Why is this study important?
Severe symptomatic tricuspid regurgitation (TR) is prevalent and causes significant morbidity. Surgical intervention is less commonly utilized, compared to left sided valve disease and there are questions regarding outcomes with surgical intervention in advanced stages. Thus, there is a need for a percutaneous intervention for native valve TR.
Should I change my practice because of these findings?
Ewards Pascal Transcatheter Repair System in the treatment of TR is investigational at this time.
What question was this study supposed to answer?
This prospective, single-arm multicenter early feasibility study was designed to evaluate the safety and performance of the PASCAL transcatheter valve repair system in symptomatic severe TR.
What did the study show?
65 patients (mean age 77; 55% women) with severe symptomatic TR despite medical therapy underwent treatment using Ewards Pascal Transcatheter Repair System. Primary endpoint was the composite of major adverse events at 30 days with follow up at six months and then annually. One-year follow up results were reported for 46 out of 65 patients in whom follow-up data was available (loss of follow up attributed to Covid-19 pandemic). Mortality was 10.8%. 18 % were hospitalized for heart failure and 16.9% experienced a major adverse event, the most common adverse event was bleeding at 9.2%. 86% had TR that was moderate or less. 75% had a two- grade reduction in TR severity. There was improvement in tricuspid annulus diameter, RV end diastolic diameter, RA volume, inferior vena cava diameter and TR jet area. Heart failure severity, six-minute walk test and quality of life were improved.
How good was the approach/methodology?
The one-year report of CLASP-TR extends the findings at 30 days regarding safety.1 Its limited due to the lack of follow-up in 19 out of 65 participants (29%). CLASP II TR is a prospective, multicenter, randomized controlled pivotal trial that is enrolling 825 participants and will provide more definitive answers regarding efficacy compared to medical therapy.
All editors: Kalkidan Bishu, MD, MS, FSCAI
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