Valvular & structural heart disease

Outcomes of tricuspid transcatheter edge-to-edge repair in subjects with endocardial leads

EuroInterventionPublished prospective, single-arm, open-label, multicentre, post-market registry

Authors' conclusion

In the bRIGHT EU PAS, T-TEER using the TriClip system was safe and effective in severe TR subjects with an endocardial lead across the TV.

Study context

Population
Subjects with endocardial leads across the tricuspid valve undergoing tricuspid TEER (T-TEER) with the TriClip system in the bRIGHT EU Post-Approval Study (PAS)subjects with an endocardial lead, of 511 enrolled subjects
Participants
110 subjects
Exposure
T-TEER in subjects with endocardial leads; safety compared with subjects without leads
  • Subjects with endocardial leadsn = 110
Outcome
Tricuspid regurgitation (TR) at least partially related to the lead
Methodological details26 sites in Europe, core laboratory echocardiographic assessment
  • 26 sites in Europe
  • Core laboratory echocardiographic assessment

Main finding

As reported in the abstract

Subjects with endocardial leads

80.7%

Observational data: associations, not effects.

Further findings

OutcomeSubjects with endocardial leads
TR of moderate or less · 30 days71%
NYHA Functional Class I-II · baseline to 30 days
Baseline17%
30 days75%
Kansas City Cardiomyopathy Questionnaire · baseline to 30 daysmean improvement 20 (SD 24) points
NYHA Functional Class I-II — increase from baseline to 30 days
p<0.0001
Kansas City Cardiomyopathy Questionnaire — p
p<0.0001

Original publication

Outcomes of tricuspid transcatheter edge-to-edge repair in subjects with endocardial leads. EuroIntervention. Published 3 March 2025. doi:10.4244/eij-d-23-01033

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