{Reference Type}: Journal Article
{Title}: Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support.
{Author}: Valdes CA;Stinson G;Sharaf OM;Jimenez Contreras F;Bilgili A;Ahmed MM;Vilaro J;Parker AM;Al-Ani MAZ;Demos D;Aranda J;Bleiweis M;Beaver TM;Jeng EI;
{Journal}: Innovations (Phila)
{Volume}: 19
{Issue}: 1
{Year}: 2024 Jan-Feb 27
暂无{DOI}: 10.1177/15569845231212157
{Abstract}: <B>UNASSIGNED: </B>Impella 5.5 (Abiomed, Danvers, MA, USA) is approved by the US Food and Drug Administration (FDA) 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.<BR><B>UNASSIGNED: </B>We retrospectively reviewed adult patients (≥18 years old) supported with Impella 5.5 at our institution (May 2020 to April 2023). Patients on prolonged support (>14 days) were compared with those supported for ≤14 days.<BR><B>UNASSIGNED: </B>There were 31 patients supported with Impella 5.5 including 14 (45.2%) supported >14 days. Median support duration for those on prolonged support was 43.5 (interquartile range [IQR] 25 to 63.5) days versus 8 (IQR 6, 13) days for those who were not (P < 0.001). Overall, the device-related complication rate was 9.7% and did not differ between groups (P = 0.08). Overall, 30-day postimplant survival was 71% and did not differ by support duration (P = 0.2). In-hospital mortality was 32% and did not differ between cohorts (P > 0.99). Among those surviving to explant (n = 22), long-term strategy included bridge to durable ventricular assist device (18%, n = 4), cardiac transplant (55%, n = 12), and cardiac recovery (27%, n = 6).<BR><B>UNASSIGNED: </B>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.