Abstract
Background: Tricuspid regurgitation (TR) is common and undertreated as the risk of surgery is high in this patient population. Transcatheter devices offer treatment with a lower procedural risk. The FORMA Tricuspid Valve Therapy system (Edwards Lifesciences) will be reviewed here.Device Description: The system combines a spacer placed in the regurgitant orifice and a rail, over which the spacer is delivered, that is anchored to the endocardial surface of the RV. The spacer provides a surface for leaflet coaptation.Outcomes: Eighteen compassionate care patients and 29 patients included in the US EFS trial are reviewed. Patients were elderly (76 years) and high risk (Euroscore 2 was 9.0 and 8.1%, respectively). There were 2 procedural failures in both groups. Mortality at 30 days was 0% in the compassionate group and 7% in the EFS trial. TR was reduced in both groups; 2D/3D EROA 2.1 ± 1.8 to 1.1 ± 0.9 cm2 in the EFS trial and vena contracta width 12.1 ± 3.3 to 7.1 ± 2.2 mm. Symptomatic improvement was seen in both groups; the proportion of patients in NYHA class III/IV decreased from 84 to 28% at 30 days in the EFS group, and from 94 to 21% at 1 year, in the compassionate group.Conclusions: Reduction of TR with FORMA system is feasible and sustained. Despite residual TR post-procedure, the significant relative reduction in TR severity contributes to substantial clinical improvements in patients with a FORMA device in place.
Highlights
Severe tricuspid regurgitation (TR) is a common and under-treated valvular pathology associated with increased morbidity and mortality [1,2,3,4]
Core lab evaluation of TR showed reductions of TR, that were mostly in the range of torrential TR at baseline, by 49% when evaluated by 2D/3D quantitative effective regurgitation orifice area (EROA) 2.1 ± 1.8 to 1.1 ± 0.9 cm2; and by 46% when using proximal isovelocity surface area (PISA) EROA 1.1 ± 0.6 to 0.6 ± 0.4 cm2
Compassionate care patients treated with the FORMA system experienced similar reductions in TR severity, these measurements were site reported
Summary
Tricuspid regurgitation (TR) is common and undertreated as the risk of surgery is high in this patient population. Outcomes: Eighteen compassionate care patients and 29 patients included in the US EFS trial are reviewed. Patients were elderly (76 years) and high risk (Euroscore 2 was 9.0 and 8.1%, respectively). Mortality at 30 days was 0% in the compassionate group and 7% in the EFS trial. TR was reduced in both groups; 2D/3D EROA 2.1 ± 1.8 to 1.1 ± 0.9 cm in the EFS trial and vena contracta width 12.1 ± 3.3 to 7.1 ± 2.2 mm. Symptomatic improvement was seen in both groups; the proportion of patients in NYHA class III/IV decreased from 84 to 28% at 30 days in the EFS group, and from 94 to 21% at 1 year, in the compassionate group
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