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A Previously Unreported Complication
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When I read Hugh G. Calkins’s journal article about what happened to Pam, I thought at first that he is not a very good writer. But now, after having read it many times, I see it as a masterpiece of mind bending logic. An article to report a previously unreported complication, which cites two previous reports of the complication being reported.
Here are two sentences in the order in which they were published in the peer-reviewed Journal of Cardiovascular Electrophysiology Vol. 13, No. 8, August 2002:
“Entrapment of a circular mapping catheter in the mitral valve apparatus during focal AF ablation is a serious and previously unreported complication. A review of the literature reveals that catheter entrapment in the mitral valve apparatus has been reported in association with catheter ablation procedures.”
The fact that this makes perfect sense to the author and his peers illustrates a main aspect of this story: The melding of Science, Medicine and Academia at teaching hospitals has rendered the patient an abstract part of the healing equation.
Catheter injury to a mitral valve, the “complication” that took Hugh Calkins by surprise in Pam’s case, has long been recognized by the American College of Cardiology as a risk of any cardiac catheterization because it is common sense: “Certain risks are associated with RF ablation. They include the general risks of any cardiac catheterization, such as valvular damage…” Hein Wellens, 1999. “The catheter should be carefully manipulated in order to avoid entrapment into the mitral valve apparatus.” Hindricks G: Eur Heart J 1993. Hugh Calkins himself has written that catheter manipulation can cause valvular damage, and he should know, because he was manipulating a catheter that damaged someone’s heart valve in 1991.
So why the compulsion to publish a story about a botched ablation? Especially since, according to what the attending physician told the patient and her family, the error occurred because he’d taken his eye off the ball. Most doctors would be embarrassed.
But if you can present it as news, as scientific discovery, then you can add another title to your list of publications. And that’s what it’s all about. In order to stay on top of the field you’ve got to publish, and to publish you’ve got to do things, you’ve got to try things and see what happens with this or that technique and then spread the word in the journals so that the state of the art can be ever advanced. The patients become statistics, they come and they go, and after a while a certain detachment begins to take hold. A scientist’s duty lies in pushing the boundaries of medicine.
Most people aren’t aware of the elitist attitude that pervades the upper echelons at hospitals like Hopkins. As a Harvard graduate recently commented, “In medical school we were actively encouraged to be leaders in medicine, and not necessarily good doctors.” Research and academic professor/physicians are generally out to prove a theory or test a procedure or product. You are not you coming to get well, you are one of forty patients in a defacto medical trial. You are an endpoint for a study, a chance to try out a new technique or device. You are a learning tool for students. Your body is the proving grounds for newcomers to medicine and their new hardware.
Here is in extract from an editorial in the Journal of Thoracic and Cardiovascular Surgery, Surgery as Spectacle by Dr. Duke Cameron of Johns Hopkins. It is a thoughtful piece discussing the pros and cons of telecasting live open heart surgery. The words in parentheses are Dr. Cameron’s, in the original text.
“Several of my colleagues have also been witness (rhymes with accomplice) to intraoperative disasters… including patient deaths in what should have been straightforward procedures… and who later confessed a sense of collective guilt and shame that discouraged them from pursuing their own experience with the new technique. I once viewed a live telecast valve repair that resulted in a clearly unacceptable outcome but was tolerated because… I suspect… the surgeon did not want to publicly acknowledge failure and replace the valve.”
A clearly unacceptable outcome was tolerated. Tolerated by whom? Maybe witness doesn’t really rhyme with accomplice, but the point is well taken. A witness to a crime may be inclined to report it and to help the victim. An accomplice would not. I doubt that Dr. Cameron and his colleagues confessed their complicity in these intraoperative disasters to the families of the victims. Shame and guilt will only go so far. Most likely, the attending surgeon came out shaking his/her head and explained to somebody’s wife or mother or son that there had been a complication, a very rare complication. And most likely, the stunned family member, having been trained to believe in the infallibility of medicine, a reader of US News & World Report, said thanks, Doc, I know you did the best you could, and they buried their loved one and tried to go on.
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Calkins, et al, would protest that publishing Circular Mapping Catheter Entrapment in the Mitral Valve Apparatus: A Previously Unreported Complication was really a selfless act designed to warn fellow practitioners of a possible complication heretofore unknown. At least that’s what he told me. Calkins told me that he was going to write Pam’s story and publish it in medical journals so that others could be spared Pam’s fate. Doctors around the world needed be to alerted to this new and dangerous complication.
Sure enough, the story was published. It sent this message, more or less, out to interventional cardiologists everywhere: Attention: Keep an Eye on that Dangerous Catheter You’ve Let Loose in Your Patient’s Beating Heart—which makes about as much sense as a safety bulletin warning about the dangers of wearing a neck tie while operating a lathe:
Necktie Entrapment While Operating a Lathe: A Previously Unrecognized Complication of Making a Lamp in Woodshop
We describe the entrapment of a Salvatore Ferragamo Gancini Print silk necktie secured with a simple windsor knot within the rotational apparatus of a Ganesh GHT-59 Super-Precision Hardinge-type 2nd operation lathe (DV-59 copy) with a 3-horsepower electronic variable speed motor. A review of Popular Mechanics reveals 16 adverse outcomes last year when some portion of a lathe operator’s neck tie became entangled in the moving parts of a lathe.
The occurrence of this previously unreported complication involving a Salvatore Ferragamo Gancini Print silk necktie stresses the need for continual monitoring and reporting of adverse effects from new devices and procedures to better inform lathe operators as to proper neck attire.
Based on our experience, several recommendations can be made that may lower the possibility of this complication occurring in the future…
Disclosures: Dr. Calkins receives research funding from the Salvatore Ferragamo Foundation, serves as a paid consultant for Ganesh Industries, and is on the editorial board of Popular Mechanics.
But I learned a few things from Circular Mapping Catheter Entrapment in the Mitral Valve Apparatus: A Previously Unreported Complication. For starters, I learned that it’s not so hard as you’d think to become an author in the world of professional medicine. And I learned that there is nothing sacred about a patient’s medical records.
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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…
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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?
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“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
Author: Mark (—.res.east.verizon.net)
Date: 11-25-09 06:58I live on the east coast, Washington DC area, but plan to be in San Francisco on December 8th. After two failed ablations at Johns Hopkins I am a little gun shy of a third attempt, but with Lone AFIB occurring every weeks and ectopics throughout the day–like each and every day–maybe a consult would be worth it. I am not sure my issue is around my pulmonary veins and the mapping technology isn’t advanced enough to tell me exactly where my problem is, so my strategy has been to hold out for the technique and technology to advance. It has been two years since my last ablation. Guess I can wait some more, but my two ablations at Johns Hopkins did not include the use of radiofrequency energy…so I am wondering whether the third time is a charm, or whether it makes sense to continue to wait.Does anybody know the best way to set up an appointment to see Doctor Natale in San Francisco? Who do you contact?Reply To This Message
Re: Andrea Natale Appointment
Author: Jackie (—.lightspeed.bcvloh.sbcglobal.net)
Date: 11-25-09 07:19Mark – You can also consider his primary location of Austin, Texas. He’s only in CA a week out of the month.http://andreanatale.com/texas.htmlDo a search here by author – JohnF… had two unsuccessful ablations and went to Texas for Dr. Natale for the third, and successful procedure.JackieReply To This Message
Re: Andrea Natale Appointment
Author: Mark (—.res.east.verizon.net)
Date: 11-25-09 07:22Thanks, Jackie. I appreciate your help.MarkReply To This Message
Re: Andrea Natale Appointment
Author: researcher (—.oc.oc.cox.net)
Date: 11-25-09 07:41″It has been two years since my last ablation. Guess I can wait some more, but my two ablations at Johns Hopkins did not include the use of radiofrequency energy..”I really have to ponder why Johns Hopkins is on anybody’s list for ablation and why their director of EP is so often included in expert panels. If they never used RF catheters for your LAF, I have to guess they used Cryo which is still currently controversial because of a high reconnection rate. I guess Cryo is good if the EP is afraid of hurting someone (although that could still happen). What were the EP’s there thinking? I noticed they finally hired a German EP recently so perhaps their competency level will start improving. I wish you a procedure well done with Natale. I believe he also does procedures at Akron General on occasion.It is likely that Richard Wu’s salary was being paid by a medical device manufacturer…
Boisense Webster Largess to Johns Hopkins…
EP Fellowship Program ‐Jan‐ 09 JOHNS HOPKINS UNIVERSITY BaltimoreMD50,000.00 ****Here is how the American College of Cardiology put it in 2002:
“… it remains increasingly critical that the practicing physician acquire and maintain an understanding of relevant first principles of Electrophysiology. 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.”
