Percutaneous Coronary Intervention Without On-Site Surgical Backup—The Times They Are A-Changin’

SCAI Expert Consensus Statement on Percutaneous Coronary Intervention Without On-Site Surgical BackupJournal of the Society for Cardiovascular Angiography & InterventionsVol. 2Issue 2100560PreviewAlthough once considered high-risk and below the standard of care, percutaneous coronary intervention (PCI) without on-site surgical backup has been performed with acceptable outcomes since the 1980s.1 An initial consensus document on PCI without surgery on site (no-SOS) was published by Society for Cardiovascular Angiography & Interventions (SCAI) in 2007 and updated in 2014.2,3 The 2014 document summarized new literature, reviewed existing guidelines and other publications related to PCI with no-SOS, and recommended best practices and requirements for facilities performing PCI with no-SOS. Full-Text PDF Open Access Many recognize the phrase attached to the title “The Times They Are A-Changin’” as the name of the 1964 record album by folk singer Bob Dylan.1Dylan B. The Times They Are A-Changin’. Columbia Records, 1964Google Scholar That phrase seems like an appropriate way to describe the new phase of percutaneous coronary intervention (PCI) delivery in the United States and the reason for a new expert consensus statement on PCI without on-site surgical backup by the Society for Cardiovascular Angiography & Interventions (SCAI).2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar In my view, we are now moving into the third phase of PCI delivery in the US. When PCI was first introduced in the US, it was restricted to hospitals with on-site surgery because up to 5.8% of patients needed urgent cardiac surgery for complications of the procedure.3Detre K.M. Holubkov R. Kelsey S. et al.Percutaneous transluminal coronary angioplasty in 1985–1986 and 1977–1981.N Engl J Med. 1988; 318: 265-270https://doi.org/10.1056/NEJM198802043180501Crossref PubMed Scopus (646) Google Scholar Fibrinolytic therapy for acute myocardial infarction (MI) was also evolving, but over time, it was surpassed by PCI as the preferred way to achieve vessel patency.4Keeley E.C. Boura J.A. Grines C.L. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials.Lancet. 2003; 361: 13-20https://doi.org/10.1016/S0140-6736(03)12113-7Abstract Full Text Full Text PDF PubMed Scopus (3667) Google Scholar Several transfer strategies combining fibrinolytic therapy and PCI emerged to provide reperfusion as fast as possible for patients in rural areas, but the success and appeal of primary PCI remained strong.5Cantor W.J. Fitchett D. Borgundvaag B. et al.Routine early angioplasty after fibrinolysis for acute myocardial infarction.N Engl J Med. 2009; 360: 2705-2718https://doi.org/10.1056/NEJMoa0808276Crossref PubMed Scopus (448) Google Scholar The second phase of PCI delivery evolved because of a desire to provide primary PCI to all patients with acute MI. Accordingly, hospitals, many located in rural areas and performing only diagnostic cardiac catheterization, pushed to provide primary PCI services without on-site surgery. By limiting procedures at hospitals without on-site surgery only to patients with acute MI, it was difficult to maintain staff and operator proficiency, and it was financially unsustainable. The improving safety and success of PCI, aided by the development of stents and new antiplatelet and antithrombotic drugs, supported expansion of PCI into other patient groups and elective procedures at sites without on-site surgery. We are now starting the third phase of PCI delivery, with expansion to ambulatory surgery centers (ASCs) and office-based laboratories (OBLs); so, “The Times They Are A-Changin’” again. Throughout the development of PCI and the expansion of PCI delivery, SCAI, in collaboration with other professional organizations, has provided guidance on the performance of PCI in these expanding settings; therefore, the new expert consensus statement on PCI without on-site surgical backup is timely.2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar,6Dehmer G.J. Blankenship J. Wharton Jr., T.P. et al.The current status and future direction of percutaneous coronary intervention without on-site surgical backup: an expert consensus document from the Society for Cardiovascular Angiography and Interventions.Catheter Cardiovasc Interv. 2007; 69: 471-478https://doi.org/10.1002/ccd.21097Crossref PubMed Scopus (51) Google Scholar,7Dehmer G.J. Blankenship J.C. Cilingiroglu M. et al.SCAI/ACC/AHA expert consensus document: 2014 update on percutaneous coronary intervention without on-site surgical backup.J Am Coll Cardiol. 2014; 63: 2624-2641https://doi.org/10.1016/j.jacc.2014.03.002Crossref PubMed Scopus (31) Google Scholar The new expert consensus statement provides a comprehensive review of past and current PCI results for a variety of lesion types, demonstrating the continuing improvement in outcomes and safety of PCI in facilities with and without on-site cardiac surgery.2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar As PCI expands to ASCs and OBLs (together referred to as ambulatory PCI), the expert consensus statement provides standards for key structural elements, such as equipment, supplies, staffing, transfer agreements, operator requirements, case selection, and surgical consultation, in such facilities.2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar A straightforward algorithm intended for experienced operators (defined as 3-10 years of experience and the ability to independently practice all of interventional cardiology