As transcatheter aortic valve implantation (TAVI) gains increasing acceptance, cardiologists and surgeons are exploring additional patient populations who may benefit from the procedure. A new paper in the Journal of the American College of Cardiology provides the first look at the use of TAVI in the small but important group of patients with pure, severe native aortic valve regurgitation (NAVR) who do not have aortic stenosis.
The authors acknowledge that TAVI will likely be used sparingly in the NAVR population:
…although these results are encouraging for those patients who are truly ineligible for surgery, surgical valve replacement remains the gold standard for those who can undergo it, even at high risk. Furthermore, there is an increasing number of patients in whom the native aortic valve can be preserved during surgery.
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The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were not eligible for surgery.
The FDA also said the device could be delivered through both the transfemoral route and the transapical route. Previously the device could only be delivered through the transfemoral route.
“Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high,” said the FDA’s Christy Foreman, in an FDA press release. “The THV serves as an alternative for some very high-risk patients.” The FDA requires that before being deemed eligible for the Sapien valve a patient must be evaluated by a heart team, which includes a heart surgeon.
The new approval in high risk patients was based on findings from the PARTNER A trial. The earlier approval in non-operable patients was based on findings from the PARTNER B trial.
The FDA will continue to require Edwards to evaluate the Sapien device through a national registry.
Click here to read the FDA and Edwards press releases…
A newly released statement contains detailed recommendations about the requirements necessary for hospitals and physicians to participate in transcatheter aortic valve replacement (TAVR) programs. The expert consensus document was released jointly by the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS) and the Society for Thoracic Surgeons (STS).
The statement is the latest result of the coordinated effort from medical societies and regulators to effect a smooth introduction of this potentially disruptive new technology. The same four societies earlier released a consensus document that provided a roadmap for the uptake of TAVR in the US, which was followed soon thereafter by the release from CMS of details of its proposed national coverage for TAVR.
The document emphasizes “a formal collaborative effort between cardiologists and cardiothoracic surgeons as the cornerstone for establishing a successful program, noting that a program without both specialties would be fundamentally deficient,” according to a press release issued by the societies.
The statement contains specific details about:
- Annual heart (aortic valve) surgery and percutaneous coronary intervention (PCI) volume requirements for institutions.
- Board certification and procedural requirements for both surgeons and interventional cardiologist.
- Monitoring of complication rates and institutional follow up.
- Participation in a national registry that will include enrollment of all patients undergoing TAVR with continued tracking of outcomes.
- Commitment to a heart team concept that is led by the surgeon and interventional cardiologist and made up of a formal collaborative effort among all medical team members. In all TAVR procedures, the interventional cardiologist and surgeon must both be present during the entire procedure ensuring joint participation and optimal patient-centered care.
Click here to read the press release from SCAI, AATS, ACCF, and STS…
Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that the introduction of TAVR would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs, leading to repeated cycles of criticism, investigations, and pullbacks.
Early signs now indicate that history may not be repeating itself and that the careful and deliberate introduction of TAVR may result in an entirely different pattern. Remember that ACC and STS requested a National Coverage Decision (NCD)from CMS and, following the initial approval of TAVI, released a critical consensus document offering a roadmap to responsible introduction of the new procedure.
Wells Fargo medical device analyst Larry Biegelsen (email), attending the STS/ACCF Transcatheter Heart Valve (THV) Symposium in Chicago last week, reports that uptake of the Edwards Sapien device has been slow, suggesting that the measured approach advocated by the ACC and STS and others has had an impact.
He cites three reasons for the slow uptake:
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