Abstract
Background
Catheter ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). The cornerstone of AF ablation is pulmonary vein isolation (PVI). The second-generation cryoballoon (2G-CB) has shown non-inferiority to radiofrequency (RF) ablation in paroxysmal AF in several trials. Growing evidence suggests that 2G-CB is also effective in patients with persistent AF (perAF). The aim of this study was to summarize and analyze available data on safety and mid-term (≥ 12 months) efficacy of PVI using 2G-CB in patients with perAF.
Methods
We did a search in PubMed, Web of Science, Cochrane Library, and clinicaltrials.gov in December 2016 for studies of 2G-CB ablation for perAF. Studies reporting clinical success rates at a follow-up (FU) of ≥ 12 months were included. Success was defined as freedom from any atrial arrhythmia lasting > 30 s after an initial blanking period of 3 months. Acute success and complication rates were also assessed. Data were analyzed applying random-effects model.
Results
A total of 917 patients from 11 studies meeting study inclusion criteria were analyzed. After a mean FU of 16.7 ± 3.0 months, 68.9% were free from recurrences [95% confidence interval (CI) 63.4–74.7%]. Overall acute success rate was 99.7% (95% CI 99.2–100%). Complications occurred in 5.5% (95% CI 2.4–9.6%). Vascular access complications were the most frequent 3.3% (95% CI 1.5–5.6%). The rate of phrenic nerve palsy/injury was 2.09% (95% CI 0.8–3.9%). No death, stroke or myocardial infarction was reported.
Conclusion
The 2G-CB seems to be safe and effective in the treatment of perAF in the mid-term.
Similar content being viewed by others
Abbreviations
- 2G-CB:
-
Second-generation cryoballoon
- AAD:
-
Antiarrhythmic drugs
- AF:
-
Atrial fibrillation
- BP:
-
Blanking period
- CB:
-
Cryoballoon
- FU:
-
Follow-up
- Pts:
-
Patients
- PxAF:
-
Paroxysmal AF
- PerAF:
-
Persistent AF
- PNP:
-
Phrenic nerve palsy/injury
- PV:
-
Pulmonary vein
- PVI:
-
Pulmonary vein isolation
- RF:
-
Radiofrequency
References
Arbelo E, Brugada J, Lundqvist CB, Laroche C, Kautzner J, Pokushalov E, Raatikainen P, Efremidis M, Hindricks G, Barrera A, Maggioni A, Tavazzi L, Dagres N (2017) Contemporary management of patients undergoing atrial fibrillation ablation: in-hospital and 1-year follow-up findings from the ESC-EHRA atrial fibrillation ablation long-term registry. Eur Heart J. doi:10.1093/eurheartj/ehw564
Aryana A, Singh SM, Kowalski M, Pujara DK, Cohen AI, Singh SK, Aleong RG, Banker RS, Fuenzalida CE, Prager NA, Bowers MR, D’Avila A, O’Neill PG (2015) Acute and long-term outcomes of catheter ablation of atrial fibrillation using the second-generation cryoballoon versus open-irrigated radiofrequency: a multicenter experience. J Cardiovasc Electrophysiol 26:832–839. doi:10.1111/jce.12695
Benjamin EJ, Wolf PA, D’Agostino RB, Silbershatz H, Kannel WB, Levy D (1998) Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation 98:946–952
Buiatti A, von Olshausen G, Barthel P, Schneider S, Luik A, Kaess B, Laugwitz KL, Hoppmann P (2016) Cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: an updated meta-analysis of randomized and observational studies. Europace. doi:10.1093/europace/euw262
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D, Heart Rhythm Society Task Force on C, Surgical Ablation of Atrial F (2012) 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm 9:632–696 e621 doi:10.1016/j.hrthm.2011.12.016
Cardoso R, Mendirichaga R, Fernandes G, Healy C, Lambrakos LK, Viles-Gonzalez JF, Goldberger JJ, Mitrani RD (2016) Cryoballoon versus radiofrequency catheter ablation in atrial fibrillation: a meta-analysis. J Cardiovasc Electrophysiol 27:1151–1159. doi:10.1111/jce.13047
Chen CF, Gao XF, Duan X, Chen B, Liu XH, Xu YZ (2017) Comparison of catheter ablation for paroxysmal atrial fibrillation between cryoballoon and radiofrequency: a meta-analysis. J Interv Card Electrophysiol. doi:10.1007/s10840-016-0220-8
Cheng X, Hu Q, Zhou C, Liu LQ, Chen T, Liu Z, Tang X (2015) The long-term efficacy of cryoballoon vs irrigated radiofrequency ablation for the treatment of atrial fibrillation: a meta-analysis. Int J Cardiol 181:297–302. doi:10.1016/j.ijcard.2014.12.002
Ciconte G, Baltogiannis G, de Asmundis C, Sieira J, Conte G, Di Giovanni G, Saitoh Y, Irfan G, Mugnai G, Hunuk B, Chierchia GB, Brugada P (2015) Circumferential pulmonary vein isolation as index procedure for persistent atrial fibrillation: a comparison between radiofrequency catheter ablation and second-generation cryoballoon ablation. Europace 17:559–565. doi:10.1093/europace/euu350
Ciconte G, de Asmundis C, Sieira J, Conte G, Di Giovanni G, Mugnai G, Saitoh Y, Baltogiannis G, Irfan G, Coutino-Moreno HE, Hunuk B, Velagic V, Brugada P, Chierchia GB (2015) Single 3-minute freeze for second-generation cryoballoon ablation: one-year follow-up after pulmonary vein isolation. Heart Rhythm 12:673–680. doi:10.1016/j.hrthm.2014.12.026
Ciconte G, Ottaviano L, de Asmundis C, Baltogiannis G, Conte G, Sieira J, Di Giovanni G, Saitoh Y, Irfan G, Mugnai G, Storti C, Montenero AS, Chierchia GB, Brugada P (2015) Pulmonary vein isolation as index procedure for persistent atrial fibrillation: one-year clinical outcome after ablation using the second-generation cryoballoon. Heart Rhythm 12:60–66. doi:10.1016/j.hrthm.2014.09.063
DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7:177–188
Di Giovanni G, Wauters K, Chierchia GB, Sieira J, Levinstein M, Conte G, de Asmundis C, Baltogiannis G, Saitoh Y, Ciconte G, Julia J, Mugnai G, Irfan G, Brugada P (2014) One-year follow-up after single procedure cryoballoon ablation: a comparison between the first and second generation balloon. J Cardiovasc Electrophysiol 25:834–839. doi:10.1111/jce.12409
Furnkranz A, Bordignon S, Dugo D, Perotta L, Gunawardene M, Schulte-Hahn B, Nowak B, Schmidt B, Chun JK (2014) Improved 1-year clinical success rate of pulmonary vein isolation with the second-generation cryoballoon in patients with paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol 25:840–844. doi:10.1111/jce.12417
Guhl EN, Siddoway D, Adelstein E, Voigt A, Saba S, Jain SK (2016) Efficacy of cryoballoon pulmonary vein isolation in patients with persistent atrial fibrillation. J Cardiovasc Electrophysiol 27:423–427. doi:10.1111/jce.12924
He X, Chen Y, Zhou Y, Huang Y, He J (2016) One-year clinical outcome of pulmonary vein isolation using the second-generation cryoballoon: a meta-analysis. Pacing Clin Electrophysiol 39:182–189. doi:10.1111/pace.12787
Higgins JP, Thompson SG, Deeks JJ, Altman DG (2003) Measuring inconsistency in meta-analyses. BMJ 327:557–560. doi:10.1136/bmj.327.7414.557
Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K (2016) 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace 18:1609–1678. doi:10.1093/europace/euw295
Knecht S, Kuhne M, Osswald S, Sticherling C (2014) Quantitative assessment of a second-generation cryoballoon ablation catheter with new cooling technology—a perspective on potential implications on outcome. J Interv Card Electrophysiol 40:17–21. doi:10.1007/s10840-014-9883-1
Koektuerk B, Yorgun H, Hengeoez O, Turan CH, Dahmen A, Yang A, Bansmann PM, Gorr E, Hoppe C, Turan RG, Horlitz M (2015) Cryoballoon ablation for pulmonary vein isolation in patients with persistent atrial fibrillation: one-year outcome using second generation cryoballoon. Circ Arrhythm Electrophysiol 8:1073–1079. doi:10.1161/CIRCEP.115.002776
