Six-month results from the TRISCEND study of the Evoque (Edwards Lifesciences) transcatheter tricuspid valve replacement system were presented during a late-breaking trial session at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual).
TRISCEND investigator Susheel Kodali (Columbia University Medical Center, New York, USA) told TCT attendees that the device demonstrated that favourable patient outcomes, which were sustained at six months.
Patients enrolled in the TRISCEND study had symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR), despite optimal medical therapy. Following positive 30-day outcomes that were presented at EuroPCR 2021 (18–20 May, virtual), the six-month results (n=56) demonstrated significant TR reduction by core laboratory assessment.
Headline figures delivered by Kodali include a significant reduction in TR severity, with 100% of patients with none/trace or mild TR in 43 patients with paired echocardiographic data available, significantly improved functional and quality-of-life outcomes, including 89% of patients in NYHA Class I or II, and a 27-point increase in KCCQ score over baseline High survival rate of 96%, and freedom from heart failure hospitalisation of 94%.
“Severe tricuspid regurgitation is becoming increasingly recognised to have a significant impact on quality of life and may be a predictor of increased mortality. Unfortunately, most patients with TR are at high risk for conventional surgery and there currently are no approved transcatheter options in the USA,” said Kodali. “The six-month results that we have seen with patients enrolled in the TRISCEND study who received the Evoque tricuspid valve replacement are truly remarkable and very promising for patients who suffer from tricuspid regurgitation.”
“We are quite encouraged by these data, not only related to the therapy and procedural success rates demonstrated by the Evoque system, but also for the significant TR reduction and sustained improvements in quality-of-life measures experienced by patients,” said Bernard J Zovighian, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “Our goal is to lead the transformation of treatment for this diverse and expansive population of tricuspid valve disease patients. We are committed to building a strong body of evidence to support emerging therapies like the Evoque system, which will continue with our randomised pivotal trial, TRISCEND II, currently underway.”
The TRISCEND study is a prospective, single-arm, multicentre study, designed to evaluate the safety and performance of the transfemoral Evoque tricuspid valve replacement system in TR. Results were reported on 132 patients enrolled, with six-month follow-up results on 56 patients. The study continues to enrol and additional patient follow-up will take place at one year and annually up to five years. The trial endpoints are device and procedural success, a composite of major adverse events (MAEs) at 30 days and TR reduction.
The Evoque valve replacement system is an investigational device and is not available for sale in any country.