“The volume floors are only there because you can’t measure quality without volume,” said Dr. Bavaria. “It’s impossible to measure quality without a certain procedure volume.”
Dr. Bavaria stressed, however, that the goal of the new document is not to limit TAVR programs based on their procedure volume, especially because another goal of the document is to ensure reasonable geographic access to TAVR for U.S. patients. “This document does not advocate for any program to shut down,” he declared. On top of that, “we have no problem with new programs,” although the document noted that “the major threat to low volume sites growing and achieving higher levels of experience is the opening of additional sites in the same geographic region.”
In 2017, 204 of the 525 sites (39%) performing TAVR at that time were performing fewer than 50 procedures annually, the document said, but added that many TAVR centers now operate in what are predominantly rural regions “and it is important that they remain active if they can document acceptable quality even if they should fall below volume thresholds to maintain patient access to care.”
Dr. Tommaso said that perhaps a TAVR center in Alaska, for example, might not meet the 50 cases/year standard, “but I don’t think anyone would worry if the volume was low because we’re serving patients in Alaska.” Currently, 84% of TAVR centers that have been operating for more than 2 years meet the 50 procedures/year threshold, he added. And TAVR centers now operate in 49 of the 50 states, with only Wyoming lacking a TAVR facility within its borders. Despite this, use of TAVR among Wyoming residents is comparable to the rate in Illinois, Dr. Bavaria said.
Both cochairs also highlighted that, with TAVR now approved for patients at moderate risk for aortic-valve surgery, the number of patients who are TAVR candidates has grown, and it’s possible that pending trial results will soon broaden TAVR’s availability to low-risk patients, a step that would greatly further expand the potential patient pool for the procedure.
The revised recommendations and requirements will make it “a little easier to start a new program, except now, for the first time, you need to start with an operator who is already experienced with TAVR,” noted Dr. Bavaria. “The TAVR technology is now mature enough that it’s inappropriate to have learning-curve mortality.” But aside from this the new standards lower the bar a bit for a center’s volume of percutaneous coronary interventions and surgical aortic valve replacements. The revision also maintains that an examination by and consultation with a single cardiac surgeon by a prospective TAVR patient is adequate, similar to the 2012 document, although the Center for Medicare & Medicaid Services mandated in its coverage decision that prospective TAVR patients consult with two cardiac surgeons, the so-called “two-surgeon rule.” If CMS eliminated the two-surgeon rule it would “streamline” the process that patients go through when being assessed for TAVR, Dr. Tommaso observed, and both he and Dr. Bavaria expressed hope that the new document might prompt CMS to reconsider this guidance.
“We felt that two surgeons weren’t needed,” but the document specifies that both the surgeon and the cardiologist whom a prospective patient consults before finalizing plans for the intervention should both be members of the multidisciplinary team that performs the procedure. Until now, these clinicians weren’t specified as necessarily members of the TAVR team, Dr. Bavaria said.
One additional new element in the revised document is specification of shared decision making as the mechanism patients should go through when considering TAVR relative to their other management options, Dr. Tommaso said.Dr. Bavaria and Dr. Tommaso had no disclosures.
SOURCE: Bavaria JE et al. JACC. 2018 Jul18. doi:10.1016/j.jacc.2018.07.002.