Skip to main content
Top
Published in: Journal of Interventional Cardiac Electrophysiology 1/2013

01-06-2013

Catheter ablation of atrial fibrillation guided by a 3D electroanatomical mapping system: a 2-year follow-up study from the Italian Registry On NavX Atrial Fibrillation ablation procedures (IRON-AF)

Authors: Giovanni B. Forleo, Giuseppe De Martino, Massimo Mantica, Endrj Menardi, Nicola Trevisi, Massimiliano Faustino, Carmine Muto, Francesco Perna, Matteo Santamaria, Claudio Pandozi, Augusto Pappalardo, Carmine Mancusi, Enrico Romano, Paolo Della Bella, Claudio Tondo

Published in: Journal of Interventional Cardiac Electrophysiology | Issue 1/2013

Login to get access

Abstract

Aims

Clinical trials have established that atrial fibrillation (AF) catheter ablation improves symptoms in appropriately selected patients. Confirmation of these results by long-term prospective observational studies is needed. This registry was created to describe the experience of 16 Italian centers with a large cohort of AF patients treated with catheter ablation guided by the NavX 3D mapping system.

Methods

From November 2006 to May 2008, 545 consecutive patients (age 60.4 ± 9.8, 67 % male) with paroxysmal (44 %), persistent (43 %), and long-standing persistent (13 %) AF referred for catheter ablation guided by the NavX system, were included in this registry. For this paper, follow-up was censored at 24 months; however, patients are being followed in the ongoing registry.

Results

Before the ablation, 80 % of patients failed to respond to at least one antiarrhythmic drug aimed at rhythm control. Pulmonary vein (PV) isolation guided by a circular mapping catheter was performed in 70 % of patients whereas non potential-guided PV encircling was performed in 30 % of patients. In 67 % of patients, additional left atrial (LA) substrate modification was performed. Image integration was performed in 9.2 % of patients. Considering a 3-month blanking period, after a single-ablation procedure, the patients had 1- and 2-year freedom from AF recurrence of 67.4 and 57.0 % (36.1 % off antiarrhythmic drugs), respectively. Cox regression analysis showed that AF recurrences during blanking (HR 2.1), and previous AF ablation (HR 3.3) were independent predictors of AF recurrences. Major procedure-related complications occurred in 53 patients (9.7 %). In 35 patients (6.7 %), a repeat procedure was performed at a median of 5 months after the initial procedure.

