A study detailing early experience of the Pascal transcatheter valve system (Edwards Lifesciences) for the treatment of severe tricuspid regurgitation (TR) has been published in the Journal of the American College of Cardiology (JACC).
The paper, authored by Susheel Kodali (Columbia University Medical Center, New York, USA) et al is the first 30-day report of the US single-arm multicentre, prospective CLASP TR early feasibility study of the Pascal device, which received the CE mark for the treatment of TR in European patients in May 2020.
The present study includes data from 29 US patients who received the Pascal device. Kodali et al write that TR represents an important unmet need, given its high prevalence, adverse prognosis, symptom burden, and direct association with progressive right heart failure. Currently there are no Class I indications for surgical repair of isolated TR, and medical therapy is limited to diuretic agents and symptom management.
The Pascal implant, they note, consists of a central spacer and adjacent paddles and clasps that attach the implant to the native leaflets to reduce regurgitation. The central spacer helps fill the regurgitant orifice and minimise stress on the leaflets. The clasps can be actuated either simultaneously or independently when clasping the leaflets.
Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study, with collected at baseline, discharge, and the 30-day follow-up. These were then reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints for the study include safety composite major adverse event (MAE) rate, echocardiographic, clinical, and functional endpoints.
Detailing the results, Kodali et al note that a total of 34 patients were enrolled in the study. The group had a mean age of 76 years, 53% were women, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Of the 34 patients, 29 (85%) received the Pascal implant. At 30 days, 85% of them achieved a TR severity reduction of at least one grade, the study team reports with 52% with moderate or less TR (p<0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention, they write.
Although the authors note that the study includes only a relatively small number of patients, they write that the consistent reduction in TR, with right ventricular remodelling and increased forward stroke volume and annular dimensions was associated with “consistent improvement in quality-of-life measures”.
In conclusion the study’s authors state: “In this early experience, the Pascal transcatheter valve repair system performed as intended, with substantial TR reductions and favourable safety results with a low MAE rate and no mortality or reintervention. At 30 days, this repair system resulted in significant functional status, exercise capacity, and quality-of-life improvements.”