The PASCAL transcatheter valve repair system was associated with a low complication rate and high survival rate in the treatment of mitral regurgitation (MR), according to a study presented during EuroPCR's e-Course 2020 and simultaneously published in JACC: Cardiovascular Interventions.

As part of the CLASP trial, John G. Webb, MD, FACC, et al., looked at safety and performance outcomes among patients who received the PASCAL system. The study's primary safety endpoint was a composite of major adverse events, defined as cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding and reintervention for device-related complications at 30 days. Primary performance endpoints included procedural and clinical success. Secondary outcomes included one-year rates of MR reduction, major adverse events, all-cause mortality, recurrent heart failure (HF) hospitalization and MR reintervention after one year.

The study enrolled 109 patients who were treated at 14 sites worldwide. Overall, the mean age was 75.5 years, 54% of participants were male and the mean STS score was 4.7%. At baseline, all patients had MR grade 3+ or 4+ and 57% of patients were in NYHA class III or IV.

Overall, the procedural success rate was 94%, with successful implantation occurring in 104 patients (94%). Among patients with successful implantation, the average number of implants was 1.4 per patient. Average procedure time was 128 minutes. The average hospital stay was 2.4 days, with 94% of patients being discharged home. After 30 days, there was one cardiovascular death (0.9%), MR ≤1 + was achieved in 80% of patients and MR ≤ 2+ in 96% of patients. In addition, 88% of patients were NYHA class I or II at 30 days.

One-year follow-up data was available for 62 patients. Of these patients, there were two cardiovascular-related deaths between 30 days and one year, resulting in an overall cardiovascular mortality rate of 6.5%. There were no strokes, reinterventions or new need for renal replacement therapy at one year. There was one patient (1.6%) who experienced an MI that was unrelated to the procedure. There were two severe bleeding events between 30 days and one year. In addition, at one year, the all-cause mortality rate was 8.1% and the HF hospitalization rate was 12%.

According to the researchers, the PASCAL system "resulted in high survival and low complication rates with robust and sustained MR reduction, accompanied by significant improvements in functional status and quality of life" after one year.

In an accompanying editorial comment, Stephan Windecker, MD, et al., writes that "head-to-head comparisons" of the PASCAL system and MitraClip system "will be of interest." The authors conclude that the "choice between different devices and sizes will further broaden the spectrum of anatomical settings amenable to leaflet approximation enabling a more individualized approach adapted to the multiplicity of mitral valve pathologies."

Clinical Topics: Heart Failure and Cardiomyopathies, Valvular Heart Disease, Acute Heart Failure, Mitral Regurgitation

Keywords: Mitral Valve Insufficiency, Mitral Valve, Survival Rate, Quality of Life, Patient Discharge, Follow-Up Studies, Hospitalization, Heart Failure, Stroke, Myocardial Infarction, Renal Replacement Therapy

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