Leadless Cardiac Pacemakers: Pacing Paradigm Change

Abstract

Traditional transvenous approach for permanent cardiac pacing can be associated with significant acute and chronic complications related partly to either the insertion of transvenous lead or subcutaneous placement of pacemaker device. We summarize the current status of a novel self-contained leadless cardiac pacemaker in the first-in-human and subsequent series of feasibility studies in patients indicated for ventricular rate-responsive pacing (VVI). Using a femoral venous approach, the device is implanted at the right ventricular apical septum region. We describe the technical and clinical characterization of this innovative technology. Two different systems of leadless pacemakers are currently implanted to the patients. Up to now, the electrical parameters, such as pacing thresholds, sensing parameters, and pacing impedances, either improved or remained stable within the accepted range. In this chapter, we also discuss the potential benefit for the future, but in summary, all available data demonstrate the feasibility of leadless cardiac pacing.

Predictors of atrial mechanical sensing and atrioventricular synchrony with a leadless ventricular pacemaker: Results from the MARVEL 2 Study

“…4 Leadless pacemakers were designed to reduce complications associated with transvenous pacemakers, particularly lead-and pocket-related complications, which historically have been reported to range as high as 2%-12%. 5,6 Leadless pacemakers have demonstrated a high safety and efficacy profile. 7 However, first-generation leadless pacemakers deliver only ventricular pacing (VVI[R] mode), which largely limits their use to patients with bradycardia and chronic AF and those considered to be at high risk for complications related to implantation of a leaded pacemaker.…”

Leadless Cardiac Pacemaker as a Novel Intervention Modality for Atrioventricular Conduction Disturbance in Hypertrophic Cardiomyopathy

“…More than 55 years ago, the first cardiac pacemaker was implanted in the heart [19]. Since then, this device has been developed into a more reliable device by adding battery lifetime, improving lead performance and enhancing device capability (i.e.…”

“…In addition, implantation procedures of this regular pacemaker also have several risks. In the short-term, it can cause mobility limitations, pneumothorax, cardiac tamponade and upper limb Deep Vein Thrombosis (DVT) [3,4,6,19]. A study showed that up to six out of ten patients with regular pacemakers developed mobility limitations in the shoulder region, where the pulse generators were implanted [6].…”

“…A study showed that up to six out of ten patients with regular pacemakers developed mobility limitations in the shoulder region, where the pulse generators were implanted [6]. In the long-term, transvenous leads are associated with the majority of complications in regular pacemakers [19]. Those transvenous leads can potentially cause obstructions in the vena cava, and they are prone to insulation breaks, conductor fractures, lead dislodgements and even a systemic infection [3,20,21].…”

Behavior of AV synchrony pacing mode in a leadless pacemaker during variable AV conduction and arrhythmias

“…The prevalence of heart conduction disorders requiring implantation of a permanent pacemaker is increasing as the population is aging. Nevertheless, despite all technological improvements over the last 6 decades, conventional pacing therapy is still associated with a complications rate ranging from 1% to 12.4% in the first 2‐month post implantation and reported up to 19.7% at 5‐year follow‐up 1–4 …”