Strategies for Reducing the Door-to-Balloon Time in Acute Myocardial Infarction
Elizabeth H. Bradley, Ph.D., Jeph Herrin, Ph.D., Yongfei Wang, M.S., Barbara A. Barton, R.N., Tashonna R. Webster, M.P.H., Jennifer A. Mattera, M.P.H., Sarah A. Roumanis, R.N., Jeptha P. Curtis, M.D., Brahmajee K. Nallamothu, M.D., David J. Magid, M.D., M.P.H., Robert L. McNamara, M.D., M.H.S., Janet Parkosewich, R.N., M.S.N., Jerod M. Loeb, Ph.D., and Harlan M. Krumholz, M.D.
Background Prompt reperfusion treatment is essential for patientswho have myocardial infarction with ST-segment elevation. Guidelinesrecommend that the interval between arrival at the hospitaland intracoronary balloon inflation (door-to-balloon time) duringprimary percutaneous coronary intervention should be 90 minutesor less. However, few hospitals meet this objective. We soughtto identify hospital strategies that were significantly associatedwith a faster door-to-balloon time.
Methods We surveyed 365 hospitals to determine whether eachof 28 specific strategies was in use. We used hierarchical generalizedlinear models and data on patients from the Centers for Medicareand Medicaid Services to determine the association between hospitalstrategies and the door-to-balloon time.
Results In multivariate analysis, six strategies were significantlyassociated with a faster door-to-balloon time. These strategiesincluded having emergency medicine physicians activate the catheterizationlaboratory (mean reduction in door-to-balloon time, 8.2 minutes),having a single call to a central page operator activate thelaboratory (13.8 minutes), having the emergency department activatethe catheterization laboratory while the patient is en routeto the hospital (15.4 minutes), expecting staff to arrive inthe catheterization laboratory within 20 minutes after beingpaged (vs. >30 minutes) (19.3 minutes), having an attendingcardiologist always on site (14.6 minutes), and having staffin the emergency department and the catheterization laboratoryuse real-time data feedback (8.6 minutes). Despite the effectivenessof these strategies, only a minority of hospitals surveyed wereusing them.
Conclusions Several specific hospital strategies are associatedwith a significant reduction in the door-to-balloon time inthe management of myocardial infarction with ST-segment elevation.
Prompt treatment increases the likelihood of survival for patientswho have myocardial infarction with ST-segment elevation.1,2,3Hospitals can therefore influence the outcomes for such patientsby developing and implementing systems and processes that minimizethe interval between arrival at the hospital and the administrationof reperfusion therapy. Since percutaneous coronary intervention(PCI) has become the preferred approach for treating myocardialinfarction with ST-segment elevation,4 hospitals are seekingways to reduce the door-to-balloon time, defined as the timebetween arrival at the hospital and the first balloon inflationduring PCI.
The importance of the door-to-balloon time is highlighted byits inclusion as one of the core quality measures collectedand reported by the Centers for Medicare and Medicaid Services(CMS) and the Joint Commission on Accreditation of HealthcareOrganizations. Concomitant with national efforts to improvethe care of patients with acute myocardial infarction have beensubstantial improvements in performance on many core measures(such as the use of aspirin and beta-blockers). However, performancewith respect to the door-to-balloon time continues to lag behindnational standards,4,5,6 which recommend an interval of 90 minutesor less. A minority of hospitals treat patients who presentwith myocardial infarction with ST-segment elevation within90 minutes after their arrival,7,8,9,10 and hospital performancehas not improved substantially in recent years.7
Previous qualitative work has identified some common approachesamong hospitals that have achieved a rapid door-to-balloon time.11,12However, it is not clear which strategies are most effectiveor how great their effect might be. We sought to identify operationaland clinical processes for treating patients who have myocardialinfarction with ST-segment elevation and to quantify the associationof these measures with hospital door-to-balloon times.
