Ivan C. Rokos

The National Cardiovascular Data Registry (NCDR) Data Quality Brief : The NCDR Data Quality Program in 2012

OBJECTIVES The National Cardiovascular Data Registry (NCDR) developed the Data Quality Program to meet the objectives of ensuring the completeness, consistency, and accuracy of data submitted to the observational clinical registries. The Data Quality Program consists of 3 main components: 1) a data quality report; 2) a set of internal quality assurance protocols; and 3) a yearly data audit program. BACKGROUND Since its inception in 1997, the NCDR has been the basis for the development of performance and quality metrics, site-level quality improvement programs, and peer-reviewed health outcomes research. METHODS Before inclusion in the registry, data are filtered through the registry-specific algorithms that require predetermined levels of completeness and consistency for submitted data fields as part of the data quality report. Internal quality assurance protocols enforce data standards before reporting. Within each registry, 300 to 625 records are audited annually in 25 randomly identified sites (i.e., 12 to 25 records per audited site). RESULTS In the 2010 audits, the participant average raw accuracy of data abstraction for the CathPCI Registry, ICD Registry, and ACTION Registry-GWTG were, respectively, 93.1% (range, 89.4% minimum, 97.4% maximum), 91.2% (range, 83.7% minimum, 95.7% maximum), and 89.7.% (range, 85% minimum, 95% maximum). CONCLUSIONS The 2010 audits provided evidence that many fields in the NCDR accurately represent the data from the medical charts. The American College of Cardiology Foundation is undertaking a series of initiatives aimed at creating a quality assurance rapid learning system, which, when complete, will monitor, evaluate, and improve data quality.

Integration of pre-hospital electrocardiograms and ST-elevation myocardial infarction receiving center (SRC) networks: impact on Door-to-Balloon times across 10 independent regions.

OBJECTIVES The aim of this study was to evaluate the rate of timely reperfusion for ST-elevation myocardial infarction (STEMI) with primary percutaneous coronary intervention (PPCI) in regional STEMI Receiving Center (SRC) networks. BACKGROUND The American College of Cardiology Door-to-Balloon (D2B) Alliance target is a >75% rate of D2B <or=90 min. Independent initiatives nationwide have organized regional SRC networks that coordinate universal access to 9-1-1 with the pre-hospital electrocardiogram (PH-ECG) diagnosis of STEMI and immediate transport to a SRC (designated PPCI-capable hospital). METHODS A pooled analysis of 10 independent, prospective, observational registries involving 72 hospitals was performed. Data were collected on all consecutive patients with a PH-ECG diagnosis of STEMI. The D2B and emergency medical services (EMS)-to-balloon (E2B) times were recorded. RESULTS Paramedics transported 2,712 patients with a PH-ECG diagnosis of STEMI directly to the nearest SRC. A PPCI was performed in 2,053 patients (76%) with an 86% rate of D2B <or=90 min (95% confidence interval: 84.4% to 87.4%). Secondary analyses of this cohort demonstrated a 50% rate of D2B <or=60 min (n = 1,031), 25% rate of D2B <or=45 min (n = 517), and an 8% rate of D2B <or=30 min (n = 155). A tertiary analysis restricted to 762 of 2,053 (37%) cases demonstrated a 68% rate of E2B <or=90 min. CONCLUSIONS Ten independent regional SRC networks demonstrated a combined 86% rate of D2B <or=90 min, and each region individually surpassed the American College of Cardiology D2B Alliance benchmark. In areas with regional SRC networks, 9-1-1 provides entire communities with timely access to quality STEMI care.

Systems of Care for ST-Segment–Elevation Myocardial Infarction: A Report From the American Heart Association’s Mission: Lifeline

