Visualizable steerable sheaths significantly reduced median left atrial procedure time (53.1 vs 59.5 minutes, p=0.04), radiofrequency delivery, and fluoroscopy exposure compared to standard sheaths during pulmonary vein isolation.
RCT (n=100)
Open-label
Randomized
No
Does a visualizable steerable sheath improve procedural metrics compared to a standard non-visualizable steerable sheath in patients undergoing PVI for AF?
Visualizable steerable sheaths significantly reduce left atrial procedure time, radiofrequency delivery, and fluoroscopy exposure during PVI for AF without compromising safety or effectiveness.
Absolute Event Rate: 53.1% vs 59.5%
p-value: p=0.04
Introduction Steerable 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. Purpose We aimed to compare procedural data of visualizable vs. non-visualizable steerable sheath assisted PVI procedures in patients with atrial fibrillation (AF). Methods In this single-centre randomized study, we enrolled a total of 100 consecutive patients who underwent PVI due to AF. Results A 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. Conclusion Compared 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.
Janosi et al. (Wed,) conducted a rct in Atrial fibrillation (n=100). Visualizable steerable sheath (VIZIGO) vs. Standard, non-visualizable steerable sheath (Agilis NxT) was evaluated on Left atrial procedure time (minutes) (p=0.04). Visualizable steerable sheaths significantly reduced median left atrial procedure time (53.1 vs 59.5 minutes, p=0.04), radiofrequency delivery, and fluoroscopy exposure compared to standard sheaths during pulmonary vein isolation.
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