Visualizable vs. non-visualizable steerable sheaths for AF procedures: randomized tiral

Abstract

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): ÚNKP-22-4 New National Excellence Program of the Ministry for Culture and Innovation from the source of the National Research, Development and Innovation Fund. Steerable sheaths (SSs) are frequently used to improve catheter stability during atrial fibrillation (AF) procedures. A new type of visualizable (by electroanatomical mapping system) SS has become available in clinical treatment. Purpose We aimed to compare procedural and follow up data of visualizable vs. non-visualizable SS assisted pulmonary vein isolation procedures in patients with AF. Methods In this single-centre randomized study, we enrolled a total of 100 consecutive patients who underwent PVI due to AF. Results 100 consecutive patients were enrolled and randomized into 2 groups (visualizable SS group: 50; non-visualizable SS group: 50). With the use of visualizable SS, left atrial (LA) procedure time (53.1 [41.3; 73.1] min vs. 59.5 [47.6; 74.1] min.; p = 0.04), LA fluoroscopy time (0 [0; 0] s vs. 17.5 [5.5; 69.25] s; p < 0.01) and LA fluoroscopy dose (0 [0; 0.27] mGy vs. 0.74 [0.16; 2.34] mGy; p < 0.01) was significantly less, however, there was no difference in the total procedural time (90 ± 35.2 min vs. 99.5 ± 31.8 min; p = 0.13), total fluoroscopy time (184 ± 89 s vs. 193 ± 44 s; p = 0.79), and total fluoroscopy dose (9.12 ± 1.98 mGy vs. 9.97 ± 2.27 mGy; p = 0.76). Compared to standard SS group total ablation time was reduced (1049 sec. [853; 1175] vs. 1265 sec. [1085; 1441]; p < 0.01) using visualizable SS, and the number of radiofrequency ablations was fewer (69 [58; 80] vs. 79 [73; 86); p < 0.01) in this group. There was no difference between the groups regarding acute ablation success (both group 100%) and first pass isolation rate (92% vs. 89%; p = 0.88). No major complications occurred in either group. During the 6 months follow up period there was no difference either in blanking period (visulaizable SS: 3/50, standard SS: 4/50; p=0.70) or at 6 months after the ablation (visulaizable SS: 3/50, standard SS: 5/50; p=0.46). Conclusion Visualizable SS significantly can reduce the left atrial procedure time, total ablation time and fluoroscopy exposure without compromising its safety or mid-term success in patients undergoing PVI procedures for AF.