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While Medicare started reimbursing elective percutaneous coronary intervention (PCI) at freestanding ambulatory surgery centers (ASCs) this year, these centers haven't measured up on certain PCI practices and outcomes to hospital outpatient departments, a study found.

From 2007 to 2016, patients with stable ischemic heart disease who underwent PCI at ASCs were not significantly more likely to experience the primary composite outcome of 30-day MI, bleeding complications, and hospital admission in propensity-matched analysis (11.7% vs 9.8% at hospital outpatient departments, OR 1.23, 95% CI 0.94-1.60).

However, ASCs were associated with increased bleeding complications (2.1% vs 0.9%, OR 2.49, 95% CI 1.25-4.95), as William Fearon, MD, of California's Stanford University, and colleagues reported in.

The increased bleeding at ASCs in their retrospective, observational analysis using commercial insurance claims from MarketScan may suggest increased risk from facility- or operator-level variation in vascular access site, use of vascular closure devices, operator volume, or other factors, they suggested.

"In particular, the overall growth of radial relative to femoral access during the study period may not have been fully realized in the ASC setting, a possible explanation for increased vascular complication rates in these facilities," they wrote.

ASCs were also linked to lower utilization of fractional flow reserve (FFR, OR 0.31, 95% CI 0.20-0.48), Fearon and colleagues reported.

"[N]either intravascular imaging nor FFR are reimbursed under new CMS [Centers for Medicare and Medicaid Services] policies, even though FFR and intravascular ultrasound guidance of elective PCI for stable ischemic heart disease have been associated with improved long-term outcomes compared with conventional angiography alone," according to the investigators.

Medicare added percutaneous transluminal coronary angioplasty and transcatheter placement of intracoronary stents to the list of procedures reimbursed at ASCs effective January 1 this year.

"This study should be a warning, not necessarily to stop or change course, but rather to proceed with caution," wrote Gregory Dehmer, MD, of Carilion Clinic in Roanoke, Virginia, in an .

"Allowing PCIs to be performed in ASCs is a logical extension of current practice that has potential for saving health care dollars. However, because it is new and unproven in the Medicare population, performing PCI in an ASC environment requires strict adherence to regulatory requirements and operational recommendations," according to Dehmer.

He noted that the Society for Cardiovascular Angiography and Interventions has published a position statement on PCI in ASCs, advocating development of a quality assurance program and recommending a specific data registry.

Included in the study were adults who underwent elective PCI at a hospital outpatient department (HOPD, n=95,492) or an ASC (n=849). Patients getting same-day coronary artery bypass grafting, who may have had PCI complications, were excluded.

Patients who underwent ASC PCI were more likely to be younger than 65 years, to live in the South, and to have managed or consumer-driven health insurance.

That patients at ASCs were younger and may reflect some pre-procedural screening, study authors said. "Of the comorbidities we measured, however, only history of stroke was inversely associated with ASC treatment setting. We did not identify other baseline differences in measured comorbidities between HOPD and ASC PCI to suggest significant pre-procedural risk stratification in the latter."

Fearon's group acknowledged that their findings may not be generalizable, given that the patients who will undergo ASC PCI under new Medicare policies will differ from the patients studied. Other limitations of the study included possible variation in coding practices across sites and short follow-up.

"Despite these limitations, we believe that this analysis provides an informative first look at the potential clinical implications of increased elective PCI volume in freestanding ASCs under Medicare, given the relative paucity of data in this area," the investigators maintained.

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