Expansion of a Regional ST-Segment Elevation Myocardial

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Granger Aluko, B. Hadley Wilson, Robert J. Applegate, Greg Mears, Claire C. Corbett and Christopher B. James G. Jollis, Hussein R. Al-Khalidi, Lisa Monk, Mayme L. Roettig, J. Lee Garvey, Akinyele O. Expansion of a Regional ST-Segment Elevation Myocardial Infarction System to an Entire State Print ISSN: 0009-7322. Online ISSN: 1524-4539 Copyright © 2012 American Heart Association, Inc. All rights reserved. is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Circulation published online June 4, 2012; Circulation. http://circ.ahajournals.org/content/early/2012/05/31/CIRCULATIONAHA.111.068049 World Wide Web at: The online version of this article, along with updated information and services, is located on the http://circ.ahajournals.org/content/suppl/2012/05/31/CIRCULATIONAHA.111.068049.DC1.html Data Supplement (unedited) at: http://circ.ahajournals.org//subscriptions/ is online at: Circulation Information about subscribing to Subscriptions: http://www.lww.com/reprints Information about reprints can be found online at: Reprints: document. Permissions and Rights Question and Answer available in the Permissions in the middle column of the Web page under Services. Further information about this process is Once the online version of the published article for which permission is being requested is located, click Request can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Circulation Requests for permissions to reproduce figures, tables, or portions of articles originally published in Permissions: by guest on June 4, 2012 http://circ.ahajournals.org/ Downloaded from

Transcript of Expansion of a Regional ST-Segment Elevation Myocardial

GrangerAluko, B. Hadley Wilson, Robert J. Applegate, Greg Mears, Claire C. Corbett and Christopher B.

James G. Jollis, Hussein R. Al-Khalidi, Lisa Monk, Mayme L. Roettig, J. Lee Garvey, Akinyele O.Expansion of a Regional ST-Segment Elevation Myocardial Infarction System to an Entire State

Print ISSN: 0009-7322. Online ISSN: 1524-4539 Copyright © 2012 American Heart Association, Inc. All rights reserved.

is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231Circulation published online June 4, 2012;Circulation. 

http://circ.ahajournals.org/content/early/2012/05/31/CIRCULATIONAHA.111.068049World Wide Web at:

The online version of this article, along with updated information and services, is located on the

http://circ.ahajournals.org/content/suppl/2012/05/31/CIRCULATIONAHA.111.068049.DC1.htmlData Supplement (unedited) at:

  http://circ.ahajournals.org//subscriptions/

is online at: Circulation Information about subscribing to Subscriptions: 

http://www.lww.com/reprints Information about reprints can be found online at: Reprints:

  document. Permissions and Rights Question and Answer available in the

Permissions in the middle column of the Web page under Services. Further information about this process isOnce the online version of the published article for which permission is being requested is located, click Request

can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office.Circulation Requests for permissions to reproduce figures, tables, or portions of articles originally published inPermissions:

by guest on June 4, 2012http://circ.ahajournals.org/Downloaded from

DOI: 10.1161/CIRCULATIONAHA.111.068049

1

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; Claire C. Corbett,

MMS7; Christopher B. Granger, MD1 on behalf of the Race Investigators

1Duke Clinical Research Institute, Duke University, Durham; 2Dept of Cardiology, Presbyterian Hospital; 3Depts of Emergency Medicine, 4Cardiology, Carolinas Medical Center, Charlotte; 5Wake Forest Health Sciences University Winston-Salem; 6EMS Performance Improvement Center, University of North Carolina at Chapel Hill, Chapel Hill; 7New Hanover Regional

Medical Center, Wilmington, NC

Correspondence:

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

B. Hadley Wilson, MD ; Robert J. Applegate, MD ; Greg Mears, MD ; Clairee C CC. . CoCorbrbetett,t,

MMS7; Christopher B. Granger, MD1 on behalf of the Race Investigagaatotoorss

1DuDukeke C CClilininicacc l ReReReses arch Institute, Duke Univerrsisiitytyty, Durham; 2Dept oof f f CaCC rdiology, PresbyterianHoHoHospspitalall;;; 33DDDeptpttss ofo Emergency Medicine, 4Caardrdr iioologygy, Carolinanan s MeMeM ddidical Center, Charlotte; 5WWWake Fororresesestt t HeHeH alalalththth S S Scicicienenencececesss UnUnU ivivivererersisitytyty W W Wininssstooon-SSSalalalememem; ; ; 6EMEMEMS S S PePePerfrfrfoormamaancncnce e e ImImImprprprovovovemememenenent CeC nter, Univiverrrsiityty oof f NoNoortrtthh CaCaarroro ilinanaa at ChChChapeeel HHilllll,l, C C Chhhapppel HHiill; 77NeNeNew w HaHHanonovvverr r RRReggigionnall

