Expansion of a Regional ST-Segment Elevation Myocardial Infarction System to an Entire State James G. Jollis, Hussein R. Al-Khalidi, Lisa Monk, Mayme L. Roettig, J. Lee Garvey, Akinyele O. Aluko, B. Hadley Wilson, Robert J. Applegate, Greg Mears, Claire C. Corbett and Christopher B. Granger Circulation. published online June 4, 2012; Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2012 American Heart Association, Inc. All rights reserved. Print ISSN: 0009-7322. Online ISSN: 1524-4539 The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circ.ahajournals.org/content/early/2012/05/31/CIRCULATIONAHA.111.068049 Data Supplement (unedited) at: http://circ.ahajournals.org/content/suppl/2012/05/31/CIRCULATIONAHA.111.068049.DC1.html Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services. Further information about this process is available in the Permissions and Rights Question and Answer document. Reprints: Information about reprints can be found online at: http://www.lww.com/reprints Subscriptions: Information about subscribing to Circulation is online at: http://circ.ahajournals.org//subscriptions/ Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 Expansion of a Regional ST-Segment Elevation Myocardial Infarction System to an Entire State Running title: Jollis et al.; Expansion of regional STEMI System to entire state James G. Jollis, MD1; Hussein R. Al-Khalidi, PhD1; Lisa Monk, RN, MSN1; Mayme L. Roettig, RN, MSN1; J. Lee Garvey, MD3; Akinyele O. Aluko, MD2; B. Hadley Wilson, MD4; Robert J. Applegate, MD5; Greg Mears, MD6; Clairee C C.. Co Corb Corbett, rbet ett, t, MMS7; Christopher B. Granger, MD1 on behalf of the Race Investiga Investigators gaato orss 1 Duke C Duke Clinical lini li nica c l Re Rese Research s arch Institute, Duke Univer University, rsiity ty, Durham; 2Dept of of Ca C Cardiology, rdiology, Presbyterian Hosp Ho Hospital; spital all; 3D Depts ept ptts of o Emergency Medicine, 4Ca Cardiology, ard r iology gy, Carolina Carolinas n s Me na M Medical di Center, Charlotte; dical 5 Wake W ake For Forest orres estt He H Health alth al th S Sci Sciences cien ci ence en cess Un ce U University iver iv ersi er sity ty W Win Winston-Salem; insstoon-S Sal alem em;; 6EM em EMS S Pe Perf Performance rfoorma rf maanc ncee Im Impr Improvement prov pr ovem ov emen em ent en C Ce Center, nter, Univ University iverrsiity ooff No North ortth Ca Carolina aro rolina inaa at Ch Chape Chapel el H Hill, illl, l, C Ch Chapel happel H Hill; ill; 7Ne New w Ha H Hanover ano novverr R Regional eggion gi nall Medical Medi Me d call Cen di Center, nter,, Wi nte W Wilmington, lm min ingt gtoon, on, NC C Correspondence: Corr Co rres espo pond nden ence ce:: James G. Jollis, MD Duke Clinical Research Institute Duke University Box 3254 DUMC Durham, NC 27710 Tel: 919-684-4015 Fax: 919-668-3575 E-mail: [email protected] Journal Subject Codes: [4] Acute myocardial infarction; [100] Health policy and outcome research 1 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 Abstract: Background - Despite national guidelines calling for timely coronary artery reperfusion, treatment is often delayed, particularly for patients requiring inter-hospital transfer. Methods and Results - 119 North Carolina hospitals developed coordinated plans to rapidly treat patients with ST segment elevation myocardial infarction (STEMI) according to presentation: walk-in, ambulance, or hospital transfer. 6841 patients with STEMI (3907 directly presenting to 21 percutaneous coronary intervention (PCI) hospitals, 2933 transferred from 98 non-PCI hospitals were treated between July 2008 and December 2009 (age 59 years, 30% women, 19% uninsured, chest pain duration 91 minutes, shock 9.2%). The rate of patients not receiving reperfusion fell from 5.4% to 4.0% (P=0.04). Treatment times for hospital transfer patients y improved. p p p p a “transfer for substantially First hospital door to device for hospitals that adopted PCI” reperfusion strategy fell from 117 minutes to 103 minutes (P=0.0008), wh hille ti time mees at while times hospitals with a mixed strategy of transfer or fibrinolysis fell from 195 minutes to 138 minutes P=0.002). Median door to device times for patients presenting directlyy to PCI hospitals fell (P=0.002). fr om 64 64 too 59 59 minutes minu mi nute tes (P<0.001). (P<0 (P 0.001 0 ). EMS-transported EMS-transp EM spor orttedd patients pati tien ents were wer erre most mo ost likely lliikelyy to reach ch door doo o r to from device dev vic goals with wit ithh 91% 91% treated trreaate tedd wi with thin th i 990 in 0 mi inu nutes an nd 52 52% % be bei ingg ttreated reat re ateed w itth 60 m inut in uttess. device within minutes and being with minutes. Pa ati tieents ents treat ated at e w ed ithi hinn guid gguideline uideelin elin ne go oal a s hhad ad a mort m ortal alit ityy of 22. .2% % ccompared omp mpar mp arred d too 5.7% 5.7% ffor or ttho or hose ho se Patients treated within goals mortality 2.2% those exce eed ediingg gu gguideline id del e in ne re recomm mmen enda dati tions (P (P<0 <0.0 .001 01)) exceeding recommendations (P<0.001) Conclusion ns - By extending ext exten endding en ng regional reg egio iona io naal coordination coor co ordi dina di nati na t on ti o to to ann entire ent ent ntir iree state, ir statte, st e rapid rap rap apid id diagnosis dia iagn gnos osis os is and and Conclusions treatment of STEMI has become an established standard of care independent of health care setting or geographic location. Key words: acute myocardial infarction 2 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 Introduction The ideal treatment of ST segment elevation myocardial infarction (STEMI) involves early