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Catheter
Ablation for Tachycardia:
My Experience as a Patient Introduction - Diagnosis - Preparation - Surgery - Recovery - Home - Pictures - Followup - Questions - Contact Dissenting Opinion |
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I’ve received several e-mails and entries in the guestbook from someone who was injured during the course of his catheter ablation treatment in about 1990, when the surgery was still new. He disagrees with the manner in which I present my experience. He asked me to either provide research papers on the procedural or take this web site down. I’m not prepared to get into a big debate with him over the applicability in any specific case or over whether it is vastly overused. I will state that while he is correct in saying that people should research any medical procedure and interview the surgeon who is to perform it, I disagree with the idea that surgery should be reserved for life-threatening situations. What I know is this: my surgery improved the quality of my life. I know that I can live long and well, and free of drugs. That means, among other things, that I can play hockey, drink coffee, and do all the other things that go along with a happy and healthy life. As a candidate for this procedure, you have to take into consideration all the risks involved in having surgery, as well as the risks of not having surgery, and decide for yourself what you want to do. May 2, 2000 E-Mail Mike: You and I have quite a few similarities. I’m a senior spacecraft engineer at Hughes in El Segundo (Los Angeles). I’m a hockey player and graduate of U of Michigan. I’m also a former race car driver and on / off road motorcyclist. I have some comments on your ablation site. Please do NOT post them on your site. [Remainder of e-mail not posted.] May 5, 2000 20:15:07 Guestbook Entry Hello all you gung-ho risk takers. Please take notice that ablation is a dangerous medical procedure, generally performed on people who are not at risk of dying. I was a very athletic person who now has no heart rhythm, a pacemaker, clotted veins in my right arm and jugular veins, open heart surgery, and a lot of emotional pain too, thanks to an errant blast of RF energy (expertly administered, of course) during my ablation procedure some years ago. Please don’t get ablated, or at least don’t let your kids get ablated unless the arrhythmia is very rapid (say 300 beats per minute), and you/they have failed drug therapies. You can have an EP study to help pick drugs if you need it, without the ablation. Plus there’s a ton of x-ray exposure during these procedures. RF ablation is not fun or magic. If you are style conscious and simply MUST have your ablation, please find a doctor who performs 200+ procedures per year, usually at the largest medical university in your state. Other REAL risks include catheter tip dislodgement in the heart, valve damage, cardiac perforation, coronary artery ablation / death, and serious infection. Many doctors reuse their ablation instruments to save money, and sometimes bend them by hand to help position them inside the heart. Unfortunately, this is an ill-advised activity because the catheter can get stuck, requiring open heart surgery to remove. Basically, RF ablation is grossly overutilized and amounts to unneccessary medical medling, except for extreme cases. However, it will save your insurance company money, in the long run, if you assume you’ll need to take medication (which is why they approve the procedure). Many people, however, can take meds only in association with activities that provoke the arrhythmia, if desired. Happy arrhythmias to all! May 5, 2000 14:51:57 Guestbook Entry (from Linda) This is in response to message 104 from slapshot. First, I’m truly sorry that your ablation procedure did not go well and that you were left with so many problems. You clearly have feelings about that. However, I think it is unfair and irresponsible to use your unfortunate experience as a scare tactic to frighten others away from having this procedure done. I am a medical professional and not someone who is too eager to have medical procedures inflicted on me. But I have had 2 ablations, both very successful and without complications. I had my procedure done at a university medical center where I felt I was in the hands of a very competent and professional team. The risks, benefits, and alternatives were clearly explained to me and there was no pressure from anyone to undergo the procedure; it was up to me to weigh the options and make my own informed choice. I doubt that anyone who has come to this decision point takes it lightly. Nor do I think they believe themselves to be "gung-ho risk takers." And it is hardly a matter of being "style