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)

EuroInterventionPublished Retrospective analysis of a prospective single-centre registry

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

GroupEffectiveSafe
Bailout MANTA75.8% (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 technique12.29 (1.99–75.99)P = 0.007
Prior use of three ProGlides0.02 (<0.01-0.39)P = 0.010

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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