PCI With No Surgeon on Standby Appears Safe

Original article

By Charles Bankhead, Staff Writer, MedPage Today Published: December 13, 2011 Reviewed by Zalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Action Points   Note that in the past, 5% to 10% of percutaneous coronary intervention (PCI) patients required emergency coronary artery bypass grafting (CABG) within 24 hours, but today, with primary stenting, the risk of requiring emergency CABG surgery is 10 times lower. Point out that the present study reports on a meta-analysis of largely observational studies and found that PCI performed at centers without onsite surgical backup were not associated with a higher incidence of inhospital mortality or emergency bypass surgery, compared with centers with onsite surgical backup. Percutaneous coronary intervention (PCI) without surgical backup did not increase the risk of inhospital mortality or need for emergency bypass surgery, according to a systematic review of published literature. Primary PCI for myocardial infarction (MI) was associated with an inhospital mortality of 4.6% and emergency bypass rate of 0.22% when performed without surgical backup, versus 7.2% and 1.03% with backup. For elective and urgent PCI procedures, rates of inhospital mortality and emergency coronary artery bypass graft (CABG) surgery were 1.4% versus 2.1%, and 0.17% versus 0.29%, for centers with and without surgical backup, respectively. "[The analysis] demonstrated that mortality and the need for emergency CABG surgery after primary PCI for non-ST segment elevation MI were similar at centers with and without onsite surgical backup," Mandeep Singh, MD, of the Mayo Clinic in Rochester, Minn., and co-authors wrote in the discussion of their findings. "The narrow funnel plot and consistent individual and combined-effect estimates for mortality support the safety of performing primary PCI at these centers. No significant publication bias was demonstrated." Current clinical guidelines recommend against elective PCI at centers that do not have onsite surgical backup. Primary PCI without surgical backup is considered acceptable, provided that additional precautions are taken to ensure patient safety (J Am Coll Cardiol 2006; 47: 216-235). Onsite surgical backup was considered mandatory in a prior era, when as many as 5% of patients required urgent or emergency CABG after failed PCI, the authors noted in their background review. Even though the need for emergency CABG after PCI has declined substantially, some concerns have persisted -- for instance, favorable results of PCI without surgical backup have come primarily from small, single-center registries; and a study involving a large administrative database showed an increased risk for elective PCI at centers without surgical backup, especially centers with a low annual PCI volume. However, since publication of the guidelines, additional positive results have come from studies at centers without surgical backup. In an effort to address some of the unresolved issues, Singh and colleagues performed a systematic literature search for relevant clinical studies published from January 1990 to May 2010. Of 1,029 articles identified, 40 included outcome data for PCI performed at centers with and without onsite surgical backup. That list was subsequently whittled to 17. The authors used pooled data for their analyses. The collective patient population comprised 124,074 patients who had primary PCI at centers with or without onsite surgical support and 914,288 patients who had elective or urgent PCI. The authors reported that 11 studies included patients who underwent primary PCI for STEMI, and nine included patients who had elective or urgent PCI procedures. The 17 studies had a cumulative total of 16,489 ST segment elevation MI (STEMI) patients treated by primary PCI at centers without surgical backup and 107,585 patients treated at centers with onsite surgical backup. The elective/non-STEMI population consisted of 30,423 patients who had procedures without surgical backup, and 883,865 who underwent PCI at centers with onsite surgical support. For primary PCI procedures, the comparison of centers with and without onsite surgical backup yielded an odds ratio of 0.96 (95% CI 0.88 to 1.05) for inhospital mortality and 0.53 for emergency bypass surgery (95% CI 0.35 to 0.79). Analysis of elective/non-STEMI procedures yielded odds ratios of 1.15 (95% CI 0.93 to 1.41) for inhospital mortality and 1.21 for emergency bypass surgery (95% CI 0.52 to 2.85). The authors acknowledged several limitations of their study, most notably, the fact that all but one of the studies included in the analyses were observational. They also emphasized that the results should not be considered definitive. Having evolved as a more definitive and potentially safer alternative to thrombolytic therapy, PCI "offers a safe mode of coronary revascularization for many patients with lifestyle-limiting symptoms or acute coronary syndromes," Scott Kinlay, MBBS, PhD, of the Veteran Affairs Boston Healthcare System, wrote in an accompanying editorial. "The prevention of adverse events is arguably less dependent on the presence of onsite CABG surgery and more dependent on an operator's skill to select appropriate patients, their technical skill to complete PCI, and their commitment to maintain skills through continued education and participation in quality assurance programs," Kinlay added. Neither the authors nor Kinlay had any relevant disclosures. From the American Heart Association: CPORT E, Outcomes of Non-Primary PCI at Hospitals with and Without On-Site Cardiac Surgery: ARandomized Study, AHA Scientific Sessions 2011 2011 ACCF/AHA/SCAI Guidelines for Percutaneous Coronary Intervention

Primary source: Journal of the American Medical Association Source reference: Singh M, et al "Percutaneoous coronary intervention at centers with and without on-site surgery. A meta-analysis" JAMA 2011; 306: 2487-2494. Additional source: Journal of the American Medical Association Source reference: Kinlay S "The trials and tribulations of percutaneous coronary intervention in hospitals without on-site CABG surgery" JAMA 2011; 306: 2507-2509.