a lawsuit filed in Baltimore City Circuit Court.The suit also claims that several Johns Hopkins officials, including President William R. Brody, acted illegitimately to further their own self-interest.

(Brody is not named as a defendant in the suit.)Baltimore-based North Family Inc., a company owned by neurosurgeon Richard North and his wife Catherine North, an oncologist, filed the pleadings. The allegations center on the 2003 sale of Stimsoft, a company formed in part by the two doctors, for more than $10 million.When Stimsoft attempted to sell its assets in a private commercial transaction – JHU set out to extract substantial funds from the transaction, and to deprive Stimsoft of monies to which it was entitled, the complaint alleges.A Johns Hopkins spokesman declined to comment on the suit this week.Richard North, the suit states, has worked on ways to cure chronic pain associated with neurological diseases by using implanted devices to stimulate patients’ nerves with low-level electrical pulses.According to the pleadings, he developed a technology for implanted devices powered and controlled by radio frequency waves transmitted through the skin from an external source, known as RF technology.Stimsoft was formed in 1997 and in 1998 the company agreed to pay certain licensing fees and royalties in relation to the RF technology to Johns Hopkins, the complaint alleges.Meanwhile, the suit states, Stimsoft also developed the Polaris technology, which unlike the RF technology, did not involve external power.The Norths, the complaint alleges, made large loans to Stimsoft and by 2002 decided that a sale was the only way to recoup their investment.In 2003, a $10 million purchase agreement was reached with Medtronic Inc. (now known as Advanced Neuromodulation Systems Inc.), the complaint alleges. Brody was a paid member of Medtronic’s board of directors, the lawsuit states.According to the suit, Medtronic also purchased Johns Hopkins’ interest in the RF technology and then asked the university to sign a release confirming that it had no claim to the intellectual property that Medtronic anticipated purchasing from Stimsoft.Hopkins demanded $1.24 million for such a waiver, an amount that was reduced to roughly $829,000 when Richard North agreed to waive $455,000 his laboratory was due to collect from the school, the complaint alleges.The suit states that Hopkins had no legitimate interest in the Polaris technology, but the Norths paid for the waiver out of fear of losing the deal.,http://findarticles.com/p/articles/mi_qn4183/is_20060317/ai_n16143147/

****************

(In the medical literature, Hugh Calkins always confirms what Jeff Brinker wrote in 1991 about cardiac catheterization in general: The experience and knowledge of the performing physician

————-

“I think I’m going to die”

——————

Medical experiment disclosure hinges on a flawed honor system Hopkins worker death raises wider questions.

By Tom Pelton, Sun Staff, August 12, 2001

Problems at Hopkins

Dr. Greg Koski, director of the federal Office of Human Research Protections, said he doesn’t know how accurate Shamoo’s figures might be, but he acknowledges that the underreporting of “adverse events” could be a problem. Koski’s agency recently suspended most experiments at Johns Hopkins when it found systemic problems with the review of experiments after the death June 2 of volunteer Ellen Roche.

Koski said his agency will work with the National Institute of Health and the Food and Drug Administration this fall to improve the national system for monitoring experiments and collecting and sharing reports of deaths and injuries. “It’s difficult to know how much is underreported,” Koski said. “Many of these adverse events are being handled at the local level, and I don’t know if they are being handled in the optimal way. There is no question that there is room for improvement.” Koski added, however, that federal law does not require researchers to report all injuries and deaths among study subjects to his agency.

It requires reports only of regulatory violations and health problems that are unexpected and likely a result of the treatment. The agency leaves it up to researchers and university review boards to sort through the sticky problem of separating which health problems are a product of illnesses and which are side effects of the drugs. Koski’s agency, with only 45 employees, would be overwhelmed with paperwork if every research institution in the United States sent in every report of problems in the thousands of federally funded experiments across the country, said Bill Hall, a spokesman for the agency.

The number of incident reports flowing into the agency has almost tripled in recent years, rising from 100 in 1997 to 290 in 2000, with at least a third of these detailing unexpected health problems suffered by volunteers, according to the agency. The increase stems from increasing awareness of federal reporting requirements and a surging amont of medical research, Koski said. In contrast to Johns Hopkins, the University of Maryland released its adverse-events numbers when asked by The Sun.

The review boards that monitor experiments at the university’s medical school received 880 reports of “serious adverse events” to volunteers during more than 1,000 experiments last year. The university defines “serious adverse events” as “any untoward medical outcome occurring in the context of research” – which could include anything from vomiting to the deaths of seriously ill cancer or cardiac patients, according to school spokesman Larry Roberts.

The majority of these health problems, in 728 cases, were judged to be unrelated to the studies – for example, volunteers injured in car accidents while away from the hospital, Roberts said. The university reported only two cases to the federal agency because they were the only cases that were unexpected and probably linked to the treatment, and not to an underlying illness, Roberts said. One was a blood infection that a researcher mistakenly gave to a 24-year-old volunteer in a metabolism study.

