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

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 6 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 preinterventionally; 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. Catheterization and Cardiovascular Interventions 86: 728-735 (2015) 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. V C 2015 Wiley Periodicals, Inc.

Gender‐related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1‐year results from the German TRAMI registry

“…The TRAMI registry is industry‐independent and founded by proprietary means of the IHF and additional funding by “Deutsche Herzstiftung e.V.”. The registry design has been described elsewhere in detail and first results have recently been published . All patients enrolled in the TRAMI registry were comprehensively informed about the MitraClip® procedure and have signed a written consent form preprocedurally.…”

Early Endocarditis Following Percutaneous Mitral Repair in a Dialysis Patient

“…Major complications reported from the EVEREST II trial and a four-year MitraClip follow up study include major bleeding, stroke or transient ischemic attack, chordal rupture, pericardial tamponade and myocardial infarction; endocarditis, however, was not one of the reported complications in the landmark EVEREST II trial [18,19]. There have been only a few reported cases of patients with infective endocarditis in the region of the MitraClip [9,10].…”

Die Nachsorge von Patienten nach MitraClip®-Implantation

“…In Deutschland hat sich bei Sinusrhythmus die lebenslange Gabe von ASS begleitet von einer Therapie mit Clopidogrel über einen Monat etabliert, wobei bei Implantation von mehreren Clips diese Kombination nach Ermessen des Behandelnden bis zu sechs Monate verlängert werden kann [15,19]. Bei Vorhofflimmern ist eine orale Antikoagulation (OAK) mit Vitamin-K-Antagonisten (VKA) oder Nicht-Vitamin-K-Antagonisten (NO-AK) zur Schlaganfallprophylaxe indiziert.…”

“…In diesem Fall wird zusätzlich die Gabe von ASS oder Clopidogrel, was in Abhängigkeit vom Blutungsrisiko, der z. B. mittels HAS-BLED-Score abzuschätzen ist, über einen Monat empfohlen [15,19]. Eine Triple-Therapie ist im Allgemeinen nicht ratsam, außer der Patient hat in zeitlichem Zusammenhang zur MitraClip ® -Implantation einen koronaren Stent erhalten [15,19].…”