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Early Invasive Therapy for Out-of-Hospital Cardiac Arrest
Quick Takes
- Patients with out-of-hospital cardiac arrest (OHCA) were randomized to early intra-arrest transport, extracorporeal cardiopulmonary resuscitation, and invasive assessment and treatment versus standard resuscitation.
- The study was stopped early for futility without clear benefit for outlined invasive therapy compared to standard treatment.
- Defining optimal therapies for patients with OHCA remains challenging and most studies remain underpowered to conclusively support specific treatment.
Study Questions:
Does an early invasive approach using extracorporeal cardiopulmonary resuscitation (ECPR) followed by immediate invasive assessment and treatment improve neurological survival in adults with refractory out-of-hospital cardiac arrest (OHCA)?
Methods:
This was a single-center randomized clinical trial of adults with a witnessed OHCA of presumed cardiac origin without return of spontaneous circulation. A total of 256 participants were enrolled between March 2013–October 2020. The invasive strategy group (n = 124) used mechanical compression followed by intra-arrest transport to a cardiac center for ECPR and immediate invasive assessment and treatment versus regular advanced cardiac life support was continued on-site in the standard strategy group (n = 132). The primary outcome was survival with a good neurologic outcome (defined as Cerebral Performance Category [CPC] 1-2) at 180 days after randomization. Secondary outcomes included neurologic recovery at 30 days (defined as CPC 1-2 at any time within the first 30 days) and cardiac recovery at 30 days (defined as no need for pharmacological or mechanical cardiac support for at least 24 hours).
Results:
The trial was stopped at the recommendation of the data and safety monitoring board when prespecified criteria for futility were met. Among 256 patients (median age, 58 years; 44 [17%] women), 256 (100%) completed the trial. In the main analysis, 39 patients (31.5%) in the invasive strategy group and 29 (22.0%) in the standard strategy group survived to 180 days with good neurologic outcome (odds ratio [OR], 1.63; 95% confidence interval [CI], 0.93-2.85; difference, 9.5%; 95% CI, −1.3% to 20.1%; p = 0.09). At 30 days, neurologic recovery had occurred in 38 patients (30.6%) in the invasive strategy group and in 24 (18.2%) in the standard strategy group (OR, 1.99; 95% CI, 1.11-3.57; difference, 12.4%; 95% CI, 1.9-22.7%; p = 0.02), and cardiac recovery had occurred in 54 (43.5%) and 45 (34.1%) patients, respectively (OR, 1.49; 95% CI, 0.91-2.47; difference, 9.4%; 95% CI, −2.5% to 21%; p = 0.12). Bleeding occurred more frequently in the invasive strategy versus standard strategy group (31% vs. 15%, respectively).
Conclusions:
Among patients with refractory OHCA, the bundle of early intra-arrest transport, ECPR, and invasive assessment and treatment did not significantly improve survival with neurologically favorable outcome at 180 days compared with standard resuscitation. However, the trial was possibly underpowered to detect a clinically relevant difference.
Perspective:
The current study was a commendable attempt at performing a randomized assessment of the benefit of an early invasive therapy including ECPR and cardiac catheterization among patients with OHCA. The study was stopped early for futility without clear benefit for outlined invasive therapy compared to standard treatment. Successfully recruiting patients into OHCA trials remains challenging and most studies remain underpowered to conclusively support specific therapies.
Clinical Topics: Arrhythmias and Clinical EP, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Advanced Cardiac Life Support, Arrhythmias, Cardiac, Cardiac Catheterization, Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation, Heart Arrest, Hemorrhage, Neurologic Manifestations, Out-of-Hospital Cardiac Arrest, Return of Spontaneous Circulation, Resuscitation, Secondary Prevention, Treatment Outcome
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