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Eur Heart J. 2016 Feb 21;37(8):703-12. doi: 10.1093/eurheartj/ehv627. Epub 2015 Nov 27.

One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry.

Author information

1
Herzzentrum, Georg-August-Universität Göttingen, Göttingen, Germany dr.m.puls@med.uni-goettingen.de.
2
Universitäres Herzzentrum Eppendorf Hamburg, Hamburg, Germany.
3
Klinikum Siegburg (Kardiologie und Angiologie), Siegburg, Germany.
4
Universitätsmedizin Mainz, 2. Med. Klinik, Mainz, Germany.
5
Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.
6
Herzzentrum Brandenburg, Bernau, Germany.
7
Universitätsklinikum Tübingen, Tübingen, Germany.
8
Universitätsklinikum Heidelberg, Heidelberg, Germany.
9
Cardio Vasculäres Centrum (CVC) Frankfurt St. Katharinen, Frankfurt am Main, Germany.
10
Universitätsklinikum Bonn (Med. Klinik und Poliklinik II), Bonn, Germany.
11
Cardioangiologisches Centrum Bethanien (CCB), Frankfurt am Main, Germany.
12
Herzzentrum, Georg-August-Universität Göttingen, Göttingen, Germany Helios Albert-Schweitzer-Klinik Northeim, Northeim, Germany.

Abstract

AIMS:

The transcatheter mitral valve interventions (TRAMI) registry was established in order to assess safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I 20.0%) between August 2010 and July 2013. We present the 1-year outcome in this MitraClip cohort-which is the largest published to date.

METHODS AND RESULTS:

Seven forty-nine patients (90.5%) were available for 1-year follow-up and included in the following analyses. Mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes were recorded. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection. The 1-year mortality was 20.3%. At 1 year, 63.3% of TRAMI patients pertained to NYHA functional classes I or II (compared with 11.0% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. Importantly, a significant proportion of patients regained the complete independence in self-care after MitraClip implantation (independence in 74.0 vs. 58.6% at baseline, P = 0.005). Predictors of 1-year mortality were NYHA class IV (hazard ratio, HR 1.62, P = 0.02), anaemia (HR 2.44, P = 0.02), previous aortic valve intervention (HR 2.12, P = 0.002), serum creatinine ≥1.5 mg/dL (HR 1.77, P = 0.002), peripheral artery disease (HR 2.12, P = 0.0003), left ventricular ejection fraction <30% (HR 1.58, P = 0.01), severe tricuspid regurgitation (HR 1.84, P = 0.003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual post-procedural severe mitral regurgitation) (HR 4.36, P < 0.0001).

CONCLUSIONS:

Treatment of significant MR with MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. In the TRAMI cohort, the failure of procedural success exhibited the highest hazard ratio concerning the prediction of 1-year mortality.

KEYWORDS:

Heart failure; MitraClip; Mitral valve regurgitation; Percutaneous mitral valve repair; TRAMI registry

PMID:
26614824
PMCID:
PMC4761401
DOI:
10.1093/eurheartj/ehv627
[Indexed for MEDLINE]
Free PMC Article
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