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Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
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Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support

Carlos Alberto Valdes1, Griffin Stinson1, Omar M Sharaf1

  • 1University of Florida, Gainesville, FL, USA.

Innovations (Philadelphia, Pa.)
|November 28, 2023
PubMed
Abstract

Insights

Prolonged use of Impella 5.5 mechanical circulatory support beyond 14 days did not increase complications or mortality in high-risk patients. This study suggests extended Impella 5.5 support is safe for patients with cardiogenic shock.

Area of Science:

  • Cardiology and Cardiovascular Surgery
  • Medical Device Technology
  • Critical Care Medicine

Background:

  • The Impella 5.5 device is FDA-approved for mechanical circulatory support for up to 14 days.
  • The safety and outcomes associated with Impella 5.5 support exceeding the approved duration are not well-established.
  • Understanding the risks of prolonged mechanical circulatory support is crucial for managing high-risk cardiac patients.

Purpose of the Study:

  • To evaluate the outcomes of Impella 5.5 mechanical circulatory support in patients requiring support beyond the FDA-approved 14-day limit.
  • To compare device-related complications and mortality rates between patients receiving short-term (≤14 days) versus prolonged (>14 days) Impella 5.5 support.
  • To assess the safety profile of extended Impella 5.5 use in a real-world clinical setting.

Main Methods:

  • Retrospective review of adult patients (≥18 years) who received Impella 5.5 support between May 2020 and April 2023.
  • Patients were stratified into two groups: prolonged support (>14 days) and standard support (≤14 days).
  • Outcomes analyzed included device-related complications, 30-day postimplant survival, and in-hospital mortality.

Main Results:

  • Of 31 patients, 14 (45.2%) received prolonged support (median 43.5 days) compared to 8 days for the standard group (P < 0.001).
  • Device-related complication rates (9.7%) and 30-day survival (71%) did not significantly differ between the groups (P = 0.08 and P = 0.2, respectively).
  • In-hospital mortality was 32% and showed no difference based on support duration (P > 0.99). Long-term strategies included bridge to VAD, transplant, or recovery.

Conclusions:

  • High-risk patients with cardiogenic shock can be supported with Impella 5.5 beyond the FDA-approved 14-day duration.
  • Extended Impella 5.5 support does not appear to be associated with an increased risk of complications or mortality.
  • This finding supports the judicious use of prolonged mechanical circulatory support in select critically ill cardiac patients.
Keywords:
Impellabridge to therapycardiogenic shockleft ventricular assist devicesmechanical circulatory support

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