Technical advance in silico and in vitro development of a new bipolar radiofrequency ablation device for renal denervation

Background Renal denervation with radiofrequency ablation has become an accepted treatment for drug-resistant hypertension. However, there is a continuing need to develop new catheters for high-accuracy, targeted ablation. We therefore developed a radiofrequency bipolar electrode for controlled, targeted ablation through Joule heating induction between 60 and 100 °C. The bipolar design can easily be assembled into a basket catheter for deployment inside the renal artery. Methods Finite element modeling was used to determine the optimum catheter design to deliver a minimum ablation zone of 4 mm (W) × 10 mm (L) × 4 mm (H) within 60 s with a 500 kHz, 60 Vp-p signal, and 3 W maximum. The in silico model was validated with in vitro experiments using a thermochromic phantom tissue prepared with polyacrylamide gel and a thermochromic ink additive that permanently changes from pink to magenta when heated over 60 °C. Results The in vitro ablation zone closely matched the size and shape of the simulated area. The new electrode design directs the current density towards the artery walls and tissue, reducing unwanted blood temperature increases by focusing energy on the ablation zone. In contrast, the basket catheter design does not block renal flow during renal denervation. Conclusions This computational model of radiofrequency ablation can be used to estimate renal artery ablation zones for highly targeted renal denervation in patients with resistant hypertension. Furthermore, this innovative catheter has short ablation times and is one of the lowest power requirements of existing designs to perform the ablation.

Low Body Mass Index as a Predictive Factor for Postoperative Infectious Complications after Ureterorenoscopic Lithotripsy

Background and Objectives: In this study, we aimed to evaluate predictive factors of postoperative fever (POF) after ureterorenoscopic lithotripsy (URSL). Materials and Methods: A total of 594 consecutive patients who underwent URSL for urinary stone disease at Gifu Municipal Hospital and Chuno Kosei Hospital between April 2016 and January 2021 were enrolled in this study. In all patients, antibiotics were routinely administered intraoperatively and the next day after surgery. We used rigid and/or flexible ureterorenoscopes depending on the stone location for URSL. Stones were fragmented using a holmium: YAG laser. The fragments of the stone were manually removed as much as possible using a stone basket catheter. A ureteral stent was placed at the end of the surgery in all cases. Results: The median age and body mass index (BMI) in all patients were 62 years and 23.8 kg/m2, respectively. The median operation duration was 52 min. The most common URSL-related complication was POF in 28 (4.7%) patients. In these patients, the rates of antibiotic administration and ureteral stent insertion before surgery were significantly higher than in those without POF. In multivariate analysis, BMI was associated with POF after URSL. There were no significant differences in predicting POF after surgery in patients who had bacteriuria or received antibiotics before surgery. Conclusions: A low BMI was significantly associated with POF after URS or URSL.

A novel algorithm for 3-D visualization of electrogram duration for substrate-mapping in patients with ischemic heart disease and ventricular tachycardia

Background Myocardial slow conduction is a cornerstone of ventricular tachycardia (VT). Prolonged electrogram (EGM) duration is a useful surrogate parameter and manual annotation of EGM characteristics are widely used during catheter-based ablation of the arrhythmogenic substrate. However, this remains time-consuming and prone to inter-operator variability. We aimed to develop an algorithm for 3-D visualization of EGM duration relative to the 17-segment American Heart Association model. Methods To calculate and visualize EGM duration, in sinus rhythm acquired high-density maps of patients with ischemic cardiomyopathy undergoing substrate-based VT ablation using a 64-mini polar basket-catheter with low noise of 0.01 mV were analyzed. Using a custom developed algorithm based on standard deviation and threshold, the relationship between EGM duration, endocardial voltage and ablation areas was studied by creating 17-segment 3-D models and 2-D polar plots. Results 140,508 EGMs from 272 segments (n = 16 patients, 94% male, age: 66±2.4, ejection fraction: 31±2%) were studied and 3-D visualization of EGM duration was performed. Analysis of signal processing parameters revealed that a 40 ms sliding SD-window, 15% SD-threshold and >70 ms EGM duration cutoff was chosen based on diagnostic odds ratio of 12.77 to visualize rapidly prolonged EGM durations. EGMs > 70 ms matched to 99% of areas within dense scar (<0.2 mV), in 95% of zones within scar border zone (0.2–1.0 mV) and detected ablated areas having resulted in non-inducibility at the end of the procedure. Ablation targets were identified with a sensitivity of 65.6% and a specificity of 94.6% avoiding false positive labeling of prolonged EGMs in segments with healthy myocardium. Conclusion The novel algorithm allows rapid visualization of prolonged EGM durations. This may facilitate more objective characterization of arrhythmogenic substrate in patients with ischemic cardiomyopathy.