Someone in the EP community felt the need to warn overeager and excited colleagues about losing their perspective in the rush to be on the cutting edge. It was a warning to a doctor who might forget to ask himself whether trying out a new technique is really in the patient’s best interest.
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http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3442t2b.pdf
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…”
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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.
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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, 2002http://www.circare.org/media/31502BS.pdf
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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 personnelhttp://www.circare.org/bna05072003.pdf
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“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.
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 …”
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.”
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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.
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
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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…
KOCHERIL: The patients were blinded to the required number of AF episodes to enroll in the study.
Dr Leslie EWING: It is the FDA’s information that the patients were aware that a minimum number of episodes were required.
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
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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.pdfDR. SCHWARTZMAN: I think I have more comments than questions. First of all, I would like to echo the others on the panel in stating appreciation to both the sponsor and the FDA for excellent presentation and clarification. At the end of the day, the numbers can only take you so far and then there’s interpretation. I respect the bias to either side.
I’m going to bring to bare the reason I’m here which is based on experience, primarily personal experience not with this particular technology but with the electrophysiologic, anatomic and clinical target and the vagaries and difficulties therein and also considering the data as presented. I first want to make comments against this proposal and then I’ll make comments in its favor.
First of all, against, the starting point to me is that this claim of continuous linear lesions is certainly unproven. Again not having primary experience with this and without data presented otherwise based on my own experience, I think it is likely that the vast minority of these lesions were continuous in the sense of transmural and contiguous, therefore acting as arcs of conduction block as conceptualized.
Secondly, I think the electrophysiologic efficacy that is EKG burden reduction is really not clear to me but my guess is it’s probably under 50 percent at six months. Again bringing experience to bare, longer follow-up is going to probably likely be worse. I know what the reducing burden data had shown from three to six months but again primarily from my own experience this is not a disease that remodels favorably over the long haul.
In that regard, I’m concerned that we’re approving a protocol or a technology technique that is going to end up being a waste of patient/physician time and money. My own personal experience with right atrial linear ablation although with similar numbers early at two years only 10 percent of these patients remained without another procedure whether that be pharmacologic or non-pharmacologic. So at the end of the day long term benefit is hard to find.
Finally I have concern regarding the safety of this technology in its inevitable use in the left atrium as soon as it gets into the hands of those of us who have our own visions about this technology. Some of the charring issues, the entity of thermometry which I think is a terrible method of guiding power titration and generally under represents interfacial temperature which is what relates to charring and presumably cardioembolic material. We get away with a tremendous amount in the heart particularly in the right side. I’m concerned about its extended use whether or not it’s labeled…”
DR. CALKINS: Al, I just have a couple of comments about where it would fit into the armamentaria of the electrophysiologist. I think it would have a very important role. Right now, in the absence of this catheter being available, people say that their one option is a pulmonary vein isolation. Anyone who is doing this procedure realizes there is a learning curve and the learning curve is very rocky as you go up on it and the complications are like no other procedure that’s ever been done in an EP lab. So right now we have the electrophysiology community in a tough spot. They’re hearing about pulmonary vein isolation. These articles are showing in circulation every week. They are getting pressure to do something for atrial fibrillation. All of a sudden they start doing it and the complications occur. We don’t know where this procedure is going. It’s evolving rapidly from periostial ablation to perianatomic ablation to different mapping techniques to different energy sources. That’s very much of a moving target. What’s nice about this procedure is that it’s not a moving target. Here’s three lesions which can be understood or reproducible. It’s clear how to deliver them. It’s a first step. So where it fits in for a center like mine where we can do whatever we please, we’ll tell the patients that they have an option. If they want to go for the home run, the cure, and they’re willing to accept a procedure with higher risks that’s in evolution and so forth, we’re happy to go ahead and do a pulmonary vein isolation. If, on the other hand, that scares them, the idea of doing a procedure where pulmonary stenosis (PH) or stroke ?- are clear risks but they say “I want to do something. I’m refractory to drugs”. We’ll say “Let’s go head and do a right-sided procedure, get that done and see if you improve. The data suggests that there’s a very good chance that will make you better. Then if you don’t improve we can always three, four, five, six months or a year from now do a pulmonary vein isolation and 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.” For the other hospitals that don’t have the ability to do pulmonary vein isolations safety or effectively, this is a procedure that instead of just doing a flutter line which I think does very little in this setting they can go in, do an atrial fibrillation ablation procedure, give the patient some benefit, make them feel better and then in the future, you’ll have to a pulmonary vein isolation as an adjunctive procedure. That’s a better way to be approaching atrial fibrillation rather than just doing a high risk procedure right from the outset.