Another was the death of a 61-year-old man with life-threatening heart disease who may have suffered a reaction to medications he was taking in a study, Roberts said. The Johns Hopkins University, unlike Maryland, refused to release information about the number of problems suffered by volunteers in its more than 2,700 experiments last year. Joann Rogers, a spokeswoman for Hopkins, said the university has no evidence of widespread problems with underreporting.

“We are looking to see if there are systemic problems,” Rogers said. “If there are, we are going to do whatever it takes to change that.” Shamoo and others complain that self-policing invites a lack of candor. “It’s an honor system,” said Arthur Caplan, director of the University of Pennsylvania’s Bioethics Program. “Many adverse events do not get reported because doctors and researchers don’t like to think about themselves causing harm. So if there’s something else to blame it on, like an illness, they will.”

“Few Decisions bespeak greater trust and confidence than the decision of the patient to proceed with surgery. Implicit in that decision is a willingness of the patient to put his life or her life in the hands of a known and trusted medical doctor… the doctor who, without the consent of the patient, permits another surgeon to operate violates not only a fundamental tenet of the medical profession, but also a legal obligation.” Supreme Court of New Jersey 92 N.J. at 463-465, 457 A.2d at 440-441.

———————–

“Uh… You Weren’t There That Day”

———————-

Risk Management: “You’ll Get Nothing!”

————————

The Wilmer Eye Center on Scratched Corneas: “Oh, we see a lot of that in the ICU.”
Catheter ablation of AF frequently requires the use of CT scan prior to the procedure and a long fluoroscopy time during the procedure. Further complicating the issue is the fact that AF ablation procedures are often done in the obese patient, increasing the exposure to patient and operator. Very low frame rate pulsed fluoroscopy systems have become the norm to minimize radiation exposure. Skin radiation “burns” with proper operating equipment are currently extremely rare http://www.medscape.com/viewarticle/558370_8

_______________________________________

Sitting across the desk from Paul Bekman in his office office overlooking Camden Yards…

draftdraft

Masking Malpractice Claims

Doctors can be removed as defendants as a case evolves. Paul Bekman of the firm Salsbury, Clements, Bekman, Marder and Atkins said Hopkins has asked him to drop doctors as defendants. He said he is “more than willing” to agree, because doing so speeds up settlements.

In a claim filed in 2003, Bekman named Johns Hopkins Hospital and Dr. Mark A. Talamini as defendants, accusing the surgeon of accidentally cutting a hole in John T. Adrian’s stomach during a nearly six-hour procedure to relieve acid reflux.

According to the claim, as Adrian was being wheeled into the operating room, Talamini said he planned to use a new robotic device for a “safer operation with fewer risks of complications.” The claim contends that Adrian would not have consented had he known that Talamini had “limited experience” with the device.

Adrian, 53, of Arlington, Va., spent more than a month in the hospital recovering after the operation, according to the claim.

Bekman said he agreed to drop Talamini from the claim in the early stages, at the request of Hopkins’ lawyers. That left the hospital as the sole defendant. The case is pending in Baltimore City Circuit Court. Hopkins has denied any negligence.

http://www.theheart.org/article/546039.do

Here is some mind-bending logic:

Experts say time has come for AF ablation RCTs: “Only thing missing is the data”

August, 2005

“We’re missing a lot of things at this point,” Dr Hugh Calkins (Johns Hopkins University Medical Center, Baltimore, MD) told heartwire. “Everything is based on, ‘This is how I think my patients are doing.’ If history holds true, the results are always worse when the procedure is held up to a multicenter, rigorous study, where you prospectively define the complications and evaluate. We need better data on the true efficacy and safety of the procedure in patients selected as part of a multicenter study in a rigorous, prospective fashion.”

Dr Andrea Natale, medical director for the Center for Atrial Fibrillation at the Cleveland Clinic, told heartwire that the center performs five to six AF ablations every day and that the waiting list extends from anywhere between four and nine months. Smaller centers perform fewer procedures, and their success and complication rates vary, he noted.

“Atrial fibrillation ablation is technically very challenging,” he said. “This is the deterrent for less skilled hands in embracing the procedure.”

st 31, 2005

Michael O’Riordan

Calkins predicts that there is probably a two- to five-year horizon before ablation of AF is a primary therapy. “Some doctors are pretty enthusiastic about ablation as a primary therapy, but they’re only enthusiastic until a patient has a stroke or some type of devastating consequence. Then the enthusiasm tends to go down a little bit,” he notes.
—————————-
Nurse’s notes Kristi w/ Walman Tom Waits

Kim,

Were you ever able to pin that lying little weasel Hugh Calkins down about his complication rate?