diagnosis followed by rapid reperfusion therapy.1-5 Such treatment becomes more challenging when the activities of diagnosis and reperfusion span multiple, loosely connected hospitals and emergency medical services (EMS). To overcome these barriers and provide ideal reperfusion as a uniform standard of care regardless of health care setting or geographic location, we established coordinated regional care across the entire state of North Carolina.6-8 Specifically, we aimed to determine whether expanding our STEMI system to all hospitals and EMS agencies in North Carolina on a voluntary and “grass roots” basis would improve the rate and speed of Appr prroaach h to to myocardial reperfusion. According to protocols established in the Regional Approach Cardiovascular Emergencies (RACE) project, we implemented processes to expedite care in 119 hoosp spit ital it alss across al acro ac ro oss a state ssta t te with a population of 9.4 million milllion residents and and area are reaa of 53,000 square hospitals milees. s 9 Hospit Hospitals talls aadopted dop oppte tedd sy ssynchronized ync nchr nc hron onnize ized sstrategies tratteg gies to o ex expedite xpedi pediitee rreperfusion ep perfu fusi sion ionn ffor or ppatients or atie at ieentts ppresenting res esen es en ntiing miles. by EMS, EM E MS, ho MS, hos hospital spitaal spit al transfer, tra rans nsfe feer, an and nd ““wa nd “walk-in.” wallk-i wa lk-iin. n.”” Methods Our work was approved by the IRB at Duke University. Data Use Agreements for a HIPAA defined limited data set were established with all primary percutaneous coronary intervention (PCI) hospitals. We implemented our system by building on a model established in prior work and by using the principles outlined in the American Heart Association Mission: Lifeline and the American College of Cardiology D2B programs. 9-12 First, we developed leadership composed of a state director, hospital system coordinators, and nursing, EMS, and physician leaders from multiple institutions across the state (see Supplemental Material). This leadership team 3 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 conferred in weekly conference calls and numerous regional and state meetings. Next, we instituted the Acute Coronary Treatment and Intervention Outcomes Network Registry -- Get With The Guidelines (AR-G) as our main data collection instrument, requesting that all participating primary percutaneous coronary intervention (PCI) hospitals participate and contribute to state-system reports.13 These data were maintained by the leadership team and were used to monitor and report treatment rates and times to individual hospitals, benchmarked to state performance. The AR-G registry at PCI hospitals represented the majority of STEMI patients in the state eligible for reperfusion during the study period, as 95% of patients treated at non-PCI hospitals were transferred to PCI hospitals prior to discharge.9 Once leadership and data systems were established, we organized all 21 P PCI CII hhospitals ospi os pita pi tals ta ls iin the he state with on-site surgery to serve as regional primary PCI centers (10 in the initial RACE intervention, nteerv rven enti en tion ti on, 11 aadditional on dd dditional for the state-wide int intervention). ter ervvention).9 Thes These se hospitals hosp sppit ital a s agreed to collect and share hare arre ARG da data, ata ta,, fu fund undd orr co co-f co-fund -ffun undd a ho hhospital spiital S sp STEMI TEM MI sy system yst s em co coordinator, oordinat oor ator orr, ac acc accept cept cep pt aall ll S STEMI TEMI TE MI patients week basis, allow for pati pa tien ti en nts t rregardless egar eg ardl dleesss of bbed ed ava ed aavailability vaail ilab abil ab ilit il ityy on a 224 it 4 hhour ou ur 7 day day pe per we w ek bbas asiis,, al allo low lo w fo or catheterization catheterizatio on la llaboratory bora bo r to ra t ry r aactivation ctiv ct i ati iv tion on bbyy a si sing single ngle ng lee ccall alll fr al from om m eemergency merg me rgen rg e cy pphysicians en hysi hy sici si c an ci anss or ttra trained r ined ra paramedics without the need for cardiology consultation, have the catheterization laboratory available within 30 minutes including the presence of an interventional cardiologists at the start of the procedure, establish a single treatment regimen agreed upon by all physicians, and provide immediate and regular feedback to the emergency physicians and paramedics who initiated the procedure. The 98 non-PCI centers (55 in the initial RACE intervention, 43 additional for the state-wide intervention) designated themselves according to their reperfusion strategy for patients presenting with STEMI: routine transfer for primary PCI, routine fibrinolytic therapy, or a mixed strategy that consisted of transfer for primary PCI when transportation was readily 4 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 available (Figure 1). Supported by the primary PCI facilities, system coordinators and their leadership approached every hospital and EMS within their referral region to establish a single plan to rapidly diagnose and reperfuse patients with an acute STEMI according to national time standards and guidelines. Emergency departments were encouraged to ascertain whether patients had potential symptoms prior to registration, designate an area and personnel to perform ECG within 10 minutes of arrival, and choose a reperfusion plan according to local consensus and resources that involved either primary PCI or fibrinolysis. Hospitals that selected fibrinolysis also developed plans for rapid primary PCI for patients with contraindications. For hospitals served erved by more than