MeMedidid ccall Cenntnteer, , WiWiW lmlmmininingtgtoonon,, NCC

CoCorrrresespopondndenencece::

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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

substantially improved. First hospital door to device for hospitals that adopted a “transfer for

PCI” reperfusion strategy fell from 117 minutes to 103 minutes (P=0.0008), while times at

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 directly to PCI hospitals fell

from 64 to 59 minutes (P<0.001). EMS-transported patients were most likely to reach door to

device goals with 91% treated within 90 minutes and 52% being treated with 60 minutes.

Patients treated within guideline goals had a mortality of 2.2% compared to 5.7% for those

exceeding guideline recommendations (P<0.001)

Conclusions - By extending regional coordination to an entire state, rapid diagnosis and

treatment of STEMI has become an established standard of care independent of health care

setting or geographic location.

Key words: acute myocardial infarction

y p p p p

PCI” reperfusion strategy fell from 117 minutes to 103 minutes (P=0.0008), whhilillee tititimemeess s atatat

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

frfromomom 6 64 4 too 555999 miminunutetes (P(P<00.0010 ).). EMEMS-transpspororttteddd patitienents wererree e moostst l liikely y toto reachch dooo r to

ddedevvivicec goals wwititith hh 9191% %% trtrreaeaateteted d d wiwithththinini 99900 miinununutes anannd 525252% % bebebeiingngg ttrereatateede wwittthh h 6060 m mminininututtesss..

PaPaatitieenentsts treatatatedede w wwiitthihinnn gguguidideelelininne e gogooalala ss hhaad d aaa mmomortrtalalitityy y ofof 2 2..2%% % ccompmpmpararreddd too o 55.5.7%7% ffooror t thohohosese

exceeedediing g gug iddele inne e rerecommmmenendadatitions (P(P<0<0.0.00101) )

Conclusionnss s -- ByByBy e extxxtenenenddingngng rrregegioioionanaall cococoorordididinananatitit onono t tooo ann ee entntntiririre ee ststatte,e,e rr rapapapididid dddiaiagnggnosososisisis aaand

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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

myocardial reperfusion. According to protocols established in the Regional Approach to

Cardiovascular Emergencies (RACE) project, we implemented processes to expedite care in 119

hospitals across a state with a population of 9.4 million residents and area of 53,000 square

miles.9 Hospitals adopted synchronized strategies to expedite reperfusion for patients presenting

by EMS, hospital transfer, and “walk-in.”

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

myocardial reperfusion. According to protocols established in the Regional Apprprroaaachchh t ttoo o

Cardiovascular Emergencies (RACE) project, we implemented processes to expedite care in 119

hoospspspitititalalalss acacacrorooss aaa s s stat te with a population of 9.4 mmmillllion residents aaand aaarerereaa of 53,000 square

mmileees.s 9 Hospittalallsss aadopoppteted dd syssyncncnchrhrononniizizeedd sstratttegggies tooo exxxppepedidiitee rrepeppeerrfufusiisiononn ffooror pppatatieieentntts s pppresesesenenntiinnng

byby E E EMMSMS,, , hohohosspspititaalal tttraransnnsfefeer,r, anndnd ““ “wawawallklk-i-iin.n.””

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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 PCI hospitals in

the state with on-site surgery to serve as regional primary PCI centers (10 in the initial RACE

intervention, 11 additional for the state-wide intervention).9 These hospitals agreed to collect and

share ARG data, fund or co-fund a hospital STEMI system coordinator, accept all STEMI

patients regardless of bed availability on a 24 hour 7 day per week basis, allow for

catheterization laboratory activation by a single call from emergency physicians or trained

