doi: 10.1161/CIRCULATIONAHA.104.478362
(Circulation. 2005;112:3509-3534.)
© 2005 American Heart Association, Inc.
Controversies in Cardiovascular Medicine |
Should patients with acute myocardial infarction be transferred to a tertiary center for primary angioplasty or receive it at qualified hospitals in the community?
The Case for Community Hospital Angioplasty
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Introduction |
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Primary percutaneous coronary intervention (PCI) has gained widespread acceptance as the preferred approach for treating ST-segment elevation acute myocardial infarction (STEMI) when it can be performed rapidly at qualified centers. Primary PCI is superior to fibrinolytic therapy in fibrinolytic-eligible patients with STEMI; it reduces the rates of death, reinfarction, cerebral bleeding, reocclusion of the infarct artery, and recurrent ischemia compared with fibrinolytic therapy.1,2 It is much more effective than fibrinolytic therapy in restoring brisk coronary flow (>90% of patients). In addition, primary PCI is potentially applicable to a much broader spectrum of patients with STEMI than is fibrinolytic therapy. It reduces mortality 2-fold or more in the large group of patients inappropriate for fibrinolytic therapy.3,4 It is particularly beneficial in women and the elderly.5,6 A recent report of Medicare patients demonstrated that fibrinolytic therapy conferred a survival disadvantage in patients >75 years old, especially in women, compared with no reperfusion therapy.6 This population represents almost one third of patients with acute myocardial infarction (AMI).7 The editorial that accompanied this study noted that "a recent observational study...has shown a marked reduction in 30-day mortality for primary PCI relative to fibrinolytic therapy in the elderly. However, primary PCI is not available at the hospitals where most elderly patients present with AMI."7
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The Need to Improve Access to Primary PCI for Patients With AMI |
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Unfortunately, only a small minority of patients with STEMI are treated with primary PCI in the United States (Figure 1).8,9 The National Registry of Myocardial Infarction (NRMI) reports that the utilization of primary PCI has increased only slowly from 1994 to 2001, with recent data indicating that only 1 of 5 patients with STEMI is treated with primary PCI. Because the utilization of fibrinolytic therapy has decreased correspondingly, the use of any reperfusion therapy has not appreciably changed over this 8-year period. It is a public health imperative that the delivery of reperfusion therapy be improved. A major effort to increase access to primary PCI is urgently needed. This is particularly important in the large group of patients with STEMI who are ineligible to receive fibrinolytic therapy or in whom this therapy fails. The only reperfusion option available to this large high-risk population is to have immediate access to a qualified coronary interventional center. The Global Utilization of Strategies to Open Occluded Arteries (GUSTO) IIb study showed that patients with STEMI had a 70% higher relative mortality at noninvasive hospitals than at interventional hospitals.10
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2 test was performed for in-hospital death and emergent CABG for the total group and then for each study separately. Statistical software (SAS 9.1) was used for the analysis.The most important determinant of how the patient with STEMI is treated is whether or not primary PCI is readily available. Most patients with AMI present to community hospitals,11 where primary PCI is generally not available and is even prohibited in many states. The delivery of this preferred reperfusion strategy for STEMI must be increased several-fold at the hospitals where most patients present. The great advances in the science and technology of primary PCI that have been made at academic centers must be accompanied by their effective dissemination into the community; otherwise, the benefit of much of this crucial work is lost. Every acute-care hospital in the United States can and should take all necessary steps to ensure that patients with STEMI can be treated with timely PCI. All tertiary centers with PCI programs should offer primary PCI 24 hours per day, 7 days per week for STEMI patients who initially present there and should stand ready to accept STEMI patients in transfer from other acute-care hospitals at all hours.
Approaches to Improve Access to Primary PCI
Early Rapid Transfer and Prehospital Ambulance Triage to PCI Centers: Advantages and Disadvantages
The lack of an on-site PCI program need not prevent a hospital from offering treatment with primary PCI. The advantage of primary PCI over fibrinolytic therapy in reducing death, reinfarction, and stroke persists even when patients must be transferred for primary PCI.1,12 Two notable European trials, The Second Danish Trial of Acute Myocardial Infarction (DANAMI-2)13 and The Second Primary Angioplasty in Patients Transferred from General Community Hospitals to Specialized PTCA Units Trial (PRAGUE-2),14 have convincingly demonstrated that early and rapid transfer for primary PCI yields superior outcomes compared with local fibrinolytic therapy in most patients with STEMI who present to noninterventional centers. These strategies of early rapid transfer and prehospital ambulance triage of such patients, analogous to the trauma center model, are beginning to be examined and implemented in various regions in the United States, including Boston, Mass, Durham, NC, and Minneapolis, Minn.15–17 The applicability of these strategies is limited mostly to urban areas, where the transport time to a PCI center may be relatively short. The strategy of prehospital ambulance triage is further limited by the fact that only half of all patients with AMI are transported to the emergency department by ambulance.18
Universal triage or transfer of patients with STEMI to cardiac surgery centers is not possible in many areas of this country where acute-care hospitals are geographically remote from tertiary centers. Helicopters cannot always fly owing to weather conditions, and ground transport may be slowed by traffic conditions in congested areas or by the need to transport over long distances. The liability risk regarding interhospital transfer of patients in the throes of AMI is appreciable. Unfortunately, some acute-care hospitals might feel pressure to not transfer all patients with STEMI because of institutional pride and loss of reimbursement. In addition, moving all patients with STEMI to tertiary centers could quickly flood the capability of many of these centers. (It is notable that in the PRAGUE-2 study, 2 of the 7 primary PCI centers in Prague did not have on-site cardiac surgery capability.) Many tertiary centers still do not offer primary PCI as routine first-line care, even for their own patients with STEMI, and thus may not have effective protocols to perform immediate PCI on critically ill patients whom they accept in transfer or by prehospital ambulance triage. With the aging of the "baby boomer" population, the current "epidemic" of diabetes and obesity, and the increasing recognition of the need to provide timely primary PCI in a large majority of patients with STEMI, this patient load will increase even further.
Even when rapid transfer is possible, not all patients are stable enough to transfer. These highest-risk patients are the very ones who are most likely to benefit from primary PCI. The transfer process itself involves risk and delay and can even be a barrier to revascularization, as discussed below. Thus, the applicability and benefits of transfer hinge on whether it can be accomplished rapidly and whether the patient can be stabilized for safe transfer.
The mortality benefit of primary PCI decreases as the time delay to PCI increases, and this benefit may disappear when the delay to PCI is more than 1 hour compared with the time to administration of a fibrinolytic agent.19 Patients in the United States who are transferred for primary PCI are treated 71 minutes later than patients who receive primary PCI locally (171 versus 100 minutes), according to data from the NRMI (Figure 2).20 This same NRMI registry demonstrates that a door-to-balloon time of 2.5 to 3 hours, as seen in patients transferred for PCI, is associated with a 60% increase in risk-adjusted mortality compared with <2 hours from door to balloon time.21
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Thus, the data from DANAMI-2 and PRAGUE-2, which demonstrate that transfer for PCI yields superior outcomes compared with local fibrinolytic therapy, may not be directly applicable in the United States22; the mean times to PCI in transferred patients were &1 hour faster in these European studies than in the US NRMI registries.20 Only 4% of patients transferred for primary PCI in the NRMI registries received PCI within 90 minutes of first presentation, and only 15% received it within 2 hours.23 In contrast, 6 studies of primary PCI at US hospitals without on-site cardiac surgery reported door-to-balloon times of 80 to 110 minutes in an aggregate of 4395 patients (Table 1).
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Moreover, even when the transfer system was as streamlined and as efficient as it was in these countries, transfer for primary PCI was not possible in 4% of patients in the DANAMI-2 study and 1% of patients in the PRAGUE-2 study who were too unstable to transfer. Three of the 4 patients in PRAGUE-2 who could not be transferred died. (Similar information on such patients in DANAMI-2 was not reported.) Of those who were transferred, 2 patients died during transfer in PRAGUE-2, and 3 others had ventricular fibrillation en route. In DANAMI-2, 8 patients had ventricular fibrillation during transfer (1.4%); 1 of these could not be resuscitated and died an hour after arrival.
In these studies, many of the sickest patients, who might have benefited the most from immediate PCI, were unable to be transferred for intervention. Primary PCI at the point of first hospital contact could be lifesaving in patients too unstable for transfer to a tertiary center. In the United States, where the transfer system is not as streamlined as it was in the DANAMI-2 and PRAGUE-2 studies, locally available PCI can obviate the much greater delay, and sometimes the barrier, of the transfer process.
PCI at the point of first hospital contact is especially important for patients with cardiogenic shock. Patients in cardiogenic shock are very difficult to stabilize sufficiently for transfer and more difficult to transfer rapidly. In some cases, transfer may not be possible in these critically ill patients. Yet these are the very patients in whom rapid and effective PCI is potentially the most lifesaving. Early revascularization of ischemic myocardium while it is still viable, with intra-aortic balloon pump support, offers the best possibility of rapidly improving cardiac function and restoring adequate circulation to the body. In the Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) study, randomization to mechanical revascularization within the first 6 hours of infarction conferred the greatest survival advantage of all subgroups examined for patients with cardiogenic shock.24
Unnecessary centralization of care to tertiary centers can lead to inappropriate underutilization of indicated cardiac procedures in the community, particularly in women, ethnic minorities, and the uninsured.25–28 A study involving individuals hospitalized for AMI in 231 hospitals in New York State found that patients in the highest quintile of income were 74% more likely to receive PCI than those in the lowest quintile of income.29
Development of More PCI Centers at Qualified Hospitals Without Cardiac Surgery
There is currently a great need for more centers that are capable of performing emergency PCI. Many acute-care community hospitals are geographically remote from tertiary centers. The transfer of ever-increasing numbers of patients with STEMI to tertiary centers that provide primary PCI will place an increasing burden on their capacity. The need for more PCI centers will increase far more rapidly than the need for more cardiac surgery facilities. With the increasing patient load, the uncoupling of PCI programs from the requirement for on-site cardiac surgery can improve access to timely PCI while avoiding the pressure to build new low-volume cardiac surgery facilities to support PCI.
