Zero-exchange workflow for cryoballoon ablation in pulmonary vein isolation using a direct over-the-needle transseptal access with the FlexCath sheath: A multicenter observational study
Abstract
Background: Transseptal puncture (TSP) is a crucial step during cryoballoon ablation (CBA) allowing for left atrium access. During the procedure an over-the-wire sheath exchange is required, which brings concerns about the exchange-related complications. An alternative option is performing the TSP through a steerable sheath and thus avoiding the exchange.
Aims: We aimed to evaluate the feasibility, efficacy and safety of a simplified zero-exchange workflow for CBA procedure.
Methods: Patients undergoing CBA (with Arctic Front Advance Pro, Medtronic) at 3 centers in Poland were prospectively enrolled and assigned to the standard approach (N=62) or the no-exchange group (N=62). The TSP in the standard approach group was performed through a fixed-curve sheath that was exchanged for a 15F steerable sheath (FlexCath Advance, Medtronic). In the no-exchange group the puncture was performed through the steerable sheath.
Results: TSP was successfully performed in all patients. In the no-exchange group compared to the standard approach group the median (IQR) procedure time and left atrium dwell time were significantly shorter (75.0 (60.0 - 90.0) min vs 80.5 (70.0 - 100.0) min; P = 0.02 and 47 (40.0 - 56.0) min vs 51.5 (43.25 - 64.5) min, P = 0.04 , respectively) with comparable median (IQR) fluoroscopy time (14.0 (8.5 - 20.4) min vs 12.25 (10.0 - 17.6) min, P = 0.74). Only one potentially TSP-related complication has occurred in each group.
Conclusion: A direct TSP with the FlexCath Advance sheath is a feasible, safe and efficient alternative to the standard approach.
Keywords: cryoballoon ablationpulmonary vein isolationtransseptal puncturezero-exchange workflow
References
- Andrade JG, Khairy P, Guerra PG, et al. Efficacy and safety of cryoballoon ablation for atrial fibrillation: A systematic review of published studies. Heart Rhythm. 2011; 8(9): 1444–1451.
- Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024; 45(36): 3314–3414.
- Russo G, Taramasso M, Maisano F. Transseptal puncture: Procedural guidance, challenging situations and management of complications. EuroIntervention. 2021; 17(9): 720–727.
- Tzeis S, Gerstenfeld EP, Kalman J, et al. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation. Europace. 2024; 26(4): euae043.
- Denysiuk P, Denysiuk A, Szczasny M, et al. Transseptal puncture for left atrial access in invasive procedures — state of the art review. Acta Angiologica. 2024; 30(2): 79–91.
- Ströker E, De Greef Y, Schwagten B, et al. Over-the-needle trans-septal access using the cryoballoon delivery sheath and dilator in atrial fibrillation ablation. Pacing Clin Electrophysiol. 2019; 42(7): 868–873.
- Yap SC, Bhagwandien RE, Szili-Torok T. Use of a novel integrated dilator-needle system in cryoballoon procedures: A zero-exchange approach. J Interv Card Electrophysiol. 2022; 65(2): 527–534.
- Tomaiko E, Ahmad Z, Su W. Eliminating transseptal catheter exchange during cryoballoon ablation with the safesept transseptal guidewire in flexcath sheath. J Am Coll Cardiol. 2019; 73(9 Suppl 1): 429.
- Denysiuk P, Szczasny M, Głowniak A, et al. Zero‑exchange approach using a steerable FlexCath Advance sheath for direct transseptal access in cryoballoon ablation for pulmonary vein isolation – case study. In Good Rythm. 2022; 2(63): 26–29.
- Bejinariu AG, Spieker M, Makimoto H, et al. A zero-exchange approach for left atrial access in pulmonary vein isolation with pulsed field ablation. J Cardiovasc Electrophysiol. 2024; 35(4): 688–693.
- Kueffer T, Madaffari A, Thalmann G, et al. Eliminating transseptal sheath exchange for pulsed field ablation procedures using a direct over-the-needle transseptal access with the Faradrive sheath. Europace. 2023; 25(4): 1500–1502.
- Marcus GM, Ren X, Tseng ZH, et al. Repeat transseptal catheterization after ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2007; 18(1): 55–59.
- Hu YF, Tai CT, Lin YJ, et al. The change in the fluoroscopy-guided transseptal puncture site and difficult punctures in catheter ablation of recurrent atrial fibrillation. Europace. 2008; 10(3): 276–279.
- Tomlinson DR, Sabharwal N, Bashir Y, et al. Interatrial septum thickness and difficulty with transseptal puncture during redo catheter ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2008; 31(12): 1606–1611.
- Kaczmarek K, Kuniewicz M, Romanek J, et al. Real-world experience with cryoballoon ablation for treatment of atrial fibrillation in Poland: 24-month outcomes from the Cryo Global Registry. Pol Heart J. 2024; 82(5): 540–542.
- Jiang J, Li J, Zhong G, et al. Efficacy and safety of the second-generation cryoballoons versus radiofrequency ablation for the treatment of paroxysmal atrial fibrillation: A systematic review and meta-analysis. J Interv Card Electrophysiol. 2017; 48(1): 69–79.
- Glowniak A, Tarkowski A, Jaroszyńska A, et al. Transient symptomatic ST-segment elevation following transseptal puncture for pulmonary vein isolation. Prog Med. 2015; 28(8): 567–569.
- Brignole M, Aksu T, Calò L, et al. Clinical controversy: Methodology and indications of cardioneuroablation for reflex syncope. Europace. 2023; 25(5): euad033.
- Xiao FY, Ju WZ, Chen HW, et al. A comparative study of pericardial effusion and pleural effusion after cryoballoon ablation or radiofrequency catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2020; 31(5): 1062–1067.
- Chierchia GB, Capulzini L, Droogmans S, et al. Pericardial effusion in atrial fibrillation ablation: A comparison between cryoballoon and radiofrequency pulmonary vein isolation. Europace. 2010; 12(3): 337–341.
- Glowniak A, Tarkowski A, Janczarek M, et al. Silent cerebral infarcts following pulmonary vein isolation with different atrial fibrillation ablation techniques — incidence and risk factors. Arch Med Sci. 2022; 18(3): 632–638.
