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October 25, 2025КАРДИОЛОГИЯ УЗБЕКИСТАНА7 citationsOpen Access

Tricuspid Valve Transcatheter Edge-to-Edge Repair in Patients With Cardiac Implantable Electronic Devices

JSJennifer von SteinPSPhilipp von SteinRPRoman Pfister

Key Result

The presence of a transvalvular cardiac implantable electronic device lead in patients undergoing tricuspid valve transcatheter edge-to-edge repair was not associated with procedural failure (residual TR >2+) compared to patients without devices (OR 0.98).

Study Design

Type

Observational (n=3,025)

Multicenter

Yes

Structured PICO

Does T-TEER provide comparable procedural and clinical outcomes in patients with severe TR and transvalvular CIED leads compared to those without CIED leads?

P
Population
3,025 patients with severe tricuspid regurgitation at high surgical risk undergoing transcatheter edge-to-edge repair, including 851 with transvalvular CIED leads, followed for a median of 269 days.
E
Exposure
Tricuspid valve transcatheter edge-to-edge repair (T-TEER) in the presence of transvalvular cardiac implantable electronic device (CIED) leads
C
Comparator
T-TEER in propensity-score matched patients without CIED leads
O
Outcome
Residual TR at discharge and follow-up, and the composite of all-cause mortality or heart failure hospitalization at 2 yearscomposite

T-TEER is safe and effective in patients with transvalvular CIED leads, achieving comparable TR reduction and 2-year clinical outcomes to patients without CIEDs.

Main Result

Odds Ratio: 0.98 (95% CI 0.7–1.38)

Absolute Event Rate: 22.4% vs 22.7%

p-value: p=0.915

Limitations

  • Observational, retrospective design
  • Site-reported nature of the registry without systematic core laboratory adjudication
  • Potential under-recognition of late events
  • Lack of systematic follow-up for lead-related complications
  • Potential for residual confounding despite propensity score matching

Abstract

BACKGROUND: Tricuspid valve transcatheter edge-to-edge repair (T-TEER) is increasingly used in patients with severe tricuspid regurgitation (TR) at high surgical risk. Long-term outcomes in those with transvalvular cardiac implantable electronic devices (CIEDs) remain insufficiently characterized. OBJECTIVES: The aim of this study was to evaluate procedural and clinical outcomes of T-TEER in patients with CIED leads in a real-world cohort. METHODS: Among 3,025 patients undergoing T-TEER at 26 centers (2016-2024), 851 (28.1%) had transvalvular CIED leads. Residual TR at discharge and follow-up and the composite of all-cause mortality or heart failure hospitalization at 2 years were assessed. CIED function was evaluated preprocedure and postprocedure. Propensity score matching (1:1) was conducted to compare outcomes between patients with and those without CIEDs. RESULTS: CIED function remained stable, and no lead revision was required. At discharge, TR ≤1+ and ≤2+ was achieved in 39.9% and 79.8%, respectively; at follow-up (median 269 days; Q1-Q3: 63-423 days), TR ≤1+ and ≤2+ persisted in 29.3% and 69.1%. In 385 matched pairs, residual TR, functional status, and 2-year heart failure hospitalization-free survival were comparable between patients with and those without CIEDs (67.1% 95% CI: 62.1%-72.5% vs 73.6% 95% CI: 68.9%-78.6%; P = 0.176). CIED presence showed a nonsignificant association with more adverse outcomes (HR: 1.31; 95% CI: 0.99-1.74; P = 0.063) but was not associated with residual TR >2+ (OR: 0.98; 95% CI: 0.70-1.38; P = 0.915). Achieving residual TR ≤2+ conferred significantly better survival irrespective of CIED presence (P < 0.001). CONCLUSIONS: T-TEER is safe and effective in selected patients with transvalvular CIED leads. Effective TR reduction remains prognostically relevant, even in this high-risk real-world population.

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Cite This Study

Stein et al. (2025) conducted an observational in Severe tricuspid regurgitation (n=3,025). Transvalvular cardiac implantable electronic device (CIED) leads vs. Patients without CIEDs was evaluated on Residual tricuspid regurgitation >2+ at discharge (OR 0.98, 95% CI 0.70-1.38, p=0.915). The presence of a transvalvular cardiac implantable electronic device lead in patients undergoing tricuspid valve transcatheter edge-to-edge repair was not associated with procedural failure (residual TR >2+) compared to patients without devices (OR 0.98).

synapsesocial.com/papers/6aa4d1ab44102162aeaa27f6https://doi.org/10.1016/j.jcin.2025.09.033
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