Thank You,

Dan Walter

Dan Walter wrote:

Kim Young wrote:

Dear Sir,
Thank you for your comments about an article on Cardiosource by Dr. Hugh
Calkins, Atrial Fibrillation: Drugs or Ablation. From your coments, it seems as
though your issue is with Dr. Calkins, and I recommend that you get in touch
with him directly. We are, however, seeking to get clarification of the
statement in question and will modify the paragraph accordingly. In the
paragraph above the one quoted by you (see below) Dr. Calkins states that the
complication rate for the procedure is 6%. This is clearly inconsistent with
his next comment of “one-in-a-thousand”. We will ask Dr. Calkins to clarify
this inconsistency for us , and correct it on the site.

Sincerely,
Kim Young
Senior Editor, Cardiosource

_____________________________________________

The Records

http://well.blogs.nytimes.com/2008/06/27/the-growing-disconnect-between-doctors-and-patients/

• 140.
  July 2nd,
  2008
  5:49 pm

  Dear Dan, (79);

  I apologize for mischaracterizing your quotation of the ACC guideline in your original comment (79). After reading your post, I assumed you were referring to the guidelines as pertaining to EP clinical research. After reading your account of your wife’s ordeal, I understand that your quote sums up your point beautifully. There is a small but increasingly vocal movement in EP and interventional cardiology which calls for restraint and reason in practice, particularly in a field where technologic advancement is so rapid.
  There is also an ever present paradox in procedure-driven fields which require intense training at well known academic centers; both the patients and the trainees go there for access to high profile practitioners. Institutions and physicians must constantly balance the care of the patient with the training of the next great, for example, electrophysiologist. As a result, all patients at these centers need to know, that 1)trainees may be involved in their care; and 2) theyhave a right to limit a trainee’s involvement if they choose.
  The best situation is when the trainee/fellow is involved all aspects of care-the consult, the office visit, the consent, and the follow up. It is always better to get to know the family as well-after all, this is what the the rest of their career will be like.
  When you get to know a patient, you tend to think of them (’how can I reduce this person’s risk and make their life better?’) before yourself (’what new technique can I try out on this patient today?’). I am convinced that this approach has led me to choose wisely, and has saved more than couple patients from complications.

  — Posted by Mike (84, 85)

• 84.
  July 1st,
  2008
  9:35 am

  Dan Walter (79) brings up an interesting point. I happen to be a “research doctor” and Electrophysiogist (a Cardiologist who studies the electrical properties of the heart).
  I agree that there is intellectual and ethical tension inherent in clinical and basic science research. On one hand, patients have a right to get care which is shown to be efficacious and safe. The entire concept of research has evolved because in the not-so distant past, treatments were based on “good ideas” rather than solid evidence. On the other hand, in order to demonstrate clinical efficacy, one needs to perform clinical research.
  There is no doubt that some researchers become so invested in their trials that they lose sight of the best interest of the individual patient. This is unacceptable. I personally meet with each patient enrolled in the study, assure them that there are alternatives to my research, and let hem know that they are entitled to receive the standard of care treatment without exception if they wish.

  However, the excerpt you quote from the ACC/AHA guidelines misses your point entirely, and is out of context. The quoted text refers to an ongoing debate regarding education, not clinical research. The admonition is akin to reminding conservatory students that it is the music, not the recording technology, that makes their calling special.

  Further, the author of the quote, a well known “research” physician” in a Boston “research hospital,” is famous for putting the individual patient above all else.

  We cannot provide patients with the care they deserve and demand without responsible clinical research.

  — Posted by Mike

• 85.
  July 1st,
  2008
  10:02 am

  Dear Dan (79),

  I just read your touching account of your wife’s ordeal. You have effectively captured an aspect of interventional cardiology and critical care medicine which we all wish did not exist. My heart goes out to you and your family, and you are in my prayers.
  My only hope is that the “lesson learned” by myself and my interventional minded colleagues is not just one of technique, but one of humility and honesty; we all (surgeons, physicians, and someties patients) tend to minimize, and sometimes forget completely, the audacity of what we are trying to do: namely, stop or alter completely a biologic process which has been evolving at least as long as we have been. When you think about it, we should be suprised that it works at all. We definitely have a long way to go.

  Again, you are in my thoughts and prayers.

  — Posted by Mike

• 112.
  July 1st,
  2008
  4:49 pm

  Dear Mike (#84)

  Thanks for your comments on my story. It is very important to me that I get it right and I am curious to know more about your feelings on the AHA/ACC quote about EP technology:

  “… Although it is exciting, it should be kept in mind that the technology facilitates the application of those fundamental principles of Electrophysiology only for the benefit of arrhythmia patients.”

  I do not think I am misreading this. It appears to me to be a caution to physicians that although this new technology (enhanced catheter ablation techniques for AFIB) is fascinating – don’t forget that is being developed for the good of the patient. The fact that “the author of the quote… is famous for putting the individual patient above all else.” would seem support my interpretation. Im not sure I understand the music analogy – aside from as it applies to patient safety.

  I would really appreciate your thoughts.

