What is the clinical evidence from this study?

Study design: RCT. Population: Atrial fibrillation (n=100). Intervention: Visualizable steerable sheath (VIZIGO) vs. Standard, non-visualizable steerable sheath (Agilis NxT). Primary outcome: Left atrial procedure time (minutes) (p=0.04).

November 16, 2022Open Access

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

Key Result

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.

Study Design

Type

RCT (n=100)

Blinding

Open-label

Randomization

Randomized

Multicenter

Structured PICO

Does a visualizable steerable sheath improve procedural metrics compared to a standard non-visualizable steerable sheath in patients undergoing PVI for AF?

Population

100 adult patients undergoing first-time pulmonary vein isolation for paroxysmal or persistent atrial fibrillation.

Intervention

Visualizable steerable sheath (by electroanatomical mapping system) during PVI

Comparator

Standard, non-visualizable steerable sheath during PVI

Outcome

Procedural data including left atrial procedure time, fluoroscopy time, and fluoroscopy dosesurrogate

Visualizable steerable sheaths significantly reduce left atrial procedure time, radiofrequency delivery, and fluoroscopy exposure during PVI for AF without compromising safety or effectiveness.

Main Result

Absolute Event Rate: 53.1% vs 59.5%

p-value: p=0.04

Limitations

Randomized, single-centre, single-operator study with a limited number of patients enrolled, which may limit generalizability
Data about contact force parameters were not available
Does not provide data on whether the long-term results are influenced by the type of steerable sheath

Abstract

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.

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