AFib Ablation Pilot: ESC-EURObservational Research Programme: 1-year follow-up of the Atrial Fibrillation Ablation Conducted by the European Heart Rhythm Association
List of Authors:
Prof. Josep Brugada / Spain
Dr. Elena Arbelo (SPAIN), Prof. Gerhard Hindricks (GERMANY), Prof. Aldo Maggioni (ITALY), Prof. Luigi Tavazzi (ITALY), Prof. Panos Vardas (GREECE), Prof. Frédéric Anselme (FRANCE), Prof. Giuseppe Inama (ITALY), Prof. Pierre Jais (FRANCE), Prof. Zbigniew Kalarus (POLAND), Prof. Josef Kautzner (CZECH REPUBLIC), Prof. Thorsten Lewalter (GERMANY), Prof. Georges Mairesse (BELGIUM), Dr. Julian Perez-Villacastin (SPAIN), Prof. Sam Riahi (DENMARK), Prof. Milos Taborsky (CZECH REPUBLIC), Dr. George Theodorakis (GREECE), Dr. Serge Trines (THE NETHERLANDS), on the behalf of the Atrial Fibrillation Ablation Pilot Study Investigators
The Atrial Fibrillation Ablation Pilot Study is a prospective, multinational registry conducted by the European Heart Rhythm Association of the European Society of Cardiology in the context of the ESC EurObservational Research Programme. This study was designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation procedure, and the diagnostic/therapeutic processes applied in these patients across Europe. We present the results of the 1-year follow-up analysis.
A total of 72 Centres in 10 European countries (Belgium, France, Germany, The Netherlands, Czech Republic, Poland, Greece, Italy, Spain and Denmark) were asked to enrol 20 consecutive patients scheduled for a first AFib ablation procedure. Site selection targeted hospitals with a medium to high expertise (performing ≥ 50 AFib ablation procedures/year). A web-based electronic case report form was developed to capture information on pre-procedural, procedural and 1-year follow-up data.
The baseline visit documented demographic characteristics, risk factors for cardiovascular diseases and co-morbidities, precipitating factors, type of AFib, clinical signs and symptoms, use of invasive/non invasive diagnostic procedures and treatment. The ablation information included: number of personnel, laboratory setting, type of catheters, type of energy, type of imaging techniques, type of anaesthesia and anticoagulation protocol, type of procedure, time of Rx exposure, acute outcomes used to define success and complications. Prior to discharge a clinical evaluation was performed and any adverse event and changes to concomitant medication were recorded.
A single visit 12 months will record: clinical evaluation, means of identification of recurrences and the existence of post-ablation AFib or atypical atrial flutter, concomitant medication changes, record adverse events and hospitalizations since last follow-up. Population: Between October 2010 and May 2011, 1410 patients were included, of which 1391 underwent an AFib ablation (98.7%). The median age was 60 years (IQR 52–66), and 28% females. Two thirds had paroxysmal AFib and 38% lone AFib. Symptoms were present in 86%. The indications for ablation were mostly symptomatic AFib, but in over a third of patients, there was also a desire for a drug-free lifestyle and the maintenance of sinus rhythm. Pulmonary vein isolation was attempted in 97% of patients, the roof line in 19.3% and the mitral isthmus line in 12.8%. Complex fractionated atrial electrograms were targeted in 1.3% and the ganglionated plexi in 3.3%. Complications occurred in 7.7%, of which 1.7% was major (i.e. cardiac perforation, MI, endocarditis, cardiac arrest, stroke, hemothorax, pneumothorax, sepsis). The median duration of hospitalization was 3 days (IQR 2–4). At discharge, 91.4% of patients were in sinus rhythm, 88.3% of patients were given vitamin K antagonists and 67% antiarrhythmic medication. There was one death after the ablation procedure.
The 12-month follow-up visit period will extend from October 2011 until May, 30th 2011.
The Atrial Fibrillation Ablation Pilot Study has provided relevant information on the current clinical practice of AFib ablation across Europe. The evaluation of the 12-month follow-up results will give us more insight of real-life outcomes of the ablation of AFib. These data may be useful when designing management strategies of patients suffering from atrial fibrillation. Finally, further analyses by geographical areas may contribute to identify regional or general needs in relation to this procedure.