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Transcatheter tricuspid valve intervention confers benefit over medical management
SAN FRANCISCO — Among patients with tricuspid regurgitation, transcatheter tricuspid valve intervention plus medical management was associated with reduced risk for death and HF rehospitalization compared with medical management alone, according to data presented at TCT 2019.
Researchers matched 268 patients with moderate or worse tricuspid regurgitation who underwent transcatheter tricuspid valve intervention with 268 similar patients who were managed medically. Compared with medical management, the transcatheter group had lower rates of 1-year mortality (23% vs. 36%; P = .001), 1-year HF rehospitalization (26% vs. 47%; P < .0001) and 1-year mortality or HF rehospitalization (32% vs. 49%; P = .0003), Maurizio Taramasso, MD, PhD, cardiac surgeon at University Hospital of Zurich, said during a press conference.
In a Cox regression analysis, transcatheter tricuspid valve intervention plus medical management was associated with reduced risk for mortality or HF rehospitalization at 1 year (HR = 0.6; 95% CI, 0.46-0.79). This finding remained consistent after adjustment for sex, NYHA class, right ventricular dysfunction and atrial fibrillation (adjusted HR = 0.39; 95% CI, 0.26-0.59) and further adjustment for mitral regurgitation and use of a pacemaker or defibrillator (aHR = 0.35; 95% CI, 0.23-0.54), Taramasso said.
In the Cox regression analysis of all-cause mortality, after all adjustments, the transcatheter group had a 59% reduced risk for death at 1 year compared with the control group (aHR = 0.41; 95% CI, 0.26-0.67), Taramasso said.
To assemble the cohort, the researchers analyzed 472 patients from the TriValve registry who underwent transcatheter tricuspid valve intervention at 22 centers in Europe and North America from 2016 to 2018. The control group was drawn from 1,179 patients who received medical management for moderate or worse tricuspid regurgitation and were included in registries at Mayo Clinic and at Leiden University in the Netherlands. Propensity matching was based on age, EuroScore II and systolic pulmonary artery pressure.
In the matched cohort, the mean age of the transcatheter group was 77 years and 56% were women, whereas the mean age of the control group was 76 years and 59% were women. Functional tricuspid regurgitation was noted in 91% of the transcatheter group and 96% of the control group.
The results were simultaneously published in the Journal of the American College of Cardiology.
“Transcatheter tricuspid valve intervention conferred better outcomes in tricuspid regurgitation compared to medical therapy alone,” Taramasso said during the press conference. “There was a significant impact of procedural success on the primary outcome. There was a significant difference between those who achieved tricuspid regurgitation reduction and those who did not. This confirms the prognostic role of tricuspid regurgitation reduction on clinical outcomes in these kinds of patients.”
In a related editorial published in JACC, Mohamad Alkhouli, MD, interventional and structural cardiologist at Mayo Clinic, and colleagues noted that this study “documented for the first time a potential for improved outcomes with transcatheter tricuspid valve intervention over medical therapy in selected patients with severe symptomatic tricuspid regurgitation. This important finding needs to be considered in light of the issues surrounding the risk of selection bias and the marked heterogeneity in both the medical and interventional treatment.”
More research is needed on the optimal timing of tricuspid valve intervention, Alkhouli and colleagues wrote in the editorial. – by Erik Swain
References:
Taramasso M, et al. Late-Breaking Science 2. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Alkhouli M, et al. J Am Coll Cardiol. 2019;doi:10.1016/j.jacc.2019.09.029.
Taramasso M, et al. J Am Coll Cardiol. 2019;doi:10.1016/j.jacc.2019.09.028.
Disclosures: Taramasso reports he is a consultant for 4TECH, Abbott Vascular, Boston Scientific and CoreMedic and has received speaker honoraria from Edwards Lifesciences. Alkhouli and colleagues report no relevant financial disclosures. Please see the study for the other authors’ relevant financial disclosures.
Perspective
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This is a difficult study to interpret because there were not concurrent controls. These were earlier controls, so there is a bit of a difference in the time lapse between the patients, but the findings are real because patients with this degree of tricuspid regurgitation tend not to do well with medical management. This is a good first step in demonstrating some good things that can be done with a catheter to reduce tricuspid regurgitation. Now, we need to focus on what we can do at earlier stages to prevent tricuspid regurgitation from ever getting this severe. There are different forms of tricuspid regurgitation, and it is usually secondary to something else such as prior mitral valve disease, primary or secondary pulmonary hypertension, or atrial fibrillation, which leads to atrial enlargement that dilates the annulus, which is a leading cause of tricuspid regurgitation. These are different kettles of fish, and the treatments will vary, as will the thresholds for when to intervene.
This is a very active field for transcatheter device development. I hope that, with time, we can get more clarity on this issue. We are at a similar stage to the early transcatheter aortic valve replacement trials, which treated the sickest of the sick. At some point, we will evaluate these technologies in lower-risk patients.