conscious." We are not talking about liposuction here. I believe, from the contacts I have had with others, that for most this was a decision that came after many years of trying other treatments and tolerating arrythmias which significantly affected their quality of life. I might point out to you that some antitarrythmia drugs carry a side effect profile just as risky or more risky, than having this procedure. All invasive procedures have some risk associated with them. Some of the tactics you talk about in your message (re-using equipment etc.) would never be employed by an ethical and ccmpetent professional. You also imply that the real risk is with the ablation itself, and not the EP study. Yet the risks you mention, perforation, catheter tip dislodgement, infection etc. are risks associated with inserting the catheters themselves, which is what is involved in doing an EP study in the first place. These risks exist whether or not an ablation is done at the time of the study. And these complications are quite rare in the hands of an experienced team. I certainly will agree with your recommendation that, if one is to have this procedure done, one choose an experienced team and a medical center that does a lot of them. That makes good sense with any procedure that is not absolutely routine and requires special expertise and equipment. I will give you the benefit of the doubt and assume you meant no harm, but I felt I could not overlook your overly negative and somewhat insulting comments. We are not idiots who cannot make an informed choice. I can understand, from your own perspective, the need to warn people about the possibility of a poor outcome. But this must be balanced with factual information and the realization that for many of us, the benefits far outweigh any risks. Oh, by the way, you are correct in one assumption. That is, ablation is not fun (but it is not awful either -I was awake during one of mine and it was certainly tolerable). But it is magic; a wonderful technology and opportunity for a lot of people, who I hope have not been freaked out by your message here. May 5, 2000 15:36:42 Guestbook Entry Hi Linda, I’m not out to scare people, but a patient’s informed consent requires that the risks be disclosed. The whole point is, if the risks scare you, you might not want to have the procedure. Ablation is a highly unusual treatment in that it is not medically necessary, yet has become mainstream medical practice as "first-line therapy." The procedure does have benefits and risks, as you pointed out. However, the assessment of the merits of the benefits as weighed against the risks is very complicated. The reason for this is that, in a standard medical decision model (statistical method wherein the probabilities of favorable and unfavorable events are weighed against eachother) it is impossible to justify ablation. Therefore, there are no published risk analysis of this type, and the FDA has not endorsed the procedure either. The reason there is a CPT code against which ablation can be reimbursed by insurers is that a "cost/benefit" analysis was completed in 1993-94 which showed that it was cheaper to treat SVT arrhythmia due to WPW via ablation rather than prophylactic drug management. Since that time, WPW has become a preferred (i.e. overused & improper) diagnosis of SVT patients with bypass tracts. The fact is, the majority of SVT bypass tracts do not constitute WPW because they do not conduct antegradily and as such will protect the patient against high ventricular rates - which is the only real risk of SVT against which the cost/benefit analysis can support a decision to ablate (even with the generally overstated, pro-ablation assumptions made therein). This is not to say WPW is a big thing either, since the risk of death due to WPW is fairly similar to the risk of dying from an ablation procedure. We could have less debate about this if those who’ve advocated ablative treatments would come to the table with an analysis. All they have is hand-waving. Moreover, I love my personal freedom, so I have no problem with someone getting ablated in the presence of complete informed consent. I don’t like kids getting ablated (they generally can’t give informed consent), or adults who’ve not had other more conservative therapy first. The risk exposure of an ablation procedure is very real, and very large relative to any other medical experience likely to have been handled by most (relatively young) SVT patients. These patients don’t generally appreciate this risk. (The same enthusiasm has recently applied to the stock market / NASDAQ index!) They are basically trading the discomfort factor of the arrhythmia against relatively high procedural risk (say 4-10% risk of needing a pacemaker, like me). That’s hard