Results from a subgroup analysis of the TriValve Registry presented at TCT 2018 showed that interventional tricuspid edge-to-edge valve repair was safe with improvement in outcomes in patients, with high procedural success rates.
In his presentation at TCT, Dr. Jörg Hausleiter highlighted the fact that there was an unmet need for transcatheter treatment of high-risk patients with symptomatic tricuspid regurgitation (TR). While the transcatheter edge-to-edge repair technique had been successfully applied to off-label/compassionate use programs in selected patients with symptomatic TR, the impact of this approach on the clinical outcomes beyond the first 30 days had not been determined. Therefore, Hausleiter and his colleagues from Munich, Germany took it upon themselves to investigate the procedural outcome, the durability of TR reduction, the 1-year outcome including mortality and unplanned hospitalizations for heart failure with this device. They also aimed to identify predictors of procedural failure and 1-year mortality using data from the large international TriValve registry.
An international, multicenter, retrospective multi-device registry was conducted on interventional tricuspid valve repair for TR. Subgroup analysis was performed on patients undergoing edge-to-edge therapy in off-label/compassionate use programs at 14 study sites. The device used was the “conventional” MitraClip. The main outcomes measured included all-cause mortality, unplanned repeat hospitalizations, NYHA class, the presence of peripheral edema, and TR grade.
“We need to expand to a larger population and prove in a controlled and randomized fashion that we are treating the right patients and that they are actually improving.”- Dr. Jörg Hausleiter, M.D.
The investigators concluded that interventional tricuspid edge-to-edge valve repair in this large patient cohort was safe. There was a high procedural success rate (77% of patients with TR ≤2+). The morphologic criteria including larger coaptation gaps, larger tenting area, larger EROA, and TR jet location were associated with procedural failure. The valve repair resulted in a durable TR reduction at 1-year follow-up, which was associated with a significant symptomatic improvement. Considering the sick and frail patient cohort, the absolute 1-year mortality rate of 17.7% was remarkably low, which was comparable to other mitral studies such as TRAMI 20.3%, TVT registry 25.8%, Everest HR 22.8%, and Mitra-Fr 24.3%. Procedural failure was identified as an independent predictor of mortality, which was suggestive of the fact that edge-to-edge tricuspid valve repair might impact survival in this high-risk patient population.
However, the investigators were mindful of certain limitations of their study such as lack of procedural recommendations, the absence of independent event adjudication and lack of a central echocardiographic core lab assessment. In an interview with Dr. C. Michael Gibson, Dr. Jörg Hausleiter spoke about the next step, “We need to expand to a larger population and prove in a controlled and randomized fashion that we are treating the right patients and that they are actually improving.”
To view the interview with Dr. C. Michael Gibson, click here.
Leave a Reply
You must be logged in to post a comment.