Assaad Sayah

Out-of-Hospital Administration of Intravenous Glucose-Insulin-Potassium in Patients With Suspected Acute Coronary Syndromes: The IMMEDIATE Randomized Controlled Trial

CONTEXT Laboratory studies suggest that in the setting of cardiac ischemia, immediate intravenous glucose-insulin-potassium (GIK) reduces ischemia-related arrhythmias and myocardial injury. Clinical trials have not consistently shown these benefits, possibly due to delayed administration. OBJECTIVE To test out-of hospital emergency medical service (EMS) administration of GIK in the first hours of suspected acute coronary syndromes (ACS). DESIGN, SETTING, AND PARTICIPANTS Randomized, placebo-controlled, double-blind effectiveness trial in 13 US cities (36 EMS agencies), from December 2006 through July 31, 2011, in which paramedics, aided by electrocardiograph (ECG)-based decision support, randomized 911 (871 enrolled) patients (mean age, 63.6 years; 71.0% men) with high probability of ACS. INTERVENTION Intravenous GIK solution (n = 411) or identical-appearing 5% glucose placebo (n = 460) administered by paramedics in the out-of-hospital setting and continued for 12 hours. MAIN OUTCOME MEASURES The prespecified primary end point was progression of ACS to myocardial infarction (MI) within 24 hours, as assessed by biomarkers and ECG evidence. Prespecified secondary end points included survival at 30 days and a composite of prehospital or in-hospital cardiac arrest or in-hospital mortality, analyzed by intent-to-treat and by presentation with ST-segment elevation. RESULTS There was no significant difference in the rate of progression to MI among patients who received GIK (n = 200; 48.7%) vs those who received placebo (n = 242; 52.6%) (odds ratio [OR], 0.88; 95% CI, 0.66-1.13; P = .28). Thirty-day mortality was 4.4% with GIK vs 6.1% with placebo (hazard ratio [HR], 0.72; 95% CI, 0.40-1.29; P = .27). The composite of cardiac arrest or in-hospital mortality occurred in 4.4% with GIK vs 8.7% with placebo (OR, 0.48; 95% CI, 0.27-0.85; P = .01). Among patients with ST-segment elevation (163 with GIK and 194 with placebo), progression to MI was 85.3% with GIK vs 88.7% with placebo (OR, 0.74; 95% CI, 0.40-1.38; P = .34); 30-day mortality was 4.9% with GIK vs 7.7% with placebo (HR, 0.63; 95% CI, 0.27-1.49; P = .29). The composite outcome of cardiac arrest or in-hospital mortality was 6.1% with GIK vs 14.4% with placebo (OR, 0.39; 95% CI, 0.18-0.82; P = .01). Serious adverse events occurred in 6.8% (n = 28) with GIK vs 8.9% (n = 41) with placebo (P = .26). CONCLUSIONS Among patients with suspected ACS, out-of-hospital administration of intravenous GIK, compared with glucose placebo, did not reduce progression to MI. Compared with placebo, GIK administration was not associated with improvement in 30-day survival but was associated with lower rates of the composite outcome of cardiac arrest or in-hospital mortality. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00091507.

Evaluation of the Time Saved by Prehospital Initiation of Reteplase for ST-Elevation Myocardial Infarction Results of the Early Retavase-Thrombolysis In Myocardial Infarction (ER-TIMI) 19 Trial

OBJECTIVES The Early Retavase-Thrombolysis In Myocardial Infarction (ER-TIMI) 19 trial tested the feasibility of prehospital initiation of the bolus fibrinolytic reteplase (rPA) and determined the time saved by prehospital rPA in the setting of contemporary emergency cardiac care. BACKGROUND Newer bolus fibrinolytics have undergone only limited evaluation for prehospital administration. In addition, as door-to-drug times have decreased, the relevance of findings from prior trials of prehospital fibrinolysis has become less certain. METHODS Patients (n = 315) with ST-elevation myocardial infarction (STEMI) were enrolled in 20 emergency medical systems in North America. The time from emergency medical service (EMS) arrival to administration of a fibrinolytic was compared between study patients receiving prehospital rPA and sequential control patients from 6 to 12 months before the study who received a fibrinolytic in the hospital. RESULTS Acute myocardial infarction was confirmed in 98%. The median time from EMS arrival to initiation of rPA was 31 min (25th to 75th percentile, 24 min to 37 min). The time from EMS arrival to in-hospital fibrinolytic for 630 control patients was 63 min (25th to 75th percentile, 48 min to 89 min), resulting in a time saved of 32 min (p < 0.0001). By 30 min after first medical contact, 49% of study patients had received the first bolus of fibrinolytic compared with only 5% of controls (p < 0.0001). In-hospital mortality was 4.7%. Intracranial hemorrhage occurred in 1.0%. CONCLUSIONS Prehospital administration of rPA is a feasible approach to accelerating reperfusion in patients with STEMI. Valuable time savings can be achieved in the setting of contemporary transport and door-to-drug times and may translate into an improvement in clinical outcomes.

