New Surgical Circulatory Support System Outcomes.

Abstract

We report the first U.S. experience of the recently approved micro-axial surgical heart pump for the treatment of ongoing cardiogenic shock following acute myocardial infarction (AMICGS), postcardiotomy cardiogenic shock (PCCS), cardiomyopathy including myocarditis, high-risk percutaneous coronary intervention (HRPCI), and coronary artery bypass surgery (HRCABG). Demographic, procedural, hemodynamic, and outcome data were obtained from the manufacturer's quality database of all Impella 5.5 implants at three centers. Fifty-five patients underwent an Impella 5.5 implant for cardiomyopathy (45%), AMICGS (29%), PCCS (13%), preop CABG (5%), OPCAB (4%), and other (4%). Thirty-five patients (63.6%) were successfully weaned off device with recovery of native heart function. Eleven patients (20.0%) were bridged to another therapy, two patients (3.6%) expired while on support, and in seven patients (12.7%) care was withdrawn. Overall survival was 83.6%. There were no device-related strokes, hemolysis, or limb ischemia observed. Four patients experienced purge sidearm damage, resulting in a pump stop in two patients. The new micro-axial surgical heart pump demonstrated successful clinical and device performance in providing both full hemodynamic support and ventricular unloading for patients with AMICGS, decompensated cardiomyopathy, and high-risk cardiac procedures. In this early U.S. experience, 83.6% of patients survived to explant with 76.1% of these patients recovering native heart function.