This single-center, single-arm prospective trial evaluated the safety and effectiveness of the excimer laser-assisted nonocclusive anastomosis (ELANA) device for constructing distal LITA-to-LAD anastomoses in CABG in 71 patients, followed for 1 year (June 2023–August 2024).
One-year device-related MACE was 2.9% (cardiac death + MI from LITA failure); overall MACE was 8.7%. Six-month LITA patency by angiography was 92.5% (FitzGibbon A: 40.6%, B: 51.6%, O: 7.8%); intravascular ultrasound in 6 FG-B patients showed no significant stenosis.
- Single-arm design with no comparator group (no hand-sewn control arm), limiting causal inference. - Single-center experience may limit generalizability. - Short follow-up (6-month patency, 1-year MACE); long-term durability is unknown.
The ELANA device appears safe for constructing distal coronary anastomoses in CABG, with a low 1-year device-related MACE rate of 2.9%. However, the high proportion of FitzGibbon B patency (51.6%) and lack of a control arm mean clinicians should await comparative and longer-term data before broad adoption.
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