in any setting) has been provided to help operators determine the type of patients, type of lesions, and procedure locations for PCI. It is important to emphasize that the expert consensus statement advises against ambulatory PCI for new operators, defined as <3 years’ experience, with limited exposure to atherectomy devices, and for patients with ST-elevation MI or shock.2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar Some might think that this is too restrictive and point out that patients with ST-elevation MI or shock are not appropriate candidates for ambulatory PCI. Several years ago, one of the major manufactures of PCI balloons had as their slogan “because no angioplasty is ever simple.” Many PCIs are straightforward until the guide catheter dissects and occludes the proximal right coronary artery; within 60 seconds, you are faced with a patient with hypotension and severe bradycardia. Even low-risk PCI can turn into a disaster, making one’s prior experience invaluable in a setting such as ambulatory PCI, which may not be optimally staffed or equipped for the situation. There is little question that ambulatory PCI provides a more convenient environment for both patients and physicians and can reduce costs. The cost savings makes this scenario very attractive to Medicare and other payers; however, moving forward to this third phase, what does this mean for the delivery of PCI and for patients and physicians? The move from the first phase, when PCI was only allowed at hospitals with on-site surgery, to the second phase, when PCI was allowed at hospitals without on-site surgery, occurred slowly and after multiple studies evaluating the safety and success of PCI without on-site surgery had been published. As shown in Table 1 of the expert consensus statement, studies examining the safety and outcomes of PCI at hospitals without on-site surgery continue to be published even though this scenario is now widely accepted both in the US and abroad.2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar This is in contrast to the body of evidence supporting the extension of PCI to ASCs and OBLs. As cited in the expert consensus statement,2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar <1% of PCIs have been performed in ASCs and OBLs, and only outcome data are unpublished. In 1 small study that used administrative data, PCIs performed in an ASC were significantly associated with higher bleeding complications and less likely to undergo functional testing of lesion severity.8Li K. Kalwani N.M. Heidenreich P.A. Fearon W.F. Elective percutaneous coronary intervention in ambulatory surgery centers.JACC Cardiovasc Interv. 2021; 14: 292-300https://doi.org/10.1016/j.jcin.2020.10.015Crossref PubMed Scopus (2) Google Scholar Because PCIs performed in hospitals without on-site surgery have outcomes and complication rates equivalent to those performed in hospitals with on-site surgery, is it appropriate to make a leap of faith and extrapolate the same results to the new care setting, ambulatory PCI? Is this a bridge too far?9Dehmer G.J. Elective percutaneous coronary intervention in ambulatory surgery centers: is this a bridge too far?.JACC Cardiovasc Interv. 2021; 14: 301-303https://doi.org/10.1016/j.jcin.2020.10.025Crossref PubMed Scopus (3) Google Scholar As defined in the expert consensus statement,2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar the care setting is clearly different; thus, in the absence of high-quality published data, questions about the safety and outcomes of ambulatory PCI remain unanswered. No doubt, the cost savings for insurance providers will result in physicians being pressured to perform procedures in ASCs or OBLs. The same cost savings pressure was observed in the early days of same-day discharge, prompting SCAI to publish guidance for same-day discharge after PCI.10Chambers C.E. Dehmer G.J. Cox D.A. et al.Defining the length of stay following percutaneous coronary intervention: an expert consensus document from the Society for Cardiovascular Angiography and Interventions endorsed by the American College of Cardiology Foundation.Catheter Cardiovasc Interv. 2009; 73: 847-858https://doi.org/10.1002/ccd.22100Crossref PubMed Scopus (86) Google Scholar As emphasized in that document, physicians, not insurers, should determine whether same-day discharge is appropriate for a patient, and that same dictum applies to the new phase of PCI in ambulatory settings. Physicians should be the final authority in deciding which of the 3 patient care environments is appropriate for their patient; however, the ownership of this decision comes with the responsibility that physicians follow proper guidance and use good judgment in making this decision. As we now enter this new phase of the delivery of ambulatory PCI, SCAI and its collaborating organizations have developed this expert consensus statement to provide needed guidance for physicians.2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar The expert consensus statement was founded upon a healthy dose of common sense and the substantial experience of the authors. The guidance set forth in the expert consensus statement provides a roadmap for all those currently involved with or contemplating involvement with PCI in ASCs and OBLs.2Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on PCI without on-site surgical backup. Preprint. Posted online. J Soc Cardiovasc Angiogr Interv. doi:.Google Scholar As Bob Dylan sang in 1964, “The Times They Are A-Changin’.” The author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.