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Most rural hospitals continued to be ineligible to offer transcatheter aortic valve replacement (TAVR) under Medicare criteria updated in 2019, while many newly eligible centers tended to be smaller and lack the resources of established programs, according to a study.

"Compared with current TAVR hospitals, candidate and ineligible TAVR hospitals were more likely to have fewer beds, be a safety net hospital, and treat less medically complex patients and less likely to have a cardiac intensive care unit," reported researchers led by Michael Thompson, PhD, of the University of Michigan Medical School in Ann Arbor.

Candidate hospitals were not more likely than current centers to be rural -- more than half of rural centers in the country remained ineligible to offer TAVR to patients, study authors showed in a paper published online in .

Thus, "persistent variability in the geographic distribution of TAVR hospitals remains, with potentially limited access to TAVR in rural and safety net hospitals," according to Thompson and colleagues.

Institutional surgical volume requirements to begin or maintain a TAVR program were relaxed under the revised national coverage determination (NCD) from the Centers for Medicare & Medicaid Services (CMS) in 2019.

One of the reasons why the NCD was overhauled in the first place was to ease unintentional barriers to TAVR for patients from certain geographic locations and socioeconomic backgrounds.

At the time of the study, there were an estimated 495 TAVR-performing hospitals, 448 candidate hospitals (those meeting 2019 NCD requirements), and 246 TAVR-ineligible acute care centers in the U.S., according to the investigators.

"Continued research is needed to monitor the effect of the revised TAVR NCD," Thompson's group urged. "Specifically, tracking quality in hospitals with low TAVR volumes will be a critical challenge given the established volume-outcome association."

"Monitoring the location, characteristics, and procedural volumes of TAVR and non-TAVR hospitals will ensure access is expanding to areas of need rather than already existing markets," the authors argued.

Thompson's group identified 1,196 acute care non-federal hospitals that had procedure codes for coronary artery bypass grafting (CABG), surgical aortic valve replacement (SAVR), or TAVR on Medicare Part A claims.

A major limitation of the study was that projected surgical volumes were based on 2015-2016 data, which may not have captured contemporary surgical or TAVR volumes.

Moreover, the number of projected candidate TAVR hospitals "may be overestimated" because investigators did not consider whether these hospitals also met percutaneous coronary intervention (PCI) volume requirements, they acknowledged.

Programs both new and old have to perform 300 PCIs per year, according to the new NCD.

Centers wishing to start new TAVR programs must have performed 50 or more open heart surgeries the prior year and 20 aortic valve-related procedures in the prior 2 years.

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