On-Site Surgical Back-up is ‘Critically’ Important for PCI! Jeff Brinker MD, FACC, FSCAI Professor of Medicine and Radiology Johns Hopkins Medical Institutions

Jeff A. Brinker, MD DISCLOSURES I have no real or perceivable conflicts of interest to report.

Does PCI Without On-site Surgery Pass the Mother Test? Or the Mother-in-law Test?

The Inevitable Wave of Change ‘Need For On-Site Surgical Support’ Coronary Angiography Primary PCI Guidelines NSTEMI/Elective PCI

Disclaimer Tom Aversano and the Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) Thrombolytic Therapy vs Primary Percutaneous Coronary Intervention for Myocardial Infarction in Patients Presenting to Hospitals Without On-site Cardiac Surgery : A Randomized Controlled Trial. JAMA 2002;287:1943 At 6 months better clinical outcome and shorter hospital stay in PCI group. Ongoing RCT: Non-emergent PCI at hospitals without vs with on-site cardiac surgery; 14,000 of target 18,000 patients enrolled.

Is STEMI an Unique Clinical Scenario? STEMI: Emergent situation in which ‘time is muscle’ Goal (limited) is establishment of TIMI 3 flow ASAP High risk for surgery; often 1 or 2 VD Less attractive for surgery Options: Thrombolytics vs PPCI; if PPCI patients triaged to PCI center with CVS on-site patients transferred to PCI center with CVS on-site PPCI at sites without CVS on site Keeley & Grines Ann Intern Med 2004;141:298 ACS: Early medical therapy acceptable Stable hemodynamics/rhythm (or can be stabilized) Higher prevalence of multivessel disease

Why Even Consider PCI Without Surgical Availability? Geographic impediment to receiving tertiary care. Extend care to the underserved. (AHJ 2008;155:668) Ability to provide safer, more effective, or less costly tertiary service. Business opportunity for hospital. Business opportunity for interventionalists. Fear of loss of patient base in competitive environment where similar hospitals are opening PCI programs.

Optimal vs Acceptable vs Unacceptable Assumption: On-site CVS is a component of an ‘Optimal’ environment for PCI. Usually implies: Higher CAD patient volumes Availability of other specialists/subspecialists System redundancy (MDs, staff, resource) Advanced equipment and techniques Assumption: ‘Acceptable’ is risk/benefit dependent. Thus lack of CVS may be acceptable for STEMI but not for non-emergent PCI.

Concerns Is there commitment to fully equip and staff 24/7 PCI facility? The sprouting up of PCI programs at multiple non-CVS community hospitals in close proximity to each other or to an on-site CVS hospital is not sound healthcare policy. Lower volume PCI sites especially when served by low volume operators have less satisfactory patient outcomes. Non-CVS hospitals may be less compliant with guideline-recommended therapy (JACC Intv 2009;2:944) Efforts to increase the case volume to meet mandated minimums provide an incentive to perform marginally indicated procedures.

Fait Accompli Primary PCI at non-CVS sites is current practice around the world and in all but a few states in the U.S. Most states in the U.S. have elective PCI performed at sites without on-site CVS. Large registry data demonstrate no significant differences in mortality or MI (however the low rates of these outcomes and risk variations of patients going to tertiary care centers make this data difficult to interpret) A SCAI consensus document (Cathet Cardiovasc Interv 2007;69:471) has suggested guidelines for the establishment of non-CVS sites elective PCI. Still, there is evidence that low volume PPCI sites lose the advantage over thrombolysis that higher volume PPCI sites have (JAMA 2000;284:3131) and when the former perform PCI for non-primary/rescue purposes there is a higher mortality than in hospitals with on-site CVS (JAMA 2004;292:1961).

Conclusion While on-site surgery doesn’t guarantee optimal PCI, optimal PCI does require on-site surgery. While off-site PPCI and EPCI are here and growth is inevitable; vigilance in quality assurance is not. It remains unclear whether dispersion of PCI will significantly extend appropriate care to underserved or simply redistribute case load increasing low volume facilities.