to justify. SVTs used to be considered a medical nusaince prior to ablation. Now that a means exists, the means will be utilized. Not everything that can be done should be done, however. Extra note: my procedure was performed by a UCLA/USC clinical professor of medicine in Los Angeles at a tertiary medical facility—this is not a safety factor. In fact, many such "professors" are more aggressive with their patients, which can make the procedure even riskier. Also, FYI, I am a highly educated engineer/scientist and am as much of an expert about cardiac EP, ablation, the complications of ablation, federal regulation, and risk analysis as you’ll meet. I’ve spent almost ten years learning about the subject. For posterity’s sake: the number of annual ablation procedures is somewhere > 60,000 today, but was only 2000 in 1990. EVERYONE DESERVES INFORMED CONSENT. Best wishes and good luck to any would-be ablatees. May 5, 2000 15:45:51 Guestbook Entry Linda: Extra note. As for the bent and reused catheters. This is, in fact, common practice—even though I agree with you (that is is unethical). FDA has had its arm twisted and has now authorized the re-sterilization processes used by the hospitals to accomplish this, typically up to 7 times. I posess plenty of documents originating from FDA and the medical literature which confirm these issues. If I was a patient, I’d ask the doctor to remove the catheter from its original packaging in my presence. And specifically ask that he/she not perform any manual bending of the catheter and discontinue the procedure if necessary. May 16, 2000 E-Mail. I’m not trying to butt heads with you at all. I recognized a long time ago that offering the full picture about ablation is difficult, unpopular and amounts to standing in front of a sunami. Therefore, I don’t do it. My discussions with you are an anomoly related to the fact that I was working on an all-night legal brief (with the assistance of FDA’s former - retired - senior scientist for electrophysiological devices). I found your site while recreating in the middle of that effort. I want you to realize that I am a credible source. Next time you watch DirecTV, you can bank on the fact that I played a major engineering role for each spacecraft up there. I am currently the senior engineer for DirecTV’s next generation spot beam satellite. Amazingly, however, the amount of energy I’ve put into researching ablation in the last 9 years far exceeds the amount I’ve applied to satellite design (i.e. the world would probably have better satellites if not for the bad outcome of my ablation procedure). As a software engineer, you are facilitating the transfer of information. So, please realize the need for credible referrences on your site. The info you’ll find on the net, particularly the sites you’ve linked to, are basicly sales brochures. Their appearance of credibility is deceptive as they do not offer informed consent. (Goto the NIH Office for Protecion for Research Risks to learn about informed consent: http://grants.nih.gov/grants/oprr/oprr.htm) At a minimum, you should post the procedural risks that are listed on FDA approved product labeling. (But, recognize that companies fight tooth and nail to keep the product labeling clean.) FDA has the labeling for some of these products in PDF format. Goto FDA’s PMA search page to locate FDA PMA file numbers (including P920047, P930029, P950005): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/search.cfm . Click on "decision date" and listing address, if available electronicly. (For example, see Medtonic Atakr http://www.fda.gov/cdrh/pdf/p930029.pdf pages 13-15) EACH PMA HAS >1000 PAGES OF CLINICAL DATA THAT ARE NOT AVAILABLE TO YOU ON THE WEB, OR TO A LARGE EXTENT, AT ALL IN THE PUBLIC DOMAIN!!! Also see FDA’s incident reporting system (MDRs), which offers a glimpse into reality: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.CFM (for example: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/Detail.CFM?ID=432564&CRIT=LPB I would describe the ablation - public information sector as follows: Basically, there is a mountain of information. Proponents (including hospitals/EP specialists) have selectively disseminated about 25% of that information, including non-FDA approved "disinformation." Further, hardly any info exists whatsoever regarding the large quantity of misuse of electrophysiology devices for non-FDA authorized indications (such as Atrial Flutter or Fibrillation). Such use amounts to unauthorized human experiments and is facilitated by a common device design, which can function in unauthorized modalities for which no clinical study has been performed. This is a unique problem for ablation. THEREFORE, IN ANY ABLATION WEBSITE, IT WOULD BE HELPFUL TO LIST THE FDA APPROVED INDICATIONS. If