Mitralign Annuloplasty FIM Study Published

June 21, 2016—Findings from the Mitralign percutaneous annuloplasty first-in-man study were published by Georg Nickenig, MD, et al in the Journal of the American College of Cardiology (JACC; 2016;67:2927–2936). The study sought to report the safety and performance data from the feasibility study with the novel Mitralign percutaneous annuloplasty system (Mitralign, Inc.) for the treatment of chronic functional mitral valve regurgitation.

The background of the study is that current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited, and additional interventional approaches are required, noted the investigators.

As summarized in JACC, 71 patients with moderate-to-severe FMR (mean, 67.7 ± 11.3 years of age; left ventricular [LV] ejection fraction, 34% ± 8.3%), on stable medical heart failure medication were prospectively enrolled. The device success rate was 70.4% (n = 50 of 71). No intraprocedural deaths occurred. In patients receiving implants, four patients (8.9%) experienced cardiac tamponade. 

The investigators reported that 30-day (n = 45) and 6-month (n = 41) rates of all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in one patient (2.4%), and nonurgent percutaneous repair was performed in seven patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades.

Concerning mitral valve (MV) annular geometry, the investigators found significant reduction of anterior-posterior (–0.31 ± 0.4 cm) and septal-lateral dimensions (–0.21 ± 0.3 cm), a decreased MV tenting area (–0.57 ± 1.1 cm²), and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (–0.2 ± 0.4 mm) and volume (–22 ± 39 mL). Treatment was associated with significant improvement in 6-minute walking distances (56.5 ± 92 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%, reported the investigators.

The investigators concluded that percutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling and provides clinical improvement during the 6 months after treatment, advised the investigators in JACC.