Stepan Cerny1, Miroslava Benesova1, Ivo Skalsky1, Nirav C Patel2, Valavanur A Subramanian3. 1. Department of Cardiac Surgery, Na Homolce Hospital, Prague, Czech Republic. 2. Department of Cardiovascular and Thoracic Surgery, Lenox Hill Hospital, New York, NY, USA. 3. Heart Repair Technologies, Morgan Hill, CA, USA.
Abstract
OBJECTIVES: Ring annuloplasty reduces the septal-lateral diameter (SLD) indirectly by circumferential annular cinching and frequently results in the recurrence of mitral regurgitation (MR) in patients with functional MR (FMR). Our goal was to report the results from the trial and the 2-year post-trial surveillance data. We evaluated whether direct reduction of the SLD with a transannular mitral bridge could achieve significant and durable MR reduction in patients with FMR. METHODS: In a prospective trial, 34 consecutive patients with FMR had a mitral bridge implanted surgically. Primary end points were MR ≤1+ at 1, 3 and 6 months postimplant and freedom from subsequent surgical mitral valve repair or replacement. RESULTS: Thirty-two of 34 (94.1%) patients met the primary end points with MR ≤1+ at 6 months. At 2 years, there were no strokes or device-related adverse events. At 2 years, MR was reduced from 3.32 ± 0.47 to 0.50 ± 0.83 (P ≤ 0.001) with ≤1+ MR in 33/34 patients, including 4 reinterventions for periprosthetic recurrent MR ≥3 without mitral bridge explants or conventional mitral repair or replacement. At 2 years, the mean mitral gradient was 2.15 ± 0.82 mmHg; the mitral annular SLD decreased from 40.4 ± 2.91 mm to 28.9 ± 1.55 mm (P ≤ 0.001). The left ventricular ejection fraction increased (57.9 ± 10.4-62.4 ± 9.7%; P ≤ 0.001). The New York Heart Association functional class improved (2.19 ± 0.76-1.41 ± 0.61; P ≤ 0.001). CONCLUSIONS: The single-centre trial data indicate that direct reduction in the SLD with a mitral bridge is feasible, safe and efficacious in patients with FMR. Validation in a larger population of patients and comparison to conventional annuloplasty ring are necessary. CLINICAL TRIAL REGISTRATION NUMBER: NCT03511716.
OBJECTIVES: Ring annuloplasty reduces the septal-lateral diameter (SLD) indirectly by circumferential annular cinching and frequently results in the recurrence of mitral regurgitation (MR) in patients with functional MR (FMR). Our goal was to report the results from the trial and the 2-year post-trial surveillance data. We evaluated whether direct reduction of the SLD with a transannular mitral bridge could achieve significant and durable MR reduction in patients with FMR. METHODS: In a prospective trial, 34 consecutive patients with FMR had a mitral bridge implanted surgically. Primary end points were MR ≤1+ at 1, 3 and 6 months postimplant and freedom from subsequent surgical mitral valve repair or replacement. RESULTS: Thirty-two of 34 (94.1%) patients met the primary end points with MR ≤1+ at 6 months. At 2 years, there were no strokes or device-related adverse events. At 2 years, MR was reduced from 3.32 ± 0.47 to 0.50 ± 0.83 (P ≤ 0.001) with ≤1+ MR in 33/34 patients, including 4 reinterventions for periprosthetic recurrent MR ≥3 without mitral bridge explants or conventional mitral repair or replacement. At 2 years, the mean mitral gradient was 2.15 ± 0.82 mmHg; the mitral annular SLD decreased from 40.4 ± 2.91 mm to 28.9 ± 1.55 mm (P ≤ 0.001). The left ventricular ejection fraction increased (57.9 ± 10.4-62.4 ± 9.7%; P ≤ 0.001). The New York Heart Association functional class improved (2.19 ± 0.76-1.41 ± 0.61; P ≤ 0.001). CONCLUSIONS: The single-centre trial data indicate that direct reduction in the SLD with a mitral bridge is feasible, safe and efficacious in patients with FMR. Validation in a larger population of patients and comparison to conventional annuloplasty ring are necessary. CLINICAL TRIAL REGISTRATION NUMBER: NCT03511716.
Authors: Antonio Mangieri; Alessandra Laricchia; Francesco Giannini; Francesco Gallo; Faraj Kargoli; Annamaria Ladanyi; Luca Testa; Antonio Colombo; Azeem Latib Journal: Front Cardiovasc Med Date: 2019-11-06