you really want this site out there, and it is getting so many hits, then do the research. First, recognize that you can’t do it on the web because medical journals only publish recent abstracts on-line. (goto pubmed/medline for recent abstracts, NASPE/PACE is the "heart" of electrophysiology journals). And, the FDA data above is only a scratching of the full story, and is limited as to electronic access and public disclosure in general. This is a difficult task. Don’t proliferate incomplete information. Also, FYI—ask any of your doctors if they have ever read the original Wolff - Parkinson - White / pre-excitation article (I haven’t met one who has). It describes, basicly, pre-excitation on an ECG and the hypothesis of an antegrade-conducting bypass tract. The important distinction being, again, with respect to the implications of antegrade vs. retrograde bypass tract. The majority are retrograde. Retrograde bypass tracts keep the AVN refractory period intact and protect the heart from excess rates that could lead to VF. This distinction is critical to the diagnosis with respect to possible SVT risks. The FDA clinical data addresses this. Toni Bevelock is a woman with a 280 BPM PSVT who declined ablation. Toni could successfully avoid SVT using any single of a variety of meds prior to competing in national raquetsports: (See U.S. National Racquetball Team—All-Time Alumni: http://www.usra.org/usra/programs/tm_alums.htm)
Best to you Mike. John May 19, 2000 16:29:33 Guestbook Entry Mike: Do you read these pages? I emailed you some link info for some of the FDA items on ablation, including risk disclosure on approved product labeling. You should kill this site, or add links to solid referrences. (For example, see Medtonic Atakr http://www.fda.gov/cdrh/pdf/p930029.pdf pages 13-15) (for example: see device injury reports (MDR) at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/Detail.CFM?ID=432564&CRIT=LPB (And refer to the NIH Office for Protection for Research Risks to help patients learn about gaining informed consent: http://grants.nih.gov/grants/oprr/oprr.htm) John July 18, 2000 14:24:03 Guestbook Entry To all: I was severely injured by this procedure, and I believe informed consent is very important for prospective patients. Please note that this site does not contain appropriate scientific/medical references and is not satisfactory for providing informed consent to possible patients. The hospital sales brochures and links to this site do not contain reasonable disclosure of procedural risks or information concerning SVTs in general, according to approved FDA standard labeling for devices used in this procedure —including the fact that the vast majority of SVTs (>>99%) are not life-threatening. Be aware that RF ablation is NOT "surgery". It is unusual in that it is a cost-effective but relatively high-risk "procedure" that is potentially curative for SVTs. The doctors who perform this procedure are cardiologists, not cardiac surgeons. There are many more cardiologists than cardiac surgeons, and the number of cardiologists engaging in electrophysiology has increased dramaticly since 1990, due to the proliferation of the RF ablation procedure. Each cardiologist is suppose to perform >= 80 procedures per year to remain "qualified" by NASPE. This creates, in essence, a demand for patients upon whom to perform the procedure. In 1990, the number of RF ablation procedures was ~2000/year in the U.S. In 2000, the number will be ~100000 or more (the procedure did not exist significantly prior to 1990). Even back in 1990, many surgeons felt that this procedure was grossly overutilized. Accordingly, it is appropriate that you demand from your electrophysiologist (PRIOR TO YOUR PROCEDURE) a copy of the FDA approved "indications" and "risks" for your diagnosis and RF ablation procedure directly from the ablation product labeling. If you do not ask for the FDA approved product labeling, there is a near certainty that this information will not be provided to you. If you want to look for similar records directly from the FDA, You can start at the following FDA/CDRH sites: . (For example, see Medtonic Atakr http://www.fda.gov/cdrh/pdf/p930029.pdf pages 13-15) (for example: see device injury reports (MDR) at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/Detail.CFM?ID=432564&CRIT=LPB Additionally—if you want to learn about informed consent in general, refer to the NIH Office for Protection for Research Risks: http://grants.nih.gov/grants/oprr/oprr.htm. If you want more info, please email to "busleaguer@netscape.net. Best wishes. John
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Catheter
Ablation for Tachycardia: My Experience as a Patient. Revised: 11/09/2001
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