1-year CLASP TR results support tricuspid regurgitation repair

Transcatheter valve repair with the PASCAL system provided further validation for transcatheter edge-to-edge repair. The prospective, multicentre CLASP TR study reported significant reductions in tricuspid regurgitation (TR) and improved quality of life (QoL) at 1 year.

Prof. Adam Greenbaum (Emory University School of Medicine, GA, USA) presented the first interim results of the CLASP TR study [1]. CLASP TR is a prospective, single-arm, multicentre study (NCT03745313) designed to evaluate the safety and performance of the PASCAL transcatheter valve repair system in patients with symptomatic severe TR [2]. The primary endpoint was the composite of major adverse events at 30 days, with follow-up at 6 months, 1 year, and every year thereafter until 5 years [2]. The analysis presented by Prof. Greenbaum was limited to the follow-up results at 1 year. The primary outcome of CLASP TR was safety, namely lack of adverse events from either the device or procedure. Key secondary events were improvement in reduction in TR grade, New York Heart Association (NYHA) Classification, the 6-minute walk test, and QoL.

Of the 65 patients who received the PASCAL transcatheter valve repair system, only 46 had complete 1-year follow-up data, as a result of the COVID-19 pandemic. Among those 46 individuals, 7 (10.8%) had died, 12 (18.5%) were rehospitalised for heart failure, and 11 (16.9%) had experienced a major adverse event. All 46 patients (100%) achieved a reduction of at least 1 grade in their TR severity, with 75% seeing a reduction of at least 2 grades and 86% achieving an overall grade of moderate or less. Significant improvements were also seen in heart failure severity, the 6-minute walk test, and patient-reported QoL.

“At 1 year of follow-up, the repair procedure appears to be safe and significantly reduced the severity of patients’ TR and improved their ability to function in daily life, maintaining gains that we previously saw at 30 days of follow-up.” The study limitations were low treatment numbers and an absence of a comparator group. The randomised CLASP II TR trial will compare outcomes for patients treated with the PASCAL and those receiving optimal medical therapy with diuretics.

1. 
   
   1. Greenbaum AB, et al. Transcatheter Treatment Of Tricuspid Regurgitation: One-year Results Of The Clasp TR Study. Abstract 409–12, ACC 2022, 2–4 April, Washington DC, USA.
   
   
   2. Kodali S, et al. J Am Coll Cardiol. 2021;77(4):345–356.

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Posted on 15 June 202224 June 2022