Dr. WALDO: The spin you put on it I understand and I’d love to believe you…
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.
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“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…
CALKINS”This study has just been chugging along coming to completion and showing very sound data and very excellent safety. CALKINS: I thought the study was very well designed at the time and very well carried out.
DR. WHITE: That may be so but you’re asking us to approve this data upon protocol you wrote and then you deviate from that protocol. I don’t know how to make up for that. I understand what you just said. When I enroll patients in protocols, I do things according to protocol.
DR. WHITE: But I don’t understand that. I’m in protocols right now where it’s clumsy to do the thing the study way. It takes a long time. I think if you sign up for a protocol, you play by the rules. If you don’t play by the rules, you get terminated. You get kicked out of the protocol if you don’t follow the rules. Or you pay the price you’re paying today for the confusion this generated. I think that’s the lesson.
DR. WHITE: Thanks. What my problem is if you’re sloppy enough to do the protocol this way then I think that runs through the whole study. That contaminates the study. It’s not that a flutter line isn’t a flutter line. It’s that you wrote the protocol and then you didn’t stick to it. I don’t like that.
DR. WHITE: These would be protocol deviations that would come up as red flags right off the bat. I don’t know why the waters were allowed to get so muddy down the road.
DR. WHITE: … the PI’s job to make sure people are sticking to the protocol. If they are not, then there is disciplinary measures and you exclude them or you terminate them or you say “You’re not playing by the rules so you can’t do this anymore.” I just think you didn’t do that. You didn’t take that very seriously. I’m telling you from my perspective that it’s a very important part of doing these kind of investigations. You have to have the discipline to follow through with what you and the FDA set about as being your protocol. I just see those deviations as problems. That’s all I have.
DR. WHITE: Thank you, Warren. I actually don’t have much really to add to what’s been said by my colleagues. I would like to ask the PI though maybe in the sponsor that as many of us are involved as being investigators in trials, I don’t quite understand the freedom of your investigators to deviate from the protocol. For example, the 20 times that study catheter was never used. Hugh was mentioning up here that if they were familiar with the catheter, they might abandon a little easier and gone with another catheter. I don’t understand never trying the experimental catheter. What was going on in their minds? These would be protocol deviations that would come up as red flags right off the bat. I don’t know why the waters were allowed to get so muddy down the road.
DR. TRACY: So it would be 20 something percent successful strictly by protocol. Forty something percent if you permit the non-protocol catheter. Eighty percent if you go by the company’s definition.
DR. TRACY: I don’t think there’s probably anything salvageable “It appears that the sponsor is using a narrow interpretation of the standard definition of adverse events… the rate of adverse events would be 19%” “This study has many serious flaws.”
DR. WALDO: One point and then one question. Very brief. Hugh was saying that the A2 front isthmus lesion doesn’t affect atrial fibrillation. The data from Walling lab showed 15 percent of cases were affected that way. They speculated a rotor that involves the flutter isthmus. So I think there are data that that lesion may have some effect.”
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“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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This was Cardiac Pathways Corporation’s business situation in 1996: “Since inception, the Company has been primarily engaged in researching, developing, testing and obtaining regulatory clearances for the mapping and ablation catheters and mapping and ablation equipment that are the components of the Company’s Ventricular Tachycardia Ablation System, Arrhythmia Mapping Systems and Atrial Fibrillation Ablation System. The Company believes that these systems and their component catheters and equipment are currently the Company’s only significant potential products.”
