Regionalization of Care for Acute Ischemic Heart Disease
2003; Lippincott Williams & Wilkins; Volume: 107; Issue: 11 Linguagem: Inglês
10.1161/01.cir.0000063680.45780.a0
ISSN1524-4539
AutoresEric J. Topol, Dean J. Kereiakes,
Tópico(s)Cardiac Imaging and Diagnostics
ResumoHomeCirculationVol. 107, No. 11Regionalization of Care for Acute Ischemic Heart Disease Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUBRegionalization of Care for Acute Ischemic Heart DiseaseA Call for Specialized Centers Eric J. Topol and Dean J. Kereiakes Eric J. TopolEric J. Topol From the Department of Cardiovascular Medicine (E.J.T.), Cleveland Clinic Foundation, Cleveland, Ohio, and the Lindner Center/Ohio Heart Health Center (D.J.K.), Cincinnati. and Dean J. KereiakesDean J. Kereiakes From the Department of Cardiovascular Medicine (E.J.T.), Cleveland Clinic Foundation, Cleveland, Ohio, and the Lindner Center/Ohio Heart Health Center (D.J.K.), Cincinnati. Originally published25 Mar 2003https://doi.org/10.1161/01.CIR.0000063680.45780.A0Circulation. 2003;107:1463–1466The past 20 years have witnessed a dramatic evolution in medical care for patients with acute coronary syndromes (ACS). As the vast majority of hospitals lack tertiary invasive cardiac facilities, most therapeutic strategies for acute myocardial infarction have focused on pharmacological reperfusion with intravenous fibrinolytics. In addition, antiplatelet and anticoagulant therapies have gained evidence-based support for early use in patients with non–ST-segment elevation myocardial infarction. Despite the benefit derived from fibrinolysis in randomized clinical trials, many community hospitals in the United States have sought to implement primary angioplasty infarct reperfusion programs in the absence of elective provisions for percutaneous coronary intervention (PCI). In the context of new data from trials of infarct reperfusion, we should at this time examine the issues that have prompted hospitals of limited resources to provide tertiary cardiovascular services and the evidence-based provisions that must be placed on such strategies.Unquestionably, the rapid restoration of normal coronary blood flow via pharmacological or mechanical recanalization of an occluded infarct-related coronary artery limits myocardial necrosis and reduces mortality. Only recently have the time-dependent efficacies for both mechanical and pharmacological reperfusion strategies been closely scrutinized and have relative differences between these treatment modalities become evident. Although the time from infarct symptom onset to initiation of fibrinolytic reperfusion is a critical determinant for successful recanalization as well as survival, the relationship of infarct duration before PCI recanalization with procedural success or survival is less direct.1 Remarkably, few patients receive PCI within 2 hours of symptom onset, even in highly experienced centers. Indeed, in the stent Primary Angioplasty in Myocardial Infarction Study (PAMI) trial only 5.9% of all patients were reperfused within 2 hours.2 Despite time delays incurred during provision of PCI, relative benefits accompany this therapy, including enhanced survival in a meta-analysis of randomized trials of PCI versus lysis.3 The authors concluded: "Based on outcomes at hospital discharge and 30 days, primary angioplasty appears to be superior to thrombolytic therapy for treatment of patients with acute myocardial infarction," with an important proviso, "that success rates for angioplasty are as good as those achieved in these trials. Data evaluating longer term outcomes, operator experience, and time delay before treatment are needed before primary angioplasty can be universally recommended as a preferred treatment."These data prompted the Cardiovascular Patient Outcomes Research Team (C-PORT) pilot trial, which tested the feasibility of performing PCI for acute myocardial infarction in smaller community hospitals that did not perform elective PCI or have on-site coronary bypass facilities.4 C-PORT involved 11 participating community hospitals in Maryland and Massachusetts and randomly assigned 451 patients presenting with ST-segment elevation acute myocardial infarction to receive either PCI or lysis treatment "on site." Extensive inservice training for the hospital staff, consignment inventory of angioplasty supplies, and performance of the PCI procedures by relatively high-volume operators from neighboring communities were notable features. Those patients randomly assigned to PCI experienced a lower incidence of death, reinfarction or stroke at both 30 days and 6 months after treatment. Although the results of this pilot experience have enticed many community hospitals to follow suit in an attempt to recreate the C-PORT experience, extrapolation