Emergency department utilization after the implementation of Massachusetts health reform

STUDY OBJECTIVE Health care reform in Massachusetts improved access to health insurance, but the extent to which reform affected utilization of the emergency department (ED) for conditions potentially amenable to primary care is unclear. Our objective is to determine the relationship between health reform and ED use for low-severity conditions. METHODS We studied ED visits, using a convenience sample of 11 Massachusetts hospitals for identical 9-month periods before and after health care reform legislation was implemented in 2006. Individuals most affected by the health reform law (the uninsured and low-income populations covered by the publicly subsidized insurance products) were compared with individuals unlikely to be affected by the legislation (those with Medicare or private insurance). Our main outcome measure was the rate of overall and low-severity ED visits for the study population and the comparison population during the period before and after health reform implementation. RESULTS Total visits increased from 424,878 in 2006 to 442,102 in 2008. Low-severity visits among publicly subsidized or uninsured patients decreased from 43.8% to 41.2% of total visits for that group (difference=2.6%; 95% confidence interval [CI] 2.25% to 2.85%), whereas low-severity visits for privately insured and Medicare patients decreased from 35.7% to 34.9% of total visits for that group (difference=0.8%; 95% CI 0.62% to 0.98%), for a difference in differences of 1.8% (95% CI 1.7% to 1.9%). CONCLUSION Although overall ED volume continues to increase, Massachusetts health reform was associated with a small but statistically significant decrease in the rate of low-severity visits for those populations most affected by health reform compared with a comparison population of individuals less likely to be affected by the reform. Our findings suggest that access to health insurance is only one of a multitude of factors affecting utilization of the ED.

End-tidal CO2 measurement in the detection of esophageal intubation during cardiac arrest

Measurement of end-tidal carbon dioxide (ETco 2 ) has been used to detect accidental esophageal tube placement in noncardiac arrest situations. The purpose of our study was to determine whether ETco 2 measurement could distinguish tracheal from esophageal tube placement during closed-chest massage (CCM). Twelve large dogs were anesthetized, and endotracheal tubes were placed in both the trachea and the esophagus. Placement was verified by fiberoptic endoscopy. Ventricular fibrillation was induced by a 60-Hz discharge through a right ventricular pacemaker. After four minutes of cardiac arrest, CCM was initiated and continued for 20 minutes. The dogs were divided into two groups: Group A was ventilated through the tracheal tube, and group B was ventilated through the esophageal tube. Unused tubes were removed. ETco 2 was recorded continuously beginning two minutes before arrest until the end of the experiment. There were no significant between-group differences in mean arterial pressure, weight, blood loss, IV fluid volume administered, or prearrest arterial blood gases. ETco 2 differed significantly between the two groups throughout CCM ( P = .001). In group A, ETco 2 ranged from 13 to 34 mm Hg (median, 20 mm Hg). In group B, ETco 2 ranged from 2 to 11 mm Hg (median, 3 mm Hg). In this experimental model, measurement of ETco 2 reliably distinguished esophageal from tracheal intubation during cardiac arrest and CCM. If confirmed in human beings, this may prove to be a quick, reliable method of detecting esophageal intubation during cardiac arrest.

One-year outcomes of out-of-hospital administration of intravenous glucose, insulin, and potassium (GIK) in patients with suspected acute coronary syndromes (from the IMMEDIATE [Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care] Trial).

The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care Trial of very early intravenous glucose-insulin-potassium (GIK) for acute coronary syndromes (ACS) in out-of-hospital emergency medical service (EMS) settings showed 80% reduction in infarct size at 30 days, suggesting potential longer-term benefits. Here we report 1-year outcomes. Prespecified 1-year end points of this randomized, placebo-controlled, double-blind, effectiveness trial included all-cause mortality and composites including cardiac arrest, mortality, or hospitalization for heart failure (HF). Of 871 participants randomized to GIK versus placebo, death occurred within 1 year in 11.6% versus 13.5%, respectively (unadjusted hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.57 to 1.23, p = 0.36). The composite of cardiac arrest or 1-year mortality was 12.8% versus 17.0% (HR 0.71, 95% CI 0.50 to 1.02, p = 0.06). The composite of hospitalization for HF or mortality within 1 year was 17.2% versus 17.2% (HR 0.98, 95% CI 0.70 to 1.37, p = 0.92). The composite of mortality, cardiac arrest, or HF hospitalization within 1 year was 18.1% versus 20.4% (HR 0.85, 95% CI 0.62 to 1.16, p = 0.30). In patients presenting with suspected ST elevation myocardial infarction, HRs for 1-year mortality and the 3 composites were, respectively, 0.65 (95% CI 0.33 to 1.27, p = 0.21), 0.52 (95% CI 0.30 to 0.92, p = 0.03), 0.63 (95% CI 0.35 to 1.16, p = 0.14), and 0.51 (95% CI 0.30 to 0.87, p = 0.01). In patients with suspected acute coronary syndromes, serious end points generally were lower with GIK than placebo, but the differences were not statistically significant. However, in those with ST elevation myocardial infarction, the composites of cardiac arrest or 1-year mortality, and of cardiac arrest, mortality, or HF hospitalization within 1 year, were significantly reduced.

