Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry.

BACKGROUND Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation. METHODS All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry. RESULTS A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year. CONCLUSIONS The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria

Right Ventricular Dysfunction Predicts Outcome After Transcatheter Mitral Valve Repair For Primary Mitral Valve Regurgitation.

AIMS Right ventricular dysfunction (RVD) as expressed by right ventricular to pulmonary artery coupling has recently been identified as a strong outcome predictor in patients undergoing mitral valve edge-to-edge repair (M-TEER) for secondary mitral regurgitation. The aim of this study was to define RVD in patients undergoing M-TEER for primary MR (PMR) and to evaluate its impact on procedural MR reduction, symptomatic development and 2-year all-cause mortality. METHODS AND RESULTS This multicenter study included patients undergoing M-TEER for symptomatic PMR at 9 international centres. The study cohort was divided into a derivation (DC) and validation cohort (VC) for calculation and validation of the best discriminatory value for RVD. 648 PMR patients were included in the study. DC and VC were comparable regarding procedural success and outcomes at follow-up. Sensitivity analysis identified RVD as an independent predictor for 2-year mortality in the DC (HR: 2.37, 95%CI: 1.47-3.81, p<0.001), which was confirmed in the VC (HR: 2.06, 95%CI: 1.36-3.13, p<0.001). Procedural success (MR ≤2+) and symptomatic at follow-up (NYHA≤II) were lower in PMR patients with RVD (MR≤2+: 82% vs. 93% p=0.002; NYHA≤II: 57,3% vs. 66.5% p=0.09 for with vs. without RVD). In all PMR patients, the presence of RVD significantly impaired 2-year survival after M-TEER (HR: 2.23, 95%CI: 1.63-3.05, p<0.001). CONCLUSIONS M-TEER is an effective treatment option for PMR patients. The presence of RVD is associated with less MR reduction, less symptomatic improvement and increased 2-year mortality. Accordingly, RVD might be included into preprocedural prognostic considerations. This article is protected by copyright. All rights reserved