Tardy Pardee: Moving Medical Effectiveness to the Forefront*
James G. Jollis, MD, FACC2,*
Duke University, Durham, North Carolina.
Ninety years ago, the New York cardiologist Harold Ensign Bennett Pardee first gave rise to the entity of ST-segment elevation myocardial infarction (STEMI) in his description of the electrocardiographic changes of acute coronary occlusion as the takeoff of the T-wave from the descending R-wave (1. This ability to recognize acute coronary occlusion became most important 20 years ago, when large randomized trials demonstrated a survival benefit with the timely administration of fibrinolytic therapy (2,3. The relevance of these 2 discoveries goes far beyond historical interest, as we continue to be challenged in applying medical diagnostics and therapeutics that are decades old. Registries indicate that roughly one-half of STEMI patients do not undergo electrocardiogram (ECG) or reperfusion in a timely fashion and that 30% of eligible patients do not receive any reperfusion treatment at all. Classic system failure scenarios include the patient with chest pain waiting to register in a crowded emergency department, and delays in primary angioplasty while the emergency physician attempts to identify which cardiology group "owns" the patient and its preferred anticoagulant regimen. What has been missing from medical science is the fundamental recognition that the greatest improvement in patient outcomes will result from the establishment of systems to routinely extend advances to every eligible patient. Efforts to advance medicine have traditionally concentrated on 3 phases: 1) basic science discovery, 2) translation to human applications, and 3) proof of efficacy in randomized clinical trials. The enormous lag in our application of medical discoveries to all patients will only be reduced with sustained efforts directed toward the fourth phase of medical therapeutics, systematic implementation. The difficulty of this final phase should not be underestimated, as success requires the transformation of thousands of medical facilities and the coordinated support of their associated personnel.
In this issue of JACC: Cardiovascular Interventions, Krumholz et al. (4 describe the methodology underlying a major effort by the American College of Cardiology (ACC) to fundamentally advance the treatment of STEMI through systematic improvement in the application of existing technologies. This intervention focused on improving coronary reperfusion is likely to have health benefits on a similar scale to clinical trials demonstrating improved survival, and the detailed methodological description contained in this report serves as a valuable model by which others may reach success in this "final stage" of medical therapeutics.
Of the 2 fundamental steps in reperfusing acutely obstructed coronary arteries, diagnosis and treatment, the Door-to-Balloon (D2B) Alliance primarily focuses on the latter step. Starting in January 2006, the D2B Alliance was joined by 900 hospitals with a commitment to improve coronary reperfusion according to the goal of "balloon inflation" within 90 min of hospital arrival for 75% of patients. Among numerous systems improvements required to expedite care, the project selected 5 structural interventions, including emergency medicine physician activation of the catheterization laboratory with a single call, laboratory availability within 20 to 30 min, prompt feedback, formation of ST-segment elevation teams, and hospital administration support. The intervention was further augmented by a number of tools, including the establishment of internet-based forums and the formation of a large alliance of health care organizations and providers beyond cardiology.
Krumholz et al. (4 provide a detailed, step-by-step description of how one of the most effective professional organizations in cardiac care goes about transforming the health system during a 2-year course to routinely provide rapid coronary reperfusion to every eligible patient. The work describes important components of the planning, enrollment, intervention, and evaluation stages of the project, each focused on deriving maximal effectiveness. For example, in selecting recommended processes at hospitals that offer percutaneous coronary intervention (PCI), the initiative took a pragmatic stance and chose 5 recommendations likely to be met with universal support. In this initial phase, the alliance avoided recommendations likely to pose logistical or political obstacles, including attending cardiologist always on-site, laboratory availability within 20 min, and laboratory activation by in-the-field electrocardiography. The tools used to bolster enrollment included media attention surrounding the public announcement and the encouragement of hospital enrollment by state chapters and local leaders. To make the intervention most effective, each hospital was provided with customized recommendations based on enrollment surveys, and the effort was supported by internet-based education.
The focus of the D2B Alliance on treatment rather than diagnosis also reflects the wisdom of the group. Highly effective catheterization laboratory systems are a requisite to approaching emergency department and emergency medical service personnel regarding rapid diagnosis. Once an STEMI is diagnosed, primary angioplasty must be available in a consistent and timely fashion. Even if hospitals and physicians chose to rely on fibrinolysis as the main approach to coronary reperfusion, the subgroups of patients at risk for bleeding or who do not reperfuse with lysis, and those in shock or older than 75 years of age must still have expedient access to primary angioplasty. If emergency physicians and medical technicians attempt to activate a cardiac catheterization laboratory and that laboratory is not rapidly available, any potential system for coronary reperfusion will break down, lacking credibility and support. Thus, it is imperative that PCI hospitals implement the recommendations of the D2B Alliance as a requirement for participation in local or regional ST-segment elevation reperfusion systems. The recommendation of "having the physician activate the catheterization laboratory with a single call" is of particular importance. On the basis of the experience organizing a 65-hospital STEMI system, Jollis et al. (5 found that, to effectively implement single call activation, patients must be immediately accepted for PCI regardless of bed availability. The ideal center should have a single interventional cardiologist on call for all cases in which a specific cardiologist cannot be readily identified or available. Furthermore, physicians at the PCI hospital should reach a consensus regarding a common pre-procedure medical regimen, ideally one that is simple for emergency departments to implement and transport crews to maintain.
Following the D2B Alliance, Krumholz et al. (4 note that the next target of this well organized and formidable alliance involves an expansion to all hospitals. Currently, approximately 1,400 of 5,000 acute care hospitals in the U.S. perform PCI. To benefit the greatest number of patients, reperfusion systems, particularly those involving primary angioplasty, need to be expanded to every hospital. There are currently 2 approaches by national organizations to achieving this goal. The ACC and others recommend that current guidelines set the standards, providing for either primary angioplasty or fibrinolysis after taking into account available resources, myocardial infarction and bleeding risk, and time of onset and time to treatment. The American Heart Association has established "Mission Lifeline," a program designed to provide primary angioplasty to all patients whenever possible, categorizing hospitals as either "STEMI receiving" or "STEMI referring" according to the availability of primary angioplasty. The pragmatic design of the former approach is most likely to be successful with existing healthcare resources. In the U.S., significant barriers to a universal system of STEMI transfer exist, including deficiencies in emergency transport, hospital overcrowding, reimbursement disincentives, and a lack of information systems by which to track STEMI care and outcomes between hospitals and EMS transport. According to the most recent registry data, the median time of 3 h from first door to device for patients transferred between hospitals for primary angioplasty indicates that many fundamental improvements like those supported by the D2B Alliance need to be implemented before primary angioplasty can be considered the sole approach to coronary reperfusion. To improve transfer times, emergency department processes at the STEMI-referring hospitals need to be streamlined. Such improvements should include forgoing delays in copying charts and completing forms, giving Emergency Medical Services (EMS) priority to patients requiring transfer for PCI, and leaving patients likely to be transferred "on the stretcher" of the initial EMS unit. An intervention that is guideline recommended but operationally and politically challenging involves diversion of EMS patients from the closest non-PCI hospital to a PCI-capable hospital, completely avoiding delays of the first hospital (6.
Ten years before Pardee recognized ST-segment elevation, Willem Einthoven’s (7 initial electrocardiography machine was termed "telecardiography," as the tracings were obtained in the hospital and transmitted through special telephone lines to a galvanometer 1 mile away in the physiology laboratory. The challenges of diagnosing acute coronary occlusion today were foreshadowed in this early experience. "Upstream" diagnostic interventions have the greatest potential to improve timely coronary reperfusion for all patients. Thus, the ACC and others are expanding their scope to involve emergency medical technicians and emergency department triage areas in rapid diagnosis. For the EMS, interventions should focus on providing adequate medical dispatch and ECG equipment to respond to every potential acute coronary scene, extending to basic and intermediate level emergency medical technicians the ability to perform ECGs, and enabling paramedics to activate reperfusion systems from the field. For the emergency department, early diagnostic interventions should include "nurse first" evaluation of chest pain patients and the provision of dedicated space and protocols to perform and interpret ECGs in a timely fashion.
