1. Persistent reduction of mitral regurgitation by implantation of a transannular mitral bridge: durability and effectiveness of the repair at 2 years—results of a prospective trial†
- Author
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Ivo Skalsky, Valavanur A. Subramanian, Nirav C. Patel, Miroslava Benesova, and Stepan Cerny
- Subjects
Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Mitral Valve Annuloplasty ,medicine.medical_treatment ,Population ,Periprosthetic ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Recurrence ,Internal medicine ,medicine ,Humans ,Prospective Studies ,cardiovascular diseases ,education ,Aged ,Mitral valve repair ,Mitral regurgitation ,education.field_of_study ,Ejection fraction ,business.industry ,Surrogate endpoint ,Mitral Valve Insufficiency ,General Medicine ,Middle Aged ,Clinical trial ,Treatment Outcome ,Bridge (graph theory) ,030228 respiratory system ,Heart Valve Prosthesis ,Cardiology ,Mitral Valve ,Female ,Surgery ,Cardiology and Cardiovascular Medicine ,business - 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.
- Published
- 2018
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