Restore EF study shows heart function, symptom improvements for high-risk PCI patients supported by Impella

The study, which published online August 12 in JSCAI, builds on the largest clinical data set ever collected for high-risk PCI and further validates the LVEF and quality of life benefits associated with Impella-supported procedures.

Restore EF is a prospective, multi-center study evaluating the best practices in contemporary PCI practice, including more complete revascularization. Participants received an Impella-supported high-risk PCI, also called an “on-pump PCI,” at one of 22 sites across the United States between August 2019 and May 2021.

At 90-day follow up, study participants had: i. A 29% relative improvement from baseline LVEF (n=251, p<0.0001), with a significantly greater improvement in lvef for those who had a complete revascularization (characterized by a residual syntax score of 0). ii. significant improvement in heart failure symptoms, with an overall 76% reduction in new york heart association class iii or iv heart failure symptoms (n="274," p><0.001). iii. significant improvement in angina symptoms, with an overall 97% reduction in canadian cardiovascular society class iii or iv angina symptoms (n="260," p><0.0001). participants with higher baseline lvef (greater than 45%) also experienced significant symptomatic improvement, similar to patients with lower lvef.

Results from Restore EF and the PROTECT III study, which published in the June 2022 edition of the American Heart Journal, further demonstrate the safety and benefits of Impella-supported high-risk PCI, including low bleeding and MACCE rates (composite of death, stroke, myocardial infarction and repeat procedures). Data from PROTECT III shows reduced MACCE rates compared to PROTECT II (15.1% vs. 21.9%, p=0.037) when Impella is used to achieve a more complete revascularization in a single setting for high-risk PCI patients. Operators from community and academic centers demonstrated low major bleeding rates of 2.5% in the Restore EF study and 1.8% in the PROTECT III study when contemporary best practices were followed.

See: "Does Mechanical Circulatory Support–Assisted Percutaneous Coronary Intervention Improve Left Ventricular Function?"-Akl C. Fahed, MD, MPH. Farouc A. Jaffer, MD, PhD Published:August122022DOI:https://doi.org/10.1016/j.jscai.2022.100387.Journal of the Society for Cardiovascular Angiography & Interventions.

See-" Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices":William W.O'NeillMD, Mark Anderson MD,DanielBurkhoff MD,PhD, Cindy L.GrinesMD, Navin K.KapurMD, et.al.https://doi.org/10.1016/j.ahj.2022.02.006 .American Heart Journal.-Volume 248, June 2022, Pages 139-149.