None listed
Conditions
Brief summary
Paroxysmal atrial fibrillation (PAF), arrhythmogenic activity usually originates in the muscle sleeves of the pulmonary veins (PVs) and may trigger and perpetuate the arrythmias. Randomized trials have shown that catheter ablation is superior to antiarrhythmic drug therapy in maintaining sinus rhythm (SR). Circumferential isolation of the PVs has become the cornerstone strategy for PAF catheter ablation with a success rate ranging from 38 - 70% after a single procedure to 65 - 90% after repeated procedures. Once initiated from a trigger, PAF will not be maintained if the appropriate substrates are not present. The atria of patients with PAF can present very different patterns during electroanatomic mapping due to atrial myocardial fibrosis which is significantly increased in patients with PAF as compared with those in sinus rhythm. There are multiple potential etiological causes for this relationship. Aging and co-existing cardiovascular diseases (e.g. hypertension) are thought to play an important role in the development of myocardial fibrosis and, consequently, in maintaining PAF. In patients with PAF and structural atrial disease, PVs ablation may fail and cause progressive atrial remodeling which explain the recurrences and the development of ‘new’ arrhythmias. Thus alternative approaches aimed at modifying atrial substrates in order to prevent maintaining PAF has been proposed. There is no consensus about the best catheter ablation strategy. The purpose of this prospective study was to determine whether ablation of both CFAEs and PVs is associated with a higher probability of maintaining sinus rhythm as compared to PV isolation alone in patients with PAF refractory to anti-arrhythmic therapy. One hundred fifty patients with paroxysmal AF refractory to at least one anti-arrhythmic drug, were consecutively enrolled for a first-time catheter ablation at Electrophysiology laboratory of Clinica Pierangeli Pescara and Electrophysiology Unit, Cardiovascular Department, “Spirito Santo” Hospital, Pescara between January 2007 and July 2012.
Interventions
Pulmonary vein isolation (PVI) during paroxysmal Atrial Fibrillation (75 patients): During the procedure, 4 catheters were introduced via the right femoral vein under lidocaine local anesthesia. A decapolar catheter (InquiryTM St. Jude Medical Inc., St.Paul, MN, USA) was positioned inside the coronary sinus (CS) and a tetrapolar catheter (SupremeTM CRD-2, St. Jude Medical Inc., St.Paul, MN, USA) on the His bundle. Left atrium access was obtained by a single interatrial septal puncture with a B
Pulmonary vein isolation (PVI) during paroxysmal Atrial Fibrillation (75 patients): During the procedure, 4 catheters were introduced via the right femoral vein under lidocaine local anesthesia. A decapolar catheter (InquiryTM St. Jude Medical Inc., St.Paul, MN, USA) was positioned inside the coronary sinus (CS) and a tetrapolar catheter (SupremeTM CRD-2, St. Jude Medical Inc., St.Paul, MN, USA) on the His bundle. Left atrium access was obtained by a single interatrial septal puncture with a BRK needle (St. Jude Medical Inc., St.Paul, MN, USA). Subsequently a circumferential decapolar catheter for pulmonary vein mapping (AFocusIITM 10 pole with a 20 mm diameter; St. Jude Medical Inc., St.Paul, MN, USA) , and the ablation catheter as were positioned into the left atrium. The ablation was performed with open irrigated ablation catheter Therapy Cool Path DuoTM (St. Jude Medical Inc., St.Paul, MN, USA). 3-D electroanatomic mapping was performed using EnSite NavXTM-software version 8.0 (St. Jude Medical Inc., St.Paul, MN, USA). The time of the procedure never exceeded four hours. The first objective was to systematically isolate all segmental ostial pulmonary veins. Pulmonary vein isolation was confirmed by entrance block. Repeated electrophysiological procedures were carried out for recurrent atrial arrhythmias (after the blanking period or 3 months). The first objective was to assess pulmonary vein reconduction, followed by electrical re-isolation.
Sponsors
Massimiliano Faustino
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria is paroxysmal atrial fibrillation was defined accordingly to the Task Force for the Management of Atrial Fibrillation of ESC/ECATS 2007
Exclusion criteria
Persistent atrial fibrillation, permanent atrial fibrillation.
Outcome results
None listed