Build upon relationships with electrophysiologists. The Company has developed strong relationships with prominent electrophysiologists worldwide who have been involved and will continue to be involved in the Company’s clinical and product development. The Company intends to continue to build these substantial relationships through clinical investigator meetings, participation in physician-run symposia and meetings to discuss clinical issues and treatments. The Company’s strategy is to leverage these relationships with leading electrophysiologists to gain market acceptance of its products in the United States and internationally.” http://tinyurl.com/Cardiac-Pathways
Hugh Calkins was one of the prominent electrophysiologists being cultivated — and presumably leveraged — by Cardiac Pathways Corporation.
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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“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.
Hugh Calkins was one of the doctors who had been working for years with companies like Johnson & Johnson, Medtronic and St. Jude Medical to develop a cardiac ablation catheter that could be used safely and effectively to cure atrial fibrillation. It was the next big thing.
“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 are listed below by likely category of complication: Major Adverse Effects (may be considered either device or procedure-related): • Valve or cardiac structure damage Calkins
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 InternationalClyde 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
MedtronicCalkins, 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
*****
Although Pam had general misgivings about going through a procedure, I never thought twice about taking her to Hopkins. Pam’s local cardiologist, of whom Pam and I were fond, was a pleasant woman and a quite capable doctor. It was she who referred Pam to Dr. Grant Simons in Annapolis, who determined that Pam should get a pacemaker. The theory was that Pam would be put on certain drugs at doses that would effectively make her heart beat so slowly that the pacemaker would take over and her heart would beat normally all the time. So Pam started taking the prescriptions, but the fact that Grant Simons had essentially screwed one of the pacemaker lead wires through Pam’s heart and into her chest wall meant that the pacemaker was never able to be used as envisioned. At first this meant weeks of trying to convince the cardiologists that something was wrong. They were in denial. That could not have happened. Initially, Pam was told to weather the discomfort for a while, since it shouldn’t be happening because nothing went wrong. But Pam kept insisting. When the pacer came on, it was sending little jolts into her chest wall muscles. The doctors finally did concede that there may have been a “microperforation” of the the heart. Nonetheless, the procedure was a success and they would adjust the pacemaker to compensate for the micro non-incident. Weeks and weeks turned into months doses of prescription heart medication were raised and then lowered, and we waited for the day of the week when the Cardima Rep came to the Doc’s office so he could turn the pacemaker settings lower, and then lower again until the pacemaker was a useless electronic lump under the skin of Pam’s left front shoulder. Right where you would pin a medal.
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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 procedurethat 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 ablatecardiac 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:
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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
“Association of Transseptal Punctures with Migraine Aura. Background: Transseptal catheterization (TSC) is performed during catheter ablation involving the lefthand side of the heart. TSC causes a transient iatrogenic atrial septal defect that can predispose patients to migraine episodes.” hugh calkinsCalkins alarm relapse holter: http://www.a-fib.com/BostonA-FibSymposium2006.htm#CalkinsDefiningSuccessfulA-FibAblation***
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
At Fell’s Point, I went down to the waterfront. A man who lived on a rickety boat that was permanently tied to the docks gave out coffee and doughnuts to people walking by on their way to work. He was telling me about how he was a sailor on the USS Forrestal, the aircraft carrier that blew up and burned off the coast off North Vietnam during the war because they had old ammo that cooked off.
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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
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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.
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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 …
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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
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Mistakes were made in the Cherry Tree affair
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In a situation like this, the second you ask for your medical records. You’ve started a war, but you don’t know it yet.
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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)
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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
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“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
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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
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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
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) -
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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
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.
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/
On the last day of March, it seemed as if winter had returned. I walked out of the hospital, buttoned my jacket and turned into the wind.
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editing …
editing…
And finally her eyes were open and she said “Who’s watching the store?”
Dorris Ziffle. I sad.
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(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 are critical, as are the experience and teamwork of laboratory personnel.)
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“I think I’m going to die”
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forbade myself a show of emotion
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.”
