The investigational transfemoral EVOQUE tricuspid valve replacement (Edwards Lifesciences) significantly reduced the severity of tricuspid regurgitation and improving the quality of life in the 30 days on the Net TRISCEND early single-arm feasibility study (EFS).
The device was deployed as planned, with no clinically significant paravalvular leakage and good safety results, and patients significantly improved the 6-minute walking distance and physical function categories of the New York Heart Association (NYHA).
Susheel K. Kodali, MD, director of the Structural Heart & Valve Center, Columbia University Medical Center, New York, reported these findings in a prominent clinical research session at the 2021 scientific session of the American College of Cardiology ( ACC).
The 56 patients in this study had an overall summary score of 46 Kansas City baseline cardiomyopathy questionnaires (indicating severe disability) that improved 19 points at 30 days (Pg <.001). This is “comparable to what we see in other transcatheter trials,” such as catheter aortic valve replacement and the mitral valve clip, he said.
The study will add more patients and will continue to evaluate patients at 6 months, 1 year, and then annually for 5 years.
“Based on the favorable results of this experiment, a randomized fundamental trial was performed, TRISCEND II has been initiated “which will compare EVOQUE plus optimal medical therapy with optimal medical therapy only,” Kodali said.
“Overall, we have seen remarkable improvements in both quality of life and the functional parameters we measure” in patients who received this tricuspid valve, co-researcher Rebecca Hahn, MD, intervention director echocardiography at Columbia University Medical Center, he said theheart.org | Cardiology Medscape.
“When we talk to patients, however, we really understand how this immediately and positively affects their daily lives.”
Excellent results, challenging anatomy
These are excellent results, especially for an initial experience with a new valve, said panelist Steven J. Yakubov, MD theheart.org | Cardiology Medscape in an email.
He said the elimination of tricuspid regurgitation “is very impressive.” He highlighted the ability to use only transesophageal echocardiography images and the high procedural success rate. Yakubov is director of the MidWest Cardiology Research Foundation, Columbus, Ohio, and did not participate in this study.
Yakubov asked Kodali to explain the challenges that tricuspid anatomy can pose in patients with tricuspid insufficiency.
“This population is similar to the first TAVR trials [transcatheter aortic valve replacement]”, Replied Kodali.” Patients have many comorbidities and 20% have ascites. It is unclear whether the right ventricle will tolerate the new valve. One-third of those patients have pacers, ”he noted.
“The possibility of imaging the tricuspid valve in someone who has undergone pre-left surgery is a challenge, and if you can’t imagine the brochures, imagine the anchors, [replacing this valve is] it is not appropriate, “he added.” We had patients present with an annular diameter of 70 [mm], which are too large. “
“I think what will really make this go forward and make it easier and better” in the future is to take images with intracardiac echocardiography, Kodali said.
Do you want to replace it instead of repairing it?
Several initial transcaterial tricuspid repair options have demonstrated their viability in early studies, but significant challenges have remained, Kodali said. There are two tricuspid valve repair devices in randomized controlled trials, TriClip (Abbott) and PASCAL (Edwards Lifesciences), as well as other devices in EFS, said theheart.org | Cardiology Medscape.
How recently reported, the results of a year of the TRILUMINATE study on tricuspid valve repair of the transcater with the TriClip were positive, and this device has already received CE approval for this use in April 2020 based on 6-month positive results.
However, the researchers speculated that “replacement of the tricuspid transcatheter valve may offer an alternative to repair in high-risk elderly patients” with tricuspid insufficiency (TR), Kodali said.
“Valve replacement offers the promise of a complete elimination of RT with the potential to eliminate the debilitating symptoms of the right heart attack“, Yakubov pointed out.
“It would complement the best medical therapy,” Yakubov said, adding that “valve replacement offers a more complete elimination of RT than TriClip or PASCAL can offer. Patients will need careful selection for the best procedure.” be it valve replacement or tricuspid clip procedures. .
Researchers done the first transcaterial tricuspid valve replacement with EVOQUE at St. John’s Hospital. Michael, Toronto, Ontario, Canada, in March 2020, building on experience using the EVOQUE valve to replace the mitral valve.
The EVOQUE tricuspid valve comes in sizes of 44, 48 and 52 mm and is inserted under the echo guide through the right femoral vein, Kodali explained. The valve is designed to attach the leaflets.
30 days of TRISCEND meetings
The TRISCEND feasibility study enrolled 56 patients in 8 sites who had moderate or severe symptomatic RT.
Access to the correct femoral vein was achieved in 100% of patients and the success of the device and the success of the procedure were achieved 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 unrelated to the procedure. Two patients died, one of cardiovascular cause.
Almost all patients (98%) had mild or no RT / traces at 30 days after the procedure.
Initially, 84% of patients had been in NYHA class 3 or 4, but 30 days after receiving the new valve, 77% were in NYHA class 1 or 2 (Pg <.001).
Patients also had significant improvements in walking distance of 6 minutes, going from being able to walk only 200 meters to being able to walk 46 meters further in that time (Pg = .001).
TRISCEND II Fundamental test in works
“Although the EFS study can enroll up to 200 patients, the decision was made to initiate the baseline trial based on this initial experience,” Kodali said.
There will be more presentations with a larger cohort. “We hope to have the first data set with a 6-month follow-up for submission later this year.”
TRISCEND II is only enrolling patients with severe tricuspid regurgitation and also has a one-arm registry to enroll patients who may not meet eligibility criteria, such as those with previous tricuspid anuloplasty devices or who have undergone a heart transplant, Said Hahn.
The study was supported by Edwards Lifesciences. Kodali Reveals Receipt of Consultant Fees for Admedus and Dura Biotech; asset compensation as a member of the scientific advisory board of Thubrikar Aortic Valve, Dura Biotech, Supira, MID, Admedus and TriFlo; and research support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and JenaValve. Hahn reveals fees for consultants from Abbott Structural, Boston Scientific, Gore & Associates, Medtronic and Philips Healthcare; Navigate ownership / partnership / principal interest; is in the office of the speaker of Edwards Lifesciences. Yakubov reveals the receipt of fees / fees from AtriCure and Boston Scientific consultants; Medtronic research grants / research and is in a Zoll speaker office.
Annual Scientific Session of the American College of Cardiology (ACC) 2021. Session 1021-05. Filed May 15, 2021.