Directed graph mapping is able to distinguish between the true and false rotors in a complex in-silico excitation pattern

Funding Acknowledgements Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Supported in part by Dirección General de Polı́tica Cientı́fica de la Generalitat Valenciana PROMETEU 2020/043 Background In realistic in-silico studies (Figure1, top row) it was shown that phase mapping PM (Figure 1, A) can detect the correct rotor as well as phantom rotors as an artefact of interpolation or due to the far field (Figure 1, B). After interpretation of the LAT, the far field detections could not be distinguished from the true rotor driving the excitation pattern. This can contribute to failure in Atrial Fibrillation (AF) ablation procedures. Objective We tested if the recently developed tool Directed Graph mapping (DGM) is less prone to far-field effects and interpolation artefacts than PM on the same in-silico data. DGM represents the excitation pattern as a directed network, from which the rotational activity is detected as cycles in that network. Methods Starting from the electrograms (EGMs) of the 64 electrode basket catheter, we interpolated to 957 equidistant electrodes and calculated local activation times (LATs) of the interpolated EGMs (Figure 1, C). We varied the minimal allowed conduction velocity and calculated the corresponding networks for the complete simulation time. Detections were considered as correct if they were located in the same region of the true core of the phasemaps. The false detections were classified in multiple different regions (Figure 1, D). Results We find that by proper choice of CVs in the graphs it is possible to achieve a 80% detection of true rotors with 26% detection of false rotors. Reducing restrictions on the CVs increased the detection rate of the false rotors. False rotors due to artifacts were not detected by DGM (Figure 1, last row). Conclusion DGM is able to distinguish between true and far field rotors. False detections due to interpolation artifacts as seen in the PM protocol were not observed. The velocity limits in the graph construction play a keyrole in eliminating the far field effects. Abstract Figure 1

In Silico and in Vitro Development of a New Bipolar Radiofrequency Ablation Device for Renal Denervation

Background: Renal denervation with radiofrequency ablation has become an accepted treatment for drug-resistant hypertension. However, there is a continuing need to develop new catheters for high-accuracy, targeted ablation. We, therefore, developed a radiofrequency ablation device with a basket catheter and bipolar electrodes for controlled, targeted ablation through Joule heating induction between 60°C and 100°C.Methods: Finite element modeling was used to determine the optimum catheter design to deliver a minimum ablation zone of 4 mm (W) x 10 mm (L) x 4 mm (H) within 60 seconds with a 500 kHz, 60 Vp-p signal, and 0.9 W maximum. The computational model was validated using in vitro phantom tissue impregnated with a color-changing thermochromic pigment.Results: The in vitro ablation zone closely matched the size and shape of the simulated area. The new electrode design directs the current density towards the artery walls and tissue, reducing unwanted blood temperature increases by focusing energy on the ablation zone. In contrast, the basket catheter design does not block renal flow during renal denervation.Conclusions: This computational model of radiofrequency ablation can be used to estimate renal artery ablation zones for highly targeted renal denervation in patients with resistant hypertension. Furthermore, this innovative catheter has short ablation times and the lowest power requirement of existing designs to perform the ablation.