Clinical adverse events and device failures for the Barrx™ radiofrequency ablation catheter system: a MAUDE database analysis

Dubrouskaya, Katsiaryna; Hagenstein, Lauren D.; Ramai, Daryl; Adler, Douglas G.

doi:10.20524/aog.2022.0721

Cited by 3 publications

(3 citation statements)

References 13 publications

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“…Radio frequency ablation (Barrx; Medtronic, Minneapolis, MN, USA) has been widely utilized for eradicating Barrett’s esophagus. AEs following this procedure include stenosis, laceration, pain, hemorrhage, perforation, ulceration, dysphagia, odynophagia, and fever [ 19 ]. These AEs were reported shortly after the procedure, typically ranging from immediately to a few days later, except for stenosis, which was reported weeks to months post-procedure.…”

Section: Discussionmentioning

confidence: 99%

Local hyperthermia mediated by gold nanoparticle-integrated silicone-covered stent: feasibility and tissue response in a rat esophageal model

Tsauo,

Liu,

Zhang

et al. 2024

Eur Radiol Exp

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Background To assess the feasibility and tissue response of using a gold nanoparticle (AuNP)-integrated silicone-covered self-expandable metal stent (SEMS) for local hyperthermia in a rat esophageal model. Methods The study involved 42 Sprague–Dawley rats. Initially, 6 animals were subjected to near-infrared (NIR) laser irradiation (power output from 0.2 to 2.4 W) to assess the in vitro heating characteristics of the AuNP-integrated SEMS immediately after its placement. The surface temperature of the stented esophagus was then measured using an infrared thermal camera before euthanizing the animals. Subsequently, the remaining 36 animals were randomly divided into 4 groups of 9 each. Groups A and B received AuNP-integrated SEMS, while groups C and D received conventional SEMS. On day 14, groups A and C underwent NIR laser irradiation at a power output of 1.6 W for 2 min. By days 15 (3 animals per group) or 28 (6 animals per group), all groups were euthanized for gross, histological, and immunohistochemical analysis. Results Under NIR laser irradiation, the surface temperature of the stented esophagus quickly increased to a steady-state level. The surface temperature of the stented esophagus increased proportionally with power outputs, being 47.3 ± 1.4 °C (mean ± standard deviation) at 1.6 W. Only group A attained full circumferential heating through all layers, from the epithelium to the muscularis propria, demonstrating marked apoptosis in these layers without noticeable necroptosis. Conclusions Local hyperthermia using the AuNP-integrated silicone-covered SEMS was feasible and induced cell death through apoptosis in a rat esophageal model. Relevance statement A gold nanoparticle-integrated silicone-covered self-expanding metal stent has been developed to mediate local hyperthermia. This approach holds potential for irreversibly damaging cancer cells, improving the sensitivity of cancer cells to therapies, and triggering systemic anticancer immune responses. Key points • A gold nanoparticle-integrated silicone-covered self-expanding metal stent was placed in the rat esophagus. • Upon near-infrared laser irradiation, this stent quickly increased the temperature of the stented esophagus. • Local hyperthermia using this stent was feasible and resulted in cell death through apoptosis. Graphical Abstract

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Section: Discussionmentioning

confidence: 99%

Local hyperthermia mediated by gold nanoparticle-integrated silicone-covered stent: feasibility and tissue response in a rat esophageal model

Tsauo,

Liu,

Zhang

et al. 2024

Eur Radiol Exp

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“…Atrial flutter has not previously been reported as a complication after the radiofrequency procedure with the Barrx™ system used in BE treatment. A recent report by Dubrouskaya et al [ 8 ] analyzed the adverse events and device malfunctions linked to the use of all available catheters compatible with the Barrx™ system using data from the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database from August 2011 to August 2021. The study showed that the most frequent patient-related adverse events were esophageal stenosis secondary to treatment, mucosal laceration or perforation of the esophagus, chest pain, and odynophagia/dysphagia.…”

Section: Discussionmentioning

confidence: 99%

Atrial Flutter After Radiofrequency Ablation for Barrett’s Esophagus: A Case Report

