IMPACT (IMpella Protected cArdiaC surgery Trial) evaluated Impella 5.5 support in adult patients undergoing cardiac surgery in the setting of severe left ventricular dysfunction. Findings demonstrated favorable post-operative outcomes and low device-related event rates with planned Impella 5.5 support initiated prior to weaning patients from cardiopulmonary bypass.
Johnson & Johnson said outcomes represent a promising device-supported therapeutic strategy for the high-risk patient population. This strategy remains investigational.
According to the medtech giant, patients undergoing high-risk cardiac surgery — particularly those with left ventricular ejection fraction (LVEF) ≤35% — may face substantial perioperative risks. Those include mortality, renal failure, stroke and postcardiotomy cardiogenic shock.
In the high-risk 100-person cohort, IMPACT demonstrated the safety and feasibility of planned Impella 5.5 use in non-shock cardiac surgery patients with severely reduced ventricular function.
J&J said the study, presented at the American Academy of Thoracic Surgery (AATS) Annual Meeting in Chicago, reflects its commitment to advancing the science of heart recovery and improving outcomes for acute and chronic heart failure patients.
“IMPACT was designed to evaluate whether a planned strategy of prophylactic Impella 5.5 support – initiated prior to separation from cardiopulmonary bypass – could be implemented safely and feasibly in high-risk cardiac surgery patients with severe left ventricular dysfunction who are particularly vulnerable to post-cardiotomy heart failure,” said Dr. Edward Soltesz, surgical director of the Kaufman Center for Heart Failure and Recovery at Cleveland Clinic and principal investigator of IMPACT. “These early positive findings support the feasibility of this approach and provide an important foundation for future studies focused on improving outcomes in this challenging patient population.”
A look at the future of the Johnson & Johnson Impella 5.5 and other Impella pumps
Impella 5.5, a microaxial flow pump, offers therapy for postcardiotomy shock and low cardiac output syndrome. The pump allows the heart to rest while also ensuring the delivery of oxygenated blood throughout the body. Early use of temporary mechanical circulatory support can help improve survival and prevent organ damage.
Other ongoing studies of Impella include the INTeGRATE post-market study for Impella 5.5. It evaluates if the pump allows for the initiation and optimization of guideline-directed medical therapy in heart failure reduced ejection fraction (HFrEF) patients with decompensated heart failure and cardiogenic shock.
PROTECT IV looks at Impella support compared to no Impella support in high-risk percutaneous coronary intervention (PCI) patients with complex coronary disease and reduced left ventricular ejection fraction.
J&J also has the OASIS study evaluating safety outcomes for patients with acute myocardial infarction with cardiogenic shock who receive Impella CP support during PCI.
“IMPACT results set the stage for future study of planned Impella 5.5 use in this complex high-risk patient population,” said Dr. Navin Kapur, chief medical and scientific officer, Heart Recovery, MedTech, Johnson & Johnson. “We remain committed to leading the science that advances cardiovascular disease therapies and improves patient outcomes.”
