The ACC, along with the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI) and the Society of Thoracic Surgeons (STS), have released an updated Expert Consensus Systems of Care document regarding operator and institutional recommendations and requirements for TAVR. The original document was published in 2011.

The updated document is intended to provide guidance and support for centers throughout the U.S. and offer a “rational balance between patient access to TAVR and quality outcomes.” It also includes additional quality metrics that complement requirements included in the first document.

Of note, the document focuses on treating all patients with aortic valve disease and therefore all forms of treatment, including TAVR, SAVR, medical care and palliative care. It also recommends that sites incorporate shared decision-making methods and processes. Like the original document, the updated version continues to place a strong emphasis on a team-based approach for patient management.

The writing group also included a multimodal approach to quality measurement that allows the recommendations and requirements to evolve in anticipation of newer treatment modalities; expansion to younger and lower-risk populations; and emerging evidence regarding patient outcomes, cost, cost-effectiveness and durability.

In the prologue, the document points out there are no recommendations that sites failing to meet all requirements should close their TAVR-SAVR programs. “It is important to patient access that TAVR sites serving low-population density areas remain active even if they don’t meet volume requirements but can document acceptable quality,” it states.

However, the document does recommend that all sites review their quarterly outcome reports and assess if they are within national benchmarks of acceptable quality of care. “An accreditation process is one means to help ensure quality, while also providing external review of programs,” according to the expert consensus document.

In addition to the release of the updated document, the ACC on July 25 participated in a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) convened by the Centers for Medicare and Medicaid Services, to discuss procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs.

Expert consensus document co-chairs, Joseph E. Bavaria, MD, FACC, and Carl L. Tommaso, MD, FACC, summarized recommendations from the Expert Consensus document, while John D. Carroll, MD, FACC, represented the College in discussing lessons from the STS/ACC TVT Registry.

“The ACC appreciated the opportunity to participate in the MEDCAC meeting on TAVR as CMS considers changes to Medicare coverage of this life-saving therapy,” said ACC President C. Michael Valentine, MD, FACC. “The presentations by medical societies and the recently published Expert Consensus document on operator and institutional requirements support infrastructure, volume and outcome standards that ensure quality patient care.”

Feedback from the MEDCAC meeting will inform coverage changes to the TAVR national coverage determination (NCD), currently under review by CMS. On July 27, the ACC partnered with AATS, SCAI and STS to submit formal public comments to CMS regarding the NCD. The comments support using the updated Expert Consensus Systems of Care document as a framework for updates to coverage.

As part of the comments, the societies do not recommend that sites failing to meet all requirements should close their TAVR programs, particularly due to areas of low population density where access to care could be impacted.

“It is essential that all TAVR sites continue reporting data on TAVR procedures to a national registry,” the comments note. “Ongoing data collection and analysis enables quality outcome measurement. Sites should review their quarterly outcome reports to assess performance in relationship to national benchmarks.”

The ACC recognizes that continued investigation of TAVR therapy accessibility is warranted, and striking the balance between maintenance of high-quality outcomes and providing adequate access to care will need to be continually assessed with evidence. The College will continue to collaborate with CMS and other stakeholders to further advance the field of TAVR therapy.

Keywords: ACC Publications, Cardiology Magazine, Advisory Committees, Thoracic Surgery, Heart Valve Diseases, Aortic Valve, Transcatheter Aortic Valve Replacement, Centers for Medicare and Medicaid Services, U.S., Heart Defects, Congenital, Accreditation, Health Policy, Angiography, Surgeons, Registries, Medicare, Medicaid

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