Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: A 4-center pilot trial

Abstract

A geometric annuloplasty ring could improve efficacy and stability of aortic valve repair. Toward this goal, a 1-piece 3-dimensional titanium annuloplasty ring with Dacron covering was developed and tested successfully in animals. The purpose of this study was to define hemodynamic outcomes with this device used as the annuloplasty component of human aortic valve repair. In a 4-center pilot trial with informed consent, 16 patients underwent aortic valve repair for aortic insufficiency, with the annuloplasty device sutured into the annulus beneath the leaflets. Preoperative annular diameter averaged 26.5 ± 2.0 (mean ± standard deviation) mm, and average ring size was 22.3 ± 1.2 mm. After annuloplasty, leaflet defects were easy to identify, and 14 of 16 patients (88%) required leaflet plication and/or autologous pericardial reconstruction for leaflet defects. Three patients had ascending aortic replacement, and 2 had remodeling root replacement. One had ultrasonic leaflet decalcification and another tricuspid valve annuloplasty. Follow-up data were from site-specific studies at the 6-month postoperative time point. There were no in-hospital mortalities or major complications. Preoperative aortic insufficiency grade (0-4 scale) was 3.6 ± 1.0 and fell to 1.0 ± 0.8 at 6 months (P < .0001). New York Heart Association class fell from 2.5 ± 0.5 to 1.1 ± 0.3 (P < .0001). Postrepair valve area was 2.7 ± 0.2 cm(2), and 6-month mean systolic gradient was 11.3 ± 3.3 mm Hg. Left ventricular end-diastolic diameter and ejection fraction both normalized (both P < .0001). Geometric ring annuloplasty facilitated aortic valve repair, allowing more precise reconstruction of leaflet defects. Aortic insufficiency reduction and systolic gradients were excellent, and expansion of valve reconstruction into broader categories of aortic valve disease seems indicated.