Methods
Study Design
We conducted a cross-sectional study of acute care hospitalsin the United States with the use of a Web-based survey to determinethe internal processes for identifying and treating patientswith myocardial infarction with ST-segment elevation who undergoPCI. Eligible hospitals were those that reported the door-to-balloontime as a CMS performance measure and had reported an annualizedvolume of at least 25 PCI cases during 2004. From the 818 eligiblehospitals, we randomly selected 500 hospitals and contactedthe chief executive officer, first by letter and then by e-mail,to explain the goals and procedures of the study and to requestthe hospital's participation. The chief executive officer providedthe contact information for the person in the organization whomthey deemed to be the most appropriate respondent for the Web-basedsurvey. This protocol was approved by the institutional reviewboard at the Yale School of Medicine.
Measures and Data Collection
From the hospital contact person, we obtained information aboutspecific hospital strategies relevant to the door-to-balloontime, using a survey developed from our previous qualitativestudy11 (see the Supplementary Appendix, available with thefull text of this article at www.nejm.org). We developed closed-ended,multiple-choice questions for each hospital strategy and field-testedthe instrument for clarity and comprehensiveness before implementation.The questionnaire asked about strategies in place at the timeof the survey (April through October 2005). The final instrumentincluded 32 items concerning 28 key hospital strategies. Responsecategories included "no standard approach" for cases of partialadoption of certain practices.
The outcome was the door-to-balloon time for patients with myocardialinfarction with ST-segment elevation who underwent PCI betweenApril and September 2005. Data on individual patients were obtainedfrom CMS. On the basis of CMS specifications,13 we includedall patients with myocardial infarction with ST-segment elevationwho were treated with PCI, except those who were transferredfrom other hospitals. CMS validates these hospital quality datareports with the use of quarterly validation samples that areabstracted and compared with the reported data.
Statistical Analysis
For each of the 28 hospital strategies, we determined the numberand percentage of hospitals in each response category, as wellas the average of the median door-to-balloon times of thosehospitals. To evaluate the association between specific hospitalstrategies and the door-to-balloon time, we used hierarchicalgeneralized linear models,14 which account for the clusteringof patients within hospitals. We used the logarithm of the door-to-balloontime in our analysis to reduce skewness. For bivariate comparisons,we constructed a separate model for each hospital strategy.
We constructed a multivariate model, including independent variablesthat added significantly to the fit of the overall model (P<0.10with the use of the likelihood ratio test for nested models),and sequentially excluded the variables that contributed theleast to the fit of the model. Although the correlations amongvariables were modest (Cramer phi coefficient, <0.20 for92% of the correlations), two variables were particularly stronglycorrelated (Cramer phi coefficient, 0.87). These variables werethe specialty of the physician who was responsible for activatingthe catheterization laboratory on day shifts and the specialtyof the physician who had that responsibility for night-and-weekendshifts. Therefore, we created a separate dummy variable forthe multivariate analysis, which indicated whether emergencymedicine physicians were responsible for activating the catheterizationlaboratory on day shifts as well as on night-and-weekend shifts.We also examined the effects of several hospital characteristics(location, teaching status, number of staffed beds, type ofownership, geographic region, capability of performing coronary-arterybypass grafting [CABG], and participation or nonparticipationin a multihospital system). However, none of these variablesmaterially changed the effects of hospital strategies on thedoor-to-balloon time, and each was removed from the multivariatemodel. In reporting the data, we used an alpha level of 0.05as the criterion for the statistical significance of the estimatedeffects of individual hospital strategies on the door-to-balloontime.
To facilitate the interpretation of the estimated effects, wecentered all independent variables on their means, so that theintercept represented the mean of all independent variables.15,16Hence, the effect of individual strategies on the door-to-balloontime was calculated as the difference between the door-to-balloontime of hospitals implementing the selected strategy and hospitalsnot implementing the selected strategy, assuming the averageresponse on all other strategies. We used simulation techniques17,18,19to transform estimated effects and confidence intervals in logunits back into their natural units (i.e., minutes). All analyseswere performed with the use of SAS software, version 9.1 (SASInstitute) and Stata 9 (Stata).
Results
Hospital Survey
We received responses from representatives of 365 of the 500hospitals contacted (73%) (Table 1). The responding personsfor each hospital were typically quality management directors,although cardiovascular nurse managers and medical directorswere also involved at many hospitals. Nonrespondent hospitalsdid not differ significantly from respondent hospitals in termsof the annualized number of PCIs performed, the number of staffedbeds, teaching status, geographic region, or median door-to-balloontime; however, rural hospitals were significantly less likelythan urban hospitals to respond (P=0.02), and for-profit hospitalswere significantly less likely than government or nonprofithospitals to respond (P=0.01). Among the 365 respondents, 3hospitals did not report data with regard to door-to-balloontimes to CMS during the study period and were excluded frombivariate and multivariate analyses; 2 additional hospitalswere missing one or more responses to survey items and wereexcluded from the multivariate analysis.
