Consensus Document Provides Roadmap to Uptake of TAVR in U.S.

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, and careful post-marketing scrutiny of this promising technology,” said Sanjay Kaul, vice chair of the writing committee, in a press release. “It is now the collective responsibility of all the stakeholders to optimize its full potential for improving the duration as well as the quality of survival in patients with severe symptomatic aortic valvular stenosis.”

Here are some of the key recommendations identified by the committee:

–Careful patient selection

–Team-based approach given the complexity of procedure coupled with the high-risk profile of suitable patients, many of whom have extensive comorbid conditions that require ongoing management

–Specialized heart centers and physician expertise in treating valve disorders; this includes use of proctors as needed to serve on the heart care team during the first few cases, as well as proper facilities (hybrid operating rooms or modified cath labs)

–TAVR screening tests to inform treatment decisions

–Enhanced patient and family education in the risk and benefits of this procedure

–Ongoing evaluation and participation in national TAVR registry to assess real world outcomes

The document also emphasizes the groups for whom TAVR is not recommended, including adults with:

–An acceptable surgical risk for conventional surgical AVR

–Known bicuspid aortic valve

–Severe mitral annular calcification or severe MR

–Moderate AS

–Other (e.g., severe AR and subaortic stenosis)

(CardioExchange Interventional Cardiology co-moderators Rick Lange and David Hillis pose questions to writing committee member Steven R. Baily here. Take a look, then share your own insights.)

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January 31st, 2012