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

Once leadership and data systems were established, we organized all 21 PPPCICII h hhososospipipitatatalslsls i in

he state with on-site surgery to serve as regional primary PCI centers (10 in the initial RACE

nnteteervrvrvenenentititiononon, 11 a aaddddditional for the state-wide inttererervveention).9 Thesse e e hospsppitititala s agreed to collect and

hhharrare e ARG daatata,, fufuundndd orr r cococo-f-ffunuund d a aa hohoh spspiital SSTTTEMMMII syyststs emem cooooorrddiinnatatororr, acacccecepptpt aallllll S SSTETETEMIMIMI

papatititienenntstst rregegegaraardldleesss ofof bbeeded a avavaaililabababilililititityy ononon aa a 2224 hhhououur 77 ddaday yy pepeper wewew ekekek b b basasiis, , alallololoww w fofoorr r

catheterizatioon n n lalal boboborarar totot ryryr aaactctctivivi aaatititiononon b by y y a a sisisingngnglelee cccalalall l frfromomm eeemememergrgrgenene cycycy p pphyhyhysisisicicic ananans s s ororor t t trarar ined

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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 by more than one primary PCI center, all PCI centers were represented in planning

meetings. Under the guidance of the North Carolina Office of EMS, emergency medical systems

were encouraged to obtain an ECG for every patient with potential STEMI symptoms, interpret

the ECG and communicate the findings of a possible STEMI to receiving hospitals, divert to PCI

centers if first medical contact to device could reliably be achieved within 90 minutes or patients

were ineligible for fibrinolysis, and provide a standard method for the EMS time data to be

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

erved by more than one primary PCI center, all PCI centers were represented inn pplalaannnninining g g

meetings. Under the guidance of the North Carolina Office of EMS, emergency medical systems

wewererere e eenncncouououraraagedd d tototo obtain an ECG for every paatititienenent with potentiialala STETEEMMMI symptoms, interpret

hhhe EECG and cocommmmmmununniccatatateee thththeee fifinndndinini gggs oof aa a ppossiibiblle STSTSTEMEMMII toto rreecceieivivivinngg hhosososppititalalals,s, d d divivivererertt totoo PPPCI

ceentntnterererss s ifif f ffiririrstsst m mededdicicaall ccconontaactctc tttooo d d deevevicicce cococouuuld dd rerer lliliaabblylyy bbbeee aacachihihievevveddd wwwititthiin n 909090 mmmininnutututeses oor r papattitienenntsddd

were ineligiblbllee e fofof rr r fififibrbrrininnolllysysysisii , ananand d prpp ovovovididide e e a a a ststtananandadadardrdr mmmetetethohohod d d fofofor thththee e EMEMEMS S S titimememe d ddatatataa a to be

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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 (inter-

quartile rage) and number (percentage), respectively. Patient characteristics and process

measures were compared using Wilcoxon rank-sum test for 2 groups comparison (Kruskal-

Wallis 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 in three

month intervals from July 2008 through December 2009 stratified according to treatment and

presentation to PCI hospital (fibrinolysis or primary PCI; presentation to PCI hospital by

transfer, self, or EMS).

For the PCI hospitals, the objectives of the RACE intervention were to reduce door-to-

device times for directly presenting patients and first medical contact to device for EMS

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

conducted with PCI hospitals as a random effect. Performance data were compararrededd inn n thththrereree e e

month intervals from July 2008 through December 2009 stratified according to treatment and

prresessenenentatatatititiononon t t to PCPCPCI I hospital (fibrinolysis or primamamaryyy PCI; presentataatit onn t ttoo o PCI hospital by r

rrannnsfs er, self, oror EE MSMSMS).))

FFororr t t thehhe P PCICII hhooospipipitatalss, , ththheee obobobjjececctiiiveveves ss offf t t thehee RRRAACACEEE inininteteervrvr enene tititionono w wwerere ee totoo r r ededducuuce e dododooror-t-tto---

device timess f ffororor d ddiririrecece tltlt y y y prprresesesenenentititingngn p ppatattieiei ntntn ss s aaandndnd f ffirirrststt m medededicicicalala cccononontaaactctct t t to o o dededeviviv cecee fffororor E EEMSMM

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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% of patients.

By medical record review, 86% of patients were felt to be reperfusion candidates and STEMI

was apparent on the initial ECG for 89% of patients.

Means of transport to the first facility was by EMS for 55% of patients and walk-in for

43% of patients. Over the course of the study, there was an increase in the percentage of patients

presenting by EMS to PCI hospitals, from 70 to 75% (P=0.04). The inverse pattern and 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 non-

PCI hospitals (P<0.01) (Figure 3). During the same period, primary PCI as reperfusion mode

had prior myocardial infarction or PCI, and shock was present on admission for 9%9%9% of f f papapatititienenentsts.

