Inglessis‐Azuaje, Ignacio

Abstract Background and Aims The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy vs medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity. Methods The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR, and randomized 2:1 to TTVR (n = 267) or control (n = 133). In a post hoc analysis, patients were stratified into severe TR (n = 172) and massive/torrential TR (n = 220) cohorts. Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan–Meier estimates for all-cause mortality and heart failure (HF) hospitalization assessed at 18 months. Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board. Results One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients. The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe {1.64 [95% confidence interval (CI): 1.11, 2.43]} and massive/torrential [2.20 (1.55, 3.14)]. At 18 months, TTVR patients had similar mortality to controls [rate difference: severe 0.2% (−11.6, 11.9), massive/torrential −5.8% (−17.6, 6.0)], whereas HF hospitalization rates favoured TTVR in the massive/torrential cohort [vs control, severe 9.8% (−3.0, 22.7), massive/torrential -15.2% (−28.9, −1.5)]. Conclusions Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.

Background Recent technologies enable real‐time 3‐dimensional intracardiac echocardiography (ICE) with the advantages of 2‐dimensional ICE and imaging capabilities of transesophageal echocardiography. The purpose of this study is to evaluate the real‐world, multicenter safety and performance of a novel 3‐dimensional ICE system in a variety of cardiac interventions used in standard clinical practice. Methods This prospective, multicenter, observational, single‐arm study enrolled patients who were scheduled for an invasive cardiac procedure involving guidance with ICE and followed until discharge or ≤48 hours postprocedure. Intracardiac imaging was performed with the 3‐dimensional ICE catheter, VeriSight Pro (Philips Inc.). Fluoroscopy was used in all cases and transesophageal echocardiography was used in some cases. The primary safety end point was device‐related adverse events. The primary efficacy end point included technical success, imaging success, and clinical success. Results Between October 2021 and November 2022, 155 patients were enrolled and screened. Percutaneous interventions performed included atrial septal defect/patent foramen ovale closures, left atrial appendage occlusion, catheter ablations, and valve procedures. No adverse events were related to the device or procedure. The technical, imaging, and clinical success rates were 98.7% (95% CI, 95.4%–99.8%), 96.1% (95% CI, 91.8%–98.6%), 94.8% (95% CI, 91.8%–98.6%), respectively. Overall, the VeriSight Pro ICE image quality was assessed to be “acceptable” or greater in relation to reference image modality among 96.2% (149 of 155) of procedures. Conclusions VeriSight ICE imaging is safe and effective in the guidance of a wide variety of percutaneous cardiovascular procedures and has provided successful and high‐quality imaging of cardiac structures.