Clinical Research & Data, Complete Revascularization, Protected PCI

Jason Wollmuth, MD, Presents RESTORE EF Data at HFSA 2021


Jason Wollmuth, MD, discusses heart failure improvement in patients with complex coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who received complete revascularization with left ventricular (LV) unloading and percutaneous coronary intervention (PCI) in the RESTORE EF study. He gave this presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in September 2021. Dr. Wollmuth is the director of complex coronary interventions at Providence Heart Institute in Portland, Oregon.

Dr. Wollmuth explains that the extent of CAD is associated with prognosis in heart failure. “The more severe the disease, the higher risk for these complex patients,” he notes. “So now we are seeing surgeons turning down more cases of high-risk patients leaving interventional cardiologists more acute patients with higher procedural complexity.” Showing data from PROTECT II and the cVAD Registry, Dr. Wollmuth emphasizes, “but in these patients that are being referred for complex revascularization, we know that Impella® can mitigate the inherent risks in patients who are surgically ineligible.”

The RESTORE EF study, which Dr. Wollmuth has been involved with for the past several years, is a multicenter, single-arm, prospective clinical study of consecutively enrolled patients following Impella supported high-risk PCI in 21 centers. Of the patients enrolled, 77% were surgical turndowns. Dr. Wollmuth describes the complexity of these patients, stating that the average number of significant lesions treated was 3 and atherectomy was used in more than half the patients. The primary endpoint of the study was left ventricular ejection fraction (LVEF) at 90-day follow-up.

Dr. Wollmuth reports on the outcomes, which demonstrate LVEF improvement at 90 days (from 35% to 45%) with a higher improvement in LVEF seen in patients with complete revascularization. Results also showed significant improvement in reported symptoms of heart failure and angina with a 76% reduction in NYHA Class III, IV and 97% reduction in CCS Angina Class III, IV. Vascular complications requiring blood transfusions were low (2.5%) with a relatively low mortality (2.7%) in the study window.

Dr. Wollmuth concludes that while more patients are being turned down for surgery and referred for complex PCI, “it’s really hemodynamic support which is allowing us to get these patients through these complex procedures successfully.”

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