Background— National guidelines call for participation in systems to rapidly diagnose and treat ST-segment–elevation myocardial infarction (STEMI). In order to characterize currently implemented STEMI reperfusion systems and identify practices common to system organization, the American Heart Association surveyed existing systems throughout the United States. Methods and Results— A STEMI system was defined as an integrated group of separate entities focused on reperfusion therapy for STEMI within a geographic region that included at least 1 hospital that performs percutaneous coronary intervention and at least 1 emergency medical service agency. Systems meeting this definition were invited to participate in a survey of 42 questions based on expert panel opinion and knowledge of existing systems. Data were collected through the American Heart Association Mission: Lifeline website. Between April 2008 and January 2010, 381 unique systems involving 899 percutaneous coronary intervention hospitals in 47 states responded to the survey, of which 255 systems (67%) involved urban regions. The predominant funding sources for STEMI systems were percutaneous coronary intervention hospitals (n = 320, 84%) and /or cardiology practices (n = 88, 23%). Predominant system characteristics identified by the survey included: STEMI patient acceptance at percutaneous coronary intervention hospital regardless of bed availability (N = 346, 97%); single phone call activation of catheterization laboratory (N = 335, 92%); emergency department physician activation of laboratory without cardiology consultation (N = 318, 87%); data registry participation (N = 311, 84%); and prehospital activation of the laboratory through emergency department notification without cardiology notification (N = 297, 78%). The most common barriers to system implementation were hospital (n = 139, 37%) and cardiology group competition (n = 81, 21%) and emergency medical services transport and finances (n = 99, 26%). Conclusions— This survey broadly describes the organizational characteristics of collaborative efforts by hospitals and emergency medical services to provide timely reperfusion in the United States. These findings serve as a benchmark for existing systems and should help guide healthcare teams in the process of organizing care for patients with STEMI.

Emergency Department Bypass for ST-Segment–Elevation Myocardial Infarction Patients Identified With a Prehospital Electrocardiogram A Report From the American Heart Association Mission: Lifeline Program

Background— For patients identified before hospital arrival with ST-segment–elevation myocardial infarction, bypassing the emergency department (ED) with direct transport to the catheterization laboratory may shorten reperfusion times. Methods and Results— We studied 12 581 ST-segment–elevation myocardial infarction patients identified with a prehospital ECG treated at 371 primary percutaneous coronary intervention–capable US hospitals participating in the Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With The Guidelines, including those participating in the American Heart Association Mission: Lifeline program from 2008 to 2011. Reperfusion times with primary percutaneous coronary intervention and in-hospital mortality rates were compared between patients undergoing ED evaluation and those bypassing the ED. ED bypass occurred in 1316 patients (10.5%). These patients had a lower frequency of heart failure and shock on presentation and nonsystem reasons for delay in percutaneous coronary intervention. ED bypass occurred more frequently during working hours compared with off-hours (18.3% versus 4.3%); ED bypass rate varied significantly across hospitals (median, 3.3%; range, 0%–71%). First medical contact to device activation time was shorter (median, 68 minutes [interquartile range, 54–85 minutes] versus 88 minutes [interquartile range, 73–106 minutes]; P<0.0001) and achieved within 90 minutes more frequently (80.7% versus 53.7%; P<0.0001) with ED bypass. The unadjusted in-hospital mortality rate was lower among ED bypass patients (2.7% versus 4.1%; P=0.01), but the adjusted mortality risk was similar (adjusted odds ratio, 0.69; 95% confidence interval, 0.45–1.03; P=0.07). Conclusions— Among ST-segment–elevation myocardial infarction patients identified with a prehospital ECG, the rate of ED bypass varied significantly across US hospitals, but ED bypass occurred infrequently and was mostly isolated to working hours. Because ED bypass was associated with shorter reperfusion times and numerically lower mortality rates, further exploration of and advocacy for the implementation of this process appear warranted.

Fibrinolysis Use Among Patients Requiring Interhospital Transfer for ST-Segment Elevation Myocardial Infarction Care: A Report From the US National Cardiovascular Data Registry

