Patient Complexity Increasing at PCI Sites Without Surgical Backup

The complexity of patients undergoing PCI at sites without surgical backup is increasing, but their outcomes are staying similar to those of cases done at centers that also offer cardiac surgery, according to an analysis spanning 9 years of US data.

“As the patient population undergoing intervention has become more complex, both surgical and nonsurgical sites have expanded their services to provide access to coronary intervention for these patients,” lead author Stephen Waldo, MD (University of Colorado School of Medicine, Aurora), told TCTMD in an email.

Referencing the updated guidance on PCI without surgical backup published in 2014 by the Society for Cardiovascular Angiography and Interventions, American College of Cardiology, and American Heart Association, he said the current findings suggest “nonsurgical facilities perform procedures that may be outside the recommendations of the current consensus statement, yet these are done with similar safety to those performed at surgical sites. Perhaps it would be reasonable to consider alternative approaches to allow these complex procedures to be performed, instead of simply considering the presence of on-site surgery in isolation.”

Because of the lack of difference in clinical outcomes across PCI sites, the results point to “an opportunity to improve access to complex interventional care without sacrificing quality,” the authors write.

But their data, with a cutoff in late 2017, don’t speak to the latest development in PCI delivery—this year, the Centers for Medicare & Medicaid Services began reimbursing for coronary interventions, including angioplasty and stenting, at ambulatory surgery centers (ASCs). The move is expected to further expand PCI outside the hospital.

Increases Before and After 2014

For the study, published online December 23, 2020, ahead of print in Circulation: Cardiovascular Interventions, Waldo and colleagues included all 75,564 patients who underwent PCI within the Veterans Affairs healthcare system between October 2009 and September 2017. A total of 71% had their procedures at a location with on-site cardiac surgery capabilities.

Overall, clinical complexity—based on the National Cardiovascular Data Registry CathPCI risk score—was greater for patients treated at sites with cardiac surgery versus those without (18.4 vs 17.9; P < 0.001). Both types of settings saw similar annual increases in clinical complexity before the 2014 document’s arrival and dips in the month after publication. Subsequently, though, clinical complexity began to increase annually again irrespective of surgical backup.

Greater anatomic complexity—as measured by the VA SYNTAX score—was observed at centers with on-site surgery across the study period (11.0 vs 10.1; P < 0.001). After 2014, this complexity decreased at sites with surgical backup and increased at those without, with the end result being a similar metric between both by the study’s end.

No matter where patients were treated, referrals for emergent cardiothoracic surgery were extremely rare, at 0.8%. In a propensity-matched analysis, the risks of all-cause mortality (HR 0.883; 95% CI 0.662-1.176) and rehospitalization for MI (HR 0.813; 95% CI 0.556-1.19) were comparable for sites with and without surgical backup.

“Because of the increasing clinical and anatomic complexity of patients undergoing intervention, we anticipated that the subpopulation of patients treated at nonsurgical sites would also evolve,” Waldo observed. “This observational analysis confirms that the complexity of patients being treated at sites without surgical backup is increasing, at times in contrast with the most recently updated consensus statements.”

He also cautioned that the findings “may not be as applicable to rural community care practices without surgical support in close geographic proximity.”

Acceptable Practice

Speaking with TCTMD, Gregory Dehmer, MD (Carilion Clinic, Roanoke, VA), who led the writing committee for the 2014 recommendations, said the study “confirms that PCI can be performed safely at sites without on-site cardiovascular surgery. . . . The results are not at all a surprise to me, because I think most people now have become quite accepting of the fact that you can perform PCI without on-site surgery and [that] you can do it with acceptable results and good safety as long as you follow some reasonable kind of recommendations for how to do this.”

Still, patients at the highest risk where the presence of immediate surgery could make a difference should undergo PCI at hospitals with on-site surgery, he said. “For example, more and more now we're seeing patients that have had not just one but two previous bypass operations, and any cardiac surgeon will tell you that to do an emergency redo operation is extremely difficult because of the time that it takes to do the surgical dissection, expose the arteries, and not damage the vein grafts.”

Dehmer advised having “a very frank and good discussion” with these patients, keeping in mind that for some “there's really no good option for surgery. . . . So you have to kind of think your way through things really carefully.”

Waldo stressed that it’s important to consider the big picture.

“The overwhelming goal of any healthcare system is providing universal access to appropriate procedural care with the highest possible quality,” Waldo said. “With this in mind, expanding the repertoire of coronary intervention at nonsurgical sites certainly improves access without significant alterations in quality, as observed in the published findings. Rather than explicitly delineate the types of patients or cases that should be performed at a given site, I believe that the availability of complex interventional services should be based on the locally available competencies especially considering the relatively limited conversion to emergent bypass (< 0.1%) in the present era.”

Looking forward as clinical complexity continues to increase, he said future research “could provide insight into the continued safety of coronary intervention without on-site surgery in the contemporary era. Incorporating more complex patients in these studies could inform an update to the guidelines that may potentially expand access to complex intervention at sites where patients cannot currently receive them.”

There’s also the next frontier of PCI to consider, Dehmer said, urging that results should be assessed carefully as procedures increase at ASCs. “If you can do PCI at a hospital that doesn't have on-site surgery, it's a logical extension to think that you can move that into PCI at an ambulatory surgery center, because the support services are probably not tremendously different,” he commented. This won’t be certain until outcomes are compared across environments “but I suspect that over time, just like PCI without on-site surgery, PCI at ambulatory surgery centers will become much more accepted.”