Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice-operator learning curve and procedural outcome at a high-volume center
© 2023 Zylla, Starrach, Rahm, Thomas, Frey and Lugenbiel..
Background: The 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.
Methods: The 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.
Results: 157/157 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.
Conclusion: Rapid 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 Registration: ClinicalTrials.gov; Identifier NCT0560361.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
Frontiers in cardiovascular medicine - 10(2023) vom: 15., Seite 1208250 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zylla, Maura M [VerfasserIn] |
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| Links: |
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| Themen: |
Atrial fibrillation |
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| Anmerkungen: |
Date Revised 02.12.2023 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.3389/fcvm.2023.1208250 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM365254991 |
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| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2023 Zylla, Starrach, Rahm, Thomas, Frey and Lugenbiel. | ||
| 520 | |a Background: The 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 | ||
| 520 | |a Methods: The 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 | ||
| 520 | |a Results: 157/157 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 | ||
| 520 | |a Conclusion: Rapid 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 | ||
| 520 | |a Clinical Trial Registration: ClinicalTrials.gov; Identifier NCT0560361 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a atrial fibrillation | |
| 650 | 4 | |a catheter ablation | |
| 650 | 4 | |a operator learning curve | |
| 650 | 4 | |a pulmonary vein isolation | |
| 650 | 4 | |a radiofrequency balloon | |
| 700 | 1 | |a Starrach, Lydia |e verfasserin |4 aut | |
| 700 | 1 | |a Rahm, Ann-Kathrin |e verfasserin |4 aut | |
| 700 | 1 | |a Thomas, Dierk |e verfasserin |4 aut | |
| 700 | 1 | |a Frey, Norbert |e verfasserin |4 aut | |
| 700 | 1 | |a Lugenbiel, Patrick |e verfasserin |4 aut | |
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