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Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study
BACKGROUND: We quantified and characterized the outcomes of ablation in persistent atrial fibrillation (PersAF) subjects, and the utility of electroanatomical mapping with a market-released high-density (HD) mapping catheter. METHODS: PersAF subjects received electroanatomical mapping with the Advis...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9735148/ https://www.ncbi.nlm.nih.gov/pubmed/36481832 http://dx.doi.org/10.1007/s10840-022-01442-3 |
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author | Fiedler, Lukas Roca, Ivo Lorgat, Faizel Lacotte, Jérôme Haqqani, Haris Jesser, Emily Williams, Christopher Roithinger, Franz Xaver Steven, Daniel |
author_facet | Fiedler, Lukas Roca, Ivo Lorgat, Faizel Lacotte, Jérôme Haqqani, Haris Jesser, Emily Williams, Christopher Roithinger, Franz Xaver Steven, Daniel |
author_sort | Fiedler, Lukas |
collection | PubMed |
description | BACKGROUND: We quantified and characterized the outcomes of ablation in persistent atrial fibrillation (PersAF) subjects, and the utility of electroanatomical mapping with a market-released high-density (HD) mapping catheter. METHODS: PersAF subjects received electroanatomical mapping with the Advisor™ HD Grid mapping catheter, Sensor Enabled™ (HD Grid) and radiofrequency (RF) ablation to gather data regarding ablation strategies, mapping efficiency, quality, and outcomes. Subjects were enrolled from January 2019 to April 2020 across 25 international sites and followed for 12 months after the procedure. RESULTS: Three hundred thirty-four PersAF subjects (average age 64.2 years; 76% male; 25.4% previous AF ablation) were enrolled. Multiple map types were generated in a variety of rhythms using HD Grid. Significant differences in low voltage areas were identified in maps generated with the HD Wave Solution™ electrode configuration when compared to the standard configuration, which in some cases, influenced physicians’ ablation strategies. PV-only ablation strategy was used in 59.0% of subjects and 34.1% of subjects received PV ablation and additional lesions. Of the subjects, 82.0% were free from recurrent atrial arrhythmias at 12 months and new or increased dose of class I/III antiarrhythmic drugs. About 6.0% of subjects experienced a serious adverse event or serious adverse device effect through 12 months including 1 event deemed related to HD Grid and the index procedure by the investigator and 1 death unrelated to study devices. CONCLUSIONS: The results of this study (NCT03733392) support the safety and utility of electroanatomical mapping with HD Grid in subjects with complex arrhythmias, such as PersAF in the real-world setting. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10840-022-01442-3. |
format | Online Article Text |
id | pubmed-9735148 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-97351482022-12-12 Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study Fiedler, Lukas Roca, Ivo Lorgat, Faizel Lacotte, Jérôme Haqqani, Haris Jesser, Emily Williams, Christopher Roithinger, Franz Xaver Steven, Daniel J Interv Card Electrophysiol Article BACKGROUND: We quantified and characterized the outcomes of ablation in persistent atrial fibrillation (PersAF) subjects, and the utility of electroanatomical mapping with a market-released high-density (HD) mapping catheter. METHODS: PersAF subjects received electroanatomical mapping with the Advisor™ HD Grid mapping catheter, Sensor Enabled™ (HD Grid) and radiofrequency (RF) ablation to gather data regarding ablation strategies, mapping efficiency, quality, and outcomes. Subjects were enrolled from January 2019 to April 2020 across 25 international sites and followed for 12 months after the procedure. RESULTS: Three hundred thirty-four PersAF subjects (average age 64.2 years; 76% male; 25.4% previous AF ablation) were enrolled. Multiple map types were generated in a variety of rhythms using HD Grid. Significant differences in low voltage areas were identified in maps generated with the HD Wave Solution™ electrode configuration when compared to the standard configuration, which in some cases, influenced physicians’ ablation strategies. PV-only ablation strategy was used in 59.0% of subjects and 34.1% of subjects received PV ablation and additional lesions. Of the subjects, 82.0% were free from recurrent atrial arrhythmias at 12 months and new or increased dose of class I/III antiarrhythmic drugs. About 6.0% of subjects experienced a serious adverse event or serious adverse device effect through 12 months including 1 event deemed related to HD Grid and the index procedure by the investigator and 1 death unrelated to study devices. CONCLUSIONS: The results of this study (NCT03733392) support the safety and utility of electroanatomical mapping with HD Grid in subjects with complex arrhythmias, such as PersAF in the real-world setting. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10840-022-01442-3. Springer US 2022-12-08 /pmc/articles/PMC9735148/ /pubmed/36481832 http://dx.doi.org/10.1007/s10840-022-01442-3 Text en © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Article Fiedler, Lukas Roca, Ivo Lorgat, Faizel Lacotte, Jérôme Haqqani, Haris Jesser, Emily Williams, Christopher Roithinger, Franz Xaver Steven, Daniel Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study |
title | Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study |
title_full | Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study |
title_fullStr | Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study |
title_full_unstemmed | Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study |
title_short | Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study |
title_sort | characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the advisor™ hd grid mapping catheter observational study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9735148/ https://www.ncbi.nlm.nih.gov/pubmed/36481832 http://dx.doi.org/10.1007/s10840-022-01442-3 |
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