Focal Impulse and Rotor Modulation Ablation vs. Pulmonary Vein isolation for the treatment of paroxysmal Atrial Fibrillation: results from the FIRMAP AF study.

AIMS: Pulmonary vein isolation (PVI) is the gold standard for atrial fibrillation (AF) ablation. Recently, catheter ablation targeting rotors or focal sources has been developed for treatment of AF. This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM)-guided ablation as the sole ablative strategy with PVI in patients with paroxysmal AF. METHODS AND RESULTS: We conducted a multicentre, randomized trial to determine whether FIRM-guided radiofrequency ablation without PVI (FIRM group) was non-inferior to PVI (PVI group) for treatment of paroxysmal AF. The two primary efficacy end points were (i) acute success defined as elimination of AF rotors (FIRM group) or isolation of all pulmonary veins (PVI group) and (ii) long-term success defined as single-procedure freedom from AF/atrial tachycardia (AT) recurrence 12 months after ablation. The study was closed early by the sponsor. At the time of study closure, any pending follow-up visits were waived. A total of 51 patients (mean age 63 ± 10.6 years, 57% male) were enrolled. All PVs were successfully isolated in the PVI group and all rotors were successfully eliminated in the FIRM group. Single-procedure effectiveness was 31.3% (5/16) in the FIRM group and 80% (8/10) in the PVI group at 12 months. Three vascular access complications occurred in the FIRM group. CONCLUSION: These partial study effectiveness results reinforce the importance of PVI in paroxysmal AF patients and indicate that FIRM-guided ablation alone (without PVI) is not an effective strategy for treatment of paroxysmal AF in most patients.

Safety and Efficacy of Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Diabetic Patients.

BACKGROUND: Cryoballoon based catheter ablation (CB-CA) is an established therapy for treatment of symptomatic atrial fibrillation (AF). However, data about AF ablation using the CB in the diabetic population is sparse. The aim of this single center retrospective study is to evaluate the safety and efficacy of CB ablation in patients with diabetes mellitus (DM) as compared to patients without DM. METHODS AND RESULTS: Between July 2015 and December 2017, 397 consecutive patients underwent CB-CA for AF. Forty-eight consecutive patients with DM (DM group, study group) were compared with propensity score-matched patients without DM (n=48, control group). All patients underwent pulmonary vein isolation (PVI) using the second-generation CB (CB2). The mean age in the DM group was 66.9±9.5 years and 69.5±8.8 in the non-DM group (p=0.18). During a follow-up of 12.7±5.1 months, single procedure success rate for the DM and the non-DM group was 68.7% and 70.8%, respectively (p=0.82). The most common complication was transient phrenic nerve palsy (4 DM group vs. 0 non-DM group, p=0.04). No severe complication such as procedure related deaths, atrio-esophageal fistula or cerebrovascular embolic events occurred. CONCLUSIONS: Our data strengthen the value of CB2 based ablation for the treatment of AF as an effective and safe procedure in DM patients, with similar success rates when compared with a non-DM population.