title: One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Herzzentrum, Georg-August-Universität Göttingen, Göttingen, Germany dr.m.puls@med.uni-goettingen.de.
authors.forename: Miriam
authors.initials: M
authors.lastname: Puls
authors.affiliation: Universitäres Herzzentrum Eppendorf Hamburg, Hamburg, Germany.
authors.forename: Edith
authors.initials: E
authors.lastname: Lubos
authors.affiliation: Klinikum Siegburg (Kardiologie und Angiologie), Siegburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Boekstegers
authors.affiliation: Universitätsmedizin Mainz, 2. Med. Klinik, Mainz, Germany.
authors.forename: Ralph Stephan
authors.initials: RS
authors.lastname: von Bardeleben
authors.affiliation: Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.
authors.forename: Taoufik
authors.initials: T
authors.lastname: Ouarrak
authors.affiliation: Herzzentrum Brandenburg, Bernau, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.affiliation: Universitätsklinikum Tübingen, Tübingen, Germany.
authors.forename: Christine S
authors.initials: CS
authors.lastname: Zuern
authors.affiliation: Universitätsklinikum Heidelberg, Heidelberg, Germany.
authors.forename: Raffi
authors.initials: R
authors.lastname: Bekeredjian
authors.affiliation: Cardio Vasculäres Centrum (CVC) Frankfurt St. Katharinen, Frankfurt am Main, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Universitätsklinikum Bonn (Med. Klinik und Poliklinik II), Bonn, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Cardioangiologisches Centrum Bethanien (CCB), Frankfurt am Main, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Eggebrecht
authors.affiliation: Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Senges
authors.affiliation: Herzzentrum, Georg-August-Universität Göttingen, Göttingen, Germany Helios Albert-Schweitzer-Klinik Northeim, Northeim, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schillinger
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization; D005260:Female; D006333:Heart Failure / Q000209:etiology; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007902:Length of Stay; D008297:Male; D058386:Mitral Valve Annuloplasty / Q000295:instrumentation / Q000379:methods; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D011788:Quality of Life; D012042:Registries; D016896:Treatment Outcome
keywords: Heart failure; MitraClip; Mitral valve regurgitation; Percutaneous mitral valve repair; TRAMI registry