PCI Complications Portend Dire Outcomes: Tracking Could Be Key

Major complications are quite rare in patients undergoing PCI today—but among those who experience a serious procedural complication, nearly one in five die, a new analysis of US registry data shows.

The findings beg the question: why is failure to rescue (FTR), such a common, long-standing concept in many medical fields, not as eagerly embraced in interventional cardiology, where it could help to guide PCI quality-improvement efforts?

For patients who’d had an in-hospital complication, the mortality rate was 15-fold higher than that seen in complication-free cases (19.7% vs 1.3%), investigators report in Circulation: Cardiovascular Interventions. Failure to rescue—the incidence of death after an adverse event or complication—rose from 17.1% to 20.1% between 2018 and 2021.

“In many other areas of medicine, including many surgical fields, failure to rescue is a very established measure and a very important measure that hospitals actively address,” said Jacob A. Doll, MD (University of Washington and VA Puget Sound Health Care System, Seattle, WA), the study’s lead author.

But the same cannot be said in interventional cardiology, he told TCTMD. “That was really striking to me. And so I got excited about doing a study where we could at least establish the very basics of what failure to rescue would look like for PCI patients.”

It’s not clear why the field hasn’t adopted the metric, Doll added, though he said the omission likely isn’t intentional.

“Interventional cardiology has historically been very open to examining our processes. We have always been a leader in performance and quality-measure development,” he noted, so perhaps FTR “just kind of slipped through the cracks.”

The rate of complications, a more common metric, is closely tied to patient characteristics, so “it can really penalize sites that are taking care of high complexity and high-risk patients,” Doll said. “We definitely don't want to cause a risk-averse behavior with any of these measures that we might develop.”

Failure to rescue, on the other hand, is calculated within the subset of patients who’ve already had a complication, he explained. “It basically says, ‘Okay, a complication happened, whether that was an avoidable or an unavoidable one. What happens now?’” Valuably, the endpoint involves not only the interventional cardiologist and cath lab team, Doll said, but also the ICU and other departments caring for the patient.

Okay, a complication happened, whether that was an avoidable or an unavoidable one. What happens now? Jacob A. Doll

For this analysis of the National Cardiovascular Data Registry (NCDR) CathPCI Registry, nearly 2.2 million patients underwent PCI across 1,483 hospitals between April 2018 and June 2021. Of these, 3.5% had at least one PCI complication: significant coronary dissection, coronary artery perforation, vascular complication, significant bleeding within 48 hours, new cardiogenic shock, or tamponade.

The NCDR data also revealed marked variation among hospitals—if two patients who were treated at two randomly selected centers had an intraprocedural PCI complication, one would be 48% more likely to die than the other.

Doll said this uneven distribution isn’t surprising, though the reasons behind the differences aren’t yet known. He speculated that things like having hemodynamic support devices on hand and adequate transfer protocols for the sickest of the sick could bring improvement. High-quality postprocedural monitoring is key, as well, whether that’s in a stepdown unit or, for highest-risk patients, in an ICU. Additionally, there also need to be “clear protocols for same-day discharge that allow for early recognition of complications that may occur during the procedure or immediately after the procedure,” said Doll.

‘Culture of Quality’

Less tangible, but very important, is having a “culture of quality,” he commented. Environments that are open and collaborative—not punitive—enable the team to address complications, said Doll. “If people are worried that their complication is going to be held against them, then they may be less likely to immediately recognize it and deal with it.”

At a system level, FTR would be fairly easy to implement in the PCI context for entities like the NCDR CathPCI Registry, US Department of Veterans Affairs, or individual hospital networks.

Doll specified, however, that due to differences in case mix, the metric isn’t “appropriate as a performance measure where we would be impacting people's employment or compensation or billing at a hospital level.” Instead, it should be reserved for quality improvement, he said. “If you see that your rate is high, you need to get into the data and figure out why, but do that in a collaborative and positive sort of fashion.”

In an accompanying editorial, Kais Hyasat, MBBS, Margaret McEntegart, MD, PhD, and Ajay J. Kirtane, MD (NewYork-Presbyterian/Columbia University Irving Medical Center and Cardiovascular Research Foundation, New York, NY), agree that FTR could prove useful in interventional cardiology.

The mortality rate with PCI is quite low, at well under 1%, and with complications it can be hard to differentiate between those “due to the PCI procedure itself versus potentially unrelated and preexisting patient factors such as frailty, acuity of clinical presentation, hemodynamics, and other comorbidities,” they write. “In many cases, only a minority of deaths at 30 days may be attributable to complications from PCI.”

Although FTR more closely ties mortality to a proximate procedural complication, to some degree it still hinges on patient factors like frailty and whether the PCI was elective or nonelective, the editorialists observe, adding that those details still need to be worked out.

“The measurement and documentation of FTR is a useful initial step for case review and the further identification of remediable change. However, a patient’s journey postprocedure is complex, and nonprocedural-related factors contributing to mortality need to be recognized. Hence, we should not overreact to any individual FTR but rather use this metric as an indicator in striving to achieve excellent patient outcomes,” they conclude.