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A clinical audit of the Hakim programmable valve in patients with complex hydrocephalus
A D Kay1, A J Fisher, C O'Kane
1Department of Neurosurgery, Institute of Neurological Sciences, Southern General Hospital, 1345 Govan Road, Glasgow G514TF, UK. adk4z@clinmed.ac.gla.uk
Insights
The Hakim programmable valve is effective for complex hydrocephalus, potentially reducing shunt revisions for headaches. Reprogramming can manage complications like subdural collections.
Area of Science:
- Neurosurgery
- Medical Devices
- Neurology
Background:
- Complex hydrocephalus presents management challenges.
- Programmable valves offer adjustable cerebrospinal fluid (CSF) diversion.
- Previous shunting systems had limitations.
Purpose of the Study:
- To evaluate the usage patterns and clinical outcomes of the Hakim (Medos) programmable valve.
- To assess the valve's efficacy in patients with complex hydrocephalus.
- To analyze complications and surgical practices associated with the valve.
Main Methods:
- Prospective audit of 139 patients with complex hydrocephalus receiving Hakim programmable valve implantation in the UK and Ireland.
- Minimum 5-year follow-up period.
- Auditing surgical practice, complications, and clinical outcomes.
Main Results:
- 64% favorable Glasgow Outcome Scale at 5 years post-implantation.
- 50% shunt revisions required, 40% within the first year.
- 36% shunts removed, 27% developed subdural collections, 18% shunt infections.
- Reprogramming improved headache in 71% of affected patients.
- Non-hemorrhagic subdural collections potentially manageable by reprogramming.
Conclusions:
- The Hakim programmable valve is a valuable tool for managing complex hydrocephalus.
- It may decrease the necessity for shunt revisions specifically for headache.
- Reprogramming is a key feature for managing valve-related complications and patient symptoms.
Abstract:
The objective of the investigation was to determine the pattern of use of the Hakim (Medos) programmable valve implanted in patients with complex hydrocephalus and their clinical outcome. A prospective audit of patients with complex hydrocephalus undergoing Hakim programmable valve implantation between 1989 and 1994 in the United Kingdom and Ireland, was followed-up for a minimum of 5 years. Surgical practice and complications were audited together with clinical outcome. One-hundred-and-thirty-nine patients (80 male, 59 female; mean age 43.4 years; median 47 years; range 1 month-84 years) with complex hydrocephalus due to a wide range of aetiologies were implanted with the Hakim programmable valve. Eighty-eight (63%) had large or massive ventricles prior to implantation; seven (5%) were slit. Fifty-five (40%) had previously been shunted with a fixed pressure system. One-hundred-and-thirty-one (94%) of the Hakim programmable shunts were ventriculoperitoneal; four (3%) ventriculoatrial; two (1.4%) cystoperitoneal; and two (1.5%) lumboperitoneal. The initial opening pressure selected ranged from 50 to 200 mmH2O (median 120). Valves were reprogrammed on average 1.7 times with 143 reprogrammings in the first year after implantation; 67 in the second; 19 in the third; three in the fourth; two in the fifth. Forty-nine (36%) valves were never reprogrammed after implantation. During the 5 years audit period, there were 70 (50%) shunt revisions, 40 of which were performed within 1 year of implantation. Thirty-six (27%) shunts were removed. There were 24 (18%) shunt infections. Subdural collections were identified in 37(27%) patients after Hakim programmable valve implantation; 10 (27%) required surgical drainage. Five (3.7%) patients developed symptomatic slit ventricles after Hakim programmable valve implantation. Headache was improved following reprogramming in 27(71%) of the 38 patients with refractory headache. After Hakim programmable valve implantation, patients underwent an average of 4.6 CT scans (range 1-25); 0.3 MRI (range 1-5) and 1.8 skull radiographs (range 1-20). The mean hospital stay per patient over 5 years was 26 days (range 1-110 days). Five years after implantation, the Glasgow Outcome scale was favourable in 64% of patients. The Hakim programmable valve is useful in the management of patients with complex hydrocephalus and may reduce the need for shunt revision for headache. Non-haemorrhagic, post-shunting, subdural collections identified on routine postoperative CT may be treated by reprogramming.