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(Circulation. 2006;113:1159-1161.)
© 2006 American Heart Association, Inc.
Editorial |
From Section of Cardiology, Boston Medical Center, Boston, Mass.
Correspondence to Alice K. Jacobs, MD, Section of Cardiology, Boston Medical Center, 88 E Newton St, Boston, MA 02118. E-mail alice.jacobs{at}bmc.org
Key Words: Editorials myocardial infarction reperfusion
The overwhelming enthusiasm for primary percutaneous coronary intervention (PCI) as the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI) is fueled by evidence from randomized trials suggesting that PCI is superior to fibrinolytic therapy alone in reducing the rates of death, reinfarction, intracranial bleeding, reocclusion of the infarct artery, and recurrent ischemia even if performed when transport to a hospital with PCI capability is required.1,2 In the United States, this enthusiasm is tempered by the reality that approximately one third of patients do not receive any reperfusion therapy despite its availability and the absence of any contraindication, and that only a minority (18%) of patients with STEMI receive primary PCI.3 Furthermore, of those patients treated with primary PCI, fewer than 40% undergo reperfusion of the infarct artery within 90 minutes after arrival to the initial hospital,4 a goal advocated by the American College of Cardiology/American Heart Association guidelines.5 Of the nearly 5000 acute-care hospitals in this country, &2200 have catheterization laboratories. Among those, only 1200 are capable of performing PCI, which makes it challenging for several states to provide primary PCI to selected patients in a timely fashion.6 In fact, several regions are beginning to organize and monitor both transfer and triage protocols for patients with STEMI.7,8
Article p 1189
In the hope of increasing the availability of timely primary PCI to a greater number of patients, a debate has ensued over the concept of regionalized care for patients with STEMI.9,10 Proponents of regionalization cite the reduction in mortality and subsequent events when primary PCI is performed at experienced centers in an expeditious fashion1; the reported relationship between procedural volume and outcomes in the setting of STEMI, such that patients treated at higher-volume hospitals by higher-volume operators experience a lower in-hospital mortality rate after the procedure11; and the potential for improved quality of care at designated centers with dedicated facilities. However, the lack of consensus on an operational definition of regionalization, the discordance between population density and the distribution of heart disease mortality across the United States,12 and the absence of data suggesting that transport to a PCI-capable hospital is feasible in terms of distance and time have limited the promulgation of regional centers of care for STEMI patients.
With these issues in mind, Nallamothu and colleagues13 performed a clever cross-sectional study using hospital-level data from the American Hospital Association Annual Survey and tract-level data on adults aged 18 years or older from the 2000 US Census. Specifically, the proportion of the adult population who lived within 60 minutes of a PCI-capable hospital and who had additional transport times within 30 minutes if directly referred to a PCI hospital instead of a closer hospital without PCI capability were evaluated. They found that median times and distances to the closest PCI hospital were 11.4 minutes and 8.0 miles, respectively. Nearly 80% of the adult population lived within 60 minutes (which included time for emergency medical system [EMS] activation, ambulance arrival, early treatment and stabilization, and driving times) of a PCI hospital. Among those with hospitals without PCI as their closest facility, nearly three quarters lived in areas where the additional time required to arrive at a PCI hospital was less than 30 minutes. Importantly, the estimates varied across regions and among urban, suburban, and rural Census tracts.
Limitations inherent to the type of analyses performedincluding the indirect determination of the number of hospitals with PCI capability; the impact of weather and traffic conditions on driving times; whether EMS activation time or time spent on the scene differed in urban, suburban, and rural areas; and the absence of data suggesting that heart disease is evenly distributed across regionsdo not serve to undermine the overall importance of the results. Indeed, this "feasibility" study, modeled after similar studies evaluating access to trauma and PCI centers,14,15 serves as the first step in assessing the ability to provide timely access to primary PCI to more patients in the United States.
