Dataset Information

Experience of robotic catheter ablation in humans using a novel remotely steerable catheter sheath.

ABSTRACT:

Background

A novel remotely controlled steerable guide catheter has been developed to enable precise manipulation and stable positioning of any eight French (Fr) or smaller electrophysiological catheter within the heart for the purposes of mapping and ablation.

Objective

To report our initial experience using this system for remotely performing catheter ablation in humans.

Methods

Consecutive patients attending for routine ablation were recruited. Various conventional diagnostic catheters were inserted through the left femoral vein in preparation for treating an accessory pathway (n = 1), atrial flutter (n = 2) and atrial fibrillation (n = 7). The steerable guide catheter was inserted into the right femoral vein through which various irrigated and non-irrigated tip ablation catheters were used. Conventional endpoints of loss of pathway conduction, bidirectional cavotricuspid isthmus block and four pulmonary vein isolation were used to determine acute procedural success.

Results

Ten patients underwent remote catheter ablation using conventional and/or 3D non-fluoroscopic mapping technologies. All procedural endpoints were achieved using the robotic control system without manual manipulation of the ablation catheter. There was no major complication. A radiation dosimeter positioned next to the operator 2.7 m away from the X-ray source showed negligible exposure despite a mean cumulative dose area product of 7,281.4 cGycm(2) for all ten ablation procedures.

Conclusions

Safe and clinically effective remote navigation of ablation catheters can be achieved using a novel remotely controlled steerable guide catheter in a variety of arrhythmias. The system is compatible with current mapping and ablation technologies Remote navigation substantially reduces radiation exposure to the operator.

SUBMITTER: Kanagaratnam P

PROVIDER: S-EPMC2262917 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Abstract Introduction Catheter placement and stability are well‐known challenges in atrial fibrillation (AF) ablation. As a result, steerable sheaths (SS) were developed to improve catheter stabilization and maintain proper catheter–tissue contact. The purpose of this systematic review and meta‐analysis is to see if employing a SS influences procedure outcome. Method We performed a comprehensive literature search for studies that evaluated the efficacy and safety of SS compared to nonsteerable sheaths (NSS) in AF ablation. The primary outcome was the rate of atrial arrhythmia (AA) freedom by the time of the last follow‐up. The secondary outcomes were the procedure‐related complications and procedural characteristics. Risk ratio (RR) or the mean difference (MD) and corresponding 95% confidence intervals (CIs) were calculated using the random‐effects model. Results A total of 10 studies, including 967 AF patients (mean age: 59.2 ± 11.1 years, 516 patients managed with SS vs. 454 with NSS), were included. SS group showed a higher rate of freedom of AA compared to NSS (RR: 1.19; 95% CI 1.09–1.29; p < .001). Both techniques had similar rate for procedural‐related complication (RR: 1.09, 95% CI 0.50–2.39; p = .83). The SS strategy had a shorter procedure time (MD −10.6 [min], 95% CI −20.97, −0.20; p = .05) but comparable fluoroscopic and radiofrequency application times to the NSS group. Conclusions The SS for AF catheter ablation not only reduced the total procedure time but also significantly increased the rate of successful ablation while maintaining a similar safety profile when compared to the traditional NSS. This meta‐analysis reveals that the use of a steerable sheath for atrial fibrillation ablation resulted in a better success rate and a lower risk of late atrial arrhythmia recurrence. However, this should be weighed against the possibility of an increase in periprocedural complications and procedure costs.

Project description:Magnetic resonance imaging (MRI) is an emerging modality for interventional radiology, giving clinicians another tool for minimally invasive image-guided interventional procedures. Difficulties associated with endovascular catheter navigation using MRI guidance led to the development of a magnetically steerable catheter. The focus of this study was to mechanically characterize deflections of two different prototypes of the magnetically steerable catheter in vitro to better understand their efficacy.A mathematical model for deflection of the magnetically steerable catheter is formulated based on the principle that at equilibrium the mechanical and magnetic torques are equal to each other. Furthermore, two different image based methods for empirically measuring the catheter deflection angle are presented. The first, referred to as the absolute tip method, measures the angle of the line that is tangential to the catheter tip. The second, referred to the base to tip method, is an approximation that is used when it is not possible to measure the angle of the tangent line. Optical images of the catheter deflection are analyzed using the absolute tip method to quantitatively validate the predicted deflections from the mathematical model. Optical images of the catheter deflection are also analyzed using the base to tip method to quantitatively determine the differences between the absolute tip and base to tip methods. Finally, the optical images are compared to MR images using the base to tip method to determine the accuracy of measuring the catheter deflection using MR.The optical catheter deflection angles measured for both catheter prototypes using the absolute tip method fit very well to the mathematical model (R(2) = 0.91 and 0.86 for each prototype, respectively). It was found that the angles measured using the base to tip method were consistently smaller than those measured using the absolute tip method. The deflection angles measured using optical data did not demonstrate a significant difference from the angles measured using MR image data when compared using the base to tip method.This study validates the theoretical description of the magnetically steerable catheter, while also giving insight into different methods and modalities for measuring the deflection angles of the prototype catheters. These results can be used to mechanically model future iterations of the design. Quantifying the difference between the different methods for measuring catheter deflection will be important when making deflection measurements in future studies. Finally, MR images can be used to reliably measure deflection angles since there is no significant difference between the MR and optical measurements.

Project description:BackgroundThe 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.MethodsThis 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.ResultsFourteen 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).ConclusionsCompared 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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