Successful Implementation of a Cardiac Interventional Program Without On-site Surgical Backup at Howard Regional Health System

Howard Regional Health System (HRHS) has successfully implemented a PCI program in the absence of an on-site cardiothoracic surgical presence. This article will show that our outcomes and length of stay are better than national and local numbers and suggest that PCI at our institution could be the standard for local care of all groups needing PCI. Furthermore, our data indicate that the HRHS program could serve as a guide and model for the development of similar programs. Current data clearly show that experienced and skilled interventional cardiologists using current technology can perform percutaneous coronary intervention (PCI) safely, with procedural mortality rates following elective interventions approaching zero and less than 3% following acute myocardial infarction.^1-7 Studies also show that the need for emergent coronary bypass graft surgery (CABG) following failed PCI has also been reduced, with rates of less than 5%.^1-7 In addition, certain technology advances such as stents, and support systems such as intra-aortic balloon counterpulsation devices, have dramatically lengthened the minimum time allowable between failed PCI and successful CABG. These events have altered the basic approach to PCI from one of having cardiothoracic surgical operating teams ready and on standby for each PCI to one of performing PCI without any surgical presence. Indeed, most PCIs are performed independently of the surgeons and usually without communication between interventional cardiologist and cardiothoracic surgeon. Studies have shown that the performance of PCI independent of communication with cardiac surgical teams has resulted in a substantial increase in time to operating room for emergency CABG following failed PCI.^4-6,8,9 Despite this increase in time, outcomes have remained outstanding. In fact, outcomes are better now than in the days when the surgical team was ready and waiting in the OR.^5,6 The increasing success of PCI using this more recent approach, and the significant increase in allowable time to successful CABG after failed PCI has raised the question of whether cardiothoracic (CT) surgical teams even need to be present at the same institution performing PCI. Studies addressing the two major components of this question, specifically the outcomes of PCI performed at institutions without the presence of CT surgery versus those that do and the time to the operating room following failed PCI at institutions with or without CT surgery, have recently been reported.^8-12 Studies evaluating outcomes of PCI show that mortality following PCI for acute myocardial infarction is statistically significantly lower when PCI is performed locally, regardless of the presence of a CT surgical program. Interestingly, the mortality rates are lowest at institutions without the presence of a CT surgical team. More importantly, and of greatest concern, is that mortality is nearly 50% (4.7% vs. 6.8%) higher if a patient is transferred from an outside hospital for PCI at an institution with CT backup.^8-13 However, it should be noted that mortality following PCI performed for acute myocardial infarction, regardless if transferred or done locally, with or without surgical presence, is still lower than mortality following lytic therapy alone.^8-17 Hence, PCI remains the standard of care and the preferred therapy for acute myocardial infarction. Studies addressing the time to OR following failed PCI show, surprisingly, that it takes less time (by about 10 minutes) for a patient to get to the OR following a failed PCI when transferred in from an outside hospital than when moved to the OR from within the same hospital.^8,9,13 These data were the same regardless of the initial indication for PCI. Specifically, the time to OR was similar for failed PCI following an acute myocardial infarction, unstable angina, or stable angina.^8,9,13 We felt these studies indicated that PCI could be performed at HRHS with a committed, talented interventional cardiologist, provided sufficient technology and institutional commitment were in place. Indeed, these data indicated that PCI should be performed under such conditions. Furthermore, once a program is established and successful, alternative approaches such as transferring patients to other institutions for PCI and lytic therapy for the treatment of acute myocardial infarction, might be considered substandard care. Getting Here from There: HRHS History The city of Kokomo is located 45 minutes north of a major metropolitan area (Indianapolis) that supports four heart hospitals. In Kokomo, we are in a very competitive market, as we are one of two hospitals in our city that provides acute care. The other hospital in our city does not perform PCI. Prior to 2000, our community hospital had one GE Advantx-VSE combo lab performing diagnostic peripheral and cardiac angiography. In August 2000, we recruited a vascular surgeon who performed not only diagnostic but peripheral interventions in the cath lab. As our CCL numbers increased, our staff became more experienced with stents and balloons. Prior to June 2002, if our patients had a positive diagnostic heart cath, they had to be transferred to a tertiary facility in Indianapolis. Officials at HRHS felt that the needs of the community could be better served through the provision of interventional cardiology services performed in our CCL. Based on the strength of research showing the safety and positive patient