one primary PCI center, all PCI centers were represented in n pplanning laannnin ingg meetings. Under the guidance of the North Carolina Office of EMS, emergency medical systems were patient potential STEMI we re eencouraged ncou ncou oura raagedd to obtain an ECG for every pa ati tien ent with potenti en ial a STE TE EMI symptoms, interpret the divert PCI he ECG ECG and communicate comm co mmun mm unniccat atee the the findings finndin fi ndin i gs of of a possible possiibl ible STEMI STEM ST EM MI to receiving recei eivi vinng hospitals, vi hos osppit ital als, al s, ddiv iver iv ertt to er oP CI centers minutes patients ce ent nter erss if first er fir irst st medical med m ed dic icaal contact con ontaact c to to device ddeevic evicce could couuldd reliably co r lia re liably y be be achieved achi achi hiev ev ved d within witthiin 90 m in nut utes es oorr pa pat tien tien nts standard method were ineligible ineligibl blle for f r fibrinolysis, fo fibr fi brrin nollys ysis i , and and provide p ov pr ovid idee a st id tan anda dard da r m rd etho et hodd fo ho for th thee EM EMS S ti time me ddata ataa to be at available to receiving hospital personnel. The final step of our intervention involved multiple levels of communication between hospitals and EMS regarding system performance, immediately after PCI, within 24 hours of a myocardial infarction admission, and in regularly scheduled hospital, EMS, regional, and state meetings. During these meetings, we shared best practices, reviewed treatment intervals (derived from symptom onset, first medical contact, door time, ECG time, departure time, catheterization lab time, device time, needle time), outcomes (deaths, complications, hospital and angiography findings) and opportunities for system improvement. Additional description of our intervention 5 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 can be found in the RACE Operations Manual [http://www.nccacc.org/RACE/RACEOperationsManualOct.09.pdf]. Statistical Analysis Descriptive statistics for continuous and categorical variables were described as median (interquartile rage) and number (percentage), respectively. Patient characteristics and process measures were compared using Wilcoxon rank-sum test for 2 groups comparison (KruskalWallis test for more than 2 groups comparison) and chi-square tests as appropriate. The Cochran-Armitage test for trend was used to assess changes in rates over time. To consider whether changes in treatment time varied by hospital, mixed-effects model analyses were conducted with PCI hospitals as a random effect. Performance data were compared compar arred d inn three thre th reee re month intervals from July 2008 through December 2009 stratified according to treatment and presentation pr ressen enta tati ta tion ti on to t PCI PCI hospital (fibrinolysis orr primary prima maryy PCI; presentation ma presenta taati t onn to to PCI hospital by transfer, ran nsf s er, self, or EMS). EMS MS). ) For the objectives RACE intervention were door-toF orr tthe he P PCI CII hhospitals, ospi pita pi talss, th he ob obj jecctiive vess off tthe hee R ACE in ACE inte teerv r en e ti tion o w on eree to er o rreduce ed duc ucee do door or-t -tto-presenting medical device EMS device timess ffor or ddirectly irec ir e tl ec t y pr res esen enti en ting ti n patients ng pattie i nt n s and and ffirst irrstt m med edic ed ical ic a ccontact al ontaact ttoo de on devi v cee ffor vi or E M MS transported patients. For non-PCI hospitals, the objectives of RACE were to reduce the door-in to door-out times and first door to device times for patients who were transferred to undergo PCI elsewhere and door-to-needle times for those receiving fibrinolysis. For both hospital settings, we also aimed to increase the rate of reperfusion among eligible patients. In cases where the first ECG did not have diagnostic ST elevation, door or first medical contact time was reset to the first diagnostic ECG. All tests were conducted at the 0.05 significance level. All patients with ischemic symptoms lasting greater than 10 minutes within 24 hours prior to arrival and an ECG with diagnostic ST segment elevation were included in the analyses. Statistical analyses were 6 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 carried out using SAS version 9.2 (SAS Institute INC, Cary, NC). Results Between July 2008 and December 2009, 6,841 patients presented with acute ST elevation myocardial infarction including 3,907 patients who presented directly (57%) and 2,933 patients who were transferred to PCI hospitals (43%). (Table 1) The median age of the cohort was 59 years (interquartile range 51-69), 30% of patients were women, and 15% were either black or of Latino ethnicity. Nineteen percent of patients had no insurance and 7% were covered by Medicaid. Median duration of chest pain from onset to ECG was 91 minutes, 20% of patients had prior myocardial infarction or PCI, and shock was present on admission for 9% off patients. pati pa tien ti ents en ts. By medical record review, 86% of patients were felt to be reperfusion candidates and STEMI wass ap apparent patients. wa app pare pare rent nt onn th thee initial ECG for 89% of patie ieent n s. facility was for and walk-in Meanss of ttransport rans ra nsspoort ttoo th thee fi ffirst rstt fa rs fac cilitty w ass bby y EM EMS S fo or 555% 5% off ppatients atie ient ntss an nt nd walk w alk l -i -inn fo fforr 43% course was percentage patients 43 3% of ppatients. attie ient nts. s. Over Over tthe h co he oursse of tthe ours he sstudy, he tudy tu dy,, th dy tthere e re w ere ass an iincrease ncrreas nc asee in n tthe he pe perc r en rc ntaage off pa atieents en The