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.
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.