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. The study was published online in the Journal of the American College of Cardiology.
According to writing committee co-chair Carl Tommaso, 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.
"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."
"In the United States, at least 500 centers do surgical aortic valve replacement [SAVR], without doing TAVR. 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 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.
"The ACC is preparing to offer an external review and accreditation process that would assist hospitals in meeting standards," William Oetgen reported. "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 told 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."
"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."
However, John D. Carroll 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.
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."