The first prospective safety and effectiveness trial of the excimer laser assisted nonocclusive anastomosis system in coronary artery bypass grafting.

Abstract

Coronary artery bypass surgery (CABG) is the most common technique in cardiac surgery. Distal anastomoses are currently almost exclusively hand-sewn, which limits the widespread implementation of less-invasive approaches. The aim of this trial is to investigate the safety and effectiveness of the excimer laser-assisted nonocclusive anastomosis (ELANA) device to construct distal anastomoses in CABG. This study is a single-center, single-arm, prospective trial. Eligible patients were included from June 2023 to August 2024. The left internal thoracic artery (LITA) to left anterior descending (LAD) anastomosis was constructed using the ELANA anastomotic system, with additional hand-sewn anastomoses if required. The primary outcome was device-related major adverse cardiac events (MACE; consisting of cardiac death, and myocardial infarction [MI] or repeat revascularization of the LAD territory) at 1 year. Secondary outcomes included 6-month LITA patency assessed by coronary angiography defined by FitzGibbon (FG) criteria and 1-year overall MACE (composite death, MI, and repeat revascularization of all coronary artery territories). In total, 71 patients (89% male, aged 71.0 ± 6.5 years) were included. One-year device-related MACE was 2.9%, consisting of cardiac death and MI due to LITA failure, whereas overall MACE was 8.7%. Six-month LITA patency was 92.5%: FG criteria A 40.6%, B 51.6%, and O 7.8%. Intravascular ultrasound was performed in 6 patients with FG B, which revealed no significant stenosis. This trial demonstrates the safety and effectiveness of the ELANA device, but long-term follow-up is needed to confirm this. Trials are needed to investigate whether this device facilitates less-invasive approaches in CABG.