Abstract

Acute and chronic feasibility of intracardiac echography (ICE)-guided contrast-free cryoballoon ablation (ICBA) was previously reported. However, one of main concerns is a use of 2 large diameter transseptal sheaths (10Fr for an ICE and 12Fr for a cryoballoon) and its chronic outcomes remain unclear. This study was conducted to compare the acute and chronic adverse event of ICBA to those of conventional radiofrequency ablation (RFA) using two 8.5Fr transseptal sheaths. Patients with atrial fibrillation (AF) underwent ICBA using periballoon leak flow assessment or conventional RFA. In ICBA group, 2 large diameter transseptal sheaths (10Fr for an ICE and 12Fr for a cryoballoon) and 6Fr sheath were placed in the right femoral vein, two 8.5Fr transseptal sheaths and 6Fr sheath in conventional RFA group. Incidence of procedure related adverse event during the follow-up (including trans-thoracic echocardiography [TTE] at 6 and/or 12 months after the procedure) were compared to those of patients underwent conventional RFA. A total of 141 (36 [ICBA] and 105 [RFA]) patients with paroxysmal or persistent AF were investigated. Procedure related adverse events including femoral vascular complications (ICBA vs. RFA: 0 [0%] vs. 2 [1.9%], P=0.99), significant bleeding (0 [0%] vs. 2 [1.9%], P=0.99) and cardiac tamponade (0 [0%] vs. 0 [0%], P=1.00) were not different between them. TTE follow-up revealed persistent interatrial shunt at 6 and 12 months after the procedure was (ICBA vs. RFA: 3 [8.3%] vs. 2 [1.9%] at 6 months, P=0.20, and 1 [2.7%] vs. 1 [1.0%] at 12 months, P=1.00, respectively). During follow-up, no other procedure related adverse event was observed including paradoxical embolization. The outcomes of this study showed the safety of ICE-guided CBA were equivalent to conventional RFA, however, we recommend TTE follow-up especially when discontinue oral anticoagulation to avoid paradoxical embolization.

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