- IMPACT pilot single‑arm trial (N=100) tested planned Impella 5.5 initiated before separation from cardiopulmonary bypass in high‑risk cardiac surgery patients with LVEF <=35%.
- Results reported safety and feasibility with low device‑related event rates in non‑shock patients.
- Trial was presented at the AATS meeting; Impella 5.5 remains investigational for this indication and is not FDA‑approved.
- Ongoing related studies include INTeGRATE, PROTECT IV and OASIS evaluating Impella devices in heart‑failure and high‑risk PCI contexts.
Study overview
The IMPACT pilot was a U.S. single‑arm trial (N=100) evaluating planned Impella 5.5 microaxial pump support initiated prior to separation from cardiopulmonary bypass in adult non‑shock cardiac surgery patients with severe left ventricular dysfunction (LVEF ≤35%).
Key results
Presented at the AATS Annual Meeting, the pilot reported that planned intraoperative Impella 5.5 use was feasible and associated with favorable postoperative outcomes and low device‑related event rates in this high‑risk cohort.
Guideline context
The Impella 5.5 is cited as a primary therapy option for postcardiotomy shock and low cardiac output syndrome in the 2025 EACTS/STS/AATS guidance, and early temporary mechanical circulatory support is a Class I recommendation for cardiogenic shock.
Regulatory status and next steps
The evaluated use is investigational and not FDA‑approved for this indication; the findings are presented as a foundation for larger studies, and related trials include INTeGRATE (post‑market Impella 5.5 in HFrEF/cardiogenic shock), PROTECT IV (randomized Impella vs no‑Impella in high‑risk PCI) and OASIS (Impella CP during PCI for AMI with cardiogenic shock).
