Capel, Jeroen

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.

The automated low‐flow ascites pump (alfapump) is an implantable device that drains ascites directly into the urinary bladder. We studied its safety (absence of serious complications) and efficacy (decreased large‐volume paracentesis [LVP] requirement and improved quality of life [QoL]) in the management of ascites in a cohort of North American patients with cirrhosis and recurrent ascites ineligible for transjugular intrahepatic portosystemic shunt (TIPS). QoL was measured by the Chronic Liver Disease Questionnaire (CLDQ) and Ascites Questionnaire (Ascites Q). Following alfapump implantation, patients were monitored for ascites control, laboratory abnormalities, QoL, adverse events, and survival at 12 months. A total of 30 patients (60.0 ± 9.9 years; 57% male; Model for End‐Stage Liver Disease score, 11.4 ± 2.7) received an alfapump, mostly by an interventional radiology approach (97%), followed by longterm prophylactic antibiotics. The alfapump removed a mean ascites volume of 230.6 ± 148.9 L/patient at 12 months, dramatically reducing the mean LVP frequency from 2.4 ± 1.4/patient/month before pump implantation to 0.2 ± 0.4/patient/month after pump implantation. All surviving patients had improved QoL (baseline versus 3 months; CLDQ, 3.9 ± 1.21 versus 5.0 ± 1.0; Ascites Q, 51.7 ± 21.9 versus 26.7 ± 18.6; P < 0.001 for both) and a better biochemical index of nutritional status (prealbumin 87.8 ± 37.5 versus 102.9 ± 45.3 mg/L at 3 months; P = 0.04). Bacterial infections (15 events in 13 patients), electrolyte abnormalities (11 events in 6 patients), and renal complications (11 events in 9 patients) were the most common severe adverse events. By 12 months, 4 patients died from complications of cirrhosis. Alfapump insertion may be a definitive treatment for refractory ascites in cirrhosis, especially in patients who are not TIPS candidates.