Figure 1 shows the frequency distribution of median door-to-balloontimes for the hospitals studied. The range of median valueswas wide, with many institutions having median times that exceededthe 90-minute interval recommended in the 2004 guidelines ofthe American Heart Association and the American College of Cardiology.4The mean [±SD] of the median door-to-balloon times ofall the hospitals was 100.4±23.5 minutes. There was alsosubstantial variation in the prevalence of specific hospitalstrategies to expedite the door-to-balloon time. A number ofstrategies had significant unadjusted (bivariate) associationswith the door-to-balloon time (Table 2).
Figure 1. Frequency Distribution for Median Door-to-Balloon Times among Study Hospitals.
The median door-to-balloon time was calculated for each hospital in the study. The mean (±SD) of these median times was 100.4±23.5 minutes, which is considerably longer than the 90-minute interval recommended in the 2004 guidelines of the American Heart Association and the American College of Cardiology.4
Table 2. Unadjusted Associations between Hospital Strategies and Door-to-Balloon Time.
The multivariate model identified six hospital strategies thatadded significantly to the fit of the model (P<0.10 for nestedmodels) and were associated with a significantly lower door-to-balloontime. Some associations were particularly strong, indicatingan estimated savings in the door-to-balloon time of 10 to 15minutes (Table 3). These strategies were generally implementedin a minority of hospitals. Hospitals that implemented a greaternumber of effective strategies tended to have a shorter door-to-balloontime (Table 4).
Table 4. Door-to-Balloon Time According to the Number of Key Strategies Used.
Hospital practices regarding activation of the catheterizationlaboratory had a significant effect on the door-to-balloon time.The intervals were shorter for hospitals in which emergencymedicine physicians activated the catheterization laboratorywithout consulting a cardiologist; those in which the catheterizationlaboratory was activated with a single call from the emergencydepartment to a central page operator, who then paged both theinterventional cardiologist and the catheterization laboratorystaff; and those in which staff were expected to arrive in thecatheterization laboratory either within 20 minutes or 21 to30 minutes after being paged (P=0.002 for the comparison withan interval of 20 minutes or less and P=0.003 for the comparisonwith an interval of more than 30 minutes). In addition, hospitalsthat always had an attending cardiologist at the hospital hada faster door-to-balloon time than did hospitals without anattending cardiologist always on site.
Hospitals that used the results of electrocardiography thatwere called in or transmitted by emergency medical servicesto activate the catheterization laboratory while the patientwas still en route to the hospital had significantly fasterdoor-to-balloon times than did hospitals that waited for thepatient to arrive before activating the catheterization laboratory(P=0.001). The hospitals that activated the laboratory whilethe patient was still en route also had significantly fasterdoor-to-balloon times than did hospitals reporting that emergencymedical services never performed electrocardiography (P=0.01).In addition, hospitals reporting that emergency medical servicescalled in or transmitted the results of electrocardiographybut also reporting various methods of handling such informationhad faster door-to-ballooon times than did hospitals that neverreceived such information (P=0.01). Methods of handling theinformation may have included activating the catheterizationlaboratory while the patient was en route to the hospital, butwith no set protocol for this procedure at the hospital. Finally,hospitals that provided real-time data feedback on the door-to-balloontime to staff members in the emergency department and catheterizationlaboratory had faster door-to-balloon times than those thatdid not (P=0.001).
One item in our survey requested an estimate of how frequentlyin the previous 6 months the catheterization laboratory hadbeen activated for PCI but then had not been needed. This questionwas used to evaluate the effect of specific hospital policieson the frequency of such false alarms. The median number offalse alarms that was reported among hospitals in which emergencymedicine physicians activated the catheterization laboratorywas 2 (interquartile range, 1 to 4), as compared with 1 falsealarm (interquartile range, 0 to 3) for all other hospitals.Among hospitals using electrocardiographic data obtained enroute to activate the catheterization laboratory, the mediannumber of false alarms was 2 (interquartile range, 1 to 4) inthe previous 6 months.