outcomes associated with providing interventional services without on-site surgical backup, including the C-PORT Trial8, a decision was made to go forward with plans to implement these services. Dr. Michael E. Ritchie was recruited to provide interventional cardiology services. We chose to do elective as well as urgent/acute PCIs. In addition to providing the best range of services for our patients, performing elective procedures along with emergency procedures helps to maintain staff competency by volume. We wanted to not only provide interventional cardiology services, but to perform them well, utilizing the Mom test as our standard: would we feel comfortable having a family member have his or her PCI procedure done in our community hospital? Overwhelmingly, the response has been yes! Several of our CCL team have had family members utilize our services, enabling them to stay in our community and closer to their emotional support network of family and friends. Our inpatient satisfaction scores, as measured and benchmarked nationally by Press Ganey, are in the 98th percentile. Based upon the American College of Cardiology recommendations^5,6 we entered into transfer agreements with three nearby tertiary hospitals, who agreed that they would be willing to take our patients on a moment’s notice if we were in need of surgical support. It takes approximately 45 minutes to pull together an OR Coronary Artery Bypass Graft (CABG) staff with room set up. That is the approximate amount of time needed to transport our patients to these facilities by ambulance with paramedic and advanced-trained RN support. Within minutes, we can identify the tertiary facility available for our patients and begin arrangements for transfer. Comparing HRHS Data to Published Data Since June 2002 at HRHS, over 300 PCIs have been performed for stable angina, unstable angina/non ST segment elevation MI, or ST segment elevation MI. Cardiovascular mortality at 24 hours and 30 days for all of these patients is 0%. This absence of 30-day cardiovascular mortality includes the over 20 patients we have intervened upon with cardiogenic shock, far exceeding even the best of published outcomes.¹⁸ Recurrent myocardial infarction is 0.3% (1 patient), with MI occurring in that patient due to acute stent thrombosis as a result of abnormal pro-coagulant activity secondary to another, unrelated medical condition. One patient (0.3%) had a failed PCI that required transfer for emergent CABG. This was successfully performed without complications. Vascular complications, as defined by blood loss for any reason requiring transfusion or prolongation of hospital stay or vascular complications requiring surgical or percutaneous therapy is 1% (3 patients). Restenosis rates are The National Registry of Myocardial Infarction (NRMI) database showed 30-day mortality rates of 4.7% for acute myocardial infarction treated by PCI at hospitals without CT surgical presence and 6.8% for acute MI patients transferred to hospitals with CT surgical presence.⁹ The AIR-PAMI trial showed similar 6.8% mortality for patients transferred for PCI (though much better than those treated locally with lytics: a 10% mortality).¹⁴ The C-PORT trial showed 6.7% mortality for those treated with PCI for acute MI, regardless if performed locally at sites without surgical backup or following transfer to site with surgery backup, with post hoc analyses showing that mortality was not influenced by the presence of a CT surgical team.⁸ A publication on the Mayo Clinic’s attempt to develop a program similar to HRHS’s described a 2.6% 30-day mortality.¹² Recurrent MI in these studies consistently borders on 4% and vascular complications routinely exceed double digits. Restenosis rates in these studies are universally over 15% and length of stay following uncomplicated myocardial infarction is rarely less than three days.^19-31 HRHS also has had great success with drug-eluting stents. We use them in approximately 80% of our population. To date, we have not had any issues with known thrombosis. Conclusion HRHS has recently started providing our data to National Registry of Myocardial Infarction (NRMI), American Heart Association’s Get With The Guidelines program, CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress ADverse Outcomes with Early Implementation of the ACC/AHA Guidelines) and, most recently, to the ACC-NCDR database. The HRHS Vascular Medical Director , Jaro Mayda II, MD, brought us into the interventional world. Our Medical Director of Cardiology, Michael E. Ritchie, MD, took us to the next level of coronary intervention. We have all grown professionally and personally in the journey. It is wonderful knowing that HRHS is safely and successfully providing this life-saving service to our community. Our patients prefer to stay in the community where they can be nearer to their support network of family and friends. There are patients that we believe may not have survived the transfer to a tertiary facility had their coronary artery not been opened at our facility prior to transfer. Being able to provide this service has established and enhanced Howard Regional Health System as a center of excellence for Cardiovascular Services. For more information, please contact: Sheree Schroeder RN, BSN, RDCS, FASE, Executive Director Cardiovascular Service Line Howard Regional Health System, Kokomo, IN 46902 (765) 453-8618, sschroed@howardregional.org Read more about the cardiac cath lab at Howard Regional Health System here: About Howard Regional Heath System's Cardiac Laboratories...

<small>1. Davies RF, Goldberg AD, Forman S, et al. Asymptomatic Cardiac Ischemia Pilot (ACIP) study two-year follow-up: outcomes of patients randomized to initial strategies of medical therapy versus revascularization. Circulation. 1997;95:2037-2043.</small><p>2. Hueb WA, Soared PR, Almeida DO, et al. Five-year follow-up of the medicine, angioplasty, or surgery study (MASS): a prospective, randomized trial of medical therapy, balloon angioplasty, or bypass surgery for single proximal left anterior descending coronary artery stenosis. Circulation. 1999;100:II107-II113. </p><p>3. Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial. RITA-2 trial participants. Lancet. 1997;350:461-468. </p><p>4. Stone GW, Grines CL, et al. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. N Engl J Med. 2002;346:957-966. </p><p>5. Van de Werf F, Baim DS. Reperfusion for ST-Segment Elevation Myocardial Infarction. An Overview of Current Treatment Options. Circulation. 2002;105:2813. </p><p>6. The ACC/AHA Task Force on Practice Guidelines. 2001 Update: ACC/AHA guidelines for percutaneous coronary intervention (Revision of the 1993 guidelines)-Executive Summary. A report from the American College of Cardiology/American Heart Association task force on practice guidelines. (Committee to Revise the 1993 Guidelines for Percutaneous Transluminal Coronary Angioplasty). J Am Coll Cardiol. 2001;37:2215-2238. </p><p>7. Gibbons RJ, Chatterjee K, Daley J, et al. ACC/AHA/ACP-ASIM guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients With Chronic Stable Angina). J Am Coll Cardiol. 1999;33:2092-2197. </p><p>8. Aversano T, Aversano LT, et al. 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;287:1943-51. </p><p>9. Sanborn TA, Jacobs AK, Frederick PD, Every NR, French WJ. Nationwide Emergent Coronary Interventions (Primary PCI) in Patients with acute myocardial infarction in hospitals with and without on-site cardiac surgery. A report from the national registry of myocardial infarction (NRMI). Circulation. 106 (Supplement II):(11): 333, 2002. </p><p>10. Weaver WD, Litwin PE, Martin JS. Use of direct angioplasty for treatment of patients with acute myocardial infarction in hospitals with and without on-site cardiac surgery. The Myocardial Infarction, Triage, and Intervention Project Investigators. Circulation. 1993;88:2067-2075. </p><p>11. Wharton TP Jr, McNamara NS, et al. Primary angioplasty for the treatment of acute myocardial infarction: experience at two community hospitals without cardiac surgery. J Am Coll Cardiol. 1999;33:1257-1265. </p><p>12. Ting HH, Garratt KN, et al. Low-risk percutaneous coronary interventions without on-site cardiac surgery: two years' observational experience and follow-up. Am Heart J. 2003;145:278-284. </p><p>13. Andersen HR, Nielsen TT, et al. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003;349:733-742. </p><p>14. Grines CL, Westerhausen DR Jr, et al. A randomized trial of transfer for primary angioplasty versus on-site thrombolysis in patients with high-risk myocardial infarction: the Air Primary Angioplasty in Myocardial Infarction study. J Am Coll Cardiol. 2002;39:1713-1719. </p><p>15. Weaver WD, Simes RJ, Betriu A, et al. Comparison of primary coronary angioplasty and intravenous thrombolytic therapy for acute myocardial infarction. A quantitative review. JAMA. 1997; 278:2093-2098. </p><p>16. Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003;361:13-20. </p><p>17. Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction. Lancet. 2001;358:605-613. </p><p>18. Hochman JS, Sleeper LA, Webb JG, for the SHOCK Investigators. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. N Engl J Med. 1999;341:625-634. </p><p>19. The EPISTENT Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa in blockade. Lancet. 1998;352:87-92. </p><p>20. Grimes CL, Marsalese DL, Brodie B, et al. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998; 31:967-972. </p><p>21. Newby KL, Eisenstein EL, Califf RM, et al. Cost-effectiveness of early discharge after acute myocardial infarction after uncomplicated myocardial infarction. N Engl J Med. 2000; 342:749-785. </p><p>22. Antman EM, Kuntz KM. The length of the hospital stay after myocardial infarction. N Engl J Med. 200;342:808-810. </p><p>23. Peterson ED, Shaw LJ, Califf RM. Risk stratification after myocardial infarction. Ann Intern Med. 1997;126:561-582. </p><p>24. Fischman DL, Leon MB, Baim DS, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994;331:496-501. </p><p>25. Serruys PW, de Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994;331:489-495. </p><p>26. Kastrati A, Schomig A, Dirschinger J, et al. A randomized trial comparing stenting with balloon angioplasty in small vessels in patients with symptomatic coronary artery disease. ISAR-SMART Study Investigators. Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries. Circulation. 2000;102:2593-2598. </p><p>27. Yokoi H, Daida H, Kuwabara Y, et al. Effectiveness of an antioxidant in preventing restenosis after percutaneous transluminal coronary angioplasty: the Probucol Angioplasty Restenosis Trial. J Am Coll Cardiol. 1997;30:855-862. </p><p>28. Friedman HZ, Cragg DR, Glazier SM, et al. Randomized prospective evaluation of prolonged versus abbreviated intravenous heparin therapy after coronary angioplasty. J Am Coll Cardiol. 1994;24:1214-1219. </p><p>29. Cohen M, Demers C, Gurfinkel E, et al. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and Safety of Enosaparin in Non-Q-Wave Coronary Events Study Group. N Engl J Med. 1997;337:447-452. </p><p>30. Brener SJ, Barr LA, et al. Randomized, placebo-controlled trial of platelet glycoprotein IIb/IIIa blockade with primary angioplasty for acute myocardial infarction. ReoPro and Primary PTCA Organization and Randomized Trial (RAPPORT) Investigators. Circulation. 1998;98:734-741. </p><p>31. Fox KA, Poole-Wilson PA, et al. Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction: the British Heart Foundation RITA 3 randomised trial. Randomized Intervention Trial of unstable Angina. Lancet. 2002;360:743-751.</p>