Only 39% of hospitals in the NRMI provide cardiac surgery.30 Most patients with AMI present to community hospitals without cardiac surgery,11 yet 600 of these hospitals have diagnostic cardiac catheterization laboratories.31 These diagnostic laboratories are often staffed by experienced interventionalists who also perform PCI at surgical centers. Thus, many community hospital catheterization laboratories may have the potential to establish effective primary PCI programs if they can provide experienced personnel, optimal interventional and imaging equipment, and formal arrangements for expeditious transfer to a surgical center.
Outcomes of Primary PCI Programs With Off-Site Surgery Backup: Evidence From the Literature
Fifteen registries and studies have demonstrated that community hospitals without on-site cardiac surgery backup can establish safe and effective primary PCI programs with excellent outcomes that are not compromised by the lack of on-site cardiac surgery (Table 1).32–49 Weaver and coworkers34,35 compared the outcomes of 472 patients with AMI treated with primary PCI in hospitals without on-site cardiac surgery with those of 592 patients with AMI in hospitals with surgery backup, using data from the Myocardial Infarction Triage and Intervention (MITI) Registry. The median times to treatment, procedural success rates, and in-hospital and 1-year mortality rates were not different for the 2 types of hospitals.
Our group has reported the outcomes of immediate coronary angiography with primary PCI when appropriate in 506 patients with AMI at 2 community hospitals without cardiac surgery.39 This is the largest single-group experience of primary PCI in hospitals without on-site cardiac surgery reported to date. In this series, more than two thirds of the patients had clinical high-risk predictors (Killip class 3 or 4, age 
75 years, anterior AMI, out-of-hospital ventricular fibrillation) and/or angiographic high-risk predictors (left main or 3-vessel disease or ejection fraction <45%). Sixty-one percent were ineligible for fibrinolytic therapy. The median time from emergency department presentation to first balloon inflation was 109 minutes. The overall in-hospital mortality rate was 5.3%. In 56 patients who presented with cardiogenic shock, the mortality rate was 23%, and in patients without shock, it was 3.0%. Stroke occurred in 2 patients, and no patient had intracerebral bleeding. Outcomes for patients who presented at night or on weekends were similar to those who presented during working hours, despite a somewhat longer door-to-balloon time due to the call-back status of the catheterization laboratory team. No patient died or needed emergency aortocoronary bypass surgery because of new myocardial jeopardy caused by a complication of the cardiac catheterization or interventional procedure. The low mortality rate in patients having primary PCI was sustained at 6 months after discharge. Our rates of successful intervention, reinfarction, stroke, and death in this series compared favorably with the outcomes of large, high-volume surgical centers reported in the literature.
Aversano and coworkers42 accomplished the only randomized study of primary PCI versus fibrinolysis at hospitals with off-site surgery backup. The Cardiovascular Patient Outcomes Research Team (C-PORT) trial, with 453 patients enrolled, demonstrated the superiority of primary PCI in reducing the composite end point of death, recurrent AMI, and stroke at 6 weeks and 6 months compared with fibrinolytic therapy. The median length of stay was also reduced in the primary PCI group. No patient was transferred to a surgical center because of a complication of the PCI procedure. (Unfortunately, this trial had to be stopped before the planned enrollment was completed because funding could not be secured.)
Kutcher and colleagues,45 in a preliminary report from the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR), found that the rates of PCI success, emergency surgery, and death for both primary and nonemergent PCI procedures at hospitals without on-site cardiac surgery were extremely favorable and similar to those at cardiac surgery centers. Sanborn and colleagues46 analyzed data from the NRMI that compared the outcomes of primary PCI at surgical hospitals with those of 1874 patients at 97 hospitals without on-site cardiac surgery. This is the largest aggregate experience of primary PCI at nonsurgical hospitals reported to date. There were comparable in-hospital mortality rates and quality-of-care indicators between the types of hospitals, whereas hospitals with off-site surgery backup had shorter door-to-balloon times than those with cardiac surgery. The outcomes of 4.7% of the patients who were transferred to another institution from hospitals without cardiac surgery were unknown, which precludes a comparison of in-hospital mortality rates.
Singh and colleagues47 compared the outcomes of 160 patients with STEMI and non-STEMI who underwent primary PCI at a Mayo Clinic satellite hospital 85 miles away from the tertiary surgical center with 160 matched controls treated with primary PCI at the surgical center. The rates of procedural success, in-hospital and 6-month mortality, Q-wave myocardial infarction, and target-vessel revascularization were low and were similar in the 2 groups. No patient was referred for emergency CABG surgery for failed PCI.
Wharton and coworkers48 prospectively enrolled 500 patients with high-risk STEMI at 19 community hospitals with off-site cardiac surgery backup in the Primary Angioplasty in Acute Myocardial Infarction–No Surgery On Site (PAMI-No SOS) study. To be enrolled, patients had to have at least 1 of the following high-risk qualifiers: Age >70 years (no upper age limit), anterior myocardial infarction or left bundle-branch block, heart rate >100 bpm, systolic blood pressure >100 mm Hg, or Killip class 2 or 3 congestive heart failure. Lower-risk patients and those with shock were excluded from enrollment to duplicate the selection criteria for the randomized Air PAMI study.50 The 30-day mortality rate in this very-high-risk group was extremely favorable at 3.4%. Outcomes were similar to those for patients transferred for primary PCI in Air PAMI, and reperfusion was more rapid by a mean of 67 minutes.
Wennberg and colleagues49 analyzed Medicare data from 1999 to 2001 and found that 178 hospitals performed PCI without on-site cardiac surgery. The rates of in-hospital mortality and bypass surgery in patients receiving primary and rescue PCI at these hospitals were similar to those at hospitals with on-site surgery. (Hospitals without on-site cardiac surgery that performed <50 Medicare PCI procedures per year had higher mortality, but only in their nonprimary/rescue PCI patients. This particular group performed an institutional average of only 6.3 Medicare nonprimary/rescue PCI procedures per year, or 18.9 per year if every hospital performed PCI in only 1 of the 3 years studied.)
These and 7 other reports from hospitals without on-site cardiac surgery indicate that primary PCI can be provided safely and effectively in a high-risk patient population, with outcomes similar to those reported from high-volume surgery centers. We are aware of no clinical evidence that suggests that primary PCI offered in hospitals without open heart surgery is less safe or results in poorer outcomes than primary PCI at tertiary surgery centers. To the contrary, this increasing body of evidence confirms that this potentially lifesaving procedure is delivered as well and more quickly at qualified hospitals with off-site cardiac surgery backup as at tertiary centers.50a This evidence indicates that the risk to those who need primary PCI and do not receive it is likely to be far greater than any postulated risk associated with the lack of an on-site surgery program.
Institutional Resources and Program Development Requirements for Primary PCI Programs at Hospitals Without Cardiac Surgery
To establish optimal primary PCI programs at hospitals without cardiac surgery, rigorous standards must be met. We have proposed operator and institutional requirements for primary PCI at hospitals with off-site cardiac surgery backup, as shown in Table 2.39,51,52 These standards have been affirmed in the most recent revisions of the American College of Cardiology/American Heart Association (ACC/AHA) PCI and AMI guidelines.53,54 Meeting these requirements presents a sometimes daunting challenge. Community hospitals offering primary PCI with off-site surgery backup must have experienced high-volume interventionalists on staff who routinely perform nonemergent PCI, a catheterization laboratory staff that has gained experience at a busy interventional laboratory, a complete array of interventional equipment (including thrombectomy and distal protection devices and covered stents), well-defined clinical and angiographic selection criteria for the performance of primary PCI and for emergency transfer to a tertiary surgery center (Table 3), and established protocols and agreements to accomplish emergency transfers expeditiously (Table 4).
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Primary PCI should be offered as routine, first-line therapy for patients presenting with STEMI 24 hours per day, 7 days per week. A critical pathway for primary PCI from prehospital contact through hospital discharge, such as the one shown in Figure 3, should be implemented on a hospital-wide basis. A rigorous program to monitor outcomes and foster quality improvement is imperative and requires a dedicated institutional data and quality coordinator. We strongly urge that any hospital that provides PCI with off-site cardiac surgery backup enroll in the ACC-NCDR.
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A higher institutional volume of primary PCI correlates with improved mortality rates. In the NRMI-2 registry, the odds-adjusted mortality of patients with STEMI who received primary PCI was 33% lower at institutions that performed more than 33 primary PCI procedures per year than at institutions that performed fewer than 12 per year.55 These higher-volume hospitals also had faster times to reperfusion. On the basis of these data, the current ACC/AHA PCI and AMI guidelines recommend a minimum volume of 36 primary PCI procedures per year for nonsurgical hospitals that perform primary PCI. This minimum volume recommendation of the ACC/AHA guidelines helps to ensure a strong institutional commitment to providing primary PCI as routine, first-line therapy on a 24-hour-per-day, 7-day-per-week basis. A single and well-practiced care plan for treatment of STEMI patients presenting at all hours can maximize institutional and operator volumes, streamline care paths, and minimize door-to-balloon times and thus optimize outcomes.
