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Operators at smaller hospitals aren't happy with a proposal to implement a two-tier system of valve centers while continuing to factor procedural volume into their performance metrics.

Last month, five major cardiology organizations recommended splitting hospitals into two groups according to the structural heart interventions they could safely perform with their experience and resources:

• Level 2: transfemoral transcatheter aortic valve replacement (TAVR), percutaneous aortic valve balloon dilation, surgical aortic valve replacement, and surgical mitral valve replacement, to name a few
• Level 1: all of the above plus alternative access TAVR, valve-in-valve procedures, MitraClip, left atrial appendage closure, atrial septal defect closure, and more

Access continues to be a challenge for valvular heart disease care in the U.S., however, some fear the problem would be exacerbated by this proposal.

"I theoretically like the concept, but the devil's in the details," Steven Goldberg, MD, of the Community Hospital of the Monterey Peninsula in California, told MedPage Today.

His center, one of many "fairly typical size" 200- to 250-bed hospitals across the country, has been doing TAVR for just over a year and is on pace to be doing about 50 of these procedures annually with good results. If this hospital didn't provide TAVR, the next closest one would be several hours away by car, he said.

"Honestly, there are lots and lots of these smaller hospitals in this situation that are not populated with people who write papers," Goldberg said. It appeared that smaller or medium-sized hospitals weren't consulted in developing the recommendations, he added.

"Part of the problem is the guys writing this [at the Level 1 centers], they're the ones with the loudest megaphone, but they're also in competition with the other centers."

Another recommendation from the societies was that valve centers be evaluated using a mix of procedural volume and procedure-specific outcome metrics -- in line with requirements for new and existing TAVR programs in the proposed National Coverage Determination from the Centers for Medicare & Medicaid Services (expected to be finalized by the end of June).

Whether smaller centers can compete in a tiered system, bound by volume requirements, can have a great impact on patients.

For example, hospitals with fewer than 500 beds performed three-quarters of valve surgeries in California in 2016, according to data from the Office of Statewide Health Planning and Development, Goldberg said.

Moreover, black and Latino patients are more likely treated at smaller community hospitals and accounted for just 3.8% each of U.S. TAVR recipients in the cited by Aaron Horne Jr., MD, of Medical City North Hills in North Richland Hills, Texas, in an interview.

"What's interesting about TAVR is it doesn't generate a lot of money for hospitals," Horne said. In light of the problem of access for many Americans, he questioned how easy it would be to grow more centers or for existing programs to continue if they don't meet those volume thresholds.

In addition, calling a center Level 2 might lead patients to consider it "second-rate," he said.

"Restricting the type of structural heart procedures performed based on a tiered system is likely too arbitrary, based on volume rather than quality, and will not only restrict patient access, but will also delay care. Requiring a sick inpatient to be transferred to a 'higher level' hospital for a procedure always confers risk," Peter Pelikan, MD, of Pacific Heart Institute in Santa Monica, California, told MedPage Today.

Horne cited a research finding that older patients just aren't willing to travel for their care.

"Someone who says, 'Just go 40 miles for a place that does TAVR,' that's just not realistic," he said. "You don't have to have centers everywhere, but have them where there is a larger population of African Americans and Latinos who frankly don't have the resources to drive more than 5-10 minutes out of their neighborhoods."

Structural interventionists and surgeons who find themselves working for a Level 2 valve center may also experience new limitations on their work.

"I certainly respect that if a procedure is being done rarely -- for example, MitraClip -- then they shouldn't be done at that hospital. There's no disagreement with the fundamental concerns, because the MitraClip procedure is one where volume makes a difference," Goldberg said. "But for some procedures, it's the specific individual that makes a difference."

Atrial septal defect repairs, for one, are to be done only at Level 1 hospitals, according to the proposal. "I personally happen to be very experienced and worked as a proctor for a company to teach this. But according to this, I shouldn't be able to do that," Goldberg said.

Pelikan criticized a recent study showing a small increase in deaths after TAVR at low- vs high-volume hospitals (3.2% vs 2.7%).

"While this was stated to be statistically significant, 8.2% of the mortality data was missing, and 13.3% of the composite outcome data were missing. With such a minor difference, and with the missing data, it is unclear if there is any volume effect whatsoever, but more importantly, a mortality difference of 0.5% attained statistical significance only due to the large size of the data set, and is likely not clinically significant."

On the other hand, an analysis limited to balloon-expandable valves found that there was no volume-operator quality relationship in TAVR, perhaps because of improvements in equipment, structural heart training programs, sharing knowledge, proctoring programs, and pre-procedure imaging, Pelikan said.

Ultimately, quality, not volume, should be the determining factor in deciding whether a program or physician may perform a procedure, he argued. "There are small-volume hospitals performing quality procedures in any area of medicine, which is also true in TAVR."

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