The final critical step in any medical intervention involves measurement. Tracking patients, processes of care, and outcomes allows for assessment of the intervention, and more importantly, data feedback to participants serves as a strong impetus for change. The D2B Alliance will perform these measurements through a number of existing data sources including follow-up hospital surveys, the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) registry, and publicly reported hospital data from the Center for Medicare and Medicaid Services (CMS) and the Hospital Quality Alliance. Some significant gaps in data remain to be closed. First, as systems move toward interhospital transfer, an existing "blind spot" needs to be illuminated. Patients who die in transfer are not reliably identified by any existing myocardial infarction registry. In building STEMI transfer systems, such deaths must be identified to ensure transfer strategies in general practice results in the best outcomes. A particularly concerning group involves cardiogenic shock. Patients in shock were excluded from most randomized trials of STEMI transfer (8,9. However, the guidelines continue to favor PCI over fibrinolysis for patients in shock, and thus systems that routinely transfer shock patients should carefully track deaths. A readily available method to identify deaths in transfer involves linking EMS data to hospital data, a step that would greatly enhance the ability of hospitals and EMS to understand and improve care. Given concerns about patient privacy, such a practical linkage may require support from federal or state statute.
Another significant data gap involves patients who are "transferred in" from another hospital for coronary reperfusion, currently excluded from CMS and Hospital Quality Alliance data. More than one-half of patients treated at regional PCI hospitals are transferred in, and given the national average of 3 h from first door to intervention, this group should be included in routine STEMI measures. The new requirement of CMS for reporting "median time to transfer for primary PCI" will substantially increase attention and measurement of these patients (10. Probably the most critical measurement issues involve the transition of the National Registry of Myocardial Infarction (NRMI), closed in 2006, to the ACTION registry. A national registry with broad participation and support from hospitals and physicians such as ACTION will provide the greatest opportunity of assuring prompt coronary reperfusion for all patients. In the conversion of NRMI to ACTION, key NRMI data elements germane to STEMI care from symptom onset to reperfusion must be maintained and further developed. With comprehensive data supporting major interventions like the D2B Alliance, T waves will promptly descend from the R-wave to baseline and the full potential of medical therapeutics will be made available to all patients.
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Footnotes
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* Editorials published in the JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology. 
2 Dr. Jollis has received grant support from Blue Cross Blue Shield of North Carolina, Genentech, and the Kate B. Reynolds Foundation.
* Reprint requests and correspondence: Dr. James G. Jollis, Duke University Medical Center, Box 3254, Durham, North Carolina 27710. (Email: james.jollis{at}duke.edu).
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- Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto Miocardico (GISSI) Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction Lancet 1986;330:397-402.
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- Krumholz HM, Bradley EH, Nallamothu BM, et al. A campaign to improve the timeliness of primary percutaneous coronary intervention: door-to-balloon: an alliance for quality J Am Coll Cardiol Intv 2008;1:97-104.[Abstract/Free Full Text]
- Jollis JG, Roettig ML, Aluko AO, et al. Implementation of a statewide system for coronary reperfusion for ST-segment elevation myocardial infarction JAMA 2007;298:2371-2380.[Abstract/Free Full Text]
- Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction) J Am Coll Cardiol 2004;44:671-719.[Free Full Text]
- Einthoven W. Le télécardiogramme Arch Int Physiol 1906;4:132-164.
- Grines CL, Westerhausen Jr. DR, Grines LL, 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.[Abstract/Free Full Text]
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Related articles in JACC Interventions:
- A Campaign to Improve the Timeliness of Primary Percutaneous Coronary Intervention: Door-to-Balloon: An Alliance for Quality
- Harlan M. Krumholz, Elizabeth H. Bradley, Brahmajee K. Nallamothu, Henry H. Ting, Wayne B. Batchelor, Eva Kline-Rogers, Amy F. Stern, Jason R. Byrd, and John E. Brush, Jr
JACC Interventions 2008 1: 97-104.
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