First experience with left atrial arrhythmia ablation using a bi-directional steerable transseptal sheath (Vizigo) visible in the CARTO system as a method to reduce fluoroscopy.

Koźluk, Edward; Łojewska, Katarzyna; Hiczkiewicz, Jarosław

doi:10.31373/ejtcm/131049

Cited by 4 publications

(6 citation statements)

References 4 publications

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“…It is difficult to comprehensively measure the clinical effectiveness and efficiency of a sheath used in RFCA with a limited sample size in a retrospective study setting. Even with a meticulous review of all documented records on the RFCA procedure, the current study was unable to replicate most of previously reported advantages of the steerable sheath in comparison to a fixed curve sheath ( 7 , 10 , 11 ) but the observed significant reduction of PVI fluoroscopy time and post-surgery LOS may be considered a promising aspect of improved clinical efficiency of steerable sheath for RFCA. In addition, these study findings can encourage future research to confirm the clinical benefits of steerable sheath in reducing the risk of electrode and sheath dislocation into the right atrium which requires fluoroscopic verification during maneuvers performed with the sheath, simplifying the ablation process, and improving initial PVI success rate.…”

Section: Discussioncontrasting

confidence: 60%

“…To mitigate such issues for interventional cardiologists and unmet medical needs of AF patients, a steerable sheath (The CARTO VIZIGO™ Bi-Directional Guiding Sheath) was introduced in China in 2018. This steerable sheath is designed to work with the CARTO ® 3 System map to visualize ablation catheter without fluoroscopy and enhance performance efficiency for the navigation and positioning of ablation catheter ( 7 ). Previous randomized clinical trials from western countries demonstrated that steerable sheath could gain more clinical benefits than non-steerable sheath by increasing clinical success rate and reducing fluoroscopy time ( 8 , 9 ).…”

Section: Introductionmentioning

confidence: 99%

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Clinical effectiveness and efficiency of a new steerable sheath technology for radiofrequency ablation in Chinese patients with atrial fibrillation: a retrospective comparative cohort study

Zhao¹,

Zhang²,

Peng³

et al. 2023

J Thorac Dis

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Background The clinical effectiveness and efficiency of a steerable sheath for radiofrequency catheter ablation (RFCA) in Chinese patients with atrial fibrillation (AF) needs to be compared with a fixed curve sheath to optimize RFCA procedure. Methods This retrospective study included adult AF patients with their first RFCA that was conducted by the same electrophysiologist using a steerable sheath (VIZIGO, Biosense Webster, Inc.) or a fixed curve sheath (NaviEase, Synaptic Medical) in a Chinese tertiary care hospital from January to November 2021. The medical records kept at the hospital were the source of study data that included patient baseline characteristics and outcome measures for the clinical effectiveness and efficiency of RFCA procedure. Multivariate generalized linear regression analyses were performed to explore the impact of sheath type on clinical effectiveness and efficiency after adjustment. Results Fourteen patients using steerable sheath and 34 patients using fixed curve sheath for RFCA were included in the data analysis. Most of patient baseline characteristics associated with the two study groups were comparable except that the steerable sheath group had significantly higher left atrium diameter (41.9±6.5 vs. 38.1±3.9 mm, P=0.017) and larger left atrium volume (150.4±29.5 vs. 126.8±27.5 mL, P=0.017) than the fixed curve sheath group. Using steerable sheath was associated with significantly shorter total pulmonary vein isolation (PVI) fluoroscopy time and post-surgery hospital length of stay (LOS) than using fixed curve sheath in both unadjusted comparisons (PVI fluoroscopy time: 1.3±1.5 vs. 4.0±3.9 min, P=0.004; post-surgery LOS: 2.1±0.7 vs. 2.9±1.5 days, P=0.034) and multivariate generalized regression analyses (PVI fluoroscopy time: coefficient =−0.859, P=0.014; post-surgery LOS: coefficient =−0.303, P=0.018). Conclusions Compared to fixed curve sheath, steerable sheath used for RFAC could have the potential to shorten the PVI fluoroscopy time and reduce post-surgery LOS in a Chinese real-world hospital setting. Future real-world studies with large sample size are needed to confirm our study findings.

