CMS advisory panel divided on TAVR volume thresholds

CMS’s advisory committee appears to be split on whether procedural volume requirements should be required for centers to begin and maintain transcatheter aortic valve replacement (TAVR) programs.

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) met last week to vote on questions dealing with the importance of volume requirements, and the results were largely split. Before voting, the panelists heard various interpretations about how much—if at all—procedural experience in percutaneous coronary intervention (PCI), surgical aortic valve replacement (SAVR) and TAVR impacts outcomes for TAVR patients.

They were also asked to weigh that evidence against the potential harms of limiting access to the treatment by closing centers that don’t achieve or maintain those numbers. Nine panelists’ responses counted toward the final tallies, which were measured on a scale of 1 to 5 (1 being lowest or no confidence and 5 representing the highest level of confidence).

CMS said the panel won’t make the new National Coverage Determination (NCD) but the agency benefits from its advice. The NCD is expected to be completed by June 25, 2019.

The average score of the votes fell between 3 and 4 for most questions, with the panelists being least confident the benefits of meeting procedural volume requirements to begin a TAVR program outweigh the harms of limiting TAVR to only those hospitals (average score: 3.11). One committee member voted 1 and two voted 5, further demonstrating the division on this issue.

However, the panelists expressed more agreement that there is sufficient evidence the principle cardiovascular surgeon and interventional cardiologist on the heart team should have a set amount of procedural experience to begin a TAVR program. The average responses to those questions yielded scores of 4.33 for the surgeon and 4.22 for the interventional cardiologist.

In an expert consensus document published by four cardiology societies, the authors argued for bolstering the procedural volume requirements for existing TAVR programs—bumping them from 20 to 50 TAVRs per year (or from 40 to 100 over a two-year span).

But representatives from Medtronic and Edwards Lifesciences, two manufacturers of TAVR devices, have indicated they’re most concerned with ensuring patient access to structural heart procedures. Quality measures, not procedural volumes, should be the primary determinants of centers’ eligibility to perform TAVR, they said.

"While considering requirements for centers and physicians to deliver quality outcomes, patient access is equally important, and we believe that any coverage policy and patient access decisions need to be supported by high-quality empirical evidence," said Pieter Kappetein, MD, vice president and chief medical officer of the Structural Heat business at Medtronic. "The evidence that we've seen to date does not show a correlation between volume and quality."

“Measuring the quality of care, rather than numbers of SAVR or TAVR individually, will provide appropriate incentives to treat patients in the manner most appropriate for them,” wrote Larry L. Wood, corporate vice president of Transcatheter Heart Valves at Edwards, in comments to CMS. “We have a system available to evaluate outcomes based on a hospital’s observed/expected in-hospital mortality using the Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score, which has undergone extensive peer-reviewed validation. Therefore, there is support and rationale for immediately measuring program outcomes and quality directly.”

Wood also said there are 150 low-volume centers which have performed less than 50 TAVRs and boast a 0 percent in-hospital mortality rate.

Several cardiologists and directors of structural heart programs in rural areas chimed in during the public comment period in advance of the MEDCAC meeting. Likewise, many of them argued for lowering or eliminating procedural volume requirements, citing how difficult it is to reach those thresholds in sparsely populated areas.

“By putting finite restrictions on the annual minimal number of TAVRs (50) and SAVRs (30), you risk the possibility of denying patients a life-saving procedure, or leaving them no choice but to have an unnecessary open surgery,” wrote Christina Dovas, MSN, NP-BC, the structural heart coordinator at Adventist Heart and Vascular Institute in St. Helena, California. “Many of these patients in rural areas going to low volume centers simply live too far and do not have the resources to travel back and forth to a larger center. … Please do consider letting the true, continued quality outcomes of TAVR programs (large and small) drive their ability to perform and do not move forward with the antiquated notion of quantity equals quality.”

Although fewer in number, other commenters cited evidence of lower complication rates at high-volume centers and said procedural cutoffs for both institutions and individual operators should factor into the NCD.