P857Comparison of pulmonary vein isolation using a laser balloon and using an open irrigated mapping and ablation catheter (nMARQ)

Abstract

Background: Pulmonary vein isolation (PVI) is the mainstay of interventional treatment of drug refractory paroxysmal and persistent atrial fibrillation (PAF). We sought to compare the safety and efficacy of the Laser Balloon (LB) and an Open Irrigated Mapping and Ablation Catheter (nMARQ) in a single-center prospective study. Methods and Results: 53 consecutive patients (pts; age 63±13 years, 22 females) with drug-refractory PAF referred for PVI were randomly assigned to pulmonary vein isolation with the use of the nMARQ catheter (n=27; 4 with persistent AF) or the LB (n=26; 6 with persistent AF). Outcome parameters were the acute success rate in establishing complete PVI and the rate of sustained sinus rhythm during follow-up (FU) at 6 and 12 months using 3-day ambulatory Holter ECG recording (recurrence of AF ≥ 30 seconds). Repeat pulmonary vein isolation was performed in 4 pts of the nMARQ and 3 pts of the LB group. Pts were classified as failure. Follow-up was 100% complete. In all patients pulmonary vein isolation was achieved with the assigned treatment device. Mean fluoroscopy time was higher in the nMARQ group (46±24 vs. 35±32 min.; p=0.012), whereas the mean total procedure duration was not significantly different between the groups (150±46 vs. 157±35 min.; p=n.s.). In the LB group two patients had minor vascular complications und two other had small pericardial effusions (no intervention needed). There were no complications in the nMARQ group. After a mean FU of 12 months, rates of sustained sinus rhythm after a single ablation procedure were 74% and 77%, respectively (p=n.s.). Conclusion: nMARQ catheter and LB are viable options to archive pulmonary vein isolation in patients with drug-refractory PAF. Acute success rates are high. The AFfree survival rate after a single ablation procedure during FU was not statistically different between groups. While, due to reported severe complications, the nMARQ catheter has been removed from the market (with further investigations ongoing), no such complications were observed in our patients.