cTnI increases are encountered in approximately a third of patients, the majority due to nonatherothrombotic conditions. Compared with patients without myonecrosis, type 2 myocardial infarction and myocardial injury have worse short-term outcomes, with mortality rates >20% at 2 years. hs-cTnI assay does not lead to more myocardial injury or infarction.
Background: Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia. Methods: A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study. Results: In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died during the 30 days after randomization. Among patients with severe COVID-19 pneumonia, the median time to recovery with Auxora was 5 days versus 12 days with SOC; the recovery rate ratio was 1.87 (95% CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction = 32%; 95% CI, − 0.07, 0.71). Outcomes measured by an 8point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO 2 /FiO 2 = 101-200.
Background: We describe implementation, evaluate performance, and report outcomes from the first program serving an entire metropolitan area designed to rapidly deliver extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation to patients with refractory ventricular fibrillation/ventricular tachycardia (VF/VT) out-of-hospital cardiac arrest (OHCA). Methods: This observational cohort study analyzed consecutive patients prospectively enrolled in the Minnesota Mobile Resuscitation Consortium's ECMO-facilitated resuscitation program. Entry criteria included: 1) adults (aged 18À75), 2) VF/VT OHCA, 3) no return of spontaneous circulation following 3 shocks, 4) automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System (LUCAS TM ), and 5) estimated transfer time of < 30 min. The primary endpoint was functionally favorable survival to hospital discharge with Cerebral Performance Category (CPC) 1 or 2. Secondary endpoints included 3-month functionally favorable survival, program benchmarks, ECMO cannulation rate, and safety. Essential program components included emergency medical services, 3 community ECMO Initiation Hospitals with emergency department ECMO cannulation sites and 24/7 cardiac catheterization laboratories, a 24/7 mobile ECMO cannulation team, and a single, centralized ECMO intensive care unit. Findings: From December 1, 2019 to April 1, 2020, 63 consecutive patients were transported and 58 (97%) met criteria and were treated by the mobile ECMO service. Mean age was 57 § 1.8 years; 46/58 (79%) were male. Program benchmarks were variably met, 100% of patients were successfully cannulated, and no safety issues were identified. Of the 58 patients, 25/58 (43% [CI:31À56%]) were both discharged from the hospital and alive at 3 months with CPC 1 or 2.
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