  — Posted by Dan Walter

http://www.massdevice.com/node/4270/20

Boston Scientific, Medtronic, five others slapped with off-label lawsuits

July 15, 2009 by MassDevice staff

Boston Scientific Corp.’s notorious acquisition of Guidant Corp. is causing even more headaches for the Natick-based devices giant, now that a federal “qui tam” whistleblower lawsuit accuses the pair (and five other medical device makers including Medtronic Inc.) of promoting the off-label use of microwave cardiac ablation and potentially bilking millions from the Medicare system.

The lawsuit accuses the two device giants, plus AtriCure Inc., St. Jude Medical Inc. and subsidiary Epicor Medical Inc. and Endoscopic Technologies of offering illegal kickbacks and free equipment to perform microwave cardiac ablation procedures not approved by the Food & Drug Administration.

The suit alleges that Guidant (both before and after its April 2006 acquisition by BSC) initiated a scheme to encourage hospitals to improperly bill Medicare for the procedures and to “upcode” their bills to get even more out of the federal health program.

The whistleblower, whose request that all personal information be redacted from court documents was granted, worked for Boston Scientific as a sales rep. According to court documents, she’s put in 16 years in the medical device industry and was a top 10 sales producer for a previous employer.

During her training to sell Guidant’s Flex 10 ablation system, she was allegedly told to “market the spread” — that is, highlight the difference between what Medicare pays for cardiac ablations (an average $30,289) and the low cost of the Flex 10 procedure (an average $10,650). That $20,000 “spread” is pure profit for the hospitals.

The scheme allegedly called for sales reps to coach hospitals to bill Medicare using codes for open-heart procedures, rather than the minimally invasive technique actually used, to bilk the system out of an extra $20,000 per procedure.

The companies are also accused of providing free marketing and advertising to physicians in return for using the products, allegedly going so far as to pay for the design, printing and publication of brochures and ads.

For hospitals or doctors who bought five of the devices, the companies would allegedly “loan” them microwave generators worth $28,000 and never ask to be repaid.

And in return for locking in an agreement to use a company’s ablation system exclusively, sales reps were allegedly allowed to confiscate — or, in some cases, disable — competitors’ equipment in those hospitals.

Cardiac ablation is a technique used to treat atrial fibrillation, or fast and irregular heartbeat. It’s a large pool of potential patients, as more than 2.2 million people have the condition and another 160,000 are diagnosed every year, according to court documents. Boston Scientific’s training materials allegedly estimated that U.S. hospitals stood to make $7 billion a year in Medicare reimbursements for treating atrial fibrillation.

And the alleged marketing scheme was likely a windfall for the accused firms; Boston Scientific’s Flex 10 alone was used in 1,600 ablation procedures and in another 15,000 operations in conjunction with other procedures, according to the documents. At about $10,000 a whack, that adds up to $166 million in sales.

When the whistleblower challenged the legality of the marketing scheme at training events and a national sales meeting, she was allegedly reprimanded and harassed before Boston Scientific fired her “as a direct cause of her acts challenging [Boston Scientific]’s marketing approach,” according to court documents.

The lawsuit seeks triple damages and penalties of up to $11,000 for each violation. Under rules of the qui tam statute, which allows private citizens to sue on behalf of the government, whistleblowers are entitled to one-third of any damages and penalties won in a successful case. In addition to that, Jane Doe is seeking two times the amount of back pay and interest she would have earned if BSC hadn’t fired her, plus legal fees.

San Ramon, Calif.-based Endoscopic Technologies agreed to pay $1.4 million to settle its part in the case. Federal investigators are still looking into the allegations against the other companies; the U.S. government has until August 21 to decide whether to join the qui tam cases against them.

Maryland Civil Pattern Jury Instruction 27:4, which states that:
Before a physician provides medical treatment to a patient, the physician is required to explain the treatment to the patient and to warn of any material risks or dangers of the treatment, so that the patient can make an intelligent and informed decision about whether or not to go forward with the proposed treatment. This is known as the doctrine of informed consent. In fulfilling the duty to disclose, the physician is required to reveal to the patient the nature of the ailment, the nature of the proposed treatment, the probability of success of the proposed treatment and any alternatives, and the material risks of unfortunate outcomes associated with such treatment.

A “material risk” is defined as “a risk which a physician knows or ought to know would be significant to a reasonable person in the patient’s position in deciding whether or not to have the particular medical treatment or procedure.” The physician’s duty to disclose material risks to the patient is based upon an objective standard rather than a subjective standard. This means that the question of whether a risk is a
“material risk” is based upon whether a reasonable person in the position of the patient would have considered the risk to be a material risk. Whether the patient would have consented to the procedure, if informed of the risk, is a relevant factor to  be considered, but is not conclusive.

The physician is not required to divulge all risks, but only those which are material to the intelligent decision of a reasonably prudent patient.****

THE DISTRICT OF DELAWARE: Yong v. Nemours, december 2004 The court will “view the underlying facts and all reasonable inferences therefrom in the light most favorable to the party opposing the motion.” The theory behind the informed consent doctrine is that every patient has the right and responsibility to determine whether to take the risk of the corrective surgery. It is no defense that the patient gave consent, if the consent was not given with a true understanding of the nature of the operation to be performed, the seriousness of it, the organs of the bodyinvolved, the disease or incapacity to be cured, and the possibleresults. Dunham, 423 F.2d at 945. Barriocanal v.Gibbs, 433 A.2d 1051, 1172 (Del. Super. Ct. 1981).

IN THE COURT OF SPECIAL APPEALS OF MARYLAND No. 462

September Term, 1998

___________________________________

DEBORAH M. BELIN

v.

LENOX DINGLE, JR., ET AL.

___________________________________

Murphy, C.J.,

Davis,

Harrell,

JJ.

___________________________________

Opinion by Murphy, C.J., Concurring and Dissenting Opinion by Harrell, J. Filed: June 30, 1999

According to the Judicial Council of the American Medical Association, to have another physician operate on one’s patient without the patient’s knowledge and consent is a deceit. The patient is entitled to choose his own physician and should be permitted to acquiesce in or refuse to accept the substitution. The surgeon’s obligation to the patient requires him to perform the surgical operation: (1) within the scope of authority granted by the consent to the operation; (2) in accordance with the terms of the contractual relationship; (3) with complete disclosure of all facts relevant to the need and the performance of the operation; and (4) to utilize his best skill in performing he operation. The patient is entitled to the services of the particular surgeon with whom he or she contracts.

The surgeon, in accepting the patient, is obligated to utilize his personal talents in the performance of the operation to the extent required by the agreement creating the physician-patient relationship. He cannot
properly delegate to another the duties which he is required to perform personally. Under normal and customary arrangement with private patients, and with reference to the usual form of consent to operation, the surgeon is obligated to perform the operation, and may use the services of assisting residents orother assisting surgeons to the extent that the operation reasonably requires the employment of such assistance. If a resident or other physician is to perform the operation under the guidance of the surgeon, it is necessary to make a full disclosure of this fact to the patient, and this should be evidenced by an appropriate statement contained in the consent. If the surgeon employed merely assists the resident or other physician in performing the operation, it is the resident or other physician who becomes the operating surgeon.
If the patient is not informed as to the identity of the operating surgeon, the situation is “ghost surgery.”
……
I hereby authorize Dr. Dingle and/or such assistants
as may be selected or supervised by him to treat the
following condition(s)

Perna v. Pirozzi, 92 N.J. 446, 457 A.2d 431 (1983), the

Supreme Court of New Jersey

Few decisions bespeak greater trust and

confidence than the decision of the patient

to proceed with surgery. Implicit in that

decision is a willingness of the patient to

put his life or her life in the hands of a

known and trusted medical doctor…

the doctor who, without the consent of the patient,

permits another surgeon to operate violates

not only a fundamental tenet of the medical

profession, but also a legal obligation.

92 N.J. at 463-465, 457 A.2d at 440-441.

Dump Beckman need records got to hopkins a raid

“Perhaps the most feared, and most lethal of the many complications that have been associated with this procedure – with mortality in excess of 75 percent.”

“ If a physician extender (e.g., physician’s assistant or nurse practitioner) or

cardiology trainee is to perform any part of a procedure, this should be stated during the process

of informed consent. Because the patient and physician together determine the diagnostic and

treatment strategy, medical facts should be presented accurately to the patient .”

American College of Cardiology Cardiac Catheterization Laboratory Standards

####

While Dr. Yuh had his toes in the sand and a drink in his hand outside the Hyatt Regency Waikiki Beach Resort and Spa ($627 per person per night), I was picking through the offerings in beautiful downtown Baltimore. A decent room in Charm City, USA was going for $186.77 a night for a room with a double bed.

I walked out of the Day’s Inn and fished a card out of my pocket that said Patient Relations and got in my car and went back to the hospital.

Looking back, I see the question was hopelessly naive, but I had logistical problems with all these people coming to be with Pam, and so I had to ask. Pam’s son, her daughter, her mother, her sisters, her stepfather — all these people needed places to stay. They could do hotels for a while, but there was no end in sight here. I went into the office with the idea that when something like this happens they probably had some deal with the local hotels for discount vouchers – or something.

They gave me some vouchers — for free coffee down in the cafeteria.

Then I heard that there was a woman who rents out apartments in the immediate area for just such purposes.

She’d started the program years earlier when she arrived in Baltimore with a sick child for the hospital and no place for her to stay. So she got in touch with local property owners and became the rental agent and manager for several apartments that were let to visitors for days or weeks – or months. She didn’t seem to be getting rich off the scheme.

It was said that a lot of the rental properties in the immmediate vicinity of the hospital were owned by doctors and that they kept the rents artificially high. I’m not saying that I know that to be true, but it is what I was told.

While Pam’s mother went to get her sister at the airport, I arranged for an efficiency apartment near the hospital with three bedrooms – about $650 a week if I remember correctly.

