Design and rationale of the Impella®-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients.

BACKGROUND

Cardiac surgery patients with severe preoperative left ventricular (LV) dysfunction are at high risk for poor postoperative outcomes including prolonged ventilation, renal failure and post-cardiotomy cardiogenic shock (PCCS). Mortality and morbidity remain high for patients who develop PCCS, thus mandating the availability of more effective prophylactic and treatment options.

METHODS

The Impella®-Protected Cardiac Surgery Trial (IMPACT) is a prospective, multicenter, single-arm pilot study assessing Impella 5.5® use prior to weaning from cardiopulmonary bypass in high-risk cardiac surgery patients. Key inclusion criteria are a baseline LV ejection fraction ≤25% or ≤35% with significant mitral regurgitation and planned mitral valve replacement or repair (MVR), and undergoing planned, on-pump isolated coronary artery bypass grafting, MVR, aortic valve replacement, or a combination of these with or without tricuspid valve replacement. The primary effectiveness endpoint is the rate of PCCF at hospital discharge. The primary safety endpoint is the composite of all-cause mortality, stroke and new requirement for renal replacement therapy evaluated through 90 days post-operation. Additional secondary endpoints include hospital and ICU lengths of stay, vasoactive-inotropic score, duration of mechanical ventilation and cardiovascular mortality. A concurrent registry will aim to collect data on patients not approached for study enrollment or who do not meet all inclusion and exclusion criteria.

CONCLUSIONS

IMPACT results will provide data on trial and technique feasibility, patient selection criteria and aid in informing future trial designs.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT05529654, https://clinicaltrials.gov/study/NCT05529654.