Valvular & structural heart disease
A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI)
Authors' conclusion
Bailout MANTA after ProGlide failure was effective and safe, but operator experience seems to be crucial.
Study context
- Population
- Patients undergoing transfemoral TAVI with failed suture-based (ProGlide) access site closureof 2,505 registry patients
- Participants
- 66 patients
- Outcome
- Efficacy: haemostasis at the access site without alternative treatment other than manual compression or endovascular ballooning; safety: freedom from vascular dissection, stenosis and occlusion requiring intervention
Methodological detailsinstitutional registry
- Institutional registry
Main finding
As reported in the abstract
| Group | Effective | Safe |
|---|---|---|
| Bailout MANTA | 75.8% (50/66) | 86.4% (57/66) |
Bailout MANTA
Effective75.8% (50/66)
Safe86.4% (57/66)
Observational data: associations, not effects.
Further findings
Independent predictors of efficacy
| OR (95% CI) | P value | ||
|---|---|---|---|
| Operator experience with the technique | 12.29 (1.99–75.99) | P = 0.007 | |
| Prior use of three ProGlides | 0.02 (<0.01-0.39) | P = 0.010 | |
| 0.050.21520Odds ratio (log scale) |
Timing of ProGlide failure
- Before large-bore sheath insertion
- 16.7%
- After sheath removal
- 83.3%
Safety
Failure modes of bailout MANTA
- Persistent bleeding (superficial application)
- 18.2% (12/66)
- Stenosis or occlusion (deep application)
- 6.1% (4/66)
Original publication
A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral TAVI. EuroIntervention. Published 18 March 2024. doi:10. 4244/ eij-d-23-00750
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