title: Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry.
abstract: OBJECTIVE
  To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry.
  
  
  RESULTS
  Data of 828 patients (mean age: 76.0 [71-81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 ± 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill pre-interventionally; in-hospital mortality was significantly higher as compared to those without procedural complications.
  
  
  CONCLUSIONS
  MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes.
authors.affiliation: Cardioangiological Center Bethanien, Frankfurt.
authors.forename: Holger
authors.initials: H
authors.lastname: Eggebrecht
authors.affiliation: Cardioangiological Center Bethanien, Frankfurt.
authors.forename: Sibylle
authors.initials: S
authors.lastname: Schelle
authors.affiliation: Department of Cardiology, University Medical Centre Göttingen, Göttingen.
authors.forename: Miriam
authors.initials: M
authors.lastname: Puls
authors.affiliation: Department of Cardiology, West-German Heart and Vascular Center, University Hospital Essen, University of Duisburg-Essen, Essen.
authors.forename: Björn
authors.initials: B
authors.lastname: Plicht
authors.affiliation: Department of Cardiology and Angiology, University Medical Center, Mainz, Germany.
authors.forename: Ralph Stephan
authors.initials: RS
authors.lastname: von Bardeleben
authors.affiliation: Heart Centre Brandenburg, Bernau/Berlin, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.affiliation: Department of Cardiology, Eberhard-Karls-University Tuebingen, Tuebingen, Germany.
authors.forename: Andreas E
authors.initials: AE
authors.lastname: May
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Edith
authors.initials: E
authors.lastname: Lubos
authors.affiliation: Department for Cardiology and Angiology, Helios Heart Center, Siegburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Boekstegers
authors.affiliation: Institute of Myocardial Infarction Research, Ludwigshafen, Germany.
authors.forename: Taoufik
authors.initials: T
authors.lastname: Ouarrak
authors.affiliation: Institute of Myocardial Infarction Research, Ludwigshafen, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Senges
authors.affiliation: Cardioangiological Center Bethanien, Frankfurt.
authors.forename: Axel
authors.initials: A
authors.lastname: Schmermund
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D016009:Chi-Square Distribution; D015331:Cohort Studies; D017558:Elective Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D008297:Male; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D061214:Patient Safety; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome; D014463:Ultrasonography
keywords: MitraClip; complications; mitral regurgitation; repair; valve surgery