The Effect of an Ambulance Diversion Ban on Emergency Department Length of Stay and Ambulance Turnaround Time

STUDY OBJECTIVE Massachusetts became the first state in the nation to ban ambulance diversion in 2009. It was feared that the diversion ban would lead to increased emergency department (ED) crowding and ambulance turnaround time. We seek to characterize the effect of a statewide ambulance diversion ban on ED length of stay and ambulance turnaround time at Boston-area EDs. METHODS We conducted a retrospective, pre-post observational analysis of 9 Boston-area hospital EDs before and after the ban. We used ED length of stay as a proxy for ED crowding. We compared hospitals individually and in aggregate to determine any changes in ED length of stay for admitted and discharged patients, ED volume, and turnaround time. RESULTS No ED experienced an increase in ED length of stay for admitted or discharged patients or ambulance turnaround time despite an increase in volume for several EDs. There was an overall 3.6% increase in ED volume in our sample, a 10.4-minute decrease in length of stay for admitted patients, and a 2.2-minute decrease in turnaround time. When we compared high- and low-diverting EDs separately, neither saw an increase in length of stay, and both saw a decrease in turnaround time. CONCLUSION After the first statewide ambulance diversion ban, there was no increase in ED length of stay or ambulance turnaround time at 9 Boston-area EDs. Several hospitals actually experienced improvements in these outcome measures. Our results suggest that the ban did not worsen ED crowding or ambulance availability at Boston-area hospitals.

Study design for the Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care (IMMEDIATE) Trial: A double-blind randomized controlled trial of intravenous glucose, insulin, and potassium for acute coronary syndromes in emergency medical services.

BACKGROUND Experimental studies suggest that metabolic myocardial support by intravenous (IV) glucose, insulin, and potassium (GIK) reduces ischemia-induced arrhythmias, cardiac arrest, mortality, progression from unstable angina pectoris to acute myocardial infarction (AMI), and myocardial infarction size. However, trials of hospital administration of IV GIK to patients with ST-elevation myocardial infarction (STEMI) have generally not shown favorable effects possibly because of the GIK intervention taking place many hours after ischemic symptom onset. A trial of GIK used in the very first hours of ischemia has been needed, consistent with the timing of benefit seen in experimental studies. OBJECTIVE The IMMEDIATE Trial tested whether, if given very early, GIK could have the impact seen in experimental studies. Accordingly, distinct from prior trials, IMMEDIATE tested the impact of GIK (1) in patients with acute coronary syndromes (ACS), rather than only AMI or STEMI, and (2) administered in prehospital emergency medical service settings, rather than later, in hospitals, after emergency department evaluation. DESIGN The IMMEDIATE Trial was an emergency medical service-based randomized placebo-controlled clinical effectiveness trial conducted in 13 cities across the United States that enrolled 911 participants. Eligible were patients 30 years or older for whom a paramedic performed a 12-lead electrocardiogram to evaluate chest pain or other symptoms suggestive of ACS for whom electrocardiograph-based acute cardiac ischemia time-insensitive predictive instrument indicated a ≥75% probability of ACS, and/or the thrombolytic predictive instrument indicated the presence of a STEMI, or if local criteria for STEMI notification of receiving hospitals were met. Prehospital IV GIK or placebo was started immediately. Prespecified were the primary end point of progression of ACS to infarction and, as major secondary end points, the composite of cardiac arrest or in-hospital mortality, 30-day mortality, and the composite of cardiac arrest, 30-day mortality, or hospitalization for heart failure. Analyses were planned on an intent-to-treat basis, on a modified intent-to-treat group who were confirmed in emergency departments to have ACS, and for participants presenting with STEMI. CONCLUSION The IMMEDIATE Trial tested whether GIK, when administered as early as possible in the course of ACS by paramedics using acute cardiac ischemia time-insensitive predictive instrument and thrombolytic predictive instrument decision support, would reduce progression to AMI, mortality, cardiac arrest, and heart failure. It also tested whether it would provide clinical and pathophysiologic information on GIKs biological mechanisms.