By medical record review, 86% of patients were felt to be reperfusion candidates and STEMI

wawas s s apapapppaparererentntnt on n thththe e initial ECG for 89% of patieieentntn ss.

Means s ofofof ttraransnsspooortrtrt t t too o thththe e fifif rsrsrst t fafaccilittyy wwass bbyy EMEMEMS S fofoor r 5555%%% ofoff ppaaatieientntntss anannd d d wwawalklkl -i-i-in n fofof rrr

4333% % % ofofof p ppatattieieientnts.s. OOvOverer ttheheh coouoursrsseee ofofof tthhehe ssstututudydydy, , , ththt eereree e wwwasss ananan iincncncrreeasasase e e ininn tthhhe e pepepercrcr enenntataagege off f papaattieenents

presenting by y y EMEMEMS S S totot P PPCICI h hhososo pipipitatatalslss,, frrromomom 7 7 70 0 tototo 757575% % % (PPP=0=00.0.0.04)4)4).. ThThhe e e inininveveversrsrse e papapattttttererern n n ana d trend

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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,

and door to needle for patients treated with fibrinolysis. Over the study period, median door to

device times for patients presenting directly to PCI hospitals fell modestly from 64 to 59 minutes

(P<0.001) with improvements in both self presenting patients from 79 to 73 minutes (P=0.01)

and EMS transported patients from 58 to 55 minutes (P=0.06) (Figure 4). The proportion of

directly presenting patients who underwent PCI within 90 minutes increased from 83% to 89%.

For patients transported directly to PCI hospitals by EMS, pre-hospital ECG rates

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

and door to needle for patients treated with fibrinolysis. Over the study period, mmmedidid anann d ddoooooor r r toto

device times for patients presenting directly to PCI hospitals fell modestly from 64 to 59 minutes

PP<0<0<0.0.0.0010101) )) wiwiwitth iimpmpmprrovements in both self presenennttit nnng patients fromomm 79 9 tototo 73 minutes (P=0.01)

anndd d EME S trannspspoorortted dd papaatititienenentststs f ffroromm m 5858 tooo 555 mmminuuuteees (P=P=P=0.0.060606) ) ((FFFiggugurere 4 4)). ThThThe e prprropopporortit oonon o oof

didirereectcttlylyly ppprereesesesentntininng g g papattieenentsts wwwhohoo unununddederwrwwenenentt t PCPCCI I I wwwitththinnn 999000 mimiminunun ttetes ss ininincrcrreaaasesed dd frfrfromomm 8 883%3%% ttto o 89899%%.%.

For papapatitit enene tststs t ttraraansnsn popoortrtrtedede d ddiriri ececectly y y totoo P PPCCCI I I hohohospspspititi alalss s bybyby EEEMSMSMS, prprpre-e-e hohohospspspititi alall E E ECGCGCG r rrata es

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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

minutes to 138 minutes by the end of the study (P=0.002). Treatment time varied substantially

by transfer distance expressed as drive times according to standard mapping software

[http://www.mapquest.com access October 21, 2010] Median first door to device time for

hospitals within 30 minutes was 94 minutes, 134 minutes for hospitals between 31 and 45

minutes drive time, and 192 minutes for hospitals exceeding 45 minutes drive time. Mixed

strategy hospitals had a 21 minute longer median drive time compared to transfer for 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

minutes to 138 minutes by the end of the study (P=0.002). Treatment time varieieedd d suss bsbsbstatatantntntiaiaialllly y

by transfer distance expressed as drive times according to standard mapping software

hhtttttp:p:p://////wwwwwww.ww mmamapqpqpquueuest.com access October 21, 2020201100] Median firrststs dooooorr r tto device time for

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trategy hospipipitatatalsls h hhadada a a 2 1 1 mimiminuuutttee e loloongnggererer m m mededediaiaann n drdrd ivivi e tititimememe c c omomompapaarerered dd tototo t t trararansnssfefefer r r fofoforr r PCI

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(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 in-

hospital 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 in the United States. Our intervention demonstrates that systematic barriers in

timely reperfusion can be overcome with a broadly organized voluntary effort to fill leadership

gaps in the health care. These gaps primarily exist between competing institutions and between

health care entities that function in separate and distinct systems. By building consensus among

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

Discussion

The RACE system is the largest state-wide ST elevation myocardial infarction system ever

mmplplplememmenennteteteddd in ttthehehe U nited States. Our intervenntititiononn demonstrates s s tht atat sysysysts ematic barriers in

iiimeemelyl reperfuusisiiononon ccanann bbbee ovovovererercocomememe w witithh a bbrbroooadlllyy orgagaganinizzzedd d vovooluuuntntararyy efeffofofortrtrt tto o fifif llllll l lleeadededersrshihihipp

gagapspsps iiinn n ththe ee hehehealalththh cccarareee. ThThessse e gagagapspsps p pririimamamariririllly eeexixix ssst bbetettweweweenenen cccomomompepepetititingngg innsnstitiitutut tititiononns s aananddd bbebetwtwweeeen

health care enenntitit titit eseses t tthahahat t fuf ncncnctititiononn i inn n seses papaarararatetete a aandndnd d ddisisstititincnctt t sysysystststememems.s.s. ByByBy b b buiuiuildldldinini g g g cococonsnsnsenenensus amongg

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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 Association STEMI

guidelines first directed device activation to occur within 90 minutes of “first medical contact”

rather than hospital door for patients initially treated by emergency personnel, defined as the

time that the EMS crew arrives at the “scene” of the patient.14 By adding scene time and

transport time to the 90 minute goal, this guideline effectively raised the bar on primary PCI and

made hospitals and emergency medical services jointly accountable for patient treatment. This

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

PCI. In 2007, the American College of Cardiology / American Heart Associatioonnn STSTS EMEMEMI II

guidelines first directed device activation to occur within 90 minutes of “first medical contact”

aaththhererer tt thhahannn hohohosppitititaalal d oor for patients initially treaeaeatetet dd by emergencycyc pererrsososonnn el, defined as the

iiimeeme t hat the EMEMMS crreeww aarrrrrriviviveeses aat t ththhe e “s“scceneee”” of ttthhee paatatiieientntt.14 14 1 BByy aadddddininingg scscenenene e titimememe a a nndn

rranannspspspororo tt titiimemem ttoo thhhe e 99090 mmmini uutute gogogoalalal, , ththhisss g g guuiuidedeelilil nnne eefffefectctctivivivelely y y raraaissededed tthhehe bbararr o o n n n prprprimimmararry PCPCIII aanand

made hospitaalslsls a aandndnd eeemememergrgenenencycyc mmmedededicici alall s s erererviviv cececes s s jojojoininintltly y acacaccococounununtatatablblee e fofofor r r papapatititienennt tt trtrtreaeaeatmtmtment. This

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patients also indicates potential for a further improvement in hospital processes such as pre-

registration 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 approximately

220 hospitals that were submitting data and this national benchmark likely reflects above average

performance. The treatment times in RACE for transferred patients also compare favorably to

selected single center or single region reports from Abbot Northwestern of 32%, Mayo Clinic of

12%, and Springfield, Illinois Stat Heart of 12%. 1, 2, 5 With national guidelines for inter-hospital

transfer continuing to call for device activation within 90 minutes of first medical contact as a

“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

within 90 minutes of first door.14 The AR-G registry involved a select group of apappprrroxxximimimatatatelelely y

220 hospitals that were submitting data and this national benchmark likely reflects above average

peerfrffororormmamancncnce.e Thehehe t t trer atment times in RACE for trtrtranannsferred patienntstt alslsso oo ccompare favorably to

eeleeectc ed single e cceennnterer oor r r sisisingngnglelele rregeggioioon n rerepporttts frommm AAbbbbbootot N NNoororththwwesesteterrrn oof f 323232%,%, M MMayaya ooo ClClClinninicic o f

1222%,%,%, a a andnd S SSprprp ininggfgfieieeldld,,, Illllilinnoisisis S SStatatattt HeHeH aarart tt ofofof 12%2%2%. . 1, 22, 55 WW Wititith hh nananatitioononalalal g guuuiddedeliliinenen s ss fofoorr r iininteteer---hohospsspitittal

ransfer contitinununuining g g totot ccalaa l fofofor r r deeeviviv cecee a ctctctivivvatatatioioion n n wiwiw thththinini 9990 00 mimiminununutetetes s ofofof fffiririrststst m m mededdicicicalalal c ccononontact as a

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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

important improvement of myocardial infarction care in North Carolina.17-19 Observations from

our RACE data also support timely treatment according to a 2.2% mortality for those receiving

reperfusion according to overall guideline time goals compare to a 5.7% mortality for those

treated beyond recommended time intervals (P<0.001).