inverse pattern presenting byy EMS EMS to t PCI PCI hospitals, hos o pi pita tals ta lss, from frrom 70 70 to 75% 75% (P=0.04). (P P=0 0.0 .04) 4).. Th 4) he in inve vers ve rsee pa rs patt tter tt ernn an er aand d trend were seen at non-PCI hospitals, where EMS presentation fell from 35 to 30% (P= 0.10). During the final quarter of data collection, pre-hospital ECGs were identified for 88% of patients presenting to PCI centers via EMS and for 32% of patients presenting to non-PCI centers (P<0.0001). (Figure 2) Treatment rates and times Among the 5,888 eligible patients, the rate of patients not receiving reperfusion fell from 5.4% to 4.0% (P=0.04) largely attributable to a 4% absolute decline in eligible untreated patients at nonPCI hospitals (P<0.01) (Figure 3). During the same period, primary PCI as reperfusion mode 7 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 increased from 52% to 66% in non-PCI hospitals with a corresponding decrease in fibrinolysis from 41% to 31% of eligible patients. For patients presenting directly to PCI hospitals, primary PCI remained stable at 95%, with only 17 patients being treated with fibrinolysis during the study period. These patients either received fibrinolysis pre-hospital or when a significant delay to catheterization laboratory availability was anticipated due to simultaneously presenting patients. Corresponding with guideline goals, treatment times of interest included door to device for patients undergoing primary PCI, first medical contact to device for patients presenting to PCI hospitals by EMS, first hospital door to device for patients transferred between hospitals, median and door to needle for patients treated with fibrinolysis. Over the study period, m edi d an di n ddoor oorr to oo device times for patients presenting directly to PCI hospitals fell modestly from 64 to 59 minutes (P<0.001) P<0 <0.0 .001 .0 01)) with 01 witth improvements wi imp mprrovements in both self presenting presen en nting patients from om m 799 to 73 minutes (P=0.01) and EMS transported patients minutes (P=0.06) 4). an nd EM E S tran nsp spoort ortedd pa ati tien ents en ts ffrom rom ro m 58 too 55 5m inuutees (P= P=0. P= 0.06 06)) ((Figure 06 Figgure gure 44) ). The The proportion prroppor orti t on on ooff directly patients who underwent PCI within minutes dire di reecttly ppresenting reese sent ntin in ng pa pat tieents ents w ho o un und derw derw wen entt PC CI w itthin th n 990 0 mi minu n tes nu tes increased incr in crreaase sedd from from m 83% 83% % to to 89%. 899%. %. For patients pati pa t en ti e ts transported traans n poort rted e directly ed dir i ec ectlyy too PCI PCI hospitals hosp ho spit sp i al it alss by EMS, EMS MS, pre-hospital prepr e ho ehosp spit sp i all ECG it ECG rates rat a es increased from 67% to 88% during the intervention. This improvement was accompanied by a decline in median time from first medical contact to device from 103 to 91 minutes (P<0.0001), with 50% of patients being treated within 90 minutes by the last quarter. The transport component of this time interval remained stable at a median of 35 minutes (interquartile range 25, 49) from first medical contact to hospital door. The percentage of patients receiving device activation within 90 minutes of first medical contact increased from 36% to 50% (P=0.0002). Patients transported by EMS were most likely to reach door to device goals, with 91% undergoing device activation within 90 minutes of hospital arrival and 52% being treated with 60 8 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 minutes by the end of the study. Treatment times for patients transferred between hospitals for primary PCI significantly improved (Figure 5). The median time from first hospital door to device activation for 1,175 patients transferred from hospitals that adopted a “transfer for PCI” strategy (52 hospitals) fell from 117 minutes to 103 minutes (P=0.0008) with 39% patients being treated within the 90 minute goal by the end of the intervention. A time interval of focus for these transferred patients involved first hospital “door in door out” time, improving from 44 to 39 minutes. The 474 patients transferred from hospitals with a “mixed” strategy of transfer and fibrinolysis (15 hospitals) had substantially longer treatment time with first door to device falling from 195 varied minutes to 138 minutes by the end of the study (P=0.002). Treatment time varie ieed su ssubstantially bsta bs tant ta ntia nt iall ia llyy by transfer distance expressed as drive times according to standard mapping software [http://www.mapquest.com access October 21, 2010] htttp: p:// //ww // www. ww w mapq mapq pquuest.com ue 20110] Median first 20 firrst s door doo ooor to to device time for hospitals within hospitals hosp p with hin 30 30 minutes minu mi utes tees was was 94 minutes, minu inutess, 134 134 minutes minu mi utees for for hospitals hosp ho spital alls between betw weeen 31 aand nd 445 5 minutes mi inu n te tess drive driv dr ivee time, iv time ti me,, and me an nd 192 19 minutes minu mi nute nu tess for te fo or hospitals hosspit ho itaalss exceeding it eexc xcee e di ee dinng ng 45 45 minutes minu mi nute nu tees drive driv dr ivee time. iv t me ti me.. Mixed Mixe Mixe x d strategy hospitals minute longer median transfer trategy hospi pita pi tals ta ls hhad a a 221 ad 1 mi minu ute lo ongger m med edia ed iaan dr ddrive i e ti iv time me ccompared ompa om paare redd to ttra rans ra nssfe ferr fo forr PCI strategy hospitals. Among the 903 patients treated with fibrinolysis prior to transfer, door to needle did not significantly improve with median times of 35 minutes and 27 minutes in the first and last quarters of the study (P=0.27) with 48% being treated within 30 minutes during the entire study period. When treatment time analyses were stratified according to patients treated at the initial RACE intervention hospitals or hospitals added for the full state intervention, the findings were similar for both subgroups of patients. When treatment times were further considered in mixed-effects models with PCI hospital as a random effect, the models were significant, indicating that some hospitals had significantly greater improvement than others 9 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 (P<0.01). Outcomes Patients treated within times suggested by guidelines had a mortality of 2.2% compared to 5.7% for patients whose treatment time exceeded guideline recommendations (P=0.001) Overall inhospital mortality was 5.7% (95% confidence interval 5.2 – 6.3%) during the study period including 5.9% during the first half of the intervention and 5.5% during the second half (P=NS). Other clinical outcomes, bleeding, stroke, hemorrhagic stroke, congestive heart failure, and shock did not significantly vary over the study period. Discussion The RACE system is the largest state-wide ST elevation myocardial infarction system ever implemented United intervention systematic mpl plem em men nte tedd in tthe he U nited States. Our interven nti tion onn demonstratess th tthat at sy syst s ematic barriers in timely overcome imely meel reperfusion reperfu usiion ccan an n bbee ov over erco er come me with wit w ithh a broadly broadlly organized bro orga gani ga nizzedd voluntary voolu unt ntar aryy effort effo ef fort fo rt to to fill f ll lleadership fi eade ders de rshi hipp hi gaps ga ps in in the the health heal he alth th h care. car aree. These Thesse gaps Th gaps primarily ppri riima mari rilly exist ri exi x st between bettwe ween en competing com ompe peti pe ting ti ngg institutions innsti nstiitu t ti tion onns and and between betw betw weeen entities health care en nti t ti t es tthat hatt fu ha ffunction ncti nc tion ti on n iinn se sseparate paara rate te aand nd distinct dissti tinc nctt systems. syst sy stem st ems. em s. By building bbui uild ui ldin ld i g consensus in cons co nsen ns ensus amongg en all primary PCI hospitals in the state, we were able to convince the majority of emergency departments and EMS systems to adopt uniform and coordinated processes for rapid diagnosis and treatment. This universal approach allowed us to establish and embed a standard of care independent of health care setting or geographic location of the patient. By the end of our intervention, our protocols were adopted by state regulation for all EMS agencies, and all PCI hospitals voluntarily agreed to continue sharing data and support regional care. http://www.ncems.org/pdf/OverviewEMSTriageandDestinationPlan.pdf The findings identify some remarkable changes in patterns of care and improvements in 10 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 performance measures. Notable achievements of the RACE system include a historically low rate of eligible but untreated of 4.0% and exceptionally fast coronary intervention for patients presenting directly to PCI facilities with 89% being treated within 90 minutes and 52% treated within 60 minutes. These results achieved across all 21 PCI hospitals in the state are comparable to those achieved by 10 select systems that reported on EMS transported patients alone by Rokos and colleagues of 86% within 90 minutes and 50% within 60 minutes.3 At the same time, this work highlights areas that need further consideration in formulating STEMI treatment guidelines and building systems of care. Two particular areas of interest include EMS transported patients and patient transferred between hospitals for primary PCI. In 2007, the American College of Cardiology / American Heart Associatio on ST S EMII EM Association STEMI guidelines first directed device activation to occur within 90 minutes of “first medical contact” ath her tth han ho han hosp pit itaal al ddoor oor for patients initially trea eate ea t d by emergency te c per cy errso sonn n el, defined as the rather than hospital treated personnel, 1 imee tthat hat the EM MS cr rew aarrives rriv rr ivees iv es aatt th he “s “sc cenee” of tthe he pa atient ati ientt.14 By B y aadding dd din ingg sc scen scene enee ti en time me aand nd time EMS crew the “scene” patient. transport ran nsp spor o t ti or time ime m tto o th the he 90 90 minute min i ute ut go goal goal, al,, th al this hiss ggu guideline uideeli uide l ne eeffectively fffect fect ctiv ivel iv elyy ra raised aissed tthe he bbar he arr oon n pr prim primary im marry PC PCII and an made hospita hospitals als aand nd eemergency merg me rgen ency en c m cy medical edic ed i all sservices ic ervi er v ce vi cess jo join jointly intl in tlyy ac acco accountable coun co unta un tabl ta blee fo forr pa pati patient tien ti en nt tr trea treatment. eatm ea tment. This tm work describes the first broad application of this new standard with 50% of patients treated within 90 minutes of first medical contact (or EMS arrival on scene) by the end of our study. Time from scene arrival to hospital door consumed a median of 36 minutes of the 90 minute goal including 15 minute scene time and 21 minute transport time. Our findings indicate that incremental improvements in all processes of care will allow a majority of EMS transported patients to meet this goal. These improvements should include universal adoption of catheterization laboratory activation by paramedics as a standard of care (median time savings 17 minutes). The 28 minute median hospital door to laboratory arrival time for EMS transported 11 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 patients also indicates potential for a further improvement in hospital processes such as preregistration of patients, proceeding directly to the catheterization laboratory when available, and cross training laboratory, emergency department, and intensive care unit personnel to cover emergent STEMI patients. To our knowledge the 39% of patients undergoing primary PCI within 90 minutes of first hospital door in “transfer strategy” hospitals represents the highest rate reported in a multicenter study. For comparison, 15% of patients requiring hospital transfer in Massachusetts State were treated within 90 minutes in 2008, the latest year data are available, and the AR-G registry reported 24% of patients transferred for PCI in the fourth quarter of 2009 had device times within 90 minutes of first door.14 The AR-G registry involved a select group of ap approximately pprrox xim imat atel at elyy el 220 hospitals that were submitting data and this national benchmark likely reflects above average performance. pe erffor orm manc manc nce. e The he treatment ttre r atment times in RACE for tr tran transferred an nsferred patien patients nts t als also lsso ccompare ompare favorably to selected eleect c ed singlee center center er oorr single sing si ngle ng le rregion eg gio on reports repportts from re mA Abbot bbot bbo ot N Northwestern orthw orth wes este terrn ooff 32 32%, %, M Mayo a o Cl ay Clin Clinic inic nic ooff 12%, Springfield, Illinois Stat Heart 12%. 12 2%, aand nd S p in pr inggfie gfieeld ld,, Il lli linnois is S tatt He ta H art of 12% art 2%.. 1, 22,, 5 Wit 2% W With ithh national it nati na tioonal onal guidelines gguuiddeli deliine n s for fo or inte iinter-hospital nteer--ho hosp spit ittal ransfer conti tinu nuin nu ingg to t ccall a l fo al forr de evi v cee aactivation ctiv ct iv vat atio ionn wi io w thin th i 990 in 0 mi minu nute nu tess of ffirst te irst ir st m med ed dic ical al ccontact ontact as a on transfer continuing device within minutes medical “systems goal,” our inability to reach this goal in a majority of patients despite focused efforts raises questions regarding the feasibility of achieving this benchmark on a broad scale.15 First door to device time varied as a function of inter-hospital drive time, from 93 minutes for hospitals within 30 minutes, 117 minutes for 31 to 45 minute drive times, and 121 minutes for hospitals beyond 45 minutes drive time. Patients transported by air were not treated faster, with median first door to device times of 125 minutes for hospitals in the 31 to 45 drive time range, and 138 minutes for hospitals beyond 45 minute drive times. Thus, treatment by the 90 minute goal for hospitals located beyond the 30 minute drive time appears less likely to occur for the 12 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 majority of patients using current processes. Our work supports the extension of the standard to 120 minutes in order to have relevance for the majority of patients undergoing hospital transfer for primary PCI.16 Mortality While there are trends toward lower STEMI mortality in North Carolina since the initiation of our regional system, our study lacked adequate sample size to reliably identify mortality differences. Pathological, imaging, and clinical data support a strong relationship between earlier treatment, less myocardial necrosis and lower mortality, and we believe the significant time improvements in coronary reperfusion resulting from our intervention represent an mportant improvement of myocardial infarction care in North Carolina.17-19 Obs Observations bsserrva v ti tion onss fr on from om important our RACE data also support timely treatment according to a 2.2% mortality for those receiving reperfusion epe perf rfuusio rf usio ionn according acco ord rdin ing to overall guideline time goals goaals compare to a 5.7% go 5.77% mortality m rtality for those mo treated reaate ted beyondd rrecommended ecom ec mmeend nded ed d ttime imee in im iintervals tervalss (P (P<0.001). P<0 0.0 .0001). ). Limitations Li imi mita tati ta tion on ns This study rel relied ellie iedd on the the voluntary vol olun untaary submission un ssub u mi ub m ss ssio io on of o data dat ataa too the the AR AR-G -G rregistry, egis eg isstrry, a ssystem yste ys tem te m that t at lacks th any mechanism for auditing. Thus, it is possible that some of the observed improvements in performance and outcome may have been due to self reporting. The extent to which our data elements overlapped with door to device and needle measures in CMS Hospital Compare, a subset of our data were subject to random audit, providing some impetus for accurate reporting.20 Our study design did not allow us to determine whether changes in care were directly attributable to the RACE interventions or whether they occurred independently of the project. During the corresponding time period from Q3 2008 to Q4 2009, the 220 hospitals submitting data to AR-G had improved median door to device times for directly presenting patients from 66 to 62 minutes 13 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 compared to 64 to 59 minutes in our study, and 120 to 113 minutes for transferred patients compared to 152 to 118 minutes in RACE. Thus, the improvements in our system were of a similar magnitude to those seen for all AR-G hospitals for directly presenting patients, and appear to be substantially larger for transferred patients. As hospitals participating in AR-G represent a select group focused on improving treatment times among the 1200 to 1400 hospitals in the United States that perform