Transcatheter valve repair treats tricuspid regurgitation in high-risk patients

Use of the PASCAL transcatheter valve repair system is an effective treatment for severe tricuspid regurgitation (TR) in high-risk patients, reveals a study. The system provides sustained TR reduction and notable clinical improvements at 1 year.

A team of investigators conducted a multicentre, retrospective, and prospective observational cohort analysis across 16 European heart valve centres in consecutive patients treated with the PASCAL transcatheter valve repair system from February 2019 to November 2023. They also carried out echocardiographic assessments at baseline, discharge, and follow-up, subjected to centralized analysis.

A total of 1,059 high-risk patients (mean age 79 years, 53 percent female, TRI-SCORE risk 23 percent, 87 percent NYHA functional class III/IV) with multiple comorbidities were included in the analysis. Of these, 96 percent had severe or higher graded TR. Most patients (85 percent) achieved intraprocedural success according to Tricuspid Valve Academic Research Consortium criteria, and 87 percent achieved ≤moderate TR reduction.

Factors independently predictive of a postprocedure residual TR of >moderate were as follows: coaptation gaps ≥8 mm (odds ratio [OR], 1.67, 95 percent confidence interval [CI], 1.03‒2.72; p=0.038), tenting height ≥10 mm (OR, 2.18, 95 percent CI, 1.30‒3.65; p=0.003), transvalvular lead presence (OR, 1.91, 95 percent CI, 1.19‒3.05; p=0.007), right ventricular dilatation >42 mm (OR, 3.35, 95 percent CI, 1.37‒9.1; p=0.009), and massive/torrential TR at baseline (OR, 4.59, 95 percent CI, 2.35‒8.96; p<0.001).

At 1-year follow-up, 83 percent of patients attained ≤moderate TR, with significant improvements such as enhanced NYHA functional class (66 percent class I/II vs 17 percent at baseline; p<0.001).

Clinical profiles and TR severity at baseline were similar between patients treated with the first-generation PASCAL system (n=570) and those treated with the new PASCAL Precision system (n=489).

However, patients in the Precision group exhibited greater TR reduction to trace/mild (63 percent vs 49 percent; p<0.001), shorter procedure times (median 93 vs 120 min; p<0.001), and higher clinical success rates based on the Tricuspid Valve Academic Research Consortium at 30 days and 1 year (87 percent vs 81 percent; p=0.021 and 56 percent vs 50 percent; p=0.044, respectively).

Of note, higher centre experience (≥21 patients/year) gave rise to higher intraprocedural and clinical success.