Live AF ablation broadcast on Today Show: what’s wrong with this picture? 17

Mauricio Arruda performed a live AF ablation at University Hospitals in Cleveland on the Today Show yesterday morning.

The 6-minute segment was relentlessly upbeat. The TV producers pulled every trick in the book to overcome the inherent difficulty of portraying a hard-to-explain disease like AF and an even harder-to-explain procedure like catheter ablation. Instead of making any effort to truly educate their viewers, the producers took the easy route. Arruda, staring at a bank of large display monitors, might as well have been playing a video game, for all anyone watching might have known. And the reporter, NBC Medical correspondent Dr Nancy Snyderman, substituted schmaltz for substance and presented the “heartwarming” story of the patient, a great-grandmother, accompanied by stirring music and sentimental images.

Although the procedure was still in progress (and in fact Arruda had not even finished the mapping portion of the procedure), Snyderman said that “thanks to technological advances in cardiology Dr Arruda will be able to fix Bernice’s heart.” The patient was also well trained and thoroughly on message: in a clip filmed before the start of the procedure she said, “I’m excited and I’m not afraid.”

Just in case anyone hadn’t somehow caught the positive message, Snyderman told her viewers that the patient’s life (even before the procedure was finished) now “has new promise thanks to a dedicated physician, a world-class medical center, and extraordinary medical advances…”

Snyderman then said the success rate of the procedure is 85%, but that wasn’t quite good enough for Arruda, who informed Snyderman that “the success rate is 85-90% with this particular technology.” As if that wasn’t upbeat enough, Snyderman then reassured her audience that “the radiation risk is minimal.”

Finally, Snyderman promised her audience that “we’ll follow-up in a few months, but by all accounts… we expect her to do really very very very well.”

Editorial comment: What’s wrong with this picture?

Watching this short segment reminded me of one of those pictures in a child’s puzzle book where the reader is asked to find everything that’s wrong in the picture, and the longer you look the more wrong things you find. Even after staring at the picture for several minutes you’re still surprised when you realize the man walking across the center of the picture has only one leg.

Didn’t anyone at NBC think about the ethics of broadcasting a live medical procedure? Suppose something had gone drastically wrong during the live broadcast? I think there are legitimate questions worth raising about the public display of any medical procedure, but a live broadcast on a major television network is  indefensible, in my opinion. (In my previous job as the editor of heartwire we investigated the issue of live case demonstrations at medical meetings near a windshield replacement houston company, though in those circumstances there was always at least a plausible case for medical education in a professional setting.) Now we have live operations for public consumption or, even worse, the spectacle of physician-reporters reporting on their own medical efforts in Haiti.

Even if you believe it is ethical to broadcast a live procedure, it’s unethical and irresponsible to report it with this kind of relentless, upbeat mindlessness. Let’s be clear: there is no evidence in the literature to support the statement of an 85-90% success rate for catheter ablation of AF. To present this kind of statistic to the general public, many of whom may have AF, or may know someone who has AF, is completely irresponsible. Catheter ablation is emerging as an important therapeutic option for some patients with AF, and it is indeed an impressive medical advance, but it comes with a lot of caveats.

The misuse of statistics illustrates another clear reason why procedures shouldn’t be broadcast live. It would have required enormous fortitude for Arruda to challenge, on live TV, Snyderman’s assertion of an 85% success rate, and it would have been equally difficult for Snyderman to press Arruda on the statistic while he’s in the middle of a procedure. Quite simply, a live television broadcast is simply not the proper place for an intelligent reflection on a complex procedure.

The shoddiness of the reporting becomes even more apparent when Snyderman declared the procedure a success, and the patient cured, before the actual ablation had even started, and without the long-term followup that can provide the only real measure of success. You would never know from the report that last year AF ablation received a mixed review from a Medicare advisory committee and was the subject of a critical AHRQ review. Further, it is typical of reporting like this that a genuine issue of concern like radiation is only mentioned in the context of saying “the radiation risk is minimal.”