Limitations

This study relied on the voluntary submission of data to the AR-G registry, a system that lacks

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

mportant improvement of myocardial infarction care in North Carolina.17-19 Obsbsserrrvavav tititiononons ss frfrfromom

our RACE data also support timely treatment according to a 2.2% mortality for those receiving

eepepeperfrfrfuususioioionn n aacccoordrdrdining to overall guideline time gogogoaalls compare to a aa 5.77% % % mom rtality for those

rreaaateted beyondd rrecececommmemeendndndededd tttimime ee inini tteerrvvalss (PPP<00.0.0001).).).

LiLiimimimitatatatitiononns s s

This study relellieieied d d ononon t t hehehe v olololunununtaaaryryry s sububu mimim ssssssioioon n n ofofo d ddatatataaa to o o thththe ee ARARAR-G-G rrregegegisisstrtrraa y,y,y, a a sssysysystetetem m m tht at lacks

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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

A uniform and comprehensive approach to organizing STEMI care across an entire state on a

voluntary basis resulted in marked improvements in timely coronary artery reperfusion. Patients

presenting directly to PCI hospitals received the fastest treatment, while those requiring inter-

hospital transfer showed the greatest improvements in treatment time. By extending our

organization to an entire state, rapid diagnosis and treatment of STEMI has become an embedded

standard of care independent of health care setting or geographic location.

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 ofthe 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. Garvey acted as a consultant for Abbott Vascular.

A uniform and comprehensive approach to organizing STEMI care across an enntitiiree staaatetete o o on n n a a

voluntary basis resulted in marked improvements in timely coronaryd artery reperfusion. Patients

prresessenenentititingngg d d diririrecctltltlyy y tot PCI hospitals received the ee fafaf ssstest treatment,t,, w hihilelele t those requiring inter-

hhohosppspital transfefer r shhhowowwededd tt thehehe g ggrrereatattesesest t immmpprovvvemmmennntss in ttrrereatattmemmentnt tiimme.e BBBy y exexextetendnddininng g oouourr r

orrgagaganininizazaz titiononon t to o aaan eentntiiree e ststatte,e,e rrrapapapididid d diiaiagngngnosososisss a a andndd tttrer atata mememennnt oooff SSSTETETEMMIMI hhhasas b bbecececomommee e anann eembmbm edededdded dff

tandard of cacaarerere i indndndepepepenenendeeentntnt o of f f hehehealalaltht cacacarerere s ssetetettitit ngngng o oorr r geeeogogograraraphphphicicic locococatatatioioion.n.n

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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.

All Direct Transfer P value 6841 3907 2933 Age (yrs) Median (IQR)

59 (51, 69) 60 (51, 70) 59 (51, 69) 0.03

Female (%) 29.6 30.0 29.1 0.36 Race (%)

White 83.9 84.3 83.4 0.03 Black 13.6 13.6 13.5 Other 2.5 2.1 3.1

Latino ethnicity (%) 1.6 1.5 1.7 0.56 Insurance (%)

Private / HMO 47.7 49.7 44.9 0.002 Medicaid 7.2 7.0 7.5 None 19.1 18.2 20.2 Other 26.1 25.2 27.4

Prior myocardial infarction (%) 20.1 21.8 17.8 <0.0001 Prior heart failure (%) 4.7 5.3 4.0 0.03 Prior PCI (%) 19.6 21.4 17.3 <0.0001 Prior coronary bypass surgery (%) 6.5 7.5 5.2 0.0002 Diabetes mellitus (%) 22.4 21.8 23.2 0.16 Chest pain duration in minutes, median (IQR) 91 (49, 190) 83 (42, 181) 100 (58, 205) <0.0001 Means of transport to first facility (%)

Self / family 43.4 26.5 65.9 <0.0001 Ambulance 55.2 71.3 33.7

Other (Air/ICU) 1.4 2.2 0.4 Shock on presentation (%) 9.2 9.6 8.6 0.18 Heart failure on presentation (%) 8.1 7.9 8.3 0.51 Reperfusion candidate 86.2 86.6 85.8 0.38 STEMI first diagnosed (%)