Kuniss M, Greiss H, Pajitnev D, Akkaya E, Deubner N, Hain A, Bodammer L, Berkowitsch A, Chierchia GB, Hamm CW, Neumann T (2016) Cryoballoon ablation of persistent atrial fibrillation: feasibility and safety of left atrial roof ablation with generation of conduction block in addition to antral pulmonary vein isolation. Europace. doi:10.1093/europace/euw146
Lemes C, Wissner E, Lin T, Mathew S, Deiss S, Rillig A, Heeger C, Wohlmuth P, Reissmann B, Tilz R, Ouyang F, Kuck KH, Metzner A (2016) One-year clinical outcome after pulmonary vein isolation in persistent atrial fibrillation using the second-generation 28 mm cryoballoon: a retrospective analysis. Europace 18:201–205. doi:10.1093/europace/euv092
Metzner A, Heeger CH, Wohlmuth P, Reissmann B, Rillig A, Tilz RR, Mathew S, Lemes C, Deiss S, Maurer T, Saguner A, Ouyang F, Kuck KH, Wissner E (2016) Two-year outcome after pulmonary vein isolation using the second-generation 28-mm cryoballoon: lessons from the bonus freeze protocol. Clin Res Cardiol 105:72–78. doi:10.1007/s00392-015-0890-8
Moher D, Liberati A, Tetzlaff J, Altman DG, Group P (2010) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg 8:336–341. doi:10.1016/j.ijsu.2010.02.007
Mont L, Bisbal F, Hernandez-Madrid A, Perez-Castellano N, Vinolas X, Arenal A, Arribas F, Fernandez-Lozano I, Bodegas A, Cobos A, Matia R, Perez-Villacastin J, Guerra JM, Avila P, Lopez-Gil M, Castro V, Arana JI, Brugada J (2014) Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J 35:501–507. doi:10.1093/eurheartj/eht457
Schnabel RB, Yin X, Gona P, Larson MG, Beiser AS, McManus DD, Newton-Cheh C, Lubitz SA, Magnani JW, Ellinor PT, Seshadri S, Wolf PA, Vasan RS, Benjamin EJ, Levy D (2015) 50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in the Framingham Heart Study: a cohort study. Lancet 386:154–162. doi:10.1016/S0140-6736(14)61774-8
Scott PA, Silberbauer J, Murgatroyd FD (2016) The impact of adjunctive complex fractionated atrial electrogram ablation and linear lesions on outcomes in persistent atrial fibrillation: a meta-analysis. Europace 18:359–367. doi:10.1093/europace/euv351
Straube F, Hartl S, Dorwarth U, Wankerl M, Bunz B, Ebersberger U, Hoffmann E (2016) Cryoballoon ablation for persistent atrial fibrillation–large single-center experience. J Cardiol 68:492–497. doi:10.1016/j.jjcc.2016.02.007
Su WW, Alzubaidi M, Tseng R, Jebaily N, Lin YJ, Wang PJ (2016) Novel usage of the cryoballoon catheter to achieve large area atrial substrate modification in persistent and long-standing persistent atrial fibrillation. J Interv Card Electrophysiol 46:275–285. doi:10.1007/s10840-016-0120-ytry
Tscholl V, Lsharaf AK, Lin T, Bellmann B, Biewener S, Nagel P, Suhail S, Lenz K, Landmesser U, Roser M, Rillig A (2016) Two years outcome in patients with persistent atrial fibrillation after pulmonary vein isolation using the second-generation 28-mm cryoballoon. Heart Rhythm 13:1817–1822. doi:10.1016/j.hrthm.2016.05.022
Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P (2015) Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med 372:1812–1822. doi:10.1056/NEJMoa1408288
Wallace BC, Dahabreh IJ, Trikalinos TA, Lau J, Trow P, Schmid CH (2012) Closing the gap between methodologists and end-users: R as a computational back-end. J Stat Softw 49:15 doi:10.18637/jss.v049.i05
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflicts of interest.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Omran, H., Gutleben, KJ., Molatta, S. et al. Second generation cryoballoon ablation for persistent atrial fibrillation: an updated meta-analysis. Clin Res Cardiol 107, 182–192 (2018). https://doi.org/10.1007/s00392-017-1171-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00392-017-1171-5