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†
Jazyk angličtina Země Německo Médium print
Typ dokumentu časopisecké články, pozorovací studie
PubMed
30590416
DOI
10.1093/ejcts/ezy423
PII: 5253831
Knihovny.cz E-zdroje
- Klíčová slova
- Annuloplasty ring, Functional mitral regurgitation, Ischaemic mitral regurgitation, Mitral valve repair, Recurrent mitral regurgitation,
- MeSH
- anuloplastika mitrální chlopně * škodlivé účinky přístrojové vybavení mortalita statistika a číselné údaje MeSH
- lidé středního věku MeSH
- lidé MeSH
- mitrální chlopeň patofyziologie chirurgie MeSH
- mitrální insuficience patofyziologie chirurgie MeSH
- prospektivní studie MeSH
- recidiva MeSH
- senioři MeSH
- srdeční chlopně umělé MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie 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
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT03511716