1st ECG 88.6 89.3 87.5 0.03 Subsequent ECG 11.4 10.7 12.5

Procedures during hospitalization (%) PCI 85.6 87.1 83.5 <0.0001

Coronary bypass surgery 6.7 6.4 7.0 0.38 Complications (%)

In-hospital death 5.7 5.8 5.5 0.60 Stroke 1.1 0.8 1.5 0.007

Hemorrhagic stroke 0.2 0.1 0.3 0.54 Cardiogenic shock 6.1 6.2 5.9 0.72

Congestive heart failure 6.1 5.4 6.9 0.02 Major bleeding 5.7 5.4 6.2 0.16 Re-infarction 0.8 0.7 0.9 0.34

IQR = Inter-quartile range (25th, 75%).

Other 2.5 2.1 3.1Latino ethnicity (%) 1.6 1.5 1.7 0.0.0 565656 Insurance (%)

Private / HMO 47.7 49.7 44.9 00 0.00202 Medicaid 7.2 7.0 7.5None 19.1 18.2 20.2 OtOtOtheheherrr 2666 1.1.1 25.2 27.4

PrPrrioioiorrr mym occararddidial iinfnfararctc ion n (%(%) ) 2020.1.1 21.8 177.88 < 0.0 0001 PPPriooor r heart faailillururee e (%(%(%)) 4.4 7 5.5.3 3 3 4.4.4.0 0 0 00.0.030303 PPriioor r PCI (%) 19.66 2221.4 4 17117.3.3 < <<0.0.000000111 PPrP iooor r coronaryryy b yppassss suurrgeeery (%(%%) ) 6.5 777.5 5..22 00.000202 DiDiDiabababetete eses mmelelellililitutus s (%(%(%) ) 2222.4.44 2221.1.1.8 8 2223.2.2.2 0 0.1.166 ChChesest tt papapaininin d d duru atatioioi nn iinin m miinin tututeses, memedididiananan ( (IQQR)R)) 91911 (( (44949,, 1919190)0)0) 8 883 3 (4(4(422,2, 11818181)) ) 1010100 0 0 (558,88, 2 2 2050505)) <0<0<0.0.0000000011 1 MeMeMeananansss ofofof tt trararansnsnspopoportrtrt tt tooo fififirsrsrsttt fafafacicicilililitytyty (( (%)%)%)

SeSeSelflflf / // f ffamaamilillyy y 434343.4.44 2226.6.6 5 55 65656 .9.99 <0.0001 A bb ll 55 2 71 3 33 7

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DOI: 10.1161/CIRCULATIONAHA.111.068049

18

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

arrival mode and quarter, median times. For trend, walk in P=0.01, EMS transported P=0.06.

Figure 5. Reperfusion times for patients presenting to hospitals without PCI facilities by quarter,

median times. Door to needle times for patients treated with fibrinolysis. First hospital door to

device time for patients transferred for PCI. For transferred patients, treatment times are

presented according to hospital reperfusion strategy. For lytic P=0.27, transfer strategy

P=0.0008, mixed strategy P=0.002.

arrival mode and quarter, median times. For trend, walk in P=0.01, EMS transpoorrrtededd PPP=0=0=0.0.006.6.6.

Fiigugugurerere 55 5. ReReReppperfrffusususioi n times for patients presentttinininggg to hospitals wwwiti hooututut P PCI facilities by quarter,

mmeddidian times. D DDoooor r toto nnneeeeedldldle e e titimmemesss fofoor patiiiennnts ttrreeateed d wiwiththt ff ibibrrinnonolylysiss ss. F FFiririrstst hhhososo pipipitataal dododooroor ttto

dedeviviv cecece t t imimee e fofofor r pppattitienentts ttraransssfefeferrrrrrededed ff fororr P P PCICICI.. . FoFoFor r tttraananssffererrrerereddd papapatitienenntststs, , trtrreaaatmtmmenenentt t titimememes s aaaree e

presented acccocoordrdrdininng g g totoo h hhossspipipitatat l rererepepeperfrr usususioioon n n stststrararateteegygygy. . F Fororor l llytytyticicic P P P=0=00.2.2.27,7,7 t ttrararansnsnsfefeer rr stststrararatetetegygg

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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

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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

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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

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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

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