First-in-Man Study of a Novel, Balloon-Adjustable Mitral Annuloplasty Ring.

Abstract

Objectives: Mitral valve repair is the current standard approach for mitral valve regurgitation. However, patients suffering from functional mitral regurgitation have a significant risk of recurrent regurgitation. Adjustable mitral rings may provide a solution for this adverse event. Methods: A single-center, first-in-man clinical study was performed on patients suffering from mitral valve regurgitation. Patients were implanted with the study ring and followed for six months. A balloon catheter can be inserted into the study ring frame at any time after implantation and inflated independently in the areas P1, P2, or P3, which reduces the anterior-posterior diameter. Results: Five patients (75.4 ± 6.1 years; EuroSCORE II 2.1 ± 0.9%; three female) were successfully implanted. Mechanisms of mitral regurgitation were prolapse of the P2-segment in three patients and annular dilation in two patients. Surgical implantation according to the protocol was feasible and is described herein. Median cardiopulmonary bypass time and cross clamp time were 105 (118; 195) and 94 (90; 151) min, respectively. The median intensive care unit stay was 2 (2; 3) days. No perioperative, 30-day, or 6-month mortality was observed, and the repair was stable without residual or recurrent regurgitation ≥ grade 2. All patients reached the primary endpoint without device-related morbidity. Conclusions: Successful implantation was completed in five patients without device-related adverse events. Ring implantation was safe and feasible for all patients. The opportunity of post-implant adjustment to improve leaflet coaptation is a promising new therapeutic strategy that is assessed in a phase II study.