Key result
Geometric ring annuloplasty for bicuspid aortic valve repair significantly reduced aortic insufficiency from a preoperative grade of 2.5 to 0.9 at 2 years (P<0.0001).
Why the study?
As bicuspid aortic valve repair evolves, more effective annular reduction and stabilization could be advantageous.
Is geometric ring annuloplasty safe and effective for reducing aortic insufficiency and maintaining acceptable gradients in patients undergoing bicuspid aortic valve repair?
Is geometric ring annuloplasty safe and effective for reducing aortic insufficiency and maintaining acceptable gradients in patients undergoing bicuspid aortic valve repair?
In a first-in-humans pilot trial, geometric ring annuloplasty for bicuspid aortic valve repair was safe and effectively reduced aortic insufficiency at 2 years.
Answers are grounded in this paper and cite their sources.
Supports feasibility of geometric ring annuloplasty for BAV repair in selected patients; leaves open need for larger trials on durability.
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-humans pilot trial are reported. Methods A prospective first-in-humans trial of BAV ring annuloplasty was completed in 16 patients. Patient age was 44.4 ± 11.3 (mean ± standard deviation) years, preoperative aortic insufficiency grade was 2.5 ± 1.0, New York Heart Association class 1.8 ± 0.4, and mean systolic gradient 13.4 ± 12.9 mm Hg. 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° subcommissural posts and were implanted subannularly. Leaflets were reconstructed using plication/cleft closure, creating an effective height of ≥8 mm, even if modest gradients were induced. Results Mean pre-repair annular diameter was 28.6 ± 3.3 mm, and the 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 follow-up. No late mortalities or valve-related complications occurred, and all patients reverted to New York Heart Association class I. Aortic insufficiency reduction was significant to grade 0.9 ± 0.5 at 2-years ( P < .0001). Mean valve gradients were acceptable (13.3 ± 5.0 mm Hg at 2 years; overall P = .11) and tended to fall over time ( P < .0001). 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.
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Rankin et al. (2020) studied Bicuspid aortic valve (BAV) (n=16). Geometric ring annuloplasty was evaluated on Aortic insufficiency grade at 2 years (p=<.0001). Geometric ring annuloplasty for bicuspid aortic valve repair significantly reduced aortic insufficiency from a preoperative grade of 2.5 to 0.9 at 2 years (P<0.0001).
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