4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview. The only available literature was 1 case series of 40 patients with refractory ascites due to liver cirrhosis.

4.1 The case series of 40 patients reported a significant reduction in the median number of large-volume paracenteses performed per month, from 3.4 (range 1–6) to 0.24 (range 0–5), in the first 6 months after the procedure (p<0.01). Forty per cent of patients did not need additional large-volume paracentesis at 6‑month follow‑up. The need for large-volume paracentesis was statistically significantly lower in patients after recommendations from an independent safety monitoring board were implemented, due to the reduced number of technical problems: 2 large-volume paracenteses in 2/19 patients after implementation, compared with 30 large-volume paracenteses in 9/21 patients before implementation (p=0.034).

4.2 The case series reported no significant changes in mean arterial pressure, Child–Turcotte–Pugh or Model for End-stage Liver Disease score (which assess the risk of surgery and prognosis in cirrhotic patients), serum bilirubin, serum sodium or serum creatinine.

4.3 The case series reported that successful implantation of the device was achieved in all patients.

4.4 The specialist advisers listed additional key efficacy outcomes as improved quality of life, control of the symptoms of ascites, reduced hospital admission rate, reduced need for albumin replacement, improved nutrition, decreased encephalopathy, decreased spontaneous bacterial peritonitis, improved renal function, and improved survival.

  • National Institute for Health and Care Excellence (NICE)