of these results to community hospital practice in the United States is questionable. In retrospect, the inclusion of a third randomized arm (transport to a high-volume center for PCI) as part of C-PORT would have been a very useful comparator for on-site community hospital PCI.The importance of such a comparison looms large in the context of both the logistic considerations for PCI program proliferation in community hospitals and the results of three recent randomized trials that have challenged the use of on-site fibrinolysis when compared with immediate transport to a regional center for PCI. These trials, which enrolled patients with ST-segment elevation myocardial infarction (Figure 1), are particularly striking for the consistency and extent of clinical benefit derived by transporting the patient to a regional center for catheter-based reperfusion as compared with the on-site (community hospital) initiation of fibrinolytic therapy. In the DANish multicenter randomized study on thrombolytic therapy versus coronary angioplasty in Acute Myocardial Infarction-2 (DANAMI-2), the PRimary Angioplasty in AMI patients from General community hospitals transported to PTCA Units versus Emergency thrombolysis trial (PRAGUE-2), and A randomIzed tRial of transfer for Primary Angioplasty versus on-site thrombolysis in patients with high-risk Myocardial Infarction (Air PAMI) trials,5–8 patients randomly assigned to fibrinolytic therapy experienced a 13% to 15% event rate for the composite clinical end point of death, recurrent myocardial infarction, or stroke. In all three of these trials, the randomized comparative strategy of patient transport to a specialized regional center for emergency angiography and coronary intervention yielded a composite event rate of ≈8.0% and thus, a consistent 40% reduction in adverse outcomes, with an almost identical intertrial point estimate. Furthermore, for patients who present with non–ST-segment elevation ACS (unstable angina, non–Q-wave myocardial infarction) 3 recent randomized trials compare an early invasive strategy of coronary angiography and revascularization with a more "conservative" approach employing medical therapy. In all 3 trials, Fragmin and Fast Revascularization during Instability in Coronary Artery Disease (FRISC II), Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy—Thrombosis in Myocardial Infarction (TACTICS TIMI-18), and the Randomized Interventional Trial of Unstable Angina (RITA 3),9–11 the invasive strategy demonstrated superiority for reduction in the composite end point of death, recurrent infarction, or severe refractory angina. In TACTICS TIMI-18, particular benefit accompanied invasive therapy for patients at high risk as reflected by an elevated TIMI risk score, serum troponin I, or C-reactive protein. In aggregate, the results from recent trials of both ST-segment elevation myocardial infarction and non–ST-segment elevation ACS strongly support a revamped healthcare system to raise the bar for acute care in ischemic heart disease to a new standard. This situation is analogous to the emergency trauma system that currently exists in the United States that comprises regional centers of excellence to which patients who have experienced significant trauma are preferentially transported, and at which experienced staff are available on a continuous basis. For such a transformation in our process of acute care for ischemic heart disease to proceed, what barriers exist? Download figureDownload PowerPointFigure 1. Odds ratio and 95% confidence intervals for the composite end point of death, reinfarction, and stroke at 30 days for the fibrinolytic (Lytic) and transport plus coronary intervention arms in 3 randomized trials. Data from references 5 to 7. DANAMI indicates the DANish multicenter randomized study on thrombolytic therapy versus coronary angioplasty in Acute Myocardial Infarction-2; PRAGUE-2, the PRimary Angioplasty in AMI patients from General community hospitals transported to PTCA Units versus Emergency thrombolysis trial; and Air PAMI, A randomIzed tRial of transfer for Primary Angioplasty versus on-site thrombolysis in patients with high-risk Myocardial Infarction.First, key practical issues such as time and transport must be acknowledged. In Denmark, where the DANAMI-2 trial was conducted in 5 specialized centers and 22 referring community hospitals that serve more than 3 million persons (≈60% of Denmark's population), the time delay for patient transport from community hospital to regional center for PCI (compared with time required to initiate on-site fibrinolysis) was only 10 minutes.5 Similarly, in the Czech Republic where the PRAGUE-2 trial was conducted country-wide, the relative time delay for transport and execution of PCI reperfusion was only 30 minutes (277 minutes for PCI versus 245 minutes for fibrinolysis).6 However, in the Air PAMI trial, in which the average distance between community and regional hospital was 32 miles, the time delay incurred by transport was 43 minutes.7 Unfortunately, time differences to coronary reperfusion between transport for PCI versus local thrombolysis (relief of chest pain or resolution of ST-segment elevation) are not discernible from these trials. As noted previously, although the time dependency of catheter-based reperfusion is substantially less than for pharmacological reperfusion, particularly for those patients who present beyond 3 hours of symptom onset, there is no reason to accept appreciable intrinsic delays in reperfusion therapy. Indeed, the time from hospital presentation to balloon-catheter–mediated reperfusion (door-to-balloon time) is directly related to mortality after PCI for myocardial infarction, and door-to-balloon times of 48 primary procedures yearly had the largest gradient for relative benefit of PCI over fibrinolytic therapy.17 In an editorial comment on this observation, Jollis and Romano stated "these data suggest that percutaneous interventions including primary angioplasty generally should not be conducted in low-volume hospitals unless there are substantial overriding concerns about geographic or socioeconomic access."18 We agree and would further extend this premise: Even the most experienced sites and operators require continuous quality assurance, surveillance of door-to-balloon times, regularly scheduled morbidity and mortality conferences, as well as rigorous standards for postintervention medical therapy and risk factor modification. The need to assure true 24/7 coverage without lapse in responsiveness is emphasized by recent data from the NRMI 2, 3 registries that the ability of hospital staff and physicians to respond for PCI (door-to-balloon time) was dependent on hospital time of arrival and was <2.2 hours only between 8 AM and 5 PM14Third, regional centers should have state-of-the-art equipment with high-quality digital radiographic imaging, hemodynamic monitoring systems, and a full inventory of guidewires, guiding and balloon catheters, and stent sizes. Intra-aortic balloon counterpulsation devices, as well as a staff trained to operate and troubleshoot this equipment, are necessary. Ideally, regional centers should have access to new technologies designed to limit myocardial injury and enhance functional recovery. Adjunctive novel pharmacotherapies or catheter-based technologies for distal atherothrombotic embolization protection are not likely to be employed by low-volume operators at community hospitals but instead should be the purview of regional centers. It remains unclear whether "facilitated" PCI with fibrinolytic therapy given as an early adjunct will be an advantage over current therapy, and trials are in progress to address this critical question.19The time has come for a transformation in the care of patients presenting with acute myocardial infarction, which requires the establishment of centers of excellence. A mandate should come from both government and private healthcare providers. The number of deaths in the United States from myocardial infarction exceeds (7-fold) that for all-cause trauma in the general population and is more than 20-fold higher in persons ≥65 years of age (Figure 2).20 A specialized center approach for trauma has already been validated in the United States for improving clinical outcomes.21,22 The lack of specialized centers for acute ischemic heart disease is not commensurate with the magnitude of this public health problem. Indeed, such a system is now validated in both Denmark and the Czech Republic.5,6 Although a considerable investment of resources would be required, the return on investment should be a reduction in death, reinfarction, and stroke for patients with acute myocardial infarction. With myocardial infarction representing the most common cause of death and disability in our society today, the time for change is past due. Download figureDownload PowerPointFigure 2. Deaths in the United States in 1999 by cause. A, Total deaths for the entire population. B, Total deaths for people ≥65 years of age. Data from reference 20.The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.FootnotesCorrespondence to Dean J. Kereiakes, MD, Medical Director, The Lindner Center for Research and Education, 2123 Auburn Ave, Suite 424, Cincinnati, OH 45219. E-mail [email protected]References1 Zijlstra F, Patel A, Jones M, et al. Clinical characteristics and outcome of patients with early ( 4 h) presentation treated by primary coronary angioplasty or thrombolytic therapy for acute myocardial infarction. Eur Heart J. 2002; 23: 550–557.CrossrefMedlineGoogle Scholar2 Brodie BR, Stone GW, Morice MC, et al, for the Stent Primary Angioplasty in Myocardial Infarction Study Group. Importance of time to reperfusion on outcomes with primary coronary angioplasty for acute myocardial infarction (results from the Stent Primary Angioplasty in Myocardial Infarction Trial). Am J Cardiol. 