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TCT CONNECT-186 Intermediate-Term Left Ventricular Function Following Non-Emergent Impella Protected PCI: Restore EF StudyFree Access


J Am Coll Cardiol, 76 (17 Supplement S) B79


Percutaneous mechanical circulatory support of patients unsuitable for bypass surgery and requiring high-risk percutaneous coronary intervention (PCI) has been shown to increase the feasibility of complete revascularization which is associated with improved outcomes likely secondary to improvement in left ventricular ejection fraction (LVEF).


Restore EF is a prospective multicenter study of high-risk PCI patients undergoing prophylactic Impella (Abiomed, Danvers, Massachusetts) support using contemporary best practices during non-emergent PCI. Pre-specified endpoints included change in symptoms of angina or heart failure and change in LVEF at 90 days compared to baseline. Patients having a planned or unplanned subsequent cardiac procedure, emergent PCI for ST-segment elevation myocardial infarction, non–ST-segment elevation myocardial infarction, or shock, or who died prior to follow-up were excluded per study protocol.


As of June 2020, a total of 150 patients (age 71 ± 10 years, 31% female, 83% Caucasian) were enrolled. Heart failure symptoms improved significantly as at baseline 66% of patients suffered New York Heart Association functional class III/IV symptoms compared to 21% at follow-up. Likewise, anginal symptoms improved with reduction of those suffering from Canadian Cardiovascular Society classification III/IV angina from 74% to 2% (p < 0.001 for both). The median LVEF improved from 35 [20 45] to 45 [35 55], (n = 68), p < 0.0001 at 90-days. The risk of Impella access site vascular complication requiring blood transfusion was noted to be 4% whereas the overall risk of mortality in the follow-up interval was 3.9%.


Protected PCI with planned Impella hemodynamic support is associated with significantly improved LVEF at 90-day follow-up. Heart failure and anginal classification also significantly improved.


CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP)