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Published on: October 16, 2021
Incidence, Predictors and Outcomes of Bleeding Following Transcatheter Tricuspid Valve Repair: The TriValve Registry
Iryna Dykun1, Giulio Russo2, Amir A Mahabadi3
1Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA; Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, Essen, Germany.
Insights
Major bleeding occurs in 11.4% of patients after transcatheter tricuspid valve repair, significantly increasing the risk of death. Optimizing patient selection and procedure duration may reduce bleeding complications.
Area of Science:
- Cardiology
- Interventional Cardiology
- Structural Heart Disease
Background:
- Bleeding is a frequent complication of catheter-based structural heart procedures.
- Clinical implications of bleeding after transcatheter tricuspid valve interventions require systematic evaluation.
Purpose of the Study:
- To assess the incidence, predictors, and prognostic impact of bleeding following transcatheter tricuspid valve repair.
- To analyze Bleeding Academic Research Consortium (BARC) bleeding events within one year post-procedure.
Main Methods:
- Retrospective analysis of 440 patients from the international TriValve registry.
- Classification of bleeding events using BARC criteria (types 2, 3, and 5).
- Evaluation of patient factors and procedural characteristics associated with bleeding.
Main Results:
- The incidence of BARC major bleeding was 11.4%.
- Predictors included postprocedural tricuspid regurgitation severity, higher pulmonary artery pressures, and longer procedure duration.
- Major bleeding was linked to increased in-hospital death and a higher risk of 1-year composite outcomes (death or readmission).
Conclusions:
- Major bleeding following transcatheter tricuspid valve repair affects approximately 11% of patients.
- Bleeding is a significant determinant of both in-hospital and 1-year mortality.
- Improved patient selection and procedural optimization, including shorter procedure times, may mitigate bleeding risk.
Background:
Bleeding remains among the most common complications following catheter-based structural heart procedures. Its clinical implications following transcatheter tricuspid valve interventions have yet to be systematically evaluated.
Objectives:
The aim of this study was to evaluate the incidence of bleeding and its predictors and prognostic implications following transcatheter tricuspid valve repair.
Methods:
TriValve (International Multisite Transcatheter Tricuspid Valve Therapies Registry; NCT03416166) is an international multicenter registry capturing a range of transcatheter tricuspid valve interventions. Bleeding events were classified according to the Bleeding Academic Research Consortium (BARC). For this analysis, BARC bleeding events type 2, 3, and 5 occurring within 1 year of transcatheter tricuspid valve repair were retrospectively evaluated.
Results:
A total of 440 patients (mean age 76.6 ± 8.9 years, 57.7% women) were included. The BARC major bleeding incidence was 11.4% (50 patients). Postprocedural tricuspid regurgitation severity (adjusted ORl]: 1.83; 95% CI: 1.12-3.01; P = 0.02), higher systolic pulmonary artery pressures (adjusted OR: 1.61; 95% CI: 1.16-2.24; P = 0.0048), and increasing procedure duration (adjusted OR: 1.49; 95% CI: 1.00-2.22; P = 0.049) were associated with bleeding, whereas concomitant oral anticoagulation was not (adjusted OR: 1.51; 95% CI: 0.74-3.10; P = 0.30). Major bleeding was associated with a markedly increased risk for in-hospital death (adjusted OR: 106; 95% CI: 1.31-8,553; P = 0.04). Likewise, bleeding was significantly associated with a 1-year composite of death or all-cause hospital readmission (adjusted HR: 2.41; 95% CI: 1.39-4.19; P = 0.002), all-cause death (adjusted HR: 3.55; 95% CI: 1.75-7.21; P = 0.0004), and cardiovascular death (adjusted HR: 3.72; 95% CI: 1.62-8.52; P = 0.002).
Conclusions:
BARC major bleeding occurs in about 11% of patients following transcatheter tricuspid valve repair and is a major determinant of in-hospital and 1-year death. Enhanced patient selection and procedural optimization (with shorter procedural times) may help curb bleeding risk.
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