Safety And Efficacy Of Prolonged Impella 5.5 Support
Carlos Alberto Valdes, BS, Omar M. Sharaf, BS, Griffin Stinson, BS, Fabian Jimenez, MD, MMCi, Mustafa Ahmed, MD, Juan Vilaro, MD, Alex Parker, MD, Mohammad Al-Ani, MD, Daniel Demos, MD, Juan Aranda, MD, Mark Bleiweis, MD, Eric I. Jeng, MD, MBA.
University of Florida College of Medicine, Gainesville, FL, USA.
BACKGROUND: Impella 5.5 is FDA-approved for mechanical circulatory support for ≤14 days. It is unknown whether prolonged support is associated with worse outcomes. We sought to review our single-center experience with Impella 5.5 and compare outcomes based on support duration. METHODS: We retrospectively reviewed adult patients (≥18 years old) supported with Impella 5.5 at our institution (May 2020-August 2022). Patients on prolonged support (>14 days) were compared to those supported for ≤14 days. RESULTS: Fifteen patients were supported with Impella 5.5 implanted by a single surgeon; 9 (60%) were supported >14 days. Median support duration for those on prolonged support was 36 (IQR 17, 72) days versus 8.5 (IQR 3, 13) days for those who were not (p=0.02). Patients undergoing prolonged support were younger, though this did not reach statistical significance (47±15 years versus 61±12 years, p=0.07). Indications for support for the entire cohort included cardiogenic shock due to decompensated heart failure (53%, n=8), ventricular tachycardia (27%, n=4), and myocardial infarction (20%, n=3), with no differences in indication of support between groups (p=0.526). Overall device-related complication rate was 20% and did not differ between groups (p=0.229).Two patients on ≤14-day support died within 30 days post-implant compared to one patient on prolonged support. Overall, 30-day post-implant survival was 80% and did not differ by support duration (p=0.525). In-hospital mortality for the cohort was 33% (33% versus 33%, p=1.00). Three patients died on Impella: one opted for comfort care and died after 11 days from cardiac arrest, another was placed on concomitant ECMO after 2 days and died from multisystem organ failure. Two additional patients died after explant but before discharge: one expired due to stroke, another of respiratory failure. Among those surviving to explant, support strategy included bridge to VAD (n=4), transplant (n=6), and recovery (n=2). There was no difference in longitudinal Kaplan-Meier survival (Figure 1). CONCLUSIONS: High-risk patients with cardiogenic shock may be supported with Impella 5.5 beyond the FDA-approved duration without increased risk of complications or mortality.
LEGEND: Kaplan Meier curve demonstrating equivalent survival between patients supported for >14 days and those supported for ≤14 days.
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