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Improvement in Door-to-Ballon(D2B)Time in Acute ST-Elevation Myocardial Infarction Through the D2B Alliance

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Circulation Journal

Official Journal of the Japanese Circulation Society http : / /ww w . j-circ.or.jp

ORIGINAL  ARTICLE

Critical Care

Improvement in Door-to-Balloon (D2B) Time in Acute

ST-Elevation Myocardial Infarction

Through the D2B Alliance

– Experience of 15 Primary Percutaneous Coronary

Intervention Centers in Taiwan –

Su-Kiat Chua, MD; Jun-Jack Cheng, MD, PhD; Kou-Gi Shyu, MD, PhD;

Jen-Yuan Kuo, MD; Yu-Lin Ko, MD; Chun-Chieh Wang, MD;

Kuan-Cheng Chang, MD; Po-Ming Ku, MD; Shih-Huang Lee, MD, PhD

Background:  Currently, the door-to-balloon (D2B) times observed in clinical practice in Taiwan are different from  those recommended by evidence-based guidelines. D2B Alliance, a countrywide initiative for quality supported by  the Taiwan Joint Commission on Hospital Accreditation, sought to achieve the goal of administering treatment to  75% of patients with ST-elevation myocardial infarction (STEMI) within 90 min of hospital 

presentation.

Methods and Results:  The  current  study  was  designed  to  be  prospective,  national,  and  multicenter.  We  con- ducted a longitudinal study of the D2B times recorded in 15 primary percutaneous coronary intervention  centers and examined the changes caused by implementing the D2B Alliance strategies. A total of 1,726 patients  were enrolled in the D2B Alliance and implementation of the D2B Alliance strategies resulted in a significant  decrease in the aver- age  D2B  times  (128.8±42.9 min  vs.  83.2±16.2 min;  P<0.001)  from  those  at  baseline.  By  the  end  of  the  year-long study, the percentage of patients treated under 90 min had increased from 46.2% to  80.1% in the hospitals enrolled in the D2B Alliance.

Conclusions:  Over the 1 year, hospitals enrolled in the D2B Alliance achieved the goal of reducing the D2B  times 

of 75% of STEMI patients to less than 90 min.    (Circ J  2013; 77: 383 –  389)

Key Words:  Acute myocardial infarction; Door-to-balloon time; National registries; Quality  improvement

atients with acute ST-segment elevation myocardial in- farction (STEMI) require quick and efficient reperfu- sion treatment. The time from arrival at the hospital

to percutaneous coronary intervention (PCI) for the infract-re- lated artery, the so-called “door-to-balloon (D2B) time”, is as- sociated with the clinical outcome of patients.17

Clinical prac- tice guidelines recommend that STEMI patients receive primary PCI (PPCI) as soon as possible, and definitely within 90 min.810

For the full realization of the benefits of PPCI in STEMI, an improved system needs to be established to decrease the total D2B time. In recent times, various innovations and key

strat-egies have been shown to be associated with short D2B times.1114 Despite the implementation of such strategies,

stud- ies published hitherto,1517 except for a few,18 indicate

that only approximately 50% of STEMI patients receive PPCI within the recommended 90-min D2B time. Many patients do not receive prompt PPCI, and some of the institutions participat- ing in the studies have shown that underuse of strategies is associated with longer D2B times. Several recent studies have examined the effectiveness of the formation of a D2B Alliance in reducing the D2B times to less than 90 min in STEMI.1921

Those studies have found marked changes in both the practice

Received June 12, 2012; revised manuscript received August 31, 2012; accepted September 27, 2012; released online November 3, 2012 Time for primary review: 35 days

Graduate Instituate of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei (S.-K.C., K.-G.S.); Division of Cardiol-ogy, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei (S.-K.C., J.-J.C., K.-G.S., S.-H.L.); College of Medicine, Taipei Medical University, Taipei (J.-J.C.); Fu-Jen Catholic University School of Medicine, Taipei (J.-J.C., S.-H.L.); Division of Cardiology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei (J.-Y.K.); Division of Cardiology, Department of Internal Medicine, Buddhist Tzu Chi General Hospital, Taipei (Y.-L.K.); Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei (C.-C.W.); Division of Cardiology, Department of Internal Medicine, China Medical University, Taipei (K.-C.C.); and Division of Cardiology, Department of Internal Medicine, Chi Mei Medical Center, Taipei

