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

Abstract

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.

Feasibility and safety of cavotricuspid isthmus ablation using exclusive intracardiac echocardiography guidance: a proof-of-concept, observational trial

“…Numerous studies have confirmed the feasibility of near-zero and zero-fluoroscopy approaches for CTI ablation, including their successful application as an extension to pulmonary vein isolation procedures within a single session ( 5 , 15 – 23 ). In addition, the advent of visualizable steerable sheaths has yielded significant advancements in mitigating radiation exposure during catheter ablation procedures ( 24 ).…”

Zero-Fluoroscopy Catheter Ablation of Supraventricular Tachycardias in the Pediatric Population

“…Along with the use of ICE, we see the introduction of a visualizable steerable sheath as an additional valuable tool in achieving a zero-fluoroscopy CA approach. According to the recently published data, the use of 3D EAM visualizable steerable sheaths increased the number of procedures that could be performed in a zero-fluoroscopy setting, and reduced left atrial procedure time and RFA time by improving ablation catheter stability, without compromising the efficacy or safety profile of pulmonary vein isolation procedures in the adult population [ 36 , 37 ].…”

Comparison of pulmonary vein isolation using cryoballoon, high-power short-duration, and conventional radiofrequency ablation for atrial fibrillation: a propensity score-weighted study

“…Steerable sheaths help the operators improve contact and stability of the ablation catheter, leading to achieve efficient lesion formation for AF ablation. Recently, with the advent of visualizable steerable sheaths, RF-PVI is associated with minimal radiation exposure ( 42 , 43 ), and zero-fluoroscopy RF-PVI ( 44 ) showed equal efficacy and safety compared with traditional procedures ( 45 ). Therefore, future direction for AF ablation using cryoballoon and radiofrequency catheter possibly studies better rhythm outcomes, lower complication rates, reduced procedure time, and also reduced radiation exposure.…”