Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers

• Published in: Journal of the American College of Cardiology Vol. 85; no. 11; pp. 1111 - 1120
• Main Authors: Neuzil, Petr, Exner, Derek V., Knops, Reinoud E., Cantillon, Daniel J., Defaye, Pascal, Banker, Rajesh, Friedman, Paul, Hubbard, Chris, Delgado, Stephanie M., Bulusu, Anuradha, Reddy, Vivek Y.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 25.03.2025
• Subjects: Adult; Aged; Aged, 80 and over; Cardiovascular; Clinical Trials, Phase I as Topic; Device Removal - adverse effects; Device Removal - methods; Equipment Design; Female; helix-fixation; Humans; leadless pacemaker; leadless pacemaker replacement; Male; Middle Aged; Multicenter Studies as Topic; Observational Studies as Topic; Pacemaker, Artificial - adverse effects; retrieval; CEC; leadless pacemaker; LP; RV; retrieval; helix-fixation; SADE; UADE; leadless pacemaker replacement; unanticipated adverse device effect; clinical events committee; serious adverse device effect; right ventricle

The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term. This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials. Subjects enrol...