Danvers, Mass.-based Abiomed’s study across 16 U.S. and German locations found a 79% survival rate at explant in 356 patients treated with Impella 5.5 with SmartAssist. A majority of surviving patients recovered native heart function without needing further mechanical support or a heart transplant, according to a news release.
Abiomed’s Impella 5.5 is a minimally-invasive device that provides full cardiac flow and stabilizes the patient by increasing cardiac power output, unloading the left ventricle and perfusing the coronaries and end organs. The SmartAssist feature is designed to assist in weaning patients off of the device and has a fiberoptic pressure sensor for aiding in deploying and repositioning the pump.
Data from the trial, which is the first large, multicenter study observing survival rates for Impella 5.5 with SmartAssist, showed 86% (141 patients) survival for cardiomyopathy cardiogenic shock patients, 67% (88 patients) survival for AMI cardiogenic shock patients and 68% (34 patients) survival for postcardiotomy cardiogenic shock patients.
“We were able to achieve a 79% overall survival rate by taking a novel approach in supporting these critically ill patients,” lead study author & Cleveland Clinicl cardiovascular & heart transplant surgeon Dr. Edward Soltesz said in the release. “I am looking forward to seeing more prospective studies around this minimally invasive, high-flow temporary device.”
“This report demonstrates the benefit of the significant unloading with Impella 5.5 use in cardiogenic shock patients. We are impressed with the improved survival rates seen with Impella 5.5 use compared to traditional therapies,” added co-author & AdventHealth (Orlando) thoracic transplant & thoracic/cardiovascular surgery director Dr. Scott Silvestry. “The use of best practices, techniques and this innovative new technology allows us to provide a better outlook to our patients.”