Updated TAVR Consensus Document Highlights Quality, Not Just Volume

Marlene Busko

July 20, 2018

Four cardiology societies issued a joint statement for requirements for centers with existing or new transcatheter aortic valve replacement (TAVR) programs, which updates a 2012 statement.   

The new document is part of a transition away from using the volume of procedures performed to the quality of patient outcomes to measure TAVR-center performance, says a co-chair of the writing committee.

This expert consensus statement, from the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons (STS) was published online July 18 in the Journal of the American College of Cardiology.

The release is timely because the US Centers for Medicare & Medicaid Services (CMS) has convened a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel meeting on July 25 to evaluate the evidence for TAVR volume requirements, and some of these data will be presented there. CMS expects to have concluded its evaluation in June 2019.

According to writing committee co-chair Carl Tommaso, MD, from NorthShore University Health System, Chicago, Illinois, TAVR was in its infancy in 2012 and the results from PARTNER were "primitive."

Over the past 5 or 6 years, however, TAVR has become more mature and is being done in many more centers and for expanded indications, and there are more data from the STS/ACC Transcatheter Valve Therapy (TVT) Registry,  Tommaso told the theheart.org | Medscape Cardiology.

"As TAVR becomes even more mature and more data is gathered, and better risk profiles are developed," he said, there is a move towards "purely quality as the [performance] marker of a center, rather than volume and quality."

Second, the new consensus statement also highlights the importance of shared decision-making, he said.

"In the United States, at least 500 centers do surgical aortic valve replacement [SAVR], without doing TAVR," he continued. "We think it's important that anybody with an aortic stenosis — whether they are at a TAVR/SAVR center or just a SAVR center — has the opportunity for full disclosure as to what the potential options are."

"Not Interested in Closing Centers"

The 2012 consensus statement recommended that TAVR centers should do at least 20 TAVRs per year or 40 in 2 years, and at least 25 SAVRs per year.

The 2018 document states that existing programs should perform at least 50 TAVRs per year or 100 in the past 2 years and at least 30 SAVRs per year or 60 within the last 2 years to have optimal outcomes, and to have continued certification.

Of the 580 centers that now offer TAVR, Tommaso said, 85% are operating at this level.

The document states that TAVR operators should be trained by a formal training program as part of a cardiology fellowship or cardiovascular surgical residency or that an established interventional cardiologist or cardiac surgeon could participate in an established TAVR program under the tutelage of an experienced team.

TAVR requires a heart team, a procedural team, and adequate support including, for example, intensive care and electrophysiology services, Tommaso noted, so "a small institution may not be able to justify the commitment of that many resources to one procedure."

However, "we're not interested in closing any centers," he stressed.  Rather, low-volume or low-quality TAVR centers should perform internal and external reviews to figure out why they are underperforming and then take steps to remedy this.

"The ACC is preparing to offer an external review and accreditation process that would assist hospitals in meeting standards," William Oetgen, MD, ACC executive vice president of science, education, quality & publishing, told theheart.org | Medscape Cardiology.

"The program will include process requirements for multidisciplinary teams, formalized training, shared decision-making and registry performance, as well as program monitoring and remediation based on volumes and outcomes."

Multiple Factors Affect Outcomes

Mark Russo, MD, from Barnabas Heart Hospital at Newark Beth Israel Medical Center, in Newark, New Jersey, told theheart.org | Medscape Cardiology that "quality metrics for TAVR shouldn't be based solely (or even largely) on case volumes and must include measured clinical outcomes to avoid restricting TAVR availability in lower-volume, high-quality centers, as well as underserved populations."

He noted that an analysis of STS/ACC TVT registry data of TAVR performed with current-generation SAPIEN 3 valves did not find significant differences in 30-day mortality, stroke, or major vascular complications in low- vs high-volume centers.

"These findings," he said, "support that good outcomes are not merely a function of quantity but influenced by a constellation of factors including technological advancements, best practices, collaborative knowledge programs, and organizational culture."

"In the modern era," said Russo, "intensive training, the heart team approach, group learning, and crowd wisdom collectively mitigate the effects of volume on outcomes, and excellent outcomes are achievable even early in a center's experience."  

However, John D. Carroll, MD, from the University of Colorado School of Medicine, Denver, and a member of the joint statement writing committee, noted that "recent data from the STS/ACC TVT registry of all recent TAVR cases, not just Sapien 3, show that a volume-outcome relationship exists" — where low-volume centers performed worse.

"The volume requirements are essential to maintain the high quality of TAVR in the US, and the requirements are supported by solid scientific evidence," he told theheart.org | Medscape Cardiology.

Carroll, who will be presenting data to the MEDCAC panel, said that "lowering standards [would] likely lead to worse outcomes for thousands of patients, and two additional studies are in press that show that TAVR still has a learning curve, a volume-outcome relationship exists, and support a volume threshold." Tommaso agrees that there is a learning curve.

"This remains an evolving field with continual changes in indications, equipment, technique, and clinical outcomes," the statement concludes. "As the indications expand to younger patients, assessing the structural durability of the valve is critical. This document reflects the current state of the art and is designed to evolve with the field."

Tommaso, Bavaria, and Oetgen have no relevant financial disclosures. Carroll reports receiving funding from St Jude Medical/Abbott for serving on the steering committee for RESPECT and the ACP Trials and on the data and safety monitoring board for the Tendyne valve trials. He is also a member of the writing committee of the 2018 TAVR Multisociety Expert Consensus Systems of Care Document and cochair of the STS-ACC TVT Registry steering committee. Russo receives research support from Boston Scientific, Edwards Lifescience, and Abbott.

J Am Coll Cardiol. Published July 18, 2018. Full text

For more from theheart.org, follow us on Twitter and Facebook


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as: