Outcomes of prolonged support on surgically implanted microaxial left ventricular assist devices for refractory cardiogenic shock

Abstract

Objective

The US Food and Drug Administration approved the use of Impella 5.5 (Abiomed) for mechanical circulatory support for up to 14 days, but many patients require longer duration of support. This study sought to compare outcomes of standard versus prolonged Impella 5.5 support.

Methods

A retrospective review of 257 patients implanted with the Impella 5.5 device between 2020 and 2024 for cardiogenic shock at 2 high-volume institutions was conducted. Patients were stratified by standard (≤14 days) (n = 143) versus prolonged (>14 days) (n = 114) device support.

Results

At baseline, the etiology of shock was more likely to be acute decompensated heart failure (74.6% vs 52.4%; P < .001) in patients requiring prolonged support. Duration of device support ranged from 1 to 133 days with median being 25.0 days (interquartile range [IQR], 19.0-36.0 days) and 7.0 days (IQR, 5.0-11.0 days) in prolonged and standard cohorts, respectively. Bridge to decision (42.1% vs 29.4%; P = .046) and ultimate destination of transplant (36.8% vs 15.8%; P < .001) were more common in the prolonged cohort. Incidence of stroke (10.5% vs 8.4%; P = .712), bleeding requiring surgical exploration (7.0% vs 4.9%; P = .650), and in-hospital mortality (23.0% vs 30.1%; P = .262) were similar between groups, although surgical site infection was more common in the prolonged cohort (11.4% vs 3.5%; P = .026). Cumulative incidence analysis showed stroke was rare beyond 30 days of device duration. In patients who survived to device explant, 60-day survival after explant was equivalent between groups (91.8% vs 88.8%; P = .430).

Conclusions

Extended Impella 5.5 device support beyond 14 days was not associated with increased incidence of mortality, major bleeding, or stroke in our study, and may be effective for patients requiring extended ventricular assist device support as bridge to heart transplant.