Clinical Evaluation of Completely Biological Engineered Vessel for Coronary Artery Bypass.

BACKGROUND

Long-term outcomes of coronary artery bypass graft (CABG) remain limited by conduit availability and durability, particularly vein grafts. Prior off-the-shelf alternatives have failed due to thrombosis and poor biological integration.

FIRST-IN-HUMAN/EARLY REPORTS SUMMARY: Vascudyne coronary artery bypass-1 is a prospective first-in-human feasibility study of an acellular tissue-engineered vessel (ATEV) with an external support structure (ESS) in 3 patients undergoing multivessel CABG. After a length-mismatch failure, computed tomography-based 3-dimensional modeling enabled 2 successful ATEV-ESS implants. All patients received a direct oral anticoagulant.

DISCUSSION: Implanted ATEVs were patent through 6 months without thrombus formation, bleeding, or a major adverse cardiac and cerebrovascular event. One graft occluded by 12 months due to proximal anastomotic distortion. The second ATEV remained patent at 12 months with stable lumen geometry. A concomitant vein graft occluded during follow-up.

NOVELTY: This first-in-human experience demonstrates the feasibility of an off-the-shelf bioengineered conduit capable of regenerating into a living vessel with 1-year patency and favorable safety outcomes.

TAKE-HOME MESSAGE: The ATEV-ESS has the potential to provide an off-the-shelf alternative for CABG.