Presentation on theme: "The Golden Hour and Acute Brain Ischemia: Presenting Features and Lytic Therapy in Over 30,000 Patients Arriving within 60 Minutes of Onset at GWTG-S."— Presentation transcript:
1 The Golden Hour and Acute Brain Ischemia: Presenting Features and Lytic Therapy in Over 30,000 Patients Arriving within 60 Minutes of Onset at GWTG-S HospitalsJeffrey L. Saver, MD; Eric E. Smith, MD, MPH;Gregg C. Fonarow, MD; Mathew J. Reeves, PhD;Xin Zhao, MS; DaiWai M. Olson, PhD, RN;Lee H. Schwamm, MD
2 DisclosuresThe Get With The Guidelines®–Stroke (GWTG-Stroke) program is provided by the American Heart Association/American Stroke Association. The GWTG-Stroke program is currently supported in part by a charitable contribution from Bristol-Myers Squib/Sanofi Pharmaceutical Partnership and the American Heart Association Pharmaceutical Roundtable. GWTG-Stroke has been funded in the past through support from Boehringer-Ingelheim and Merck.The individual author disclosures are listed in the manuscript
3 BackgroundThe benefit of intravenous thrombolytic therapy in acute brain ischemia is strongly time dependentTherapeutic yield is maximal in the first minutes after symptom onset and declines steadily during the first 3 hours
4 BackgroundThe Joint Commission target for Primary Stroke Centers is to achieve a Door-to-Needle time of within 60 minutes in 80% of patientsHospitals participating in the Get With The Guidelines®–Stroke Quality Improvement program have been shown to successfully deliver intravenous fibrinolytic therapy to patients arriving within the first 60 minutes of onset
5 IntroductionThe benefit of intravenous thrombolytic therapy in acute brain ischemia is strongly time dependent. Therapeutic yield is maximal in the first minutes after symptom onset and declines rapidly over the next 4.5 hours.In the typical large artery ischemic stroke, in each minute in which reperfusion is delayed, 2 million nerve cells die.Patients receiving treatment within the first 60 minutes (the “Golden Hour”) of onset of symptoms, have the greatest opportunity to benefit from recanalization therapyHyperacute-arriving patients and their treatment have not previously not been well characterized
6 ObjectiveTo examine the frequency, characteristics and treatment of Ischemic Stroke patients arriving at hospitals within the “Golden Hour”
7 Methods Data SourceHospitals participating in GWTG-Stroke who utilize the web-based patient management tool for data collectionOutcome Sciences, Inc. served as the data collection and coordination centerThe Duke Clinical Research Institute (DCRI) served as the data analysis center
8 Methods Study Population Between April 1, 2003 to December 31, 2007905 GWTG-Stroke Hospitals431,170 Ischemic Stroke and TIA patients arriving to Hospital Emergency Departments (ED’s) within 60 minutes of “last known well time”
9 Methods Case Identification Trained hospital personnel instructed to ascertain consecutive Acute Stoke AdmissionsMethods included regular surveillance of Emergency Dept. records, ward census logs and/or neurological consultationsThe eligibility of each acute stroke admission was confirmed at chart review prior to abstraction
10 Methods Characteristics Patient Data included:DemographicsMedical historyInitial head computerized tomography findingsIn-hospital treatment and eventsDischarge treatmentMortalityDischarge destination
11 Methods Characteristics Hospital level data included:Bed sizeAcademic or non-academic statusAnnual volume of stroke dischargesGeographical region
12 Methods Data AnalyzedContingency tables were developed to assess differences in:Demographics (age, sex)Stroke severityArrival Mode (ambulance, private vehicle)Door-to-Needle (DTN) TimeDoor-to-Imaging (DTI) TimeOutcome Destination at DischargeGeneralized estimating equations logistics regression models, accounting for in-hospital clustering, were generated to identify independent predictors of Onset-to-Door Time (OTD) and Door-to-Needle Time (DTN) < 60 minutes
13 Results Analysis Sample During the 4.75 year time period, at 905 hospital sites, data for 431,170 Ischemic Stroke and TIA patients were entered into the GWTG-Stroke database.Main analysis performed upon 106,924 patients in this cohort with Ischemic Stroke, a documented last known well-time and presentation directly to the Emergency Department by ambulance or private vehicle.
