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Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model.
- Source :
- Circulation: Arrhythmia & Electrophysiology; Oct2023, Vol. 16 Issue 10, p572-578, 7p
- Publication Year :
- 2023
-
Abstract
- 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-catheterout, 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, dualchamber LP systems, paving the way for clinical studies of LP retrieval. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 19413149
- Volume :
- 16
- Issue :
- 10
- Database :
- Supplemental Index
- Journal :
- Circulation: Arrhythmia & Electrophysiology
- Publication Type :
- Academic Journal
- Accession number :
- 173355967
- Full Text :
- https://doi.org/10.1161/CIRCEP.123.012232