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Section: Discussioncontrasting

confidence: 60%

Section: Introductionmentioning

confidence: 99%

Clinical effectiveness and efficiency of a new steerable sheath technology for radiofrequency ablation in Chinese patients with atrial fibrillation: a retrospective comparative cohort study

Zhao¹,

Zhang²,

Peng³

et al. 2023

J Thorac Dis

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“…Previous reports have shown that this visualizable steerable sheath increases PVI success rates, improves procedural efficiency, and reduces fluoroscopy time compared with non-steerable sheaths in patients undergoing catheter ablation for paroxysmal AF or complex left atrial arrhythmias. 10 , 13–15 Additionally, a previous analysis of the US Food and Drug Administration’s Manufacturer And User Facility Device Experience database showed a comparable safety profile for this visualizable steerable sheath and a steerable sheath that is not visualizable on the EAM system (Agilis NxT Steerable Introducer; Abbott Laboratories, Chicago, IL, USA). 16 …”

Section: Introductionmentioning

confidence: 89%

The impact of steerable sheath visualization during catheter ablation for atrial fibrillation

et al. 2023

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Aims Incorporating a steerable sheath that can be visualized using an electroanatomical mapping (EAM) system may allow for more efficient mapping and catheter placement, while reducing radiation exposure, during ablation procedures for atrial fibrillation (AF). This study evaluated fluoroscopy usage and procedure times when a visualizable steerable sheath was used compared with a non-visualizable steerable sheath for catheter ablation for AF. Methods and results In this retrospective, observational, single-centre study, patients underwent catheter ablation for AF using a steerable sheath that is visualizable using the CARTO EAM (VIZIGO; n = 57) or a non-visualizable steerable sheath (n = 34). The acute procedural success rate was 100%, with no acute complications in either group. Use of the visualizable sheath vs. the non-visualizable sheath was associated with a significantly shorter fluoroscopy time [median (first quartile, third quartile), 3.4 (2.1, 5.4) vs. 5.8 (3.8, 8.6) min; P = 0.003], significantly lower fluoroscopy dose [10.0 (5.0, 20.0) vs. 18.5 (12.3, 34.0) mGy; P = 0.015], and significantly lower dose area product [93.0 (48.0, 197.9) vs. 182.2 (124.5, 355.0) μGy·m2; P = 0.017] but with a significantly longer mapping time [12.0 (9.0, 15.0) vs. 9.0 (7.0, 11.0) min; P = 0.004]. There was no significant difference between the visualizable and non-visualizable sheaths in skin-to-skin time [72.0 (60.0, 82.0) vs. 72.0 (55.5, 80.8) min; P = 0.623]. Conclusion In this retrospective study, use of a visualizable steerable sheath for catheter ablation of AF significantly reduced radiation exposure vs. a non-visualizable steerable sheath. Although mapping time was longer with the visualizable sheath, the overall procedure time was not increased.

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“…Anatomical mapping of the right atrium was performed. Based on the images obtained, both catheters (the DiamondTemp and Advisor) were introduced into the left atrium through the leak in the septum using technique presented in previous publication [17]. In all 3 patients pulmonary vein isolation was performed us-ing the "close protocol" (the distance between neighboring ablation points was < 6 mm) [18] using DiamondTemp catheter (Medtronic) with nominal high-power (50 W) under temperature control (Fig.…”

Section: Methodsmentioning

confidence: 99%

Irrigated DiamondTemp catheter and return to ablation under temperature control. First Polish experience with DiamondTemp catheter in pulmonary vein isolation.

Koźluk¹,

Piątkowska²,

Rodkiewicz³

et al. 2021

Eur J Trans Clin Med

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First experience with left atrial arrhythmia ablation using a bi-directional steerable transseptal sheath (Vizigo) visible in the CARTO system as a method to reduce fluoroscopy.

Cited by 4 publications

References 4 publications

Clinical effectiveness and efficiency of a new steerable sheath technology for radiofrequency ablation in Chinese patients with atrial fibrillation: a retrospective comparative cohort study

Clinical effectiveness and efficiency of a new steerable sheath technology for radiofrequency ablation in Chinese patients with atrial fibrillation: a retrospective comparative cohort study

The impact of steerable sheath visualization during catheter ablation for atrial fibrillation

Irrigated DiamondTemp catheter and return to ablation under temperature control. First Polish experience with DiamondTemp catheter in pulmonary vein isolation.

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