New data confirm benefit of TEER for severe tricuspid regurgitation
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Key takeaways:
- Researchers conducted a pooled analysis of patients who underwent transcatheter edge-to-edge repair for severe tricuspid regurgitation.
- Patients with complex anatomies benefited from the procedure.
SAN FRANCISCO — In a pooled analysis, transcatheter edge-to-edge repair benefited patients with severe tricuspid regurgitation, even those with complex anatomies.
As Healio previously reported, in the TRILUMINATE Pivotal study, transcatheter edge-to-edge repair (TEER) using the TriClip G4 delivery system (Abbott) was superior to medical therapy for the primary composite outcome of mortality or tricuspid valve surgery, hospitalization for HF and quality-of-life improvement of at least 15 points using the Kansas City Cardiomyopathy Questionnaire (KCCQ). David H. Adams, MD, the Marie-Josee and Henry R. Kravis Professor and System Chairman in the department of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai and the cardiac surgeon-in-chief for the Mount Sinai Health System, presented at TCT 2023 a pooled analysis of the TRILUMINATE Pivotal population plus participants from a single-arm study who did not meet criteria for inclusion in the randomized trial because they were not expected to have tricuspid regurgitation reduced to moderate or less.
Clinical data
Compared with the randomized population of 572 patients (59% women), the single-arm population of 100 patients (53% women) was older (80 years vs. 78 years), more likely to have cardiac leads (35% vs. 16%), more likely to have had a past mitral or aortic intervention (44% vs. 36%) and more likely to have torrential tricuspid regurgitation (74% vs. 50%; P for all < .05).
“This group had very complex tricuspid regurgitation and we didn’t think we would be able to eliminate the tricuspid regurgitation with clips,” Adams said at a press conference.
At 30 days, the single-arm population, all of whom underwent TEER, had no major adverse events and a low rate of other adverse events, according to Adams.
“In the surgical population, you can never achieve these kinds of outcomes in a cohort like this,” Adams said.
At 12 months, 81% of the single-arm population and 89% of the TEER group from the randomized trial had moderate or less tricuspid regurgitation, Adams said.
“We weren’t very good at predicting which patients wouldn’t get good results with the TriClip,” Adams said. “In this group that we didn’t think we could get to moderate tricuspid regurgitation, in fact, 81% had moderate or less, so we were under-calling what the ability of this device was to eliminate or reduce tricuspid regurgitation in this population.”
Improvement in KCCQ Overall Summary Score at 12 months was similar in the single-arm population and the device arm of the randomized trial population (14.5 vs. 15.2, respectively), according to Adams.
“Our data from the expanded ... cohort has strengthened the conclusions of our previously reported analysis,” Adams said. “We have learned that even with more complex anatomies, in sicker and older patients, the TriClip is actually quite effective in reducing the tricuspid regurgitation, it is very safe, and it is associated with improvement in KCCQ score.”
The TriClip family of devices is not yet approved for commercial use in the United States.
Quality-of-life data
In a separate presentation, Suzanne V. Arnold, MD, MHA, professor of medicine at the University of Missouri-Kansas City School of Medicine and clinical scholar for Saint Luke's Mid-America Heart Institute, discussed outcomes of an analysis of quality-of-life metrics from patients in the tricuspid TEER (T-TEER) arm and those in the medical therapy arm in TRILUMINATE Pivotal (n = 175 in both groups).
“We wanted to perform an in-depth analysis of the health status outcomes,” Arnold said at a press conference. “We had two major aims. The first was to describe the timing, magnitude and consistency of the health status benefits of T-TEER. Second, because we were dealing with a patient-reported outcome, we wanted to estimate the biologic correlates of health status after T-TEER, as well as the clinical significance of the health status benefit that was observed.”
All patients took the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 month, 6 months and 1 year. To be considered “alive and well,” a patient needed a KCCQ Overall Summary (KCCQ-OS) Score of 60 or higher and to have not declined at least 10 points from baseline at 1 year. The results were simultaneously published in the Journal of the American College of Cardiology.
Compared with the medical arm, the T-TEER arm had greater improvement in KCCQ-OS score at 1 month (between-group difference, 9.4 points; 95% CI, 5.3-13.4) and at 1 year (between-group difference, 10.4 points; 95% CI, 6.3-14.6), the researchers found.
In addition, Arnold said, patients in the T-TEER group were more likely than those in the medical group to be alive and well at 1 year (74.8% vs. 45.9%; P < .001; number needed to treat, 3.5).
The benefit of T-TEER decreased with increasing baseline KCCQ-OS score (P for interaction < .001), Arnold and colleagues found.
In exploratory analyses, each 1-grade improvement in tricuspid regurgitation was associated with a 4.1-point (95% CI, 1.8-6.5) increase in KCCQ-OS score, and a 10-point increase in KCCQ-OS score at 1 month was associated with reduced risk at 1 year for death (HR = 0.76; 95% CI, 0.64-0.9; P = .001), HF hospitalization (HR = 0.75; 95% CI, 0.64-0.89; P = .001) and death or HF hospitalization (HR = 0.74; 95% CI, 0.65-0.84; P < .001).
“T-TEER provided substantial benefit in terms of symptoms, functional status and quality of life,” Arnold said at the press conference. “This difference was present by 1 month. It was moderately large and fully sustained through 1 year. Patients with worse health status at baseline were most likely to benefit. Although we cannot fully exclude responder bias or placebo effect, the exploratory analysis suggests that the observed health status improvement is at least partially biologically mediated. We think that these results support the use of T-TEER for improvement in symptoms, functional limitations and quality of life.”
Reference:
- Arnold SV, et al. Late-breaking clinical trials: Session III, in collaboration with the Journal of the American Medical Association. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
- Arnold SV, et al. J Am Coll Cardiol. 2023;doi:10.1016/j.jacc.2023.10.008.
- Sorajja P, et al. N Engl J Med. 2023;doi:10.1056/NEJMoa2300525.
Perspective
Back to TopYousif Ahmad, BMedSci, BMBS, MRCP, PhD, FSCAI, FACC
The quality-of-life data are interesting and reassuring. The thing I found most reassuring was that the beneficial effect in terms of quality of life with the device arm was maintained out to 1 year. We always worry about potential placebo effect with unblinded device trials, and there is probably some contribution, but I think it is less when it is maintained out to 1 year. These are meaningful differences for patients.
It is always helpful to have more than one treatment option available. For the transcatheter approach, there is a repair option and a replacement option, and hopefully in time we will learn how to choose between them and tailor them to patients and perhaps get even better outcomes than we have seen in the trials. Comparing them to surgery is an interesting question. Outcomes with surgery have historically not been good for various reasons. These are very sick patient populations. A huge chunk of patients in the transcatheter trials are probably not surgical candidates anyway, so if we can offer them a safe, efficacious procedure, we are going to be treating a lot more patients overall.
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Adams DH, et al. Late-breaking clinical science: Session I, in collaboration with the Journal of the American College of Cardiology. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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