Use of the PASCAL system during transcatheter valve repair for symptomatic tricuspid regurgitation (TR) was found to be safe and effective at 30 days, according to a study published in the Journal of the American College of Cardiology.
In this multicenter, prospective study (Edwards PASCAL TrAnScatheter Valve RePair System in TR Early Feasibility Study; ClinicalTrials.gov Identifier: NCT03745313), 34 adults (76±10 years; 53% women) with severe symptomatic functional or degenerative TR were recruited in 2019 at 7 sites in the United States. Participants were given heparan during the procedure and aspirin for 30 days and underwent electrocardiography at hospital discharge and at 30 days.
The PASCAL implants comprised a central spacer, adjacent paddles, and clasps tethering the implant to native leaflets to mitigate regurgitation. Use of a central spacer contributes to lower stress on leaflets. The implant was delivered with a 22-F guide sheath, steerable guide catheter, and implant catheter.
In this cohort, 88.2% had atrial fibrillation or flutter, 94.1% had systemic hypertension, and 79.4% had New York Heart Association (NYHA) functional class III or IV, and 55% had torrential TR, 18% massive TR, and 24% had severe TR at baseline. At baseline, mean proximal isovelocity surface area (PISA) effective regurgitant orifice area was 0.71±0.33 cm2, mean PISA regurgitant volume was 47.4±22.5 mL, and mean left ventricular ejection fraction was 57.4±7.0%.
Deployment of the PASCAL implant was successful in 85% and 100% of participants in the intention to treat (ITT) analysis and in 100% of participants in the and as-treated (AT) analyses, respectively. A total of 32% of patients required 2 implants. The procedure was deemed clinically successful in 73.3% and 88.0% of patients in the ITT and AT analyses, respectively.
The mean time from first implant to release was 168±152 minutes, mean duration of fluoroscopy was 39.3±20.1 minutes, and mean hospital stay was 2.5±3.6 days.
The percentage of patients with ≥severe TR decreased from 96% at baseline to 48% at day 30 (P <.001), and 85% and 70% had ≥1- and ≥2- TR grade reduction, respectively, 30 days after the procedure. The percentage of participants with NYHA functional class I or II increased from 22% at baseline to 89% at 30 days (P <.001).
From baseline to 30 days, there were reductions in: mean PISA effective regurgitant orifice (38% reduction; P =.007), mean vena contracta width (1.50±0.48 vs 0.78±0.36 cm, respectively; P <.001), mean mid right ventricular end-diastolic diameter (3.9±0.9 vs 2.6±0.8 cm, respectively; P =.041), and mean inferior vena cava diameter (2.8±0.9 vs 2.4±0.7 cm, respectively; P =.03). In addition, mean left ventricular stroke volume index increased (baseline, 33.9±8.6 mL/m2; 30 days, 38.7±7.5 mL/m2; P <.001).
Major adverse events occurred in 5.9% of patients (2 gastrointestinal bleeds; single-leaflet device attachment), and no patient died.
This study may have been limited by its low sample size and power, and it remains unclear whether gastrointestinal bleeds may be common during procedures using the PASCAL system.
“In this early experience, the PASCAL transcatheter valve repair system performed as intended, with substantial TR reductions and favorable safety results with a low [major adverse event] rate and no mortality or reintervention. At 30 days, this repair system resulted in significant functional status, exercise capacity, and quality-of-life improvements,” concluded the study authors.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Kodali S, Hahn R T, Eleid M F, et al. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2021;77(4):345-356. doi:10.1016/j.jacc.2020.11.047