Vol. 29 No. 2 (2025)
CASE REPORTS

The first use of POLARx FIT cryoballoon catheter with adjustable diameter: case series

pdf (Русский)
  • Yuri Virstyuk,
  • Zaur Shugushev
Yuri Virstyuk
ЧУЗ ЦКБ РЖД-Медицина
Zaur Shugushev
Русский
DOI: https://doi.org/10.21688/1681-3472-2025-2-37-46

Published 2025-10-08

Keywords

  • Atrial fibrillation; Catheter ablation; Cryoballoon ablation

How to Cite

Virstyuk, Y. ., & Shugushev, Z. (2025). The first use of POLARx FIT cryoballoon catheter with adjustable diameter: case series. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 29(2), 37–46. https://doi.org/10.21688/1681-3472-2025-2-37-46

Copyright (c) 2025 Юрий Вирстюк, Заурбек Шугушев

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

Objective: The study was aimed to present the first clinical experience of using the POLARx FIT cryobalon catheter with adjustable diameter for cryoballoon ablation (CBA) in patients with atrial fibrillation (AF) in the Russian Federation.

Methods: We describe three clinical procedures of cryoballoon ablation performed in two patients with paroxysmal AF and a patient with persistent AF. Transesophageal echocardiography was conducted prior to the procedure to exclude intracardiac thrombi. The CBA procedure utilized a catheter with dual diameters (28 mm and 31 mm). Each pulmonary vein was isolated using a single balloon application provided by classical pulmonary vein entry into the left atrium with verification by fluoroscopic control and construction of activation maps of the left atrium. In case of a common ostium of the left pulmonary veins, segmental stepwise cryoablation was performed, followed by construction of an activation map of the left atrium.

Results: All procedures were successfully accomplished without complications. Stable isolation of the pulmonary veins was achieved in 100% of cases. Time-to-isolation (TTI) was recorded in 10 out of 12 pulmonary veins. The 31 mm diameter was recorded to provide a more antral isolation and facilitated this procedure in patients with complex pulmonary vein anatomy.

Conclusion: The POLARx FIT cryoballoon catheter with adjustable diameter appears to be a promising innovation in the treatment of arrhythmias. The adaptability of the unit to various patient anatomical features may enhance long-term therapeutic outcomes.

pdf (Русский)

