Hemodynamically supported high-risk percutaneous coronary intervention (HRPCI) is associated with significant improvement in 90-day left ventricular ejection fraction (LVEF), according to a study published in the Journal of the Society for Cardiovascular Angiography & Interventions.
The observational, multicenter RESTORE EF (ClinicalTrials.gov Identifier: NCT04648306) study assessed the 90-day change in LVEF and clinical symptoms of heart failure and angina in patients who received standard of care, percutaneous ventricular assist device-supported, elective or urgent PCI performed at US centers with expertise in HRPCI. All participants underwent HRPCI supported with the Impella microaxial rotary pump (Abiomed).
The primary endpoint was LVEF at 90 days after PCI (60- to 180-day window), and secondary endpoints included change in heart failure and angina symptoms at follow-up and completeness of revascularization.
A total of 406 patients were enrolled at 22 US sites between August 2019 and May 2021. The participants had a mean age of 70.2±11.4 years, 106 (26.1%) were women, and the mean baseline LVEF was 37±16%.
Among 251 patients with baseline and 90-day follow-up LVEF measurements available, baseline LVEF improved from 35±15% to 45±14% at 90 days (P <.0001).
Participants with a baseline LVEF of 20% or less had the greatest improvement in LVEF. In subset analyses, all baseline quartiles of LVEF were associated with significant improvement at 90 days, except for patients with baseline LVEF over 45%, who had significant improvement in New York Heart Association (NYHA) class III/IV heart failure symptoms and Canadian Cardiovascular Society (CCS) class III/IV anginal symptoms at follow-up.
LVEF improvement at 90 days was significantly higher in patients with residual SYNTAX score I of 0 (10% LVEF improvement vs 5% improvement in those with residual SYNTAX Score I >0; P =.007).
Of the 274 patients with baseline and follow-up NYHA heart failure classification, 62% were NYHA class III or IV at baseline (32% class IV, 30% class III). The percentage of patients who were NYHA class III/IV decreased to 15% at the last follow-up (P <.0001), with 1% class IV and 14% class III.
For the 260 patients who had baseline and follow-up CCS angina classification, 72% were CCS class III or IV at baseline (44% class IV, 28% class III), which declined to 2% at the last follow-up (P <.0001), with 0% class IV and 2% class III.
The main study limitations are the observational, nonrandomized design and absence of a comparator. In addition, the data are investigator-reported, and the final study population included only patients who survived at 90 days, with no intervening cardiac procedures. Furthermore, the study was conducted primarily during the COVID-19 pandemic, and the role of optimal heart failure medical therapy in augmenting LV function cannot be reliably determined.
“This observational study suggests that hemodynamically supported HRPCI may afford a significant improvement in LVEF at 90 days, along with significant relief of angina and heart failure symptoms, in an ideal patient population with successful HRPCI and without the need for subsequent procedures,” the researchers wrote. “In this setting, complete revascularization was associated with a more significant improvement in LVEF.”
Disclosure: This study was funded by Abiomed, Inc. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Wollmuth J, Patel MP, Dahle T, et al. Ejection fraction improvement following contemporary high-risk percutaneous coronary intervention: RESTORE EF study results. J Soc Cardiovasc Angiogr Interv. Published online August 12, 2022. doi.org/10.1016/j.jscai.2022.100350