primary PCI, we believe that the improvements in North Carolina, particularly among transferred patients, likely reflect the effect of our system. Conclusions entire state A uniform and comprehensive approach to organizing STEMI care across an en ntiiree sta ate oonn a voluntary basis resulted in markedd improvements in timely coronary artery reperfusion. Patients presenting directly requiring interpr ressen enti ting ti ngg ddir irecctl ir tlyy to t PCI hospitals received thee fa ffastest stest treatment, t,, while whi hile le those t hospital transfer showed improvements time. By extending hospital hosp p transfe ferr sh how wed d tthe he ggreatest reattes reat estt im mprov vem menntss in ttreatment reattme reat ment nt ti ime. e B y ex exte tend nddin ng our our organization state, diagnosis STEMI or rga gani niza ni z ti za tion on to to aan n eentire ntiiree st nt stat te, e rrapid apid ap id ddi iagn iagn gnos osiss aand os nd d ttreatment r at re a me mennt ooff S TEM TE MI hhas MI as bbecome ecom ec om me an n eembedded m ed mb eddded standard care independent health tandard of ca are iind ndep nd epen ep endeent ooff he en heal alth al t ca care re ssetting etti et t ng or ti or geographic geeog ogra raph ra phic ph ic location. loc ocat oc atio at ion. io n n. Funding Sources: Unrestricted grants from Phillips, Sanofi Aventis, Medtronic Foundation. Phillips, Sanofi Aventis, and the Medtronic Foundation had no role in the design and conduct of the study, analysis and interpretation of the data, or in the preparation, review, or approval of the manuscript Conflict of Interest Disclosures: Jollis received research grants from Phillips, Sanofi Aventis, Medtronic Foundation and The Medicines Company. He also acted as a consultant for United Healthcare and Blue Cross Blue Shield North Carolina. Granger received research grants from Astellas, Medtronic Foundation, Astra Zeneca, Merck, Boehringer Ingelheim, Bristol-Myers Squibb, The Medicines Company, GlaxoSmithKline, and Sanofi Aventis. He also acted as a consultant for Boehringer Ingelheim, Sanofi Aventis, Astra Zeneca, Bristol-Myers Squibb, GlaxoSmithKline, Roche, Novarti, and The Medicines Company. Applegate acted as a consultant for Abbott, St. Jude, and Terumo Medical Corporation. Wilson acted as a consultant for Boston Scientific. 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Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, 2004 Writing Committee Members; Antman EM, Anbe DT, Armstrong PW, Bates, ER, Green LA, LA, A Hand Han H andd M, M Pearle Sloan Hochman JS Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pe earrle D DL, L, Slo S loan a MA, Smith SC Jr, Task Force Members: Jacobs AK, Adams CD, Anderson JL, Buller Bul ulle lerr CE le CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Page Nishimura R,, Pag age RL, Riegel B, Tarkington LG, G Yancy CW l. 2007 Focused update of the ACC/AHA AC CC/ C/AH AHA AH A 2004 2 044 Guidelines 20 Gui u delines for the Management nt of of Patients With th h ST-Elevation STT-El Elev El e ation Myocardial Infarction. report American College Cardiology/American Heart Association Task nfaarcti t on. A re epo port r ooff th rt tthee Am A eric er ican ic a C an Col olle lege g ooff C ge arrdiol olog ogy/ og y/Am y/ Am mer eric ican an H eart rt A ssoc ss o ia oc iati tion on T askk as Force Circulation. F orc rce c on Practice Pract ctic icee Guidelines. Guid Gu i el id elin ines in es. Circ es C irccula ulatio on. 22008;117:296-329. 0008;1117 117:2296-3 6-329. 9. 15.http://www.cardiosource.org/~/media/Files/Science%20and%20Quality/NCDR/Slidesets/AC 15 5.h .htt ttp: tt p:// p: //ww www. ww w.ca caarddio iossouurc urce.o .oorgg/~/ ~/me meddia/ a/Fi a/ Filles/ Fi s/Sc s/ Scie Sc ienc nce% e%20 e% 20an 20 nd% d%20 200Qu Quallit ity/ y//NC NCDR DR R/Sli /Slide dese de sets tss/A AC TIONGWTG%20ResultsQ309_Q210.ashx Accessed 12/18/2010. TION ONGW GWTG T %2 %20R Res esultssQ3 Q 09 09_Q Q21 2 0.asshx A cces cc e sedd 12 12/1 /18/ 8/20 20100. 16. Le Levine GN, Bates ER, Blankenship Bailey SR, Bittl Cercek B, C Chambers CE, El Ellis 16 Levi vine ne G N B ates at es E R B lank la nken ensh ship ip JJC, C B aile ai leyy S R B ittl it tl JJA, A C erce er cekk B hamb ha mber erss CE Elli liss SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;124:e574-651. 17. Reimer KA, Jennings RB. The "wavefront phenomenon" of myocardial ischemic cell death. II. Transmural progression of necrosis within the framework of ischemic bed size (myocardium at risk) and collateral flow. Lab Invest. 1979;40:633-44. 18. De Luca G, Suryapranata H, Ottervanger JP, Antman EM. Time delay to treatment and mortality in primary angioplasty for acute myocardial infarction: every minute of delay counts. Circulation. 2004;109:1223-5. 19. Hedström E, Engblom H, Frogner F, Åström-Olsson K, Öhlin H, Jovinge S, Arheden H. Infarct evolution in man studied in patients with first-time coronary occlusion in comparison to 16 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 DOI: 10.1161/CIRCULATIONAHA.111.068049 different species - implications for assessment of myocardial salvage. J Cardiovasc Magn Reson. 2009;11:38. 