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†
Language English Country Germany Media print
Document type Journal Article, Observational Study
PubMed
30590416
DOI
10.1093/ejcts/ezy423
PII: 5253831
Knihovny.cz E-resources
- Keywords
- Annuloplasty ring, Functional mitral regurgitation, Ischaemic mitral regurgitation, Mitral valve repair, Recurrent mitral regurgitation,
- MeSH
- Mitral Valve Annuloplasty * adverse effects instrumentation mortality statistics & numerical data MeSH
- Middle Aged MeSH
- Humans MeSH
- Mitral Valve physiopathology surgery MeSH
- Mitral Valve Insufficiency physiopathology surgery MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Aged MeSH
- Heart Valve Prosthesis MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Observational Study MeSH
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.
Department of Cardiac Surgery Na Homolce Hospital Prague Czech Republic
Department of Cardiovascular and Thoracic Surgery Lenox Hill Hospital New York NY USA
References provided by Crossref.org
ClinicalTrials.gov
NCT03511716
