The Effects of alfapump on Ascites Control and Quality of Life in Patients with Cirrhosis and Recurrent or Refractory Ascites.

Aim: 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 (M) post-implant. Primary efficacy endpoint assessed at 6M was reduction in paracentesis requirement; safety end point was device related adverse events resulting in intervention, explant, or death.

Results: 40 patients with RA, (mean MELD-Na: 15±4) received an alfapump. TP requirement decreased from 3.2±1.5 sessions/M pre-implant to 0.2±0.6 sessions/M at 6M post-implant (p<0.001), with 77% of patients having ≥50% reduction. Six (15%) pumps were explanted within 6M 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 0-6M post-implant 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 pre- to 32.2±21.9 at 6M post-implant (p<0.001). Physical but not mental components of Short Form 36 improved (p<0.001). The 5 deaths within 6M post-implant were not directly related to device or alfapump therapy.

Conclusions: 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.