Fassari,

De Blasi,

Basile

et al. 2023

Am J Case Rep

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Patient: Male, 74-year-old Final Diagnosis: Atrial flutter • Barrett’s esophagus Symptoms: Palpitations • dyspnea • chest pain Clinical Procedure: Atrial flutter ablation • laparoscopic Nissen fundoplication • radiofrequency ablation (RFA) procedure with the Barrx™ catheter system Specialty: Cardiology • Gastroenterology and Hepatology Objective: Rare coexistence of disease or pathology Background: Barrett’s esophagus (BE) is a metaplastic change in the normal esophageal squamous epithelium and is a well-recognized precursor of esophageal adenocarcinoma (EAC). Nowadays, focal radiofrequency ablation is a valid technique for BE treatment by inducing a superficial and focal thermic destruction of metaplastic tissues. According to the literature, the most frequent patient-related adverse events of this procedure are esophageal iatrogenic stenosis, mucosal laceration or perforation of the esophagus, chest pain, and odynophagia/dysphagia. Postoperative heart rhythm abnormalities have been reported very rarely. Case Report: A 74-year-old patient with HE was treated by radiofrequency ablation (RFA) with the Barrx™ catheter system. He had 2 symptomatic episodes of atrial flutter in the immediate postoperative period requiring an external electrical cardioversion to induce a return to sinus cardiac rhythm. After atrial flutter ablation, 2 more radio-frequency procedures were performed, without adverse events. A laparoscopic Nissen fundoplication was carried out with complete endoscopic and histologic eradication of BE after 12-month follow-up. To the best of our knowledge, this is the first reported case of atrial flutter after esophageal RFA. Different mechanisms acting on an anatomic predisposing substrate can potentially play a role in starting atrial flutter, and include inflammation, autonomic activation, and myocardial injury. Conclusions: The occurrence of this new type of adverse effect could potentially modify indications and postoperative monitoring of RFA treatment for BE. Endoscopists should know the possibility of this procedural complication in high-risk patients and they should propose alternative techniques or implement close cardiac monitoring in the postoperative period.

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“…In a recent post-marketing surveillance data analysis from August 2011 to August 2021 from the Food and Drug Administration's Manufacturer and User Facility Device, a total of 87 patient-related adverse events including 15 strictures (17.2%), 13 mucosal laceration (14.9%), and 10 episodes of chest pain (11.4%) were reported in addition to 78 device-related malfunctions for RFA devices. The Barrx 360 express was involved in 61% of patient-related adverse events and 67% of device malfunction events; all the 15 oesophageal strictures secondary to treatment occurred with circumferential ablation devices [82]. Among these, the Barrx 360 express might present the highest rate of patient-related and device-related adverse events.…”

Section: Ablation Treatments For Barrett's Oesophagusmentioning

confidence: 99%

Endoscopic Management of Dysplastic Barrett’s Oesophagus and Early Oesophageal Adenocarcinoma

Eusebi,

Telese,

Castellana

et al. 2023

Cancers

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Barrett’s oesophagus is a pathological condition whereby the normal oesophageal squamous mucosa is replaced by specialised, intestinal-type metaplasia, which is strongly linked to chronic gastro-oesophageal reflux. A correct endoscopic and histological diagnosis is pivotal in the management of Barrett’s oesophagus to identify patients who are at high risk of progression to neoplasia. The presence and grade of dysplasia and the characteristics of visible lesions within the mucosa of Barrett’s oesophagus are both important to guide the most appropriate endoscopic therapy. In this review, we provide an overview on the management of Barrett’s oesophagus, with a particular focus on recent advances in the diagnosis and recommendations for endoscopic therapy to reduce the risk of developing oesophageal adenocarcinoma.

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Clinical adverse events and device failures for the Barrx™ radiofrequency ablation catheter system: a MAUDE database analysis

Cited by 3 publications

References 13 publications

Local hyperthermia mediated by gold nanoparticle-integrated silicone-covered stent: feasibility and tissue response in a rat esophageal model

Local hyperthermia mediated by gold nanoparticle-integrated silicone-covered stent: feasibility and tissue response in a rat esophageal model

Atrial Flutter After Radiofrequency Ablation for Barrett’s Esophagus: A Case Report

Endoscopic Management of Dysplastic Barrett’s Oesophagus and Early Oesophageal Adenocarcinoma

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