Patients deserve effective care options that may reduce pain and reinterventions while preserving quality of life.*1 Managing acute cholecystitis to give patients a drain-free life may be achieved through minimally invasive treatment alternatives including internal EUS-guided drainage or IR-guided gallstone removal. Boston Scientific offers a portfolio to assist in these treatments. We offer AXIOS™ Stent and Delivery System for internal drainage and SpyGlass™ Discover Digital Catheter for IR-guided gallstone removal.
When surgery is not an option, learn how EUS-guided gallbladder drainage with the AXIOS Stent may work as a viable treatment alternative.
Clinical benefits of AXIOS Stent technology
EUS-guided GBD with the AXIOS Stent and Electrocautery Enhanced Delivery System may keep patients free of an external drain from the onset, reducing the need for repeat drain procedures – and the risk of infection.†,2,3
Clinical background
In most cases, early laparoscopic cholecystectomy is the treatment of choice for acute cholecystitis. Yet it’s considered a high-risk procedure for the elderly, critically ill, those with significant comorbidities, and other nonsurgical candidates, making GBD a recommended treatment alternative.4
Percutaneous transhepatic gallbladder drainage (PT-GBD) has been the most common GBD technique used in clinical practice, but now there’s another option. EUS-guided GBD gives surgeons, interventional radiologists, and therapeutic endoscopists a treatment pathway that has benefits for patients, clinical teams, and hospitals.
Clinical outcomes and patient experience
With an expanded indication in the U.S., EUS-guided GBD using AXIOS Stent technology offers another viable treatment for managing acute cholecystitis for patients deemed as nonsurgical candidates.
EUS-guided GBD provides several clinical outcome benefits compared to PT-GBD, including reduced:
- Short- and long-term adverse event rates*1
- Reoccurrence rates*1
- Reinterventions*1
- Post-procedural pain*1
EUS-guided GBD also reduces negative quality-of-life impacts associated with external drains, including:
- Pain at drain site†2
- Inconvenience of maintenance†2
- Risk of infection at drain site†3
- Risk of inadvertent dislodgement*†2
A groundbreaking endoscopic option for acute cholecystitis management
EUS-guided GBD adoption can reduce unplanned:
- Hospital readmissions‡1
- Procedures related to external drain exchanges1
- Risk of infection at drain site†3
- Risk of inadvertent dislodgement2
Clinical trial results: EUS-guided GBD versus PT-GBD
First prospective, multicenter, randomized controlled trial provides outcomes of EUS-guided GBD (n=39) versus PT-GBD (n=40). This study has shown that technical success, clinical success, and 30-day mortality rates are similar. However, patients undergoing EUS-guided GBD had significantly lower rates of 30-day and 1-year adverse events (AEs), recurrence, reintervention, unplanned admission, and post-procedural pain.1
Outcome | Study Reported Results (95% Confidence Interval) |
Technical Success | 97.4% (86.5%, 99.9%) |
Clinical Success | 92.3% (79.1%, 98.4%) |
Recurrent Cholecystitis | 2.6% (0.1%, 13.5%) |
Procedure-related AEs | 12.8% (4.3%, 27.4%) |
Overall AEs | 25.6% (13.0%, 42.1%) |
Re-interventions | 2.6% (0.1%, 13.5%) |
Retrospective, multicenter, comparative trial of 90 high-risk surgical patients with acute cholecystitis who underwent GBD. This study has shown that EUS-guided GBD has similar rates of technical and clinical success as PT-GBD, but reports shorter hospital stays, decreased need for reintervention, and a trend toward fewer adverse events.2
Outcome | Study Reported Results (95% Confidence Interval) |
Technical Success | 97.8% (88.2%, 99.9%) |
Clinical Success | 95.6% (84.9%, 99.5%) |
Recurrent Cholecystitis | 6.7% (1.4%, 18.3%) |
Procedure-related AEs | 17.8% (8.0%, 32.1%) |
Overall AEs | 17.8% (8.0%, 32.1%) |
Re-interventions | 24.4% (12.9%, 39.5%) |