In February 2018, NICE issued an update of Medical technologies guidance [MTG9] about PleurX peritoneal catheter drainage system for vacuum-assisted drainage of treatment-resistant, recurrent malignant ascites in the community setting. This guidance has been updated to include a review of the cost model using more recent values. New evidence and updated costs identified during the guidance review are denoted as . Next review is foreseen for 2021.
The available clinical evidence suggests that the PleurX peritoneal catheter drainage system is clinically effective, has a low complication rate and has the potential to improve quality of life. It enables early and frequent treatment of symptoms of ascites, in the community, rather than waiting for inpatient treatment.
The PleurX peritoneal catheter drainage system should be considered for use in patients with treatment-resistant, recurrent malignant ascites. It is associated with an estimated cost saving of 1,051 GBP per patient when compared with inpatient large-volume paracentesis .
The PleurX peritoneal catheter is made of silicone and is 71 cm in length and 5.12 mm (15.5 Fr) in diameter. The distal end of the catheter has several side holes and is placed in the peritoneal cavity. There is a polyester cuff midway along the catheter, which is sited 1–2 cm within a subcutaneous tunnel and helps to secure the catheter in place by encouraging tissue growth into the polyester. The external end of the PleurX peritoneal catheter has a safety valve that prevents air entering or fluid leaking out of the catheter. A cap protects the valve and prevents debris from building up.
The drainage system comprises a 1-litre vacuum bottle with a drainage line that connects to the PleurX peritoneal catheter for fluid removal. It also includes a procedure pack that contains the supplies needed to perform the drainage procedure and to replace the cap and the gauze pad dressing over the catheter.
The PleurX peritoneal catheter is designed to remain in place indefinitely and patients and carers are trained to perform fluid drainage when needed by attaching the vacuum bottle to the catheter. A fresh valve cap and dressing are applied once the drainage is completed. For the majority of the time, the catheter is coiled up and covered with a gauze pad and a waterproof dressing.
The claimed benefits of the PleurX peritoneal catheter drainage system are:
- Repeated drainage of ascitic fluid in community settings may allow greater patient independence, and the flexibility to fit the drainage procedure into their daily lives.
- Better symptom control by frequent drainage of smaller quantities of ascitic fluid. Symptoms associated with the accumulation of large amounts of ascites include breathlessness, nausea, bloating, acid reflux, abdominal pain, early satiety, reduced mobility and psychological distress related to negative body image.
- Reduced need for repeated large-volume paracentesis procedures and the associated risk of infection from repeated catheter insertion.
- Resource savings through a reduced need for hospital physician and nurse time, outpatient visits and hospital bed days.
The conventional management of treatment-resistant, recurrent malignant ascites involves repeated large-volume paracentesis procedures that are carried out in hospital. Most commonly this is done as an inpatient procedure, although some centres are able to offer paracentesis as a day case procedure. Inpatient paracentesis is carried out when patients have developed troublesome symptoms from recurrent ascites. This can entail some delay while waiting for admission, during which the patient continues to experience symptoms.
Paracentesis involves inserting a catheter, often under local anaesthetic, into the peritoneal cavity to drain ascitic fluid. During large-volume paracentesis the catheter stays in place until most of the ascites has been drained, which often exceeds 5 litres of fluid. This may be done in one go, but some patients cannot tolerate rapid drainage and may need to stay in hospital for one or more nights for repeated drainage procedures.
The clinical evidence for the PleurX peritoneal catheter drainage system was based on 9 observational studies (10 manuscripts), 2 of which were conducted in the UK. Six studies were case series with 10 or more patients, one study was a qualitative case series (4 patients), and there were 3 case reports (4 or fewer patients). The external assessment centre considered all the studies identified by the sponsor to be relevant and did not identify any further studies.
The appraisal committee considered that the decision to start treatment with the PleurX peritoneal catheter drainage system should be shared between clinicians and patients.