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Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study
BACKGROUND: The second‐generation cryoballoon significantly improves outcome of pulmonary vein isolation (PVI) but may cause more complications than the first generation. Currently, no consensus regarding optimal cryoballoon application time exists. The 123‐study aimed to assess the minimal cryoball...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850154/ https://www.ncbi.nlm.nih.gov/pubmed/30756393 http://dx.doi.org/10.1111/pace.13626 |
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author | Molenaar, Marleen M.D. Timmermans, Carl C. Hesselink, Tim Scholten, Marcoen F. ter Bekke, Rachel M.A. Luermans, Justin G.L.M. Brusse‐Keizer, Marjolein Kraaier, Karin ten Haken, Bernard Grandjean, Jan G. Vernooy, Kevin van Opstal, Jurren M. |
author_facet | Molenaar, Marleen M.D. Timmermans, Carl C. Hesselink, Tim Scholten, Marcoen F. ter Bekke, Rachel M.A. Luermans, Justin G.L.M. Brusse‐Keizer, Marjolein Kraaier, Karin ten Haken, Bernard Grandjean, Jan G. Vernooy, Kevin van Opstal, Jurren M. |
author_sort | Molenaar, Marleen M.D. |
collection | PubMed |
description | BACKGROUND: The second‐generation cryoballoon significantly improves outcome of pulmonary vein isolation (PVI) but may cause more complications than the first generation. Currently, no consensus regarding optimal cryoballoon application time exists. The 123‐study aimed to assess the minimal cryoballoon application duration necessary to achieve PVI (primary endpoint) and the effect of application duration on prevention of phrenic nerve injury (PNI). METHODS: Patients <75 years of age with paroxysmal atrial fibrillation, normal PV anatomy, and left atrial size <40 cc/m² or <50 mm were randomized to two applications of different duration: “short,” “medium,” or “long.” A total of 222 patients were enrolled, 74 per group. RESULTS: Duration per application was 105 (101‐108), 164 (160‐168), and 224 (219‐226) s and isolation was achieved in 79, 89, and 90% (P < 0.001) of the PVs after two applications in groups short, medium, and long, respectively. Only for the left PVs, the success rate of the short group was significantly less compared to the medium‐ and long‐duration groups (P < 0.001). PNI during the procedure occurred in 19 PVs (6.5%) in the medium and in 20 PVs (6.8%) in the long duration groups compared to only five PVs (1.7%) in the short duration group (P < 0.001). CONCLUSIONS: Short cryoballoon ablation application times, less than 2 min, did affect the success for the left PVs but not for the right PVs and resulted in less PNI. A PV tailored approach with shorter application times for the right PVs might be advocated. |
format | Online Article Text |
id | pubmed-6850154 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-68501542019-11-15 Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study Molenaar, Marleen M.D. Timmermans, Carl C. Hesselink, Tim Scholten, Marcoen F. ter Bekke, Rachel M.A. Luermans, Justin G.L.M. Brusse‐Keizer, Marjolein Kraaier, Karin ten Haken, Bernard Grandjean, Jan G. Vernooy, Kevin van Opstal, Jurren M. Pacing Clin Electrophysiol Electrophysiology BACKGROUND: The second‐generation cryoballoon significantly improves outcome of pulmonary vein isolation (PVI) but may cause more complications than the first generation. Currently, no consensus regarding optimal cryoballoon application time exists. The 123‐study aimed to assess the minimal cryoballoon application duration necessary to achieve PVI (primary endpoint) and the effect of application duration on prevention of phrenic nerve injury (PNI). METHODS: Patients <75 years of age with paroxysmal atrial fibrillation, normal PV anatomy, and left atrial size <40 cc/m² or <50 mm were randomized to two applications of different duration: “short,” “medium,” or “long.” A total of 222 patients were enrolled, 74 per group. RESULTS: Duration per application was 105 (101‐108), 164 (160‐168), and 224 (219‐226) s and isolation was achieved in 79, 89, and 90% (P < 0.001) of the PVs after two applications in groups short, medium, and long, respectively. Only for the left PVs, the success rate of the short group was significantly less compared to the medium‐ and long‐duration groups (P < 0.001). PNI during the procedure occurred in 19 PVs (6.5%) in the medium and in 20 PVs (6.8%) in the long duration groups compared to only five PVs (1.7%) in the short duration group (P < 0.001). CONCLUSIONS: Short cryoballoon ablation application times, less than 2 min, did affect the success for the left PVs but not for the right PVs and resulted in less PNI. A PV tailored approach with shorter application times for the right PVs might be advocated. John Wiley and Sons Inc. 2019-03-05 2019-05 /pmc/articles/PMC6850154/ /pubmed/30756393 http://dx.doi.org/10.1111/pace.13626 Text en © 2019 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Electrophysiology Molenaar, Marleen M.D. Timmermans, Carl C. Hesselink, Tim Scholten, Marcoen F. ter Bekke, Rachel M.A. Luermans, Justin G.L.M. Brusse‐Keizer, Marjolein Kraaier, Karin ten Haken, Bernard Grandjean, Jan G. Vernooy, Kevin van Opstal, Jurren M. Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study |
title | Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study |
title_full | Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study |
title_fullStr | Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study |
title_full_unstemmed | Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study |
title_short | Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study |
title_sort | shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: results of the randomized 123 study |
topic | Electrophysiology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850154/ https://www.ncbi.nlm.nih.gov/pubmed/30756393 http://dx.doi.org/10.1111/pace.13626 |
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