Comparative effectiveness of catheter ablation devices in the treatment of atrial fibrillation: a network meta-analysis
Publication: Journal of Comparative Effectiveness Research
Abstract
Atrial fibrillation (AF) ablation is most commonly performed using radiofrequency (RF) and cryoballoon (CB) catheters. Ablation Index is a novel lesion-quality marker associated with improved outcomes in RF ablation. Due to lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option. Aim: To conduct a network meta-analysis to evaluate the comparative effectiveness of RF with Ablation Index to other catheter ablation devices in the treatment of AF. Methods: Searches for randomized and nonrandomized prospective comparative studies of ablation catheters were conducted in multiple databases. The outcome of interest was 12-month freedom from atrial arrhythmias after a single ablation procedure. Studies were grouped as high-, low- and unclear-quality based on study design and balanced baseline patient characteristics. Bayesian hierarchical network meta-analysis was conducted and results presented as relative risk ratios with 95% credible intervals (CrIs). Results: 12 studies evaluating five different catheter ablation devices were included. Radiofrequency ablation with Ablation Index was associated with statistically significantly greater probability of 12-month freedom from atrial arrhythmias than Arctic Front (relative risk: 1.77; 95% CrI: 1.21–2.87), Arctic Front Advance™ (1.41; 1.06–2.47), THERMOCOOL™ (1.34; 1.17–1.48) and THERMOCOOL SMARTTOUCH™ (1.09; 1–1.3). Results were robust in multiple sensitivity analyses. Conclusion: Radiofrequency catheter with Ablation Index is superior to currently available options for 12-month freedom from atrial arrhythmias after AF ablation. This study provides decision-makers with robust, pooled, comparative evidence of the latest ablation technologies.
Supplementary Material
File (supplementary_appendicies.docx)
- Download
- 820.13 KB
References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Calkins H, Hindricks G, Cappato R et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 14(10), e275–e444 (2017).
• An expert consensus statement on catheter and surgical ablation of atrial fibrillation (AF). Ablation is routinely performed using radiofrequency (RF) and cryoballoon (CB) catheters, with RF catheters being the most widely used technology.
2.
January CT, Wann LS, Alpert JS et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J. Am. Coll. Cardiol. 64(21), e1–e76 (2014).
3.
Kirchhof P, Benussi S, Kotecha D et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur. J. Cardiothorac. Surg. 50(5), e1–e88 (2016).
4.
Chen J, Dagres N, Hocini M et al. Catheter ablation for atrial fibrillation: results from the first European Snapshot Survey on Procedural Routines for Atrial Fibrillation Ablation (ESS-PRAFA) Part II. Europace 17(11), 1727–1732 (2015).
5.
Andrade JG, Monir G, Pollak SJ et al. Pulmonary vein isolation using ‘contact force’ ablation: the effect on dormant conduction and long-term freedom from recurrent atrial fibrillation – a prospective study. Heart Rhythm 11(11), 1919–1924 (2014).
6.
Marijon E, Fazaa S, Narayanan K et al. Real-time contact force sensing for pulmonary vein isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year results. J. Cardiovasc. Electrophysiol. 25(2), 130–137 (2014).
7.
Itoh T, Kimura M, Tomita H et al. Reduced residual conduction gaps and favourable outcome in contact force-guided circumferential pulmonary vein isolation. Europace 18(4), 531–537 (2016).
8.
Nair GM, Yeo C, MacDonald Z et al. Three-year outcomes and reconnection patterns after initial contact force guided pulmonary vein isolation for paroxysmal atrial fibrillation. J. Cardiovasc. Electrophysiol. 28(9), 984–993 (2017).
9.
Lee G, Hunter RJ, Lovell MJ et al. Use of a contact force-sensing ablation catheter with advanced catheter location significantly reduces fluoroscopy time and radiation dose in catheter ablation of atrial fibrillation. Europace 18(2), 211–218 (2016).
10.
Sciarra L, Golia P, Natalizia A et al. Which is the best catheter to perform atrial fibrillation ablation? A comparison between standard ThermoCool, SmartTouch, and Surround Flow catheters. J. Interv. Cardiac Electrophysiol. 39(3), 193–200 (2014).
11.
Martinek M, Lemes C, Sigmund E et al. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin. Electrophysiol. 35(11), 1312–1318 (2012).
12.
Zhou X, Lv W, Zhang W et al. Impact of contact force technology on reducing the recurrence and major complications of atrial fibrillation ablation: a systematic review and meta-analysis. Anatol. J. Cardiol. 17(2), 82–91 (2017).
