Tuesday, August 01, 2006

Non-Electrophysiologists and Defibrillator Implantation

To appreciate an example of the latest furor between general cardiologists ("plumbers") and cardiac electrophysiologists ("electricians" or heart rhythm specialists), one only needs to read the front page of the New York Times this morning. Non-electrophysiologists implanting defibrillators: it's a mess and a disgrace to us "electricians," but it was bound to happen.

The New York Times points out the questionable ethics of defibrillator companies like Biotronik paying for training of physicians for free and NOT requiring them to have any long-term formal training or testing to perform these implantations. But hungry non-US device companies eager to gain market-share do what is needed to compete. And doctors in their eagerness to increase revenues and isolated geographically from other centers with experienced board-certified electrophysiologists, now use 'patient convenience' as their excuse to perform these procedures locally in their center, despite very little training. Ten cases and a voluntary test is all they need to be certified? Hogwash.

Cardiologists will argue that implantation of these devices is no different than implanting pacemakers. I disagree. Here's an example. These devices are considerably larger than conventional pacemakers. How many of these cardiologists have had experience with a subpectoral (placing the device beneath the breast muscle) implantation in their 10 cases? I would suspect none. But if these devices are implanted subcutaneously (beneath the skin and above the breast muscle) in very skinny individuals, there is a greatly increased long-term risk of the device eroding through the skin and becoming infected. Will these doctors have the judgement to do what's right for the patient during the initial implant? Obviously not, since they would never have gained the surgical skills required and are unlikely to have ever seen a device erosion in their limited experience.

And don't get me started about the follow-up of these devices AFTER they are implanted. How many cardiologists have dealt with repetitive firing of the defibrillator due to improper programming, or upper chamber rhythm disturbances, or malignant lower chamber (ventricular) arrhythmias? Will 10 implants teach them how to troubleshoot correctly or how to revise the system to correct the problem? Hardly.

One more tidbit: the computer programmer to communicate with these devices is specific to the implanted device and must be available at medical centers if you have a problem with your device. In my experience with Biotronik, they have nowhere near the number of technical support staff or market penetration as the other US-based companies to assist physicians with these complicated devices. If you travel, you might want to inquire about this.

But perhaps most disappointing for those of us in this field, is the fact that the Heart Rhythm Society folded to the influence of the device industry to permit the "fast track" option for training of implantation of defibrillators in the first place. It devalues the expertise of those who have acquired the conventional electrophysiology training, and leaves in question why anyone should have to endure the 12-24 months of their subspeciality training in cardiac electrophysiology in the first place.

There is huge financial incentive for Medtronic, St. Jude, Boston Scientific, and Biotronik to capitalize on the expanded indications for defibrillator implantation. These are very expensive devices that represent the majority of revenues to medical device companies. So much so that there was significant political pressure imposed by the industry on our elected officials of the Heart Rhythm Society to address industry's concerns that there were not enough physicians trained capable of implanting these devices relative to industry's perceived number of devices that would be required - and hence the "fast track" implantation training was born.

Yet here we sit. Our lab is NOT to capacity. We have never turned away a consult or been unable to provide a defibrillator implant in a timely fashion to any patient referred to us. Even the business community is rocked by the "slow-down" in the number of devices implanted recently. Real concern exists as well that these minimally-trained cardiologists might not select the best device for their patients. And yet our Heart Rhythm Society made a fast-track despite significant concerns by other colleagues in their field.

As this "get-rich quick" scheme plays out across the country, patients might want to ask several questions of their defibrillator implanter:

1) Are you board certified in cardiac electrophysiology?
2) How did you document your skill at defibrillator implantation?
3) Which manufacturer's device will you be implanting? Why?
3) Have you ever performed a subpectoral implantation?
4) Do you have a defibrillator follow-up clinic or will I be sent to someone else for this? If so, how often do they see patients?
5) How many defibrillator implantations (not just pacemaker implantations) and revisions have you performed?

And if you're still not sure. Get a second opinion, preferably from a board-certified cardiac electrophysiologist.


For disclosure and out of fairness, I am a speaker and consultant to Medtronic, Inc.

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