'Single-shot' pulmonary vein isolation using a novel lotos pulsed field ablation catheter : a pre-clinical evaluation of feasibility, safety, and 30-day efficacy
© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology..
AIMS: Pulsed field ablation (PFA) is emerging as a non-thermal, tissue-specific technique for pulmonary vein isolation (PVI) in atrial fibrillation therapy. This pre-clinical study aims to investigate the feasibility and safety of PVI using a novel PFA system including a nanosecond-scale PFA generator, a novel lotos PFA catheter, and a customized 12 Fr steerable sheath.
METHODS AND RESULTS: A total of 11 Yorkshire swine were included in this study, with 4 in the acute cohort and 7 in the chronic cohort. Under general anaesthesia, transseptal puncture and pulmonary vein (PV) angiography was initially performed. The PFA catheter was navigated to position at the right and left PV antrum after the electroanatomic reconstruction of the left atrium. Biphasic PFA applications were performed on PVs in both the spindle-shaped and the lotos-shaped poses. Pulmonary vein isolation and PFA-associated safety were assessed 30 min after ablation in both cohorts and 30 days later in the chronic cohort. Detailed necropsy and histopathology were performed. Additional intracardiac echocardiography and coronary angiogram were evaluated for safety. All target PVs (n = 20) were successfully isolated on the first attempt. No spasm of coronary artery or microbubble was seen during the procedure. Eleven of 12 PVs (91.6%) remained in isolation at the 30-day invasive study. No evidence of PV stenosis was observed in any targets. However, transient diaphragm capture occurred in 17.6%. Histopathological examinations showed no evidence of collateral injury.
CONCLUSION: This study provides scientific evidence demonstrating the safety and efficacy of the novel PFA catheter and system for single-shot PVI, which shows great potential.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
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| Enthalten in: |
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology - 26(2023), 1 vom: 28. Dez. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pu, Sijia [VerfasserIn] |
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| Links: |
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| Themen: |
Atrial fibrillation |
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| Anmerkungen: |
Date Completed 01.01.2024 Date Revised 15.01.2024 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/europace/euad362 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Pu, Sijia |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 'Single-shot' pulmonary vein isolation using a novel lotos pulsed field ablation catheter |b a pre-clinical evaluation of feasibility, safety, and 30-day efficacy |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. | ||
| 520 | |a AIMS: Pulsed field ablation (PFA) is emerging as a non-thermal, tissue-specific technique for pulmonary vein isolation (PVI) in atrial fibrillation therapy. This pre-clinical study aims to investigate the feasibility and safety of PVI using a novel PFA system including a nanosecond-scale PFA generator, a novel lotos PFA catheter, and a customized 12 Fr steerable sheath | ||
| 520 | |a METHODS AND RESULTS: A total of 11 Yorkshire swine were included in this study, with 4 in the acute cohort and 7 in the chronic cohort. Under general anaesthesia, transseptal puncture and pulmonary vein (PV) angiography was initially performed. The PFA catheter was navigated to position at the right and left PV antrum after the electroanatomic reconstruction of the left atrium. Biphasic PFA applications were performed on PVs in both the spindle-shaped and the lotos-shaped poses. Pulmonary vein isolation and PFA-associated safety were assessed 30 min after ablation in both cohorts and 30 days later in the chronic cohort. Detailed necropsy and histopathology were performed. Additional intracardiac echocardiography and coronary angiogram were evaluated for safety. All target PVs (n = 20) were successfully isolated on the first attempt. No spasm of coronary artery or microbubble was seen during the procedure. Eleven of 12 PVs (91.6%) remained in isolation at the 30-day invasive study. No evidence of PV stenosis was observed in any targets. However, transient diaphragm capture occurred in 17.6%. Histopathological examinations showed no evidence of collateral injury | ||
| 520 | |a CONCLUSION: This study provides scientific evidence demonstrating the safety and efficacy of the novel PFA catheter and system for single-shot PVI, which shows great potential | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Atrial fibrillation | |
| 650 | 4 | |a Catheter ablation | |
| 650 | 4 | |a Nanosecond | |
| 650 | 4 | |a Pulmonary vein isolation | |
| 650 | 4 | |a Pulsed field ablation | |
| 650 | 4 | |a Single shot | |
| 700 | 1 | |a Liu, Fangzhou |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yuhan |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Cihua |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Peng |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yanlin |e verfasserin |4 aut | |
| 700 | 1 | |a Fu, Lu |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Huiyi |e verfasserin |4 aut | |
| 700 | 1 | |a Ye, Xingdong |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Shulin |e verfasserin |4 aut | |
| 700 | 1 | |a Xue, Yumei |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Weidong |e verfasserin |4 aut | |
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