Dive Brief:

• Rural hospitals were less likely to be eligible to start a transcatheter aortic valve replacement (TAVR) program under a revised CMS coverage policy, a research letter published April 1 in JAMA Cardiology suggests.
• The research sought to determine the characteristics of hospitals meeting new surgical volume thresholds and those that remained ineligible to offer TAVR according to the updated Medicare coverage guidelines.
• The analysis found that the number of cardiac surgical hospitals providing TAVR could double under the new surgical volume requirements, but it raised questions about whether the geographic distribution of new programs would ensure access is increased where it is needed most.

Dive Insight:

The growing popularity of TAVR, a minimally invasive procedure to treat patients with heart valve disease, prompted CMS to revisit its coverage policy. The agency announced a revised national coverage determination (NCD) last year that eased volume requirements for hospitals to launch a TAVR program.

Now, hospitals without TAVR experience looking to qualify for coverage must have performed at least 50 open heart surgeries in the previous year and 20 aortic valve procedures in the prior two years. To maintain a program, hospitals must perform at least 50 aortic valve replacements, of either the transcatheter or surgical variety, each year, including at least 20 TAVR procedures in the prior year, or at least 100 valve replacements every two years.

In the JAMA Cardiology article, the authors compared data for 495 current TAVR hospitals (41.4%), 448 candidate TAVR hospitals (37.7%) and 246 TAVR ineligible hospitals (20.7%).

Looking at location, they found that 426 hospitals that were candidates for TAVR were urban and 22 were rural, while 211 ineligible facilities were urban and 35 were rural. Among safety net hospitals, 94 facilities were new candidates for TAVR and 104 were ineligible.

Michael Thompson, lead author of the research letter, said the new TAVR offerings in rural areas could be important, but he questioned the need for additional hospitals performing TAVR in already crowded markets.

"We're expanding access, but we don't yet know if it's in the right areas," Thompson, an assistant professor of cardiac surgery at the University of Michigan Medical School, said in a press release.

More research is needed to monitor the effect of the revised TAVR NCD to make sure access is expanding to areas of need rather than already existing markets, the researchers said.

Separately, a study assessing outcomes for more than 50,000 TAVR patients across 301 sites revealed some unevenness in rates of serious complications tied to the procedure. That research, presented in late March in conjunction with the American College of Cardiology's virtual annual conference, determined that 11% of facilities performing TAVR saw worse than expected outcomes in their patients who underwent the procedure.

Edwards Lifesciences and Medtronic dominate the TAVR market. Boston Scientific became the third device maker to gain access to the U.S. market with FDA approval last year of its Lotus Edge system. Abbott is expecting U.S. approval this year for its Portico TAVR device.