*****

http://www.a-fib.com/BostonA-FibSymposium2006.htm:

“Cured” patients were found to be in A-Fib 31% of the time. 82% of these A-Fib attacks were silent (asymptomatic). (In this study 57% of patients who thought they were  experiencing A-Fib symptoms were actually in normal sinus rhythm. Symptoms of shortness of breath and chest discomfort were good predictors of being in A-Fib, whereas skipped beats was a poor predictor.)
Dr. Calkins suggested a different way of defining success after AF Ablation which he called “reducing the A-Fib Burden,” rather than complete elimination of A-Fib symptoms. For example, after a “successful” A-Fib Ablation a patient may go from constant (Chronic) A-Fib to occasional (Paroxysmal) A-Fib which is a “reduction of their A-Fib burden.”

Marchlinski Chilli v standard ablation catheter study http://www3.interscience.wiley.com/cgi-bin/fulltext/118574459/PDFSTART 2006.”   Study Design:

“This was a single center, patient-blinded pilot study in which participating subjects were randomized (using a 2 × 2 factorial table) to undergo EI of all versus arrhythmogenic PVs only using either an 8-mm tip (NaviStarTM Biosense Webster, Diamond Bar, CA, USA) or cooled tip (Chilli Boston Scientific, Natick, MA, USA) catheter. The study protocol and consent forms were approved by the institutional review board of the University of Pennsylvania.”

****

(To be printed on the physician’s letterhead. Please insert specific evidence of medical necessity from the patient’s medical record)

April 9, 2007

Coventry Healthcare of Delaware, Inc.

Attention: Appeals Coordinator

2751 Centerville Road

Suite 400

Wilmington, Delaware 19808

RE: Pre-Service Appeal

CPT 33255 is medically necessary.

Please call me at your earliest convenience to understand the numerous patient benefits.

Patient:

Subscriber ID#:

Date of Birth:

Facility:

Address:

Dear Appeals Coordinator:

The purpose of this letter is to establish the medical necessity of a procedure that I must perform on your subscriber as soon as possible. Last week, Coventry issued a pre-service denial and I would like a board-certified cardiothoracic surgeon to review this request for reconsideration.

CPT 33255 [Operative tissue ablation and reconstruction of atria, extensive (e.g. maze procedure); without cardiopulmonary bypass] is medically necessary.

In view of numerous CPT coding changes that took effect on January 1, 2007, I am hopeful this pre-service denial was simply the result of a miscommunication? As you may know, the AMA released five new CPT codes in the Surgery/Cardiovascular “Electrophysiologic Operative Procedure” section of CPT 2007. I am not performing an investigational/experimental procedure. The CPT code I selected is not a Category III T-code used for tracking new and emerging technologies. I selected a fully-valued Level I CPT code recently surveyed by the Society of Thoracic Surgeons (STS) in 2006 and released by the AMA in 2007. Please consult with a cardiothoracic surgeon, the STS and/or AMA to better appreciate that tissue ablation can be accomplished by many different methods. Simplification of the maze procedure has been made possible by different ablation techniques. The acceptance of alternative energy technology that shortens and simplifies the surgical management of atrial fibrillation (AF) was the reason behind these new CPT codes. The “cut-and sew” maze CPT code 33253 was deleted in 2006 and replaced with 5 new CPT codes to better match contemporary surgical practice.

While some payers continue to view the classic “cut-and-sew” Cox-maze procedure to be the surgical “gold standard”, it is very important that you fully appreciate the risks associated with this lengthy, complex and difficult procedure. The requirement for cardiopulmonary bypass (CPB) and the technical difficulty of this approach have limited its use¹ Everyday in clinical practice, cardiothoracic surgeons create alternative lines of conduction blocks with improved technology without the known morbidity associated with a full sternotomy and CPB. If Anthem BCBS, the largest private payer in the U.S, considers this CPT code and ICD-9-CM Procedure Code 37.33 (excision or destruction of other lesions or tissue of heart open approach/ trans-thoracic approach) to be medically necessary for drug resistant atrial fibrillation or flutter, then so should you. Anthem’s medical policy for the Maze procedure is attached for your review and consideration.

My surgical plan for your subscriber is to use an ablative device that delivers targeted bi-polar radiofrequency energy to create discrete linear transmural lesions. Contrary to your maze medical policy, I am NOT performing a catheter ablation! Your medical policy is not in step with contemporary cardiovascular surgical practice for the treatment of persistent AF. It is outdated and in need of immediate revision. For example, it currently identifies the deleted maze CPT code 33253 as a covered benefit. Besides reviewing CPT 2007, please consult with a board certified cardiothoracic surgeon and/or me for a peer-to-peer discussion of the references cited on the enclosed bibliography.