Hospital policies regarding the performance and assessment ofelectrocardiography in the emergency department did not havea significant effect on the door-to-balloon time, in eitherbivariate or multivariate analyses. These policies includedthe use of written criteria for deciding which patients shouldundergo immediate electrocardiography, provision of formal trainingin the assessment of acute coronary syndromes for triage staffmembers in the emergency department, inclusion of dedicatedelectrocardiographic technicians in the emergency department,and provision of dedicated space for performing electrocardiographyin the triage area. In addition, policies and practices relatedto transporting patients from the emergency department to thecatheterization laboratory (e.g., timing and staff required)were not significantly related to the door-to-balloon time inmultivariate analysis. Practices in the catheterization laboratorythat were surveyed were also not significantly associated withthe door-to-balloon time in either bivariate or multivariateanalyses. These practices included rescheduling elective PCIcases as emergency PCI cases, leaving the catheterization laboratoryprepared for the next PCI to begin promptly, involving cardiologyfellows in performing PCI, and locating the catheterizationlaboratory on the same floor as the emergency department.
Discussion
In a cross-sectional study of 365 acute care hospitals in theUnited States, we identified several hospital strategies thatwere strongly associated with the door-to-balloon time in theperformance of PCI for patients with acute myocardial infarctionwith ST-segment elevation. In some cases, specific practiceswere associated with time savings of 10 to 15 minutes, a clinicallyimportant advantage in a group of institutions with a mean valueof 100 minutes for median door-to-balloon times. Many of thestrategies are not commonly used in hospitals in the UnitedStates, which may account in part for the relatively poor performanceof such hospitals in meeting guidelines for the door-to-balloontime.
Although implementation of some of the advantageous strategieswould require investment in new resources, other strategiesthat are currently used by only a minority of hospitals couldbe implemented with existing resources. For instance, havingemergency medicine physicians determine whether a myocardialinfarction with ST-segment elevation is present and activatethe catheterization team without involvement of a cardiologistwas strongly associated with a reduced door-to-balloon timebut was used in only about 23% of hospitals during weekdaysand in 27% of hospitals at night or on weekends. Furthermore,having the catheterization laboratory activated by a singlecall from the emergency department to a central page operator,who then paged both the interventional cardiologist and thecatheterization laboratory staff, was strongly associated witha faster door-to-balloon time, but the single-call process wasused in only about 14% of hospitals in this study. Researchon the time to fibrinolytic therapy20 and small, single-hospitalstudies of the door-to-balloon time21,22 have also indicatedthat treatment is more rapid if emergency medicine physiciansmake the treatment decision without the involvement of a cardiologist.Nonetheless, most hospitals still involve a cardiologist inthe decision to activate the catheterization laboratory.
In addition to the strategies that focus on processes withinthe hospital, the hospital's coordination with emergency medicalservices was strongly associated with the door-to-balloon time.Previous studies23,24,25 have shown that performing electrocardiographyen route to the hospital can reduce the door-to-balloon time,and the National Heart Attack Alert Program Coordinating Committee26has recommended increased use of such electrocardiographic services.In our study, the percentage of patients with acute coronarysyndrome who underwent electrocardiography en route was notassociated with the door-to-balloon time. Instead, it was theway that such electrocardiograms were used by hospitals thatwas important. Hospitals that activated the catheterizationlaboratory on the basis of electrocardiography performed whilethe patient was en route and those that had varied strategiesto respond to electrocardiographic data transmitted from emergencymedical services had an advantage. Determining the optimal approachfor incorporating such electrocardiographic data into hospitalprocesses to expedite the door-to-balloon time is an importantarea for future research.
False alarms were reported to be infrequent in our study, evenat hospitals where emergency medicine physicians were responsiblefor activation of the catheterization laboratory on the basisof electrocardiography performed en route to the hospital. Wewere not able to obtain independent confirmation of the accuracyof the hospitals' estimates of false alarms. However, we haveno evidence to suggest that these data are inaccurate, and webelieve that perceptions about the number of false alarms areprobably as important as is the true number of false alarmsin determining whether noncardiologists are permitted to activatethe catheterization laboratory. This issue may be clarifiedby further study.
