A direct wire pacing device for transcatheter heart valve and coronary interventions: a first-in-human, multicentre study of the Electroducer Sleeve
Why the study?
Cardiac pacing during TAVI and complex PCI generally requires an additional venous access site for a temporary lead, prompting evaluation of the purpose-built Electroducer Sleeve for direct wire pacing.
Does the Electroducer Sleeve device provide safe and effective temporary cardiac pacing in patients undergoing TAVI or PCI?
Comparison
Direct wire pacing using the Electroducer Sleeve
Design
Multicentre, non-randomised, prospective, first-in-human, single-arm pilot study
Authors
Discussion
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Implication
Early data support safety of the Electroducer Sleeve for direct wire pacing; hypothesis-generating and requires randomized validation before adoption.
Structured PICO
Does the Electroducer Sleeve device provide safe and effective temporary cardiac pacing in patients undergoing TAVI or PCI?
P
Population
60 patients (mean age 77.9±9.6 years) undergoing TAVI (n=39, 65%) or PCI (n=21, 35%) from 4 centres in France.
I
Intervention
Temporary cardiac pacing using the Electroducer Sleeve device for direct wire pacing.
O
Outcome
Safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site.safety
The Electroducer Sleeve is a safe and effective novel device for temporary cardiac pacing during TAVI and PCI, potentially eliminating the need for a separate temporary venous pacemaker.
Limitations
- Small sample size
- Requires larger prospective studies
Cite This Study
Wintzer-Wehekind et al. (2023) studied this question.