PCI at Ambulatory Centers: More Bleeding but No Penalty in Overall Outcomes

Patients who undergo elective PCI at an ambulatory surgery center (ASC) have outcomes similar to those treated at a hospital outpatient department (HOPD), but they are at increased risk of bleeding, an observational analysis suggests. Moreover, physiological assessment and advanced imaging were less often used in the ASC setting.

The data, derived from commercial insurance claims over a decade-long period ending in 2016, precede the decision by Centers for Medicare & Medicaid Services (CMS) to begin reimbursing for ASC-based PCI this year.

While this study, published online this week by JACC: Cardiovascular Interventions, may offer a preview of what’s to come as PCI expands beyond the hospital setting, researchers say it’s too soon to say how the ASC uptake will play out. “[It’s] possible that the population of patients who will undergo ASC PCI under new Medicare policies will differ from the patients in the present study, which could limit the generalizability of our results,” Kevin Li, MD (Stanford University, CA), and colleagues acknowledge.

Senior author William Fearon, MD (Stanford University), said this provides a first glimpse at ASC PCI, with the aim of better understanding whether CV interventions can be done safely outside of hospitals. “It’s a starting point for future studies that will have to look at this in bigger populations, broader sample size, and so forth,” he noted to TCTMD.

The rollout of peripheral interventions in nonhospital outpatient environments, which got CMS coverage in 2008, may provide clues. Many have cited benefits to patients, physicians, and payers alike: improved access to care, greater freedom, and the chance to save healthcare dollars. As highlighted by a TCTMD investigation last year, though, concerns over the potential for profit-driven, substandard care have inspired clinicians to call for quality.

W. Schuyler Jones, MD (Duke University Medical Center, Durham, NC), whose research has tracked what happened after the 2008 CMS pivot, agreed that office-based care can offer advantages “if done appropriately” and is especially appealing “in COVID times when you don’t necessarily want to go to the mega-hospital.”

To face the changes head-on, the Society for Cardiovascular Angiography and Interventions (SCAI) issued a position statement in May giving advice on how to proceed with ASC PCI.

Lyndon Box, MD (West Valley Specialty Clinic, Caldwell, ID), who chaired the SCAI document’s writing group, told TCTMD that what he “found most interesting and most concerning” in this report is that fractional flow reserve (FFR) was 69% less commonly done at ASCs. The SCAI Governmental Relations Committee, for which he also serves as chair, has “repeatedly lobbied” for CMS to reimburse for FFR as well as IVUS and optical coherence tomography, he said. “So far they’ve chosen not to do that, and I think that is something that is really to the detriment of patients.”

While Box said the current results may not be generalizable, partly thanks to changes in practices that have occurred in the 4 years since 2016, he specified that “we want more of these kinds of studies” charting the ASC impact.

Fearon said he isn’t convinced that reimbursement concerns are holding back physiologic assessment, noting that these facilities should have similar access compared with hospitals. “I don’t think that’s an explanation for the lower use,” he said.

Based on what they found for bleeding and procedural guidance, “we need to focus more attention to the quality and type of PCI technique that’s being applied in the ASCs,” he said, “to make sure that it is based on guideline-directed strategies so that patient outcomes are optimized.”

Now it’s time to figure out “whether these findings are real and what to do about it,” Fearon added.

Bleeding Stands Out

Here, the investigators looked at the MarketScan database to identify commercial insurance claims for 95,492 elective PCIs done at an HOPD and 849 at an ASC between 2007 and 2016. States with the highest proportion of ASC PCI were Alaska, Texas, Kentucky, Indiana, and Kansas.

Patients treated outside of the hospital in an ASC tended to be younger than 65 years, to live in the South, and to have managed or consumer-driven/high-deductible insurance versus comprehensive plans. They were more apt to have dyslipidemia and less apt to have had stroke than the HOPD group.

ASC-based cases were less likely to involve stenting and glycoprotein IIb/IIIa inhibitors. They also were less likely to include physiologic and advanced imaging (12.5% vs 18.3%; P < 0.001). Specifically, FFR use was less common at ASCs than HOPDs (adjusted OR 0.31; 95% CI 0.20-0.48).

Patients treated at an ASC were at higher risk of experiencing the primary composite of 30-day MI, bleeding, and hospital admission (adjusted OR 1.25; 95% CI 1.01-1.56) and bleeding complications (adjusted 1.80; 95% CI 1.11-2.90). Using propensity-matched analysis, the difference in the primary outcome lost significance (OR 1.23; 95% CI 0.94-1.60), while the risk of bleeding complications among ASC-treated patients grew (OR 2.49; 95% CI 1.25-4.95).

The persistent difference in bleeding “may suggest increased risk associated with procedures performed in ASCs due to facility- or operator-level variation across factors such as vascular-access site, use of vascular closure devices, and operator volume,” Li et al observe.

Although the bleeding was apparently not severe enough to tilt the balance when it came to rehospitalization, “our findings underscore the need for further study of postprocedural outcomes in the freestanding setting,” they say, “especially as ASCs may not always be staffed to manage problems like early hematoma formation that could otherwise be observed overnight under outpatient status in a hospital.”

This is especially true given that the current data set lacked details such as whether procedures involved radial access and whether complications arose directly from the index PCI, the investigators note.

A ‘Pivot Point’

Referring to the ASC shift, editorialist Gregory J. Dehmer, MD (Virginia Tech Carilion School of Medicine, Roanoke), poses the question: “Is this setting for PCI a bridge too far?”

It may simply be a “next logical step” in the field’s evolution, following developments like same-day discharge as well better stents, pharmacotherapy, and procedural techniques, he suggests. “Those years of progress now deliver us at the doorstep of PCI in ASCs.”

Li and colleagues’ findings “should be a warning, not necessarily to stop or change course, but rather to proceed with caution,” Dehmer urges, adding that quality control and data collection are crucial.

Similarly, Jones observed that while the idea of ASCs is “great,” key in their success will be “execution and implementation.”

For now, said Box, operators should take steps to reduce bleeding—first and foremost, radial access. If femoral access is expected, consider doing the procedure in a hospital environment. And if femoral access is used in the ASC setting, don’t always count on closure devices, he advised. “Think about alternative approaches of how you might get people to early discharge, or start your femoral cases at an earlier time so that you could do manual compression if necessary.”

Jones, describing the 2020 CMS shift as a “pivot point,” emphasized it comes down to knowing which cases should be done where, and by whom: “Deliver the right service to the right patient at the right place by the right person.”