Study Explores Expanded Use For Edwards’ And Medtronic’s New Heart Valves

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…

Click here to continue reading…

FDA Grants Earlier Than Expected Approval For Medtronic’s CoreValve

CoreValve Family Sizing

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….

Click here to continue reading…

FDA Issues Warning Letter To CoreValve Investigator

The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer. The subject of the FDA…

Click here to continue reading…

Small Study Explores Expanded Use For TAVI In Native Valve Aortic Regurgitation

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…

Click here to continue reading…

TCT: Impressive Survival Benefit For TAVR In Inoperable Patients At 3 Years

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…

Click here to continue reading…

FDA Approves The Sapien Transcatheter Heart Valve For High Risk Patients

sapien

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…

Click here to continue reading…

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…

Click here to continue reading…

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 US approval. Now,…

Click here to continue reading…

CMS Issues National Coverage Decision for TAVR

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…

Click here to continue reading…

Four Cardiovascular Societies Release Criteria for TAVR Programs and Operators

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…

Click here to continue reading…

Slow Uptake of Transcatheter Aortic Valves: Learning from History?

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…

Click here to continue reading…

CMS Releases Details Of Proposed National Coverage For TAVR

(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…

Click here to continue reading…

Consensus Document Provides Roadmap To Uptake Of TAVI In US

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…

Click here to continue reading…