The growing and enthusiastic adoption of transcatheter aortic valve implantation (TAVI) in Europe has no justification, according to three researchers who performed a health technology assessment for the Belgian government. In a paper published in BMJ, the authors from the Belgian Health Care Knowledge Centre conclude that TAVI should only be used in patients “who are…
The Name Game: Why Did “TAVI” Suddenly Become “TAVR”?
July 12, 2012 by 2 Comments
One of the great, unexplained mysteries of the cardiology world in recent years is the sudden name change from TAVI (transcatheter aortic valve implantation), which had been the universally-used name for the procedure during most of its development period, to TAVR (transcatheter aortic valve replacement) about the time when the procedure edged closer to US approval. Now,…
FDA Advisory Panel Recommends Expanded Indication For Sapien Transcatheter Heart Valve
June 14, 2012 by Leave a Comment
The FDA’s Circulatory System Devices Panel voted overwhelmingly on Wednesday to recommend an expanded indication for the Edwards Sapien Transcatheter Heart Valve in patients with symptomatic severe aortic stenosis who have high operative risk. The device is currently approved for use only in patients who are not surgical candidates. The committee voted 10-2 that the Sapien device…
Live Blog: FDA Advisory Panel For Edwards Sapien Transcatheter Heart Valve
June 13, 2012 by Leave a Comment
Here’s my live-blog of the FDA’s meeting of the Circulatory System Devices Panel to consider the premarket approval (PMA) application for the Edwards Sapien Transcatheter Heart Valve for use in patients with symptomatic severe aortic stenosis who have high operative risk. As reported here earlier this week, FDA reviewers have raised a number of questions about the safety and…
FDA Reviewers Raise Questions About Sapien Heart Valve System
June 11, 2012 by 1 Comment
FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. The review was published online ahead of Wednesday’s meeting of the Circulatory System Devices Panel meeting to evaluate the Sapien system for use in patients eligible but at high risk for aortic valve surgery. The Sapien system…
Politics and Transcatheter Aortic Valve Replacement
May 4, 2012 by 2 Comments
From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears: Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people. The stampede to stake a claim in a promising, highly lucrative new territory would…
CMS Issues National Coverage Decision for TAVR
May 1, 2012 by 1 Comment
The Centers for Medicare & Medicaid Services (CMS) today issued its national coverage decision (NCD) for transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic…
PARTNER: TAVR Results Appear Durable at Two Years
March 26, 2012 by Leave a Comment
Two year results of the influential PARTNER trial provide continued support for the growing acceptance of transcatheter aortic valve replacement (TAVR) in clinical practice. Previously, results of PARTNER at one year had demonstrated a similar mortality in high risk patients with aortic stenosis who received TAVR and surgery. The two year results were presented at the American College…
Four Cardiovascular Societies Release Criteria for TAVR Programs and Operators
March 2, 2012 by 1 Comment
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…
Slow Uptake of Transcatheter Aortic Valves: Learning from History?
February 28, 2012 by Leave a Comment
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…
CMS Releases Details Of Proposed National Coverage For TAVR
February 2, 2012 by 5 Comments
(Updated with statement from the ACC and STS) On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for TAVR (transcatheter aortic valve replacement). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and…
Consensus Document Provides Roadmap To Uptake Of TAVI In US
January 31, 2012 by 3 Comments
Following the recent approval by the FDA of transcatheter aortic valve replacement (TAVR), the ACC, AATS, SCAI, and STS, in conjunction with several other medical organizations, have released a critical consensus document to guide use of the new landmark procedure. “We have tried to collate the evidence into a coherent road map for judicious use, rational…
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