Implementation of other strategies that were associated withfaster door-to-balloon time may be more complex. The presenceof an attending cardiologist at the hospital at all times wasassociated with a significantly faster door-to-balloon time.These strategies may be impractical or prohibitively expensiveto implement in many hospitals.
Several considerations are important in interpreting our results.First, the survey data were reported by a single respondentat the hospital, and the reported policies and practices werenot independently confirmed. However, respondents were selectedby the chief executive officer of each hospital as the personwho was most familiar with activities in this area, and thequestions were field-tested before their use to ensure theirclarity and completeness.
Second, the hospitals were restricted to those that reportedthe door-to-balloon time as one of their CMS performance measures.These hospitals may have been more aggressive than others intheir efforts to reduce the door-to-balloon time. Therefore,the prevalence of some strategies may be overestimated, buteven for this group, the overall rates were low for most ofthe strategies. In addition, it may not have been possible todetect the influence of some practices because of a high prevalenceof the preferred practice (e.g., 97% of surveyed hospitals donot wait for laboratory and radiographic results to activatethe catheterization laboratory). Nevertheless, the respondenthospitals did reflect a spectrum of performance in the door-to-balloontime.
Third, with the observational study design, we could not determinewhether some of the strategies identified were surrogates forunmeasured care processes that might have been important contributorsto a reduced door-to-balloon time. The processes tested, however,emerged from qualitative studies11,12 and have strong face validityfor a causal relationship. In addition, some strategies maybe important in particular institutions but not across the fullsample, and our results should not inhibit innovations thatmay be effective in particular settings.
Finally, we were unable to examine efforts that may reduce thetime from the onset of symptoms to admission or the time afterarrival at the first hospital to balloon inflation for patientswho were transferred to a hospital in which PCI is performed.These are important topics for future study, because delaysin reperfusion therapy are commonplace for transferred patients.27
In conclusion, this study used survey information from 365 acutecare hospitals to determine which specific policies and practiceswere in use for facilitating rapid PCI in patients with acutemyocardial infarction with ST-segment elevation. These policiesand practices, as reported, were correlated with data on individualpatients with regard to the door-to-balloon time, permittingthe identification of hospital strategies associated with themost prompt performance of this critical intervention.
Supported by a grant (R01HL072575) from the National Heart,Lung, and Blood Institute in Bethesda, MD, and by a grant (02-102,to Dr. Bradley) from the Patrick and Catherine Weldon DonaghueMedical Research Foundation in Hartford, CT. The analyses onwhich this article is based were performed under contract HHSM-500-2005-CO001C,entitled "Utilization and Quality Control Quality ImprovementOrganization for the State of Colorado," sponsored by the CMS.
No potential conflict of interest relevant to this article wasreported.
The views expressed in this article are those of the authorsand do not necessarily reflect the views of the Department ofHealth and Human Services, nor does mention of trade names,commercial products, or organizations imply endorsement by theU.S. government.
We thank Steven Jencks, M.D., for his suggestions regardingthe manuscript.
Source Information
From the Departments of Epidemiology and Public Health (E.H.B., T.R.W., H.M.K.) and Medicine (J.H., Y.W., J.P.C., R.L.M., H.M.K.), Yale University School of Medicine; Yale–New Haven Hospital (B.A.B., J.A.M., S.A.R., J.P., H.M.K.); and Yale University School of Nursing (J.P.) — all in New Haven, CT; the University of Michigan Medical Center and the Ann Arbor Veterans Affairs Medical Center, Ann Arbor (B.K.N.); Kaiser Permanente and the University of Colorado Health Sciences Center, Denver (D.J.M.); and the Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, IL (J.M.L.). This article was published at www.nejm.org on November 13, 2006.
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Door-to-Balloon Time in Acute Myocardial Infarction
Dalby M., Roughton M., Ilsley C., de LaCoussaye J. E., Carli P. A., Umans V. A., Peels H. O., Wharton T., Hall J., Roberts T., deBelder M., Townend J. N., Bradley E. H., Krumholz H. M., Moscucci M., Eagle K. A.
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