13.
Pranata R, Vania R, Huang I. Ablation-index guided versus conventional contact-force guided ablation in pulmonary vein isolation – systematic review and meta-analysis. Indian Pacing Electrophysiol. J. 19(4), 155–160 (2019).
•• A systematic review and meta-analysis showing significantly lower 12-month incidence of AF, atrial tachycardia (AT) and atrial flutter and significantly shorter fluoroscopy time and total ablation time with an ablation index-guided procedure than a conventional RF ablation procedure.
14.
Fürnkranz A, Bordignon S, Schmidt B et al. Improved procedural efficacy of pulmonary vein isolation using the novel second-generation cryoballoon. J. Cardiovasc. Electrophysiol. 24(5), 492–497 (2013).
15.
Koektuerk B, Yorgun H, Koch A et al. Pulmonary vein isolation in patients with paroxysmal atrial fibrillation: long-term clinical outcomes with first- and second-generation cryoballoons. Herz 42(1), 91–97 (2017).
16.
Heeger CH, Schuette C, Seitelberger V et al. Time-to-effect guided pulmonary vein isolation utilizing the third-generation versus second generation cryoballoon: one year clinical success. Cardiol. J. (2018). (Epub ahead of print).
17.
Aryana A, Kowalski M, O’Neill PG et al. Catheter ablation using the third-generation cryoballoon provides an enhanced ability to assess time to pulmonary vein isolation facilitating the ablation strategy: short- and long-term results of a multicenter study. Heart Rhythm 13(12), 2306–2313 (2016).
18.
Kuck KH, Brugada J, Furnkranz A et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N. Engl. J. Med. 374(23), 2235–2245 (2016).
• A randomized trial found the efficacy for the treatment of paroxysmal AF with CB ablation was noninferior to RF ablation and found no significant difference in overall safety between the two groups. Notably, the study did not randomize patients to advanced technologies within the CB and RF groups and was not sufficiently powered to compare advanced technologies.
19.
Hunter RJ, Baker V, Finlay MC et al. Point-by-point radiofrequency ablation versus the cryoballoon or a novel combined approach: a randomized trial comparing 3 methods of pulmonary vein isolation for paroxysmal atrial fibrillation (the cryo versus RF trial). J. Cardiovasc. Electrophysiol. 26(12), 1307–1314 (2015).
20.
Luik A, Radzewitz A, Kieser M et al. Cryoballoon versus open irrigated radiofrequency ablation in patients with paroxysmal atrial fibrillation: the prospective, randomized, controlled, noninferiority freeze AF study. Circulation 132(14), 1311–1319 (2015).
21.
Perez-Castellano N, Fernandez-Cavazos R, Moreno J et al. The COR trial: a randomized study with continuous rhythm monitoring to compare the efficacy of cryoenergy and radiofrequency for pulmonary vein isolation. Heart Rhythm 11(1), 8–14 (2014).
22.
Gunawardene MA, Hoffmann BA, Schaeffer B et al. Influence of energy source on early atrial fibrillation recurrences: a comparison of cryoballoon vs. radiofrequency current energy ablation with the endpoint of unexcitability in pulmonary vein isolation. Europace 20(1), 43–49 (2018).
23.
Davtyan K, Shatakhtsyan V, Poghosyan H et al. Radiofrequency versus cryoballoon ablation of atrial fibrillation: an evaluation using ECG, holter monitoring, and implantable loop recorders to monitor absolute and clinical effectiveness. BioMed Res. Int. 2018, 3629384, 1–7 (2018).
24.
Tonin FS, Rotta I, Mendes AM, Pontarolo R. Network meta-analysis: a technique to gather evidence from direct and indirect comparisons. Pharm. Pract. (Granada) 15(1), 943 (2017).
25.
Hutton B, Salanti G, Caldwell DM et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann. Intern. Med. 162(11), 777–784 (2015).
26.
Higgins JP, Altman DG, Gotzsche PC et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 343, d5928 (2011).
27.
Sterne JA, Hernan MA, Reeves BC et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ 355, i4919 (2016).
28.
Dias S, Welton NJ, Sutton AJ, Ades AE. NICE DSU technical support document 2: a generalised linear framework for pairwise and network meta-analysis of randomized controlled trials. 1–98 (2011). http://www.nicedsu.org.uk
29.
Efthimiou O, Mavridis D, Debray TP et al. Combining randomized and non-randomized evidence in network meta-analysis. Stat. Med. 36(8), 1210–1226 (2017).
