Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support.
Innovations (Phila)
; 19(1): 46-53, 2024.
Article
em En
| MEDLINE
| ID: mdl-38013250
ABSTRACT
OBJECTIVE:
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.METHODS:
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.RESULTS:
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).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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Coração Auxiliar
/
Transplante de Coração
Limite:
Adolescent
/
Adult
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Innovations (Phila)
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos