One-Year German TRAMI Registry Supports MitraClip Therapy

March 1, 2016—One-year outcomes and predictors of mortality after MitraClip therapy (Abbott Vascular) in contemporary clinical practice in the German transcatheter mitral intervention (TRAMI) registry were published by Miriam Puls, MD, et al in the European Heart Journal (2016;37:703–712).

The investigators noted that the TRAMI registry was established to assess valve safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I, 20%) between August 2010 and July 2013. The 1-year outcome in this MitraClip cohort is reported in the European Heart Journal.

There were 749 patients (90.5%) available for 1-year follow-up and were included in the following analyses. The investigators recorded mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection.

As summarized in the European Heart Journal, the 1-year mortality was 20.3%, and 63.3% of TRAMI patients pertained to NYHA functional classes 1 or 2 (compared with 11% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. 

The investigators noted that a significant proportion of patients regained complete independence in self-care after MitraClip implantation (independence in 74% vs 58.6% at baseline; P = .005). Predictors of 1-year mortality were NYHA class IV (hazard ratio [HR], 1.62; P = .02), anemia (HR, 2.44; P = .02), previous aortic valve intervention (HR, 2.12; P = .002), serum creatinine ≥ 1.5 mg/dL (HR, 1.77; P = .002), peripheral artery disease (HR, 2.12; P = .0003), left ventricular ejection fraction < 30% (HR, 1.58; P = .01), severe tricuspid regurgitation (HR, 1.84; P = .003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual postprocedural severe mitral regurgitation) (HR 4.36; P < .0001).

Treatment of significant mitral regurgitation with the MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. Additionally, in the TRAMI cohort, the failure of procedural success exhibited the highest HR concerning the prediction of 1-year mortality.