Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model
Language English Country United States Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
- Keywords
- cardiac pacemaker, artificial, feasibility study, intracardiac catheters, preclinical, right atrium, right ventricle,
- MeSH
- Equipment Design MeSH
- Atrial Fibrillation * MeSH
- Pacemaker, Artificial * MeSH
- Humans MeSH
- Lipopolysaccharides MeSH
- Sheep, Domestic MeSH
- Sheep MeSH
- Heart Ventricles MeSH
- Animals MeSH
- Check Tag
- Humans MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Lipopolysaccharides MeSH
BACKGROUND: The clinical utilization of leadless pacemakers (LPs) as an alternative to traditional transvenous pacemakers is likely to increase with the advent of dual-chamber LP systems. Since device retrieval to allow LP upgrade or replacement will become an important capability, the first such dual-chamber, helix-fixation LP system (Aveir DR; Abbott, Abbott Park, IL) was specifically designed to allow catheter-based retrieval. In this study, the preclinical performance and safety of retrieving chronically implanted dual-chamber LPs was evaluated. METHODS: Atrial and ventricular LPs were implanted in the right atrial appendage and right ventricular apex of 9 healthy ovine subjects. After ≈2 years, the LPs were retrieved using a dedicated transvenous retrieval catheter (Aveir Retrieval Catheter; Abbott) by snaring, docking, and unscrewing from the myocardium. Comprehensive necropsy/histopathology studies were conducted to evaluate device- and procedure-related outcomes. RESULTS: At a median of 1.9 years postimplant (range, 1.8-2.6), all 18 of 18 (100%) LPs were retrieved from 9 ovine subjects without complications. The median retrieval procedure duration for both LPs, from first-catheter-in to last-catheter-out, was 13.3 minutes (range, 2.5-36.4). Postretrieval, all right atrial, and right ventricular implant sites demonstrated minimal tissue disruption, with intact fibrous tissue limited to the distal device body. No significant device-related trauma, perforation, pericardial effusion, right heart or tricuspid valve injury, or chronic pulmonary thromboembolism were observed at necropsy. CONCLUSIONS: This preclinical study demonstrated the safe and effective retrieval of chronically implanted, helix-fixation, dual-chamber LP systems, paving the way for clinical studies of LP retrieval.
Hoag Memorial Hospital Newport Beach CA
Huntington Hospital Pasadena CA
Icahn School of Medicine at Mount Sinai Hospital NY
Keck USC School of Medicine Los Angeles
Kokura Memorial Hospital Kitakyushu Japan
Libin Cardiovascular Institute of Alberta Calgary Canada
Na Homolce Hospital Prague Czech Republic
Rippy Pathology Solutions Inc Woodbury MN
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