An anecdote is not evidence. By focusing exclusively and obsessively on single stories with happy endings, reporting like this has raised viewers expectations to such a degree that they will inevitably be disappointed and give up on the very real but more modest and unmiraculous aspects of modern medicine.

Update: EP physician Westby Fisher, aka Dr Wes, posted a thoughtful critical analysis of the 85-90% success rate mentioned in the segment.

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17 comments

  1. Agree with your column. The valve patient death on the table at the TCT during a live case should have been the end to live cases for PR purposes.

  2. Larry–

    I am of two minds. On the one hand, I complement “Today” for delving into a subject more substantial than the latest Hollywood who-ha. There was once a time when programs such as Today were significant sources of consumer health care news.

    The other hand agrees with you in that Today, like so many other former news programs (don’t get me started about 48 Hours and Dateline!), have sacrificed substance for style. Dr. Snyderman knows better than to produce a chirpy report on AF, but her producers and management do not.

    BtW, last year the Kaiser Family Foundation published an analysis of which media outlets continue to focus on health news. Sadly, television was not high on the list.

    Last year the Kaiser Family Foundation published a depressing

  3. Nice review. I couldn’t agree with you more.

    The fact that she used the company’s marketing spin of this technology being “more precise” makes me wonder how much they helped her develop her talking points.

  4. I thought the report was engaging, professional, and extremely valuable in terms of increasing awareness and educating those afflicted with AF that ablation therapy may be able to improve their quality of life. Although you criticized doing the procedure live, for me it was reminiscient of ISRG’s many televised procedures over the years and bespeaks the confidence the Dr Arruda has in his own abilities and the sophisticated Stereotaxis robotic equipment he is using. It also makes it clear that his hospital administrators also have extreme confidence in his capabilities with that equipment, and that Steroetaxis, though never mentioned by name or given any credit for that matter, shares that confidence in their ability to deliver safe, effective and consistent results.

    You came close to ranting about the lack of objectivity of the 85-90% statistics, suggesting there is no support for those assertions. On the contrary, there is now extensive peer reviewed, published clinical data on similar results on the Stereotaxis equipment, and many of the world’s top EP clinicians share their comparable results in various industry symposia which you must not be attending, in their patient info presentations and on their websites and similar. On that point, I was surprised to hear them discuss the need for touch up procedures on some cases. Even the world’s best acknowledge that is sometimes needed, generally in the 10-15% range, particularly on persistent AF cases.

    I also disagree with your inference that people are being misled by the all is roses commentary. No one who has AF or knows anything about it would think new, safe ablation techniques are any magic bullet. To my observation, they inferred nothing of the sort, only that for some, the new equipment and technique may offer a promising new alternative. Your comments on fluorscope times are disturbing — the doctor was making a simple comment that fluor times are not generally dangerous on the equipment. He was too busy and preoccupied with the procedure to elaborate. On that note, it was also confidence inspiring to note that he was not only able, but willing to divert some attention to the reporter during the procedure. It was almost like saying, this is complicated and requires competence, but it is routine for an experienced operator after a brief learning curve.

    I also note that it is not possible to have a 2 hour procedure
    with roughly half mapping and half ablating comport nicely with live TV scheduling. For me, that only added to the sense of comfort I had that this is stunning new equipment and technique are for real and going to play a big role helping many patients enjoy more years with an improved lifestyle.

    Finally, members of the Heart Rhythm Society are a thoughful group and have issued a key statement of position on the hows and whys and whens of ablation therapy. They are far more qualified to assess patient needs and treatment options than is the Medicare enterprise, and I’m surprised you gave such commentary as to cast doubt on the legitimacy of what is emerging as the standard of care when ablation is indicated. The FDA’s approval of JNJ’s irrigated catheters for AF last year speaks volumes about that agency’s perspective on this.

    • As a patient, and retired physician, I have had two ablations done
      before …. years ago…. I now have recurrent atrial fibrillation and
      contemplate having the exact same procedure done by one of
      Dr. Arruda’s colleagues, whom I saw yesterday.

      I was very interested in this program, the information it conveyed;
      the more precise mapping of the conductive pathways which
      are achievable using robotics.

