Interventions for valvular disease and heart failure

A direct wire pacing device for transcatheter heart valve and coronary interventions: a first-in-human, multicentre study of the Electroducer Sleeve

EuroIntervention 2023;18:1150-1555. DOI: 10.4244/EIJ-D-22-00662

Jérôme Wintzer-Wehekind
Jérôme Wintzer-Wehekind1,2, MD; Thierry Lefèvre3, MD; Hakim Benamer3, MD; Jacques Monsegu1,2, MD; Didier Tchétché4, MD; Philippe Garot3, MD; Benjamin Honton4, MD; Nicolas Dumonteil4, MD; Mohamed Abdellaoui1,2, MD
1. Institut Cardiovasculaire de Grenoble, Grenoble, France; 2. Médipôle Lyon-Villeurbanne, Villeurbanne, France; 3. Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France; 4. Groupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France

Background: Transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary interventions (PCI) may require cardiac pacing during device delivery, generally requiring the insertion of a temporary pacing lead via an additional venous access site. The purpose-built Electroducer Sleeve device provides direct wire pacing without the need for a temporary venous pacemaker.

Aims: This study assessed the safety of temporary cardiac pacing using the novel sleeve device during PCI.

Methods: This was a multicentre, non-randomised, prospective, first-in-human, single-arm, pilot study. The primary endpoint was analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of effectiveness and qualitative outcomes.

Results: Sixty patients (mean age: 77.9±9.6 years) from 4 centres in France were included: 39 (65%) underwent TAVI, and 21 (35%) underwent PCI. Procedures were performed using the sleeve with access through the radial (32 patients; 53.3%) or femoral arteries (26; 43.3%), or the femoral vein (2; 3.3%). Primary endpoint analysis revealed that 2 patients (3.3%) developed EArly Discharge After Transradial Stenting of CoronarY Arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%). Analyses of other secondary endpoints showed that 2 patients (6.3%) presented asymptomatic radial artery occlusion. No allergies were reported.

Conclusions: This first-in-human trial using the Electroducer Sleeve indicated that this novel, purpose-built, temporary pacing device was safe and effective. Larger prospective studies are required to confirm these findings.

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