Have the ACC/AHA Guidelines for STEMI Kept Pace With the Evidence?
The latest revision of the ACC/AHA guidelines for STEMI, published in July 2004,54 has not changed the Class IIb indication status for primary PCI at hospitals without on-site cardiac surgery ("usefulness/efficacy less well established by evidence/opinion"). We believe that the increasing body of newer literature now provides sufficient evidence to move this classification upward to Class IIa ("weight of evidence/opinion is in favor of usefulness/efficacy"). Despite the decision of the majority of the members of the STEMI guidelines committee to maintain the Class IIb indication, several other cardiology thought-leaders have recently encouraged primary PCI at qualified hospitals with off-site surgery backup or directly advocated this classification upgrade.
For example, Weaver56 observes that most patients with AMI are admitted to hospitals without cardiac surgery and thus calls for more qualified nonsurgical hospitals to establish primary PCI programs. Noting that some states require on-site cardiac surgery for hospitals that perform PCI, he states, "In my mind, these restrictive regulations must be changed." He continues, "Geography should not determine the type of treatment we receive for life-threatening conditions such as AMI." Ryan57 states, "... for rural America, it is important to nurture and further develop existing institutions without nearby surgical capability that can demonstrate their ability to undertake life-saving techniques, such as primary PCI, safely and effectively to make that technology more available to the patient in need." Cannon58 concludes, "... if a community hospital makes a strong institutional commitment to establishing a comprehensive program, performance of primary PCI will be beneficial to patients." Brodie59 urges that the indication for primary PCI at hospitals with off-site backup be changed to Class IIa: "We, as a cardiology community, should vigorously promote making mechanical reperfusion more available. The performance of primary PCI at facilities with interventional capabilities but without on-site cardiac surgery will help us toward this goal."
We also advocate advancing the classification of primary PCI at hospitals with off-site surgery backup to Class IIa. The fact that 80% of patients with STEMI in the United States are not treated with primary PCI is a major public health problem. We strongly encourage the increased availability of primary PCI in broader geographical regions. Upgrading the indication to Class IIa would be a very important step toward facilitating the delivery of primary PCI to a greater proportion of patients with STEMI. In the words of Weaver, "Too often in cardiology, we generate evidence to support a new treatment [primary PCI] but fail to effectively implement it. This cannot be another such example!"56
Table 1 summarizes basic elements of the 15 published registries and studies of primary PCI at hospitals without on-site cardiac surgery. The first 6 studies were published before the 2001 ACC/AHA PCI guidelines53 and included 1076 PCI procedures at 10 hospitals. The Class IIb indication designated in the 2001 PCI guidelines was based on 5 of the first 6 studies (the 50-patient Moquet report37 was not referenced in these guidelines), which reported a total of 1026 PCI procedures at 9 sites. In these 6 studies, the procedural success rate averaged 90%, with an in-hospital mortality rate of 7.6%. Only 10 (0.93%) of 1076 patients required emergency coronary bypass surgery for PCI failure.
Since publication of the 2001 ACC/AHA PCI guidelines, 9 more studies have been recognized, including 1 randomized trial and 2 abstracts. These newer studies include 7319 more patients from 180 sites and bring the total number of reported patients having primary PCI at nonsurgical hospitals to 8359. In these more recent studies, performed in the era of newer-generation stents and antiplatelet medications, the procedural success rate improved to 95% in the 6 studies that reported these data, with an in-hospital mortality rate of only 5.8% for all studies. (Five of these studies included patients with cardiogenic shock.) Only 11 (0.53%) of the 2055 patients in whom the information is available required emergency coronary bypass surgery for PCI failure.
Very importantly, door-to-balloon times were reported in 9 of these 15 studies in an aggregate of 5750 patients. The reperfusion times in these studies ranged from 80 to 110 minutes, or 61 to 91 minutes faster than in patients transferred for PCI according to the most recent NRMI data (Figure 2).20
Of these 9 newer studies, it is noteworthy that the study by Politi et al44 was not cited in the STEMI guidelines, and the study by Wennberg et al49 was published after the guidelines were released. These 2 studies, which report an aggregate of 2796 primary PCI procedures performed without on-site surgery, were thus not considered by the STEMI guidelines committee. In addition, the studies by Sanborn et al,46 Singh et al,47 and Wharton et al48 were published only 1 month before the STEMI guidelines were released. Thus, the STEMI guidelines committee may not have been able to fully consider the implications of these 3 other studies, which report an aggregate of 2474 more primary PCI procedures. We wonder whether the STEMI guidelines committee would have reached the same conclusion about the Class IIb indication for primary PCI at hospitals with off-site surgery backup had these 5 studies, with an aggregate of 5270 procedures, been available earlier in the guidelines writing process. In view of these 9 new reports, which include 1 new randomized trial, of very favorable outcomes in nearly 7 times as many primary PCI procedures from 18 times as many hospitals as were included in the studies cited by the 2001 ACC/AHA PCI guidelines, and with no unfavorable evidence published to the contrary, we assert that there is now quite sufficient evidence (at a guidelines-defined "Level of Evidence B," or "data derived from a single randomized trial, or nonrandomized studies") to support a guidelines upgrade to a Class IIa indication ("weight of evidence ... in favor of usefulness/efficacy") for primary PCI at qualified nonsurgical hospitals.
Well over 100 community hospitals in the United States are now providing primary PCI with off-site backup as routine treatment for patients with STEMI. Because this represents a costly and potentially controversial endeavor, it is difficult to ascribe selfish or financial motives to this effort, as some have done. These community hospitals have stepped out ahead of the guidelines and chosen to make this extraordinary and costly commitment because they want to provide this "best" therapy to a greater proportion of their patients with STEMI. It is regrettable that this strong and growing grass-roots movement in the United States has no strong support from the ACC/AHA guidelines themselves and no voice of experience in community intervention sitting on the guidelines committees.
It is unlikely that there will be any more randomized trials of this approach. The 1 randomized trial, C-PORT,41 was stopped before completion of the planned enrollment because funding could not be secured. In lieu of a randomized trial, all hospitals that perform PCI with off-site cardiac surgery backup should be required to submit their data to the ACC-NCDR. As the amount of information on this approach mounts, the likelihood of future guidelines indication classification upgrades should also increase, not only for primary PCI but also for the growing movement to provide selective nonemergent PCI at hospitals with off-site surgery backup. (In the report from NRMI,46 50 hospitals provided elective as well as primary PCI with off-site cardiac surgery backup.)
In 1988, the first ACC/AHA guidelines on percutaneous transluminal coronary angioplasty took a very strong and uncompromising position on this issue. These guidelines stated, "An experienced cardiovascular surgical team should be available within the institution for all angioplasty procedures," and "there should be no exception to this requirement." They further stated, "all arrangements requiring transportation of patients to off-site surgical facilities fail to meet the necessary standards of care exercised by prudent physicians and cannot be condoned"60 [emphasis added]. Despite this uncompromising position, interventionalists at many community hospitals without on-site cardiac surgery in the United States (including ourselves) nevertheless began to offer primary PCI to high-risk and lytic-ineligible patients who had no reperfusion alternative, once the advantages of primary PCI had been described by its earliest investigators.61,62 The ACC/AHA guidelines for AMI and PCI, cognizant of this early experience at hospitals with off-site surgery backup (Table 1),32,34–36,38,39 have evolved considerably over the 16 years since the 1988 guidelines were published. We hope for and look forward to the further evolution of these guidelines.
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Conclusions |
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TopIntroductionThe Need to Improve...ConclusionsReferencesLimited Availability of Primary...ConclusionsAcknowledgments References References References |
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Acute coronary intervention is now the preferred reperfusion strategy for patients with STEMI if it can be delivered rapidly at high-quality PCI centers. It is imperative that this optimal therapy be more widely available at community hospitals, where most patients with AMI present. The great developments in the science and technology of mechanical reperfusion must be accompanied by extensive changes in our healthcare system to ensure its effective dissemination into the community; otherwise, the benefit of much of this work will not be realized.
There are 3 necessary and interdependent solutions to improving the delivery of primary PCI to patients with STEMI: (1) The development of rapid and effective emergency transfer protocols to qualified PCI centers; (2) the development of regional systems for prehospital ambulance triage of STEMI patients to PCI centers with 24-hour, 365-day emergency capability (after the model of trauma centers); and (3) the development of more PCI centers at qualified hospitals with off-site cardiac surgery backup. These 3 solutions are interdependent; the widespread use of prehospital ambulance triage and emergency transfer will ultimately depend on the development of more interventional programs in broader geographic regions. The first 2 solutions alone are not adequate by themselves, for the reasons of access, demand, and rapid delivery that have been discussed.
The evidence from the literature and the vast experience at numerous community hospitals in the United States demonstrate that safe, effective, and rapid primary PCI can be delivered at qualified hospitals with off-site cardiac surgery backup that meet rigorous standards. The lack of cardiac surgery backup per se need not limit the safety or efficacy of this valuable therapy for AMI. Improving the delivery of coronary intervention to increasing numbers of patients with STEMI in more centers over broader geographic regions will provide a substantial healthcare benefit to society. The processes to accomplish this should be supported and encouraged by the responsible regulatory agencies and the appropriate scientific bodies of the medical profession.
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Acknowledgments |
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I wish to thank Nancy Sinclair, RN, BSN, cardiology research nurse-coordinator at Exeter Hospital, Exeter, NH, for many valuable ideas, suggestions, and contributions to this manuscript.
