Published online before print June 11, 2007, doi: 10.1161/CIRCULATIONAHA.106.677401
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(Circulation. 2007;116:67-76.)
© 2007 American Heart Association, Inc.
Interventional Cardiology |
Emergency Department Physician Activation of the Catheterization Laboratory and Immediate Transfer to an Immediately Available Catheterization Laboratory Reduce Door-to-Balloon Time in ST-Elevation Myocardial Infarction
From the Indiana Heart Physicians, Indianapolis (U.N.K., M.B.K., S.R.S., W.J.B.); St. Francis Hospital and Health Centers, Beech Grove (M.L.J.); Curtis Ramsey and Associates, Indianapolis (C.S.); and Emergency Physicians of Indianapolis, Beech Grove (R.T.), Ind.
Correspondence to Umesh N. Khot, MD, Indiana Heart Physicians/St. Francis Heart Center, 5330 E Stop 11 Rd, Indianapolis, IN 46237. E-mail khot{at}cvresearch.net
Received November 20, 2006; accepted April 20, 2007.
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Abstract |
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Background— Consensus guidelines and hospital quality-of-care programs recommend that ST-elevation myocardial infarction patients achieve a door-to-balloon time of
90 minutes. However, there are limited prospective data on specific measures to significantly reduce door-to-balloon time. Methods and Results— We prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization laboratory and (2) immediate transfer of the patient to an immediately available catheterization laboratory by an in-house transfer team consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse. We collected door-to-balloon time for 60 consecutive ST-elevation myocardial infarction patients undergoing emergency percutaneous intervention within 24 hours of presentation from October 1, 2004, through August 31, 2005, and compared this group with 86 consecutive ST-elevation myocardial infarction patients from September 1, 2005, through June 26, 2006, after protocol implementation. Median door-to-balloon time decreased overall (113.5 versus 75.5 minutes; P<0.0001), during regular hours (83.5 versus 64.5 minutes; P=0.005), during off-hours (123.5 versus 77.5 minutes; P<0.0001), and with transfer from an outside affiliated emergency department (147 versus 85 minutes; P=0.0006). Treatment within 90 minutes increased from 28% to 71% (P<0.0001). Mean infarct size decreased (peak creatinine kinase, 2623±3329 versus 1517±1556 IU/L; P=0.0089), as did hospital length of stay (5±7 versus 3±2 days; P=0.0097) and total hospital costs per admission ($26 826±29 497 versus $18 280±8943; P=0.0125).
Conclusions— Emergency department physician activation of the catheterization laboratory and immediate transfer of the patient to an immediately available catheterization laboratory reduce door-to-balloon time, leading to a reduction in myocardial infarct size, hospital length of stay, and total hospital costs.
Key Words: angioplasty • myocardial infarction • quality of health care • stents • quality indicators, health care
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Introduction |
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Emergency percutaneous intervention (PCI) is increasingly used in the management of ST-elevation myocardial infarction (STEMI). The benefits of emergency PCI are time dependent, with door-to-balloon time delays associated with increasing mortality.1 Therefore, consensus guidelines recommend that STEMI patients achieve a door-to-balloon time of
90 minutes.2 More recently, the American College of Cardiology, American Heart Association, the Centers for Medicare and Medicaid Services, and the Joint Commission on Accreditation of Healthcare Organizations have all included door-to-balloon time as a core hospital quality-of-care indicator.3–5 Despite the increased emphasis on achieving appropriate door-to-balloon times, only 32% of patients overall in the United States receive PCI within 90 minutes.6,7 In addition, there has been limited temporal improvement in door-to- balloon time,8 leading some to suggest that future improvements in door-to-balloon time are unlikely.9 Interestingly, select hospitals have achieved improvements in door-to-balloon times, and recent studies have highlighted qualitative characteristics unique to these institutions.10 More recently, a survey of hospital strategies revealed that activation of the catheterization laboratory by the emergency department physician rather than cardiologist was associated with faster door-to-balloon times.11 Prior studies actually implementing emergency department physician activation have shown improvements in door-to-balloon time. One report revealed a reduction in median door-to-balloon from 88 to 61 minutes.12 However, the results of that study were confounded by simultaneous conversion of reperfusion strategy from a combination of thrombolytics and PCI to solely PCI. In addition, the study excluded data from a 6-month transition period between strategies. In a recent retrospective study, emergency department physician activation reduced door-to-balloon time from 118 to 89 minutes.13 There are limited prospective data on the effect of adopting emergency department physician activation of the catheterization laboratory on door-to-balloon time in centers already dedicated to primary PCI. We therefore prospectively determined the impact on door-to-balloon time of emergency department physician activation of the catheterization laboratory, combined with a novel strategy of immediate physical transfer of the patient to an immediately available catheterization laboratory by in-house nursing staff.
Editorial p 6
Clinical Perspective p 76
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Methods |
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Study Design
The present prospective study was conducted between October 1, 2004, and June 26, 2006, at St Francis Hospital and Health Center (Beech Grove and Indianapolis, Ind), a 591-bed tertiary care community hospital consisting of 2 campuses 7 miles apart (13-minute drive). Both campuses have emergency departments staffed with emergency medicine residency–trained physicians; cardiology services are located within the Indianapolis campus. During the study period, the hospital performed primary PCI for all STEMI patients presenting at either campus. A single 20-physician group provides cardiology services at both campuses (Indiana Heart Physicians, Indianapolis). Cardiologists take in-hospital call. Call consists of a noninterventional cardiologist on call with interventional cardiologist on backup call at home
80% of the time; the other 20% of the time, an interventional cardiologist takes primary call. Call pattern was unchanged during the study period. Four catheterization staff members take home call during off-hours and are expected to arrive to the hospital within 30 minutes of laboratory activation. We prospectively enrolled consecutive patients who presented to either the Beech Grove or Indianapolis emergency department with STEMI who received PCI within 24 hours of presentation.4,5 We excluded STEMI patients who were hospital inpatients at the time of diagnosis.
Protocol During Cardiology Activation/Routine Transfer Period (October 1, 2004, Through August 31, 2005)
Emergency department physicians requested immediate cardiology evaluation for all STEMI patients. After patient evaluation, the cardiologist activated the catheterization laboratory by contacting the catheterization laboratory coordinator during regular hours (7 AM to 5 PM weekdays) or the hospital operator during off-hours (weekends and 5 PM to 7 AM weekdays). During regular hours, the catheterization laboratory coordinator notified the emergency department to transfer the patient when a catheterization room became available. During off-hours, transfer to the catheterization laboratory occurred on arrival of 2 catheterization staff members.
Protocol During Emergency Department Activation/Immediate Transfer Period (September 1, 2005, Through June 26, 2006)
On September 1, 2005, at 7 AM, we implemented a protocol mandating (1) emergency department physician activation of the catheterization laboratory and (2) immediate transfer of the patient to an immediately available catheterization laboratory by an in-house emergency heart attack response team (EHART) consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse. The only exceptions to immediate transfer by the nursing staff were hemodynamic compromise (requiring pressors, temporary pacing, or balloon pump) and ongoing cardiopulmonary resuscitation; these patients were prepared for immediate transfer but transferred by the nursing staff with the cardiologist. The emergency department physician contacted the hospital operator to activate the catheterization laboratory. The operator subsequently paged the cardiology physician assistant, catheterization laboratory coordinator, and critical care unit nurse during regular hours or the on-call cardiologist, interventional cardiologist, critical care unit nurse, chest pain unit nurse, and on-call catheterization team during off-hours. On catheterization laboratory activation, the critical care unit nurse proceeded to the emergency department and subsequently transferred the patient to the catheterization laboratory with the emergency department nurse. During transfer, in case of sustained hypotension or arrest, the critical care unit nurse could administer dopamine or norepinephrine intravenous drips, perform defibrillation, and request intubation by respiratory therapy, all without prior physician approval. The critical care unit modified the work requirements for the EHART nurse by assigning the nurse 1 patient instead of 2 patients.
To make the catheterization laboratory immediately available during regular hours, the catheterization laboratory coordinator identified a catheterization room and staff for the patient. The catheterization laboratory coordinator could remove an elective patient from the catheterization laboratory if the case had not started (defined as cardiologist fully scrubbed at bedside obtaining access). If all rooms were occupied with cases in progress, then the STEMI patient went to the first available room. On patient placement on the catheterization laboratory table, the EHART team members transferred the patient’s nursing care to the catheterization team.
To make the catheterization laboratory immediately available during off-hours, the chest pain unit nurse proceeded to the catheterization laboratory, activated the catheterization laboratory imaging equipment, and confirmed that the temporary pacemaker, balloon pump, defibrillator, and activated clotting time machine were in working order. This individual subsequently assisted the critical care unit nurse and emergency department nurse in the initial setup of the patient, including placement on the catheterization table, monitoring equipment setup, prepping of groin, and assistance with the sterile catheterization laboratory table. The emergency department nurse and critical care nurse monitored the patient until the third and fourth catheterization staff members arrived and subsequently transferred nursing care to the catheterization team. If the patient was unstable, all staff attended to the patient until safe transfer of care was possible. Table 1 compares the processes in the 2 time periods.
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All activities in the emergency department, during the transfer to the catheterization laboratory, and during initial setup in the catheterization laboratory did not require cardiologist presence or input (see the order set available at www.stfrancishospitals.org/heart). The cardiologist evaluated the patient and determined the appropriateness for emergency catheterization in the emergency department, en route to the catheterization laboratory, or in the catheterization laboratory.
Study End Points and Statistical Analysis
The primary end point was median door-to-balloon time.3 Door time represented the arrival time at the initial emergency department. Secondary end points included the individual components of door-to-balloon time (ie, door-to-ECG time), infarct size measured by peak creatinine kinase within the first 24 hours,14 hospital costs (total, direct, and indirect), hospital length of stay, and all-cause in-hospital mortality. Hospital cost data reflect the actual costs involved in the delivery of care to each patient and were determined by the cost-accounting software of the hospital (Alliance for Decision Support, Avega, El Segundo, Calif). Cost data for all patients (including outliers) were analyzed. All-cause in-hospital mortality was presented in unadjusted fashion. We determined the prevalence of "false-positive" activation, defined as a patient sent to the catheterization laboratory by the emergency department physician but who subsequently was determined to be an inappropriate activation by the cardiologist. All patients provided informed consent. Our institutional review board approved the study.
Time values are presented as medians with interquartile ranges and were analyzed using 2-sample Wilcoxon rank sum tests. Other continuous data are presented as mean±SD and were analyzed by 2-sample t tests. Categorical data are presented as proportions and were analyzed by Fisher exact test. Values of P<0.05 were considered statistically significant. Stata software was used for statistical analyses (version 8.2, Stata Corp, College Station, Tex).
The authors had full access to and take responsibility for the integrity of the data. All authors have read and agree to the manuscript as written.
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Results |
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From October 1, 2004, to August 30, 2005, 68 consecutive patients presented with STEMI, and 60 patients met the inclusion criteria (Figure 1). From September 1, 2005, to June 26, 2006, 96 consecutive patients presented with STEMI, and 86 patients met the inclusion criteria. The proportions of patients with normal/mild coronary artery disease (4.4% versus 5.2%; P=1), significant coronary artery disease (>50% stenosis) managed medically (1.5% versus 1%; P=1), or coronary artery bypass grafting (2.9% versus 1%, P=0.57) were similar. Unadjusted all-cause in-hospital mortality was similar (intention to treat, 7.4% versus 5.2%, P=0.74; post-PCI, 5% versus 4.7%, P=1).
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Demographics, initial presentation details, and treatments were similar (Table 2
). Emergency department physician catheterization laboratory activation increased from 0% to 87% (P<0.0001).
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Median door-to-balloon time decreased from 113.5 to 75.5 minutes (P<0.0001) (Table 3). Reductions in door-to-balloon time were seen during regular hours, during off-hours, and with transfer from 1 campus to another (Table 3). Improvements were seen regardless of gender, ambulance or nonambulance presentation, or need for additional procedures (defibrillation, pacemaker, balloon pump) before PCI. Patients presenting during regular hours had a median door-to-balloon time of 45 minutes.
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The most substantial decrease occurred in time spent in the emergency department and in transportation to the catheterization laboratory (Table 3). Door-to-ECG and catheterization laboratory–to–sheath placement times showed no change, although there was a modest but statistically significant decrease in sheath-to-balloon time. Mean infarct size and hospital length of stay decreased. Total hospital costs, direct hospital costs, and indirect hospital costs all decreased.
The proportion of patients treated within 90 minutes increased from 28% to 71% (P<0.0001) (Table 4). There was a >2-fold increase in the treatment within 60 minutes and a nearly 10-fold reduction in treatment requiring >120 minutes (P<0.0001).
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During the 10-month emergency department activation/immediate transfer period, the prevalence of "false-positive" activation by an emergency department physician was 1% (1 of 97). A patient with flash-pulmonary edema was misrouted to the catheterization laboratory instead of the critical care unit. This case occurred early in the implementation of the program, and focused review indicated that emergency department physician-cardiologist misunderstanding was the root cause of the problem (patient not included in Figure 1).
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Discussion |
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Emergency department physician activation of the catheterization laboratory and immediate transfer of the patient to an immediately available catheterization laboratory by an in-house nursing team led to a substantial reduction in door-to-balloon time. This reduction was seen regardless of time of day, ambulance or nonambulance presentation, and clinical characteristics of the patient (Table 3). The success of our protocol came from transforming a rigid system of stepwise serial processes into a parallel process system with nearly simultaneous performance of catheterization laboratory activation, physical transfer to catheterization laboratory, initial catheterization laboratory setup, and cardiology evaluation (Figure 2). In addition, our data confirm a recent survey of hospital practices highlighting the importance of emergency department physician activation of the catheterization laboratory and add an immediate transfer process to the list of strategies that reduce door-to-balloon time.11 Finally, the present study is one of the first prospective studies to reveal that decreasing door-to-balloon time leads to decreased infarct size, length of stay, and hospital costs.
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Providing timely emergency PCI is a complex undertaking demanding rapid coordination of care by multiple physicians, nurses, and hospital staff. In prior reports, an audit process, in-depth continuous quality control improvement analysis, and multidisciplinary quality initiatives have all improved door-to-balloon time.15–19 However, the specific steps recommended have varied between these studies, making it challenging for other institutions to adopt specific protocols to improve their door-to-balloon time. In addition, the recommended measures have been multiple and often complex, typically requiring months to years for full implementation.18,19 In contrast, the present study showed that 2 simple, focused modifications rapidly reduced door-to-balloon time and could be implemented rapidly within a day.
Our protocol was resisted initially because of concerns that emergency department physician activation of the catheterization laboratory would not reduce door-to-balloon time since our cardiologists took in-house call. However, this simple change allowed catheterization laboratory staff to arrive 20 to 40 minutes earlier (Table 3), indicating that there are considerable delays associated with even waiting for in-house cardiology evaluation. In addition, although emergency department physician interpretation of ST-segment elevation typically is accurate,20 our cardiologists were concerned about inappropriate activation of the catheterization laboratory by the emergency department physicians. We overcame this resistance by emphasizing that the decision to activate the laboratory and the decision to perform catheterization and intervention were distinct. Thus, the final decision regarding appropriateness for emergency catheterization remained with cardiology, and our cardiologists were instructed to perform catheterization only if they agreed with the emergency department assessment. We further audited all cases for appropriateness and provided this information to the emergency department physicians and cardiologists. Ultimately, inappropriate activations occurred rarely11 and were eventually accepted as necessary to improve the overall care of STEMI patients.
The largest component of door-to-balloon time is the time spent within the emergency department and transferring to the catheterization laboratory.15,18 Transfer out of the emergency department to the catheterization laboratory often is hampered by structural impediments such as strict requirements for cardiology consultation or catheterization laboratory readiness before transfer.11 Furthermore, during day hours, the catheterization laboratory can be occupied by elective cases, further impeding the STEMI patient’s access to the catheterization laboratory. The importance of addressing the transfer process was underscored by a report showing that simply preparing patients for transfer to the catheterization laboratory reduced emergency department time.15 Although a recent survey of hospital practices did not identify transfer process as a factor in door-to-balloon time, this is likely related to the fact that 93% of hospitals practiced in a manner similar to the routine transfer period of the present study and required the catheterization laboratory to notify the emergency department when it was ready before transfer. In fact, none of the hospitals in the survey had an immediate transfer policy in place.11 The present study shows that the decision to transfer the patient should originate in the emergency department and that the catheterization laboratory should be immediately prepared to receive the patient.
Any transfer of a critically ill patient within the hospital is associated with a potential risk of decompensation or adverse event during transfer, and there was concern regarding the safety of transfer without a cardiologist. To maximize patient safety during transfer, the transfer team included a critical care nurse who had standing orders for events such as unstable heart rhythms or hypotension. We also excluded from immediate transfer patients with ongoing cardiopulmonary resuscitation or hemodynamic instability. In addition, because our cardiologists were in-house, the time without cardiologist presence was minimized. Finally, even in critically ill patients, proceeding to the catheterization laboratory as soon as possible was believed to allow more timely delivery of lifesaving interventions, outweighing the potential risk of transfer.
The present study included patients who were transferred for emergency PCI from another emergency department at our other campus. Such transfer patients are typically excluded from most analyses15,18 and are specifically excluded from public reporting of quality indicators despite having the longest door-to-balloon times.4,5 In the National Registry of Myocardial Infarction, transfer patients had a median door-to-balloon time of 180 minutes, with only 4.2% achieving reperfusion within 90 minutes.7 With our new protocol, the median door-to-balloon time decreased to 85 minutes, and 62% of these patients were treated within 90 minutes. Thus, our protocol leads to improvement in the care of STEMI patients transferred directly for PCI.
Most patients undergoing emergency PCI present during off-hours, and only 26% undergo reperfusion in 90 minutes.6 It has been suggested that hospitals that perform PCI have catheterization staff on site 24 hours to ensure timely revascularization or to cross-train in-house staff to perform catheterization staff duties.6 However, even in high-volume centers, 24-hour coverage would be prohibitively expensive, and maintaining proficiency of cross-trained staff exposed to nighttime myocardial infarction cases only would be challenging. Our use of an in-house transfer team allowed us to substantially improve the care of off-hours patients while maintaining the delivery of care by a highly trained catheterization staff.
Study Limitations
Although the 2 cohorts were similar, baseline differences cannot be completely accounted for between the 2 time periods because of the nonrandomized nature of the present study. Nevertheless, the present study design reflects the "real-life" manner in which physicians and hospitals implement process improvements and is similar to other process improvement studies.21 The present study was performed in a community hospital setting with cardiologists taking in-house call. However, the protocol could be adapted for cardiologists taking home call only or for the inclusion of residents and fellows in academic settings. Our results could be explained by increased attention to door-to-balloon time; however, our results during the baseline time period were widely presented to physician and hospital staff with no door-to-balloon time improvement. Our transfer patients traveled a 7-mile distance, and our results may not be applicable to longer transfer distances. Emergency medicine residency–trained physicians staffed our emergency departments, and staffing by a different mix of physicians may not be able to duplicate our results. Our results occurred with limited availability of prehospital ECG, but we believe the use of ECGs is complementary and could further reduce door-to-balloon time. However, 50% of STEMI patients nationwide do not present by ambulance, underscoring the importance of protocols that improve the care of all patients.22
Emergency department activation of the catheterization laboratory and immediate transfer of the patient to an immediately available catheterization laboratory by an in-house transfer team are 2 specific measures that allow the delivery of PCI in a timely fashion to a broad population of patients. Additional benefits include reductions in myocardial infarct size, hospital length of stay, and total hospital costs. Widespread implementation of this simple strategy can substantially improve the quality of care of STEMI patients undergoing emergency PCI. An electronic copy of the order set used in the EHART protocol is available at www.stfrancishospitals.org/heart.
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Appendix |
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The following individuals participated in the present study. Indiana Heart Physicians, Indianapolis: A. Akinwande, M. Barron, J. Christie, H. Genovely, J. Graham, D. Hadian, M. Jones, S. Karanam, D. Kovacich, I. Labin, S. Lall, J. Mossler, G. Revytak, and R. Shea. Emergency Physicians of Indianapolis, Beech Grove, Ind: S. Antoine, D. Blank, S. Boha, M. Brown, W. Corbett, D. Debikey, B. Dillman, K. Ernsting, M. Fitzpatrick, G. Godfrey, C. Hartman, B. Johnston, S. Kistler, H. Levitin, R. Mara, W. McDaniel, E. Olson, M. Overfelt, M. Russell, A. Stern, M. Stone, and E. Weinstein.
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Acknowledgments |
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We are indebted to Mechelle L. Peck, RN; Diana L. Brown, RN; Mark Manning, CCT; Patricia L. Wray, RN; Stephen H. Kliman, MD; Juan E. Weksler, MD; Carl L. Rouch, MD; and Horace O. Hickman, MD, who were intimately involved in the implementation of the present study.
Sources of Funding
Indiana Heart Physicians and St Francis Hospital and Health Centers provided funding for the present study. The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Disclosures
None.
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