Prospective European Survey on Atrial Fibrillation Ablation: Clinical Characteristics of Patients and Ablation Strategies Used in Different Countries Sakis Themistoclakis, M.D.*, Antonio Raviele, M.D.*, Paolo China, M.D.*, Carlo Pappone, M.D.†, Roberto De Ponti, M.D.‡, Amiran Revishvili, M.D.§, Etienne Aliot, M.D.¶, Karl-Heinz Kuck, M.D.**, Per Ivar Hoff, M.D.I††, Dipen Shah, M.D.‡‡, Jesús Almendral, M.D.§§, Antonis S. Manolis, M.D.¶¶, Gian-Battista Chierchia, M.D.***, Ali Oto, M.D.†††, Radu G. Vatasescu, M.D.‡‡‡, Matjaz

Sinkovec, M.D.§§§, Riccardo Cappato, M.D.¶¶¶ on behalf of the Atrial

Fibrillation Survey Investigators**** *

Department of Cardiothoracic & Vascular Medicine, Dell’Angelo Hospital, Mestre-Venice, Italy; †Arrhythmology Department, Villa Maria Cecilia Hospital, Cotignola, Italy; ‡ Department of Heart, Brain and Vessels, Ospedale di Circolo- University of Insubria, Varese, Italy; §Bakoulev Center for Cardiovascular Surgery, Moscow, Russian Federation; ¶ Département de Cardiologie, CHU de Nancy, Hôpital de Brabois, Nancy, France; ** Cardiology Department, AK St. Georg, Hamburg, Germany; ††Institute of Medicine, Department of Heart Disease, Haukeland University Hospital, University of Bergen, Bergen, Norway; ‡‡Department of Cardiology, Geneva University Hospital, Geneva, Switzerland; §§ Cardiac Arrhythmia Unit, Grupo Hospital de Madrid, Universidad CEU-San Pablo, Madrid, Spain; ¶¶ First Department of Cardiology, Evangelismos General Hospital, Athens University School of Medicine, Athens, Greece; ***Heart Rhythm Management Center, Cardiovascular Division, UZ Brussels, Belgium; †††Department of Cardiology, Hacettepe University, Ankara, Turkey; ‡‡‡Department of Cardiology, Clinic Emergency Hospital, Bucharest, Romania; §§§ Department of Cardiology, University Medical Center, Ljubljana, Slovenia; ¶¶¶Arrhythmia and Electrophysiology Center, IRCCS Policlinico San Donato, Milan, Italy. **** Committee members and all investigators are reported in the Appendix 1 Short title: Survey on Atrial Fibrillation Ablation Address for correspondence: Sakis Themistoclakis, MD Department of Cardiothoracic & Vascular Medicine Dell’Angelo Hospital Via Paccagnella, 11 30170 Mestre-Venezia Italy Tel: +390419657201 Fax: +390419657235 E-Mail: [email protected]

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/jce.12462. This article is protected by copyright. All rights reserved.

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The task of producing the present survey was committed by the European Cardiac Arrhythmia Society (ECAS) to a group of independent electrophysiology experts who would serve on behalf of ECAS to generate the requested information. The work was made possible by a research grant from Biosense Webster, part of Johnson&Johnson family of companies.

S. Themistoclakis reports participation on a research grant supported by Biosense Webster and serving as a consultant/advisory board member for the company. R. De Ponti reports compensation for participation on a speakers’ bureau and serving as a consultant/advisory board member for Biosense Webster. E Aliot reports consulting for Meda, Sonofi-Aventis, Boehringer Ingelheim, Pfizer/BMS, GlaxoSmithKline. D. Shah reports participation on research grants supported by Biosense Webster, St. Jude Medical and Bard. J. Almendral reports honoraria relevant to this study from Medtronic and St. Jude Medical. G-B Chierchia reports honoraria relevant to this topic from Biosense Webster, Medtronic, AF Solutions, and serving on advisory boards of Medtronic and AF Solutions. R. Cappato reports participation on research grants and other research support, but did not specify the entity. Other authors: No disclosures. ABSTRACT Background Atrial fibrillation (AF) ablation is widely adopted. Our aim was to conduct a prospective multicenter survey to verify patients’ characteristics, approaches and technologies adopted across Europe. Methods and Results A total of 35 centers in 12 countries actively participated in the study and 940 patients (median age 60 years) were enrolled.

AF was paroxysmal, persistent and long-lasting

persistent in 52.4%, 36% and 11.6% of patients, respectively; 95.5% of patients were symptomatic and 91.4% were refractory to antiarrhythmic therapy. Redo procedures were performed in 20.9%. Pulmonary vein isolation (PVI) emerged as the cornerstone of ablative This article is protected by copyright. All rights reserved.

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therapy and has been performed in 98.7% of procedures, with confirmation of PVI in 92.9% of cases. The ablation of non-paroxysmal AF was not generally limited to isolating the PVs and several adjunctive approaches are adopted, particularly in the case of long-lasting persistent AF. Linear lesions or elimination of complex fractionated atrial electrograms were more frequently added. Circular mapping catheters and imaging techniques were seen to be used in about two-thirds of cases.

Radiofrequency energy was delivered through open

irrigated catheters in 68% of cases. Conclusions European centers are largely following the recommendations of the guidelines and the expert consensus documents for AF ablation. AF ablation is mainly performed in relatively young patients with symptomatic drug refractory AF and no or minimal heart disease. Patients with paroxysmal AF are the most frequently treated with a quite uniform ablative approach across Europe. A less standardized approach was observed in non-paroxysmal AF patients.

Keywords: atrial fibrillation, catheter ablation, survey

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INTRODUCTION Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, with a prevalence of between 0.95% and 2.5% in the general population and an increasing incidence with age.1,2 This arrhythmia is associated with a 5-fold increase in the risk of thromboembolic events3, a 3-fold increase in the risk of heart failure4 and a 2-fold increase in the risk of death.5 Catheter ablation has been proved to effectively treat patients with symptomatic and drug refractory AF and is widely performed in various electrophysiology (EP) laboratories. Two consensus documents on the indications, techniques and results of transcatheter ablation have recently been presented in an attempt to standardize this procedure as far as possible.

6,7

However,

data on the implementation of this therapy in large patient populations in clinical practice have mainly been gathered through retrospective surveys.

8,9

More information about the

daily routine of EP laboratories by describing the clinical features of the patients treated, the approaches undertaken, the technologies utilized and the procedural endpoints are needed. Our aim was therefore to carry out a prospective survey on a large number of patients treated in EP laboratories in various European countries.

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METHODS An independent international steering committee drew up a detailed questionnaire composed of 21 items grouped into two sections (see appendices 2 and 3).

The first 11 items

investigated the clinical features of the patients treated: age, sex, type and duration of AF, associated symptoms, comorbidities, NYHA class, echocardiographic data, antiarrhythmic prophylaxis, CHADS2 score, antithrombotic therapy administered and any previous ablative procedures undertaken.

The second group of 10 items focused on procedural aspects:

ablative strategy, mapping techniques, imaging utilized, type of energy, ablation parameters, duration of the procedure and fluoroscopy time. The steering committee included 18 countries in the study and, in collaboration with a previously appointed national coordinator, identified 85 EP centers that performed procedures for the ablation of AF. Thirty-five centers from 12 countries accepted to participate at the survey: Belgium, France, Germany, Greece, Italy, Norway, Romania, Russia, Slovenia, Spain, Switzerland and Turkey. Data were collected prospectively and consecutively in an online website from 1st July 2010 to 31st March 2011 by an independent institution and inserted into a database by means of Microsoft® Excel (2007 release for Windows Vista). Subsequently, these data were read by a single observer, who then re-checked the reading of each datum. It must be pointed out that, for reasons of different local regulatory process, not all the centers were activated simultaneously; indeed, some began enrolment only towards the end of the 6-month period scheduled for the survey.

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Statistical analysis Descriptive statistics Absolute, relative and cumulative frequencies were used to describe qualitative variables. Quantitative variables with a normal distribution were reported as mean ± standard deviation, while variables not normally distributed were reported as median (1st - 3rd quartiles). In the figures, qualitative variables were represented by bar-plots. Inferential statistics Normality of the distribution of quantitative variables was tested by means of the Kolmogorov-Smirnov technique. The hypothesis that categorical variables would be independently distributed was assessed by means of the Chi-square test. With regard to quantitative variables, the non-parametric Mann-Whitney test and the Kruskal-Wallis test were used to test the hypothesis that two or more samples would come from the same population. To compare the distribution of subgroups among the centers, we used only the data from centers that had enrolled at least 30 patients. In all tests, probability values below 5% (p

Prospective European survey on atrial fibrillation ablation: clinical characteristics of patients and ablation strategies used in different countries.

Atrial fibrillation (AF) ablation is widely adopted. Our aim was to conduct a prospective multicenter survey to verify patients' characteristics, appr...
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