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References |
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15. Moyer P, Feldman J, Levine J, Beshansky J, Selker HP, Barnewolt B, Brown DFM, Cardoza JP, Grossman SA, Jacobs A, Kerman B, Kimmelstiel C, Larson R, Losordo D, Pearlmutter M, Pozner C, Ramirez A, Rosenfield K, Ryan TJ, Zane RD, Cannon CP. Implications of the mechanical (PCI) vs thrombolytic controversy for ST segment elevation myocardial infarction on the organization of emergency medical services: the Boston EMS experience. Crit Pathways Cardiol. 2004; 3: 53–61.[CrossRef]
16. Waters RE II, Singh KP, Roe MT, Lotfi M, Sketch MH Jr, Mahaffey KW, Newby LK, Alexander JH, Harrington RA, Califf RM, Granger CB. Rationale and strategies for implementing community-based transfer protocols for primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2004; 43: 2153–2159.
17. Larson DM, Sharkey SW, Unger BT, Mooney MR, Madison JD, Henry TH. Is rapid transfer of ST-elevation myocardial infarction patients for primary angioplasty feasible in the United States? Am J Cardiol. 2003; 92 (suppl 6A): 152L–153L.Abstract.
18. Canto JG, Zalenski RJ, Ornato JP, Rogers WJ, Kiefe CI, Magid D, Shlipak MG, Frederick PD, Lambrew CG, Littrell KA, Barron HV; National Registry of Myocardial Infarction 2 Investigators. Use of emergency medical services in acute myocardial infarction and subsequent quality of care: observations from the National Registry of Myocardial Infarction 2. Circulation. 2002; 106: 3018–3023.
19. Nallamothu BK, Bates ER. Percutaneous coronary intervention versus fibrinolytic therapy in acute myocardial infarction:is timing (almost) everything? Am J Cardiol. 2003; 92: 824–826.[CrossRef][Medline] [Order article via Infotrieve]
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21. Cannon CP, Gibson CM, Lambrew CT, Shoultz DA, Levy D, French WJ, Gore JM, Weaver WD, Rogers WJ, Tiefenbrunn AJ. 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.
22. Hermann HC. Transfer for primary angioplasty: the importance of time. Circulation. 2005; 111: 718–720.
23. Nallamothu BK, Bates ER, Herrin J, Wang Y, Bradley EH, Krumholz HM, for the NRMI investigators. Times to treatment in transfer patients undergoing primary percutaneous coronary intervention in the United States: National Registry of Myocardial Infarction (NRMI)-3/4 analysis. Circulation. 2005; 111: 761–767.
24. Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock: SHOCK Investigators: Should we emergently revascularize occluded coronaries for cardiogenic shock. N Engl J Med. 1999; 341: 625–634.
25. Petersen LA, Normand SL, Leape LL, McNeil BJ. Regionalization and the underuse of angiography in the Veterans Affairs Health Care System as compared with a fee-for-service system. N Engl J Med. 2003; 348: 2209–2217.
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31. Sheldon WC. Trends in cardiac catheterization laboratories in the United States. Catheter Cardiovasc Interv. 2001; 53: 40–45.[CrossRef][Medline] [Order article via Infotrieve]
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34. Weaver WD, Parsons L, Every N, for the MITI project investigators. Primary coronary angioplasty in hospitals with and without surgery backup. J Invasive Cardiol. 1995; 7: 34F–39F.[Medline] [Order article via Infotrieve]
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36. Brush JE, Thompson S, Ciuffo AA, Parker J, Stine RA, Mansfield CL, Hagerman P. Retrospective comparison of a strategy of primary coronary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction in a community hospital without cardiac surgical backup. J Invasive Cardiol. 1996; 8: 91–98.[Medline] [Order article via Infotrieve]
37. Moquet B, Huguet RG, Cami G, Linassier P, Decomis MP, Guille des Buttes P, Goralski M, Lepifre P, Pigale C, Placente M. Primary angioplasty in acute myocardial infarction: a one-year experience in a small urban community. Arch Mal Coeur Vaiss. 1997; 90: 11–15.
38. Smyth DW, Richards AM, Elliott JM. Direct angioplasty for myocardial infarction: one-year experience in a center with surgical back-up 220 miles away. J Invasive Cardiol. 1997; 9: 324–332.[Medline] [Order article via Infotrieve]
39. Wharton TP, McNamara NS, Fedele FA, Jacobs MI, Gladstone AR, Funk EJ. 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.
40. Ribichini F. Experiences with primary angioplasty without on site-cardiac surgery. Semin Interv Cardiol. 1999; 4: 47–53.[Medline] [Order article via Infotrieve]
41. Ribichini F, Steffenino G, Dellavalle A. Primary angioplasty without surgical back-up at all: results of a five years experience in a community hospital in Europe. J Am Coll Cardiol. 2000; 35: 364A. Abstract.
42. Aversano T, Aversano LT, Passamani E, Knatterud GL, Terrin ML, Williams DO, Forman SA; 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.
43. Aversano T. Primary angioplasty at hospitals without cardiac surgery: C-PORT Registry outcomes. Circulation. 2003; 108 (suppl IV): IV-613. Abstract.
44. Politi A, Zerboni S, Galli M, Mameli S, Botto GL, Lombardi R, Bonatti R, Ferrari G. Primary angioplasty in acute myocardial infarction: experience and results in the first 1,000 consecutive patients. Ital Heart J Suppl. 2003; 4: 755–763.[Medline] [Order article via Infotrieve]
45. Kutcher MA, Klein LW, Wharton TP, Applegate RJ, Brindis RG, Shaw RE, Weintraub WS. Clinical outcomes in coronary angioplasty centers with off-site versus on-site cardiac surgery capabilities: a preliminary report from the American College of Cardiology-National Cardiovascular Data Registry. J Am Coll Cardiol. 2004; 43: 96a. Abstract.
46. Sanborn TA, Jacobs AK, Frederick PD, Every NR, French WJ; National Registry of Myocardial Infarction 3 and 4 Investigators. Comparability of quality-of-care indicators for emergency coronary angioplasty in patients with acute myocardial infarction regardless of on-site cardiac surgery (report from the National Registry of Myocardial Infarction). Am J Cardiol. 2004; 93: 1335–1339.[CrossRef][Medline] [Order article via Infotrieve]
47. Singh M, Ting HH, Berger PB, Garratt KN, Holmes DR Jr, Gersh BJ. Rationale for on-site cardiac surgery for primary angioplasty: a time for reappraisal. J Am Coll Cardiol. 2002; 39: 1881–1889.
48. Wharton TP Jr, Grines LL, Turco MA, Johnston JD, Souther J, Lew DC, Shaikh AZ, Bilnoski W, Singhi SK, Atay AE, Sinclair N, Shaddinger DE, Barsamian M, Graham M, Boura J, Grines CL. Primary Angioplasty in Acute Myocardial Infarction at Hospitals With No Surgery On-Site (the PAMI-No SOS study) versus transfer to surgical centers for primary angioplasty. J Am Coll Cardiol. 2004; 43: 1943–1950.
49. Wennberg DE, Lucas FL, Siewers AE, Kellett MA, Malenka DJ. Outcomes of percutaneous coronary interventions performed at centers without and with onsite coronary artery bypass graft surgery. JAMA. 2004; 292: 1961–1968.
50. Grines CL, Westerhausen DR, Grines LL, Hanlon JT, Logemann TL, Niemela M, Weaver WD, Graham M, Boura J, O’Neill WW, Balestrini C; Air PAMI Study Group. A randomized trial of transfer for primary angioplasty versus on-site thrombolysis in patients with high-risk myocardial infarction. J Am Coll Cardiol. 2002; 39: 1713–1719.
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51. McNamara NS, Wharton T. Critical pathways for primary angioplasty in acute myocardial infarction at community hospitals without cardiac surgery. In: Cannon C, O’Gara P, eds. Critical Pathways in Cardiology. Baltimore, Md: Lippincott Williams & Wilkins; 2001: 67–105.
52. McNamara NS, Wharton TP Jr. Critical pathways for primary angioplasty in acute myocardial infarction at community hospitals without cardiac surgery. Crit Pathways Cardiol. 2002; 1: 74–102.
53. Smith SC Jr, Dove JT, Jacobs AK, Kennedy JW, Kereiakes D, Kern MJ, Kuntz RE, Popma JJ, Schaff HV, Williams DO. ACC/AHA guidelines for percutaneous coronary intervention: executive summary and recommendations: a report of 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.
54. Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr. 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). 2004. Available at: www.acc.org/clinical/guidelines/stemi/index.pdf. Accessed November 15, 2005.
55. Canto JG, Every NR, Magid DJ, Rogers WJ, Malmgren JA, Frederick PD, French WJ, Tiefenbrunn AJ, Misra VK, Kiefe CI, Barron HV. The volume of primary angioplasty procedures and survival after acute myocardial infarction. N Engl J Med. 2000; 342: 1573–1580.
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61. Hartzler GO, Rutherford BD, McConahay DR, Johnson WL Jr, McCallister BD, Gura GM Jr, Conn RC, Crockett JE. Percutaneous transluminal coronary angioplasty with and without thrombolytic therapy for treatment of acute myocardial infarction. Am Heart J. 1983; 106: 965–973.[CrossRef][Medline] [Order article via Infotrieve]
62. O’Neill WW, Timmis GC, Bourdillon PD, Lai P, Ganghadarhan V, Walton J Jr, Ramos R, Laufer N, Gordon S, Schork MA. A prospective randomized clinical trial of intracoronary streptokinase versus coronary angioplasty for acute myocardial infarction. N Engl J Med. 1986; 314: 812–818.[Abstract]
One of the most contentious debates in cardiology in the last decade has been that of choice of reperfusion therapy in patients with ST-segment elevation myocardial infarction (STEMI); specifically, whether thrombolytic therapy or primary percutaneous coronary intervention (PCI) is more effective in these patients. Although data from 23 randomized controlled trials show that primary PCI is superior to thrombolytic therapy by significantly decreasing short-term death, nonfatal reinfarction, stroke, and the combined end point of death, nonfatal reinfarction, and stroke,1 the majority of STEMI patients still receive thrombolytic therapy owing to the limited availability of primary PCI.2 The next debate in this area is likely to be whether STEMI patients should be transferred to a tertiary, high-volume primary PCI center for primary PCI or undergo this procedure in community hospitals. Although these 2 strategies are not mutually exclusive, we present data supporting the case that emergent transfer for primary PCI to high-volume PCI centers results in better clinical outcomes and therefore is the strategy of choice.
Should patients with acute myocardial infarction be transferred to a tertiary center for primary angioplasty or receive it at qualified hospitals in the community?
The Case for Community Hospital Angioplasty
The Case for Emergency Transfer for Primary Percutaneous Coronary Intervention
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Limited Availability of Primary PCI |
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The main problem with primary PCI is that it is not readily available to most patients with STEMI. Data from the Cooperative Cardiovascular Project from Michigan show that patients with STEMI are taken to the nearest acute-care hospital, and in most instances, this is a community hospital without PCI capability3; of the 6838 Medicare beneficiaries in Michigan, 4107 (60%) were admitted to a community hospital, and 2731 (40%) were admitted directly to a tertiary care center. The community hospital, therefore, plays an integral role in the care of the STEMI patient, because the majority of patients with STEMI initially present to community hospitals. This statistic is even more daunting considering that 50% or more of patients with STEMI drive themselves to the nearest hospital instead of calling the emergency medical system.4–6 Accordingly, there has been an increase in the number of community hospitals performing primary PCI. An analysis using data from the Third National Registry of Myocardial Infarction (including 1553 hospitals from April 1998 to June 2000) and Fourth National Registry of Myocardial Infarction (including 1272 hospitals from July 2000 to October 2002) showed a sharp rise in the use of primary PCI: Of the patients with STEMI, 81 679 (53%) received early reperfusion therapy, of whom 39 440 (48%) were treated with primary PCI.7 In 2005, it is estimated that an even greater proportion of patients will be treated with primary PCI. One approach, therefore, to increase the availability of primary PCI is for more community hospitals to perform the procedure. However, nearly 1000 community hospitals in the United States perform diagnostic cardiac catheterization but do not have cardiac surgery capability.8 Moreover, many community hospitals do not have the annual PCI volume needed to maintain the skills of the interventionalist and the cardiac catheterization laboratory staff, which is crucial in the treatment of high-risk, hemodynamically unstable STEMI patients.
Role of Community Hospitals With PCI Capability but Not Cardiac Surgery Capability
Emergent coronary artery bypass (CABG) surgery due to acute or threatened closure of the coronary artery during a PCI procedure has become extremely infrequent with the increased use of intracoronary stents. For example, only 4 (0.4%) of the 1100 STEMI patients enrolled in the Primary Angioplasty in Myocardial Infarction (PAMI)-2 trial required emergent CABG for a failed PCI procedure9; in a review of 6 major randomized trials comparing balloon angioplasty to coronary stenting in STEMI,10–15 only 6 (0.31%) of 1953 patients required emergent CABG for a failed PCI.16 It is against this background that early observational studies on the safety and efficacy of primary PCI in STEMI patients admitted to hospitals without on-site cardiac surgery were performed.
The largest prospective multicenter registry to date that evaluated this strategy compared the clinical outcomes of 500 high-risk STEMI patients undergoing primary PCI in community hospitals without on-site cardiac surgery (the Primary Angioplasty in acute Myocardial Infarction at hospitals with No Surgery On-Site [PAMI-No SOS])17 with 71 high-risk STEMI patients transferred for primary PCI (the transfer arm of the Air PAMI trial).18 In this nonrandomized study, significantly more patients presenting with anterior infarctions were transferred for primary PCI rather than undergoing primary PCI in the community hospital (77% versus 52%, P<0.0001). This is likely secondary to selection bias and is a major limitation of the study. Transferred patients had a mean delay to treatment of 67 minutes (187 versus 120 minutes, P<0.0001) and lower rates of final Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow (86% versus 96%, P=0.004) compared with patients treated on site. Two patients who underwent primary PCI in community hospitals without on-site cardiac surgery required emergent transfer for surgery due to a failed PCI (0.4%), and another 5% were transferred owing to critical coronary anatomy amenable to elective surgical revascularization. In the transfer arm of the Air PAMI trial, 5.6% of the patients underwent surgery for critical coronary anatomy, but none was due to a failed PCI. The primary end point of death, nonfatal reinfarction, or disabling stroke at 30 days was 8.5% in those transferred versus 5.0% in those treated with primary PCI without on-site cardiac surgery (P=0.27). The success of this approach depends not only on the availability of stents but also on the maintenance of high standards of care. For example, in order for the hospital to be part of the Air PAMI-No SOS registry, adherence to rigorous guidelines was mandated, including the following: (1) Experienced interventionalists who regularly perform elective PCI procedures at a surgical center, (2) experienced cardiac catheterization laboratory staff on a 24-hours-per-day, 7-days-per week call schedule, (3) a fully equipped catheterization laboratory with digital imaging, (4) intra-aortic balloon pump capability, (5) formalized written protocols for immediate transfer to a surgical center, and (6) continuous quality assurance and outcomes monitoring.
Only 1 randomized controlled trial, the Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) trial, has evaluated the safety and efficacy of primary PCI performed in community hospitals without on-site surgical backup compared with thrombolytic therapy.19 It did not include transfer for primary PCI as a treatment arm. This trial enrolled 453 patients presenting to 11 community hospitals in Massachusetts and Maryland. Patients treated with primary PCI had a 42% lower incidence of the combined end point of death, recurrent infarction, and stroke at 6 months than patients treated with thrombolytic therapy (12.4% versus 19.9%, P=0.03). No patient in the primary PCI group required emergency cardiac surgery for a PCI-related complication or failure, and the median length of stay was significantly shorter in patients treated with primary PCI than in those treated with thrombolytic therapy (4.5 versus 6 days, P=0.02). The results of this trial, however, must be viewed in the context that it is the only randomized trial of its kind to date and that it was terminated early because of lack of funding, and thus, it is underpowered. In addition, it did not compare primary PCI in community hospitals without on-site cardiac surgery to transfer to high-volume, tertiary care centers for primary PCI. Moreover, the majority of patients enrolled in the C-PORT trial were randomized during normal working hours (between 8 AM and 4 PM), which may have contributed to the median door-to-balloon time of 102 minutes and the excellent clinical outcomes. Thus, it is uncertain whether similar outcomes would be seen in STEMI patients presenting "off-hours" to community hospitals without on-site cardiac surgery.
The C-PORT trial investigators required continual quality assurance monitoring, the adoption of rigorous guidelines for each community hospital and cardiac catheterization laboratory staff, and the development of formal primary PCI programs before patient enrollment (a process that took &3 months to complete). Because primary PCI is performed in patients who are often hemodynamically unstable, substantial additional skilled experience is required compared with elective PCI in stable patients. If performed by less skilled operators in inexperienced cardiac catheterization laboratories, the benefits of primary PCI may not be realized. The extensive preparation required in developing primary PCI programs in community hospitals without on-site cardiac surgery has been documented similarly by others.20 Lastly, although the need for emergent CABG due to a failed PCI procedure is infrequent and associated with complex lesion morphology, it is relatively unpredictable and results in increased morbidity and mortality when it occurs.21,22 It has been estimated that the risk of causing significant harm by transferring patients with failed PCI results from hospitals without on-site cardiac surgery to hospitals with cardiac surgery capability is 1 to 2 patients per 1000 angioplasties.22 No trial has been adequately powered to test for mortality. Accordingly, primary PCI is considered a class IIb indication for STEMI in hospitals without on-site cardiac surgery.23
Importance of Hospital and Operator Volume and Expertise
The volume and expertise of hospitals and operators in the care of the STEMI patient are important determinants of clinical outcomes. STEMI patients transferred to PCI-capable hospitals are more likely to receive evidence-based, and presumably superior, therapies.24–26 It has been shown that STEMI patients who are admitted directly to hospitals that have more experience treating STEMI have lower mortality rates than patients admitted to hospitals with less experience treating STEMI: STEMI patients treated by high-volume admitting physicians have lower mortality rates (11.8% versus 15.3%, P<0.001) than those admitted to low-volume admitting physicians who only occasionally treat STEMI patients.27 Moreover, by concentrating the care of STEMI patients in regional centers, the annual volume of PCI and CABG procedures remains high. This is important because there is a direct relationship between higher procedural volume and better clinical outcomes for both PCI28–33 and CABG34,35 procedures. Although patients treated with primary PCI in low-volume community hospitals are still less likely to have strokes or to undergo subsequent revascularization procedures than those treated with thrombolytic therapy,36 patients treated in high-volume primary PCI centers are treated more quickly, have lower rates of emergent CABG, and have lower in-hospital mortality rates than those admitted to intermediate- and low-volume centers.29,36–38 In fact, high-volume centers offer a protective effect, even if patients are treated by low-volume operators.39,40 This suggests that a well-organized, high-volume system may minimize the effect of operator skill on PCI outcomes. Although some level of experience is important to maintain the skills and judgment of the interventionalist, a minimum volume of &70 PCI procedures annually may be sufficient if performed in high- or very-high-volume centers (>600 procedures per year).40,41 A retrospective analysis of more than 360 000 PCI procedures performed from 1998 to 2000 (one third of which were primary PCI procedures) found that patients treated at hospitals that performed fewer than 200 PCI procedures annually had a higher risk of in-hospital mortality—2.56% in low-volume centers (<200 PCI procedures per year), 1.83% in medium-volume centers (200 to 399 PCI procedures per year), 1.64% in high-volume centers (400 to 999 PCI procedures per year), and 1.36% in very-high-volume centers (1000 PCI procedures per year; P<0.001 for trend)—and remained at increased risk for in-hospital mortality (odds ratio 1.21, 95% confidence interval 1.06 to 1.38) after multivariate analysis.42 Pooled data from more than 1 million hospital discharges show that patients undergoing PCI at high-volume PCI centers (defined as 200 procedures per year) have a significantly decreased risk of in-hospital death31,32,42–46 and emergent CABG31,32,43–46 compared with patients undergoing PCI at low-volume centers (defined as <200 procedures per year; Figure 1). We propose 2 complementary approaches to increase the availability of primary PCI while maintaining the standards associated with the excellent clinical outcomes seen in the randomized controlled trials: (1) Emergent hospital-to-hospital transfer of patients to high-volume primary PCI centers (already operational in several states47), and (2) institution of an emergency medical system triage arrangement, similar to that used in the care of trauma patients, in which STEMI patients are taken directly from the field to a regional PCI center and not necessarily to the nearest emergency department.48
Emergent Hospital-to-Hospital Transfer for Primary PCI
The literature clearly indicates that STEMI patients presenting to hospitals without PCI capability who have contraindications to thrombolytic therapy49 or who are hemodynamically unstable and in cardiogenic shock50 should be transferred quickly to a hospital that can perform primary PCI. It has also been shown that patients presenting with STEMI complicated by congestive heart failure have a greater mortality benefit with primary PCI than with thrombolytic therapy.51 Randomized controlled trials now support the strategy of transferring thrombolytic-eligible STEMI patients to primary PCI centers instead of treating them with on-site thrombolytic therapy.
The feasibility and safety of emergent transfer for primary PCI were initially described in small case series52–57 and more recently in 5 randomized controlled trials.18,58–61 Combined data from these 5 trials showed that despite the inherent delay involved in transfer, primary PCI was associated with a significant reduction in nonfatal reinfarction (1.8% versus 6.7%, P<0.0001), total stroke (1.1% versus 2.2%, P=0.049), and the combined end point of death, nonfatal reinfarction, and stroke (8.2% versus 15%, P<0.0001) compared with on-site thrombolysis (Figure 2).1 Similar findings were shown in a separate review.62
Individually, the 5 transfer trials yielded varied results: 3 significantly favored transfer for primary PCI;59–61 and although 2 showed no significant difference in the primary end points because of small sample size, major adverse cardiac events were reduced by 38% to 50% in patients transferred for primary PCI.18,58 A subsequent meta-analysis63 of the 5 transfer trials18,58–61 and 1 additional trial comparing primary PCI with prehospital thrombolytic therapy64 analyzed clinical outcomes in a total of 3750 patients, 1887 of whom were randomized to emergent transfer for primary PCI and 1863 to on-site (or prehospital) thrombolytic therapy. In this meta-analysis, the primary end point, a combined end point of death, reinfarction, and stroke at 30 days, was reduced by 42% (P<0.001) in the group transferred for primary PCI compared with the group receiving thrombolytic therapy.
The safety of transferring critically ill STEMI patients has also been evaluated. Individual studies have shown that transfer is safe even in high-risk patients (defined as >70 years of age, anterior myocardial infarction, Killip class II/III, heart rate >100 bpm or systolic blood pressure <100 mm Hg, cardiogenic shock, need for cardiopulmonary resuscitation before transfer, and contraindications for thrombolytic therapy).18,52,55 In a subgroup analysis,1 the risks associated with transfer for primary PCI were calculated for the 5 transfer trials.18,58–61 Overall, events during transfer occurred infrequently: 0.5% risk of death (reported in 1 study60), 0.7 to 1.4% risk of ventricular arrhythmias,58–61 and a 2.3% risk of second- or third-degree heart block (reported in 1 study61).
The majority of STEMI patients who are admitted to a noninvasive facility are ultimately transferred for coronary angiography. For example, more than half of all STEMI patients admitted to noninvasive community hospitals and treated with thrombolytic therapy in the Second National Registry of Myocardial Infarction were subsequently transferred to hospitals capable of performing coronary angiography.65 Similarly, data from the Global Use of Streptokinase and TPA for Occluded Coronary Arteries (GUSTO)-1 trial showed that 59% of patients admitted to non-PCI facilities and treated with thrombolytic therapy were subsequently transferred for coronary angiography.24 Furthermore, in a randomized trial comparing the efficacy of prehospital thrombolytic therapy with primary PCI,64 26% of patients treated with thrombolytic therapy required rescue PCI because of persistent ischemia, and 70% required PCI within 1 month. Emergent transfer to a high-volume center for primary PCI is preferable to the treatment of STEMI in community hospitals because (1) it is associated with superior clinical outcomes compared with thrombolytic therapy and avoids the risk of rescue PCI, a scenario associated with increased reocclusion and death,66,67 and (2) it is associated with decreased mortality and the need for emergent CABG compared with primary PCI performed in low-volume centers. One of the biggest concerns with the strategy of emergent transfer for primary PCI, however, is the inherent delay involved and its effect on clinical outcomes.
Treatment Delay Due to Transfer and Its Impact on Clinical Outcomes
To date, there are no randomized controlled trials directly comparing primary PCI in community hospitals (with or without on-site cardiac surgery) with emergent transfer to a high-volume primary PCI center. Therefore, the data regarding treatment delay and its impact on clinical outcomes come from studies of primary PCI versus thrombolytic therapy. Although the efficacy of thrombolytic therapy decreases with increasing age of the occlusive coronary thrombus,68–72 the efficacy of primary PCI remains relatively stable over time,73–76 which makes the strategy of transfer for primary PCI feasible. In the PRAGUE (Primary Angioplasty in AMI Patients From General Community Hospitals Transported to PTCA Units versus Emergency Thrombolysis)-2 trial,60 patients who presented from 3 to 12 hours after symptom onset and were treated with primary PCI had significantly reduced mortality compared with patients treated with thrombolytic therapy (6.0% versus 15.3%, P<0.02). In a subsequent meta-analysis of the PRAGUE-1 and -2 trials,77 patients treated with primary PCI had lower mortality rates than those treated with thrombolytic therapy regardless of time to randomization. Similarly, other investigators have shown that patients treated with primary PCI have lower combined rates of death, nonfatal reinfarction, and stroke than patients treated with thrombolytic therapy whether they present with <2 hours of symptoms (5.8% versus 12.5%), 2 to 4 hours of symptoms (8.6% versus 14.2%), or 4 hours of symptoms (7.7% versus 19.4%).73 The Primary Coronary Angioplasty versus Thrombolysis (PCAT)-2 investigators recently reported individual patient data from 6903 patients enrolled in randomized trials comparing primary PCI with thrombolytic therapy78; patients treated with primary PCI had lower mortality rates than those treated with thrombolytic therapy regardless of the length of time from symptom onset to randomization. In fact, the reduction in 30-day mortality seen with primary PCI was seen not only in patients who were randomized within 6 hours of symptom onset (4.2% reduction in mortality compared with thrombolytic therapy) but also in patients randomized very early, within 1 hour of symptom onset (1.3% reduction in mortality compared with thrombolytic therapy). Even with a >75-minute PCI-related delay (additional time required to perform PCI compared with time required to administer thrombolytic therapy), the PCAT-2 investigators found that STEMI patients treated with primary PCI had a significantly decreased risk of death compared with those treated with thrombolytic therapy (Figure 3).79 Similarly, data from the meta-analysis of the PRAGUE-1 and -2 trials show that despite the delay due to transfer, patients transferred for primary PCI had lower mortality rates than those treated with thrombolytic therapy.77
There have been no studies randomizing patients to early versus delayed reperfusion. Although observational studies have reported that early reperfusion with primary PCI in high-risk patients and patients with cardiogenic shock resulted in lower short- and long-term mortality,76,80 improved myocardial salvage, and recovery of left ventricular function compared with later reperfusion,10,57,74,80–84 sicker patients (diabetics, elderly, and those with multiple comorbidities) are reperfused later. Some argue that prolonged treatment delays involved in transfer may negate the mortality benefit that primary PCI offers over thrombolytic therapy85–88 or primary PCI performed in community hospitals. However, thrombolytic therapy has never been shown to be superior to primary PCI, and PCI in high-volume centers is associated with better clinical outcomes than PCI performed in low-volume centers (Figure 1).
