A new expert consensus statement from the Society for Cardiovascular Angiography & Interventions (SCAI) suggests that percutaneous coronary intervention (PCI) without surgery on site (no-SOS) is as safe as PCI at centers with on-site surgery across randomized controlled trials, observational studies, and international experiences. The statement, published today in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) and JACC: Cardiovascular Interventions, explains that adequate operator experience, appropriate clinical judgment and case selection, and facility preparation are essential to a safe and successful PCI program with no-SOS.
PCI is an interventional procedure performed in one or more arteries to the heart (coronary) through a puncture or small incision in the skin (percutaneous) rather than surgery. Although PCI with no-SOS was once considered high-risk, it has been performed with acceptable outcomes for nearly four decades. In 2007, SCAI published an initial consensus statement on the procedure within this setting, with the last update in 2014.
"Since we released the last consensus statement in 2014, same-day discharge after elective PCI has increased to 28.6% of all PCIs and 39.7% of radial PCIs in the United States," said Cindy L. Grines, MD, MSCAI, chair of the writing group and SCAI past president. "Elective PCI in no-SOS settings have increased in volume and complexity. Concurrently, there have been operators performing PCI in office-based laboratories (OBLs)and ambulatory surgery centers (ASCs) with positive outcomes." "Thanks to improvement in PCI safety and several global studies in recent years, we now know that PCI at ASCs may improve access, patient satisfaction, and reduce costs."
Statement highlights:
1. Elective PCI in settings with no-SOS has increased in volume and complexity (extending beyond the simple lesion recommendations in the 2014 document). In addition, PCI is now being performed outside of the hospital setting, in office-based laboratories (OBLs) and ambulatory surgery centers (ASCs).
2. Several new studies in the United States and abroad have demonstrated that PCIs performed at no-SOS centers have very low rates of complications and similar outcomes to PCIs performed at surgical centers.
3. Despite increase in age, comorbidities, and lesion complexity, the rate of periprocedural complications has remained constant, or declined, with rates of emergency surgery as low as 0.1% in many series.
4. Complex PCI, including unprotected left main, is being performed in some no-SOS centers, with no increase in major adverse cardio-vascular events or emergency coronary artery bypass graft surgery compared with PCI at surgical centers.
5. The SCAI writing group proposes a new PCI treatment algorithm that expands the type of cases that can be performed with no-SOS compared with the2014 document, with consideration of the patients' clinical and lesion risk, the operator experience (both recent and accumulated), and the experience and rescue capabilities of the site.
6. In the United States, there are considerable financial savings (to insurers and Medicare) for PCI to be performed in ASC and OBL settings, thus out-migration of procedures from hospitals should be anticipated.
This expert consensus statement has been developed according to SCAI Publications Committee policies for writing group composition, disclosure, and management of relationships with industry, internal and external review, and organizational approval. The writing group has been organized to ensure diversity of perspectives and demographics, multistakeholder representation, and appropriate balance of relationships with industry. Relevant author disclosures are included as a supplement in the manuscript.
This expert consensus statement was endorsed by the American College of Cardiology (ACC), American Heart Association (AHA), British Cardiovascular Intervention Society (BCIS), Canadian Association of Interventional Cardiologists (CAIC), and Outpatient Endovascular and Interventional Society (OEIS).