Your subscriber needs surgery now! Early intervention will increase the likelihood of restoring this patient to normal sinus rhythm. The most significant predictor of long-term AF recurrence is the duration of pre-operative AF. While the classic cut-and-sew maze procedure is extremely effective, it has been supplanted by newer operations that rely on alternate energy, such as radiofrequency, to create lines of conduction block² In a systematic review of the surgical treatment of AF, Khargi et al (2005) could not identify any significant difference in the post-op sinus rhythm conversion rates between classic “cut & sew” Cox-Maze technique that requires an open sternotomy versus alternative energy sources, such as radiofrequency, which simply requires trans-thoracic incisions. The surgical objective through an open sternotomy with CPB or trans-thoracic incisions is the same – to interrupt the aberrant atrial conduction pathways in the heart that are causing the patient’s atrial fibrillation. The expected outcomes from either approach is to restore normal sinus rhythm and prevent ischemic stroke. Availability of alternative energy sources to create lesions sets has virtually eliminated the need for the cut-and-sew Cox-maze procedure³. The clinical and economic gains associated with avoiding a full sternotomy and CPB are quite significant to me, my patient, and your health plan.

CLINICAL JUSTIFICATION

Atrial fibrillation (AF) is the most commonly occurring cardiac arrhythmia. It affects more than 2.5 million people in the United States, and its prevalence rises with age. It is associated with numerous cardiac morbidities, decreased quality of life and decreased survival. Symptoms include palpitations, decreased exercise tolerance and dyspnea. Stroke is the most feared complication of atrial fibrillation. It is well-known that patients with AF are five times more likely to suffer a stroke than patients in normal sinus rhythm. Among patients with AF, there is a 5% annual risk of stroke.

Per 2006 ACC/AHA/ESC Practice Guidelines for the “Management of Patients with Atrial Fibrillation”, the inconsistent efficacy and potential toxicity of antiarrhythmic drug therapies have established the need for non-pharmacologic treatments in patients with persistent AF who fail to respond to anti-arrhythmic drug therapy⁴. Your subscriber is an ideal candidate for an operative tissue ablation through a trans-thoracic approach (ICD-9-CM Procedure code 37.33), but as shown below, time is of the essence for this patient’s well-being.

SUBSCRIBER’S MEDICAL NECESSITY

(Please insert specific information about the patient, such as age, chief compliant, current medications, significant events in the past medical history, employment status, family issues). For example, this is a 46 year old independent contractor, who has suffered with AF for more than 5 years despite taking numerous anti-arrhythmics. While this patient recognizes the need for surgery, he can not afford to be out-of-work for 8-12 weeks following an open surgical procedure. With a trans-thoracic approach, I anticipate he can return to work for within 2-3 weeks.

Upon your review of the enclosed NEW evidence, please do not hesitate to call me with any further questions to better appreciate the medical necessity of this surgery. I would be very happy to share additional clinical information, as well as provide further evidence regarding the effectiveness of operative tissue ablation and reconstruction of the atria through a trans-thoracic incision. In advance, thank-you for your time and re-consideration. At your earliest convenience, I await your reply in writing.

Sincerely,

Name of Surgeon

Phone:

Citations in the peer-reviewed literature that establish the medical necessity of CPT 33255

Barnett SD, and Ad N. Surgical ablation as treatment for elimination of atrial fibrillation: a META analysis. J Thorac Cardiovasc Surg 2006;131:1029-35.

Benjamin EJ, et al. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52.

Cox JL. The surgical treatment of atrial fibrillation. IV. Surgical technique. J Thorac Cardiovasc Surg 1991 ;101 :584-92.

Doukas G, et al. Left atrial radiofrequency ablation during mitral valve surgery for continuous atrial fibrillation: a randomized controlled trial. JAMA 2005 Nov 9;294(18):2323-9.

Fuster V, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. JACC 2006;48(4):e149-246.

Gaynor SL, et al. Surgical treatment of atrial fibrillation: predictors of late recurrence. J Thorac Cardiovasc Surg 2005 Jan;129(1):104-11).

Gaynor SL, et al. A prospective, single-center clinical trial of a modified Cox maze procedure with bipolar radiofrequency ablation. J Thorac Cardiovasc Surg 2004 Oct; 128(4):535-42.

Gillinov AM and Saltman AE. Ablation of atrial fibrillation with concomitant cardiac surgery. Semin Thorac Cardiovasc Surg. 2007 Spring; 19 (1): 25-32.

Gillinov AM. Advances in surgical treatment of atrial fibrillation. Stroke. 2007 Feb; 38 (2 Suppl): 618-23.

Gillinov AM et al. Surgery for permanent atrial fibrillation: impact of patient factors and lesion sets. Ann Thorac Surg. 2006 Aug; 82 (2): 502-13.

Gillinov AM, Wolf RK. Surgical ablation of atrial fibrillation. Prog Cardiovasc Dis. 2005 Nov-Dec;48(3):169-77.

Gillinov AM. Ablation of atrial fibrillation with mitral valve surgery. Curr Opin Cardiol. 2005 Mar;20(2):107-14.

Gillinov AM, et al. Stapled excision of the left atrial appendage. J Thorac Cardiovasc Surg 2005 Mar;129(3):679-80.

Gillinov AM, et al. Surgical ablation of atrial fibrillation with bipolar radiofrequency as the primary modality. J Thorac Cardiovasc Surg. 2005 Jun;129(6):1322-9.