Transfer Delays in Randomized Controlled Trials
A valid concern is that in the "real world," transfer delays are significantly longer than those seen in randomized controlled trials and that this translates into poor clinical outcomes. The largest of the transfer trials, the Danish Multicenter Randomized Study on Thrombolytic Therapy versus Coronary Angioplasty in Acute Myocardial Infarction (DANAMI-2) trial,61 was performed in Denmark. In this trial, the median transfer time was 67 minutes, and the median transfer distance was 50 km (range of 3 to 150 km). Importantly, 96% of the patients transferred were transferred in less than 2 hours (43% in less than 1 hour and 53% in 1 to 2 hours). Only 4% of the transferred patients had transfer times of between 2 and 3 hours. Similarly, in the PRAGUE-2 study60 performed in the Czech Republic, the time between randomization and balloon inflation was 97±28 minutes, and the median transfer time was only 48 minutes. Only 1 trial, Air-PAMI (A Randomized Trial of Transfer for Primary Angioplasty versus On-site Thrombolysis in High-Risk Myocardial Infarction) has addressed this issue in the United States.18 In this trial, transport times over the 32±36 mile interhospital distance took only 26 minutes with ambulances (79%) and helicopters (21%). However, the time involved in initiating the transfer significantly increased the delay (mean of 52 minutes, median of 38 minutes), primarily because of delayed arrival of transportation.
Importantly, even outside the context of the randomized trials, door-to-balloon times of patients transferred for primary PCI have improved in the community. Data from the National Registry of Myocardial Infarction 1 through 4 studies show a marked and steady decrease in door-to-balloon times over the past decade among patients transferred for primary PCI (from 228 to 171 minutes).89 If we extrapolate the data from the transfer trials that compared on-site thrombolytic therapy with transfer for primary PCI, we can arrive at the conclusion that the inherent delay involved in the transfer of STEMI patients from community hospitals to tertiary PCI centers should not negatively impact clinical outcomes as long as the patient is transferred to a ready-and-waiting cardiac catheterization laboratory at the PCI center in 
2 hours. Although transfer for primary PCI is not prohibitive in the United States, in order for it to be maximally efficient and safe, efforts must be focused on minimizing transfer delay and choosing the recipient PCI center on the basis of rigorous criteria, most importantly the annual procedural volume. For example, in a recently published observational study of the National Registry of Myocardial Infarction 3 and 4,88 83% of the hospitals receiving STEMI patients in transfer for primary PCI performed <40 primary PCI procedures per year and 45% performed <20 primary PCI procedures per year. It is not surprising, therefore, that the median total door-to-balloon time (time from the initial hospital arrival to the first balloon inflation at the PCI center) was 180 minutes, the median door-to-door time was 120 minutes, and the median PCI hospital door-to-balloon time was 53 minutes. These median delays underscore the fact that in order for transfer for primary PCI to be maximally efficient and result in clinical outcomes consistent with those of the randomized trials, patients should be transferred to high-volume centers, and streamlined, prearranged transport protocols need to be in place, including early activation of the cardiac catheterization laboratory on-call team so that patients are transferred quickly to a ready-and-waiting cardiac catheterization laboratory. One dilemma in the present healthcare system is that the hospital-to-hospital transfer of patients is the lowest priority of the emergency medical system, which makes transfer times for STEMI patients excessive; for example, much of the transfer delay in the Air-PAMI trial was waiting for the transportation vehicle to arrive at the community hospital, not the actual patient transport time.
Patient and Hospital-Related Factors Contributing to Treatment Delays
It is striking that only 20% to 25% of patients with STEMI present early after symptom onset,90–92 and prolonged delay to treatment occurs primarily in higher-risk patients (Table 1). Patient- and hospital-related factors contributing to delays in treatment were assessed in a study of 40 017 STEMI patients referred for primary PCI in the second and third National Registry of Myocardial Infarction.93 Median door-to-balloon time among all patients was 111 minutes, but the proportion of patients with a delay of >120 minutes was greater among high-risk patients: The elderly, women, nonwhite patients, patients with complex medical histories (including diabetes, previous stroke, and CABG), patients with contraindications to thrombolytic therapy, and patients without chest pain on admission. Delay was also more common when patients were transferred from another hospital, when they presented outside the hours of 8 AM to 4 PM, and when they presented to hospitals that performed <49 primary PCIs per year. These findings are consistent with other studies that have shown that the elderly, nonwhite patients, women, and the poor have longer symptom onset–to-treatment times.67,73,94,95 These studies reflect the fact that sicker patients not only present later but also have longer door-to-balloon times. The higher mortality rates seen in retrospective studies of patients presenting late to the cardiac catheterization laboratory, therefore, cannot be attributed solely to longer door-to-balloon times. The clinical outcomes of 1047 STEMI patients presenting during peak hours (Monday through Friday, 8 AM to 8 PM) were compared with 989 STEMI patients presenting during off-peak hours (weeknights from 8 PM to 8 AM, and weekends) in the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.96 Despite an additional 21-minute delay to balloon inflation in STEMI patients who underwent primary PCI during off-peak hours, there was no difference in mortality, achievement of TIMI grade 3 flow, or myocardial function compared with patients treated during peak hours. Further investigation is required to more fully understand the role of patient-related factors (eg, increased hypercoagulable state during the early morning hours, delayed presentation resulting in longer total ischemic times67,76) and program-related factors (eg, less-experienced on-call staff, sleep deprivation affecting the clinical judgment of the on-call interventionalist) in primary PCI outcomes. Although community education efforts stressing the importance of seeking medical attention early should continue, the long-term results have been disappointing.5 The 2 most important approaches that will decrease treatment delays in patients being transferred for primary PCI are the establishment of prearranged and efficient transfer agreements and protocols and making the transfer of STEMI patients a top priority for the emergency medical system.
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Facilitated PCI and Its Role in Transfer for PCI
The strategy of facilitated PCI (pretreatment with thrombolytic therapy, platelet glycoprotein IIb/IIIa inhibitors, or a combination of both before PCI) has attracted increasing interest, particularly for STEMI patients being transferred for primary PCI.97,98 However, none of the randomized controlled trials comparing facilitated PCI with primary PCI alone to date have shown benefit with the facilitated approach. Importantly, some studies have shown excess harm with the facilitated approach, including an increased risk of death and major bleeding (Table 2; Figure 4).99–111 The ongoing Facilitated Intervention With Enhanced Reperfusion Speed to Stop Events (FINESSE) trial112 and the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-4) trial will assess the efficacy and safety of pretreatment with various doses and combinations of intravenous thrombolytic therapy and platelet glycoprotein IIb/IIIa inhibitors in STEMI patients with prolonged delays to PCI.
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Indications for Transfer for Primary PCI
We contend that all high-risk STEMI patients and patients with symptoms for >1 hour who present to community hospitals that are not high-volume primary PCI centers should be transferred to a PCI center provided that the transfer delay is 2 hours (Figure 5). To decrease delays, if the patient arrives by ambulance, the diagnosis of STEMI should be verified while the patient is still on the stretcher in the ambulance; in this way, immediate transfer to a high-volume PCI center can be achieved much more quickly (removing the delay involved in waiting for the emergency medical system transportation to arrive). Simultaneous activation of the cardiac catheterization on-call team during the transfer period is crucial in minimizing further treatment delay; the STEMI patient should be preregistered while in transfer and brought directly to a ready-and-waiting cardiac catheterization laboratory and not to the emergency department or coronary care unit. The suspected infarct-related coronary artery should be engaged directly with a guiding catheter to expedite the PCI procedure and achieve reperfusion as quickly as possible. Low-risk STEMI patients (young, uncomplicated inferior infarct without reciprocal ECG changes, nonshock) who present very early after symptom onset (1 hour) should be treated with thrombolytic therapy at the community hospital, because early thrombolytic therapy may abort the myocardial infarction, and these patients are at low risk of dying even if thrombolysis fails.91,113–115 Even patients treated early with thrombolytic therapy, however, are still at increased risk of hemorrhagic stroke, reinfarction, and recurrent ischemia,1 and the majority will ultimately undergo subsequent coronary angiography.24
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Emergency Medical System Triage to Regional Primary PCI Centers
Recently, there have been calls for the regionalization of STEMI treatment in special centers of excellence capable of performing primary PCI,116–118 a strategy that has already been proven to be beneficial for high-risk surgery.119–121 The direct transport of STEMI patients from the field to a tertiary, high-volume primary PCI center offers a number of advantages.
First, a prehospital 12-lead ECG, an American Heart Association/American College of Cardiology class IIa recommendation, is a quick, simple, and inexpensive test that can make the diagnosis of STEMI in the field. This can result in substantial improvements in the ability to provide primary PCI in a timely fashion by (1) avoiding the delay in diagnosis of STEMI, (2) allowing the emergency medical system to transport the patient directly to a regional primary PCI center instead of to the nearest hospital, which may not provide primary PCI, and (3) facilitating activation of the cardiac catheterization laboratory in advance of patient arrival so that the patient is transported directly to a ready-and-waiting catheterization laboratory, with a shortened door-to-balloon time. Compared with in-hospital diagnosis, the prehospital diagnosis of STEMI has been shown to decrease the time from ambulance call to the first balloon inflation by 41 minutes (P<0.001) in STEMI patients who initially presented to a non–PCI-capable community hospital and were emergently transferred to a primary PCI center and 81 minutes (P<0.001) in STEMI patients transported directly to a primary PCI center from the field.122 Second, regionalizing STEMI care permits the concentration of expensive resources such as state-of-the-art, fully stocked cardiac catheterization laboratories, and high-acuity coronary care units that may help to control healthcare expenditures and make primary PCI more cost-effective.
One study has already shown that the regionalization of PCI procedures in 3 states (New York, New Jersey, and Florida) would not increase travel distance for most patients123; in fact, <1% of patients would travel more than 50 miles farther. The state of Maryland has already taken steps toward the regionalization of STEMI care.48 Questions regarding the economic and logistic repercussions of the redistribution of STEMI patients and the coordination and oversight of this undertaking underscore the fact that more data are needed.124 However, it is likely that regionalization will have a role in the overall goal of making primary PCI available to the majority of STEMI patients.
