News | Structural Heart | November 08, 2021

Six-Month Outcomes Positive for Transfemoral Tricuspid Valve in Tricuspid Regurgitation Patients

Trial testing safety and efficacy of the Edwards Evoque transcatheter tricuspid valve replacement system

The Edwards Lifesciences Evoque transcatheter tricuspid valve replacement system demonstrated sustained favorable patient outcomes at six months in the TRISCEND study.

The Edwards Lifesciences Evoque transcatheter tricuspid valve replacement system demonstrated sustained favorable patient outcomes at six months in the TRISCEND study.


November 8, 2021 — Results from a clinical trial of the Edwards Lifesciences Evoque transcatheter tricuspid valve replacement system demonstrated favorable patient outcomes were sustained at six months. Results from the TRISCEND study, treating patients with tricuspid regurgitation, were presented during the late-breaking clinical science session at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting of the Cardiovascular Research Foundation.

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 earlier this year, the 6-month results (n=56) demonstrated significant TR reduction by core laboratory assessment. Specifically, at 6 months:
   • Significant reduction in TR severity, with 100 percent 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 hospitalization of 94%.

"Severe tricuspid regurgitation is becoming increasingly recognized 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 US," said Susheel Kodali, M.D., Columbia University Irving Medical Center and TRISCEND Study Principal Investigator. "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."

The TRISCEND study is a prospective, single-arm, multicenter 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 6-month follow-up results on 56 patients. The study continues to enroll and additional patient follow-up will take place at 1 year and annually up to 5 years. The trial endpoints are device and procedural success, a composite of major adverse events (MAEs) at 30 days and TR reduction.

"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 randomized pivotal trial, TRISCEND II, currently underway."

The Evoque valve replacement system is an investigational device and is not available for sale in any country.

 

Links to All the TCT 2021 Late-Breaking Clinical Trials

More structural heart technology news

 

For more information: www.edwards.com

Related Content

Feature | TCT

November 10, 2021 — There were nine late-breaking trials and 13 late-breaking science presentations at the 2021 ...

Home November 10, 2021
Home
Feature | TCT | Dave Fornell, Editor

Here are some of the key takeaways from the late-breaking interventional cardiology and structural heart trials ...

Home October 29, 2020
Home
Feature | TCT

October 15, 2020 — The late-breaking studies are one of the hallmarks of the annual Transcatheter Cardiovascular ...

Home October 15, 2020
Home
News | TCT

October 14, 2020 — The American College of Cardiology (ACC) and the Cardiovascular Research Foundation (CRF) are ...

Home October 14, 2020
Home
Videos | TCT

With COVID-19 forcing all medical conferences to go virtual in 2020, Juan F. Granada, M.D., CEO of the Cardiovascular ...

Home August 01, 2020
Home
Feature | TCT | Dave Fornell, Editor

The latest in interventional cardiology clinical data and new device technologies were highlighted at the annual ...

Home November 04, 2019
Home
Feature | TCT

October 10, 2019 — Here are the Cardiovascular Research Foundation (CRF) 12 late-breaking trials and 16 late-breaking ...

Home October 11, 2019
Home
Videos | TCT

Chandan Devireddy, M.D., offers insights about what he saw as the top take aways from the 2019 Transcatheter ...

Home October 04, 2019
Home
Videos | TCT

DAIC Editor Dave Fornell takes a tour of some of the most innovative new cardiovascular technology he found on the expo ...

Home October 03, 2018
Home
Feature | TCT

October 4, 2018 – The Cardiovascular Research Foundation (CRF) had 15 late-breaking trials and 12 late-breaking clinical ...

Home September 21, 2018
Home
Subscribe Now