The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee on Wednesday voted to recommend approval of the Edwards SAPIEN Transcatheter Heart Valve. The Edwards valve was tested in the PARTNER trial, which examined its effectiveness in inoperable patients with severe aortic stenosis. PARTNER found that transcatheter aortic replacement (TAVR) significantly reduced symptomatic mortality and composite endpoints at one year compared to medical therapy for specific patient populations (particularly the elderly with multiple comorbidities). FDA is not required to follow the recommendations of its panels, but typically does.

I spoke at the meeting, as did Michael Mack, MD, president of the Society of Thoracic Surgeons (STS), Gus Picard, MD, from the Society for Cardiovascular Angiography and Interventions and others prominent in this field. On the panel was Rick Page (chair), chair of ACC’s EP Committee and immediate past president of ACC Ralph Brindis, MD, MACC. There were many other ACC members in attendance as well.

During my comments, I outlined ACC’s recommendations for rational dispersion and post-market surveillance of the Edwards device. The ACC believes that dispersion will rely of three key players: Edwards, in educating physicians on how to properly use this specific device; the ACC, STS and other applicable specialty societies, in educating physicians about the particular disease state and therapeutic options; and the government, which must facilitate interactions and collaboration among all involved. In these modern times, novel implantable devices, such as the Edwards valve, require that relations between federal agencies and professional societies be revisited with a creative and visionary eye.

My comments stressed practical elements that will be required to ensure that implementation of TAVR improves quality. First and foremost, the procedure must be completed by a multi-disciplinary team; no one subspecialty should perform TAVR alone. Additionally, because patient selection is so important, there must be further development of the criteria used for patient selection. In terms of facilities, the ACC supports the development of centers with specialized expertise in TAVR.  This is based upon the literature that has indicated that structural heart disease outcomes have a direct relationship to center procedure volume. Finally, the ACC recommends tracking patient outcomes and safety through a registry for valvular heart disease, created by linking clinical and administrative databases.

There was also detailed discussion of the risk-benefit ratio in terms of periprocedural stroke.  This in-depth discussion extended the information available in the published trial.  The panel included experts in the field of stroke, and there was much discussion on the etiology of the stroke and development of preventive strategies.

In addition, there was detailed discussion of the issue of patients who might be too grail or who have such extensive comorbidities that they would not benefit from the procedure.  Better patient selection criteria are needed to identify patients who are too frail, in whom intervention may be futile.

Following the hearing, the Advisory Committee voted on three main questions:

1. In a vote of 7-3, the committee agreed there was "reasonable assurance that the Edwards SAPIEN™ Transcatheter Heart Valve is safe for use in patients with severe aortic stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis."
2. In a vote of 9-1, the committee said there is "reasonable assurance that the Edwards SAPIEN™ Transcatheter Heart Valve is effective for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication." 
3.  In a vote of 9-0-1, the committee said the "benefits of the Edwards SAPIEN™ Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication outweigh the risks of the Edwards SAPIEN™ Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication."

The ACC submitted written comments in advance of the panel meeting as well. The ACC and STS in June released an overview document of transcatheter valve therapy, and it is the first of a series of documents that will address the issues critical to successful integration of TAVR into medical practice. Look here and to CardioSource for more as these documents are released. For more on the initial overview document and PARTNER results, see my previous blog.

Here’s the video again: