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 in | Pacing and clinical electrophysiology Vol. 47; no. 8; pp. 1124 - 1127 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Wiley Subscription Services, Inc
01.08.2024
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Online Access | Get full text |
ISSN | 0147-8389 1540-8159 1540-8159 |
DOI | 10.1111/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. |
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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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Cites_doi | 10.1111/pace.14776 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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References_xml | – volume: 24 start-page: 1119 issue: 7 year: 2022 end-page: 1126 article-title: Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker publication-title: Europace – volume: 25 issue: 9 year: 2023 article-title: Anatomic, histologic, and mechanical features of the right atrium: implications for leadless atrial pacemaker implantation publication-title: Europace – volume: 388 start-page: 2360 issue: 25 year: 2023 end-page: 2370 article-title: A dual‐chamber leadless pacemaker publication-title: N Engl J Med – volume: 21 start-page: 66 issue: 1 year: 2024 end-page: 73 article-title: Outcomes of patients implanted with an atrioventricular synchronous leadless ventricular pacemaker in the Medicare population publication-title: Heart Rhythm – volume: 6 start-page: 94 issue: 1 year: 2020 end-page: 106 article-title: Atrioventricular synchronous pacing using a leadless ventricular pacemaker: results from the MARVEL 2 study publication-title: JACC Clin Electrophysiol – volume: 46 start-page: 1085 issue: 9 year: 2023 end-page: 1091 article-title: Preclinical cardiac perforation reduction in leadless pacing: an update to the Micra leadless pacemaker delivery system publication-title: Pacing Clin Electrophysiol – volume: 6 start-page: 1318 issue: 10 year: 2020 end-page: 1331 article-title: Tine‐based leadless pacemaker: strategies for safe implantation in unconventional clinical scenarios publication-title: JACC Clin Electrophysiol – ident: e_1_2_10_6_1 doi: 10.1111/pace.14776 – ident: e_1_2_10_8_1 doi: 10.1093/europace/euad235 – ident: e_1_2_10_3_1 doi: 10.1016/j.jacep.2019.10.017 – ident: e_1_2_10_2_1 doi: 10.1016/j.jacep.2020.08.021 – ident: e_1_2_10_5_1 doi: 10.1056/NEJMoa2300080 – ident: e_1_2_10_4_1 doi: 10.1093/europace/euab315 – ident: e_1_2_10_7_1 doi: 10.1016/j.hrthm.2023.09.017 |
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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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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 |
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