Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry

Catheter Cardiovasc Interv. 2015 Oct;86(4):728-35. doi: 10.1002/ccd.25838. Epub 2015 Feb 12.

Abstract

Aims: 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.

Methods and 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.

Keywords: MitraClip; complications; mitral regurgitation; repair; valve surgery.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / methods*
  • Chi-Square Distribution
  • Cohort Studies
  • Elective Surgical Procedures / adverse effects
  • Elective Surgical Procedures / methods*
  • Female
  • Follow-Up Studies
  • Germany
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / methods*
  • Hospital Mortality / trends
  • Humans
  • Male
  • Mitral Valve Insufficiency / diagnostic imaging
  • Mitral Valve Insufficiency / mortality
  • Mitral Valve Insufficiency / therapy*
  • Patient Safety
  • Prosthesis Design
  • Prosthesis Failure*
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Statistics, Nonparametric
  • Survival Rate
  • Treatment Outcome
  • Ultrasonography