Conclusions

This prospective, multicenter clinical experience provides significant insights into current ablation care of patients with AF. Despite favorable outcomes, real-world complication rates appear higher than previously recognized.
Appendix
Available only for authorised users
Literature
1.
go back to reference Wazni, O. M., Marrouche, N. F., Martin, D. O., Verma, A., Bhargava, M., Saliba, W., et al. (2005). Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. Journal of the American Medical Association, 293, 2634–2640.PubMedCrossRef Wazni, O. M., Marrouche, N. F., Martin, D. O., Verma, A., Bhargava, M., Saliba, W., et al. (2005). Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. Journal of the American Medical Association, 293, 2634–2640.PubMedCrossRef
2.
go back to reference Stabile, G., Bertaglia, E., Senatore, G., De Simone, A., Zoppo, F., Donnici, G., et al. (2006). Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study. European Heart Journal, 27, 216–221.PubMedCrossRef Stabile, G., Bertaglia, E., Senatore, G., De Simone, A., Zoppo, F., Donnici, G., et al. (2006). Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study. European Heart Journal, 27, 216–221.PubMedCrossRef
3.
go back to reference Pappone, C., Augello, G., Sala, S., Gugliotta, F., Vicedomini, G., Gulletta, S., et al. (2006). A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study. Journal of the American College of Cardiology, 48, 2340–2347.PubMedCrossRef Pappone, C., Augello, G., Sala, S., Gugliotta, F., Vicedomini, G., Gulletta, S., et al. (2006). A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study. Journal of the American College of Cardiology, 48, 2340–2347.PubMedCrossRef
4.
go back to reference Jaïs, P., Cauchemez, B., Macle, L., Daoud, E., Khairy, P., Subbiah, R., et al. (2008). Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation, 118, 2498–2505.PubMedCrossRef Jaïs, P., Cauchemez, B., Macle, L., Daoud, E., Khairy, P., Subbiah, R., et al. (2008). Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation, 118, 2498–2505.PubMedCrossRef
5.
go back to reference Forleo, G. B., Mantica, M., De Luca, L., Leo, R., Santini, L., Panigada, S., et al. (2009). Catheter ablation of atrial fibrillation in patients with diabetes mellitus type 2: results from a randomized study comparing pulmonary vein isolation versus antiarrhythmic drug therapy. Journal of Cardiovascular Electrophysiology, 20, 22–28.PubMedCrossRef Forleo, G. B., Mantica, M., De Luca, L., Leo, R., Santini, L., Panigada, S., et al. (2009). Catheter ablation of atrial fibrillation in patients with diabetes mellitus type 2: results from a randomized study comparing pulmonary vein isolation versus antiarrhythmic drug therapy. Journal of Cardiovascular Electrophysiology, 20, 22–28.PubMedCrossRef
6.
go back to reference Wilber, D. J., Pappone, C., Neuzil, P., De Paola, A., Marchlinski, F., Natale, A., et al. (2010). Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. Journal of the American Medical Association, 303, 333–340.PubMedCrossRef Wilber, D. J., Pappone, C., Neuzil, P., De Paola, A., Marchlinski, F., Natale, A., et al. (2010). Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. Journal of the American Medical Association, 303, 333–340.PubMedCrossRef
7.
go back to reference Bertaglia, E., Tondo, C., De Simone, A., Zoppo, F., Mantica, M., Turco, P., et al. (2010). Does catheter ablation cure atrial fibrillation? Single-procedure outcome of drug-refractory atrial fibrillation ablation: a 6-year multicentre experience. Europace, 12, 181–7.PubMedCrossRef Bertaglia, E., Tondo, C., De Simone, A., Zoppo, F., Mantica, M., Turco, P., et al. (2010). Does catheter ablation cure atrial fibrillation? Single-procedure outcome of drug-refractory atrial fibrillation ablation: a 6-year multicentre experience. Europace, 12, 181–7.PubMedCrossRef
8.
go back to reference Cappato, R., Calkins, H., Chen, S. A., Davies, W., Iesaka, Y., Kalman, J., et al. (2010). Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation. Arrhythmia and Electrophysiology, 1, 32–8.CrossRef Cappato, R., Calkins, H., Chen, S. A., Davies, W., Iesaka, Y., Kalman, J., et al. (2010). Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation. Arrhythmia and Electrophysiology, 1, 32–8.CrossRef
9.
go back to reference Arya, A., Hindricks, G., Sommer, P., Huo, Y., Bollmann, A., Gaspar, T., et al. (2010). Long-term results and the predictors of outcome of catheter ablation of atrial fibrillation using steerable sheath catheter navigation after single procedure in 674 patients. Europace, 12, 173–180.PubMedCrossRef Arya, A., Hindricks, G., Sommer, P., Huo, Y., Bollmann, A., Gaspar, T., et al. (2010). Long-term results and the predictors of outcome of catheter ablation of atrial fibrillation using steerable sheath catheter navigation after single procedure in 674 patients. Europace, 12, 173–180.PubMedCrossRef
10.
