Abstract 14131: Early Experience With a Novel Extravascular Pacemaker Lead

Abstract

Introduction: Transvenous pacemaker leads (TVL) provide electrical support for symptomatic bradycardia patients but requires wiring the vasculature and heart. TVLs create complications such as bleeding, infection and cardiac perforation. We examine here a novel method to deliver an extravascular pacemaker lead (EVL) via the anterior chest without touching the heart. Hypothesis: This novel AtaCor extra cardiac pacemaker lead will achieve appropriate pacing in an ambulatory model without significant macro- or micro-dislodgement. Methods: 4 patients were enrolled to evaluate prototype EVLs for performance and safety. The patients were indicated for permanent pacemaker insertion as an index procedure. The study involved a similar paddle lead that was specifically designed for the anterior mediastinal space. The leads were matched to a delivery tool and delivered via the anterior parasternal left chest. We are developing a sustainable pacing system that provides capture without touching the heart in an ambulatory patient. The imaging was performed by fluoroscopy and x-ray. The position, stability of the lead and the electrical performance will be described in detail and related to the imaging results for up to 7 days in an ambulatory patient as a self-control. Results: Stable group (2 patients) showed no micro-dislodgement on fluoroscopic imaging with simultaneous successful pacing. Unstable group (2 patients) showed micro-dislodgement on fluoroscopic imaging which was correlated to poor pacing capture. No patients showed macro-dislodgement on chest x-ray (PA and Lateral). Conclusions: AtaCor’s novel extra cardiac pacemaker lead successfully gains temporary pacing. However, due to the size of the cathode electrode, there are limitations in the ambulatory patient population. We recommend the development of further prototype iterations based on this data.