2001; 88: 1085–1090.CrossrefMedlineGoogle Scholar3 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.CrossrefMedlineGoogle Scholar4 Aversano T, Aversano LT, Passamani E, et al, for 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: 1943–1951.CrossrefMedlineGoogle Scholar5 Andersen HR. Danish trial in acute myocardial infarction (DANAMI-2). Presented at: American College of Cardiology Scientific Sessions; March 20, 2002: Atlanta, Ga.Google Scholar6 Widimsky P. The PRAGUE-2 results. Presented at the European Society of Cardiology (ESC); September 1, 2002: Berlin, Germany.Google Scholar7 Grines CL, Westerhausen DR, Grines LL, et al, for the Air PAMI Study Group. 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.CrossrefMedlineGoogle Scholar8 Widimsky P, Groch L, Zelizko M, et al, for the PRAGUE Study Group Investigators. Multicentre randomized trial comparing transport to primary angioplasty vs immediate thrombolysis vs combined strategy for patients with acute myocardial infarction presenting to a community hospital without a catheterization laboratory: the PRAGUE study. Eur Heart J. 2000; 21: 823–831.CrossrefMedlineGoogle Scholar9 FRISC II Investigators. FRagmin, and fast revascularization during InStability in Coronary artery disease: Invasive compared with noninvasive treatment in unstable coronary artery disease: FRISC II prospective randomized multicenter study. Lancet. 1999; 354: 708–715.CrossrefMedlineGoogle Scholar10 Cannon CP, Weintraub WS, Demopoulos LA, et al, for the TACTICS-Thrombolysis in Myocardial Infarction 18 Investigators. Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N Engl J Med. 2001; 344: 1879–1887.CrossrefMedlineGoogle Scholar11 Fox KAA, Poole-Wilson PA, Henderson RA, et al, for the Randomized Intervention Trial of unstable Angina (RITA) investigators. Interventional versus conservative treatment for patients with unstable angina or non–ST elevation myocardial infarction: the British Heart Foundation RITA 3 randomized trial. Lancet. 2002; 360: 743–751.CrossrefMedlineGoogle Scholar12 Berger PB, Ellis SG, Holmes Jr DR, et al, for the GUSTO-II Investigators. Relationship between delay in performing direct coronary angioplasty and early clinical outcome in patients with acute myocardial infarction. Circulation. 1999; 100: 14–20.LinkGoogle Scholar13 Cannon CP, Gibson CM, Lambrew CT, et al. Relationship of symptom-onset-to-balloon time and door-to-balloon time with mortality in patients undergoing angioplasty for acute myocardial infarction. JAMA. 2000; 283: 2941–2947.CrossrefMedlineGoogle Scholar14 Angeja BG, Gibson CM, Chin R, et al, for the Participants in the National Registry of Myocardial Infarction 2–3. Predictors of door-to-balloon delay in primary angioplasty. Am J Cardiology. 2002; 89: 1156–1161.CrossrefMedlineGoogle Scholar15 Cannon CP. Primary percutaneous coronary intervention for all? JAMA. 2002; 287: 1987–1989.CrossrefMedlineGoogle Scholar16 McGrath PD, Wennberg DE, Dickens JD Jr, et al. Relation between operator and hospital volume and outcomes following percutaneous coronary interventions in the era of the coronary stent. JAMA. 2000; 284: 3139–3144.CrossrefMedlineGoogle Scholar17 Magid DJ, Calonge BN, Rumsfeld JS, et al, for the National Registry of Myocardial Infarction 2, and 3 Investigators. Relation between hospital primary angioplasty volume and mortality for patients with acute MI treated with primary angioplasty vs thrombolytic therapy. JAMA. 2000; 284: 3131–3138.CrossrefMedlineGoogle Scholar18 Jollis JG, Romano PS. Volume-outcome relationship in acute myocardial infarction: the balloon and the needle. JAMA. 2000; 284: 3169–3170.CrossrefMedlineGoogle Scholar19 Herrmann HC, Moliterno DJ, Ohman EM, et al. Facilitation of early percutaneous coronary intervention after reteplase with or without abciximab in acute myocardial infarction: results from the SPEED (GUSTO-4 Pilot) Trial. J Am Coll Cardiol. 2000; 36: 1489–1496.CrossrefMedlineGoogle Scholar20 Anderson RN. Deaths: leading causes for 1999. National Vital Statistics Report. Vol 49 no 11. Hyattsville, Md: National Center for Health Statistics. October 12, 2001.Google Scholar21 Mullins RJ, Mann NC. Population-based research assessing the effectiveness of trauma systems. J Trauma. 1999; 47: S59–S66.CrossrefMedlineGoogle Scholar22 Nathens A, Jurkovich GJ, Rivara FP, et al. Effectiveness of state trauma systems in reducing injury—related mortality: a national evaluation. 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