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CMS panel: Procedural volume requirements for TAVR may be necessary
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The Medicare Evidence Development and Coverage Advisory Committee of the CMS voted that it was moderately confident that there is sufficient evidence to support the need for procedural volume thresholds in centers with new or existing transcatheter aortic valve replacement programs.
The panel convened to reconsider the National Coverage Determination (NCD) for TAVR, with specific focus on TAVR, surgical AVR, PCI and other relevant structural heart disease procedural volume requirements. Despite a general consensus, opinions across each of the nine voting questions posed to the committee varied, as did thoughts among individual panel members, with some questioning the level of available evidence.
“The key phrase is ‘sufficient evidence,’” panel member Gregory Joseph Dehmer, MD, director of quality and outcomes for the Cardiovascular Institute at Carilion Clinic, said during a discussion on whether a threshold for surgical AVR procedural volume should be required to begin a TAVR program at hospitals without previous TAVR experience.
“We would all be very comfortable voting if we had multiple randomized trials showing us the number to use, but failing that kind of evidence, it’s important to fall back on the opinion of experts. Fortunately, we do have a document that has been crafted by experts and I put a lot of weight on that,” he said, referring to a recently published new multisociety expert consensus systems of care document.
New TAVR programs
During the meeting, the panel was asked to consider whether enough evidence exists to support procedural volume requirements for hospitals without previous TAVR experience seeking to start TAVR programs.
Most committee members agreed, with varying degrees of confidence, that sufficient evidence exists to support that a certain threshold of surgical AVR procedural volumes is required to begin a TAVR program in hospitals without previous TAVR experience. Familiarity with the aorta and treating aortic stenosis was the primary reason why some favored surgical AVR volume requirements. Others, however, said they had not seen evidence correlating surgical AVR with TAVR.
The same sentiments were reflected in the vote regarding PCI, with much of the panel expressing moderate confidence that a certain threshold of PCI procedural volumes is necessary for hospitals starting a TAVR program.
“PCI is not a perfect proxy for TAVR, but it is a proxy nonetheless,” panel member Daniel A. Ollendorf, PhD, chief scientific officer of the Institute for Clinical and Economic Review, said during the discussion.
Nevertheless, other panel members echoed concerns about the lack of data correlating PCI with TAVR outcomes.
The committee also mostly agreed that the benefits of procedural volume requirements would outweigh the harms of limiting access to TAVR to only those hospitals meeting the requirements. However, panel members appeared to be less confident in this decision, with several noting that the risk-benefit is questionable and that there are little data looking at this association.
“I was torn right down the middle,” Smadar Kort, MD, FACC, FASE, FAHA, professor of medicine and director of the valve center, noninvasive cardiac imaging and echocardiography at Stony Brook University Hospital, said during the panel discussion.
Additionally, for those starting a TAVR program, the panel had moderate to high confidence that surgical AVR and TAVR procedural volume requirements should be in place for the principal CV surgeon and that structural heart disease procedural volume requirements should be required for the principal interventional cardiologist.
Existing TAVR programs
The panel was also asked the same questions with respect to maintaining TAVR programs at hospitals with TAVR experience.
Again, the committee was overall moderately confident that surgical AVR procedural volume requirements are required for hospitals to maintain TAVR programs, with most panel members citing the same reasoning behind the need for surgical AVR procedural volume requirements in hospitals without TAVR experience. However, some remained concerned about the ramifications for hospitals with existing programs.
“As the TAVR program grows, the surgical AVR volume is expected to go down and that should not be the reason to close programs and not meet requirements,” one panel member said.
In terms of PCI, the committee expressed moderate confidence that a certain threshold of procedural volumes is required to maintain an existing TAVR program.
The committee was also moderately confident that, for hospitals with existing TAVR programs, the benefits of procedural volume requirements outweigh the potential harms of limiting treatment to only hospitals meeting volume requirements.
For existing TAVR programs to maintain proficiency, the panel also had moderate confidence that evidence was sufficient to support TAVR procedural volume requirements for the principal CV surgeon, the principal interventional cardiologist and the combined experience of the principal surgeon and principal interventional cardiologists on a heart team.
Potential unintended consequences
During a presentation, Peter Pelikan, MD, FACC, FSCAI, medical director of the cardiac catheterization lab at Providence Saint John’s Health Center and director of interventional cardiology at the Pacific Heart Institute, urged the panel to consider quality over quantity. The procedure, he noted, is no longer considered experimental or risky and is now commonplace.
Furthermore, Martin B. Leon, MD, professor of medicine at Columbia University Medical Center, director of the Center for Interventional Vascular Therapy, director of the cardiac catheterization laboratories and a member of the executive board of the Columbia-NewYork-Presbyterian Heart Valve Center, and founder of the Cardiovascular Research Foundation, who spoke on behalf of AdvaMed, said that the research does not definitively link surgical AVR, PCI and TAVR volume with improved outcomes, with some of the existing studies being hampered by small sample sizes, confounders and early time bias. Additionally, no studies specifically assessed the recommended volume thresholds, he noted.
Leon also cited suggestions made in the recently published expert consensus systems of care document — commissioned by the American Association of Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons — that recommends a shift away from volume requirements to outcome-based requirements now that physicians have gained experience with TAVR and that it is a common procedure.
Volume requirements also create barriers to TAVR based on geographic location, sex, ethnicity, race, socioeconomic status and more by limiting the number of centers performing the procedure, according to several invited speakers at the meeting.
Many panel members acknowledged that volume requirements may contribute to disparities in care but also said that it was only one piece of the puzzle.
“There are other factors that people don’t even consider among patients and providers and there is a whole universe of questions to ask, so this idea that volume is a barrier may or may not be the case because it really depends on where patients are receiving primary and tertiary care,” Aloysius B. Cuyjet, MD, MPH, medical director at HealthCare Partners, IPA, said. – by Melissa Foster
Disclosure: Leon reports his travel and accommodations to attend the meeting were supported by AdvaMed and he received grant or research support from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic. Pelikan reports no relevant financial disclosures.