Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial

Jason G. Andrade; Laurent Macle; Matthew T. Bennett; Nathaniel M. Hawkins; Vidal Essebag; Jean Champagne; Jean Francois Roux; Bhavanesh Makanjee; Anthony Tang; Allan Skanes; Yaariv Khaykin; Carlos Morillo; Umjeet Jolly; Evan Lockwood; Guy Amit; Paul Angaran; John Sapp; Stephan Wardell; George A. Wells; Atul Verma; Marc W. Deyell

doi:10.1007/s10840-022-01277-y

Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial

Jason G. Andrade, Laurent Macle, Matthew T. Bennett, Nathaniel M. Hawkins, Vidal Essebag, Jean Champagne, Jean Francois Roux, Bhavanesh Makanjee, Anthony Tang, Allan Skanes, Yaariv Khaykin, Carlos Morillo, Umjeet Jolly, Evan Lockwood, Guy Amit, Paul Angaran, John Sapp, Stephan Wardell, George A. Wells, Atul VermaMarc W. Deyell

Medicine

Résultat de recherche: Article › examen par les pairs

14 Citations (Scopus)

Résumé

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.

Langue d'origine	English
Journal	Journal of Interventional Cardiac Electrophysiology
DOI	https://doi.org/10.1007/s10840-022-01277-y
Statut de publication	Accepted/In press - 2022

Note bibliographique

Funding Information:
The Cryoballoon-Left Atrial Transseptal (CRYO-LATS) study was funded by a peer-reviewed grant from the Cardiac Arrhythmia Network of Canada, with additional financial support from Baylis Medical. Drs. Andrade and Deyell are supported by a Michael Smith Foundation for Health Research Scholar Award. Dr. Essebag is supported by a Clinical Research Scholar Award from the Fonds de recherche du Québec-Santé (FRQS). The funding sources had no role in the design of this study and did not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

Funding Information:
Dr. Andrade reports grants and personal fees from Medtronic, grants from Baylis, personal fees from Biosense-Webster; Dr. M Bennett reports grants from Medtronic, outside the submitted work; Dr. V Essebag reports personal fees from Biosense, Abbott, and Medtronic; Dr. L Macle reports grants and personal fees from Biosense-Webster and BMS-Pfizer; Dr. J Champagne has nothing to disclose; Dr. J-F Roux reports personal fees from Biosense-Webster and Medtronic; Dr. B Makanjee has nothing to disclose; Dr. A Skanes has nothing to disclose; Dr. Khaykin has nothing to disclose; Dr. C Morillo reports grants and personal fees from Medtronic and Abbott, and personal fees from Novartis; Dr. U Jolly has nothing to disclose; Dr E Lockwood reports personal fees from Bayer and Pfizer-BMS; Dr G Amit reports personal fees from Johnson and Johnson and St Jude Medical; Dr P Angaran reports grants from Servier Canada and Pfizer; Dr. J Sapp reports personal fees from Medtronic, grants and personal fees from Abbott and Biosense Webster; Dr S Wardell reports grants from Medtronic Canada and Baylis Medical; Dr. S Lauck has nothing to disclose; Dr. G Wells has nothing to disclose; Dr. A Verma reports grant support from Biotronik, Bristol Meyers Squibb, Boehringer Ingelheim, grant support, advisory board fees, and lecture fees from Bayer and Biosense Webster, advisory board fees, lecture fees and principal investigator (PULSED AF and DIAMOND II trial) from Medtronic, consulting fees and steering committees from Boston Scientific, Kardium, Medlumics, and Thermedical, and lecture fees from Servier. Dr. Deyell reports grants from Biosense-Webster; Dr Essebag reports personal fees from Abbott, Biosense-Webster, and Medtronic.

Publisher Copyright:
© 2022, The Author(s).