Gillinov AM, McCarthy PM. Advances in the surgical treatment of atrial fibrillation. Cardiol Clin. 2004 Feb;22(1):147-57.

Gillinov AM, McCarthy PM. Curative surgery for atrial fibrillation: current status and minimally invasive approaches. Expert Rev Cardiovasc Ther. 2003 Nov;1(4):595-603.

Gillinov AM, et al. Contemporary treatment for atrial fibrillation. Pacing Clin Electrophysiol. 2003 Jul;26(7 pt 2):1641-4.

Gillinov AM, McCarthy PM. Atricure bipolar radiofrequency clamp for intraoperative ablation of atrial fibrillation. Ann Thorac Surg 2002 Dec;74(6):2165-8.

Gillinov AM, Blackstone EH, McCarthy PM. Atrial fibrillation: current surgical options and their assessment. Ann Thorac Surg. 2002 Dec;74(6):2210-7.

Hart RG, Halperin JL, et al. Lessons from the stroke prevention in atrial fibrillation trials. Ann Intern Med. 2003 May 20; 138(10):831-8.

Khargi K et al. Surgical treatment of atrial fibrillation: A systemic review. Eur J Cardiovasc Surg. 2005; 129 (1) 104-111.

Lemery R, Guiraudon G. Catheter and surgical ablation strategies in atrial fibrillation: what have we learned? Curr Opin Cardiol. 2005;20(1)26-30.

Misaki T et al. Recent topics on the surgical treatment for atrial fibrillation. Ann Thorac Cardiovascular Surg. 2004; 10 (5):277-280.

Mokadam NA, et al. A prospective multicenter trial of bipolar radiofrequency ablation for atrial fibrillation: early results. Ann Thorac Surg 2004 Nov;78(5):1665-70.

Pruitt JC, et al. Totally endoscopic ablation of lone atrial fibrillation: initial clinical experience. Ann Thorac Surg 2006 Apr;81(4):1325-30.

1 Damiano RJ et al. The long-term outcomes of patients with coronary disease and atrial fibrillation undergoing the Cox maze procedure. Journal of thoracic and cardiovascular surgery. 2003; 126:2016-21.

2 Gillinov AM and Saltman AE. Ablation of atrial fibrillation with concomitant cardiac surgery. Semin Thorac Cardiovascu Surg. 2007 Spring; 19 (1): 25-32.

3 Gillinov et al. Surgery for permanent atrial fibrillation: impact of patient factors and lesion set. Ann Thorac Surg. 2006 Aug; 82 (2): 502-13.

4 Fuster V, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. JACC 2006;48(4):e149-246.

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Office of the Inspector General HHS: http://oig.hhs.gov/publications/docs/press/2003/021403release.pdf

“According to the allegations, Johns Hopkins submitted or caused the submission of false claims to the Medicare program on behalf of certain faculty physicians employed by the university without documentation to show that these physicians were personally involved in providing the services claimed by JHU. Instead, the government contends these services were actually delivered by an intern or resident of the teaching hospital.”

“cozy relationship” autism device maker hopkins: 1992 http://oig.hhs.gov/oas/reports/phs/c9000009.pdf

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I wish you the best of luck Al, but if you start running short of breath in 2-3 months make sure you see your electrophysiologist. I’ve been suffering from AF for most of my life. I was a rock climber, mc rider, and windsurfer. My electrophysiologist suggested I have an ablation at my young age and excellent health now instead of waiting until I was older and not able to tolerate the operation. He also told me I nothing to worry about because he was going to do circumferential burns to prevent any damage to my heart. I had my ablation in the spring of 2005 and felt great for a couple of months. By summers end I was suffering shortness of breath from what my electrophysiologist told me was “In my head”, my cardiologist was totally puzzled and my pulmonary doctor told me it was asthma… I finally went to a second cardiologist with the article below in hand (yes, I was diagnosed by my daughters research). My new cardiologist put me thru tests the next day and I was formally diagnosed with pulmonary stenosis. It turned out that no matter how diligent the surgeon is, there is still a chance of burning the wrong locations. It’s a moving target. Everyone in these posts have negative things to say about being subjected to unfair constraints by the FDA, but “misrepresentation for profit is misrepresentation for profit”. You cannot compare the crooks that steal your money to the ones that steal your life. I now have 2 of my 4 pulmonary veins occluded from scarring, a very disappointing cardiogram, totally disabled and hardly able to walk. Before the operation I had a structurally sound heart with a decent electrocardiogram, except for the PVC’s every minute or so. I had a benign ‘lone atrial fibrillation’. If I would have read the article below, been informed the about the dangers of the procedure or told that the equipment was not FDA approved, I never would have elected for it.

Full Text
Pulmonary Vein Stenosis after Catheter Ablation of Atrial Fibrillation: Emergence of a New Clinical Syndrome
Ann Intern Med April 15, 2003 138:634-638 www.annals.org