The 30-day outcomes from the TRISCEND study of the transfemoral Evoque tricuspid valve replacement system demonstrated technical feasibility and an acceptable safety profile, along with improvements in tricuspid regurgitation (TR) and symptoms in patients with clinically significant TR.
June 7, 2021 — Edwards Lifesciences recently announced that clinical results from the company's transcatheter mitral and tricuspid programs, presented as part of the late-breaking clinical trials at EuroPCR and ACC 2021. Both valve programs demonstrated positive outcomes for patients impacted by mitral or tricuspid heart valve disease.
The structural heart device clinical data presentations provided the following updates:
• The 30-day outcomes from the TRISCEND study of the transfemoral Evoque tricuspid valve replacement system demonstrated technical feasibility and an acceptable safety profile, along with improvements in tricuspid regurgitation (TR) and symptoms in patients with clinically significant TR. The favorable 30-day results showed high device and procedural success rates of 98% and 94%, respectively, and significant reduction in TR severity, with 98% of patients experiencing mild or less.
• Two-year outcomes from the CLASP study of the PASCAL system for mitral valve repair demonstrated a sustained high rate of survival at 80%, as well as 87% clinical events committee (CEC) adjudicated freedom from heart failure rehospitalization and an 85% reduction in annualized heart failure hospitalization rates. Patients enrolled in the CLASP study had symptomatic, clinically significant mitral regurgitation (MR) despite optimal medical therapy. Patients treated with the PASCAL system also experienced durable MR reduction, with evidence of left ventricular reverse remodeling. At two years, 78% of patients had mild (1+) or none/trace MR and 97 percent had ≤2+ MR, with echo core lab adjudication.
• The 6-month outcomes from the CLASP TR early feasibility study of the Pascal system for tricuspid valve repair demonstrated favorable safety and significant TR reduction. The results showed high implant, procedural and clinical success rates, while also demonstrating low complication rates. Patients enrolled in the CLASP TR study had symptomatic severe TR, and, at six months after treatment, 78% of patients had mild or moderate TR. In addition to the clinical improvements, patients also experienced positive functional and quality of life outcomes, which were sustained at 6 months.
• Results at 30 days from the TriBand post-market clinical follow-up study of the Cardioband tricuspid valve reconstruction system demonstrated high device success of 97%, and low all-cause mortality of 1.6%. Patients in the study had chronic symptomatic TR, and 94% of patients had severe or greater TR at baseline. Data from 30 days after treatment with the Cardioband system showed that 85% of patients experienced at least one grade reduction of significant TR, as well as improvements in functional status and quality of life measures.
"In addition to the positive clinical outcomes the patients treated in these studies experienced, it was also encouraging to see improvements in functional status and quality of life," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "The patient populations impacted by mitral and tricuspid valve disease are large, diverse and complex. As we pursue our focus to lead and transform their treatment, the results from clinical studies that span our differentiated portfolio of therapies are important contributors to building the evidence to support these transformative transcatheter mitral and tricuspid treatments in different types of patients."
The Pascal system and Cardioband system received CE mark for treatment of patients with both mitral and tricuspid valve disease, and both therapies are available commercially in Europe; neither are approved in the United States and are only available via clinical trials.
The Evoque valve replacement system is an investigational device and is not available for sale in any country.