The publications five years ago of the two part PARTNER trial brought a major change in the treatment options available to some people with aortic valve disease, which is often an extremely serious condition with a poor prognosis. The trial demonstrated that transcatheter aortic valve replacement (TAVR) was a reasonable treatment option, first for patients who…
High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic
March 10, 2015 by Leave a Comment
Transcatheter aortic valve replacement (TAVR) is one of the most important advances in cardiovascular medicine in recent years. TAVR devices, introduced recently in the US by Edwards Lifesciences and Medtronic, are associated with very high risks, but offer a less invasive alternative to traditional aortic valve replacement surgery. Because of early concerns about potential overuse and misuse of…
Study Explores Expanded Use For Edwards’ And Medtronic’s New Heart Valves
July 8, 2014 by Leave a Comment
In the last few years transcatheter aortic valve replacements from Edwards Lifesciences and Medtronic have entered the marketplace and now offer an alternative to surgery for some patients. Now these valves are being considered for use in patients who have already undergone surgery but whose bioprosthetic valves have failed. Although surgeons and patients increasingly prefer…
Medtronic’s CoreValve Gains New Indication For High Risk Patients
June 12, 2014 by Leave a Comment
Medtronic’s CoreValve system today gained a second indication from the FDA for use in patients with severe aortic stenosis who are at high risk for surgery. … Click here to read the full post on Forbes. …
First TAVR Comparison Trial Favors Sapien XT Over CoreValve
March 30, 2014 by Leave a Comment
With two devices now approved for transcatheter aortic valve replacement (TAVR), the marketing battle has begun to win the hearts and minds of cardiologists. On Saturday at the ACC, Medtronic gained bragging rights showing the first mortality benefit for its CoreValve device. A similar improvement did not occur in the PARTNER trials with the Edwards…
Survival Advantage for TAVR Over Surgery in High-Risk Patients
March 29, 2014 by Leave a Comment
Transcatheter aortic valve replacement (TAVR), which has been slowly and cautiously entering the clinical arena, will probably get a big boost from a new trial showing a significant mortality advtange for TAVR over traditional surgery. Results from the U.S. CoreValve High-Risk Study were presented at the American College of Cardiology in Washington, DC, and published…
French Surgeons Perform First Aortic Valve Surgery Without Opening The Chest
March 11, 2014 by Leave a Comment
Surgeons in France report that they have performed the first total endoscopic aortic valve replacement (TEAVR) in 2 human patients. Their paper has been published in the the Journal of Thoracic and Cardiovascular Surgery [subscription required]. … The new procedure may enable surgeons to replace the aortic valve without opening the chest, though it will still require cardiopulmonary…
Dangerous Rapid Calcification Observed In Pediatric Patients After Aortic Valve Replacement
January 21, 2014 by Leave a Comment
Pediatric cardiac surgeons at Boston Children’s Hospital are warning the medical community about a potentially fatal problem in children and young adults who received a bioprosthetic valve manufactured by Sorin. The surgeons initially became concerned when a young asymptomatic patient died suddenly after her valve underwent rapid calcification, only 7 months after a routine followup echocardiogram found…
FDA Grants Earlier Than Expected Approval For Medtronic’s CoreValve
January 17, 2014 by Leave a Comment
The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting. … Click here to read the full post on Forbes….
Longer Warfarin Therapy After Bioprosthetic Aortic Valve Replacement May Be Beneficial
November 27, 2012 by Leave a Comment
Three months of warfarin is the usual standard of care following bioprosthetic aortic valve replacement (AVR), although the supporting evidence base for this practice is limited. Now a large new registry study published in JAMA suggests that more prolonged warfarin therapy may be beneficial. Danish researchers identified 4,075 patients who underwent bioprosthetic AVR. As expected,…
TCT: Impressive Survival Benefit For TAVR In Inoperable Patients At 3 Years
October 24, 2012 by Leave a Comment
At the TCT meeting in Miami Murat Tuzcu presented the latest findings from the PARTNER B trial comparing transcatheter aortic valve replacement (TAVR) with standard therapy in patients who are not considered eligible for surgical valve replacement. At three years the mortality advantage continued to grow for TAVR over standard therapy in patients who are…
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…
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…
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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