January 31st, 2012
Guiding TAVR into Clinical Practice
Steven Bailey, MD, Richard A. Lange, MD, MBA and L. David Hillis, MD
The ACC, AATS, SCAI, and STS have issued a critical consensus document to guide the use of transcatheter aortic valve replacement (TAVR) as it enters clinical practice in the U.S. (see also our CardioExchange news coverage here). CardioExchange Interventional Cardiology moderators Rick Lange and David Hillis posed the following questions to writing committee member Steven R Bailey, the Janey Briscoe Distinguished Professor of […]
January 31st, 2012
Consensus Document Provides Roadmap to Uptake of TAVR in U.S.
Larry Husten, PHD
Following the recent FDA approval 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 dispersion, […]
December 14th, 2011
Study Examines New-Onset Atrial Fibrillation After TAVI
Larry Husten, PHD
The broad enthusiasm for TAVI (transcatheter aortic valve implantation) as it enters the marketplace has been partially offset by concerns about an increased risk for stroke associated with the procedure. The role of one major cause of stroke, atrial fibrillation (AF), has not been the subject of close scrutiny. Now a study from Quebec, published in […]
December 1st, 2011
ACC and STS Announce Launch of TAVR Registry
Larry Husten, PHD
Following the approval of the first device for transcathether aortic valve replacement therapy (TAVR) earlier this month, the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have announced the launch of the TVT Registry, a joint initiative that will monitor the rollout of the new technology. The registry was created in response to the […]
November 11th, 2011
Transapical TAVR on the Ropes: Is It Down for the Count?
Richard A. Lange, MD, MBA and L. David Hillis, MD
STACCATO showed more adverse events with transapical transcatheter aortic valve replacement (TAVR) than with aortic valve replacement (AVR) in low risk, elderly patients. In patients with severe, symptomatic aortic stenosis who are believed to have high surgical risk, PARTNER substudy results presented at the AHA show Transapical TAVR provided no increase (and even a possible decrease) in quality […]
November 11th, 2011
TAVI at TCT: Enthusiasm Tempered by Poor Transapical Outcomes
Larry Husten, PHD
Continued enthusiasm for transcatheter aortic valve implantation (TAVI) with the Edwards’ Sapien device was tempered somewhat by poor outcomes observed in the group of patients for whom the procedure was performed using the transapical instead of the transfemoral approach. Results of 3 new studies from the PARTNER trials and a controversial new trial, STACCATO, were […]
October 19th, 2011
U.K. Registry Tracks Long-Term TAVI Outcomes
Larry Husten, PHD
The excitement over transcatheter aortic valve implantation (TAVI) has been tempered by the absence of long-term outcomes data and concerns that the procedure may not live up to its initial promise in real-world settings. Now a report from the U.K. TAVI Registry, which keeps track of every TAVI procedure performed in the U.K., sheds new […]
October 17th, 2011
Sapien Transcatheter Heart Valve Might Be Delayed
Larry Husten, PHD
Approval for the highly anticipated Sapien transcatheter aortic heart valve might be delayed for 6 months, until April 2012. The FDA had been expected to reach a decision this month. But now a member of the FDA advisory panel that recommended approval for Sapien, Jeffrey Borer, in a public statement made at the ACC/AATS Heart […]
July 21st, 2011
Sapien Transcatheter Heart Valve Receives Strong Support from FDA Advisory Panel
Larry Husten, PHD
The FDA Circulatory Systems Devices Panel has given a strong vote of support in favor of the Sapien Transcatheter Heart Valve (THV) for use in patients with inoperable severe aortic stenosis and with no comorbidities precluding benefit from correction of the stenosis. By large majorities, the panel voted that the procedure was safe (7-3), that […]
June 5th, 2011
PARTNER A Results Published in NEJM
Larry Husten, PHD
Following its initial presentation at the ACC meeting in March, the results of PARTNER A have now been published online in the New England Journal of Medicine, in conjunction with a presentation at the Transcatheter Valve Therapies meeting in Vancouver. As reported previously, 699 high-risk older patients with severe aortic stenosis were randomized to either transcatheter aortic […]