Radiofrequency catheter ablation maintains its efficacy better than antiarrhythmic medication in patients with paroxysmal atrial fibrillation: On-treatment analysis of the randomized controlled MANTRA-PAF trial.

BACKGROUND: The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) is a randomized trial comparing radiofrequency catheter ablation (RFA) to antiarrhythmic drugs (AADs) as first-line treatment of paroxysmal atrial fibrillation (PAF). In order to eliminate the clouding effect of crossover we performed an on-treatment analysis of the data. METHODS AND RESULTS: Patients (n=294) were divided into three groups: those receiving only the assigned therapy (RFA and AAD groups) and those receiving both therapies (crossover group). The primary end points were AF burden in 7-day Holter recordings at 3, 6, 12, 18, and 24 months and cumulative AF burden in all recordings. At 24 months, AF burden was significantly lower in the RFA (n=110) than in the AAD (n=92) and the crossover (n=84) groups (90th percentile 1% vs. 10% vs. 16%, P=0.007), and more patients were free from any AF (89% vs. 73% vs. 74%, P=0.006). In the RFA, AAD and the crossover groups 63%, 59% and 21% (P<0.001) of the patients had no AF episodes in any Holter recording, respectively. Quality of life improved significantly in all groups. There were no differences in serious adverse events between the RFA, AAD and crossover groups (19% vs. 8% vs. 23%) (P=0.10). CONCLUSIONS: In the treatment of antiarrhythmic therapy naïve patients with PAF long-term efficacy of RFA was superior to AAD therapy. Thus, it is reasonable to offer RFA as first-line treatment for highly symptomatic patients who accept the risks of the procedure and are aware of frequent need for reablation(s).

Radiofrequency ablation vs. antiarrhythmic drug therapy as first line treatment of symptomatic atrial fibrillation: systematic review and meta-analysis.

AIMS: New evidence about first-line radiofrequency catheter ablation (RFA) in symptomatic atrial fibrillation (AF) has emerged. In a single study the comparative treatment effect is potentially diminished by the high rate of cross-over to the alternative therapy. Therefore, we conducted a systematic review and meta-analysis of the available data to further evaluate the efficacy and safety of RFA vs. antiarrhythmic drugs (AADs). METHODS AND RESULTS: Five databases were searched for randomized controlled trials comparing RFA and AAD therapy as first-line treatment of AF in August 2014. Three studies with 491 patients with recurrent symptomatic AF were included. The patients were relatively young and the majority of them had paroxysmal AF (98.7%) and no major comorbidity. Radiofrequency catheter ablation was associated with significantly higher freedom from AF recurrence compared with AAD therapy [risk ratio (RR) 0.63, 95% confidence interval (CI) 0.44-0.92, P = 0.02]. The difference in the rate of symptomatic AF recurrences was not statistically significant (RR 0.57, 95% CI 0.30-1.08, P = 0.09). There was one procedure-related death and seven tamponades with RFA, whereas symptomatic bradycardia was more frequent with AAD therapy. CONCLUSION: Radiofrequency catheter ablation seems to be more effective than medical therapy as first-line treatment of paroxysmal AF in relatively young and otherwise healthy patients, but may also cause more severe adverse effects. These findings support the use of RFA as first-line therapy in selected patients, who understand the benefits and risks of the procedure.

Catheter ablation of atrial fibrillation in patients with therapeutic oral anticoagulation treatment.

AIMS: Current guidelines recommend discontinuation of oral anticoagulation treatment (OAT) and switch to heparin 2-5 days before catheter ablation of atrial fibrillation (AF). However, increasing evidence leans against the 'bridge therapy' and support continuation of OAT during the procedure. METHODS AND RESULTS: We evaluated the safety of AF ablation among patients with therapeutic OAT. The study population comprised 193 consecutive patients who underwent 228 AF ablation procedures guided by electroanatomical mapping. Periprocedural international normalized ratio was <2 (1.6 ± 0.3) in 103 cases (Group 1) and ≥2 (2.4 ± 0.4) in 125 cases (Group 2). Heparin (5000 IU bolus followed by continuous infusion through an open-irrigated ablation catheter) was used in both groups. No intracardiac echocardiographic guidance was used and activated clotting time (ACT) was not monitored. The incidence of major (intracranial bleeding, tamponade, bleeding that required surgical intervention, or blood transfusion) and minor bleeding complications and all thrombo-embolic events were registered during the 3-month follow-up. There was no statistical difference in major (P = 1.0) and minor complications (P = 0.74) between the groups. The bleeding complications included one surgically corrected groin haematoma in both groups (0.9%), 25 small haematomas at the puncture site (11 in Group 1 (10.7%) and 14 in Group 2 (11.2%), P = 0.90), and two minor pericardial effusions in Group 1. In Group 2, one patient had ischaemic stroke 16 days after the procedure. CONCLUSION: Transseptal puncture and AF ablation can be performed safely in patients with ongoing OAT without intracardiac echocardiographic guidance and ACT monitoring.