There are no definitive therapies for patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Therefore, new therapeutic strategies are needed to improve clinical outcomes, particularly in patients with severe disease. This case series explores the safety and effectiveness of intravenous allogeneic cardiosphere-derived cells (CDCs), formulated as CAP-1002, in critically ill patients with confirmed coronavirus disease 2019 (COVID-19). Adverse reactions to CAP-1002, clinical status on the World Health Organization (WHO) ordinal scale, and changes in pro-inflammatory biomarkers and leukocyte counts were analyzed. All patients (n = 6; age range 19-75 years, 1 female) required ventilatory support (invasive mechanical ventilation, n = 5) with PaO₂/FiO₂ ranging from 69 to 198. No adverse events related to CAP-1002 administration were observed. Four patients (67%) were weaned from respiratory support and discharged from the hospital. One patient remains mechanically ventilated as of April 28th, 2020; all survive. A contemporaneous control group of critically ill COVID-19 patients (n = 34) at our institution showed 18% overall mortality at a similar stage of hospitalization. Ferritin was elevated in all patients at baseline (range of all patients 605.43-2991.52 ng/ml) and decreased in 5/6 patients (range of all patients 252.89-1029.90 ng/ml). Absolute lymphocyte counts were low in 5/6 patients at baseline (range 0.26-0.82 × 10³/µl) but had increased in three of these five patients at last follow-up (range 0.23-1.02 × 10³/µl). In this series of six critically ill COVID-19 patients, intravenous infusion of CAP-1002 was well tolerated and associated with resolution of critical illness in 4 patients. This series demonstrates the apparent safety of CAP-1002 in COVID-19. While this initial experience is promising, efficacy will need to be further assessed in a randomized controlled trial.

BACKGROUND: The SynCardia temporary total artificial heart (TAH-t) is an effective bridge to transplantation for patients with severe biventricular failure. However, granular single-center data from high-volume centers are lacking. We report our experience with the first 100 TAH-t recipients. METHODS: A prospective institutional database was used to identify 100 patients who underwent 101 TAH-t implantations between 2012 and 2022. Patients were stratified and compared according to Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 vs 2 or greater. Median follow-up on device support was 94 days (interquartile range, 33-276), and median follow-up after transplantation was 4.6 years (interquartile range, 2.1-6.0). RESULTS: Overall, 61 patients (61%) were successfully bridged to transplantation and 39 (39%) died on TAH-t support. Successful bridge rates between INTERMACS profile 1 and INTERMACS profile 2 or greater patients were similar (55.6% [95% CI, 40.4%-68.3%] vs 67.4% [95% CI, 50.5%-79.6%], respectively; P = .50). The most common adverse events (rates per 100 patient-months) on TAH-t support included infection (15.8), ischemic stroke (4.6), reoperation for mediastinal bleeding (3.5), and gastrointestinal bleeding requiring intervention (4.3). The most common cause of death on TAH-t support was multisystem organ failure (n = 20, 52.6%). Thirty-day survival after transplantation was 96.7%; survival at 6 months, 1 year, and 5 years after transplantation was 95.1% (95% CI, 85.4%-98.4%), 86.6% (95% CI, 74.9%-93.0%), and 77.5% (95% CI, 64.2%-86.3%), respectively. CONCLUSIONS: Acceptable outcomes can be achieved in the highest acuity patients using the TAH-t as a bridge to heart transplantation.