Valvular & structural heart disease
Medium-term outcomes and prognostic factors after transcatheter paravalvular leak closure: an international prospective multicentre registry
Authors' conclusion
Transcatheter PVL closure offers a durable therapeutic option for high-risk patients when early clinical success is achieved. Mitral valve involvement, mechanical prostheses, and haemolytic anaemia remain key predictors of poor outcomes over a 2-year follow-up.
Study context
- Population
- Consecutive symptomatic patients undergoing transcatheter paravalvular leak (PVL) closure across European centres between 2017 and 2019symptomatic patients who underwent 237 procedures
- Participants
- 213 patients
- Outcome
- Survival without the need for surgical reintervention
- Follow-up
- 2 years
Methodological detailsconsecutive symptomatic patients, 24 European centres
- Consecutive symptomatic patients
- 24 European centres
Main finding
As reported in the abstract
Survival rate without the need for surgical reintervention
66.1% (95% confidence interval [CI]: 60.1-72.7)
Observational data: associations, not effects.
Further findings
Adverse outcomes, by absence of clinical success at 1 month
| Hazard ratio (95% CI) | P value | ||
|---|---|---|---|
| Absence of clinical success at 1 monthStrongest predictor of adverse outcomes | 5.00 (2.70–9.09) | P = 0.001 | |
| 0.10.31310Hazard ratio (log scale) |
Independent risk factors for adverse outcomes during follow-up (multivariate analysis)
- Mitral PVL, mechanical valves, and haemolytic anaemia identified as independent risk factors
Baseline and procedural characteristics
- Mean age
- 68±11 years
- Median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II
- 6 (interquartile range [IQR] 4-10)
- Mitral valve PVL
- 64.6% of cases
- Mechanical prostheses
- 53.3%
- Heart failure
- 89.5%
- Haemolytic anaemia
- 49.8%
- Transapical approach
- 6.8% of cases
Technical and clinical success
- Technical success
- 87.3% of procedures
- Clinical success at 1 month
- 70.5% of patients
Original publication
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