Incidence and in-hospital Safety Outcomes of Patients undergoing Percutaneous Mitral Valve Edge-to-Edge Repair Using MitraClip® - 5 year German national patient sample including 13,575 implants.

Aims: The number of percutaneous edge-to-edge mitral regurgitation valve repairs with MitraClip implantation has increased during recent years. Published studies showed promising safety outcomes in relatively small cohorts, while results from large samples are sparse. Thus, we aimed to evaluate trends and safety outcomes in the German nationwide in-patient sample. Methods and results: We analysed data on patients' characteristics and in-hospital safety outcomes for all percutaneous mitral valve repairs using the MitraClip technique in Germany between 2011 and 2015. Overall, 13,575 in-patients were included. The annual number of MitraClip implantations increased from 815 in 2011 to 4,432 in 2015 (beta 1.00 [95% CI: 0.96-1.03], p<0.001). The in-hospital mortality (p=0.193) and major adverse cardiac and cerebrovascular events (MACCE) (p=0.183) rate remained unchanged. Important independent predictors of in-hospital mortality were heart failure (OR 1.91 [95% CI: 1.43-2.54], p<0.001), transfusion of erythrocyte concentrates (OR 9.04 [95% CI: 7.45-10.96], p<0.001), stroke (OR 6.82 [95% CI: 4.34-10.72], p<0.001), endocarditis (OR 19.52 [95% CI: 9.04-42.14], p<0.001), pulmonary embolism (OR 7.61 [95% CI: 3.44-16.81], p<0.001), pericardial tamponade (OR 14.08 [95% CI: 7.09-27.96], p<0.001) and pericardial effusion (OR 2.59 [95% CI: 1.66-4.04], p<0.001). Conclusions: MitraClip implantations increased markedly (5.4-fold) between 2011 and 2015, with a constant in-hospital mortality and MACCE rate. Our data indicate that edge-to-edge mitral valve repair using the MitraClip technique has acceptable in-hospital safety outcomes in a real-world scenario.