A first-in-human trial using a purpose-built device to provide direct wire pacing without the need for a temporary venous pacemaker during transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary intervention (PCI) has found that the device was safe and effective.
According to Electroducer, the company behind the Electroducer Sleeve, the device is an electro-conductive device made of highly innovative material which is intended to transmit, in a safe way for the patient, the electrical signal from an external pacemaker to the heart through the guidewire.
Results of the first-in-man study were published in the journal EuroIntervention. Researchers from four French medical centres—the Clinique Pasteur in Toulouse, the Cardiovascular Institute in Grenoble, the Médipôle Lyon-Villeurbanne Hospital in Villeurbanne and the Jacques Cartier private Hospital in Massy—enrolled 60 patients in the study (mean age: 77.9±9.6 years), 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%).
The primary endpoint was an 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.
Primary endpoint analysis revealed that two 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 two patients (6.3%) presented asymptomatic radial artery occlusion.
Jérôme Wintzer-Wekehind (Cardiovascular Institute, Grenoble, France) principal investigator on the study, said: “As well as offering benefits for patients, this device is simple and universal—these advantages mean there will certainly be widespread uptake and usage.”
Nicolas Dumonteil (Clinique Pasteur, Toulouse, France), added: “I am confident that in a few years’ time, Electroducer Sleeve will replace our conventional technique, providing physicians and patients with a faster, safer and simpler procedure.”
According to a press release from Electroducer, the Electroducer Sleeve is expected to reach the US market in 2023, followed by the European market in 2024, once it receives US Food and Drug Administration (FDA) authorisation and a CE marking respectively.