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Comparative study of two customary cerebrospinal fluid shunting systems in early childhood hydrocephalus
1Neurochirurgische Universitätsklinik, Neurozentrum, Freiburg, Federal Republic of Germany.
Insights
Hydrocephalic infants treated with the Orbis-Sigma Valve (OSV) system experienced significantly fewer shunt complications than those receiving the Holter Valve (HV) system. This study highlights the OSV system
Area of Science:
- Neurosurgery
- Pediatric Neurology
- Medical Device Technology
Background:
- Clinical studies on hydrocephalus treatment are often limited by patient and device variability.
- Shunt systems are crucial for managing hydrocephalus in infants and children.
- Comparing different shunt systems is essential for optimizing patient outcomes.
Purpose of the Study:
- To conduct a homogeneous clinical study comparing the Orbis-Sigma Valve (OSV) system with the Holter Valve (HV) system in hydrocephalic infants.
- To evaluate shunt insufficiency and complication rates between the two valve systems.
- To analyze revision and survival rates associated with each shunt system.
Main Methods:
- A cohort of 66 hydrocephalic newborns and infants were exclusively treated with the CORDIS Orbis-Sigma Valve (OSV) system (1990-1995).
- Results were compared to an equivalent group of 53 children treated with the CODMAN Holter Valve (HV) system (1986-1991).
- Shunt insufficiency and complication reasons were investigated for both groups.
Main Results:
- Patients treated with the ventriculo-peritoneal OSV system (VP-OSV) showed a significantly lower risk of shunt complications compared to ventriculo-atrial HV treated patients (VA-HV).
- The mean surgical procedures per person were 1.98 for VP-OSV versus 4.22 for VA-HV.
- Differences in revision and survival rates between the two systems were observed and discussed.
Conclusions:
- The CORDIS Orbis-Sigma Valve (OSV) system, particularly in ventriculo-peritoneal placement, demonstrates a superior safety profile with fewer complications than the CODMAN Holter Valve (HV) system in pediatric hydrocephalus.
- The findings suggest that device selection significantly impacts shunt complication rates and the need for revision surgeries.
- Further discussion on specific challenges and long-term outcomes associated with each system is warranted.
Abstract:
The validity of clinical studies on shunt-treated hydrocephalic patients is often hindered by inhomogeneity of the patient population examined, technical devices used, or by other specific factors. In an effort to introduce a homogeneous clinical study on hydrocephalic patients 66 hydrocephalic newborns and infants have been treated exclusively with CORDIS Orbis-Sigma Valve (OSV) System (CORDIS Corporation, Miami, USA) in 1990-1995. The results are compared with an equivalent group of 53 children treated with CODMAN Holter Valve (HV) System (CODMAN Inc., Randolph, USA) during a similar 5-year-period (e.g., 1986-1991). Searching for different reasons of shunt insufficiency in both groups demonstrates a more than double risk of shunt complication for ventriculo-atrial HV treated patients (VA-HV) in comparison with those treated ventriculo-peritoneally with OSV System (VP-OSV): 4.22 versus 1.98 mean surgical procedures per person. The different revision and survival rates are discussed and specific problems are mentioned.