Policy and Financial Implications of Transfer and the Formation of Regional PCI Centers
One caveat is that in the United States, care of STEMI patients is one of the most profitable hospital services. The low enrollment in the AIR-PAMI trial18 suggests that there may be a reluctance on the part of hospitals and physicians to transfer STEMI patients. The referring hospital may be reluctant to transfer because of loss of revenue, the impact of empty hospital beds, its reputation in the community, and competition with other hospitals for patients. Similarly, the referring physician may be reluctant to transfer because of financial implications and potential loss of their patient referral base. These are important issues that must be considered when proposing transfer for primary PCI. Once treated and stabilized, STEMI patients should be transferred back to the referring community hospital, as is done in other countries with efficient and effective primary PCI transfer systems, such as Denmark. This type of arrangement will both minimize the financial disincentives for community hospitals and referring physicians and localize primary PCI procedures in high-volume centers where the clinical outcomes have been shown to be better.
We propose a system in which hospitals in every community form a STEMI treatment network, in which each hospital plays an integral role (Figure 5). This system must include performance of primary PCI in qualified hospitals, emergent transfer for primary PCI, and prehospital 12-lead ECG with direct triage from the field to regional primary PCI centers. All hospitals performing primary PCI must be willing and able to dedicate the resources necessary to perform this procedure as the only reperfusion therapy for STEMI 24 hours a day, 7 days a week; they must also be willing to maintain high clinical standards and to accept patients in transfer for primary PCI from local community hospitals. The benefits of a community-based STEMI treatment network system include an increase in the availability of primary PCI to all patients with STEMI and a decrease in time-to-treatment delays. The steps required for implementing dedicated transfer strategies in the community have been delineated previously47 and include (1) designation of centers proven to have expertise in primary PCI that are located within a reasonable distance from all referral hospitals; (2) development of STEMI teams at community hospitals that accurately identify STEMI patients, provide appropriate medications, and rapidly transfer patients to the PCI center; (3) central coordination and management of care at the community and tertiary hospitals; (4) continual quality assurance monitoring; and (5) development of clinical research networks to extend STEMI research into community hospitals and provide a structure to prospectively evaluate transfer strategies and adjunctive pharmacological regimens.
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Primary PCI is superior to thrombolytic therapy for the treatment of STEMI, and all STEMI patients should be afforded the opportunity to be treated with this reperfusion therapy. Our efforts must now focus on making primary PCI universally available to all STEMI patients on a timely basis and on evaluating adjunctive pharmacological pretreatment strategies that may improve PCI outcomes even further. This goal will only be accomplished if every qualified hospital capable of providing primary PCI performs this procedure effectively and efficiently 24 hours a day, every day of the week, and if community hospitals, the emergency medical system, and high-volume PCI centers form community-based STEMI treatment networks and develop prearranged rapid transfer protocols. These networks must provide a multitiered approach to providing primary PCI, including (1) emergent, rapid hospital-to-hospital transfer of patients from community hospitals to high-volume primary PCI centers and (2) prehospital diagnosis of STEMI, with direct transfer from the home or workplace to the closest designated high-volume primary PCI center.
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We gratefully acknowledge and would like to thank Judith A. Boura, MS (William Beaumont Hospital, Royal Oak, Mich) for her expert statistical help.
Disclosure
Dr Grines has received research grants from Berlex, Pfizer, GlaxoSmithKline, Aventis, Guidant, Eli Lilly, SciMed, Johnson & Johnson, Amersham Health, Otsuka, Esperion Therapeutics, Innercool Therapies, Cardiovascular Research Foundation, CV Therapeutics, Takeda Pharmaceuticals, and AstraZeneca, and has served as a consultant to or on the advisory board of Innercool Therapies, Pfizer, Sanofi-Synthelabo, Inc, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, and GlaxoSmithKline (Global Cardiovascular Advisory Board). Dr Keeley reports no conflicts.
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Should patients with acute myocardial infarction be transferred to a tertiary center for primary angioplasty or receive it at qualified hospitals in the community?
Response to Keeley and Grines
Our common goal is to make rapid, safe, effective primary PCI universally available. We agree that complementary approaches are needed and affirm the value of rapid interhospital transfer and ambulance triage But to maintain that these are sufficient to provide universal access is to ignore problems of geographic remoteness and the risk, delay, and barrier of transfer.
Keeley and Grines, advocating for PCI only at "high-volume" (and thus, presumably, surgical) centers, are often unclear in whether they refer to primary or total PCI volume. Minimum volume standards differ for primary (>36/year) and elective PCI. This primary PCI volume standard should be attainable at most nonsurgical hospitals that offer primary PCI around-the-clock. (The minimum elective volume is now arguably 200/year,1 also achievable at nonsurgical PCI programs that perform nonemergent PCI.2) The best measure is outcomes, not volumes; published outcomes at nonsurgical hospitals (Table 1 of our Controversies article) show outstanding safety, efficacy, and speed.
Certain of the assertations by Keeley and Grines are misleading. Our AIR-PAMI No-SOS registry3 was designed (not "biased") to select high-risk (including anterior) AMI patients. The cited report estimating risk of harm by delay to surgery for failed PCI4 did not examine interhospital transfer—only delay of >2 hours—and did not demonstrate that interhospital transfer would cause additional delay. In discussing the low risk of transfer, Keeley and Grines ignore the problem of patients who are too unstable for transfer (4% in DANAMI-25 and 1% in PRAGUE-26).
Rather than debating which approach should be adopted instead of the other, efforts should be made toward developing extensive and efficient community-based STEMI networks of tertiary and community hospitals that offer around-the-clock primary PCI.
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1. Epstein AJ, Rathore SS, Volpp KG, Krumholz HM. Hospital percutaneous coronary intervention volume and patient mortality, 1998 to 2000:does the evidence support current procedure volume minimums? J Am Coll Cardiol. 2004; 43: 1755–1762.
2. Wharton TP Jr. Non-emergent percutaneous coronary intervention with off-site surgery backup: an emerging new path to access. Crit Path Cardiol. 2005: 4: 98–106.
3. Wharton TP Jr, Grines LL, Turco MA, Johnston JD, Souther J, Lew DC, Shaikh AZ, Bilnoski W, Singhi SK, Atay AE, Sinclair N, Shaddinger DE, Barsamian M, Graham M, Boura J, Grines CL. Primary angioplasty in acute myocardial infarction at hospitals with no surgery on-site (the PAMI No SOS study) versus transfer to surgical centers for primary angioplasty. J Am Coll Card. 2004; 43: 1943–1950.
4. Lofti M, Mackie K, Dzavik V, Seidelin PH. Impact of delays to cardiac surgery after failed angioplasty and stenting. J Am Coll Cardiol. 2004; 43: 337–342.
5. Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, Abildgaard U, Pedersen F, Madsen JK, Grande P, Villadsen AB, Krusell LR, Haghfelt T, Lomholt P, Husted SE, Vigholt E, Kjaergard HK, Mortensen LS; DANAMI-2 Investigators. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003; 349: 733–742.
6. Widimsky P, Budesinsky T, Vorac D, Groch L, Zelizko M, Aschermann M, Branny M, St’asek J, Formanek P; PRAGUE Study Group Investigators. Long distance transport for primary angioplasty vs immediate thrombolysis in acute myocardial infarction. Eur Heart J. 2003; 24: 94–104.
Should patients with acute myocardial infarction be transferred to a tertiary center for primary angioplasty or receive it at qualified hospitals in the community?
Response to Keeley and Grines
Response to Wharton
Correspondence to Thomas P. Wharton, Jr, MD, The Perry Medical Services Building, Suite 101, 3 Alumni Drive, Exeter, NH 03833 (e-mail tom.wharton{at}comcast.net); or Ellen C. Keeley, MD, UT Southwestern Medical Center, Division of Cardiology, 5323 Harry Hines Blvd, Dallas, TX 75390-8837 (e-mail Ellen.Keeley@UTSouthwestern.edu).
We contend that there are 4 main reasons why STEMI patients should be emergently transferred to high-volume PCI centers for primary PCI rather than undergoing this procedure in small hospitals without on-site surgical backup, as proposed by Wharton. First, patients undergoing PCI in high-volume centers are treated more quickly and have lower rates of emergent CABG surgery and lower in-hospital mortality rates than those admitted to low-volume centers.1–4 Hospitals that do not fulfill the annual PCI volume required to maintain the skills of the interventionalist and the cardiac catheterization laboratory staff should not perform primary PCI. Second, the favorable results seen with primary PCI in highly selected STEMI patients in highly selected community hospitals without on-site surgical backup cannot be extrapolated to all STEMI patients presenting to community hospitals in the country. Significant dedication and effort on the part of the staff and the hospital and significant resources are required to develop and maintain a primary PCI program and ensure quality outcomes.5,6 Third, although the need for emergent CABG is uncommon, it is unpredictable and when it occurs, the inherent delay due to transfer results in high morbidity and mortality rates.7,8 Finally, although it is clear that primary PCI in high-volume centers with surgical backup is safe and effective (given data from 23 randomized trials comparing thrombolytic therapy with primary PCI at high-volume centers9 and many more randomized trials that evaluated primary PCI outcomes10–13), there are insufficient data regarding primary PCI in community hospitals without surgical backup (1 small, underpowered randomized trial5).
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The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.
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