March 31, 2026КАРДИОЛОГИЯ УЗБЕКИСТАНА2 citations
View Full PaperIncidence, Clinical Implications, and Predictors of Paravalvular Leak Following Transcatheter Tricuspid Valve Replacement
Key Result
Moderate or severe paravalvular leak occurred in 6.1% of patients post-TTVR and was associated with increased 1-year mortality (adjusted HR 2.6; 95% CI 1.2-5.7) compared to mild or no/trace PVL.
Key Points
- This study investigates the incidence and predictors of moderate or severe paravalvular leak following transcatheter tricuspid valve replacement.
- Data collected from the multicenter TRIPLACE registry on eligible patients undergoing TTVR.
- Primary endpoint assessed was moderate or severe paravalvular leak post-TTVR.
- Outcomes analyzed using logistic regression, Cox regression, and Gray's test.
- 6.1% of TTVR patients experienced moderate or severe paravalvular leak postoperatively.
- 1-year mortality was significantly higher in patients with moderate or severe PVL (39.7% vs 12.6% with mild PVL; adjusted HR: 2.6; 95% CI: 1.2-5.7).
- Indicators for higher risk of PVL included larger right atrial volume and device malposition.
Study Design
Type
Observational (n=394)
Multicenter
Yes
Structured PICO
Does moderate or severe paravalvular leak post-TTVR worsen clinical outcomes and mortality in patients undergoing transcatheter tricuspid valve replacement?
P
Population
394 patients undergoing transcatheter tricuspid valve replacement (TTVR) in the Global Multicenter Registry on Transcatheter Tricuspid Valve Replacement (TRIPLACE)
I
Intervention
Transcatheter tricuspid valve replacement (TTVR) resulting in moderate or severe paravalvular leak (PVL)
C
Comparator
Transcatheter tricuspid valve replacement (TTVR) resulting in mild, trace, or no paravalvular leak (PVL)
O
Outcome
Occurrence of moderate or severe PVL post-TTVRsurrogate
Moderate or severe paravalvular leak after transcatheter tricuspid valve replacement occurs in approximately 6% of patients and is strongly associated with increased 1-year mortality and worse functional status.
Abstract
BACKGROUND: The clinical efficacy of transcatheter tricuspid valve replacement (TTVR) in abolishing tricuspid regurgitation might be attenuated by the occurrence of paravalvular leak (PVL). OBJECTIVES: The aim of this study was to investigate the incidence, outcomes, and predictors of moderate or severe PVL post-TTVR. METHODS: All eligible patients undergoing TTVR in the multicenter TRIPLACE (Global Multicenter Registry on Transcatheter Tricuspid Valve Replacement) registry were stratified according to predischarge PVL severity. The primary endpoint was the occurrence of moderate or severe PVL post-TTVR. Secondary endpoints were 1-year mortality, 1-year heart failure hospitalization, and post-TTVR NYHA functional class III or IV. Outcomes were analyzed using logistic regression (PVL), Cox regression (mortality), and Gray's test (heart failure). RESULTS: Of 394 TTVR patients, 24 (6.1%) had moderate or severe, 88 (22.3%) mild, and 282 (71.6%) no or trace PVL post-TTVR. Patients with moderate or severe PVL had significantly higher TRI-SCOREs (P < 0.001), lower estimated glomerular filtration rates (P = 0.001), and larger right ventricular and right atrial dimensions (P = 0.002 for both). Patients with moderate or severe PVL post-TTVR had worse 1-month functional class (53% in NYHA functional class III or IV) than those with mild (16%) or no or trace (15%) PVL. The presence of moderate or severe PVL post-TTVR was associated with increased 1-year mortality (39.7%; adjusted HR: 2.6; 95% CI: 1.2-5.7) compared with those with mild (12.6%) or no or trace (10.5%) PVL. A larger right atrial volume (P = 0.02), device malposition (P = 0.0002), and type IV valve morphology (P = 0.01) were independently associated with moderate or severe PVL post-TTVR. CONCLUSIONS: Moderate or greater PVL occurred in 6.1% of patients post-TTVR and was associated with increased 1-year mortality and worse functional status. A larger right atrial volume, device malposition, and type IV valve morphology conferred a higher risk for developing moderate or severe PVL post-TTVR. These findings have important implications for future TTVR design and procedural optimization. (Global Multicenter Registry on Transcatheter Tricuspid Valve Replacement TRIPLACE; NCT06033274).