Hemodynamic support appears to improve LV ejection fraction in high-risk PCI
Among patients undergoing high-risk PCI with mechanical circulatory support who survived to 90 days without further major cardiac complications, many had improved left ventricular ejection fraction, according to data from RESTORE EF.
Researchers retrospectively analyzed prospectively collected observational data from 406 patients who underwent high-risk PCI with mechanical circulatory support (Impella family of devices, Abiomed) between August 2019 and May 2021.
“The RESTORE EF study results add to the growing body of evidence demonstrating that Impella-supported high-risk PCI can lead to a more complete revascularization and considerable LVEF improvement,” Jason Wollmuth, MD, an interventional cardiologist at Providence Heart Institute in Portland, Oregon, said in a press release. “The improvement in angina and heart failure symptoms in those with near normal LVEF provides a clear benefit to this patient population that is aligned with the FDA’s 2018 decision to expand Impella’s indication to patients undergoing high-risk PCI with or without depressed ejection fractions.”
All patients (mean age, 70 years; 26% women) had Impella-supported high-risk PCI and survived to 90 days with no intervening cardiac procedures.
In 251 patients with LVEF measurements at baseline and 90 days, mean LVEF improved from 35% at baseline to 45% at 90 days (P < .0001) and was most pronounced in patients with complete revascularization, defined as a residual SYNTAX I score of 0, Wollmuth and colleagues wrote.
Among the cohort, 62% had NYHA class III or IV HF at baseline, but that percentage dropped to 15% at last follow-up (P < .001). Similarly, the percentage of patients with Canadian Cardiovascular Society grade III or IV symptoms dropped from 72% at baseline to 2% at last follow-up (P < .0001), according to the researchers.
“These results further demonstrate that high-risk PCI procedures supported by Impella employing contemporary best practices are safe and effective, providing a treatment option for patients who historically have had limited options to improve their quality of life,” Mitul Patel, MD, an interventional cardiologist at the University of California, San Diego Health, said in the release.
“This observational study of a highly selected population with [ischemic cardiomyopathy] provides new evidence that Impella-supported PCI can improve heart failure and LVEF and is consistent with prior studies,” Akl C. Fahed, MD, MPH, FACC, an interventional cardiologist and physician-scientist at Massachusetts General Hospital and instructor in medicine at Harvard Medical School, and Farouc A. Jaffer, MD, PhD, director of coronary intervention at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, wrote in a related editorial.
"Based on the encouraging report from Wollmuth et al, a heart team-based recommendation for PCI in CABG-ineligible patients appears reasonable for patients with ischemic cardiomyopathy,” they wrote.
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Wollmuth J, et al. J Soc Cardiovasc Angiography Interv. 2022;doi:10.1016/j.jscai.2022.100350.