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Feasibility of balloon-based endobiliary radiofrequency ablation under cholangioscopy guidance in a swine model.

ABSTRACT: Although endobiliary radiofrequency ablation (RFA) has demonstrated considerable potential for the treatment of biliary strictures, conventional catheter RFA has several limitations. This study aimed to evaluate the feasibility of a novel cholangioscopy (CS)-guided balloon-based RFA procedure in vivo using a swine model. CS-guided balloon-RFA was performed under endoscopic retrograde cholangiography guidance at target temperatures of 60 ℃ or 70 ℃, which were maintained for 60 s. We evaluated the technical feasibility, adverse events, and histological effects associated with the procedure. Twelve sites were ablated in seven miniature pigs. The CS-guided balloon-RFA procedure was technically successful in all cases without any hindrance. Mucosal changes could be detected during RFA, and the ablation area was identified on CS. Necropsy was performed in four pigs on the same day as the procedure: the tissue samples showed coagulative necrosis, and the entire internal circumference of the bile duct was uniformly ablated. The mean lengths of the ablation area in the samples ablated at 60 °C and 70 °C were 20.64 and 22.18 mm, respectively, while the mean depths were 3.46 and 5.07 mm, respectively. The other three pigs were reared and euthanized and autopsied 35 days after the procedure. The site to be ablated had replaced the granulation tissue and fibrotic changes. No adverse events were observed in any case. CS-guided balloon-RFA appears to be a promising option for treating biliary strictures. This preliminary study could pave the way for the evaluation of this procedure in future human clinical trials.

SUBMITTER: Inoue T

PROVIDER: S-EPMC8270987 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Optimal reproduction of a porcine benign biliary stricture model using endobiliary radiofrequency ablation.

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Comparison between regular additional endobiliary radiofrequency ablation and photodynamic therapy in patients with advanced extrahepatic cholangiocarcinoma under systemic chemotherapy.

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Epicardial electroanatomical mapping, radiofrequency ablation, and lesion imaging in the porcine left ventricle under real-time magnetic resonance imaging guidance-an in vivo feasibility study.

Project description:Aims:Magnetic resonance imaging (MRI) is the gold standard for defining myocardial substrate in 3D and can be used to guide ventricular tachycardia ablation. We describe the feasibility of using a prototype magnetic resonance-guided electrophysiology (MR-EP) system in a pre-clinical model to perform real-time MRI-guided epicardial mapping, ablation, and lesion imaging with active catheter tracking. Methods and results:Experiments were performed in vivo in pigs (n?=?6) using an MR-EP guidance system research prototype (Siemens Healthcare) with an irrigated ablation catheter (Vision-MR, Imricor) and a dedicated electrophysiology recording system (Advantage-MR, Imricor). Following epicardial access, local activation and voltage maps were acquired, and targeted radiofrequency (RF) ablation lesions were delivered. Ablation lesions were visualized in real time during RF delivery using MR-thermometry and dosimetry. Hyper-acute and acute assessment of ablation lesions was also performed using native T1 mapping and late-gadolinium enhancement (LGE), respectively. High-quality epicardial bipolar electrograms were recorded with a signal-to-noise ratio of greater than 10:1 for a signal of 1.5?mV. During epicardial ablation, localized temperature elevation could be visualized with a maximum temperature rise of 35?°C within 2?mm of the catheter tip relative to remote myocardium. Decreased native T1 times were observed (882?±?107?ms) in the lesion core 3-5?min after lesion delivery and relative location of lesions matched well to LGE. There was a good correlation between ablation lesion site on the iCMR platform and autopsy. Conclusion:The MR-EP system was able to successfully acquire epicardial voltage and activation maps in swine, deliver, and visualize ablation lesions, demonstrating feasibility for intraprocedural guidance and real-time assessment of ablation injury.

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Wide area circumferential ablation for pulmonary vein isolation using radiofrequency versus laser balloon ablation.

