Screening for transcatheter mitral valve replacement: a decision tree algorithm.

AIMS: The high frequency of screening failure for anatomical reasons in patients with severe mitral valve regurgitation (MR) is a limiting factor in the screening process for transcatheter mitral valve replacement (TMVR). However, data on optimal patient selection are scarce. The present study aimed to develop a screening algorithm based on TMVR screening data. METHODS AND RESULTS: A total of 195 screenings for six different TMVR devices were performed in 94 high-risk patients with severe MR. We compared baseline echocardiographic and multislice computed tomography (MSCT) parameters between the subgroups of patients accepted (N=33) and rejected for TMVR (N=61). Reasons for screening failure were assessed, and a decision tree algorithm was statistically derived. Reasons for screening failure were small LV dimensions (30.6%), small (7.5%) or large (22.5%) annular size, potential risk of LVOT obstruction (22.0%) or mitral annulus calcification (15.6%). A four-step decision tree algorithm to assess TMVR eligibility was developed resulting in an AUC of 0.80 (95% CI: 0.71, 0.89, p<0.0001). CONCLUSIONS: This study presents the first screening algorithm to assess anatomical eligibility for TMVR in patients with severe MR, based on simple MSCT criteria. Given the high rate of TMVR screening failure, this algorithm may facilitate the identification of potential TMVR candidates.

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

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

Angiographic score assessment improves cardiovascular risk prediction: the clinical value of SYNTAX and Gensini application.

BACKGROUND: Severity of coronary artery disease (CAD) is related to cardiovascular outcome. We aimed to assess the long-term follow-up depending on Synergy between percutaneous coronary intervention with Taxus and cardiac surgery (SYNTAX) and Gensini score for prognosis. Both scores increase with complexity and thus reflect risk of cardiovascular events. METHODS AND RESULTS: We determined complexity and extent of CAD by the SYNTAX and Gensini score in the AtheroGene cohort (N = 1,974, with 22.6 % women). The endpoint was non-fatal myocardial infarction (N = 132) and cardiovascular death (N = 159) over a median follow-up of 5.4 (Q1: 5.23/Q3: 5.57) years up to 8 years maximum (follow-up rate 99.4%). For SYNTAX score, the following distribution was used: low (≤22, N = 1,404), medium (23-32, N = 314), high score (>32, N = 256). Gensini score was split into thirds. Cox regression analysis showed a hazard ratio (HR) of 1.5 (95% confidence interval 1.16-1.95; p = 0.0024) for the log transformed SYNTAX score in a fully adjusted model and a HR of 1.41 (95% CI 1.13-1.77; p = 0.0025) for the Gensini score. The SYNTAX score alone had a C-index of 0.62, whereas adding clinical variables increased the C-index to 0.67. Similar results were obtained for the Gensini score. Regarding the SYNTAX score using net reclassification index, discrimination of events and non-events was enhanced by 37.2% in a model of clinical variables and biomarkers and by 31.8% for the Gensini score. CONCLUSION: The SYNTAX and Gensini score in combination with clinical variables could be used to predict the cardiovascular prognosis during a long-term follow-up of up to 8 years in CAD patients.