Midterm Results Published From the International TriValve Registry
January 22, 2019–Midterm results from the International Multisite Transcatheter Tricuspid Valve Therapies registry (TriValve registry) were published by Maurizio Taramasso, MD, PhD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2019;12:155–165). The prospective international registry is evaluating the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices in a large high-risk population of patients with severe, symptomatic tricuspid regurgitation (TR).
As summarized in JACC: Cardiovascular Interventions, the TriValve registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9% ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular; Pascal, Edwards Lifesciences), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4Tech Cardio Ltd.; Trialign, Mitralign), or coaptation (Forma, Edwards Lifesciences) and replacement (NaviGate caval implants, NaviGate Cardiac Structures). Clinical outcomes were prospectively determined during midterm follow-up.
The investigators reported that a total of 108 (34.6%) patients had previous left heart valve intervention (84 surgical, 24 transcatheter). The TR etiology was functional in 93% of patients, and the mean annular diameter was 46.9 ± 9 mm.
In 75% of patients, the regurgitant jet was central (vena contracta, 1.1 ± 0.5; effective regurgitant orifice area, 0.78 ± 0.6 cm2). The preprocedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg.
Implanted devices included MitraClip in 210 cases, Trialign in 18 cases, the first-generation TriCinch in 14 cases, caval valve implantation in 30 cases, Forma in 24 cases, Cardioband in 13 cases, NaviGate in six cases, and Pascal in one case.
In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤ 2+) was 72.8%.
The TriValve investigators found that greater coaptation depth (odds ratio, 24.1; P = .002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs 6.9%; P = .04); Actuarial survival at 1.5 years was 82.8% ± 4% and was significantly higher among patients who had procedural success.
TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Additionally, midterm survival is favorable in this high-risk population, and greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality, concluded the investigators in JACC: Cardiovascular Interventions.