Project description:BackgroundPersistent atrial fibrillation (AF) is associated with high recurrence rates of AF and atypical atrial flutters or tachycardia (AFT) postablation. Laser balloon (LB) ablation of the pulmonary vein (PV) ostia has similar efficacy as radiofrequency wide area circumferential ablation (RF-WACA); however, an approach of LB wide area circumferential ablation (LB-WACA) may further improve success rates.ObjectiveTo evaluate freedom from atrial tachyarrhythmia (AFT/AF) recurrence postablation using RF-WACA versus LB-WACA in persistent AF patients.MethodsThis was a retrospective multicenter study. Patients were followed for up to 24 months via office visits, Holter, and/or device monitoring. The primary endpoint was freedom from AFT/AF after a single ablation procedure. Secondary endpoints included freedom from AF, freedom from AFT, first-pass isolation of all PVs, and procedural complications.ResultsTwo hundred and four patients were studied (LB-WACA: n = 103; RF-WACA: n = 101). Patients' baseline characteristics were similar except patients in the RF-WACA group were older (64 vs. 68, p = .03). First-pass isolation was achieved more often during LBA (LB-WACA: 88% vs. RF-WACA 75%; p = .04). Procedure (p = .36), LA dwell (p = .41), and fluoroscopy (p = .44) time were similar. The mean follow-up was 506 ± 279 days. Sixty-six patients had arrhythmic events including 24 AFT and 59 AF recurrences. LB-WACA group had higher arrhythmia-free survival (p = .009) after single ablation procedures. In the multivariate Cox regression model, RF-WACA was associated with a higher recurrence of AFT compared with LB-WACA (Adjusted HR 3.16 [95% CI: 1.13-8.83]; p = .03).ConclusionsLB-WACA was associated with higher freedom from atrial arrhythmias mostly driven by the lower occurrence of AFT compared with RF-WACA.

| S-EPMC9237344 | biostudies-literature

First in-human modified atrial septostomy combining radiofrequency ablation and balloon dilation.

Project description:ObjectivePreclinical research suggests that the combined use of radiofrequency ablation and balloon dilation (CURB) could create stable interatrial communications without device implantation. This study examined the first in-human use of CURB for modified atrial septostomy in patients with severe pulmonary arterial hypertension (PAH).MethodsBetween July 2018 and October 2021, CURB was performed in 19 patients with severe PAH (age: 31.5±9.1 years; mean pulmonary artery pressure: 73 mm Hg (IQR: 66-92); pulmonary vascular resistance: 18.7 Wood units (IQR: 17.8-23.3)). Under guidance of intracardiac echocardiography and three-dimensional location system, (1) fossae ovalis was reconstructed and ablated point-by-point with radiofrequency; (2) then graded balloon dilation was performed after transseptal puncture and the optimal size was determined according to the level of arterial oxygen saturation (SatO2); (3) radiofrequency ablation was repeated around the rims of the created fenestration. The interatrial fenestrations were followed-up serially.ResultsAfter CURB, the immediate fenestration size was 4.4 mm (IQR: 4.1-5.1) with intracardiac echocardiography, systolic aortic pressure increased by 10.2±6.9 mm Hg, cardiac index increased by 0.7±0.3 L/min/m2 and room-air resting SatO2 decreased by 6.2±1.9% (p<0.001). One patient experienced increased pericardiac effusion postoperatively; the others had no complications. On follow-up (median: 15.5 months), all interatrial communications were patent with stable size (intraclass correlation coefficient=0.96, 95%CI:0.89 to 0.99). The WHO functional class increased by 1 (IQR: 1-2) (p<0.001) with improvement of exercise capacity (+159.5 m, P<0.001).ConclusionThe interatrial communications created with CURB in patients with severe PAH were stable and the mid-term outcomes were satisfactory.Trial registration numberNCT03554330.

| S-EPMC9606506 | biostudies-literature

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