In atrial fibrillation therapy, not all the hype is true…

Atrial fibrillation therapy continues to grow in complexity.  Thus far, an easy cure has remained elusive.  The potential of discovering an easy cure of AF –and the resultant immense profits –has provided fertile soil for medical device companies.  But, like in a garden, fertile soil provides for the growth of both beautiful plants and weeds.

The WSJ reports on the the use of non-FDA approved medical devices for the surgical ablation of atrial fibrillation.  Good for them.   However, in reading the reactions to this story, clarification from the real world seems to be warranted.

Surgical treatment for AF is significantly different than the more extensively studied, and guideline-approved catheter based radiofrequency ablation approach.

Historically, as is often the case, cardiac surgeons paved the way for catheter ablation.  The original surgical maze procedure pioneered by Dr J Cox provided the scaffold for modern day catheter ablation techniques. A less invasive maze-type surgical procedure is done in St Louis, and Dr Damiano and colleagues have published excellent data.  As such, this particular surgical approach is widely respected in the heart rhythm community.  I have sent patients to Washington University, and have been pleased with the care rendered.  The WSJ story speaks of a much different surgery.

The surgical approaches to AF described in the WSJ were unproven non-St Louis approaches by local surgeons, often trained by sales staff.  The central theme of these approaches involved differing mechanisms of getting to the pulmonary veins from an external approach –an epicardial approach to PV isolation.
Problems with these surgical approaches:
The non-approved devices clamp the PV trunk and deliver RF energy.  Ablation is done distally in the PV which often miss triggers in the left atrial antrum.  There is no testing for conduction block, no looking for external triggers of AF, and patient selection by surgeons unfamiliar with AF is very questionable.  Unlike catheter ablation approaches to AF, randomized trials in major heart journals using these particular clamp intensive surgical approaches are universally lacking.  Accordingly, the lack of controlled data precludes the FDA from approving these devices specifically for AF therapy.

Background:
AF is a remarkably common problem which increases with age.  As modern medicine increases the human lifespan, AF prevalence will continue to increase.  Increased obesity, sleep disorders, and hypertension further accentuate the likelihood of AF.
In the past few years, the rise in the use of coronary stents has rendered CV surgeons much less busy.  Less bypass surgery means there is available time to play with the treatment of atrial fibrillation.
The medical device companies see AF therapy as a gold mine of potential.  As such, they have built devices for surgically ablating in the left atrium via an external approach.  The companies market directly to the less busy CV surgeon, and voila, an AF therapy is spontaneously generated.  This is a farce.  It happened in my city, and in neighboring cities.  Surgeons, who had no expertise in AF, began doing an unproven stand alone surgery with a non-approved device.  Of course, reports were of 100% success.  Problem is, patients were either not being followed, or ECGs and 24 hour monitors were not done.
Recently, an 88 year old women sought me out for a second opinion after a local CV surgeon offered her a surgical cure of asymptomatic AF which she had had for 20 years.   Ouch.
How could this debacle have started?

Over the past decade, the catheter based EP approach to AF ablation has evolved into a relatively safe and moderately effective procedure.   AF ablation in the EP lab is laborious, difficult to learn, dangerous in the unexperienced hand, and requires meticulous attention to detail. Intelligent application of this challenging procedure, and communication to the patient on the realities of their impending journey is critical.  As I have said previously, AF ablation is unlike most other ablations, or one-time curative surgeries.

Given these extreme complexities, electrophysiologists in the real world approached AF ablation cautiously.  This proved too slow for the device companies.   These profit driven companies completely bypassed the AF experts in the EP community; marketing directly and simultaneously to the general public and the CV surgery community –an end around to the pot of gold, with the like minded hospital marketing divisions in tow.  The billboards and media spots touting these unproven surgical cures of AF became commonplace.

Congratulations to the WSJ for getting this story out.

Conclusions from an AF ablator:

The FDA should not mandate all the specifics of which catheter can be used for a specific disease. An experienced electrophysiologist using a catheter with a proven safety record is in a much better position to make these application decisions.

In this case of marketing unproven devices, and bypassing the real experts in the EP community, the medical device companies were clearly out of line.  We should expect this of them, as they compete in a capitalist milieu, and are beholden to both shareholders and patients.  Like a good child who occasionally misbehaves, medical device companies warrant surveillance, and guidance. Where would we be without the innovation of medical device companies?

There are specific surgical approaches to AF that have accepted benefit, but not all surgical approaches are the same.  Patients with AF should seek opinions from electrophysiologists, and often second or third opinions are warranted.  Any good doctor welcomes other opinions.

For patients, understanding options of AF therapy remains a major challenge.  Exposing the debacle of unproven surgical approaches manufactured by medical device companies adds another chapter to the long book of AF therapy.

JMM

5 comments

  1. It is as we have said all along: non busy surgeons looking for something to do. Most of these are minimally invasive and maximally expensive; and as you and I have noted, with no science, just records of achievement.

  2. You may not be too popular with some of the local heart surgeons after they read this.

    I'll be watching for this in my community. Haven't seen much of it yet.

    -Steve

  3. John,
    Any doctor who is not very busy can be very dangerous. They start getting into things they have no business doing.
    Bill

  4. One of the benefits of being busy is never having even the remotest temptation to do things outside one's realm of expertise.

    Innovative procedures/therapies that push the envelope are an important part of moving medicine forward. However, it seems obvious, and honest, and ethical to describe them to patients as such. To call these unproven treatments routine, or to inflate their success rates, or to deny the role of industry borders on outrageous.

    Writing words, while actively practicing medicine demands restraint, which in cases like the aforementioned is difficult.

    JMM

  5. Being an electrophysiologist, I am in agreement with Dr. Mandrola that stand alone surgical procedures for atrial fibrillation tend to lack the typical scientific data that is seen in the electrophysiologic community. However, I think that we should not overlook the potential benefits that a surgical approach has to offer the patient and the physician. Certainly a clamp type device on the pulmonary veins in an attempt to isolated them is likely to do little benefit to the patient with valvular or ischemic heart disease with left ventricular dysfunction and an atrial size greater than 4.5 cm; as we all know that the arrhythmic disease has progressed far beyond a cure by isolating the pulmonary veins.
    We as physicians tend to bash other specialties when they attempt to enter into a territory that is consider "ours". As noted, the basis for an EP's approach to AF is based on the Cox procedure – pioneered by a surgeon. So it would seem that they might have something to offer.
    Dr Andy Kiser created a non-thoracotomy – minimally invasive – approach for the treatment of persistent AF. This is a patient population that is historically difficult to treat with catheter ablation. He team up with myself to develop the Convergent Procedure that combines the positive aspect of each discipline. Surgically offering robust ablation lesions with near complete isolation of the pulmonary veins, isolation of the posterior left atrium with the electrophysiologist completing the isolation of the veins, creating a mitral annular line, coronary sinus debulking and isthmus line. This requires approximately 3 hours of the EP's time with about 40 minutes of fluoro. One year data reveals a success rate of ~80% in this patient population which far exceeds catheter success rates. Early data was presented at AHA (Circulation. 2009;120:S707) and an additional abstract has been accepted at HRS.
    Let us not count out our surgical colleague's but work together to achieve the best outcomes for our patients.

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