Real-life data collected in Europe outside of clinical trials support both the safety and benefits of two edge-to-edge (TEER) transcatheter devices designed specifically for the treatment of tricuspid regurgitation (TR).
For the TriClip system (Abbott), data was obtained from a prospective post-marketing registry, and for the EVOQUE system (Edwards Lifesciences), data was obtained from a charity program.
The TriClip system is approved and available in Europe, but neither system is approved by the US regulators.
Two sets of data, each presented at the annual meeting of the European Association for Transcutaneous Cardiovascular Interventions, are consistent with controlled trials. Each system was associated with high procedural success rates, low rates of adverse events, and sustained improvements in quality of life.
Real backup for TRILUMINATE
Submitted just a few days before the flagship multinational TRILUMINATE study was published in New England Journal of Medicinea post-marketing study with the bRIGHT TriClip device showed a successful procedure and subsequent reduction in TR that was at least as good, but in significantly ill patients.
“To evaluate these results, you have to evaluate the baseline TR level in our population,” said Philipp Lurtz, MD, Leipzig Heart Center, University of Leipzig, Germany. Whereas only 70% of patients randomized to TRILUMINATE had a grade 4 (massive) or 5 (torrential) TR, in bRIGHT this proportion was 90%.
The proportion with TR of moderate or less severity was 77% when assessed after 30 days in bRIGHT compared to 72%, however, when assessed after 1 year in TRILUMINATE. In addition, the success of procedures in both studies was 99%, despite the fact that patients in bRIGHT were on average older and had more comorbidities. At baseline, 80% of patients with bRIGHT were New York Heart Association (NYHA) class III or IV. heart failure compared to 59% in the TRILUMINATE group.
The TRILUMINATE data, presented prior to publication at the American College of Cardiology annual meeting earlier this year, did not link transcatheter TR repair with reduced mortality or reduced hospitalizations for heart failure, which were the first two of three hierarchical outcomes. endpoints, but it did show benefit in a third, namely quality of life. According to the Kansas City Cardiomyopathy Questionnaire (KCCQ), patients in the transcatheter repair group scored 12.3 compared to 0.6 (12).P < 0.001) on drug therapy.
In the bRIGHT registry, patients scored 19 on the KCCQ scale after treatment. By day 30, the proportion of patients with NHYA class III/IV decreased from 80% to 20%. The rate of major adverse events of 2.5% at 30 days was only slightly higher than the rate of 1.7% at 30 days in TRILUMINATE.
“The safety profile remained strong despite the heavier population treated in the registry,” said Lurtz, whose results were simultaneously published in the Journal of the American College of Cardiology (JACC).
The analysis of the bRIGHT registry was based on 511 patients treated in 26 centers in Europe. Lurtz described it as “the first prospective, single-arm, open, multicenter, aftermarket registry to evaluate the safety and efficacy of any transcatheter tricuspid catheter. valve repair system.”
In a panel discussion following the presentation, Nicole Karam, MD, co-head of the heart valve department at the Georges Pompidou Hospital in Paris, praised the field study of the TEER tricuspid valve device, but indicated that the question of who to treat remains unanswered. While symptom relief is important for a condition that can lead to a significant reduction in quality of life, she called for more data to identify optimal candidates, especially if there is consistently no significant impact on hard endpoints.
Lurz agreed. In the bRIGHT study, predictors of moderate or smaller FR at discharge included shorter tether distance, smaller right ventricular diastolic size, smaller right atrial volume, and smaller tricuspid annulus diameter.
Each of these predictors favors earlier treatment, he says, even though later treatment in clinical trials is more likely to eventually show benefits on hard endpoints.
Evidence from a much smaller compassionate evaluation of the use of the EVOQUE system resulted in similar evidence for safety and benefit, and showed that earlier intervention was more likely to prevent irreversible progression. At a much longer follow-up, a compassionate use analysis, in which patients participated even in a more severe condition than patients included in bRIGHT, showed that these repairs are durable.
In this retrospective analysis of 38 patients treated at eight centers in Europe, the US, and Canada, mortality increased steadily over 2 years of follow-up, reaching 29% at 2 years, despite TR being reduced to <1%. after the procedure and remained long-term suppressed at a median follow-up of 520 days.
Tricuspid valve repair with the EVOQUE system “was associated with a significant reduction in heart failure symptoms and a significant improvement in NYHA functional class up to a maximum of 1074 days post-intervention,” said Lukas Stolz, MD, Interventional Cardiologist at Ludwig Maximilian University, Munich .
In the data he presented at EuroPCR, which were published simultaneously in a letter to JACC, he reported that favorable right ventricular remodeling, which was observed as early as 30 days after the procedure, was maintained at long-term follow-up.
Uncontrolled compassionate data, such as the bRIGHT registry, could not confirm that tricuspid repair alters the trajectory of progressive heart disease, but the positive effects reported by Stoltz on cardiovascular function, not just symptoms, support this idea.
Lurz has financial relationships with Edwards Lifesciences, ReCor and Abbott, which funded the bRIGHT registry. Karam reports financial relationships with Abbott, Edwards Lifesciences and Medtronic. Stoltz reports no potential conflicts of interest, but the other retrospective co-investigators have a financial relationship with Edwards Lifesciences, which is developing the EVOQUE system.
This story originally appeared on MDedge.compart of the Medscape professional network.