New Haven, CT - Although substantial progress has been made in the diagnosis and treatment of ST-segment-elevation myocardial infarction (STEMI), there are still concerns that the quality of care provided to STEMI patients falls short. Just last week, for example, a new consensus statement issued by the American Heart Association (AHA) called for improvements in the implementation and timeliness of PCI for STEMI patients [1].

Because of gaps in treatment and the difficulties implementing data from clinical trials into clinical practice, some experts believe it is time to establish a national policy for the treatment of STEMI, not unlike the coordinated system for trauma care. In a commentary published in the April 7, 2006 issue of the Journal of the American College of Cardiology, Dr Timothy Henry (Minneapolis Heart Institute Foundation, MN) and colleagues argue that the definitive treatment of trauma victims in the US has been concentrated in trauma centers with clear triage and treatment guidelines, leading to improved outcomes[2].

"With this in mind, is it time to establish national or state policies with a coordinated system for the treatment of STEMI?" ask the authors. "Should we adopt a policy of primary PCI in centers with cardiac catheterization laboratories as well as in centers within easy transfer distance?"

Is it time to establish national or state policies with a coordinated system for the treatment of STEMI?

Henry and colleagues answer these questions in the affirmative, noting that it is increasingly clear that primary PCI is the preferred approach in STEMI patients, if performed in a timely manner. To implement the guidelines and improve clinical practice, the time is now ripe for a national policy and a coordinated treatment system for the management of STEMI, they argue. Based on available data, the authors contend that a coordinated system for direct PCI would prevent six to eight events per 100 patients, affecting 35 000 patients per year.

Yet not everybody is convinced. In fact, some experts argue that although improving the treatment of STEMI is a laudable goal, the benefits of regionalizing care are not likely to be realized, and more important, such a move has the potential to cause harm [3]. In an interview with heartwire, Dr Harlan Krumholz (Yale University School of Medicine, New Haven, CT), senior author of a commentary accompanying the published views of Henry et al, said there is a lack of data supporting such sweeping changes in clinical practice and a lack of attention being paid to the practical implications of a regionalized approach to ACS care.

"There has been this surge of enthusiasm to see whether we can push the country toward STEMI regionalization," said Krumholz. "Our group has been trying to say that this is an interesting idea, it might have some merit, particularly in some parts of the country, but we have to be careful about trying to impose policies like this across the country without a clear idea of what we're trying to accomplish, how much it is going to cost, and what the potential unintended consequences might be."

The purpose of his group's paper, said Krumholz, was to explain why some of the claimed benefits of STEMI regionalization might not work. Specifically, he said, the current evidence for the purported benefits of regionalized STEMI care has important limitations, including a limited applicability to the US healthcare system.

In their evaluation of a coordinated national policy for the treatment of STEMI, Krumholz and colleagues challenge some of the assumptions and claims embedded in the concept of regionalization. These assumptions include:

• Primary PCI is superior to fibrinolytic therapy for all patients.
• Directing patients to ACS centers with higher volume, more specialists, and more intensive treatment will improve their outcomes.
• European-based studies of transferring patients for primary PCI are generalizable to the US.
• STEMI regionalization can be organized like a level-1 trauma system.

In discussing the paper, Krumholz said that although primary PCI yields better clinical outcomes than fibrinolytic therapy when delivered promptly and at experienced centers, not all patients benefit. Data suggest, he noted, that the benefit of primary PCI is modified by patient risk and that lower-risk patients fare just as well with fibrinolytic therapy.

But when you're talking about regionalization and the diversion of patients from the closest hospitals to PCI hospitals, then all things aren't equal anymore. 

Moreover, transferring patients to regional STEMI centers and bypassing closer hospitals capable of providing fibrinolytic therapy will increase the time to treatment, resulting in an increased risk of in-hospital and long-term mortality. Krumholz told heartwire there has been only a relatively limited discussion about how much additional delay is acceptable to obtain treatment in patients eligible for immediate fibrinolytic treatment.

"I think that most of us would agree that, all things being equal, primary PCI is the preferred strategy," said Krumholz. "But when you're talking about regionalization and the diversion of patients from the closest hospitals to PCI hospitals, then all things aren't equal anymore because you have to really pay attention to the time issue. If you end up adding too much time to reperfusion therapy because you're trying to preferentially go to a PCI hospital, you might negate any advantage that PCI has over lytic therapy. You might actually cause a worsening of outcomes."

