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)

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

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)87-95
Number of pages9
JournalJournal of Interventional Cardiac Electrophysiology
Volume37
Issue number1
DOIs
Publication statusPublished - Jun 2013

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Catheter Ablation
varespladib methyl
Atrial Fibrillation
Registries
Pulmonary Veins
Anti-Arrhythmia Agents
Recurrence
Observational Studies
Patient Care
Catheters
Regression Analysis
Clinical Trials
Prospective Studies

Keywords

  • 3D mapping
  • Atrial fibrillation
  • Catheter ablation
  • Image integration
  • Long-term outcomes
  • Survey

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

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

In: Journal of Interventional Cardiac Electrophysiology, Vol. 37, No. 1, 06.2013, p. 87-95.

Research output: Contribution to journalArticle

Forleo, Giovanni B. ; De Martino, Giuseppe ; Mantica, Massimo ; Menardi, Endrj ; Trevisi, Nicola ; Faustino, Massimiliano ; Muto, Carmine ; Perna, Francesco ; Santamaria, Matteo ; Pandozi, Claudio ; Pappalardo, Augusto ; Mancusi, Carmine ; Romano, Enrico ; Della Bella, Paolo ; Tondo, Claudio. / 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). In: Journal of Interventional Cardiac Electrophysiology. 2013 ; Vol. 37, No. 1. pp. 87-95.
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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.",
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T1 - Catheter ablation of atrial fibrillation guided by a 3D electroanatomical mapping system

T2 - A 2-year follow-up study from the Italian Registry on NavX Atrial Fibrillation ablation procedures (IRON-AF)

AU - Forleo, Giovanni B.

AU - De Martino, Giuseppe

AU - Mantica, Massimo

AU - Menardi, Endrj

AU - Trevisi, Nicola

AU - Faustino, Massimiliano

AU - Muto, Carmine

AU - Perna, Francesco

AU - Santamaria, Matteo

AU - Pandozi, Claudio

AU - Pappalardo, Augusto

AU - Mancusi, Carmine

AU - Romano, Enrico

AU - Della Bella, Paolo

AU - Tondo, Claudio

PY - 2013/6

Y1 - 2013/6

N2 - 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.

AB - 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.

KW - 3D mapping

KW - Atrial fibrillation

KW - Catheter ablation

KW - Image integration

KW - Long-term outcomes

KW - Survey

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