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(P.-M.K.), Taiwan

Mailing address: Jun-Jack Cheng, MD, PhD, Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, No. 95, Wen Chang Road, Shih-Lin District, Taipei, Taiwan. E-mail: M001001@ms.skh.org.t w

ISSN-1346-9843 doi:10.1253/circj.CJ-12-0646

All rights are reserved to the Japanese Circulation Society. For permissions, please e-mail: cj@j-circ.or.jp Circulation Journal  Vol.77,  February  2013

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Table. Characteristics of Primary Percutaneous Coronary Intervention Centers Enrolled in the D2B Alliance

D2B Alliance n 15 Geography     Location         Rural 6 (40)         Urban 9 (60)     Region         Northern Taiwan 8 (53)         Central Taiwan 3 (20)         Southern Taiwan 4 (27)         Eastern Taiwan 0 (0)       Bed size         <500 4 (27)         ≥500 11 (73)       Ownership         Government 2 (13)         For profit 14 (87)  

Part of a multi-hospital system

    No 12 (80)  

    Yes 3 (20)

384 CHUA SK et al.

and performance of PPCI for STEMI patients in the involved hospitals.

A comparison of the data from the Taiwan Acute Coronary Syndrome (ACS) Full Spectrum Registry22 and

findings of a retrospective study on the quality of care of ACS patients in Taiwan23 indicates a disparity between the

D2B times recom- mended by evidence-based guidelines and those observed in clinical practice. The Taiwan Joint Commission on Hospital Accreditation has recently initiated a D2B Alliance to improve hospital performance with respect to D2B times. The goal of the D2B Alliance is to attain D2B times of less than 90 min for at least 75% of non-transfer STEMI patients by using the strat- egies described in previous studies.12,13 In this study, the dif- ferences in the

D2B times brought about by the adoption of the recommended strategies were examined in PPCI centers involved in the D2B Alliance.

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Study Design

Methods

Values are n (%). D2B, door-to-balloon.

The current investigation was designed as a prospective, na-tional, multicenter study comprising 15 PPCI centers enrolled in the D2B Alliance. Each participating site recruited approxi- mately 50–100 consecutive eligible patients. The sites were selected by the Scientific Committee of Taiwan Joint Com- mission on Hospital Accreditation to ensure good representa- tion of the STEMI population. Data from all enrolled hospitals were used to examine the differences in performance before

Figure 1.    (A) Time from arrival at the emergency department (ED) to acquiring the 12-lead electrocardiogram. (B) Time until  ST- elevation myocardial infarction was diagnosed by ED physicians. (C) Time elapsed between the paging and arrival of an  interven- tional cardiologist before and after forming the Door-to-Balloon (D2B) Alliance. (D) Time elapsed between the paging  and arrival of catheterization laboratory staff. *P<0.05 when examined alongside intervals before forming the D2B Alliance.

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Figure 2.    (A) Length of patient’s stay in the emergency department (ED). (B ) Time to transport patient from the ED to the cath-eterization  laboratory;  (C)  Time  from  arrival  at  the  catheterization  laboratory  to  balloon  inflation  of  the  infarct-related  artery before and after forming the Door-to-Balloon (D2B) Alliance. *P<0.05 when examined alongside the interval before  forming the D2B Alliance.

and after joining the D2B Alliance. A baseline survey of the participating centers before enrollment was conducted from July 2008 to June 2009, and the follow-up survey was con-ducted from July 2009 to June 2010. The principle goal of the D2B Alliance was that the involved hospitals administer PPCI to 75% of their non-transfer STEMI patients within 90 min of arrival at the hospital. The chief executive officer provided contact information for the person in the organization deemed most appropriate for responding to this survey. The institu- tional review boards at the local institutions approved the study protocol.

Data Collection and Measures

The data for all STEMI patients admitted to emergency de-partments (ED) between July 2008 and June 2010 for PPCI were pooled to analyze the differences in performance before and after implementing the D2B Alliance strategies. STEMI was diagnosed by the presence of chest pain lasting >30 min, ST-segment elevation >1.0 mm in at least 2 contiguous leads on electrocardiogram (ECG), and >3-fold increase in serum creatine kinase (CK) above the normal value.24,25 The

exclu- sion criteria were: (1) fibrinolytic therapy before cardiac cath- eterization; (2) D2B times >6 h or unknown, because these cases likely did not represent PPCI cases; (3) transfer from another acute-care facility, and (4) occurrence of STEMI after arrival at the ED. The D2B time was specifically defined as the

num-ber of minutes from hospital arrival to first balloon inflation, thrombus aspiration or device deployment to establish reper-fusion.19

This research was completed using surveys of hospitals that administered PPCI and submitted publicly available data to the Taiwan Joint Commission on Hospital Accreditation. In order to improve the D2B times in the 15 participating PPCI centers, a variety of learning processes derived from a breakthrough series model and evidence-based methods were implemented. The following techniques were found to have considerable and significant relationships to shorter D2B times: (1) mobilization of the catheterization laboratory by ED physicians; (2) require- ment of only one call by ED physicians to page an interven- tional cardiologist and catheterization laboratory staff; (3) avail- ability of catheterization laboratory staff in less than 30 min from being paged; (4) quick (<1 week) data feedback regarding D2B times to both the ED and catheterization laboratory staff; (5) quick patient transportation from the ED to the catheterization room; (6) storage of STEMI drug packs in the ED; (7) packag- ing of single-catheter device in the catheterization laboratory; and (8) availability of an interventional cardiologist and cath- eterization team within the hospital at all times.12,14,21,2628

The principle result was the difference in the percentage of STEMI patients receiving PPCI treatment with D2B times <90 min during the observed period. The difference in time was also evaluated in terms of the following parameters: (1)

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386 CHUA SK et al.

Figure 3.    Mean difference between each interval before and after forming the Door-to-Balloon (D2B) Alliance. ECG, electrocar-diogram; ED, emergency department; STEMI, ST-elevation myocardial infarction; *P<0.05 when examined alongside the interval  before forming the D2B Alliance.

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time to complete 12-lead ECG; (2) time to confirm the STEMI diagnosis by ED physicians; (3) arrival of an interventional cardiologist at the ED after paging; (4) paging and arrival of staff to the catheterization laboratory; (5) length of patient’s stay in the ED; (6) time to move patient from the ED to the catheterization laboratory; (7) time between arrival at the cath- eterization laboratory and balloon inflation of the infarct-related artery; (8) average of D2B times; and (9) percentage of STEMI patients with D2B time <90 min.

Statistical Analysis

Quantitative data are expressed as mean ± SD. Non-parametric data were analyzed with a t-test. P<0.05 was considered statis- tically significant. The percentage of patients with D2B times

<90 min was plotted against months since enrollment in the D2B Alliance in order to describe the differences in D2B times before and after implementing the recommended strategies.

Results

Study Samples

Hospitals enrolled in the D2B Alliance with respect to size, geographic location, and nature of ownership are summarized in Table. In all, 1,726 non-transferred, consecutive STEMI pa- tients underwent PPCI at the 15 PPCI centers were enrolled in the D2B Alliance. Of these patients, 781 were enrolled before (July 1, 2008 to June 30, 2009) and 945 after (July 1, 2009 to June 30, 2010) the formation of the D2B Alliance.

Time Trends Among Techniques After Forming the D2B  Alliance

After the launch of the D2B Alliance campaign, considerable improvement was noted in the following parameters: time from arrival at the ED to completion of the 12-lead ECG recording (Figure 1A), time for ED physicians to diagnose STEMI (Figure 1B), and the interval between paging and arrival of the catheterization laboratory staff

(Figure 1D). However, the in- terval between the paging and

arrival of the interventional car- diologist at the ED (Figure 1C) did not show any significant difference.

Similarly, a significant decrease was noted in the length of patients’ stay in the ED and in the time to move patients from the ED to the catheterization laboratory (Figures 2A,B) after the implementation of the D2B Alliance strategies. However, no such change was noted in the duration from arrival at the catheterization laboratory door-to-balloon inflation of the in- farct-related artery (Figure 2C).

