Abbott’s transcatheter tricuspid valve repair (TTVR) system is a safe and effective approach to treating tricuspid regurgitation (TR) in heart patients with few other options, according to data published in The Lancet.
In the U.S., around one in 30 people over the age of 65 struggle with moderate to severe tricuspid regurgitation, a condition that results in potentially fatal backflow of blood into the right chamber of the heart. But surgery is often too high-risk to attempt in older patients, leaving them without a clear path to better health.
According to Abbott, the investigational TTVR system builds on the success of the company’s MitraClip, a well-loved innovation that facilitates the repair of leaky mitral valves. TRILUMINATE results were first presented at EuroPCR 2019 in Paris this past spring, and at the time first author Georg Nickenig, MD, PhD, reported that patients who’d undergone treatment with the TTVR system saw improvements in both health status and quality of life at 30 days.
“Treating a leaky tricuspid heart valve has long presented a significant challenge for cardiologists, because it is an extremely complex and difficult heart valve to treat,” Nickenig said in a May statement. “These data are extremely encouraging, and I am excited about the potential of transcatheter tricuspid valve repair as a minimally invasive treatment option for these very ill patients who have no other options.”
Diving into the data
Nickenig’s paper, which he co-first-authored with Marcel Weber, MD, a colleague at University Hospital in Bonn, Germany, was published some six months after his team’s preliminary results were presented in Paris. The study spanned 21 sites in Europe and the U.S. and included 85 patients with moderate or severe TR who were classified as New York Heart Association class II or higher.
All participants were treated with Abbott’s edge-to-edge TriClip tricuspid valve repair system and followed for around six months after their procedure. TR was graded on a five-point scale that ranged from “mild” to “torrential,” expanding on the standard American Society of Echocardiography grading scheme.
The authors analyzed their primary efficacy endpoint—defined as a reduction in TR severity of at least one grade at 30 days post-op with a performance goal of 35%—in all patients who underwent attempted tricuspid valve repair upon a femoral vein puncture. Patients were excluded from the study’s primary safety analysis, based on an endpoint of composite major adverse events at six months with a performance goal of 39%, if they failed to reach six-month follow-up.
Between August 2017 and November 2018, all 85 patients underwent successful TriClip implantation. TR severity was reduced by at least one grade at 30 days in 86% of patients; the one-sided lower 97.5% confidence limit was 76%, much higher than the study’s performance goal of 35%.
“The TriClip procedure led to a substantial improvement of the clinical parameters reported by self-assessment and judged by the treating physicians,” Nickenig and co-authors wrote in their analysis. “Although only 25% of patients entered the study with NYHA I-II heart failure symptoms, 87% of patients were in NYHA I-II after six months, despite the fact that 42% of the patients still showed severe or greater TR.
“Preliminary analyses show that patients benefited from the procedure, irrespective of the severity of tricuspid regurgitation they had before treatment.”
Six months into follow-up, 4% of patients—three of the total 84—had experienced a major adverse event, which was less than the prespecified performance goal of 39%. Single leaflet attachment was present in 7% of patients, but the authors didn’t note any periprocedural deaths, conversions to surgery, device embolizations, MIs or strokes in their study cohort.
The team reported that at six months, just four of 84 patients had died from any cause, suggesting the TriClip system is safe and effective for these people and can result in improved clinical outcomes. Nickenig et al. said future randomized trials should investigate the effect of catheter-based TR solutions on longer-term outcomes.