Ejection Fraction Improvement Following Contemporary High-Risk Percutaneous Coronary Intervention: RESTORE EF Study Results

Abstract

BackgroundDespite many reports of clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (HRPCI) with hemodynamic support, little is known about whether this approach improves left ventricular ejection fraction (LVEF). The purpose of the present observational study was to examine, in an ideal patient population with Impella-supported HRPCI, whether there is an impact on left ventricular function at midterm follow-up.MethodsRESTORE EF is a multicenter, retrospective analysis of a prospectively collected observational data set that aimed to assess 90-day LVEF in patients undergoing Impella-supported nonemergent HRPCI (NCT04648306), who survived with no intervening cardiac procedures prior to the primary endpoint follow-up window (90-day LVEF assessment). Secondary endpoints included change in New York Heart Association Functional Classification and Canadian Cardiovascular Society Angina Grade at the last follow-up.ResultsFrom August 2019 to May 2021, 406 patients were enrolled at 22 US sites. Age was 70.2 ​​± ​​11.4 ​​years; 26% were female. In paired assessment at 90-day follow-up, baseline LVEF improved from 35 ​​± ​​15% to 45 ​​± ​​14% (N = 251, P < .0001), with significantly greater improvement in patients with residual SYNTAX score I of 0. Percentage classified as New York Heart Association class III/IV decreased from 62% at baseline to 15% at last follow-up (P < .001), and percentage with Canadian Cardiovascular Society grade III/IV symptoms decreased from 72% to 2% (P < .0001).ConclusionsIn an ideal cohort of HRPCI patients, there is a signal that hemodynamically supported HRPCI affords significant improvement in 90-day LVEF, with complete revascularization associated with greater LVEF improvement. These hypothesis-generating findings merit further assessment in large, all-comer studies and randomized trials.