ASJC Scopus Subject Areas

Cardiology and Cardiovascular Medicine
Physiology (medical)

PubMed: MeSH publication types

Journal Article
Randomized Controlled Trial

Accès au document

10.1007/s10840-022-01277-y

Autres fichiers et liens

Citer

Andrade, J. G., Macle, L., Bennett, M. T., Hawkins, N. M., Essebag, V., Champagne, J., Roux, J. F., Makanjee, B., Tang, A., Skanes, A., Khaykin, Y., Morillo, C., Jolly, U., Lockwood, E., Amit, G., Angaran, P., Sapp, J., Wardell, S., Wells, G. A., ... Deyell, M. W. (Accepter/ En production). Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial. Journal of Interventional Cardiac Electrophysiology. https://doi.org/10.1007/s10840-022-01277-y

Andrade, JG, Macle, L, Bennett, MT, Hawkins, NM, Essebag, V, Champagne, J, Roux, JF, Makanjee, B, Tang, A, Skanes, A, Khaykin, Y, Morillo, C, Jolly, U, Lockwood, E, Amit, G, Angaran, P, Sapp, J, Wardell, S, Wells, GA, Verma, A & Deyell, MW 2022, 'Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial', Journal of Interventional Cardiac Electrophysiology. https://doi.org/10.1007/s10840-022-01277-y

@article{c09ea976a889427486722db1fcc18f7a,

title = "Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial",

abstract = "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.",

author = "Andrade, {Jason G.} and Laurent Macle and Bennett, {Matthew T.} and Hawkins, {Nathaniel M.} and Vidal Essebag and Jean Champagne and Roux, {Jean Francois} and Bhavanesh Makanjee and Anthony Tang and Allan Skanes and Yaariv Khaykin and Carlos Morillo and Umjeet Jolly and Evan Lockwood and Guy Amit and Paul Angaran and John Sapp and Stephan Wardell and Wells, {George A.} and Atul Verma and Deyell, {Marc W.}",

note = "Funding Information: The Cryoballoon-Left Atrial Transseptal (CRYO-LATS) study was funded by a peer-reviewed grant from the Cardiac Arrhythmia Network of Canada, with additional financial support from Baylis Medical. Drs. Andrade and Deyell are supported by a Michael Smith Foundation for Health Research Scholar Award. Dr. Essebag is supported by a Clinical Research Scholar Award from the Fonds de recherche du Qu{\'e}bec-Sant{\'e} (FRQS). The funding sources had no role in the design of this study and did not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Funding Information: Dr. Andrade reports grants and personal fees from Medtronic, grants from Baylis, personal fees from Biosense-Webster; Dr. M Bennett reports grants from Medtronic, outside the submitted work; Dr. V Essebag reports personal fees from Biosense, Abbott, and Medtronic; Dr. L Macle reports grants and personal fees from Biosense-Webster and BMS-Pfizer; Dr. J Champagne has nothing to disclose; Dr. J-F Roux reports personal fees from Biosense-Webster and Medtronic; Dr. B Makanjee has nothing to disclose; Dr. A Skanes has nothing to disclose; Dr. Khaykin has nothing to disclose; Dr. C Morillo reports grants and personal fees from Medtronic and Abbott, and personal fees from Novartis; Dr. U Jolly has nothing to disclose; Dr E Lockwood reports personal fees from Bayer and Pfizer-BMS; Dr G Amit reports personal fees from Johnson and Johnson and St Jude Medical; Dr P Angaran reports grants from Servier Canada and Pfizer; Dr. J Sapp reports personal fees from Medtronic, grants and personal fees from Abbott and Biosense Webster; Dr S Wardell reports grants from Medtronic Canada and Baylis Medical; Dr. S Lauck has nothing to disclose; Dr. G Wells has nothing to disclose; Dr. A Verma reports grant support from Biotronik, Bristol Meyers Squibb, Boehringer Ingelheim, grant support, advisory board fees, and lecture fees from Bayer and Biosense Webster, advisory board fees, lecture fees and principal investigator (PULSED AF and DIAMOND II trial) from Medtronic, consulting fees and steering committees from Boston Scientific, Kardium, Medlumics, and Thermedical, and lecture fees from Servier. Dr. Deyell reports grants from Biosense-Webster; Dr Essebag reports personal fees from Abbott, Biosense-Webster, and Medtronic. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

doi = "10.1007/s10840-022-01277-y",

language = "English",

journal = "Journal of Interventional Cardiac Electrophysiology",

issn = "1383-875X",

publisher = "Springer Netherlands",

}

TY - JOUR

T1 - Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation

T2 - the CRYO-LATS trial

AU - Andrade, Jason G.

