Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study).

Background: Transcatheter tricuspid valve repair (TTVr) has significantly expanded treatment options for tricuspid regurgitation (TR). However, a sizeable proportion of patients are still declined for TTVr and little is known about their clinical characteristics and cardiac morphology.
Objectives: This study sought to characterize patients who screen fail for TTVr with respect to their clinical characteristics and cardiac morphology.
Methods: A total of 547 patients were evaluated for TTVr between January 2016 to December 2021 from 3 centers in the United States and Germany. Clinical records and echocardiographic studies were used to assess medical history and right ventricular (RV) and tricuspid valve (TV) characteristics.
Results: Median age was 80 (IQR: 74-83) years and 60.0% were female. Over half (58.1%) were accepted for TTVr. Of those who were deemed unsuitable for TTVr (41.9%), the most common exclusion reasons were anatomical criteria (56.8%). In the regression analysis, RV and right atrial size, TV coaptation gap, and tethering area were identified as independent screen failure predictors. Other rejection reasons included clinical futility (17.9%), low symptom burden (12.7%), and technical limitations (12.7%). Most of the excluded patients (71.6%) were managed conservatively with medical therapy, while a small number either proceeded to TV surgery (22.3%) or subsequently became eligible for transcatheter tricuspid valve replacement in later available clinical trials in the United States (6.1%).
Conclusions: The majority of TTVr screen failure patients are excluded due to TV, right atrial, and RV enlargement. However, a significant proportion is excluded due to clinical futility. These identifiable anatomical and clinical characteristics emphasize the importance of earlier referral and intervention of TR and the need for continued innovation of Transcatheter tricuspid valve interventions.
Competing Interests: Funding Support and Author Disclosures Dr Gerçek has received research grant support from the German Heart Foundation. Dr Puthumana has received speaker honoraria from Abbott. Dr Malaisrie received research grant support and served as a consultant for Edwards Lifesciences. Dr Thomas has received consulting fees from Abbott, GE, egnite, EchoIQ, and Caption Health. Drs Rudolph and Rudolph have received research grants and speaker honoraria from Abbott and Edwards Lifesciences. Dr Pfister has received speaker honoraria and consultancy fees from Edwards Lifesciences and Abbott. Dr Davidson received research grants from Abbott and Edwards Lifesciences; served as an uncompensated consultant for Edwards Lifesciences; and received Honoria from Philips Healthcare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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