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HOT AXIOS™ is a ground-breaking endoscopic option for the management of symptomatic cholecystitis in patients who are at high risk or unsuitable for surgery?
Early laparoscopic cholecystectomy is considered in most cases the treatment of choice for acute cholecystitis. However, in the elderly, in critically ill patients, and in those with significant comorbidities, cholecystectomy is considered a high-risk procedure, and gallbladder drainage (GBD) is recommended as an alternative treatment.¹
Until now, percutaneous transhepatic gallbladder drainage (PT-GBD) has been the most common GBD technique used in clinical practice. An internal meta-analysis was conducted for Hot AXIOS Stent and Electrocautery Enhanced Delivery System and PT-GBD for Gallbladder drainage. The technical and clinical success rates for Hot AXIOS Stent and Electrocautery Enhanced Delivery System are 96.3% and 95.5 % retrospectively compared to a technical success rate of 99.8% and clinical success rate of 90.3% for PTGBD.*
Additionally the rates of recurrent cholecystitis, procedural related complications, and overall complications were evaluated. The clinical literature reviewed summarized the rates for the Hot AXIOS Stent and Electrocautery Enhanced Delivery System for recurrent cholecystitis were 2.5%, procedure related complications were 4%, overall complications were 20.4%.
HOT AXIOS™ Stent and Electrocautery-Enhanced Delivery System is one additional treatment option for patients at high risk or unsuitable for surgery. Hot AXIOS™ is specifically designed and indicated for the drainage of the biliary tract. Published literature has demonstrated clinical and technical success for symptomatic cholecystitis in patients at high risk or unsuitable for surgery by creating a new temporary opening between the gall-bladder and GI tract. EUS-GBD using Hot AXIOS™ is an option in high-risk surgical patients with acute cholecystitis when performed by an experienced endoscopist.³
Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System indicated for use to facilitate transgastric or transduodenal endoscopic drainage of:
- a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content
- gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery
- the bile duct after failed ERCP in patients with biliary obstruction due to a malignant stricture
ESGE Recommendations
ESGE recommends that, in patients at high surgical risk, EUS-guided gallbladder drainage (GBD) should be favored over percutaneous gallbladder drainage where both techniques are available, owing to the lower rates of adverse events and need for re-interventions in EUS-GBD.⁶
How is the Hot AXIOS™ implanted?
The endoscope is inserted and site for AXIOS Stent placement is identified. Using EUS, the stomach and duodenum are surveyed to identify a site that is clear of intervening blood vessel, where the gall bladder is close to the GI tract (within 10mm), and at an angle providing enough diameter to accommodate insertion of the HOT AXIOS Delivery Catheter (catheter should pass 3-4cm into the target structure).
The Hot AXIOS™ stent catheter is unlocked and advanced forward to until the distal tip is visible. The distal ceramic tip contains a diathermy cutting ring which allows for a direct access technique. Electrocautery is applied and the catheter advanced into the gallbladder.
The yellow safety clip is removed and stent lock is unlocked. Under EUS imaging the deployment hub is retracted to the halfway point. A click will be heard as the stent deployment hub automatically locks into place.
Verify with EUS imagining that the distal flange is deployed inside the target structure.
To prepare for proximal flange deployment the catheter is unlocked and the control hub retracted until the distal flange sits gently against the inner wall of the gall bladder.
Maintaining the distal flange of the stent against the inner wall with an oval shape the catheter lock is engaged.
The proximal flange is deployed by unlocking the stent lock and retracting the stent deployment hub until it stops.
The proximal flange is released from the channel of the endoscope by unlocking and advancing the catheter control hub whilst retracting the scope.
Once deployed the delivery system is removed
The final position of the stent is confirmed using EUS.
X-ray can also be used to verify the position although not required.
Confirmation of drainage is confirmed with endoscopic view
ENDO-679803-AA
Innovative Technology
The Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System enables therapeutic endoscopists to access a symptomatic pancreatic pseudocyst, wallled-off necrosis or the biliary tract via a transgastric or transduodenal approach and place the Hot AXIOS™ Stent.
The system combines a cautery-enabled access catheter with the therapeutic Hot AXIOS™ Stent for a streamlined, exchange-free procedure.
The Hot AXIOS™ System is used under combined endoscopic and EUS guidance. Its electrocautery-enhanced delivery system is designed to facilitate smooth, efficient access into the target structure.
Over 400 endoscopists across Europe area already performing drainage procedures with LAMS for PFC/WON and have the ability to offer this novel procedure to non-surgical patients with acute cholecystitis who would previously have had to receive a percutaneous drain.⁴
About the Hot AXIOS™ Procedure
The stent is implanted by an endoscopist using a therapeutic EUS scope.The scope is advanced and the transducer used to identify the target structure on the EUS image. The physician may choose to approach the target either transgastrically or transduodenally depending on the patient’s anatomy, and position of the target.
Once the target has been identified the Hot AXIOS™ stent is passed though the working channel of the endoscope and locked into place.
Electrocautery is connected and the tip of the delivery system exposed by unlocking the catheter and moving slowly forward until visible on the EUS image.
After using EUS to look for potential blood vessels, adjusting position to avoid them if necessary, the diathermy pedal is depressed and the delivery system advanced into the target structure with a smooth, steady action.
The first (distal) flange of the stent is released into the target structure, before being retracted to create apposition with the gastric/duodenal wall. Finally the second (proximal) flange is deployed to create the anastomosis, and the delivery system is removed.
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*PT-GBD rates for recurrent cholecystitis were 7.7%, procedure related complications were 0.8%, overall complications were 40.7%.
References:
1. Mori et al. Tokyo Guidelines 2018: management strategies for gallbladder drainage in patients with acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci 2018.
2. Boston Scientific Clinical Evaluation Report #91149546 Revision AN. Data for the Hot AXIOS Stent and Electrocautery Enhanced Delivery System included 10 references with a total of 345 subjects evaluated. Data for PT-GBD included 3 references with a total of 217 subjects evaluated.
3. Walter et al. EUS-guided gallbladder drainage with a lumen-apposing metal stent: a prospective long-term evaluation. Gut 2016; 65:6-8.
4. Data on file – trained physicians logged in windchill here – General Document – 92256942. Storage Location for AXIOS Physician Training Log, BSC, 17.3. Active accounts tracked through sales data.
5. Kahaleh M, et al. International collaborative study on EUS-guided gallbladder drainage: Are we ready for primetime? Dig Liver Dis (2016).
6. van der Merwe SW, van Wanrooij RLJ, Bronswijk M, et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022;54(2):185-205. doi:10.1055/a-1717-1391.
Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.
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This material not intended for use in France.