Shlomovitz, Eran

INTRODUCTION: The alfapump system has been shown to be a possible alternative to repeat therapeutic paracentesis (TP) in selected patients with refractory ascites (RA). The objective of this study was to assess the safety and efficacy of alfapump on ascites control and quality of life in these patients. METHODS: Patients with cirrhosis and RA requiring ≥2 TPs 30 days prior were enrolled and followed for 24 months postimplant. Primary efficacy end point assessed at 6 months was reduction in paracentesis requirement; safety end point was device-related adverse events resulting in intervention, explant, or death. RESULTS: Forty patients with RA (mean Model of End-stage Liver Disease-Sodium: 15 ± 4) received an alfapump. TP requirement was decreased from 3.2 ± 1.5 sessions per month preimplant to 0.2 ± 0.6 sessions per month at 6 months postimplant ( P < 0.001), with 77% of patients having ≥50% reduction. Six pumps (15%) were explanted within 6 months due to device-related adverse events, 3 (7.5%) due to pump site skin erosion, and 3 (7.5%) due to bladder discomfort. Twenty-four renal events occurred in the 0–6 month postimplant period; 16 cases were readily reversible stage 1 acute kidney injury. Ascites-related symptoms assessed with an Ascites Q score improved from 51.0 ± 19.3 preimplant to 32.2 ± 21.9 at 6 months postimplant ( P < 0.001). Physical but not mental components of Short Form 36 improved ( P < 0.001). The 5 deaths within 6 months postimplant were not directly related to the device or alfapump therapy. DISCUSSION: The alfapump system effectively controlled ascites, which improved quality of life. It may be considered as an alternative to repeat TP in select patients with RA. Complication rates were similar to those expected in patients with RA.

Objective: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). Background: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. Methods: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). Results: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. Conclusions: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.