go back to reference Hussein, A. A., Saliba, W. I., Martin, D. O., Bhargava, M., Sherman, M., Magnelli-Reyes, C., et al. (2011). Natural history and long-term outcomes of ablated atrial fibrillation. Circulation. Arrhythmia and Electrophysiology, 4, 271–278.PubMedCrossRef Hussein, A. A., Saliba, W. I., Martin, D. O., Bhargava, M., Sherman, M., Magnelli-Reyes, C., et al. (2011). Natural history and long-term outcomes of ablated atrial fibrillation. Circulation. Arrhythmia and Electrophysiology, 4, 271–278.PubMedCrossRef
11.
go back to reference Della Bella, P., Riva, S., Fassini, G., Casella, M., Carbucicchio, C., Trevisi, N., et al. (2005). Long-term follow-up after radiofrequency catheter ablation of atrial fibrillation: role of the acute procedure outcome and of the clinical presentation. Europace, 7, 95–103.PubMedCrossRef Della Bella, P., Riva, S., Fassini, G., Casella, M., Carbucicchio, C., Trevisi, N., et al. (2005). Long-term follow-up after radiofrequency catheter ablation of atrial fibrillation: role of the acute procedure outcome and of the clinical presentation. Europace, 7, 95–103.PubMedCrossRef
12.
go back to reference Calkins, H., Brugada, J., Packer, D. L., Cappato, R., Chen, S. A., Crijns, H. J. G., et al. (2007). HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. Heart Rhythm, 4, 816–861.PubMedCrossRef Calkins, H., Brugada, J., Packer, D. L., Cappato, R., Chen, S. A., Crijns, H. J. G., et al. (2007). HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. Heart Rhythm, 4, 816–861.PubMedCrossRef
13.
go back to reference Forleo, G. B., Mantica, M., De Luca, L., Dello Russo, A., Casella, M., Santini, L., et al. (2008). Impact of pre-existent areas of complex fractionated atrial electrograms on outcome after pulmonary vein isolation. Journal of Interventional Cardiac Electrophysiology, 21, 227–34.PubMedCrossRef Forleo, G. B., Mantica, M., De Luca, L., Dello Russo, A., Casella, M., Santini, L., et al. (2008). Impact of pre-existent areas of complex fractionated atrial electrograms on outcome after pulmonary vein isolation. Journal of Interventional Cardiac Electrophysiology, 21, 227–34.PubMedCrossRef
14.
go back to reference Feinberg, W. M., Blackshear, J. L., Laupacis, A., Kronmal, R., & Hart, R. G. (1995). Prevalence age distribution gender of patients with atrial fibrillation. Analysis and implications. Archives of Internal Medicine, 155, 469–73.PubMedCrossRef Feinberg, W. M., Blackshear, J. L., Laupacis, A., Kronmal, R., & Hart, R. G. (1995). Prevalence age distribution gender of patients with atrial fibrillation. Analysis and implications. Archives of Internal Medicine, 155, 469–73.PubMedCrossRef
15.
go back to reference Levy, S., Maarek, M., Coumel, P., Gutzel, L., Lekieffre, J., Madwedowsky, J. L., et al. (1999). Characterization of different subsets of atrial fibrillation in general practice in France: the ALFA study. The College of French Cardiologists. Circulation, 99, 3028–35.PubMedCrossRef Levy, S., Maarek, M., Coumel, P., Gutzel, L., Lekieffre, J., Madwedowsky, J. L., et al. (1999). Characterization of different subsets of atrial fibrillation in general practice in France: the ALFA study. The College of French Cardiologists. Circulation, 99, 3028–35.PubMedCrossRef
16.
go back to reference Patel, D., Mohanty, P., Di Biase, L., Sanchez, J. E., Shaheen, M. H., Burkhardt, J. D., et al. (2010). Outcomes and complications of catheter ablation for atrial fibrillation in females. Heart Rhythm, 7, 167–172.PubMedCrossRef Patel, D., Mohanty, P., Di Biase, L., Sanchez, J. E., Shaheen, M. H., Burkhardt, J. D., et al. (2010). Outcomes and complications of catheter ablation for atrial fibrillation in females. Heart Rhythm, 7, 167–172.PubMedCrossRef
17.
go back to reference Forleo, G., Tondo, C., Luca, L., Dello Russo, A., Casella, M., De Sanctis, V., et al. (2007). Gender-related differences in catheter ablation of atrial fibrillation. Europace, 9, 613–620.PubMedCrossRef Forleo, G., Tondo, C., Luca, L., Dello Russo, A., Casella, M., De Sanctis, V., et al. (2007). Gender-related differences in catheter ablation of atrial fibrillation. Europace, 9, 613–620.PubMedCrossRef
18.
go back to reference Lee, S. H., Tai, C. T., Hseih, M. H., Lin, J. Y., Chang, S. L., et al. (2005). Predictors of nonpulmonary vein ectopic beats initiating paroxysmal atrial fibrillation: implications for catheter ablation. Journal of the American College of Cardiology, 46, 1056–1059. Lee, S. H., Tai, C. T., Hseih, M. H., Lin, J. Y., Chang, S. L., et al. (2005). Predictors of nonpulmonary vein ectopic beats initiating paroxysmal atrial fibrillation: implications for catheter ablation. Journal of the American College of Cardiology, 46, 1056–1059.
19.
go back to reference Haissaguerre, M., Jais, P., Shah, D. C., Takahashi, A., Hocini, M., Quiniou, G., et al. (1998). Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. The New England Journal of Medicine, 339, 659–666.PubMedCrossRef Haissaguerre, M., Jais, P., Shah, D. C., Takahashi, A., Hocini, M., Quiniou, G., et al. (1998). Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. The New England Journal of Medicine, 339, 659–666.PubMedCrossRef