The differences in the parameters before and after imple-mentation of the D2B Alliance strategies, with the average of each interval, are summarized in Figure 3. The implemen- tation of the D2B Alliance strategies resulted in a significant decrease in the following parameters compared with base- line: time to completion of the 12-lead ECG recording (17.0±

16.6 min vs. 6.5±3.9 min, P=0.03), time to confirm STEMI diagnosis (24.0±18.2 min vs. 8.6±4.9 min, P=0.01), paging and arrival of catheterization laboratory staff (27.1±10.6 min vs. 16.5±7.2 min, P=0.01), length of patient’s stay in the ED (78.1±36.5 min vs. 51.4±12.8 min, P=0.02), and the time to

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Figure 4.    (A)  Tracking  of  the  average  door-to-balloon  (D2B)  times  recorded  over  the  year  after  forming  the  D2B  Alliance.  (B) Contrast  of  the  average  D2B  times  before  and  after  forming  the  D2B  Alliance.  *P<0.05  when  examined  alongside  the  interval before forming the D2B Alliance; #P<0.001 when examined alongside the interval before forming the D2B  Alliance.

Figure 5.    (A) Tracking of the percentage of ST-elevation myocardial infarction patients with door-to-balloon (D2B) times under  90 min before and 1 year after forming the D2B Alliance; (B) Contrast of D2B times of less than 90 min before, 1–6 months after,  and 7–12 months after forming the D2B Alliance.

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Figure 6.    Percentage  of  door-to-balloon  (D2B)  time  within 

90 min in hospitals participating in the D2B Alliance in the  12- month trend.

transport patients from the ED to the catheterization labora-tory (25.3±27.6 min vs. 7.8±2.9 min, P=0.03). However, the time between the paging and arrival of an interventional car- diologist at the ED (9.9±8.4 min vs. 9.5±6.3 min, P=0.90) and the time between arrival at the catheterization laboratory and balloon inflation of the infarct-related artery (27.5±8.0 min vs.

24.7±5.8 min, P=0.31) displayed no significant change after implementation of the D2B Alliance strategies.

Time Trends in D2B Times Among All Hospitals

The charting of D2B times over 1 year showed significant improvement after implementing the D2B Alliance strategies. The average D2B times showed considerable improvement within 3 months of implementing the D2B Alliance strategies (Figure 4A). The improvement steadily continued until the end of the observation period. Compared with the baseline values, the average D2B times at the end of the study period were considerably shorter (128.8±42.9 min vs. 83.2±16.2 min, P<0.001; Figure 4B).

Only 32.3% of STEMI patients had D2B times <90 min be- fore implementing the D2B Alliance. This percentage improved every month after implementing the D2B Alliance strategies (Figure 5A); within 6 months, the value was 73.5%. This im- provement steadily continued, and by the end of the study,

80.1% of STEMI patients had D2B times <90 min. After im- plementation of the D2B Alliance strategies, the average per- centage showed considerable improvement during the first 6 months (from 32.3±25.3% to 68.3±21.0%, P<0.001), and even more improvement in the subsequent months (80.2±15.3%, P<0.001). Overall, the extent of improvement of this percent- age among the 15 participating PPCI centers was 37±17%.

We plotted the percentage of patients who received treat-ment in less than 90 min against the 12 months of enrollment in the D2B Alliance. By the end for the study period, this per- centage had increased from 46.2% to 80.1% in the hospitals enrolled in the D2B Alliance

(Figure 6). The percentage of patients receiving treatment

in less than 90 min over the year after forming the D2B Alliance increased by 3.2% per month.

Discussion

In this study, a significant improvement was noted in the

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times recorded in the hospitals enrolled in the D2B Alliance. Improvements in the D2B times were first noticed as early as 3 months after the formation of the D2B Alliance and imple-mentation of its strategies and the goal of reducing the D2B times of 75% of STEMI patients to less than 90 min was achieved in the first 6 months. Our findings show that the trend of improvement continued until the end of the study period.

Improvements were noted in both the time to acquire and interpret a 12-lead ECG after arrival at the hospital and time to readiness of the catheterization laboratory after mobilization. These improvements contributed to the shortening of the length of the patient’s stay in the ED. This useful reference point was also used in this study for comparing the differences in the D2B times before and after forming the D2B Alliance. The percentage of patients receiving treatment in less than 90 min over the 1 year after forming the D2B Alliance increased by approximately 4% per month. Our findings are consistent with those of previous studies indicating that the D2B Alliance was successful in achieving a widespread coalition of practitio- ners, hospitals, and organizations agreeing to improve D2B times.1921

The present study demonstrated significantly greater im- provement in the D2B times recorded in the hospitals enrolled in the D2B Alliance. These findings support the theory that the combined efforts of using the D2B Alliance strategies played a substantial role in improving the D2B times recorded in the involved hospitals. Although our findings indicate consider- able improvement in the D2B times after forming the D2B Alliance, they do not necessarily establish a causal relation. It is difficult to determine whether some of the techniques were surrogates for unmeasured care procedures that might have contributed significantly to the reduction in D2B times.

