JACC Case Rep. 2026 Mar 19:107487. doi: 10.1016/j.jaccas.2026.107487. Online ahead of print.
ABSTRACT
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.
PMID:41854569 | DOI:10.1016/j.jaccas.2026.107487