Utilization of Emergency Medical Services by Patients with Acute Coronary Syndromes in the Arab Gulf States

BACKGROUND Emergency Medical Services (EMS) play a central role in caring for patients with acute coronary syndromes (ACS). To date, no data exist on utilization of EMS systems in the Arab Gulf States. OBJECTIVE To examine EMS use by patients with ACS in the Gulf Registry of Acute Coronary Events (Gulf RACE). METHODS Gulf RACE was a prospective, multinational study conducted in 2007 of all patients hospitalized with ACS in 65 centers in six Arab countries. Data were analyzed based on mode of presentation (EMS vs. other). RESULTS Of 7859 patients hospitalized with ACS through the emergency department (ED), only 1336 (17%) used EMS, with wide variation among countries (2% in Yemen to 37% in Oman). Younger age (odds ratio [OR] 1.09; 95% confidence interval [CI] 1.03-1.15 per 10-year decrement), presence of chest pain (OR 1.73; 95% CI 1.48-2.03), prior myocardial infarction (OR 1.58; 95% CI 1.34-1.86), prior percutaneous coronary intervention (OR 1.27; 95% CI 1.02-1.59), family history of premature coronary disease (OR 1.25; 95% CI 1.09-1.51), and current smoking (OR 1.30; 95% CI 1.13-1.50) were independently associated with not utilizing EMS. Patients with ST-segment elevation myocardial infarction/left bundle branch block myocardial infarction who were transported by EMS were significantly less likely to exhibit major delay in presentation, and were significantly more likely to receive favorable processes of care, including shorter door-to-electrocardiogram time, more frequent coronary reperfusion therapy, and thrombolytic therapy within 30 min of arrival at the ED. CONCLUSION Despite current recommendations, fewer than 1 in 5 patients with ACS use EMS in the Arab Gulf States, highlighting a significant opportunity for improvement. Factors causing this underutilization deserve further investigation.

Reasons Why Patients Remain Uninsured after Massachusetts’ Health Care Reform: A Survey of Patients at a Safety-Net Hospital

ABSTRACTBACKGROUNDFollowing the 2006 Massachusetts health care reform, an estimated 316,492 residents remain uninsured. However, there have been no published studies that examine why Massachusetts residents remain uninsured four years into health reform.OBJECTIVETo describe the characteristics of uninsured patients seeking acute medical care in Massachusetts after implementation of health care reform and reasons for lacking insurance.DESIGN AND PARTICIPANTSWe performed an in-person survey of a convenience sample of patients visiting the emergency department of the state’s second largest safety net hospital between July 25, 2009 and March 20, 2010. We interviewed 431 patients age 18–64, 189 of whom were uninsured.MAIN MEASURESDemographic and clinical characteristics, employment and insurance history, reasons for lacking insurance and views of the state’s new “individual mandate”.KEY RESULTSThe uninsured were largely employed (65.9%), but only a quarter (25.1%) of the employed uninsured had access to employer-sponsored insurance. The majority qualified for subsidized insurance (85.7% earned ≤300% of the federal poverty level), yet many reported being unable to find affordable insurance (32.7%). Over a third (35.2%) were uninsured because they had lost insurance due predominantly to job loss or policy cancellation. For nearly half of the uninsured (48.6%), the individual mandate had motivated them to try to find insurance, but they were unable to find insurance they could afford.CONCLUSIONSAfter full implementation of the Massachusetts health reform, those remaining without insurance are largely the working poor who do not have access to, or cannot afford, either employer sponsored insurance or state subsidized insurance.

Minimizing ED Waiting Times and Improving Patient Flow and Experience of Care.

We conducted a pre- and postintervention analysis to assess the impact of a process improvement project at the Cambridge Hospital ED. Through a comprehensive and collaborative process, we reengineered the emergency patient experience from arrival to departure. The ED operational changes have had a significant positive impact on all measured metrics. Ambulance diversion decreased from a mean of 148 hours per quarter before changes in July 2006 to 0 hours since April 2007. ED total length of stay decreased from a mean of 204 minutes before the changes to 132 minutes. Press Ganey patient satisfaction scores rose from the 12th percentile to the 59th percentile. ED patient volume grew by 11%, from a mean of 7,221 patients per quarter to 8,044 patients per quarter. Compliance with ED specific quality core measures improved from a mean of 71% to 97%. The mean rate of ED patients that left without being seen (LWBS) dropped from 4.1% to 0.9%. Improving ED operational efficiency allowed us to accommodate increasing volume while improving the quality of care and satisfaction of the ED patients with minimal additional resources, space, or staffing.