A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty.

Background. Annular stabilization is important during bicuspid aortic valve (BAV) repair to obtain the best long-term results. This report describes the early outcomes of a novel bicuspid annuloplasty ring for this purpose. Methods. Under regulatory supervision (NCT02071849), a geometric bicuspid annuloplasty ring was used during valve repair in 16 patients. Three patients had Sievers type 0 valves, 11 had Sievers type 1, and 2 had Sievers type 2. Thirteen patients had left-/right-coronary cusp fusion, 1 had right-/noncoronary cusp fusion, and 2 had both. Moderate to severe aortic insufficiency (AI) was present in 13 of 16 patients, and 3 had mild AI with aortic aneurysms. Ascending aortic aneurysms, root aneurysms, or both were replaced in 7 of 16 patients. The Dacron-covered titanium ring had circular base geometry and two outwardly flaring subcommissural posts positioned opposite on the circumference. The ring was implanted into the annulus beneath the valve, and then leaflet repair was performed. Results. Immediate postrepair echocardiograms showed grade 0 residual AI in all patients, with good cusp mobility and effective height, and satisfactory gradients. There were no in-hospital or late mortalities. Two patients experienced leaflet tears from long annular suture tails, requiring late valve replacement. After implementation of a lateral suture fixation technique, no more failures occurred. At a mean follow-up time of 9 months, the remaining 14 patients were in New York Heart Association class I, with predominant grade 0 AI. Conclusions. As a technique for BAV repair, internal ring annuloplasty produces major annular remodeling and stabilization. Annular reduction and reshaping to a 50/50% symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation. Geometric ring annuloplasty could have useful applications in BAV repair. (C) 2015 by The Society of Thoracic Surgeons