Visualizable vs. standard, non-visualizable steerable sheath for pulmonary vein isolation procedures: Randomized, single-centre trial

IntroductionSteerable sheaths (SSs) are frequently used to improve catheter contact during pulmonary vein isolation (PVI) procedures. A new type of visualizable (by electroanatomical mapping system) SS has become available in clinical treatment. PurposeWe aimed to compare procedural data of visualizable vs. non-visualizable steerable sheath assisted PVI procedures in patients with atrial fibrillation (AF). MethodsIn this single-centre randomized study, we enrolled a total of 100 consecutive patients who underwent PVI due to AF. ResultsA total of 100 patients were randomized into 2 groups (visualizable SS group: 50; non-visualizable SS group: 50). Acute ablation success was 100% and the rate of the first pass isolation were similar (92% vs. 89%; p = 0.88). Using 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, non-visualizable SS group, the number of radiofrequency ablations was fewer (69 [58; 80] vs. 79 [73; 86); p < 0.01) as well as total ablation time was reduced (1049 sec. [853; 1175] vs. 1265 sec. [1085; 1441]; p < 0.01) in the visualizable SS cohort. No major complications occurred in either group. ConclusionCompared to the standard, non-visualizable SS, visualizable SS significantly reduces the left atrial procedure time, RF delivery and fluoroscopy exposure without compromising its safety or effectiveness in patients undergoing PVI procedures for AF.

Automated summary

Visualizable steerable sheaths significantly reduce left atrial procedure time, radiofrequency ablations, and fluoroscopy exposure without compromising safety or efficacy in patients undergoing pulmonary vein isolation procedures for atrial fibrillation.