Reconsidering FDA Guidelines : A Single-Center Experience of Prolonged Impella 5.5 Support
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
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| Enthalten in: |
Innovations (Philadelphia, Pa.) - 19(2024), 1 vom: 11. Jan., Seite 46-53 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Valdes, Carlos Alberto [VerfasserIn] |
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| Links: |
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| Themen: |
Bridge to therapy |
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| Anmerkungen: |
Date Completed 06.03.2024 Date Revised 06.03.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1177/15569845231212157 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Impella | |
| 650 | 4 | |a bridge to therapy | |
| 650 | 4 | |a cardiogenic shock | |
| 650 | 4 | |a left ventricular assist devices | |
| 650 | 4 | |a mechanical circulatory support | |
| 700 | 1 | |a Stinson, Griffin |e verfasserin |4 aut | |
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| 700 | 1 | |a Bilgili, Ahmet |e verfasserin |4 aut | |
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| 700 | 1 | |a Al-Ani, Mohammad A Z |e verfasserin |4 aut | |
| 700 | 1 | |a Demos, Daniel |e verfasserin |4 aut | |
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| 700 | 1 | |a Bleiweis, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Beaver, Thomas M |e verfasserin |4 aut | |
| 700 | 1 | |a Jeng, Eric I |e verfasserin |4 aut | |
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