IMPORTANCE Guidelines for patients with ST-segment elevation myocardial infarction (STEMI) recommend timely reperfusion with primary percutaneous coronary intervention (pPCI) or fibrinolysis. Among patients with STEMI who require interhospital transfer, it is unclear how reperfusion strategy selection and outcomes vary with interhospital drive times. OBJECTIVE To assess the association of estimated interhospital drive times with reperfusion strategy selection among transferred patients with STEMI in the United States. DESIGN, SETTING, AND PARTICIPANTS We identified 22,481 patients eligible for pPCI or fibrinolysis who were transferred from 1771 STEMI referring centers to 366 STEMI receiving centers in the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines database between July 1, 2008, and March 31, 2012. MAIN OUTCOMES AND MEASURES In-hospital mortality and major bleeding. RESULTS The median estimated interhospital drive time was 57 minutes (interquartile range [IQR], 36-88 minutes). When the estimated drive time exceeded 30 minutes, only 42.6% of transfer patients treated with pPCI achieved the first door-to-balloon time within 120 minutes. Only 52.7% of eligible patients with a drive time exceeding 60 minutes received fibrinolysis. Among 15,437 patients with estimated drive times of 30 to 120 minutes who were eligible for fibrinolysis or pPCI, 5296 (34.3%) received pretransfer fibrinolysis, with a median door-to-needle time of 34 minutes (IQR, 23-53 minutes). After fibrinolysis, the median time to transfer to the STEMI receiving center was 49 minutes (IQR, 34-69 minutes), and 97.1% underwent follow-up angiography. Patients treated with fibrinolysis vs pPCI had no significant mortality difference (3.7% vs 3.9%; adjusted odds ratio, 1.13; 95% CI, 0.94-1.36) but had higher bleeding risk (10.7% vs 9.5%; adjusted odds ratio, 1.17; 95% CI, 1.02-1.33). CONCLUSIONS AND RELEVANCE In the United States, neither fibrinolysis nor pPCI is being optimally used to achieve guideline-recommended reperfusion targets. For patients who are unlikely to receive timely pPCI, pretransfer fibrinolysis, followed by early transfer for angiography, may be a reperfusion option when potential benefits of timely reperfusion outweigh bleeding risk.

Regional Systems of Care Demonstration Project: American Heart Association Mission: Lifeline STEMI Systems Accelerator.

Background: Up to 50% of patients fail to meet ST-segment–elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact–to–device time of <90 minutes for patients directly presenting to percutaneous coronary intervention–capable hospitals and <120 minutes for transferred patients. We sought to increase the proportion of patients treated within guideline goals by organizing coordinated regional reperfusion plans. Methods: We established leadership teams, coordinated protocols, and provided regular feedback for 484 hospitals and 1253 emergency medical services (EMS) agencies in 16 regions across the United States. Results: Between July 2012 and December 2013, 23 809 patients presented with acute STEMI (direct to percutaneous coronary intervention hospital: 11 765 EMS transported and 6502 self-transported; 5542 transferred). EMS-transported patients differed from self-transported patients in symptom onset to first medical contact time (median, 47 versus 114 minutes), incidence of cardiac arrest (10% versus 3%), shock on admission (11% versus 3%), and in-hospital mortality (8% versus 3%; P <0.001 for all comparisons). There was a significant increase in the proportion of patients meeting guideline goals of first medical contact–to–device time, including those directly presenting via EMS (50% to 55%; P <0.001) and transferred patients (44%−48%; P =0.002). Despite regional variability, the greatest gains occurred among patients in the 5 most improved regions, increasing from 45% to 57% (direct EMS; P <0.001) and 38% to 50% (transfers; P <0.001). Conclusions: This Mission: Lifeline STEMI Systems Accelerator demonstration project represents the largest national effort to organize regional STEMI care. By focusing on first medical contact–to–device time, coordinated treatment protocols, and regional data collection and reporting, we were able to increase significantly the proportion of patients treated within guideline goals. # Clinical Perspective {#article-title-31}Background: Up to 50% of patients fail to meet ST-segment–elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact–to–device time of <90 minutes for patients directly presenting to percutaneous coronary intervention–capable hospitals and <120 minutes for transferred patients. We sought to increase the proportion of patients treated within guideline goals by organizing coordinated regional reperfusion plans. Methods: We established leadership teams, coordinated protocols, and provided regular feedback for 484 hospitals and 1253 emergency medical services (EMS) agencies in 16 regions across the United States. Results: Between July 2012 and December 2013, 23 809 patients presented with acute STEMI (direct to percutaneous coronary intervention hospital: 11 765 EMS transported and 6502 self-transported; 5542 transferred). EMS-transported patients differed from self-transported patients in symptom onset to first medical contact time (median, 47 versus 114 minutes), incidence of cardiac arrest (10% versus 3%), shock on admission (11% versus 3%), and in-hospital mortality (8% versus 3%; P<0.001 for all comparisons). There was a significant increase in the proportion of patients meeting guideline goals of first medical contact–to–device time, including those directly presenting via EMS (50% to 55%; P<0.001) and transferred patients (44%−48%; P=0.002). Despite regional variability, the greatest gains occurred among patients in the 5 most improved regions, increasing from 45% to 57% (direct EMS; P<0.001) and 38% to 50% (transfers; P<0.001). Conclusions: This Mission: Lifeline STEMI Systems Accelerator demonstration project represents the largest national effort to organize regional STEMI care. By focusing on first medical contact–to–device time, coordinated treatment protocols, and regional data collection and reporting, we were able to increase significantly the proportion of patients treated within guideline goals.

Correlation between index electrocardiographic patterns and pre-intervention angiographic findings: insights from the HORIZONS-AMI trial.

Objectives: To improve ECG interpretation accuracy in patients with chest pain prior to activation of the cardiac catheterization laboratory for primary percutaneous coronary intervention (PPCI). Background: Despite current guideline‐based ECG criteria, challenges remain in optimizing the rate of appropriate catheterization laboratory activation. Methods: The HORIZONS‐AMI trial enrolled 3,602 patients with chest pain consistent with myocardial infarction (MI). ECG and angiographic core laboratory databases were analyzed for correlation between the qualifying study ECG and the baseline coronary angiogram. Results: LAD occlusion manifested in >80% of cases as ST‐segment elevation in leads V2 and V3, while the culprit vessel was the RCA and LCx in 75 and 25% of cases, respectively, for inferior MI ECG patterns. The study threshold of ≥1.0 mm ST‐segment elevation in ≥2 contiguous ECG leads was not met in 189 (5.3%) patients. When stratified by culprit artery, the prevalence of reciprocal ST‐segment depression ranged from 24 to 88%, being least common for lesions in the mid‐ and distal left anterior descending artery. Despite study eligibility, no posterior MIs were enrolled. Only 36 LBBB cases were identified (25% of whom did not undergo PCI), and 5 of 11 left main coronary occlusions (45%) had ST‐segment elevation in lead aVR. Conclusions: The present study confirms prior ischemic ECG findings predicted by vectorcardiography, validates certain ECG patterns as reliable surrogate markers for acute coronary occlusion, and provides novel insights correlating index ECG ischemic changes and pre‐intervention coronary angiography. These results may enhance the rate of appropriate catheterization laboratory activation.

Regional systems of care demonstration project

Background: Up to 50% of patients fail to meet ST-segment–elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact–to–device time of <90 minutes for patients directly presenting to percutaneous coronary intervention–capable hospitals and <120 minutes for transferred patients. We sought to increase the proportion of patients treated within guideline goals by organizing coordinated regional reperfusion plans. Methods: We established leadership teams, coordinated protocols, and provided regular feedback for 484 hospitals and 1253 emergency medical services (EMS) agencies in 16 regions across the United States. Results: Between July 2012 and December 2013, 23 809 patients presented with acute STEMI (direct to percutaneous coronary intervention hospital: 11 765 EMS transported and 6502 self-transported; 5542 transferred). EMS-transported patients differed from self-transported patients in symptom onset to first medical contact time (median, 47 versus 114 minutes), incidence of cardiac arrest (10% versus 3%), shock on admission (11% versus 3%), and in-hospital mortality (8% versus 3%; P <0.001 for all comparisons). There was a significant increase in the proportion of patients meeting guideline goals of first medical contact–to–device time, including those directly presenting via EMS (50% to 55%; P <0.001) and transferred patients (44%−48%; P =0.002). Despite regional variability, the greatest gains occurred among patients in the 5 most improved regions, increasing from 45% to 57% (direct EMS; P <0.001) and 38% to 50% (transfers; P <0.001). Conclusions: This Mission: Lifeline STEMI Systems Accelerator demonstration project represents the largest national effort to organize regional STEMI care. By focusing on first medical contact–to–device time, coordinated treatment protocols, and regional data collection and reporting, we were able to increase significantly the proportion of patients treated within guideline goals. # Clinical Perspective {#article-title-31}Background: Up to 50% of patients fail to meet ST-segment–elevation myocardial infarction (STEMI) guideline goals recommending a first medical contact–to–device time of <90 minutes for patients directly presenting to percutaneous coronary intervention–capable hospitals and <120 minutes for transferred patients. We sought to increase the proportion of patients treated within guideline goals by organizing coordinated regional reperfusion plans. Methods: We established leadership teams, coordinated protocols, and provided regular feedback for 484 hospitals and 1253 emergency medical services (EMS) agencies in 16 regions across the United States. Results: Between July 2012 and December 2013, 23 809 patients presented with acute STEMI (direct to percutaneous coronary intervention hospital: 11 765 EMS transported and 6502 self-transported; 5542 transferred). EMS-transported patients differed from self-transported patients in symptom onset to first medical contact time (median, 47 versus 114 minutes), incidence of cardiac arrest (10% versus 3%), shock on admission (11% versus 3%), and in-hospital mortality (8% versus 3%; P<0.001 for all comparisons). There was a significant increase in the proportion of patients meeting guideline goals of first medical contact–to–device time, including those directly presenting via EMS (50% to 55%; P<0.001) and transferred patients (44%−48%; P=0.002). Despite regional variability, the greatest gains occurred among patients in the 5 most improved regions, increasing from 45% to 57% (direct EMS; P<0.001) and 38% to 50% (transfers; P<0.001). Conclusions: This Mission: Lifeline STEMI Systems Accelerator demonstration project represents the largest national effort to organize regional STEMI care. By focusing on first medical contact–to–device time, coordinated treatment protocols, and regional data collection and reporting, we were able to increase significantly the proportion of patients treated within guideline goals.

