Leadless pacemaker implementation at the right atrial appendage apex: An initial preclinical assessment

Objective This study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming to address the limitations of atrial pacing with current leadless devices like the Medtronic Micra, which is typically used for ri...

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Published inPacing and clinical electrophysiology Vol. 47; no. 8; pp. 1124 - 1127
Main Authors Lin, Yu‐Sheng, Wu, Lung‐Sheng, Ho, Wan‐Chun, Lai, Chao‐Sung, Su, Wilber, Chu, Pao‐Hsien
Format Journal Article
LanguageEnglish
Published United States Wiley Subscription Services, Inc 01.08.2024
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ISSN0147-8389
1540-8159
1540-8159
DOI10.1111/pace.15003

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Abstract Objective This study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming to address the limitations of atrial pacing with current leadless devices like the Medtronic Micra, which is typically used for right ventricular implantation. Methods Four minipigs, each with a median body weight of 45.8 ± 10.0 kg, underwent placement of the Micra transcatheter pacing system (TPS) via the right femoral vein into the RAA apex. The pacing performance was assessed over 1‐week (short‐term) and 3‐month (long‐term) periods. Outcomes The initial findings indicated successful implantation, with satisfactory intrinsic R‐wave amplitudes and pacing threshold. In the following period, the sensitivity, threshold, and impedance were stable with time. Notably, upon explanation at 3 months, a deep myocardial penetration by the device was observed, necessitating a redesign for safe long‐term use in a growing subject's heart. Conclusion While initial results suggest that RAA apex placement of the Micra TPS is promising for potential inclusion in a dual‐chamber pacing system, the issue of myocardial penetration highlights the need for device redesign to ensure safety and effectiveness in long‐term applications.
AbstractList This study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming to address the limitations of atrial pacing with current leadless devices like the Medtronic Micra, which is typically used for right ventricular implantation.OBJECTIVEThis study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming to address the limitations of atrial pacing with current leadless devices like the Medtronic Micra, which is typically used for right ventricular implantation.Four minipigs, each with a median body weight of 45.8 ± 10.0 kg, underwent placement of the Micra transcatheter pacing system (TPS) via the right femoral vein into the RAA apex. The pacing performance was assessed over 1-week (short-term) and 3-month (long-term) periods.METHODSFour minipigs, each with a median body weight of 45.8 ± 10.0 kg, underwent placement of the Micra transcatheter pacing system (TPS) via the right femoral vein into the RAA apex. The pacing performance was assessed over 1-week (short-term) and 3-month (long-term) periods.The initial findings indicated successful implantation, with satisfactory intrinsic R-wave amplitudes and pacing threshold. In the following period, the sensitivity, threshold, and impedance were stable with time. Notably, upon explanation at 3 months, a deep myocardial penetration by the device was observed, necessitating a redesign for safe long-term use in a growing subject's heart.OUTCOMESThe initial findings indicated successful implantation, with satisfactory intrinsic R-wave amplitudes and pacing threshold. In the following period, the sensitivity, threshold, and impedance were stable with time. Notably, upon explanation at 3 months, a deep myocardial penetration by the device was observed, necessitating a redesign for safe long-term use in a growing subject's heart.While initial results suggest that RAA apex placement of the Micra TPS is promising for potential inclusion in a dual-chamber pacing system, the issue of myocardial penetration highlights the need for device redesign to ensure safety and effectiveness in long-term applications.CONCLUSIONWhile initial results suggest that RAA apex placement of the Micra TPS is promising for potential inclusion in a dual-chamber pacing system, the issue of myocardial penetration highlights the need for device redesign to ensure safety and effectiveness in long-term applications.
This study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming to address the limitations of atrial pacing with current leadless devices like the Medtronic Micra, which is typically used for right ventricular implantation. Four minipigs, each with a median body weight of 45.8 ± 10.0 kg, underwent placement of the Micra transcatheter pacing system (TPS) via the right femoral vein into the RAA apex. The pacing performance was assessed over 1-week (short-term) and 3-month (long-term) periods. The initial findings indicated successful implantation, with satisfactory intrinsic R-wave amplitudes and pacing threshold. In the following period, the sensitivity, threshold, and impedance were stable with time. Notably, upon explanation at 3 months, a deep myocardial penetration by the device was observed, necessitating a redesign for safe long-term use in a growing subject's heart. While initial results suggest that RAA apex placement of the Micra TPS is promising for potential inclusion in a dual-chamber pacing system, the issue of myocardial penetration highlights the need for device redesign to ensure safety and effectiveness in long-term applications.
ObjectiveThis study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming to address the limitations of atrial pacing with current leadless devices like the Medtronic Micra, which is typically used for right ventricular implantation.MethodsFour minipigs, each with a median body weight of 45.8 ± 10.0 kg, underwent placement of the Micra transcatheter pacing system (TPS) via the right femoral vein into the RAA apex. The pacing performance was assessed over 1‐week (short‐term) and 3‐month (long‐term) periods.OutcomesThe initial findings indicated successful implantation, with satisfactory intrinsic R‐wave amplitudes and pacing threshold. In the following period, the sensitivity, threshold, and impedance were stable with time. Notably, upon explanation at 3 months, a deep myocardial penetration by the device was observed, necessitating a redesign for safe long‐term use in a growing subject's heart.ConclusionWhile initial results suggest that RAA apex placement of the Micra TPS is promising for potential inclusion in a dual‐chamber pacing system, the issue of myocardial penetration highlights the need for device redesign to ensure safety and effectiveness in long‐term applications.
Objective This study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming to address the limitations of atrial pacing with current leadless devices like the Medtronic Micra, which is typically used for right ventricular implantation. Methods Four minipigs, each with a median body weight of 45.8 ± 10.0 kg, underwent placement of the Micra transcatheter pacing system (TPS) via the right femoral vein into the RAA apex. The pacing performance was assessed over 1‐week (short‐term) and 3‐month (long‐term) periods. Outcomes The initial findings indicated successful implantation, with satisfactory intrinsic R‐wave amplitudes and pacing threshold. In the following period, the sensitivity, threshold, and impedance were stable with time. Notably, upon explanation at 3 months, a deep myocardial penetration by the device was observed, necessitating a redesign for safe long‐term use in a growing subject's heart. Conclusion While initial results suggest that RAA apex placement of the Micra TPS is promising for potential inclusion in a dual‐chamber pacing system, the issue of myocardial penetration highlights the need for device redesign to ensure safety and effectiveness in long‐term applications.
Author Lin, Yu‐Sheng
Lai, Chao‐Sung
Su, Wilber
Ho, Wan‐Chun
Chu, Pao‐Hsien
Wu, Lung‐Sheng
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10.1093/europace/euad235
10.1016/j.jacep.2019.10.017
10.1016/j.jacep.2020.08.021
10.1056/NEJMoa2300080
10.1093/europace/euab315
10.1016/j.hrthm.2023.09.017
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Keywords transcatheter pacing system
right atrial appendage
leadless pacemaker
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Snippet Objective This study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig...
This study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig model, aiming...
ObjectiveThis study evaluates the feasibility and efficacy of implanting a leadless pacemaker at the right atrial appendage (RAA) in a preclinical minipig...
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StartPage 1124
SubjectTerms Animals
Atrial Appendage - surgery
Body weight
Cardiac Pacing, Artificial - methods
Equipment Design
Feasibility Studies
Heart
leadless pacemaker
Pacemaker, Artificial
Pacemakers
right atrial appendage
Swine
Swine, Miniature
transcatheter pacing system
Title Leadless pacemaker implementation at the right atrial appendage apex: An initial preclinical assessment
URI https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fpace.15003
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