Safety of pulmonary vein isolation and left atrial complex fractionated atrial electrograms ablation for atrial fibrillation with phased radiofrequency energy and multi-electrode catheters.

AIMS: Recently, a multi-electrode catheter system using phased radiofrequency (RF) energy was developed specifically for atrial fibrillation (AF) ablation: the pulmonary vein ablation catheter (PVAC), the multi-array septal catheter (MASC), and the multi-array ablation catheter (MAAC). Initial results of small trials have been promising: shorter procedure times and low adverse event rates. In a large single-centre registry, we evaluated the adverse events associated with multi-electrode ablation catheter procedures with PVAC alone, or combined with MASC and MAAC. METHODS AND RESULTS: In all, 634 consecutive patients with AF had 663 procedures with multi-electrode ablation catheters, 502 patients with the PVAC alone, 128 patients with PVAC/MASC/MAAC, 29 redo procedures with the PVAC or PVAC/MASC/MAAC, and 4 patients had a complicated transseptal puncture. Major and minor adverse events during 6 month follow-up were registered. In 15 cases (2.3%), major adverse events were seen within the first month after the procedure. These included complicated transseptal puncture (4), stroke (2), transient ischaemic attack (5), acute coronary syndrome (2), femoral pseudoaneurysm (1), and arteriovenous fistulae (1). Minor adverse events were seen in 10.7% at 6 months, mostly due to femoral haematoma (3.9%), and non-significant PV stenosis (5.2%). There was no difference in the occurrence of major adverse events between PVAC alone, or PVAC/MASC/MAAC ablation. CONCLUSION: Ablation with phased RF and multi-electrode catheters is accompanied by a major adverse event rate of 2.3% within 1 month and a minor event rate of 10.7% at 6 months.

Pulmonary vein isolation and left atrial complex-fractionated atrial electrograms ablation for persistent atrial fibrillation with phased radio frequency energy and multi-electrode catheters: efficacy and safety during 12 months follow-up.

AIMS: Ablation for persistent atrial fibrillation (AF) remains a difficult and time-consuming procedure with varying degrees of success. We evaluated the long-term effects of a novel approach for ablation of persistent AF using multi-electrode catheters. METHODS AND RESULTS: In 89 patients with longstanding persistent AF (>1 year), multi-electrode ablation was performed with a pulmonary vein ablation catheter (PVAC), a multi-array septal catheter (MASC), and a multi-array ablation catheter (MAAC) for ablation of complex-fractionated atrial electrograms (CFAE) at the septum, left atrial (LA) roof, floor, posterior wall, and mitral isthmus. Follow-up was performed at 6 and 12 months with electrocardiogram, 7 days Holter, and occasionally ambulant event recordings. Average procedure and fluoroscopy times were 112 ± 32 and 21 ± 10 min. The pre-specified endpoint of pulmonary vein isolation and LA CFAE ablation was reached in all patients. No procedural complications were observed. At 12 months after a single treatment 44 of 89 (49%) remained in sinus rhythm, including direct current cardioversion in 12 patients. At 12 months, after a redo PVAC/MASC/MAAC, an additional 6 of 15 patients (40%) were free of AF. In 18 of 89 (20%) patients AF was changed to paroxysmal. CONCLUSIONS: In this single centre study, ablation for longstanding persistent AF with the PVAC/MASC/MAAC resulted in 56% freedom of AF at 1 year after 1.2 ± 0.4 procedures. This approach is time efficient and has a favourable safety profile.

Effect of fish oil on ventricular tachyarrhythmia and death in patients with implantable cardioverter defibrillators: the Study on Omega-3 Fatty Acids and Ventricular Arrhythmia (SOFA) randomized trial.

CONTEXT: Very-long-chain n-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish are thought to reduce risk of sudden death, possibly by reducing susceptibility to cardiac arrhythmia. OBJECTIVE: To study the effect of supplemental fish oil vs placebo on ventricular tachyarrhythmia or death. DESIGN, SETTING, AND PATIENTS: The Study on Omega-3 Fatty acids and ventricular Arrhythmia (SOFA) was a randomized, parallel, placebo-controlled, double-blind trial conducted at 26 cardiology clinics across Europe. A total of 546 patients with implantable cardioverter-defibrillators (ICDs) and prior documented malignant ventricular tachycardia (VT) or ventricular fibrillation (VF) were enrolled between October 2001 and August 2004. Patients were randomly assigned to receive 2 g/d of fish oil (n = 273) or placebo (n = 273) for a median period of 356 days (range, 14-379 days). MAIN OUTCOME MEASURE: Appropriate ICD intervention for VT or VF, or all-cause death. RESULTS: The primary end point occurred in 81 (30%) patients taking fish oil vs 90 (33%) patients taking placebo (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.64-1.16; P = .33). In prespecified subgroup analyses, the HR was 0.91 (95% CI, 0.66-1.26) for fish oil vs placebo in the 411 patients who had experienced VT in the year before the study, and 0.76 (95% CI, 0.52-1.11) for 332 patients with prior myocardial infarctions. CONCLUSION: Our findings do not indicate evidence of a strong protective effect of intake of omega-3 PUFAs from fish oil against ventricular arrhythmia in patients with ICDs. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00110838.