CardioExchange Archive

June 14th, 2012

FDA Advisory Panel Recommends Expanded Indication for Sapien Transcatheter Heart Valve

Larry Husten, PHD

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 […]

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June 11th, 2012

FDA Reviewers Raise Questions About Sapien Heart Valve System

Larry Husten, PHD

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 […]

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May 8th, 2012

Selections from Richard Lehman’s Literature Review: Week of May 7th

Richard Lehman, BM, BCh, MRCGP

This week’s topics include a comparison of abciximab and manual aspiration thrombectomy in STEMI, the quality of U.S. clinical trials, 2-year data on PARTNER, TAVR in inoperable decompensating stenosis, clopidogrel genetic testing, and strategies to reduce MI mortality.

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May 7th, 2012

Politics and Transcatheter Aortic Valve Replacement

Larry Husten, PHD

Larry Husten takes to task a conservative activist who is trying to inject politics where it’s neither needed nor wanted.

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May 2nd, 2012

CMS Issues National Coverage Decision for TAVR

Larry Husten, PHD

The Centers for Medicare & Medicaid Services (CMS) issued on Tuesday 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 […]

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April 26th, 2012

Frailty Evaluation and High-Risk Interventions

John A. Dodson, MD

When taking care of older patients, we often have an intuitive sense of which ones will do well after an intervention and which ones won’t. This has been termed the “foot of the bed” test, or alternately something which separates a “young 80-year old” from an “old 80-year old.”  Frailty is a syndrome defined as […]

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March 26th, 2012

PARTNER: TAVR Results Appear Durable at 2 Years

Larry Husten, PHD

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 […]

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March 2nd, 2012

Four Cardiovascular Societies Release Criteria for TAVR Programs and Operators

Larry Husten, PHD

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 […]

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February 28th, 2012

Slow Uptake of Transcatheter Aortic Valves: Learning from History?

Larry Husten, PHD

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 its introduction would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs […]

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February 3rd, 2012

CMS Releases Details of Proposed National Coverage for TAVR

Larry Husten, PHD

On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for transcatheter aortic valve replacement (TAVR). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). The memo will be open […]

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