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- Document type:
- Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
- Author(s):
- Pausch, Jonas; Harmel, Eva; Reichenspurner, Hermann; Kempfert, Jörg; Kuntze, Thomas; Owais, Tamer; Holubec, Tomas; Walther, Thomas; Krane, Markus; Vitanova, Keti; Borger, Michael Andrew; Eden, Matthias; Hachaturyan, Violetta; Bramlage, Peter; Falk, Volkmar; Girdauskas, Evaldas
- Title:
- Subannular repair in secondary mitral regurgitation with restricted leaflet motion during systole.
- Abstract:
- OBJECTIVE: Ventricular secondary mitral regurgitation (SMR) (Carpentier type IIIb) results from left ventricular (LV) remodelling, displacement of papillary muscles and tethering of mitral leaflets. The most appropriate treatment approach remains controversial. We aimed to assess the safety and efficacy of standardised relocation of both papillary muscles (subannular repair) at 1-year follow-up (FU). METHODS: REFORM-MR (Reform-Mitral Regurgitation) is a prospective, multicentre registry that enrolled consecutive patients with ventricular SMR (Carpentier type IIIb) undergoing standardised subannular mitral valve (MV) repair in combination with annuloplasty at five sites in Germany. Here, we report survival, freedom from recurrence of MR >2+, freedom from major adverse cardiac and cerebrovascular events (MACCEs), including cardiovascular death, myocardial infarction, stroke, MV reintervention and echocardiographic parameters of residual leaflet tethering at 1-year FU. RESULTS: A total of 94 patients (69.1% male) with a mean age of 65.1±9.7 years met the inclusion criteria. Advanced LV dysfunction (mean left ventricular ejection fraction 36.4±10.5%) and severe LV dilatation (mean left ventricular end-diastolic diameter 61.0±9.3 mm) resulted in severe mitral leaflet tethering (mean tenting height 10.6±3.0 mm) and an elevated mean EURO Score II of 4.8±4.6 prior to surgery. Subannular repair was successfully performed in all patients, without operative mortality or complications. One-year survival was 95.5%. At 12 months, a durable reduction of mitral leaflet tethering resulted in a low rate (4.2%) of recurrent MR >2+. In addition to a significant improvement in New York Heart Association (NYHA) class (22.4% patients in NYHA III/IV vs 64.5% patients at baseline, p<0.001), freedom from MACCE was observed in 91.1% of patients. CONCLUSIONS: Our study demonstrates the safety and feasibility of standardised subannular repair to treat ventricular SMR (Carpentier type IIIb) in a multicentre setting. By addressing mitral leaflet tethering, papillary muscle relocation results in very satisfactory 1-year outcomes and has the potential to durably restore MV geometry; nevertheless, long-term FU is mandatory. TRIAL REGISTRATION NUMBER: NCT03470155.
- Journal title abbreviation:
- Heart
- Year:
- 2023
- Journal volume:
- 109
- Journal issue:
- 18
- Pages contribution:
- 1394-1400
- Fulltext / DOI:
- doi:10.1136/heartjnl-2022-322239
- Pubmed ID:
- http://view.ncbi.nlm.nih.gov/pubmed/37376817
- Print-ISSN:
- 1355-6037
- TUM Institution:
- Klinik für Herz- und Gefäßchirurgie (DHM) (Prof. Krane)
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