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Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial
BACKGROUND: Transseptal puncture to achieve left atrial access is necessary for many cardiac procedures, including atrial fibrillation ablation. More recently, there has been an increasing need for left atrial access using large caliber sheaths, which increases risk of perforation associated with th...
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/PMC9640463/ https://www.ncbi.nlm.nih.gov/pubmed/35739438 http://dx.doi.org/10.1007/s10840-022-01277-y |
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author | Andrade, Jason G. Macle, Laurent Bennett, Matthew T. Hawkins, Nathaniel M. Essebag, Vidal Champagne, Jean Roux, Jean-Francois Makanjee, Bhavanesh Tang, Anthony Skanes, Allan Khaykin, Yaariv Morillo, Carlos Jolly, Umjeet Lockwood, Evan Amit, Guy Angaran, Paul Sapp, John Wardell, Stephan Wells, George A. Verma, Atul Deyell, Marc W. |
author_facet | Andrade, Jason G. Macle, Laurent Bennett, Matthew T. Hawkins, Nathaniel M. Essebag, Vidal Champagne, Jean Roux, Jean-Francois Makanjee, Bhavanesh Tang, Anthony Skanes, Allan Khaykin, Yaariv Morillo, Carlos Jolly, Umjeet Lockwood, Evan Amit, Guy Angaran, Paul Sapp, John Wardell, Stephan Wells, George A. Verma, Atul Deyell, Marc W. |
author_sort | Andrade, Jason G. |
collection | PubMed |
description | BACKGROUND: Transseptal puncture to achieve left atrial access is necessary for many cardiac procedures, including atrial fibrillation ablation. More recently, there has been an increasing need for left atrial access using large caliber sheaths, which increases risk of perforation associated with the initial advancement into the left atrium. We compared the effectiveness of a radiofrequency needle-based transseptal system versus conventional needle for transseptal access. METHODS: This prospective controlled trial randomized 161 patients with symptomatic paroxysmal atrial fibrillation undergoing cryoballoon pulmonary vein isolation to transseptal access with a commercially available transseptal system (radiofrequency needle plus stiff pigtail wire; RF + Pigtail group) versus conventional transseptal access (standard group). The primary outcome was time required for left atrial access. Secondary outcomes included failure of the assigned transseptal system, radiation exposure, and complications. RESULTS: The median transseptal puncture time was significantly shorter using the radiofrequency needle plus stiff pigtail wire transseptal system compared with conventional transseptal (840 ± 323 vs. 956 ± 407 s, P = 0.0489). Compared to conventional transseptal puncture, fewer transseptal attempts were required (1.0 ± 0.5 RF applications vs. 1.3 ± 0.8 mechanical punctures, P = 0.0123) and the fluoroscopy time was significantly shorter (72.0 [IQR 48.0, 129.0] vs. 93.0 [IQR 60.0, 171.0] s, P = 0.0490) with the radiofrequency needle plus stiff pigtail wire transseptal system. Failure to achieve transseptal LA access with the assigned system was rarely observed (1.3% vs. 5.7%, P = 0.2192). There were no procedural complications observed with either system. CONCLUSIONS: The use of a radiofrequency needle plus stiff pigtail wire resulted in shorter time to left atrial access and reduced fluoroscopy time compared to left atrial access using conventional transseptal equipment. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03199703. |
format | Online Article Text |
id | pubmed-9640463 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-96404632022-11-15 Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial Andrade, Jason G. Macle, Laurent Bennett, Matthew T. Hawkins, Nathaniel M. Essebag, Vidal Champagne, Jean Roux, Jean-Francois Makanjee, Bhavanesh Tang, Anthony Skanes, Allan Khaykin, Yaariv Morillo, Carlos Jolly, Umjeet Lockwood, Evan Amit, Guy Angaran, Paul Sapp, John Wardell, Stephan Wells, George A. Verma, Atul Deyell, Marc W. J Interv Card Electrophysiol Article BACKGROUND: Transseptal puncture to achieve left atrial access is necessary for many cardiac procedures, including atrial fibrillation ablation. More recently, there has been an increasing need for left atrial access using large caliber sheaths, which increases risk of perforation associated with the initial advancement into the left atrium. We compared the effectiveness of a radiofrequency needle-based transseptal system versus conventional needle for transseptal access. METHODS: This prospective controlled trial randomized 161 patients with symptomatic paroxysmal atrial fibrillation undergoing cryoballoon pulmonary vein isolation to transseptal access with a commercially available transseptal system (radiofrequency needle plus stiff pigtail wire; RF + Pigtail group) versus conventional transseptal access (standard group). The primary outcome was time required for left atrial access. Secondary outcomes included failure of the assigned transseptal system, radiation exposure, and complications. RESULTS: The median transseptal puncture time was significantly shorter using the radiofrequency needle plus stiff pigtail wire transseptal system compared with conventional transseptal (840 ± 323 vs. 956 ± 407 s, P = 0.0489). Compared to conventional transseptal puncture, fewer transseptal attempts were required (1.0 ± 0.5 RF applications vs. 1.3 ± 0.8 mechanical punctures, P = 0.0123) and the fluoroscopy time was significantly shorter (72.0 [IQR 48.0, 129.0] vs. 93.0 [IQR 60.0, 171.0] s, P = 0.0490) with the radiofrequency needle plus stiff pigtail wire transseptal system. Failure to achieve transseptal LA access with the assigned system was rarely observed (1.3% vs. 5.7%, P = 0.2192). There were no procedural complications observed with either system. CONCLUSIONS: The use of a radiofrequency needle plus stiff pigtail wire resulted in shorter time to left atrial access and reduced fluoroscopy time compared to left atrial access using conventional transseptal equipment. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03199703. Springer US 2022-06-24 2022 /pmc/articles/PMC9640463/ /pubmed/35739438 http://dx.doi.org/10.1007/s10840-022-01277-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Andrade, Jason G. Macle, Laurent Bennett, Matthew T. Hawkins, Nathaniel M. Essebag, Vidal Champagne, Jean Roux, Jean-Francois Makanjee, Bhavanesh Tang, Anthony Skanes, Allan Khaykin, Yaariv Morillo, Carlos Jolly, Umjeet Lockwood, Evan Amit, Guy Angaran, Paul Sapp, John Wardell, Stephan Wells, George A. Verma, Atul Deyell, Marc W. Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial |
title | Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial |
title_full | Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial |
title_fullStr | Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial |
title_full_unstemmed | Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial |
title_short | Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial |
title_sort | randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the cryo-lats trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9640463/ https://www.ncbi.nlm.nih.gov/pubmed/35739438 http://dx.doi.org/10.1007/s10840-022-01277-y |
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