References

  1. Hart R.G., Benavente O., McBride R., Pearce L.A. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med. 1999 Oct 5;131(7):492-501. PMID: 10507957. https://doi.org/10.7326/0003-4819-131-7-199910050-00003
  2. Isabelle C. Van Gelder, Michiel Rienstra, Karina V. Bunting, Ruben Casado-Arroyo, Valeria Caso, Harry J. G. M. Crijns, Tom J. R. De Potter, Jeremy Dwight, Luigina Guasti, Thorsten Hanke, Tiny Jaarsma, Maddalena Lettino, Maja-Lisa Løchen, R. Thomas Lumbers, Bart Maesen, Inge Mølgaard, Giuseppe M.C. Rosano, Prashanthan Sanders, Renate B. Schnabel, Piotr Suwalski, Emma Svennberg, Juan Tamargo, Otilia Tica, Vassil Traykov, Stylianos Tzeis, Dipak Kotecha, ESC Scientific Document Group, 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): Developed by the task force for the management of atrial fibrillation of the European Society of Cardiology (ESC), with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Endorsed by the European Stroke Organisation (ESO). European Heart Journal. 2024; 45(36):3314– 3414. https://doi.org/10.1093/eurheartj/ehae176
  3. Lemola K., Dubuc M., Khairy P. Transcatheter cryoablation part II: clinical utility. Pacing Clin Electrophysiol. 2008 Feb;31(2):235-44. PMID: 18233979. https://doi.org/10.1111/j.1540-8159.2007.00975.x
  4. Andrew P., Hamad Y., Jerat S., Montenero A., O'Connor S. Approaching a decade of cryo catheter ablation for type 1 atrial flutter-a meta-analysis and systematic review. J Interv Card Electrophysiol. 2011 Oct;32(1):17-27. Epub 2011 Jun 11. PMID: 21667098. https://doi.org/10.1007/s10840-011-9582-0
  5. Kuck K.H., Brugada J., Fürnkranz A., Metzner A., Ouyang F., Chun K.R., Elvan A., Arentz T., Bestehorn K., Pocock S.J., Albenque J.P., Tondo C.; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. Epub 2016 Apr 4. PMID: 27042964. https://doi.org/10.1056/NEJMoa1602014
  6. Andrade J.G., Champagne J., Dubuc M., Deyell M.W., Verma A., Macle L., Leong-Sit P., Novak P., Badra-Verdu M., Sapp J., Mangat I., Khoo C., Steinberg C., Bennett M.T., Tang A.S.L, Khairy P.; CIRCA-DOSE Study Investigators. Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial. Circulation. 2019 Nov 26;140(22):1779-1788. Epub 2019 Oct 21. PMID: 31630538. https://doi.org/10.1161/ CIRCULATIONAHA.119.042622
  7. Leitz P., Mönnig G., Güner F., Dechering D.G., Wasmer K., Reinke F., Lange P.S., Eckardt L., Frommeyer G.. Comparing learning curves of two established "single-shot" devices for ablation of atrial fibrillation. J Interv Card Electrophysiol. 2018 Dec;53(3):317-322. Epub 2018 Apr 20. PMID: 29679185. https://doi.org/10.1007/s10840-018-0361-z
  8. Creta A., Kanthasamy V., Schilling R.J., Rosengarten J., Khan F., Honarbakhsh S., Earley M.J., Hunter R.J., Finlay M. First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison. J Cardiovasc Electrophysiol. 2021 Apr;32(4):925-930. Epub 2021 Mar 4. PMID: 33590568. https://doi.org/10.1111/jce.14951
  9. Yap S.C., Anic A., Breskovic T., Haas A., Bhagwandien R.E., Jurisic Z., Szili-Torok T., Luik A. Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience. J Cardiovasc Electrophysiol. 2021 Mar;32(3):580-587. Epub 2021 Feb 1. PMID: 33492749; PMCID: PMC7986676. https://doi.org/10.1111/jce.14915
  10. Heeger C.H., Pott A., Sohns C., Riesinger L., Sommer P., Gasperetti A., Tondo C., Fassini G., Moser F., Lucas P., Weinmann K., Bohnen J.E., Dahme T., Rillig A., Kuck K.H., Wakili R., Metzner A., Tilz R.R. Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study. Europace. 2022 Dec 9;24(12):1917-1925. PMID: 36026521; PMCID: PMC9733956. https://doi.org/10.1093/europace/euac148
  11. Martin C.A., Tilz R.R.R., Anic A., Defaye P., Luik A., de Asmundis C., Champ-Rigot L., Iacopino S., Sommer P., Albrecht E.M., Raybuck J.D., Richards E., Cielen N., Yap S.C.; POLAR ICE Investigators. Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study. J Cardiovasc Electrophysiol. 2023 Apr;34(4):833-840. Epub 2023 Feb 23. PMID: 36786515. https://doi.org/10.1111/jce.15861
  12. Tilz R.R., Meyer-Saraei R., Eitel C., Fink T., Sciacca V., Lopez L.D., Kirstein B., Schlüter M., Vogler J., Kuck K.H., Heeger C.H. Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation - The Prospective ICE-AGE-X Study. Circ J. 2021 Jul 21;85(8):1296-1304. Epub 2021 Apr 13. PMID: 33854004. https://doi.org/10.1253/circj.CJ-21-0094
  13. Beiert T., Lodde P.C., Linneborn L.P.T., Werner J., Prinz L., Stöckigt F., Linhart M., Lickfett L., Nickenig G., Schrickel J.W., Andrié R.P. Outcome in patients with left common pulmonary vein after cryoablation with second-generation cryoballoon. Pacing Clin Electrophysiol. 2018 Jan;41(1):22-27. Epub 2017 Dec 28. PMID: 29211301. https://doi.org/10.1111/pace.13247
  14. Rovaris G., Ciconte G., Schiavone M., Mitacchione G., Gasperetti A., Piazzi E., Negro G., Montemerlo E., Rondine R., Pozzi M., Casiraghi M., De Ceglia S., Giacopelli D., Viecca M., Vicedomini G., Forleo G.B., Pappone C. Second-generation laser balloon ablation for the treatment of atrial fibrillation assessed by continuous rhythm monitoring: the LIGHT-AF study. Europace. 2021 Sep 8;23(9):1380-1390. PMID: 33837418. https://doi.org/10.1093/europace/euab085
  15. Tanese N., Almorad A., Pannone L., Defaye P., Jacob S., Kilani M.B., Chierchia G., Venier S., Cardin C., Jacon P., Combes S., Deschamps E., Menè R., de Asmundis C., Boveda S. Outcomes after cryoballoon ablation of paroxysmal atrial fibrillation with the PolarX or the Arctic Front Advance Pro: a prospective multicentre experience. Europace. 2023 Mar 30;25(3):873-879. PMID: 36695332; PMCID: PMC10062287. https://doi.org/10.1093/europace/euad005
  16. Kochi A.N., Moltrasio M., Tundo F., Riva S., Ascione C., Dessanai M.A., Pizzamiglio F., Vettor G., Cellucci S., Gasperetti A., Tondo C., Fassini G. Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform. J Cardiovasc Electrophysiol. 2021 Mar;32(3):588-594. Epub 2021 Feb 10. PMID: 33537996. https://doi.org/10.1111/jce.14930
  17. Assaf A., Bhagwandien R.E., Szili-Torok T., Yap S.C. Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis. Int J Cardiol Heart Vasc. 2022 Sep 5;42:101115. PMID: 36097550; PMCID: PMC9463571. https://doi.org/10.1016/j.ijcha.2022.101115
  18. Sorgente A., Chierchia G.B., de Asmundis C., Sarkozy A., Namdar M., Capulzini L., Yazaki Y., Müller-Burri S.A., Bayrak F., Brugada P. Pulmonary vein ostium shape and orientation as possible predictors of occlusion in patients with drug- refractory paroxysmal atrial fibrillation undergoing cryoballoon ablation. Europace. 2011 Feb;13(2):205-12. Epub 2010 Oct 25. PMID: 20974756. https://doi.org/10.1093/ europace/euq388
  19. Kajiyama T., Miyazaki S., Matsuda J., Watanabe T., Niida T., Takagi T., Nakamura H., Taniguchi H., Hachiya H., Iesaka Y. Anatomic Parameters Predicting Procedural Difficulty and Balloon Temperature Predicting Successful Applications in Individual Pulmonary Veins During 28-mm Second- Generation Cryoballoon Ablation. JACC Clin Electrophysiol. 2017 Jun;3(6):580-588. Epub 2017 Mar 29. PMID: 29759431. https://doi.org/10.1016/j.jacep.2017.01.004
  20. Frommeyer G., Ellermann C., Wolfes J., Lange P.S., Güner F., Eckardt L. Feasibility and efficacy of a novel size adjustable cryoballoon for ablation of atrial fibrillation. J Interv Card Electrophysiol. 2024 Mar;67(2):253-255. Epub 2023 Sep 16. PMID: 37715834; PMCID: PMC10902017. https://doi.org/10.1007/s10840-023-01645-2
  21. Conte G., Soejima K., de Asmundis C., Chierchia G.B., Badini M., Miwa Y., Caputo M.L., Özkartal T., Maffessanti F., Sieira J., Degreef Y., Stroker E., Regoli F., Moccetti T., Brugada P., Auricchio A. Value of high-resolution mapping in optimizing cryoballoon ablation of atrial fibrillation. Int J Cardiol. 2018 Nov 1;270:136-142. Epub 2018 Jun 1. PMID: 29929934. https://doi.org/10.1016/j.ijcard.2018.05.135
  22. Millenaar D., Becker N., Pavlicek V., Wintrich J., Böhm M., Mahfoud F., Ukena C. Inducibility of atrial fibrillation after catheter ablation predicts recurrences of atrial fibrillation: a meta-analysis. Pacing Clin Electrophysiol. 2021 Apr;44(4):667- 676. Epub 2021 Mar 17. PMID: 33686680. https://doi.org/10.1111/pace.14216
  23. García-Bolao I., Ballesteros G., Ramos P., Menéndez D., Erkiaga A., Neglia R., Jiménez Martín M., Vives-Rodríguez E. Identification of pulmonary vein reconnection gaps with high-density mapping in redo atrial fibrillation ablation procedures. Europace. 2018 Nov 1;20(FI_3):f351-f358. PMID: 28637187. https://doi.org/10.1093/europace/eux184
  24. Рачкова Ю.И., Сергеева О.А., Горев М.В., Нардая Ш.Г., Гайду- кова Н.А., Петелько С.В., Макарычева О.В., Долгинина С.И., Рзаев Ф.Г., Васильева Е.Ю., Шпектор А.В. Влияние допол- нительных воздействий в левом предсердии на эффек- тивность криобаллонной аблации у пациентов с парок- сизмальной формой фибрилляции предсердий. Вестник аритмологии. 2023;30(2):27-34. https://doi.org/10.35336/VA-2023-2-04 Rachkova Iu.I, Sergeeva O.A, Gorev M.V, Nardaia Sh.G, Gaidukova N.A, Petelko S.V, Makarycheva O.V, Dolginina S.I, Rzaev F.G, Vasilieva E.Yu, Shpektor A.V. Additional left atrial lesions improve the effect of cryoballoon pulmonary vein isolation in paroxysmal atrial fibrillation patients. Journal of Arrhythmology. 2023;30(2):27-34. https://doi.org/10.35336/VA-2023-2-04