Bicuspid Aortic Valve Repair using Geometric Ring Annuloplasty: A First-in-Man Pilot Trial

Abstract Objective As bicuspid aortic valve (BAV) repair evolves, more effective annular reduction and stabilization could be advantageous. A geometric annuloplasty ring has been developed, and 2-year regulatory outcomes of a first-in-man pilot trial are reported. Methods A prospective first-in-man trial of BAV ring annuloplasty was completed in 16 patients. Patient age was 44.4±11.3 (mean±SD) years, preoperative aortic insufficiency (AI) Grade was 2.5±1.0, NYHA Class 1.8±0.4, and mean systolic gradient 13.4±12.9 mmHg. Three patients had Sievers Type-0 BAV, 11 had Type-1, and 2 were Type-2. The Dacron-covered titanium rings had circular base geometry with 180° sub-commissural posts, and were implanted sub-annularly. Leaflets were reconstructed using plication/cleft closure, creating an effective height of ≥8mm, even if modest gradients were induced. Results Mean pre-repair annular diameter was 28.6±3.3 mm, and average ring diameter was 22.3±1.6 mm. All valves required leaflet plication/reconstruction; pericardium was avoided; and 7 patients had aortic replacement for aneurysms. No early mortalities or major complications occurred. Two patients required early prosthetic valve replacement for technical errors, and all were between 24-38 months postoperative at followup. No late mortalities or valve-related complications occurred, and all patients reverted to NYHA Class I. AI reduction was significant to Grade 0.9±0.5 at 2-years (p Conclusions Geometric ring annuloplasty was safe and effective for BAV repair. AI reduction was significant, valve gradients were satisfactory, and clinical outcomes were excellent. Geometric ring annuloplasty could simplify and standardize BAV repair.