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The investigational transfemoral EVOQUE tricuspid valve replacement system (Edwards Lifesciences) significantly reduced severity of tricuspid regurgitation and improved quality of life at 30 days in the TRISCEND single-arm early feasibility study (EFS).

The device deployed as intended, with no clinically significant paravalvular leak and good safety outcomes, and patients had significant improvements in 6-minute walk distance and New York Heart Association (NYHA) physical function categories.

Susheel K. Kodali, MD, director of the Structural Heart & Valve Center, Columbia University Medical Center, New York City, reported these findings in a Featured Clinical Research session at the American College of Cardiology (ACC) 2021 Scientific Session.

The 56 patients in this study had an average Kansas City Cardiomyopathy Questionnaire overall summary score of 46 at baseline (indicating severe disability) that improved by 19 points at 30 days (P < .001). This is “comparable to what we see in other transcatheter trials, falcon 4.0 allied force manual ” such as transcatheter aortic valve replacement and mitral valve clip, he said.

The study will add more patients and continue to evaluate the patients at 6 months, 1 year, and thereafter each year for 5 years.

“Based on the favorable results from this experience, a randomized pivotal trial, TRISCEND II has been initiated,” which will compare EVOQUE plus optimal medical therapy versus optimal medical therapy alone, Kodali said.

“In general, we have seen remarkable improvements in both quality of life and functional parameters that we measure” in patients who received this tricuspid valve, co-investigator Rebecca Hahn, MD, director of interventional echocardiography at Columbia University Medical Center, told theheart.org | Medscape Cardiology.

“When we speak to the patients, however, we really understand how this immediately and positively affects their daily living.”

Excellent Results, Challenging Anatomy

These are excellent results, especially for an initial experience with a new valve, panelist Steven J. Yakubov, MD, told theheart.org | Medscape Cardiology in an email.

The elimination of tricuspid regurgitation, he said, “is most impressive.” The ability to use only transesophageal echocardiography imaging, and the high procedural success rate, also stood out, he noted. Yakubov is director of the MidWest Cardiology Research Foundation, Columbus, Ohio, and was not involved with this study.

Yakubov asked Kodali to elaborate on challenges that tricuspid anatomy can pose in patients with tricuspid regurgitation.

“This population is similar to early trials of TAVR [transcatheter aortic valve replacement],” Kodali replied. “The patients have many comorbidities, and 20% have ascites. It is not clear if the right ventricle will tolerate the new valve. A third of such patients have pacers,” he noted.

“The ability to image the tricuspid valve in someone who’s had prior left-sided surgery is a challenge, and if you can’t image the leaflets, image the anchors, [replacing this valve is] not appropriate,” he added. “We’ve had patients present with annular diameters of 70 [mm], which are too large.”

“I think what is really going to make this go forward and make it better and easier” in future is imaging with intracardiac echocardiography, Kodali said.

Replace Rather Than Repair?

Various initial transcatheter tricuspid repair options have demonstrated feasibility in early studies, but significant challenges have remained, said Kodali. There are two tricuspid valve repair devices in randomized controlled trials, TriClip (Abbott) and PASCAL (Edwards Lifesciences), as well as other devices in EFSs, he told theheart.org | Medscape Cardiology.

As recently reported, the 1-year outcomes of the TRILUMINATE study of transcatheter tricuspid valve repair using the TriClip were positive, and that device already received CE approval for this use in April 2020 based on positive 6-month results.

However, researchers speculated that “transcatheter tricuspid valve replacement may offer an alternative to repair in elderly high-risk patients” with tricuspid regurgitation (TR), Kodali said.

“Valve replacement offers the promise of total elimination of TR with the potential to eliminate the debilitating symptoms of right heart failure,” Yakubov noted.

“It would complement best medical therapy,” said Yakubov, adding that “the valve replacement offers a more complete elimination of TR than TriClip or PASCAL may offer. Patients will need careful selection for the best procedure,” whether valve replacement or tricuspid clip procedures. 

Researchers performed the first transcatheter tricuspid valve replacement with EVOQUE at St. Michael’s Hospital, Toronto, Ontario, Canada, in March 2020, building on experience using the EVOQUE valve for mitral valve replacement.

The EVOQUE tricuspid valve comes in 44-, 48-, and 52-mm sizes and is inserted under echo guidance through the right femoral vein, Kodali explained. The valve is designed to engage the leaflets.

30-Day Findings From TRISCEND

The TRISCEND feasibility study enrolled 56 patients at 8 sites who had symptomatic moderate or severe TR.

The patients had a mean age of 79 and 77% were women. Almost all had severe TR (92%) and atrial fibrillation (91%). Two-thirds had chronic kidney disease (66%) and 21% had diabetes.

Right femoral vein access was attained in 100% of patients, and device success and procedure success were attained in 98% and 94% of patients, respectively. The average time from implant insertion to release was 70 minutes.

Twelve of the 53 patients with 30-day data (22.6%) had a major adverse event consisting of severe bleeding that in most cases was not procedure-related. Two patients died, one of a cardiovascular cause.

Almost all patients (98%) had mild or no/trace TR at 30 days after the procedure.

At baseline, 84% of the patients had been in NYHA class 3 or 4, but at 30 days after receiving the new valve, 77% were now in NYHA class 1 or 2 (P < .001). 

The patients also had significant improvements in 6-minute walk distance, going from being able to walk only 200 meters to being able to walk 46 meters farther in that time (P = .001).

TRISCEND II Pivotal Trial in the Works

“Although the EFS study can enroll up to 200 patients, the decision was made to start the pivotal trial based on this initial experience,” said Kodali.

There will be further presentations with a larger cohort. “We are hoping to have the first set of data with 6-month follow-up for presentation later this year.”

TRISCEND II is enrolling only patients with severe tricuspid regurgitation, and it also has a single-arm registry to enroll patients who might not meet eligibility criteria, such as those with prior tricuspid annuloplasty devices or who have undergone a heart transplantation, Hahn said.

The study was supported by Edwards Lifesciences. Kodali discloses receiving consultant honoraria for Admedus and Dura Biotech; equity compensation as a scientific advisory board member for Thubrikar Aortic Valve, Dura Biotech, Supira, MID, Admedus, and TriFlo; and research support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and JenaValve. Hahn discloses receiving consultant fees/honoraria from Abbott Structural, Boston Scientific, Gore & Associates, Medtronic, and Philips Healthcare; ownership interest/partnership/principal from Navigate; she is on the speaker’s bureau for Edwards Lifesciences. Yakubov discloses receiving consultant fees/honoraria from AtriCure and Boston Scientific; research/research grants from Medtronic, and is on a speaker’s bureau for Zoll.

American College of Cardiology (ACC) 2021 Annual Scientific Session. Session 1021-05. Presented May 15, 2021.  

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