High-risk PCI with circulatory support linked to improved LVEF in 90 days

Dynamically assisted high-risk percutaneous coronary intervention (HRPCI) is associated with a significant improvement in the 90-day left ventricular ejection fraction (LVEF), according to a study published in Journal of the Society of Cardiovascular Angiography and Interventions.

RESTORE EF Multicenter Observational EF (ClinicalTrials.gov defined: NCT04648306) A study evaluated the 90-day change in LVEF and clinical symptoms of heart failure and angina pectoris in patients who received standard care, percutaneous ventricular assist device support, elective or urgent PCI performed at US centers with expertise in HRPCI. All participants underwent HRPCI powered by an Impella micro-circulator pump (Abiomed).

The primary endpoint was LVEF at 90 days after PCI (a 60- to 180-day window), and secondary endpoints included the change in heart failure symptoms and angina pectoris at follow-up and completion of revascularization.


Continue reading

A total of 406 patients were enrolled at 22 US sites between August 2019 and May 2021. The mean age of the participants was 70.2 ± 11.4 years, 106 (26.1%) were women, and the mean left ventricular ejection baseline was 37 ± 16%.

Among the 251 patients with baseline LVEF measurements and a 90-day follow-up, baseline LVEF improved from 35 ± 15% to 45 ± 14% at 90 days (s <.0001).

Participants with a baseline LVEF of 20% or less had the greatest improvement in LVEF. In subgroup analyses, all baseline LVEF quartiles were associated with significant improvement at 90 days, except for patients with baseline LVEF >45%, who had significant improvement in New York Heart Association (NYHA) Class III/IV symptoms of heart failure. ) and Canadian Cardiovascular Society (CCS) Class III/IV angina symptoms at follow-up.

Left ventricular ejection fraction improvement at 90 days was significantly higher in patients with residual SYNTAX score I of 0 (10% LVEF improvement versus 5% improvement in those with residual SYNTAX score I>0; s = .007).

Of the 274 patients with NYHA baseline and follow-up 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 last follow-up (s <.0001), 1% class IV and 14% class III.

For the 260 patients with primary angina classification at follow-up, 72% were category III or IV at baseline (44% category IV, 28% category III), which decreased to 2% at last follow-up (s <.0001), with 0% class IV and 2% class III.

The main study limitations are observation, non-randomized design, and lack of comparison. In addition, the data were reported by the investigators, and the final study population included only patients who survived for 90 days, with no intervening cardiac procedures. Furthermore, the study was conducted primarily during the COVID-19 pandemic, and the role of optimization heart failure Medical treatment of increased LV function cannot be determined reliably.

“This observational study indicates that dynamically supported HRPCI may provide significant improvement in LVEF at 90 days, along with significant relief of symptoms of angina and heart failure, in an ideal population of patients with successful HRPCI and without the need for subsequent procedures,” the researchers wrote. . In this setting, revascularization was associated with a greater improvement in He wrapped. “

Disclosure: This study was funded by Abiomed, Inc. Some of the study authors announced their association with biotechnology, pharmaceutical, and/or device companies. Please see the original reference for a full list of author disclosures.

reference

Wollmuth J, Patel MP, Dahle T, et al. Ejection fraction improvement after contemporary high-risk coronary intervention: results from the RESTORE EF . study. J Soc Cardiovasc Angiogr Interv. Published online August 12, 2022. doi.org/10.1016/j.jscai.2022.100350