Abstract 15795: First Human Experience of the Linear Ablation Catheter for the Ablation of Right Atrial Flutter (Linear LAAF-141 Study): First Results
Introduction: Right atrial flutter (AFL) ablation is performed by creating point by point a line of bidirectional conduction block (BDB) across the cavotricuspid isthmus (CVI). The Linear Study evaluates the safety and effectiveness of the linear ablation system (LAS), consisting of a new multi-channel radiofrequency (RF) generator with a new ablation catheter designed to perform linear lesions.
Methods: Linear is a prospective, single center, non-randomized, clinical feasibility study in patients undergoing RF ablation for CTI-dependent right AFL. Transesophageal or intracardiac echocardiography is used to exclude intracardiac thrombus. The study device is a quadripolar catheter (Biosense Webster) with 2 RF electrodes (position 1 and 3, tip and ring) capable of performing bipolar (B) ablation between electrodes or unipolar (U) ablation from either one electrode or simultaneously. Electroanatomical mapping of RA is performed with the CARTO system. The maximum power settings used are 40 W for U tip ablation and 20 W for U ring or B (tip to ring) ablation. The flow rate is 60ml/min during ablation with temperature setting at 45° C and a maximum application duration of 60 sec. Confirmation of BDB is obtained by differential pacing and mapping of the ablation line. Primary endpoints include procedure and device-related serious adverse events (SAE) within 7 days or 1 month follow up (FU) and acute procedural effectiveness defined as confirmed complete BDB across CVI.
Results: To date 17 patients enrolled, 16 evaluable, 13 males, age 68±6 were treated with LAS. Underlying disease: hypertension (11), coronary heart disease (3), valvular (5), dilated cardiomyopathy (1). 14 patients presented with counterclockwise and 2 with clockwise AFL. In all patients BDB was achieved and no repeat procedure was needed. All patients had a 7 day and 1 month FU and no SAEs have been reported. The mean ablation time was 29±21min and mean fluoroscopy time was 4.8±4.3min. The mean number of RF applications per patient was 6±3.6 for B applications and 7.1±5.8 for U applications.
Conclusion: First results of the Linear LAAF-141 study indicate that the LAS appears to provide rapid, safe and effective BDB across the CVI. Continued evaluation is warranted to further characterize the LAS.
- © 2012 by American Heart Association, Inc.