Efficiency and safety in AF ablation using a novel loop-shaped cryoablation catheter

Abstract

Abstract Background Different single shot ablation systems are under development to improve the efficiency and safety of pulmonary vein isolation for the treatment of atrial fibrillation (AF). Purpose Evaluation of effectiveness and safety of a novel cryoloop catheter (figure 1) for pulmonary vein isolation. Methods In a single centre prospective registry, patients with drug-refactory AF underwent pulmonary vein isolation (PVI) using a novel loop-shaped cryoablation catheter. For efficiency assessment the following parameters were registered: 1: the number of successfully isolated pulmonary veins (PV) confirmed by entrance- and exit block; 2: total procedure time, left atrial dwell time, total cryoablation time and applications as well as total fluoroscopy time; 3: freedom from atrial arrhythmia after 6 months. For safety assessment the following parameters were studied: 1: periinterventional adverse events like pericardial effusion, thromboembolic events and bleedings according to BARC classification; 2: endoscopic detected esophageal lesions (EDEL); 3: phrenic nerve palsy; 4: computed tomography angiography (CTA) detected PV stenosis until 6 months after PVI. Results In total, 25 subjects were enrolled in the current registry and received PVI with the loop-shaped cryoablation catheter. In terms of efficiency, successful acute PVI could be achieved in 91/100 treated PVs. Total procedure, atrial dwell, cryoablation and total fluoroscopy times were 130.5 ± 24.2 min, 101.4 ± 19.8 min, 40.8 ± 11.0 min and 22.5 ± 5.5 min, respectively. On average, 4.5 cryoenergy applications per PV were required for acute PVI. Out of the blanking period of 3 months, after 6 months 18/25 subjects (72%) were free from any atrial arrhythmia. With respect to safety, no pericardial effusion, thromboembolic event or bleeding complication occurred. 2/25 subjects experienced a transient phrenic nerve palsy. Additionally, no EDEL or PV stenosis could be detected. Conclusion The present single centre registry confirmed the effectiveness and safety of the novel loop-shaped cryoablation catheter for the treatment of atrial fibrillation.Figure 1: cryoloop catheter