Prospective Cohort Study for Evaluating the Safety and Efficacy of Mobile, Motorized Enhanced Extracorporeal Counterpulsation in Patients With Refractory Angina

Abstract

Enhanced external counterpulsation (EECP) is a noninvasive medical device designed for patients with refractory angina, a condition in which angina symptoms persist despite adequate medical therapy or revascularization.1 Despite its class IIb recommendation for relieving refractory angina symptoms, existing EECP equipment has limited use owing to cost, noise, vibration, and fixed compression power, causing discomfort for patients.1-3 In addition, its large size and immobility restrict its application for critically ill patients unable to use EECP equipment. To address these limitations, we introduce mobile, motorized enhanced extracorporeal counterpulsation (MECP), equipped with electric motors and individually adjustable compression cuffs. These enhancements aim to reduce operational noise, minimize physical impact, and improve mobility and accessibility (Figure 1). Thus, this study aims to investigate the efficacy and safety of MECP for patients with refractory angina. This prospective cohort observational study was conducted from September 2020 to December 2022 at 2 tertiary centers and received approval from the institutional review board of each institution (institutional review board numbers: 1-2020-0060 and 2021-03-026). Patients with refractory angina, presenting with angina symptoms (Canadian Cardiovascular Society [CCS] classification) class II or greater, and who were adequately treated with antianginal medication were enrolled. Subjects with contraindications for EECP treatment were excluded.