Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice—operator learning curve and procedural outcome at a high-volume center / Maura M. Zylla, Lydia Starrach, Ann-Kathrin Rahm, Dierk Thomas, Norbert Frey and Patrick Lugenbiel
BackgroundThe novel multielectrode radiofrequency (RF) balloon catheter (HELIOSTAR™. Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining RF-ablation and 3D-mapping visualization with the concept of a “single-shot”-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the multielectrode RF-balloon at a high-volume center.MethodsThe first 40 patients undergoing PVI by multielectrode RF-balloon catheter at Heidelberg University Hospital were included in this prospective study. Procedural outcome was analyzed over the course of increasing experience with the device.Results157/157 pulmonary veins (PVs) were successfully isolated with the RF-balloon catheter, in 73.2% by a single RF-application. Median time to isolation (TTI) was 11.0 s (Q1 = 8.0 s; Q3 = 13.8 s). Median procedure time was 62.5 min (Q1 = 50.0 min; Q3 = 70.5 min). LA-dwell time was 28.5 min (Q1 = 23.3 min; Q3 = 36.5 min). Median fluoroscopy duration was 11.6 min (Q1 = 10.1 min; Q3 = 13.7 min). No serious procedure-related complications were observed, apart from one case of unclear, post-procedural acute-on-chronic kidney injury. With increasing operator experience, an additional reduction in procedure duration was observed.ConclusionRapid implementation of a “single shot”-ablation device combining RF-ablation and 3D-mapping can be achieved with high acute procedural efficacy and safety at a high-volume center. Previous experience with “single-shot” ablation devices may be advantageous for time-efficient introduction of the novel RF-balloon catheter into clinical practice.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT05603611..
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E-Artikel |
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Erscheinungsjahr: |
14 July 2023 2023 |
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Erschienen: |
14 July 2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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Enthalten in: |
Frontiers in Cardiovascular Medicine - 10(2023), Seite 1-9 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Zylla, Maura Magdalena, 1985- [VerfasserIn] |
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Links: |
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Anmerkungen: |
Gesehen am 23.01.2024 |
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Umfang: |
Illustrationen 9 |
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doi: |
10.3389/fcvm.2023.1208250 |
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funding: |
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PPN (Katalog-ID): |
187870589X |
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520 | |a BackgroundThe novel multielectrode radiofrequency (RF) balloon catheter (HELIOSTAR™. Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining RF-ablation and 3D-mapping visualization with the concept of a “single-shot”-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the multielectrode RF-balloon at a high-volume center.MethodsThe first 40 patients undergoing PVI by multielectrode RF-balloon catheter at Heidelberg University Hospital were included in this prospective study. Procedural outcome was analyzed over the course of increasing experience with the device.Results157/157 pulmonary veins (PVs) were successfully isolated with the RF-balloon catheter, in 73.2% by a single RF-application. Median time to isolation (TTI) was 11.0 s (Q1 = 8.0 s; Q3 = 13.8 s). Median procedure time was 62.5 min (Q1 = 50.0 min; Q3 = 70.5 min). LA-dwell time was 28.5 min (Q1 = 23.3 min; Q3 = 36.5 min). Median fluoroscopy duration was 11.6 min (Q1 = 10.1 min; Q3 = 13.7 min). No serious procedure-related complications were observed, apart from one case of unclear, post-procedural acute-on-chronic kidney injury. With increasing operator experience, an additional reduction in procedure duration was observed.ConclusionRapid implementation of a “single shot”-ablation device combining RF-ablation and 3D-mapping can be achieved with high acute procedural efficacy and safety at a high-volume center. Previous experience with “single-shot” ablation devices may be advantageous for time-efficient introduction of the novel RF-balloon catheter into clinical practice.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT05603611. | ||
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