TY - JOUR
T1 - Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model
AU - Banker, Rajesh S
AU - Rippy, Marian K
AU - Cooper, Nicole
AU - Neužil, Petr
AU - Exner, Derek V
AU - Nair, Devi G
AU - Booth, Daniel F
AU - Ligon, David
AU - Badie, Nima
AU - Krans, Mark
AU - Ando, Kenji
AU - Knops, Reinoud E
AU - Ip, James E
AU - Doshi, Rahul N
AU - Rashtian, Mayer
AU - Reddy, Vivek Y
N1 - Funding Information: This study was funded by Abbott. Publisher Copyright: © 2023 American Heart Association, Inc.
PY - 2023/10/1
Y1 - 2023/10/1
N2 - 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.
AB - 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.
KW - cardiac pacemaker, artificial
KW - feasibility study
KW - intracardiac catheters
KW - preclinical
KW - right atrium
KW - right ventricle
UR - http://www.scopus.com/inward/record.url?scp=85174751358&partnerID=8YFLogxK
U2 - https://doi.org/10.1161/CIRCEP.123.012232
DO - https://doi.org/10.1161/CIRCEP.123.012232
M3 - Article
C2 - 37767710
SN - 1941-3149
VL - 16
SP - e012232
JO - Circulation. Arrhythmia and electrophysiology
JF - Circulation. Arrhythmia and electrophysiology
IS - 10
ER -