Fur-thermore, although some methods may have been significant in individual institutions, they may not be valid across the com- plete sample of centers, and our results should not inhibit in- novations that may be effective in specific settings.

Clinical Implications

STEMI presents a true medical emergency in which the rela-tionship between treatment and mortality is measured in min- utes. Every minute of delay in the treatment of STEMI patients affects their long-term mortality. Therefore, the total ischemic time should be shortened by any and all possible efforts.

Study Limitations

First, the prehospital ECGs of the patients were not obtained at the institute involved in this study. Recent studies have shown that prehospital ECG diagnosis of STEMI with mobilization of the cardiac catheterization laboratory can markedly reduce D2B time.29,30 The D2B times noted in

this study might be reduced even further by obtaining prehospital ECGs. Second, it is difficult to attribute the changes of D2B times to a single strategy, because multiple strategies were performed simulta- neously. However, the rapid improvement in the timeliness of care for STEMI patients is an impressive national accomplish- ment. Third, the investigated data were reported by hospitals using different strategies, so verification of these data was lim- ited to some extent. These circumstances could have resulted in a variation in the on-site data collection across the partici-pating PPCI centers.

Conclusions

The establishment of the D2B Alliance resulted in a signifi-cant improvement in the time to administer PPCI to STEMI

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patients. Attributing the differences to a single strategy is dif- ficult because multiple methods were simultaneously employed. However, the maintenance of D2B time at less than 90 min will probably require interdisciplinary cooperation, organiza- tional leadership, and effective innovations to overcome the barriers to organizational change.

Acknowledgments

We thank Ching-Yin Yeh of the Graduate Institute of Public Health, Taipei Medical University, for her support with the statistical analysis of the D2B Alliance data. We also express our sincerest thanks and appre-ciation to the physicians and nurses who participated in the D2B Alliance.

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Mattera JA, et al. Achieving door-to-balloon times that meet quality guidelines: How do successful hospitals do it? J Am Coll Cardiol 2005; 46: 1236 – 1241.

27. Bradley EH, Curry LA, Webster TR, Mattera JA, Roumanis SA, Radford MJ, et al. Achieving rapid door-to-balloon times: How top hospitals improve complex clinical systems. Circulation 2006; 113: 1079 – 1085.

28. Nallamothu BK, Bradley EH, Krumholz HM. Time to treatment in primary percutaneous coronary intervention. N Engl J Med 2007; 357: 1631 – 1638.

29. Garvey JL, MacLeod BA, Sopko G, Hand MM. Pre-hospital 12-lead

electrocardiography programs: A call for implementation by emer-gency medical services systems providing advanced life support: National Heart Attack Alert Program (NHAAP) Coordinating Com-mittee; National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health. J Am Coll Cardiol 2006; 47: 485 – 491. 30. Brown JP, Mahmud E, Dunford JV, Ben-Yehuda O. Effect of

pre-hospital 12-lead electrocardiogram on activation of the cardiac cath-eterization laboratory and door-to-balloon time in ST-segment eleva-tion acute myocardial infarceleva-tion. Am J Cardiol 2008; 101: 158 – 161.

數據

Figure 1.      (A) Time from arrival at the emergency department (ED) to acquiring the 12-lead electrocardiogram. (B) Time until  ST-  elevation myocardial infarction was diagnosed by ED physicians. (C) Time elapsed between the paging and arrival of an  in
Figure 2.      (A) Length of patient’s stay in the emergency department (ED). (B) Time to transport patient from the ED to the cath- (A) Length of patient’s stay in the emergency department (ED). (B) Time to transport patient from the ED to the cath-eteriz
Figure 3.      Mean difference between each interval before and after forming the Door-to-Balloon (D2B) Alliance. ECG, electrocar- Mean difference between each interval before and after forming the Door-to-Balloon (D2B) Alliance. ECG, electrocar-diogram; E
Figure 5.    (A) Tracking of the percentage of ST-elevation myocardial infarction patients with door-to-balloon (D2B) times under  90 min before and 1 year after forming the D2B Alliance; (B) Contrast of D2B times of less than 90 min before, 1–6 months aft
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