20.
go back to reference Pappone, C., Rosanio, S., & Oreto, G. (2000). Circumferential radiofrequency ablation of pulmonary vein ostia. Circulation, 102, 2619–2628.PubMedCrossRef Pappone, C., Rosanio, S., & Oreto, G. (2000). Circumferential radiofrequency ablation of pulmonary vein ostia. Circulation, 102, 2619–2628.PubMedCrossRef
21.
go back to reference Oral, H., Scharf, C., Chugh, A., Hall, B., Cheung, P., Good, E., et al. (2003). Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation, 108, 2355–2360.PubMedCrossRef Oral, H., Scharf, C., Chugh, A., Hall, B., Cheung, P., Good, E., et al. (2003). Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation, 108, 2355–2360.PubMedCrossRef
22.
go back to reference Khaykin, Y., Skanes, A., Champagne, J., Themistoclakis, S., Gula, L., Rossillo, A., et al. (2009). A randomized controlled trial of the efficacy and safety of electroanatomic circumferential pulmonary vein ablation supplemented by ablation of complex fractionated atrial electrograms versus potential-guided pulmonary vein antrum isolation guided by intracardiac ultrasound. Circ Arrhythm Electrophysiology, 2, 481–487.CrossRef Khaykin, Y., Skanes, A., Champagne, J., Themistoclakis, S., Gula, L., Rossillo, A., et al. (2009). A randomized controlled trial of the efficacy and safety of electroanatomic circumferential pulmonary vein ablation supplemented by ablation of complex fractionated atrial electrograms versus potential-guided pulmonary vein antrum isolation guided by intracardiac ultrasound. Circ Arrhythm Electrophysiology, 2, 481–487.CrossRef
23.
go back to reference Di Biase, L., Fahmy, T. S., Patel, D., Bai, R., Civello, K., Wazni, O. M., et al. (2007). Remote magnetic navigation: human experience in pulmonary vein ablation. Journal of the American College of Cardiology, 28(50), 868–74.CrossRef Di Biase, L., Fahmy, T. S., Patel, D., Bai, R., Civello, K., Wazni, O. M., et al. (2007). Remote magnetic navigation: human experience in pulmonary vein ablation. Journal of the American College of Cardiology, 28(50), 868–74.CrossRef
24.
go back to reference Karch, M. R., Zrenner, B., Deisenhofer, I., Schreieck, J., Ndrepepa, G., Dong, J., et al. (2005). Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation, 111, 2875–2880.PubMedCrossRef Karch, M. R., Zrenner, B., Deisenhofer, I., Schreieck, J., Ndrepepa, G., Dong, J., et al. (2005). Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation, 111, 2875–2880.PubMedCrossRef
25.
go back to reference Bertaglia, E., Zoppo, F., Tondo, C., Colella, A., Mantovan, R., Senatore, G., et al. (2007). Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. Heart Rhythm, 4, 1265–1271.PubMedCrossRef Bertaglia, E., Zoppo, F., Tondo, C., Colella, A., Mantovan, R., Senatore, G., et al. (2007). Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. Heart Rhythm, 4, 1265–1271.PubMedCrossRef
26.
go back to reference Fenelon, G., Scanavacca, M., Atié, J., Zimerman, L., Magalhães, L. P., Lorga Filho, A., et al. (2007). Brazilian society of cardiac arrhythmias. atrial fibrillation ablation in brazil: results of the registry of the Brazilian society of cardiac arrhythmias. Arquivos Brasileiros de Cardiologia, 89, 258–262.PubMedCrossRef Fenelon, G., Scanavacca, M., Atié, J., Zimerman, L., Magalhães, L. P., Lorga Filho, A., et al. (2007). Brazilian society of cardiac arrhythmias. atrial fibrillation ablation in brazil: results of the registry of the Brazilian society of cardiac arrhythmias. Arquivos Brasileiros de Cardiologia, 89, 258–262.PubMedCrossRef
27.
go back to reference Arbelo, E., Brugada, J., Hindricks, G., Maggioni, A., Tavazzi, L., Vardas, P., et al. (2012). ESC-EURObservational Research Programme: the Atrial Fibrillation Ablation Pilot Study, conducted by the European Heart Rhythm Association. Europace, 14, 1094–1103.PubMedCrossRef Arbelo, E., Brugada, J., Hindricks, G., Maggioni, A., Tavazzi, L., Vardas, P., et al. (2012). ESC-EURObservational Research Programme: the Atrial Fibrillation Ablation Pilot Study, conducted by the European Heart Rhythm Association. Europace, 14, 1094–1103.PubMedCrossRef
Metadata
Title
Catheter ablation of atrial fibrillation guided by a 3D electroanatomical mapping system: a 2-year follow-up study from the Italian Registry On NavX Atrial Fibrillation ablation procedures (IRON-AF)
Authors
Giovanni B. Forleo
Giuseppe De Martino
Massimo Mantica
Endrj Menardi
Nicola Trevisi
Massimiliano Faustino
Carmine Muto
Francesco Perna
Matteo Santamaria
Claudio Pandozi
Augusto Pappalardo
Carmine Mancusi
Enrico Romano
Paolo Della Bella
Claudio Tondo
Publication date
01-06-2013
Publisher
Springer US
Published in
Journal of Interventional Cardiac Electrophysiology / Issue 1/2013
Print ISSN: 1383-875X
Electronic ISSN: 1572-8595
DOI
https://doi.org/10.1007/s10840-012-9772-4

Other articles of this Issue 1/2013

Journal of Interventional Cardiac Electrophysiology 1/2013 Go to the issue