Russian registry of cryoballon ablation of atrial fibrillation: characteristics of the procedure and features of patient’s management

Aim. To study the characteristics of the atrial fibrillation (AF) cryoballoon ablation (CBA) procedure and features of patient’s management in real clinical practice in Russia.

Methods. “Prospective Atrial Fibrillation Cryoablation Registry” is an observational prospective national multicenter study. It was conducted from 01.2017 to 12.2019 in centers of Russian Federation. The registry included patients over the age of 18 who were agreed to participate this study and had indications for CBA of AF. The study protocol did not provide for significant restrictions on inclusion criteria, procedure technique and postoperative follow-up. The data was collected prior to the CBA of AF, during hospitalization for CBA and on the 12-month follow-up.

Results. Participating centers enroll 980 patients according to inclusion criteria. CBA of AF was performed in 976 (99.6%) (mean age 59.7±9.2 years, 545 (55.8%) men) primary procedure - 840 (86.1%), re-ablation - 136 (13.9%). Parox- ysmal AF occurred in 828 (84.8%) patients and persistent AF (mean time of persistence 4.4±3.7 months) - in 145 (15.1%) patients. The average procedure time was 108.1±33.3 minutes and mean fluoroscopy time was 24.9±13.6 min. Most of the procedures were performed under general anesthesia. Complications after AF CBA occurred in 53 (5.4%) patients. The most common complication was paresis of the phrenic nerve - 20 (37.7%) cases which were associated with lower temperatures of CBA application of the right pulmonary veins (τ=0.08; p<0.05). The features of antiarrhythmic and anticoagulant therapy were evaluated. A group of patients without adequate anticoagulant therapy in the postoperative period was identified. Due to COVID-19 restrictions only 374 (38.3%) patients completed 12-month follow-up. The recurrence of arrhythmia was occurred in 85 (22.7%) patients. Multivariate regression analysis revealed the following predictors of arrhythmia recurrence: the first procedure (OR 3.96; p=0.023), male sex (OR 1.77; p=0.014), duration of the procedure (min) (OR 1.01; p=0.007).

Conclusion. CBA is an effective and relatively safe procedure for the treatment of paroxysmal and persistent AF. Data from real clinical practice show a low proportion of serious complications of AF CBA. Data on the dynamics of drug therapy, including anticoagulant and antiarrhythmic therapy, were obtained. The attention of specialists performing AF catheter ablation and patient monitoring is required, since errors in patient management have been identified.

1. Tsao CW, Aday AW, Almarzooq ZI, et al. Heart disease and stroke statistics-2023 update: a report from the American Heart Association. Circulation. 2023;147: e93-e621. https://doi.org/10.1161/CIR.0000000000001123.

2. Yakusevich V.V., Yakusevich V.V., Martsevich S.Yu., et al. Patients with atrial fibrillation in outpatient practice: clinical characteristics and outcomes over a 10-year observation period (data from the REQUAZAAF registrу - Yaroslavl). Rational Pharmacotherapy in Cardiology. 2023;19(5): 486-494. (In Russ.) https://doi.org/10.20996/1819-6446-2023-2945.

3. Ruddox V, Sandven I, Munkhaugen J, et al. Atrial fibrillation and the risk for myocardial infarction, all-cause mortality and heart failure: a systematic review and meta-analysis. European Journal of Preventive Cardiology. 2017;24: 1555-1566. https://doi.org/10.1177/2047487317715769.

4. Kirchhof P, Camm AJ, Goette A, et al. Early rhythm-control therapy in patients with atrial fibrillation. The New England Journal of Medicine. 2020; 383(14): 1305-1316 https://doi.org/2020;383:1305-1316. https://doi.org/10.1056/NEJMoa2019422.

5. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149(1): e1-e156. https://doi.org/10.1161/CIR.0000000000001193.

6. Tzeis S, Gerstenfeld EP, Kalman J, et al. European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2024;21(9): e31-e149. https://doi.org/10.1016/j.hrthm.2024.03.017.

7. Wazni, OM, Dandamudi G, Sood, N, et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. The New England Journal of Medicine. 2021;384(4): 316-324. https://doi.org/10.1056/nejmoa2029554

8. Malte Kuniss, Nikola Pavlovic, Vedran Velagic, et al. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. EP Europace. 2021;23(7): 1033-1041. https://doi.org/10.1093/europace/euab029

9. Kuck, K.-H., Brugada, J., Fürnkranz, A., et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. The New England Journal of Medicine. 2021; 374(23): 2235-2245. https://doi.org/10.1056/nejmoa1602014

10. Andrade, J.G., Dubuc, M., Guerra, P.G., et al. The Biophysics and Biomechanics of Cryoballoon Ablation. Pacing and Clinical Electrophysiology. 2012; 35: 1162-1168. https://doi.org/10.1111/j.1540-8159.2012.03436.x

11. Mikhailov EN, Lyubimtseva TA, Davtyan KV. Cryoablation in atrial fibrillation: rationale of the national prospective registry and preliminary results. Russian Journal of Cardiology. 2018;(7): 21-25. (In Russ.) https://doi.org/10.15829/1560-4071-2018-7-21-25

12. Ferrero-De-Loma-Osorio Á, Cózar R, García-Alberola A, et al. Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study. Scientific Reports. 2021;11(1): 17268. https://doi.org/10.1038/s41598-021-96655-3.

13. Chun KRJ, Okumura K, Scazzuso F, et al. Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real-world global setting: Results from the Cryo AF Global Registry. Journal of Arrhythmia. 2021;37(2): 356-367. https://doi.org/10.1002/joa3.12504.

14. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf22/P220032B.pdf

15. Su WW, Reddy VY, Bhasin K, et al. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020;17(11): 1841-1847. https://doi.org/10.1016/j.hrthm.2020.06.020.

16. Sawhney V, Schilling RJ, Providencia R, et al. Cryoablation for persistent and longstanding persistent atrial fibrillation: results from a multicentre European registry. EP Europace. 2020;22(3): 375-381. https://doi.org/10.1093/europace/euz313.

17. Mikhailov EN, Lebedev DS, Pokushalov EA et al. Cryoballoon ablation in russian sites of interventional atrial fibrillation management treatment: results of the first nationwide survey. Russian Journal of Cardiology. 2015;(11): 86-91. (In Russ.) https://doi.org/10.15829/1560-4071-2015-11-86-91

18. Chew DS, Black-Maier E, Loring Z, et al. Diagnosis-to-ablation time and recurrence of atrial fibrillation following catheter ablation: a systematic review and meta-analysis of observational. Circulation. Arrhythmia and electrophysiology. 2020;13(4): e008128. https://doi.org/10.1161/CIRCEP.119.008128

19. Wasserlauf J, Knight BP, Li Z, et al. Moderate Sedation Reduces Lab Time Compared to General Anesthesia during Cryoballoon Ablation for AF Without Compromising Safety or Long-Term Efficacy. Pacing and clinical electrophysiology: PACE. 2016;39(12): 1359-1365. https://doi.org10.1111/pace.12961

20. Wissner E, Heeger CH, Grahn H et al. One-year clinical success of a ‘no-bonus’ freeze protocol using the second-generation 28 mm cryoballoon for pulmonary vein isolation. Europace. 2015;17(8): 1236-40. https://doi.org/10.1093/europace/euv02

21. Straube F, Dorwarth U, Hartl S et al. Outcome of paroxysmal atrial fibrillation ablation with the cryoballoon using two different application times: the 4-versus 3-min protocol. Journal of interventional cardiac electrophysiology: an international journal of arrhythmias and pacing. 2016;45(2): 169-77. https://doi.org/10.1007/s10840-015-0084-3