30.
Dias S, Welton NJ, Sutton AJ, Caldwell DM, Lu G, Ades AE. Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials. Med. Decis. Making 33(5), 641–656 (2013).
31.
Buist TJ, Adiyaman A, Smit JJJ, Ramdat Misier AR, Elvan A. Arrhythmia-free survival and pulmonary vein reconnection patterns after second-generation cryoballoon and contact-force radiofrequency pulmonary vein isolation. Clin. Res. Cardiol. 107(6), 498–506 (2018).
32.
Jourda F, Providencia R, Marijon E et al. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace 17(2), 225–231 (2015).
33.
Dhillon G, Ahsan S, Honarbakhsh S et al. A multicentered evaluation of ablation at higher power guided by Ablation Index: establishing ablation targets for pulmonary vein isolation. J. Cardiovasc. Electrophysiol. 30(3), 357–365 (2019).
• A comparative study showing the rate of acute pulmonary vein (PV) reconnection was significantly lower and the rate of freedom from atrial arrhythmia at 12-month follow-up was higher in patients who received the Ablation Index-guided procedure than in patients who received a conventional contact force (CF)-guided procedure.
34.
Hussein A, Das M, Chaturvedi V et al. Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation. J. Cardiovasc. Electrophysiol. 28(9), 1037–1047 (2017).
• A comparative study showing that Ablation Index-guided procedure was associated with a significantly improved rate of PV isolation success, and a significantly lower rate of acute PV reconnection and AT recurrence at 12-month follow-up than a group of propensity-matched controls who underwent CF-guided ablation.
35.
Sciarra L, Iacopino S, Palama Z et al. Impact of the third generation cryoballoon on atrial fibrillation ablation: an useful tool? Indian Pacing Electrophysiol. J. 18(4), 127–132 (2018).
36.
Solimene F, Schillaci V, Shopova G et al. Safety and efficacy of atrial fibrillation ablation guided by Ablation Index module. J. Interv. Cardiac Electrophysiol. 54(1), 9–15 (2019).
• A prospective, single-arm registry showing Ablation Index-guided ablation is feasible (i.e., high rate of PV isolation success), safe (i.e., low rate of complications) and effective (i.e., high single-procedure arrhythmia-free survival).
37.
Zhao A, Squara F, Marijon E, Thomas O. Two-year clinical outcome after a single cryoballoon ablation procedure: a comparison of first- and second-generation cryoballoons. Arch. Cardiovasc. Dis. 110(10), 543–549 (2017).
38.
Phlips T, Taghji P, El Haddad M et al. Improving procedural and one-year outcome after contact force-guided pulmonary vein isolation: the role of interlesion distance, Ablation Index, and contact force variability in the ‘CLOSE’-protocol. Europace 20(Fi_3), f419–f427 (2018).
• A comparative study showing 12-month freedom from AF, atrial flutter and AT was significantly higher in patients who received the Ablation Index-guided procedure than patients who received the conventional CF procedure. Additionally, procedure time and total RF time were significantly shorter in patients who received the Ablation Index-guided procedure.
39.
Schnell-Inderst P, Hunger T, Conrads-Frank A, Arvandi M, Siebert U. Ten recommendations for assessing the comparative effectiveness of therapeutic medical devices: a targeted review and adaptation. J. Clin. Epidemiol. 94, 97–113 (2018).
40.
Cameron C, Fireman B, Hutton B et al. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities. Syst. Rev. 4, 147–147 (2015).
41.
Husereau D. Real-world evidence: what role can it play in real-world decision-making? Summary report of the IHE Roundtable. Edmonton (AB). Institute of Health Economics, 1–12 (2017).
Information & Authors
Information
Published In
Pages: 115 - 126
PubMed: 31913063
Copyright
© 2020 Laura Goldstein. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
History
Received: 5 November 2019
Accepted: 27 November 2019
Published online: 8 January 2020
Keywords:
Topics
Authors
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
Comparative effectiveness of catheter ablation devices in the treatment of atrial fibrillation: a network meta-analysis. (2020) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2019-0165
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- Chukwuka Elendu, Nkechi P. Ogwu, Alexander U. Okatta, Eunice K. Omeludike, Emmanuel C. Ogelle, Babajide T. Obidigbo, Mary C. Joseph, Emmanuella I Osamuyi, Afeez O. Ogidan, Klein A. Jingwa, Abdul-Rahaman A Ottun, Mariam M.F. Eldorghamy, Tuvakbibi Gurbanova, Fathy E.A.E. Soltan, Umesh Bhadana, Vaibhav S. Nasre, Cyrus P. Yadav, Rishabh Jaiswal, Global Research Progress on Radiofrequency Ablation in Cardiology, Annals of Medicine & Surgery, 10.1097/MS9.0000000000002858, 87, 2, (725-747), (2025).
