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, 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

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.

Keywords: Catheter ablation; Radiofrequency; Transseptal puncture.

Conflict of interest statement

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.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Repositioning attempts (A) and number of punctures (B) required for left atrial access
Fig. 2
Fig. 2
Transseptal puncture procedure time by assigned group. Plots show the mean and standard deviation. Total time to cryoballoon entry was defined as time from the first pull-down of the needle/sheath/dilator apparatus from the superior vena cava to first entrance of the cryoballoon catheter into the left atrium. Transseptal access was defined as the time from first pull-down to first entrance of the transseptal sheath into the left atrium. FlexCath entry to LA was defined as the time from engagement of the interatrial septum to FlexCath advancement into the left atrium. Times are inclusive of crossover time
Fig. 3
Fig. 3
Fluoroscopy time by assigned group. Plots show the median with 95% confidence interval. Total time to cryoballoon entry was defined as time from the first pull-down of the needle/sheath/dilator apparatus from the superior vena cava to first entrance of the cryoballoon catheter into the left atrium. Transseptal access was defined as the time from first pull-down to first entrance of the transseptal sheath into the left atrium. FlexCath entry to LA was defined as the time from engagement of the interatrial septum to FlexCath advancement into the left atrium. Times are inclusive of crossover time
Fig. 4
Fig. 4
Transseptal puncture location. The distribution of transseptal puncture location for patients undergoing echocardiographically guided transseptal access. An inferior-anterior position is more desirable for cryoballoon ablation procedures due to difficulty engaging the right inferior pulmonary vein with the deflectable sheath

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Source: PubMed

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