3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 8 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial (described in 2 publications) and 6 case series, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: reduction in need for paracentesis, and quality of life (including disease-specific outcomes).
3.3 The specialist advisers and the committee considered the key safety outcomes to be: technical failure (including pump durability), infection and acute kidney injury.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted the published evidence shows a relatively high incidence of device failure.
3.6 The committee noted that the procedure is associated with an increased incidence of acute kidney injury.
3.7 The committee was informed that after the procedure patients need regular monitoring, and they may need infusions of albumin.
3.8 The committee noted that most of the published evidence on the procedure only included patients for whom a transjugular intrahepatic portosystemic shunt is unsuitable.
3.9 The committee was informed that the procedure has the potential to improve quality of life for patients with refractory ascites, and also that of their families or carers.
3.10 The committee was informed that the technology for this procedure is evolving.