Regarding PCI volume, Krumholz points out that whereas higher-volume PCI centers have better outcomes than lower-volume centers, there are data suggesting PCI volume is a poor marker of hospital outcomes. Moreover, PCI-volume-associated differences in mortality have declined in the past two decades, such that differences between high- and low-volume centers are fairly negligible. As the group, led by Saif Rathore (Yale University School of Medicine), points out in their paper, there are no experimental data examining whether shifting patients from low-volume centers to high-volume centers improves outcomes.

Krumholz tells heartwire that the scale of STEMI care is enormous compared with that of trauma, and any analogies between the two are faulty. Regionalizing MI care would require shifting massive amounts of resources, placing greater burdens on emergency medical service teams, who would be responsible for transporting and diagnosing large numbers of patients for primary PCI. Also, prehospital triage for STEMI patients would be more difficult than for trauma patients, because it is less obvious which patients are having an MI.

"One question that comes up is whether or not you can truly identify all the STEMI patients to divert them," said Krumholz. "There are certainly patients who present with the classic symptoms of heart attack—they clutch their chests and everybody knows it's a heart attack—but we also know that it is common for patients to have a variety of other symptoms that could be confused with things besides heart attacks, like indigestion, fullness, sweating, nausea, and shortness of breath. Strategically, what's your plan going to be? To take any patient with any symptom that could possibly be a heart attack to these centers? It would overload them, as well as having consequences for the hospitals the patient bypasses."

Krumholz pointed out that hospitals break even financially with cardiovascular care and some even make money, making most acute-care hospitals very unreceptive to the idea of cardiac specialty hospitals encroaching on their territory. Such a system would reinforce the division between the "haves" and the "have-nots," he argues.

In addition to these economic concerns, Krumholz said that cardiac patients are still going to present at these hospitals. If the hospital is no longer designated a cardiac center, it might lack the necessary resources to treat STEMI patients presenting at the ER and top cardiologists, who will have moved to the specialized centers, possibly resulting in poorer outcomes for the presenting patients.

So far, the only study in the US to look at the transfer of PCI patients was the Randomized Trial of Transfer for PrimaryAngioplasty versus On-site Thrombolysis in Patients with High-riskMyocardial Infarction (AIR-PAMI). Other than AIR-PAMI, a study that enrolled just 83 patients, all evidence supporting the benefits of transferring patients for primary PCI is based on the results of randomized controlled trials in Europe. In addition to excluding patients not eligible for transport, these studies were conducted in small geographic regions with centralized hospital systems.

Most of the primary PCI hospitals in this country are not performing as well as they could in terms of being able to take somebody to the cath lab who comes to their front door.

Krumholz told heartwire that he is not against regionalizing STEMI care, although he is skeptical. However, before a national triage policy can be put into place, pilot projects must be tested to determine whether regionalization can reduce STEMI morbidity and mortality. He pointed out that most of the enthusiasm for primary PCI and a national regionalization policy depends on where clinicians practice. For doctors practicing at the Cleveland Clinic, Christ Hospital in Cincinnati, or Boston University, for example, bypassing smaller hospitals means only a five- or 10-minute diversion to bring a patient to a major cardiac center, which makes a lot of sense, he said. For others, where a longer diversion is required, more evidence is needed to determine whether such a delay is acceptable.

Essentially, Krumholz believes many hospitals and operators are getting ahead of themselves, thinking too big before solving their existing inefficiencies. Work still needs to be done to cut down on basic time to reperfusion, he said.

"Most of the primary PCI hospitals in this country are not performing as well as they could in terms of being able to take somebody to the cath lab who comes to their front door," said Krumholz. "This has nothing to do with the regionalization policy. It is about optimizing STEMI care. I would personally like to see all the energy that we're talking about putting into regionalization . . . go into optimizing door-to-balloon times, because that's the first step. . . . If doctors can't fix this in their own hospital, they are getting ahead of themselves."

One of the major quality-improvement efforts of the American College of Cardiology is to cut down the time to reperfusion, noted Krumholz, and he is working with Heart House to implement policies to help hospitals improve efficiency and reduce door-to-balloon times.