      I think the whole segment was well-done. In a setting more attuned
      to the healthcare professional, I would like to have seen the entire
      procedure, beginning to end.

  5. Wes, I enjoy your blog and your perspective, always. With all due respect, there is a huge success rate disparity between different centers both in the JNJ Thermocool data set and in AF registry II so I am not surprised that some high volume centers are getting much higher success rate than mediocre centers that hover around 60% and lower success rate. Haissaguerre’s group is around 90% for persistent AF now (although I wish their cohort is larger than 40) and so is Natale and other top guns here in the US. I don’t know Arruda very well but I respect him enough not to doubt his honesty. Maybe we should all go back to the days when Carto and NavX didn’t exist. Real men don’t need no stinking technology. ;-)

  6. John Sinclair, I’m going to take a wild guess that you work for industry. Care to disclose? In any case, I’d be very interested to see a few citations to back up your support of the 85-90% success rate.
    Let me make one point clear: I have no axe to grind against AF ablation or Stereotaxis. But unwarranted claims– not only to physicians but to consumers– and proclaiming success before a procedure is even finished, is really indefensible, and those responsible should have their feet held to the fire. And it seems to me that supporters of these new technologies should be the first to do so, since in the end this kind of irresponsible and unthinking support ultimately damages their credibility.

    • The value of exposing this new technique to the public (and even medical professionals) is immeasurable. People living with AF are frequently depressed after experiencing deteriorating health. If this report leads to more patient inquiry regarding potential solutions then it is well worth the exposure. I agree that the doctor and the company making the apparatus must have been supremely confident in the technology to allow this kind of live television exposure. How many thousands of people might now raise the question with their doctor that were unaware of the potential to cure rather than just treat the condition? Looking forward to the followup report.

  7. Larry,
    I do not work for any medical equipment or device maker and have never recieved and form of compensation from any firm in the industry. I am a portfolio manager with allocations in many sectors, and have a particular interest in game changing technologies, including robotics (e.g., ISRG).

    On the topic of “success rates” referred to, the context was acute success on paroxsymal AF, Dr Arruda’s clinical experiences on Niobe are entirely consistent with results obtained by the world’s elite as published and presented in various forums including HRS, ACC, and Boston AF Symposia as well as numerous professional journals and in their own website and patient information materials, all of which are entirely consistent with these results. Your attention is directed to those sources, and an easy start might be the Erasmus and TCAI sources. When it comes to objectivity, the world’s elite doctors have unassailable integrity in my experience with them and their peers. They are a cordial, respectful, collegial, collaborative group that often spend several hours a day conferring with each other on difficult or otherwise unique cases. For you to challenge Dr Arruda, or any of these other doctors committed to patient safety first (that’s why they use Niobe) and improving patients’ lives is what i think is “irresponsible and unthinking”, and no matter how one-sided the views expressed by you and Dr Wes have been on this topic, they do not sustainably impair the EP doctors’ “credibility”.

    The recap of low success rates in Wes’ commentary also seems to be related to the JNJ data used by Dr. Wilber to present the case for FDA approval of the AF indication for the JNJ maual irrigated Thermocool catheters. Why not mention the very stringent criteria used to select those patients? You may not know, that they had already failed AAD therapy and that “failure was defined to include even 1 event during the follow up period? It seems likely that many patients in the “failure” column, having really failed on AAD drug therapy and finding themselves with a terrible inability to have any semblance of a “normal” lifestyle would hardly figure that the ablation therapy was a “fdailure” for them.

    I also found your inclusion of Dr. Wes’ comments re ineffectiveness on pvi and couagulum to be out of context and stale dated. If you are going to air such noise, why not include Dr Pappone’s response at the January 2009 Boston AF conference to the Natale et al data from cases done on the 4mm over two years ago? Better still, why not use the 5 part segment Dr. Pappone filmed two years ago showing his technique and success using Niobe to perform pvi? Still better, why not call and ask Dr. Natale how he feels about the new magnetic Thermocool catheters and what he knows about acute and chronic success rates on AF, both paroxsymal and persistent types. you may also want to include the list of who is who on rf abaltion; Dr. Pappone, Dr Kuck, Dr. Schwiekhardt, Dr Chen, Dr. Nakagawa, or Dr Hindricks and so on all have articulated or begun publishing outstanding results on the new Thermocool magnetic catheters. they are not making up data, nor are they compromising their integrity to make the point that Stereotaxis’ important new technology is added great value to many patients’ lives.

