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Background: TRILUMINATE Pivotal is a prospective, randomized, controlled study of patients with severe tricuspid regurgitation (TR). Venous congestion due to TR may lead to end-organ dysfunction and failure. The potential to reverse or stop further deterioration in end-organ function is an important goal of treatment., Objectives: Examine changes in end-organ function after tricuspid transcatheter edge-to-edge repair (TEER) and assess the association of baseline end-organ function with heart failure (HF) hospitalizations and mortality., Methods: Subjects were randomized 1:1 to either the TEER group (TriClip™ System + medical therapy) or Control group (medical therapy alone). Laboratory assessments and TR grading were performed at baseline and at all follow-up visits (discharge, 30 days, 6 months, and 12 months). An independent echocardiography core laboratory assessed TR severity and an independent clinical events committee adjudicated adverse events., Results: 572 subjects were enrolled and randomized (285 TEER, 287 Control). Patients with moderate to severe end-organ impairment (eGFR <45 ml/min/1.73m 2 or MELD-XI >15) at baseline had increased incidence of HF hospitalization and death through 12 months, regardless of treatment. There were no statistically significant differences between TEER and Control in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared to control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 vs 0.07 ± 1.10 , p=0.022) and MELD-XI (-0.52 ± 0.18 vs 0.34 ± 0.18, p=0.0007) improved., Conclusions: Baseline end-organ function were associated with HF hospitalization and death in patients with severe TR. At 12 months, eGFR and MELD-XI scores were not statistically significantly different between the overall TEER and Control groups. In patients who had successful TEER, statistically significant, yet small, favorable changes occurred for both eGFR and MELD-XI. Further investigation is needed to assess whether these changes in end-organ function after successful TEER are clinically meaningful and reduce HF hospitalization or death., (Copyright © 2024. Published by Elsevier Inc.)

Background: The use of oversizing in mitral valve-in-valve (MViV) procedures can lead to non-uniform expansion of transcatheter heart valves (THV). This may have implications for THV durability., Aims: The objective of this study was to assess the extent and predictors of THV deformation in MViV procedures., Methods: We examined 33 patients who underwent MViV with SAPIEN prostheses. The extent of THV deformation (deformation index, eccentricity, neosinus volume, asymmetric leaflet expansion and vertical deformation) and hypoattenuating leaflet thickening (HALT) were assessed using cardiac computed tomography (CT), performed prospectively at 30 days post-procedure. For descriptive purposes, the THV deformation index was calculated, with values >1.00 representing a more hourglass shape., Results: Non-uniform underexpansion of THV was common after MViV implantation, with a median expansion area of 74.0% (interquartile range 68.1-84.1) at the narrowest level and a THV deformation index of 1.21 (1.13-1.29), but circularity was maintained with eccentricity ranging from 0.24 to 0.28. The degree of oversizing was a key factor associated with greater underexpansion and a higher deformation index (β=-0.634; p<0.001; β=0.594; p<0.001, respectively). Overall, the incidence of HALT on the 30-day postprocedural CT was 27.3% (9 of 33). Most patients (32 of 33) were on anticoagulation therapy, but the prothrombin time and international normalised ratio (PT-INR) at the time of the CT scan was <2.5 in 23 of 32 patients. Among patients with a PT-INR of <2.5, HALT was predominantly observed with a high THV deformation index of ≥1.18., Conclusions: THV deformation, i.e., underexpansion and an hourglass shape, commonly occurs after MViV implantation and is negatively affected by excessive oversizing. Optimising THV expansion during MViV could potentially prevent HALT.

Background: TAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability., Aims: We aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomatic severe AS., Methods: This was a first-in-human (FIH), prospective, non-randomised, single-arm, single-centre study. Patients with severe, symptomatic AS of any surgical risk and who were eligible for the DurAVR THV prosthesis were recruited; they were assessed at baseline, 30 days, 6 months, and 1 year post-procedure for implant success, haemodynamic performance, and safety., Results: Thirteen patients (73.9±6.4 years old, 77% female) were enrolled. The DurAVR THV was successfully implanted in 100% of cases with no device-related complications. One access site complication, one permanent pacemaker implantation, and one case of moderate aortic regurgitation occurred. Otherwise, no deaths, stroke, bleeding, reinterventions, or myocardial infarction were reported during any of the follow-up visits. Despite a mean annulus size of 22.95±1.09 mm, favourable haemodynamic results were observed at 30 days (effective orifice area [EOA] 2.00±0.17 cm 2 , and mean pressure gradient [MPG] 9.02±2.68 mmHg) and were sustained at 1 year (EOA 1.96±0.11 cm 2 , MPG 8.82±1.38 mmHg), resulting in zero patients with any degree of prosthesis-patient mismatch. Additionally, new valve performance measures derived from cardiovascular magnetic resonance displayed restoration of laminar flow, consistent with a predisease state, in conjunction with a mean coaptation length of 8.3±1.7 mm., Conclusions: Preliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics. Further clinical investigation is warranted to evaluate how DurAVR THV may play a role in addressing the challenge of lifetime management in AS patients.