15 Patient and Hospital Level Characteristics Independently Associated with ED Arrival within the First 60 Minutes of OnsetCharacteristicOR (95% CI)P valueSevere deficit (NIHSS 9-41 vs 0-3)1.84 ( )<0.001Arrival mode (EMS vs Private transportation1.78 ( )H/o atrial fibrillation1.21 ( )Moderate deficit (NIHSS 4-8 vs 0-3)1.16 ( )CAD/prior MI1.08 ( )Prior stroke/TIA0.96 ( )0.049H/o HTN0.95 ( )0.018Sex (F vs M)0.94 ( )0.002Age (per 10 year increase)0.91 ( )Race-ethnicity, Black vs White, non-Hispanic0.91 (0.004Hospital Region (South vs West)0.87 ( )0.024Moderate annual hospital stroke admits ( vs ≤100)0.87 ( )0.012Smoker0.84 ( )Race-ethnicity, Asian vs White, non-Hispanic0.78 ( )Diabetes Mellitus0.77 ( )High annual hospital stroke admits (>300 vs ≤100)0.76 ( )
16 Result Patient Characteristics Patients with documented “Last Known Well Time”, saw a:Higher arrival by EMSHigher use of TPAHigher Stroke SeverityLower frequency of Blacks
17 Results Onset-to-Door Time 106,924 ischemic stroke patients arrived directly to GWTG-S hospital EDs by ambulance or private vehicleOnset to Door TimesNPercent< 60 mins30,22028.3%mins33,85831.7%> 180 mins42,84640.1%Among < 60 mins patients, mean onset to door (OTD) time: 39.9 mins (SD 14.8)
18 Results Time Of Arrival cohorts Race/EthnicitySlightly more often were non-Hispanic white in both 1 hour or under and 1-3 hour arrivalLess often Black or Asian in same time framesStroke SeverityGreatest among Golden Hour arriving patientsIntermediate among 1-3 hour arriving patientsLeast among beyond 3 hour arriving patientsFrequency of Arrival to Hospital by Ambulance79% in 1 hour or under patients72.2% in 1-3 hour patients55% in beyond 3 hour patientsAll above groups similar in age and genderArrival occurred mildly more often at hospitals located in the Northeast and West
19 Results Symptom Onset-to-Door Time Patient and Hospital Factors independently associated with Symptom OTD Time less than or equal to 1 hour (Golden Hour)Increased odds of early arrivalSevere neurologic deficitArrival by ambulance rather than private transportAtrial FibrillationDecreased odds of early arrivalHospital location in the SouthHigher annual number of Stroke Admissions
20 Results IV TPA given to: 12,545 direct ED IS patients 159 direct ED aborted IS patients (TPA-induced TIA)11.8% of all direct ED, IS patients with documented OTD5.0% of all direct ED IS patients
21 Onset to Door Times Among IV TPA Patients ResultsMean OTD 56.3 mins, DTN 84.1minsIV TPA more frequent among golden hour patients than 1-3 hour27.1% vs 12.9%, p <Onset to Door Times Among IV TPA PatientsNPercent< 60 mins811164.7%mins432734.5%> 180 mins1070.9%
22 Results: IV TPA DTN Times DTN in all 12,545 IV TPA patients: 86 mins (SD 42)Longer DTN in golden hr patients: mean 90.6 v 76.7 mins, p <Inverse relation OTD – DTN times: r =
24 Results Target DTN Time ≤ 60 Minutes Target DTN ≤ 60 mins achieved in 18.3% of golden hour-arriving patientsModest increase in proportion of patients with target DTN times by calendar yearAbsolute increase 1.2% per year, p=.027YearProportion with DTN ≤ 60 mins200312.8%200415.9%200518.9%200617.8%200719.5%
25 Results Target DTN Time ≤ 60 Minutes No substantial increase in proportion of patients with target DTN times duration of hospital participation in GWTG-Sp = 0.65Year Participating in GWTG-SProportion with DTN ≤ 60 mins118.0%218.5%318.4%419.0%518.9%
26 LimitationsParticipation in GWTG is voluntary and may select for higher performing hospitals.Hospitals participating in GWTG-Stroke are likely to have more well-organized stroke systems of care than nonparticipating hospitals, so other US hospitals are likely on average to have worse lytic treatment rates and door to needle times than observed in this cohort.The last known well time was documented in 42% of patients.Additional factors important in fostering rapid care were not captured in the GWTG-Stroke database and therefore not analyzed, including policies of local Emergency Medical Service (EMS) agencies, hospital provision of education programs to EMS, location of CT or MRI scanners in the ED, and policies regarding need for ancillary testing before treatment such as coagulation studies, CT angiography and CT perfusion imaging, or multimodal MRI imaging, etc.
27 ConclusionsAt GWTG-S hospital ED’s, these patients arrive within 1 hour of onset symptoms:More than 1/4 of patients with documented Onset TimeAt least 1/8 of all Ischemic Stroke patientsThese Golden Hour patients:receive thrombolytic therapy more frequently but more slowly than late arrivers.Target Door-To-Needle Time of less than 60 minutes achieved in less than 1/5 of these patientsThe findings support public health initiatives to increase early presentation and shorten Door-to-Needle times in patients arriving within the Golden Hour.
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