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Updated: Mar 21, 2026
Engineering Biological-Based Vascular Grafts Using a Pulsatile Bioreactor
Published on: June 14, 2011
Clinical Evaluation of Completely Biological Engineered Vessel for Coronary Artery Bypass
Adrian Ebner1, Matthew Soule2, Abrielle Krouse3
1Sanatorio Italiano Hospital, Asunción, Paraguay.
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.
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