Association of Rapid Care Process Implementation on Reperfusion Times Across Multiple ST-Segment–Elevation Myocardial Infarction Networks

Background— The Mission: Lifeline STEMI Systems Accelerator program, implemented in 16 US metropolitan regions, resulted in more patients receiving timely reperfusion. We assessed whether implementing key care processes was associated with system performance improvement. Methods and Results— Hospitals (n=167 with 23 498 ST-segment–elevation myocardial infarction patients) were surveyed before (March 2012) and after (July 2014) program intervention. Data were merged with patient-level clinical data over the same period. For reperfusion, hospitals were grouped by whether a specific process of care was implemented, preexisting, or never implemented. Uptake of 4 key care processes increased after intervention: prehospital catheterization laboratory activation (62%–91%; P<0.001), single call transfer protocol from an outside facility (45%–70%; P<0.001), and emergency department bypass for emergency medical services direct presenters (48%–59%; P=0.002) and transfers (56%–79%; P=0.001). There were significant differences in median first medical contact-to-device times among groups implementing prehospital activation (88 minutes implementers versus 89 minutes preexisting versus 98 minutes nonimplementers; P<0.001 for comparisons). Similarly, patients treated at hospitals implementing single call transfer protocols had shorter median first medical contact-to-device times (112 versus 128 versus 152 minutes; P<0.001). Emergency department bypass was also associated with shorter median first medical contact-to-device times for emergency medical services direct presenters (84 versus 88 versus 94 minutes; P<0.001) and transfers (123 versus 127 versus 167 minutes; P<0.001). Conclusions— The Accelerator program increased uptake of key care processes, which were associated with improved system performance. These findings support efforts to implement regional ST-segment–elevation myocardial infarction networks focused on prehospital catheterization laboratory activation, single call transfer protocols, and emergency department bypass.

Call 911 STEMI protocol to reduce delays in transfer of patients from non primary percutaneous coronary intervention referral Centers.

Primary percutaneous coronary intervention (PPCI) is the preferred method of reperfusion for ST-segment elevation myocardial infarction (STEMI), if it can be performed in a timely manner by an experienced interventional cardiologist at a high volume STEMI Receiving Center. However, an estimated 50% of STEMI patients present to STEMI Referral Centers without PPCI capability. Transfer of STEMI patients for PPCI has been shown to improve outcomes as compared with fibrinolysis given at the presenting hospital. Nonetheless, transfer of STEMI patients for PPCI has not been used extensively in the United States and is associated with markedly prolonged transfer times. This study demonstrates that rapid transfer of STEMI patients from community hospitals without PPCI capability to a STEMI Receiving Center is both safe and feasible using a standardized protocol with an integrated transfer system.