麻豆传媒

As Centers for Medicare and Medicaid Services (CMS) reconsiders its requirements for coverage of transcatheter aortic valve replacement (TAVR), cardiology societies advocated strengthening those operator and institutional experience standards.

A Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel will meet Wednesday, July 25 to vote on what they think the new National Coverage Determination (NCD) for TAVR should look like. The current requirements, set in 2012, revolve around operators having skills that would be necessary to perform TAVR.

Actual TAVR experience should be the basis of those requirements now, according to an expert consensus document released to inform that panel meeting on behalf of the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS).

"At this time, it is felt that such skills are best learned by doing TAVR. Therefore, the prerequisite skills have been replaced by TAVR experience," wrote the writing committee chaired by Joseph Bavaria, MD, and Carl Tommaso, MD.

Among the coalition's recommendations, interventional cardiologists should have experience participating in at least 100 transfemoral TAVRs (including 50 as primary operator) to start a new TAVR program. The current requirement is just experience with 100 structural heart disease procedures or 30 left-sided structural procedures per year (60% of which should be balloon aortic valvuloplasty).

The societies also pushed for the requirement that when a TAVR program already exists at a center, interventional cardiologists should perform at least 50 TAVRs per year (or 100 over 2 years) and not be an outlier on outcomes by falling in the top 10% for STS/ACC TVT Registry-reported 30-day risk-adjusted all-cause TAVR mortality. The current NCD requires a combined total of 20 TAVRs in the prior year between the cardiovascular surgeon and the interventional cardiologist (or 40 in 2 years).

The new recommendations were in the Journal of the American College of Cardiology and co-published in Catheterization and Cardiovascular Interventions, The Journal of Thoracic and Cardiovascular Surgery, and The Annals of Thoracic Surgery.

As of 2018, there are over 550 active TAVR sites in the U.S., with TAVR volume being used as a surrogate for quality across all sites.

But by 2025, few surgical aortic valve replacement (SAVR)-only sites will remain, so TAVR volume can be used to document a site's maintenance of its TAVR program while quality requirements can pivot toward actual site performance in the form of mature risk-adjusted outcome measures, the recommendations argued.

"The metrics for assessment of TAVR site performance are not yet at a state of maturity as compared to SAVR and the STS star rating system. Similar performance metrics are under development for TAVR by the STS/ACC and should be tested and implemented when feasible," according to the writers.

"This document does not recommend that sites failing to meet all requirements should close their TAVR-SAVR programs. Rather, the committee recommends that all sites review their quarterly outcome reports and assess if they are within national benchmarks of acceptable quality of care," they noted.

An external review and accreditation process is being formed by the ACC to help TAVR centers meet new NCD standards and undergo remediation if they under-perform on quality measures. This program will support hospitals in several ways, William Oetgen, MD, ACC executive vice president of Science, Education, Quality & Publishing, told 麻豆传媒:

• Evaluating if centers are able to maintain a multidisciplinary team, develop quality improvement plans based on registry results, train clinicians and engage patients in shared decision making, and have sufficient resources and facilities to support TAVR
• Separate monitoring of low-volume centers for root-cause analysis of any complications or deaths
• Remediation process for programs that are outliers in quality, giving centers a way to evaluate and address quality gaps

The ACC announced the societies are using the expert consensus document as support for public comments submitted for the National Coverage Analysis.

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