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.
Transcatheter Valve Replacement in Severe Tricuspid Regurgitation
Background: Tricuspid edge to edge repair (TEER) is a novel treatment for severe tricuspid regurgitation and is highly dependent on intraprocedural image quality. To date, transesophageal echocardiography (TEE) has been the primary imaging modality used to guide TEER. The role of intracardiac echocardiography (ICE) has not been assessed. The objective of this study was to describe the use and role of 2-dimensional ICE in the early experience of TEER. Methods: Consecutive patients undergoing TEER (with or without concomitant mitral repair) with off-label use of MitraClip (Abbott, Santa Clara, CA) were included in the study. Utilization of 2-dimensional ICE in comparison with TEE imaging were collected in each procedure through retrospective review of the procedural reports and images. Results: Of 42 TEER cases, ICE was used in 15 (36%) and concomitant mitral repair was performed in 37 (86%). ICE was increasingly used over time for TEER. ICE was able to visualize the tricuspid leaflets with high resolution and provided superior leaflet visualization to TEE in 40% of cases where it was used. Patients treated with ICE guidance tended to have a greater baseline severity of tricuspid regurgitation compared with patients treated with TEE guidance alone (8/15 [53%] massive or greater tricuspid regurgitation versus 6/27 [22%]; P =0.09). Degree of tricuspid regurgitation reduction was similar with TEE alone versus ICE plus TEE guidance (1.9±1.0 versus 2.1±1.1 grade reduction, P =0.28). Conclusions: ICE was increasingly used in the early experience of TEER over time. ICE facilitates leaflet visualization for grasping and is a useful adjunct to TEE during TEER.