Off-site PCI as Safe as PCI Performed With Surgical Backup: UK BCIS Registry

July 20, 2015

BETHESDA, MD — PCI performed in hospitals that did not have on-site cardiothoracic support in place to deal with rare catastrophic adverse outcomes was not associated with an increased risk of mortality in the short or long term, according to data from a large UK registry. The results suggest that PCI can be safely performed in clinical centers without surgical backup, say investigators[1].

"We showed that, after taking into account multiple confounders that would be present in a large observational cohort, there was no identifiable difference in mortality when we looked at patient outcomes at 30 days, 1 year, or 5 years of follow-up," lead investigator Dr Scot Garg (East Lancashire Hospitals/National Health Services Trust, Blackburn, UK) told heartwire from Medscape. "Even if we separate the population by whether they were treated for unstable angina, non-ST-segment elevation MI [STEMI], or STEMI, after adjustment, there was no difference in mortality for any of those subgroups at any of the time points."

The data, he added, should provide reassurance to patients undergoing PCI at hospitals without surgical backup, some of whom might believe PCI off-site is riskier or inferior to PCI performed with a cardiac surgeon and team available in case of an emergency.

Drs Ashvin Pande and Alice Jacobs (Boston University Medical Center, MA), who wrote an accompanying editorial[2], agree with those conclusions, although they are cautious in their interpretation of the data.

"When faced with changes in the practice of medicine, like aviation, we generally favor conservative approaches," write Pande and Jacobs. "Safety is paramount, and the medical community is reluctant to withdraw a safety net until a compelling new paradigm of need and safety can be put in its place." The editorialists say accumulating evidence and critical opinion in the cardiovascular community leans toward expansion of PCI to facilities without on-site cardiac surgery, "but we must take steps to ensure that this occurs in the context of appropriate standards and program development to best serve and protect our patients."

The study and editorial were published July 20, 2015 in the Journal of the American College of Cardiology.

Difference Between US and UK

According to the 2011 American College of Cardiology/American Heart Association (ACC/AHA) PCI guidelines, performing elective PCI without surgical backup is a class IIb recommendation, while primary PCI without backup is a class IIa recommendation.

In the US, PCI without on-site surgical support is performed less frequently than in the UK. As the researchers point out in the article, data from the US National Cardiovascular Data Registry showed that just 13% of PCI centers were without surgical support in 2009. These "off-site" PCI procedures accounted for just 3% of all PCIs performed in the US. By 2011, approximately 12% of PCIs in the US were done in centers without on-site surgery.

In the UK, however, almost 40% of all PCIs are performed at centers without surgical backup. Nearly two-thirds of UK PCI centers are off-site centers without surgical support. To heartwire, Garg said off-site PCI centers are required to have an operational agreement with a hospital capable of performing major cardiac surgery in the event of an emergency.

"In the UK, over the past 10 years or so, there has been a rapid expansion of interventional centers, but the number of centers with surgical support has not changed," said Garg. The expansion, he added, has partly been facilitated by operators and regulatory authorities comfortable with physicians performing cardiovascular interventions in off-site centers.

The UK study is a retrospective analysis of index procedures in the British Cardiovascular Intervention Society (BCIS) database between 2006 and 2012. Follow-up data were available for 384,013 patients undergoing PCI, of whom 119,096 underwent PCI at a center without cardiothoracic support. Patients treated at centers with surgical backup were more likely to undergo PCI for STEMI, multivessel disease, and bypass graft lesions, as well as undergo PCI with circulatory support. Median follow-up was 3.4 years.

In terms of the primary end point, which was all-cause mortality at 30 days, 2.0% of patients in off-site centers and 2.2% treated at hospitals with surgical support died (P<0.001). After adjustment for multiple confounding variables, however, there was no significant difference in mortality at 30 days, 1 year, or 5 years between the two groups. Importantly, investigators saw no difference in mortality when patients were stratified based on procedural indication, such as unstable angina, NSTEMI, or STEMI. The results were confirmed in a sensitivity analysis of a propensity-matched cohort that included more than 74,000 patients.

"The bottom line is that there was no adverse risk," said Garg, referring to PCIs performed at centers without surgical backup. "With the data, we showed that an 'all-comer' patient population can be treated at an off-site surgical center."

Still Some Unanswered Questions

In their editorial, Pande and Jacobs note that the introduction of modern stents and improvements in device technology, procedural techniques, adjunctive pharmacology, and operator experience have reduced the incidence of emergency CABG after PCI from between 6% to 10% to as low as 0.1%. Although a randomized, head-to-head comparison of PCI performed on- vs off-site is the best means to address the clinical question, such a trial is unlikely to be done, they point out.

Despite the positive data, the editorialists urge caution, noting the current study does not engage in "the question of program development for expansion of PCI." One of the issues of expanding PCI to off-site centers is the "atomization" of PCI volume and experience, with physicians and centers doing less volume. Although the UK registry data suggest the expansion of off-site PCI did not come at the expense of on-site surgical volume, this might be a reflection of the UK national health system (ie, the expansion of off-site PCI to underserved areas) not applicable to the US. Such a rapid expansion of off-site PCI in the US has the potential to "cannibalize" center volume in certain regions, diminishing PCI quality and training of fellows.

The editorialists note that the benefits of on-site cardiac surgery go beyond bailout emergency surgery in catastrophic cases. The surgical ward includes more physicians—in essence, an interdisciplinary heart team—which is currently recommended by the revascularization guidelines.

"At its best, such a team works together to determine the ideal approach for patients with complex coronary disease and may offer patients the fullest range of options," they write. "Although current communication technology may allow for an improvised virtual heart team, it is unclear whether PCI facilities without on-site cardiac surgery can incorporate surgical counsel from partnering institutions and provide a comparable experience for optimal patient care."

To heartwire, Garg said that the data published are the largest to date comparing the safety of PCI performed off-site against the traditional standard of PCI performed with surgical backup. The data, he added, reinforce what he and other operators believe, that PCI can be safely done in an environment without surgical support.

The authors and editorialists have no relevant financial relationships.

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