________________________________________________________
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=623585
(Notes: 2003 calkins sez 80% success rate. Check this put real figures after the graph.
Consent Forms:
” … and yes I said yes I will Yes. “
“Doctors love to patronize and dominate. Their arrogance and indifference to the philosophy of informed consent is widely known. Surprisingly, most residents and doctors in teaching public hospitals tacitly endorse such reservations against information sharing. To most of them getting informed consent is a needless nuisance, to be delegated to a raw resident whose sole responsibility is to get the patient’s signature on the dotted line.” Journal of Medical Ethics, October 2000.
The fact that a consent form was signed may be evidence of informed consent, but it is not conclusive, especially in this case because the contents of the form were lacking and the time and circumstances of the signing were inappropriate. To this day, Pam Walter has never met Richard Wu. People who were with her at every moment up until she was wheeled into the procedure room confirm that they never met Richard Wu. The consent form was among many papers hurriedly signed at 7AM as the patient was in an anxious state. According to nurses’ notes, Pam was crying as she was wheeled in to the laboratory.
Even if Richard Wu had met Pam Walter in the early morning of March 25th, the American College of Cardiology guidelines state that “… a discussion of the risks, benefits, and alternatives should be undertaken in an unpressured environment well before the procedure.” Richard Wu’s supposed interaction with Pam in the anxious moments before she was to be wheeled into a laboratory and strapped to a gurney would fall well short of the intent and spirit of informed consent doctrine. (ACC/SCA&I CLINICAL EXPERT CONSENSUS DOCUMENT ON CATHETERIZATION LABORATORY STANDARDS JACC VOL. 37, NO. 8, JUNE 2001:2170-214)
Accepting the fact that Pam signed a standard consent form in the stressful moments before the procedure, the form contains no such language as is offered at other hospitals:
I authorize Dr. ____________, and such physicians in training and assistants as (s)he may select, to treat my condition… I UNDERSTAND THAT PHYSICIANS IN TRAINING MAY PERFORM PORTIONS OF THE PROCEDURES DESCRIBED BELOW …” (Emphasis Original) University of Virgina Health System.
Contrary to professional guidelines, the form at Hopkins makes no mention of the specific involvement of a trainee in the procedure. A barely legible scrawl of the word “staff” can hardly be considered full, comprehensive and specific material information.
I hereby give my consent and authorize Doctor ___Calkins/staff____of the Johns Hopkins Hospital to perform the following operation or other procedure: ELECTROPHYSIOLOGY TESTING AND ABLATION
One could be forgiven for thinking that since the person who proposed and explained the procedure was Hugh Calkins, and that Hugh Calkins made clear that operator experience is essential to minimize risks and insure success, and that Hugh Calkins made clear that he – Hugh Calkins – was just the experienced professional operator needed in this situation, well one could be forgiven for making the ordinary assumption that /staff meant nurses and technicians and the like.
“A perfunctory, signing of a consent form elicits mere passive assent, not active consent. It neither enhances patient understanding nor helps the patient take responsibility for his or her choices. There is a substantial consensus in our society that it is unethical to impose risks on people without their consent.” – Dr. Harold J. Bursztajn, Associate Clinical Professor and Co-Director, Program in Psychiatry and the Law, Harvard Medical School.
“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.
Disclosure
“Hugh Calkins, MD, FACC, FAHA, FHRS, has disclosed that he has served as a consultant to ProRhythm, Ablation Frontiers, CryoCor, and Biosense Webster. Dr. Calkins has also disclosed that he has served as a speaker for Biosense Webster and Reliant” http://www.medscape.com/viewprogram/7535_authors
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The Great Chest Tube Mystery
How did those scars get there?
———————–
“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
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.
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Nurse’s notes Kristi w/ Walman Tom WaitsKim,
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/
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)
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
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
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
- y 2nd,
2008
5:49 pmDear 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)
http://www.massdevice.com/node/4270/20
Boston Scientific, Medtronic, five others slapped with off-label lawsuits
July 15, 2009 by MassDevice staff
The two device giants and five other companies are accused of promoting the off-label use of microwave cardiac ablation products and of bilking the Medicare system in a federal whistleblower lawsuit.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
13
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.****
