Rankin J Scott, Mazzitelli Domenico, Fischlein Theodor J M, Choi Yeong-Hoon, Aicher Diana, Wei Lawrence M, Badhwar Vinay
Department of Cardiovascular and Thoracic Surgery, West Virginia University Heart and Vascular Institute, Morgantown, WVa.
Department of Cardiac Surgery, Klinikum Bogenhausen, Munich, Germany.
JTCVS Tech. 2020 Jan 23;1:18-25. doi: 10.1016/j.xjtc.2019.12.005. eCollection 2020 Mar.
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.
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.
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 ( < .0001). Mean valve gradients were acceptable (13.3 ± 5.0 mm Hg at 2 years; overall = .11) and tended to fall over time ( < .0001).
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.
随着二叶式主动脉瓣（BAV）修复技术的发展，更有效的瓣环缩小和稳定可能具有优势。一种几何形状的瓣环成形环已被研发出来，本文报告了一项首次人体试验的2年监管结果。
对16例患者完成了BAV瓣环成形环的前瞻性首次人体试验。患者年龄为44.4±11.3（均值±标准差）岁，术前主动脉瓣关闭不全分级为2.5±1.0，纽约心脏协会心功能分级为1.8±0.4，平均收缩期压力阶差为13.4±12.9mmHg。3例患者为Sievers 0型BAV，11例为1型，2例为2型。涤纶覆盖的钛环具有圆形基部几何形状，带有180°瓣叶交界下支柱，在瓣环下植入。使用折叠/裂口闭合重建瓣叶，即使产生适度的压力阶差，也能形成≥8mm的有效高度。
修复前平均瓣环直径为28.6±3.3mm，平均环直径为22.3±1.6mm。所有瓣膜都需要瓣叶折叠/重建；未使用心包；7例患者因动脉瘤进行了主动脉置换。无早期死亡或重大并发症发生。2例患者因技术失误需要早期人工瓣膜置换，随访时所有患者术后时间均在24 - 38个月之间。无晚期死亡或瓣膜相关并发症发生，所有患者均恢复到纽约心脏协会I级。2年时主动脉瓣关闭不全显著减轻至0.9±0.5级（P<0.0001）。平均瓣膜压力阶差可接受（2年时为13.3±5.0mmHg；总体P = 0.11），且随时间有下降趋势（P<0.0001）。
几何形状的瓣环成形术对BAV修复安全有效。主动脉瓣关闭不全显著减轻，瓣膜压力阶差令人满意，临床结果良好。几何形状的瓣环成形术可简化和标准化BAV修复。
