Transcatheter mitral valve interventions (TRAMI) registry: The German mitral valve registry [TRAMI (Transcatheter Mitral Valve Interventions)-Register: Das Deutsche Mitralklappen-Register]

摘要

The transcatheter mitral valve interventions (TRAMI) registry was established in 2010 in order to assess the safety and efficacy of percutaneous mitral valve therapy in Germany and to document baseline characteristics and decision-making in different subgroups of patients. The TRAMI registry is available to all German sites performing percutaneous mitral valve therapy. Follow-up is scheduled at 30 days, 1, 3, and 5 years. In addition, patients can be enrolled retrospectively without predefined times of follow-up. The vast majority of patients enrolled in TRAMI underwent MitraClip? therapy. As of march 2013, a total of 1,064 patients treated with MitraClip? have been enrolled at 21 different German sites. Preliminary results show that patients treated with MitraClip? in Germany were mainly elderly patients with significant comorbidities and high or inacceptable risk of surgery. The majority of patients had secondary mitral regurgitation and a large proportion of patients had reduced left ventricular ejection fraction (LV-EF). Nevertheless, MitraClip? was found to be safe and established risk factors for conventional cardiac mitral valve surgery, such as advanced age (≥76 years), female gender, severely reduced LV-EF (<30%) and high logistic EuroScore (≥20%) were not predictive for mortality or major complication rates. In contrast, severely reduced renal function was predictive for adverse outcome. The TRAMI registry is the largest real world cohort of patients treated with MitraClip?. As long as randomized studies in this high-risk cohort of patients are lacking, TRAMI provides important information on outcomes after MitraClip? therapy. The data are important for hypothesis generation for randomized trials and TRAMI is an important tool for quality assurance after percutaneous mitral valve therapy in Germany.