Leadless Pacemaker Performance Promising | Journal Scan

Study Questions:

What are the mid-term outcomes of patients with a leadless pacemaker?


The mid-term follow-up data were reported among 31 patients from the LEADLESS trial who underwent implantation of a novel leadless pacemaker for symptomatic bradycardia. The device encompasses both the pacing/sensing electrode and battery (total volume, 1 cc; estimated battery longevity, 9 years), and is implanted in the septal aspect of the right ventricular apex via the femoral vein. The median implant time was 24 minutes. About one-third of the patients required repositioning during the original procedure. Two patients who had also undergone the procedure were not included: one experienced cardiac perforation and required cardiac surgery, but died several days later following a stroke; and another in whom the device was explanted due to new indication for an implantable defibrillator. Rate-response (driven by changes in blood temperature) function was also described.


The mean follow-up duration was 1.2 years. There was no instance of device embolization, late perforation, ventricular arrhythmias, or thrombus. Pacing parameters were excellent, and remained stable during follow-up. In 19 patients, the rate-response sensor was activated with adequate response.


The mid-term results among patients who received the novel leadless pacemaker are promising.


Current transvenous pacing systems are limited by acute (infection, pocket discomfort/hematoma, cardiac and lung perforation, vascular bleeding/thrombosis) and chronic complications (infection, venous insufficiency/obstruction, lead failure). The leadless pacemaker offers a number of advantages in this regard. Future directions include minimizing acute complications, inclusion of atrial pacing, improving rate response, management at time of battery depletion (implant another leadless device vs. conventional transvenous system), and extraction of chronic devices.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Interventions and Vascular Medicine

Keywords: Arrhythmias, Cardiac, Bradycardia, Cardiac Surgical Procedures, Defibrillators, Implantable, Femoral Vein, Follow-Up Studies, Heart Conduction System, Hematoma, Pacemaker, Artificial, Stroke, Thrombosis, Vascular Diseases, Venous Insufficiency

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