Although proximity to an existing PCI-capable hospital for the majority of the population lends credence to the enthusiasm for regionalization of STEMI care, physical time and distance to PCI is only 1 component of an integrated system of care for STEMI patients. Numerous potential barriers to the implementation of regional STEMI centers currently exist. First, patients experiencing a myocardial infarction must recognize their symptoms and promptly contact the medical system. To date, public education campaigns initiated to reduce the delay between the onset of symptoms and presentation to a hospital have not yet demonstrated an improvement in rapid access to care.16 Second, rapid transport to a PCI-capable facility is limited by a minority (10%) of EMS systems with the ability to perform 12-lead ECGs in the field17 and the mandate in many states to deliver the patient to the nearest hospital, even when the patient may not be a candidate for fibrinolytic therapy and the closest facility does not provide primary PCI. Furthermore, if a patient in a facility without PCI capability requires transfer for primary PCI, it is often necessary to join a queue for the next available ambulance, a practice that leads to prolonged delay. Third, the decision process on arrival to the hospital may be delayed, particularly in patients with comorbid conditions, the absence of chest pain, and late presentation after the onset of symptoms, as well as in PCI-capable facilities where primary PCI is not routinely available. In fact, in 1 large-scale registry, nearly 50% of patients presenting to PCI-capable hospitals were treated with fibrinolytic therapy.18 Finally, there is the requisite time to implement the PCI strategy and to assemble the catheterization laboratory team, and this takes even longer during off-hours. It has been reported that STEMI patients presenting for primary PCI during evenings and weekends have higher (adjusted) in-hospital mortality than patients who arrived during the day on weekdays.19
In addition to the 4 system components noted above that limit access to expeditious reperfusion with primary PCI, it is anticipated that additional problems will be encountered in creating coordinated systems of care. Transfer times from a facility without PCI to a PCI-capable hospital are currently unacceptably long.4 Emergency departments in both teaching and nonteaching facilities are frequently on diversion, meaning patients who initially are targeted to be brought to their facility must be diverted to another hospital. Indeed, a survey performed in 2002 reported that more than 50% of urban hospitals reported time on diversion, citing lack of staff and hospital beds.20 Finally, financial disincentives for hospitals without PCI capability associated with the transfer or triage of STEMI patients to PCI hospitals exist, and the loss of STEMI (and potentially other cardiac) patients may limit their viability and therefore their ability to provide access to other medical services for the local community.
Given these issues and barriers, we are faced with the challenge of providing optimal primary PCI to the nearly 400 000 patients who experience STEMI each year in the United States. Certainly, the analysis by Nallamothu and colleagues13 presented herein supports the feasibility of prehospital triage protocols, the first step along the road to regional PCI centers for the majority of the population. Several pilot programs7,8 suggest that triage and transfer to PCI centers can be accomplished in an expeditious fashion. In the United States, the systems approach to the delivery of trauma care, although not without its challenges, is widely accepted as an effective strategy for reducing death due to injury.14 Interestingly, the existing 1200 catheterization laboratories with PCI capability are analogous to the 703 (level I, II, or III) trauma centers throughout the country.14 Furthermore, facilitated PCI (combined fibrinolytic therapy with or without platelet inhibitors in addition to PCI), a strategy under investigation, may allow additional time, particularly in rural areas.
It has been proposed that criteria be established to designate regional centers in urban areas that can perform primary PCI 24 hours per day, 7 days per week and that have adequate volume and expertise; to standardize EMS transfer and triage protocols; and to institute a quality-assurance registry. In rural areas, a limited number of catheterization laboratories could be converted to regional centers based on need, while continuing to evaluate the strategy of facilitated PCI. It will be critical to evaluate the safety of transporting patients with STEMI longer distances, as well as the impact of the added travel time on the mortality benefit of primary PCI. This will be particularly important in rural areas and for the 43.6 million adults who live outside a 60-minute prehospital time period to arrive at a PCI facility, as well as for the 25% of the population living in areas where the additional time required to reach a PCI hospital exceeds 30 minutes.
The totality of evidence strongly favors primary PCI as the preferred reperfusion strategy for the majority of STEMI patients, especially for those patients at high risk (anterior myocardial infarction, cardiogenic shock), those who present 2 to 3 hours after symptom onset, and those in whom fibrinolysis is contraindicated. Therefore, we must continue to explore the safety, efficacy, and feasibility of regional systems of care. It will be necessary to bring together the stakeholders (patients, physicians, healthcare providers, community hospitals, tertiary centers, EMS, and payers) in the care of STEMI patients to understand the gaps between the current and ideal systems of care, and the American Heart Association is leading an initiative to do so. Certainly, it will be necessary to balance financial disincentives for hospitals without PCI capability with incentives to treat (according to evidence-based American College of Cardiology/American Heart Association guidelines) and transfer STEMI patients and with the savings to the global healthcare system, not only in dollars but in the number of lives saved. Only then will we be able to translate the benefits of primary PCI into clinical practice.
| Acknowledgments |
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None.
| Footnotes |
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| References |
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