- Tom De Potter, Cindy Tong, Sonia Maccioni, Maria Velleca, Thibaut Galvain, Cost‐utility of VISITAG SURPOINT in catheter ablation of atrial fibrillation, Pacing and Clinical Electrophysiology, 10.1111/pace.14931, 47, 4, (568-576), (2024).
- Biqi Zhang, Jie Han, Dongchen Zhou, Jiajia Jiang, Jiawei Zhong, Yunlong Lu, Chenyu Zuo, Xingwei Lu, Jianwei Xuan, Aohan Zu, Yuxian He, Xingang Sun, Lu Chen, Liangrong Zheng, Radiofrequency ablation using the ThermoCool SmartTouch Catheter guided by ablation index versus antiarrhythmic drugs in atrial fibrillation treatment in China: a cost-consequence analysis, Journal of Comparative Effectiveness Research, 10.57264/cer-2023-0035, 13, 2, (2024).
- Qin-Dan Yan, Ke-Zeng Gong, Xue-Hai Chen, Jian-Hua Chen, Zhe Xu, Wei-Wei Wang, Fei-Long Zhang, Comparison of Second-Generation Cryoballoon Ablation and Quantitative Radiofrequency Ablation Guided by Ablation Index for Atrial Fibrillation, Angiology, 10.1177/00033197231159254, 75, 5, (462-471), (2023).
- Dong-Sung Won, Yubeen Park, Jinsu An, Dae Sung Ryu, Jeon Min Kang, Ji Won Kim, Song Hee Kim, Chu Hui Zeng, Hongbae Kim, Hyung-Sik Kim, Jung-Hoon Park, Sang Soo Lee, Stent-based electrode for radiofrequency ablation in the rat esophagus: a preliminary study, Scientific Reports, 10.1038/s41598-022-23472-7, 12, 1, (2022).
- Min Hu, Yi Han, Wangyang Zhao, Wen Chen, Long-Term Cost-Effectiveness Comparison of Catheter Ablation and Antiarrhythmic Drugs in Atrial Fibrillation Treatment Using Discrete Event Simulation, Value in Health, 10.1016/j.jval.2021.10.014, 25, 6, (975-983), (2022).
- Emmanouil Charitakis, Silvia Metelli, Lars O. Karlsson, Antonios P. Antoniadis, Konstantinos D. Rizas, Ioan Liuba, Henrik Almroth, Anders Hassel Jönsson, Jonas Schwieler, Dimitrios Tsartsalis, Skevos Sideris, Elena Dragioti, Nikolaos Fragakis, Anna Chaimani, Comparing efficacy and safety in catheter ablation strategies for atrial fibrillation: a network meta-analysis, BMC Medicine, 10.1186/s12916-022-02385-2, 20, 1, (2022).
- Adam E Berman, Sonia Maccioni, Rahul Khanna, Atrial fibrillation ablation with advanced radiofrequency catheter versus second-generation cryoballoon catheter, Journal of Comparative Effectiveness Research, 10.2217/cer-2021-0170, 11, 9, (659-668), (2022).
- Emmanouil Charitakis, Silvia Metelli, Lars O. Karlsson, Antonios P. Antoniadis, Ioan Liuba, Henrik Almroth, Anders Hassel Jönsson, Jonas Schwieler, Skevos Sideris, Dimitrios Tsartsalis, Elena Dragioti, Nikolaos Fragakis, Anna Chaimani, Comparing Efficacy and Safety in Catheter Ablation Strategies for Paroxysmal Atrial Fibrillation: A Network Meta-Analysis of Randomized Controlled Trials, Diagnostics, 10.3390/diagnostics12020433, 12, 2, (433), (2022).
- Chenxia Wu, Xinyi Li, Zhengtian Lv, Qian Chen, Yang Lou, Wei Mao, Xinbin Zhou, Second-generation cryoballoon versus contact force radiofrequency ablation for atrial fibrillation: an updated meta-analysis of evidence from randomized controlled trials, Scientific Reports, 10.1038/s41598-021-96820-8, 11, 1, (2021).