Risk and Outcomes of Complications During and After MitraClip Implantation: Experience in 828 Patients From the German TRAnscatheter Mitral Valve Interventions (TRAMI) Registry

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.