5 Safety

5 Safety

This section describes safety 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 the case series of 40 patients with refractory ascites due to liver cirrhosis.

5.1 Haemorrhage into the bladder during catheter implantation was reported in 1 patient in the case series of 40 patients. The device was removed within 24 hours of the procedure. Further details were not reported.

5.2 Problems with the catheter to the bladder were reported in 22% (9/40) of patients. These included catheter dislocations or dislodgements in 12% (5/40) of patients (this occurred in early cases but was avoided after recommendations from the independent safety monitoring board were implemented, including increasing the length of the catheter and suturing it to the suprapubic aponeurosis); 4 episodes of catheter prolapse into the urethra due to excess catheter length in 8% (3/40) of patients, resolved by cystoscopic shortening of the catheter; and a kinked catheter that needed 'repairing' in 2% (1 patient).

5.3 Peritoneal catheter problems were reported in 12% (5/40) of patients. These were blocked catheters in 5% (2/40) of patients, catheter migration towards the perihepatic space in 5% (2/40) of patients and an unspecified problem in 1 patient. Catheter migration was managed in 1 patient by relocating the catheter laparoscopically and fixing the tip in the pouch of Douglas; but in the other patient, surgical re‑intervention failed. The blocked peritoneal catheters were replaced after 26 and 62 days.

5.4 Pump failures were reported in 5% (2/40) of patients (1 because of motor malfunction and 1 because of a microprocessor communication error). Further details were not reported.

5.5 Early device explantations were reported in 32% (13/40) of patients. These were because of difficult-to-manage infections in 18% (7/40) of patients (of these, 1 patient had sclerosing peritonitis and subsequently had a liver transplant); withdrawn consent following bladder or peritoneal catheter dislodgement issues in 8% (3/40) of patients; withdrawn consent in 5% (2/40) of patients (reasons not reported); and emergency removal because of wound dehiscence and subcutaneous tunnel infection around the bladder catheter in 1 patient.

5.6 Cirrhosis-related infections were reported in 60% (24/40) of patients (some patients had more than one type of infection and others had recurrent infections of one type). These included 16 episodes of spontaneous bacterial peritonitis in 30% (12/40) of patients, other infections in 13% (5/40) of patients, systemic inflammatory response syndrome in 18% (7/40) of patients, and 6 urinary tract infections in 8% (3/40) of patients. Patients with spontaneous bacterial peritonitis fully recovered after antibiotic therapy, except for 1 patient who had sclerosing peritonitis. Treatment details were not reported for urinary tract infections or systemic inflammatory response syndrome. The reported rate of infections decreased significantly in cohort 2 after recommendations from the independent safety monitoring board were implemented (76% [16/21]) vs. (42% [8/19]), p=0.09.Pump pocket infections refractory to antibiotic therapy were reported in 5% (2/40) of patients. The devices were removed from these patients 42 and 74 days after implantation.

5.7 Ascitic fluid leakage through implant wounds was reported in 8% (3/40) of patients. Further details were not reported.

5.8 The specialist advisers listed an additional anecdotal event as hepatorenal syndrome. They listed theoretical adverse events including damage to the bowel or bladder, the risk of passing hepatitis viral infection to others through passage of urine that contains peritoneal fluid, intravascular depletion, hypotension, cardiovascular collapse, reduced renal blood flow leading to renal failure in the short or long term, urinary tract infections ascending into the abdominal cavity, 'abdominal cocoon formation' with use of pumps, and implantation of tumour cells in the bladder.

  • National Institute for Health and Care Excellence (NICE)