22. Ciconte G, Sieira-Moret J, Hacioglu E et al. Single 3-Minute versus Double 4-Minute Freeze Strategy for Second-Generation Cryoballoon Ablation: A Single-Center Experience. Journal of cardiovascular electrophysiology. 2016;27(7): 796-803. https://doi.org/10.1111/jce.12986

23. Aryana A, Kenigsberg DN, Kowalski M et al. Verification of a novel atrial fibrillation cryoablation dosing algorithm guided by time-to-pulmonary vein isolation: Results from the Cryo-DOSING Study (Cryoballoon-ablation DOSING Based on the Assessment of Time-to-Effect and Pulmonary Vein Isolation Guidance). Heart rhythm. 2017;14(9): 1319-1325. https://doi.org/10.1016/j.hrthm.2017.06.020

24. Chun KR, Stich M, Fürnkranz A et al. Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial. Heart rhythm. 2017;14(4): 495-500. https://doi.org/10.1016/j.hrthm.2016.12.014

25. Korobchenko LE, Bayramova SA, Kharats VE et al. Antiarrhythmic drug therapy after atrial fibrillation ablation: data of the ESC-EHRA registry. Russian Journal of Cardiology. 2020;25(5): 3874. https://doi.org/10.15829/1560-4071-2020-3874

26. Arakelyan MG, Bockeria LA, Vasilieva EYu, et al. 2020 Clinical guidelines for Atrial fibrillation and atrial flutter. Russian Journal of Cardiology. 2021;26(7): 4594. (In Russ.) https://doi.org/10.15829/1560-4071-2021-4594

27. Loukianov MM, Andreenko EYu, Martsevich SYu, et al. Patients with Atrial Fibrillation in Clinical Practice: Comorbidity, Drug Treatment and Outcomes (Data from RECVASA Registries). Rational Pharmacotherapy in Cardiology. 2020;16(6): 888-898. (In Russ.) https://doi.org/10.20996/1819-6446-2020-12-01.

28. Van Gelder, Isabelle C, Michiel Rienstra, Karina V Bunting et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). European heart journal. 2024;45(36): 3314-3414. https://doi:10.1093/eurheartj/ehae176

29. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149(1): e1-e156. https://doi.org/10.1161/CIR.0000000000001193.

30. Valembois L, Audureau E, Takeda A, et al. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Systematic Review. 2019; 9(9): https://doi.org/10.1002/14651858.CD005049.pub5.

31. Braam SR, Tertoolen L, Casini S, et al. Repolarization reserve determines drug responses in human pluripotent stem cell derived cardiomyocytes. Stem Cell Research. 2013;10(1): 48-56. https://doi.org/10.1016/j.scr.2012.08.007.

32. Kaab S. Sotalol testing unmasks altered repolarization in patients with suspected acquired long-QT-syndrome?a case-control pilot study using i.v. sotalol. European Heart Journal. 2003;24(7): 649-657. https://doi.org/10.1016/S0195-668X(02)00806-0.

33. Cardoso R, Knijnik L, Bhonsale A, et al. An updated meta-analysis of novel oral anticoagulants versus vitamin K antagonists for uninterrupted anticoagulation in atrial fibrillation catheter ablation. Heart Rhythm. 2018;15(1): 107-115. https://doi.org/10.1016/j.hrthm.2017.09.011.

34. Romero J, Cerrud-Rodriguez RC, Alviz I, et al. Significant Benefit of Uninterrupted DOACs Versus VKA During Catheter Ablation of Atrial Fibrillation. JACC: Clinical Electrophysiology. 2019;5(12): 1396-1405. https://doi.org/10.1016/j.jacep.2019.08.010.

35. Di Biase L, Burkhardt JD, Santangeli P, et al. Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial. Circulation. 2014;129(25): 2638-2644. https://doi.org/10.1161/CIRCULATIONAHA.113.006426.