Posts Tagged ‘aortic valve replacement’

September 5th, 2012

Databases and Decisions

What’s an “excellent” mortality rate for elective ascending aorta/arch replacement, and how would we know?

August 6th, 2012

TAVR and the Price of Innovation

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In an article published in Circulation, Daniel Mark and Robert Mentz of the Duke Clinical Research Institute and University Medical Center examine the economic and policy implications of the recent validation of transcatheter aortic valve replacement (TAVR) in the PARTNER trials. CardioExchange is fortunate and pleased to present Dr. Mark’s responses to questions about his […]

July 31st, 2012

TAVI: Belgian Researchers Slam Evidence Base and Overuse in Europe

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 deemed inoperable […]

July 16th, 2012

The Name Game: Why Did “TAVI” Suddenly Become “TAVR”?

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 U.S. approval. Now, in […]

June 26th, 2012

Unlikely PARTNERs Support TAVR

The FDA approval of TAVR and the design of postmarketing surveillance involved a remarkable degree of collaboration and cooperation among the stakeholders. What to do while we wait for data to accumulate?

June 14th, 2012

FDA Advisory Panel Recommends Expanded Indication for Sapien Transcatheter Heart Valve

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 was […]

June 11th, 2012

FDA Reviewers Raise Questions About Sapien Heart Valve System

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 was […]

May 2nd, 2012

Real-World Experience with TAVI: Vive la France!


A study of data from FRANCE 2, a prospectively maintained, multicenter registry of the French national experience with transcatheter aortic valve implantation (TAVI), has now been published in the New England Journal of Medicine. The registry captured every TAVI performed at all 34 active centers in France and Monaco; it therefore reflects “real-life” experience with TAVI in patients with […]

March 26th, 2012

PARTNER: TAVR Results Appear Durable at 2 Years

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 1 year had demonstrated similar mortality in high-risk patients with aortic stenosis who underwent TAVR or surgery. Now, the 2-year results have been presented at the American College of Cardiology […]

March 1st, 2012

Is Age Just a Number?


An 89-year-old woman with severe aortic stenosis is referred to a cardiologist at a major academic center that offers transcatheter aortic valve implantation (TAVI). A widow for 20 years, the patient lives alone and does well with the assistance of her daughter, who lives nearby. She has two more children in the same town, as well […]