20. http://www.hospitalcompare.hhs.gov Accessed 12/18/2010. Table 1. Patient characteristics, procedures, and outcomes according to direct or transfer presentation to percutanous coronary intervention hospital. Age (yrs) Median (IQR) Female (%) Race (%) White Black Other Latino ethnicity (%) Insurance (%) Private / HMO Medicaid None Other Othe Ot herr he Prrio iorr my m occar arddial di iinfarction nfar nf arct c ionn (% (%)) Prior myocardial Prior failure Prio or heart fa aillur uree (% (%)) Prior Priior PCI (%) Prior surgery (%) P rio or coronary ry y bbypass yp passs su urgeery (% %) Diabetes mellitus Diab Di abet ab e es m et elli el litu li tuss (% (%)) Chest minutes, median (IQR) Ches Ch estt pa pain in duration ddur u at atio i n in io in m mi inut in utes tes, me medi dian di an ((IQ QR)) Means first facility Mean Me anss of transport an ttra rans ra nspo ns port po rt to to fi firs rstt fa rs faci cili ci lity li ty ((%) %) Self Se lf / ffamily amil am illy Ambulance A b l Other (Air/ICU) Shock on presentation (%) Heart failure on presentation (%) Reperfusion candidate STEMI first diagnosed (%) 1st ECG Subsequent ECG Procedures during hospitalization (%) PCI Coronary bypass surgery Complications (%) In-hospital death Stroke Hemorrhagic stroke Cardiogenic shock Congestive heart failure Major bleeding Re-infarction IQR = Inter-quartile range (25th, 75%). All 6841 59 (51, 69) Direct 3907 60 (51, 70) Transfer 2933 59 (51, 69) P value 29.6 30.0 29.1 0.36 83.9 13.6 2.5 1.6 84.3 13.6 2.1 1.5 83.4 13.5 3.1 1.7 0.03 47.7 7.2 19.1 26.1 26 6.11 20.1 20.1 44.7 4. 7 19.66 6.5 22.4 22.4 4 (49, 91 1 ((4 49, 190) 49, 190) 49.7 7.0 18.2 25.2 21.8 5.33 5. 21.4 21.44 77.5 .5 221.8 1.88 1. (42, 8833 (4 (42 2, 1181) 2, 81)) 81 44.9 7.5 20.2 27.4 17 7.8 8 17.8 4.00 4. 117.3 17 7.3 .3 5.2 5. .2 223.2 3.2 .2 (58, 205) 1000 (5 10 58, 8, 2205 05)) 05 43.4 43 .4 4 55.2 55 2 1.4 9.2 8.1 86.2 226.5 65 6. 71.3 71 3 2.2 9.6 7.9 86.6 665.9 65 .9 9 33.7 33 7 0.4 8.6 8.3 85.8 <0.0001 88.6 11.4 89.3 10.7 87.5 12.5 0.03 85.6 6.7 87.1 6.4 83.5 7.0 <0.0001 0.38 5.7 1.1 0.2 6.1 6.1 5.7 0.8 5.8 0.8 0.1 6.2 5.4 5.4 0.7 5.5 1.5 0.3 5.9 6.9 6.2 0.9 0.60 0.007 0.54 0.72 0.02 0.16 0.34 17 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 0.03 00.56 0. 56 00.002 .002 002 < 0 0001 0. <0.0001 0.03 0.03 <0.0001 < 0.00 0. 00 0011 00.0002 .0002 02 0.16 00.1 .166 <0.0001 <0.0 <0 .0 000 0011 0.18 0.51 0.38 DOI: 10.1161/CIRCULATIONAHA.111.068049 Figure Legends: Figure 1. North Carolina hospitals according to reperfusion strategy. Figure 2. Pre-hospital ECG for patients presenting directly to PCI hospitals by EMS. Figure 3. Reperfusion treatment by quarter, all eligible patients. P=0.04 for trend. Figure 4. Hospital door to device times for patients presenting directly to PCI hospitals by orted ed dP =0.0 =0 .006. arrival mode and quarter, median times. For trend, walk in P=0.01, EMS transpo transported P=0.06. Fiigu gure re 55. Reperfusion Repperf Re rffus usio i n times for patients present tin ingg to hospitals without wit i hoout PCI P facilities by quarter, Figure presenting meddian di times. D oor to nneedle eeedl dlee times tim ti mes for mes fo or patients patiien nts treated treateed with with t fibrinolysis. fib ibrrinnoly nolysi s s. F irst ir st hhospital o pi os pita taal do door or tto o median Door First device devi de v ce ttime vi imee fo im forr ppatients attien tientts ttransferred ranssfe ra ferr rred rr ed ffor orr P PCI PCI. CI.. Fo CI Forr ttransferred raans ansferrre redd pa pati patients, tien en nts ts,, tr treatment reaatm men entt ti time times mess aare me ree cco ord rdin in ng to o hhospital osspi pita t l re ta repe perf pe r us usio io on st stra rate ra teegy gy.. F For or llytic ytic yt ic P P=0 =0 0.2 .27, 7 ttransfer 7, rans ra nsfe ns feer st stra rate ra tegy te g presented ac according reperfusion strategy. P=0.27, strategy P=0.0008, mixed strategy P=0.002. 18 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 . Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 . Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 . Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 Supplemental Material RACE Investigators State Project Leader Lisa Monk, RN, MSN Central Organizing Committee Christopher B. Granger, MD James G. Jollis, MD Mayme Lou Roettig, RN, MSN EMS Regional Coordinators Claire Corbett, MMS, NREMT-P Scott Starnes, NREMT-P Nurse System Coordinators Tracey Blevins, RN, BSN, MBA Harriet Buss, RN, BSN, MSHA Joanne Cary, BS, RN, CN, Frank Castelblanco, RN, ADN, BA Bridget Harding, RN, MSN Cheryl Henderson, RN,BSN Michelle Keasling, RN, MSN Robyn Keller, RN, BSN Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 Jan Matthews, RN, Jeannie Moore, RN, BSN Linda Newton, RN, MSN Heather Norman, MHA, RN, BSN Gloria Paul, RN, MSN Mary Printz, RN, MSN, FNC Susan Rouse, RN, BSN Betsy Russell, RN Stephanie Starling, BSN, RN, MHA Jennifer Sarafin, RN, MSN Amanda Thompson, RN, BSN, MHA April Traxler, RN, BSN Annette Winkler, RN, MSN Other Systems Coordinators Keith Pendergrass, RRT, RCP Cathy Rabb, RRT, RCP David Reich RCIS, BS Charles H. Wilson, MD Interventional Cardiology Leaders Akinyele O. Aluko, MD Robert J. Applegate, MD Joseph D. Babb, MD Christopher C. Barber, MD Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 Bruce R. Brodie, MD Brian P. Hearon, MD R. Lee Jobe, MD Kevin R. Kruse, MD Michael R. Komada, MD William T. Maddox, MD Robert B. Preli, MD Steven C. Rohrbeck, MD John R. Sinden, MD Patrick J. Simpson, MD George A. Stouffer, III, MD Thomas D. Stuckey, MD Mark A. Thompson, MD F. Scott Valeri, MD John A. Williams, III, MD B. Hadley Wilson, MD Emergency Medicine Leaders Robert L. Beaton, MD Joshua N. Cochrane, MD Sidney M. Fletcher, MD J. Lee Garvey, MD Penny Jo Hamilton-Gaertner, MD Matthew R. Harmody, MD James W. Hoekstra, MD Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012 Paul E. Horton, MD Jonathan D. Kelly, MD Scott T. Miekley, MD R. Darrell Nelson, MD Brad A. Watling, MD Randall N. Willard, MD Emergency Medical Service Leaders David Cuddeback, NREMT-P Greg Mears, MD J. Brent Myers, MD Drexdal R. Pratt Dwayne R. Young, BS, REMTP Downloaded from http://circ.ahajournals.org/ by guest on June 5, 2012