Valvular & structural heart diseaseCohort study
Transcatheter Valve Repair for Tricuspid Regurgitation
- Observational cohort study (registry)
- investigator-initiated
- multicentre
- retrospective and prospective
- 16 European centres
- consecutive patients
- centralised echocardiographic analysis
Authors' conclusion
The PASCAL system effectively treats severe TR in high-risk patients, offering sustained TR reduction and significant clinical improvements at 1-year follow-up.
Study context
- Population
- High-risk patients with severe tricuspid regurgitation (TR) treated with the PASCAL transcatheter valve repair system, 16 European centres, February 2019 to November 2023
- Participants
- 1,059 patients
- Exposure
- PASCAL Precision vs first-generation PASCAL system
- PASCAL Precisionn = 489
- First-generation PASCALn = 570reference
Main finding
As reported in the abstract
Intraprocedural success (TVARC) and TR reduction to ≤moderate
Intraprocedural success (TVARC)
85%
TR reduced to ≤moderate
87%
Observational data: associations, not effects.
Further findings
| Outcome | OR | P value | |
|---|---|---|---|
| Independent predictors of postprocedure residual TR >moderate — coaptation gaps ≥8 mm vs First-generation PASCAL | 1.67 (95% CI 1.03–2.72) | P = 0.038 | |
| Independent predictors of postprocedure residual TR >moderate — tenting height ≥10 mm vs First-generation PASCAL | 2.18 (CI 1.30–3.65) | P = 0.003 | |
| Independent predictors of postprocedure residual TR >moderate — presence of a transvalvular lead vs First-generation PASCAL | 1.91 (95% CI 1.19–3.05) | P = 0.007 | |
| Independent predictors of postprocedure residual TR >moderate — right ventricular dilatation >42 mm vs First-generation PASCAL | 3.35 (95% CI 1.37–9.1) | P = 0.009 | |
| Independent predictors of postprocedure residual TR >moderate — massive/torrential TR at baseline vs First-generation PASCAL | 4.59 (95% CI 2.35–8.96) | P < 0.001 | |
| 0.10.31310Odds ratio (log scale) |
| Outcome | First-generation PASCAL | PASCAL Precision | Estimate | P value |
|---|---|---|---|---|
| TR reduction to trace/mild, PASCAL Precision vs first-generation PASCAL | Not reported in the abstract | 63% | P < 0.001 | |
| Procedure time, PASCAL Precision vs first-generation PASCAL | Not reported in the abstract | median 93 (IQR 69–130) minutes | P < 0.001 | |
| TVARC clinical success, PASCAL Precision vs first-generation PASCAL · 30 days and 1 year — PASCAL Precision vs PASCAL · 30 days: 87% vs 81% | P = 0.021 | |||
| TVARC clinical success, PASCAL Precision vs first-generation PASCAL · 30 days and 1 year — PASCAL Precision vs PASCAL · 1 year: 56% vs 50% | P = 0.044 |
- TR reduction to trace/mild, PASCAL Precision vs first-generation PASCAL: PASCAL 49%
- Procedure time, PASCAL Precision vs first-generation PASCAL: PASCAL median 120 (IQR 82–165) minutes
TR ≤moderate · 1 year
- Patients with ≤moderate TR
- 83%
NYHA class I/II · 1 year
- NYHA class I/II vs baseline
- 66% vs 17%; P < 0.001
Center experience (≥21 patients/year)
- Higher center experience resulted in higher intraprocedural and clinical success
Original publication
Transcatheter Valve Repair for Tricuspid Regurgitation. J Am Coll Cardiol. Published 28 October 2024. doi:10.1016/j.jacc.2024.10.068
Summarised from the published abstract; every number is checked against it