Novel arm‐width‐expandable transcatheter edge‐to‐edge repair system: Preclinical experiment and first‐in‐human study

Abstract

Background The ValveClasp system is a novel transcatheter edge‐to‐edge repair (TEER) device with an arm‐width‐expandable clip that allows treatment of patients with only one clip more frequently. Objectives This study aimed to evaluate the feasibility and safety of a novel TEER device in porcine models and patients. Methods Fourteen young adult pigs were enrolled. A clip with an expanded arm was implanted under epicardial echocardiography and fluoroscopy guidance. Five patients with at least moderate‐to‐severe mitral regurgitation underwent TEER using the ValveClasp system to test the safety and effectiveness of the device. Results The device success rate was 100% (14/14) in the animal experiments, and all clips were deployed at the A2P2 segments, forming a double‐orifice mitral valve. Gross observations on day 180 showed a wide and continuous tissue bridge between the leaflets. The acute procedural success rate was 100% (5/5). Only one clip was required in all patients, and all achieved effective postoperative endpoints (grade ≤2+). During 30‐day follow‐up, no adverse events occurred. All patients' vena Contracta width (from 8.04 0.71 mm to 3.84 ± 1.18 mm, p = 0.012), mitral regurgitation area (from 12.75 ± 3.13 cm2 to 3.50 ± 1.66 cm2, p = 0.008), and left ventricular end diastolic diameter (from 52.00 ± 2.92 mm to 46.00 ± 3.08 mm, p = 0.040) were considerably decreased, without obvious mitral stenosis. Conclusions The novel arm‐width‐expandable ValveClasp device is safe for TEER for treating severe mitral regurgitation.