AU - Macle, Laurent

AU - Bennett, Matthew T.

AU - Hawkins, Nathaniel M.

AU - Essebag, Vidal

AU - Champagne, Jean

AU - Roux, Jean Francois

AU - Makanjee, Bhavanesh

AU - Tang, Anthony

AU - Skanes, Allan

AU - Khaykin, Yaariv

AU - Morillo, Carlos

AU - Jolly, Umjeet

AU - Lockwood, Evan

AU - Amit, Guy

AU - Angaran, Paul

AU - Sapp, John

AU - Wardell, Stephan

AU - Wells, George A.

AU - Verma, Atul

AU - Deyell, Marc W.

N1 - Funding Information: The Cryoballoon-Left Atrial Transseptal (CRYO-LATS) study was funded by a peer-reviewed grant from the Cardiac Arrhythmia Network of Canada, with additional financial support from Baylis Medical. Drs. Andrade and Deyell are supported by a Michael Smith Foundation for Health Research Scholar Award. Dr. Essebag is supported by a Clinical Research Scholar Award from the Fonds de recherche du Québec-Santé (FRQS). The funding sources had no role in the design of this study and did not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Funding Information: Dr. Andrade reports grants and personal fees from Medtronic, grants from Baylis, personal fees from Biosense-Webster; Dr. M Bennett reports grants from Medtronic, outside the submitted work; Dr. V Essebag reports personal fees from Biosense, Abbott, and Medtronic; Dr. L Macle reports grants and personal fees from Biosense-Webster and BMS-Pfizer; Dr. J Champagne has nothing to disclose; Dr. J-F Roux reports personal fees from Biosense-Webster and Medtronic; Dr. B Makanjee has nothing to disclose; Dr. A Skanes has nothing to disclose; Dr. Khaykin has nothing to disclose; Dr. C Morillo reports grants and personal fees from Medtronic and Abbott, and personal fees from Novartis; Dr. U Jolly has nothing to disclose; Dr E Lockwood reports personal fees from Bayer and Pfizer-BMS; Dr G Amit reports personal fees from Johnson and Johnson and St Jude Medical; Dr P Angaran reports grants from Servier Canada and Pfizer; Dr. J Sapp reports personal fees from Medtronic, grants and personal fees from Abbott and Biosense Webster; Dr S Wardell reports grants from Medtronic Canada and Baylis Medical; Dr. S Lauck has nothing to disclose; Dr. G Wells has nothing to disclose; Dr. A Verma reports grant support from Biotronik, Bristol Meyers Squibb, Boehringer Ingelheim, grant support, advisory board fees, and lecture fees from Bayer and Biosense Webster, advisory board fees, lecture fees and principal investigator (PULSED AF and DIAMOND II trial) from Medtronic, consulting fees and steering committees from Boston Scientific, Kardium, Medlumics, and Thermedical, and lecture fees from Servier. Dr. Deyell reports grants from Biosense-Webster; Dr Essebag reports personal fees from Abbott, Biosense-Webster, and Medtronic. Publisher Copyright: © 2022, The Author(s).

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85132069026&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85132069026&partnerID=8YFLogxK

U2 - 10.1007/s10840-022-01277-y

DO - 10.1007/s10840-022-01277-y

M3 - Article

C2 - 35739438

AN - SCOPUS:85132069026

SN - 1383-875X

JO - Journal of Interventional Cardiac Electrophysiology

JF - Journal of Interventional Cardiac Electrophysiology

ER -

Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial

Résumé

Note bibliographique

ASJC Scopus Subject Areas

PubMed: MeSH publication types

Accès au document

Autres fichiers et liens

Empreinte numérique

Citer