    Assuming you are one who has studied the literature, your entire take seems ironic. Here these doctors and the Steroetaxis technology are trying to reach more debilitated arrythmia patients and expand awareness of potential solutions for many with ablation therapy endorsed by the HRS, and there you are trying to discredit honorable men, including me, and discounting the effort of the care providers. I wonder who is compensating you, or if you are really just uninformed.

  8. Mr. Sinclair-
    I wonder if you would be so kind to point us to the peer-reviewed journal articles discussing the success rates quoted in the piece and reviewing the “precision” claims made by the reporter.

  9. Some of you guys need to calm down and look at your own centers with a critical eye instead of saying somebody else is making up data.

    A while back, I extracted some data from the latest AF registry data and here is a table of long term (>12 months) success rate without AAD’s. The first column is procedure volume and the second column success rate. Link to Cappato’s presentation of AF registry below. The registry data includes patients treated prior to 2006. The presentation covers other topics like protocol, safety, complications and mortality.

    Procedure Volume Success Rate
    300 74.5

    Those are the center’s results in aggregate. There will be variation within each center as well depending on skills and experience. Not everybody gets an A+ in Physics lab, only those that deserve to.

    http://www.heartrhythmondemand.org/heartrhythm2009/AF/play/?prd=090502-AF&prn=AF08.3017

  10. I don’t want to fall into the trap of debating true believers like John Sinclair, so I’ll just make a few observations:

    1. Even if Sinclair doesn’t work for industry he obviously has financial interests in companies in this space. A COI by itself does not invalidate his position, but it does raise questions.

    2. Doctors frequently report case series with success rates that are almost never replicated in randomized trials or under the harsh scrutiny of objective reviews by FDA, Medicare, etc. EPs, alas, are no exception. I’ll repeat Dr. Wes’s request for genuine literature citations of a high success rate.

    3. But– and this is the most important point– even if the success rate is as high as 85%, that still would NOT provide any justification for Snyderman’s reporting, or the ethical challenges inherent in a live broadcast of a medical procedure. Once again: it is simply substandard and irresponsible journalism to report a procedure to be a success before it is over. Is there anyone out there actually willing to debate this point???

    Best,

    Larry

    • I didn’t write Snyderman’s job description at NBC but why should society have a problem with live medical procedures? Particularly low risk procedures? I went through some of her other episodes and they serve an educational purpose just like the one we are debating about. Should only the heart.org, ACC, etc. be allowed to have live sessions because those people can take it if something goes wrong? Besides, AF ablation has low complication risk (1/10000 mortality on average) when done by someone with skill and experience.

      Yes, I agree she was jumping the gun about success. We should make sure that she follows up after the blanking period which is 90 days. The company acted responsibly in not doing a press release before the procedure was completed and waited until the patient had acute success and was out of the OR before doing a press release.

  11. Larry, you and Wes are way out of date with regard to success rate. Sinclair shouldn’t have to do the work for you guys. Just google it. I mentioned Haissaguerre persistent AF results in my post. This should be old news to you and any EP that’s doing his home work. 95% for persistent AF and the top guns are getting better all the time.

    http://www.medscape.com/viewarticle/515974

    • Doug-

      Interesting reference you pulled. 24 of 60 patients (60%) were “successful” on the first try. Only after repeat ablation procedures for atrial tachycardias and macroreentrant atrial arrhythmias was there any chance of achieving the 95% percent sucess rate you claim on a single procedure – even for the “top guns.”

  12. Pingback: The Today Show Misinforms People About Robot-Guided Heart Procedure - Better Health

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