Zusammenfassung:
Background and objectives: Previously, we studied the flow in ventricular catheters under steady and pulsatile boundary conditions using computational fluid dynamics in catheter designs with homogeneous flow patterns. Out of which, one prototype was chosen after a validation study for a clinical test. We tested the effectiveness of the flow ventricular catheter in a prospective, multicenter, comparative study in 2018. We now aim to present the long-term functionality results of the flow ventricular catheter previous study.
Methods: A clinical trial was approved and initiated in selected hospitals from 3 continents. Three hospitals included pediatric patients, 1 hospital included mixed adult-pediatric cases, and adult-only patients were from 2 hospitals. The trial enrolled patients with overt hydrocephalus undergoing initial ventriculoperitoneal shunt placement or revision.
Results: A total of 86 hydrocephalic patients were included in this trial, with 58 pediatric cases (age range: 5-14 years, mean = 7.1 years) and 28 adult cases (age range: 18-86 years, mean = 67.5 years). The flow catheter demonstrated significantly lower proximal obstruction rates than regular ventricular catheters over a mean follow-up of 6 years. No obstructions occurred in the flow group (0/40, 0%), while the regular catheter group had 7 cases (7/43, 16.28%) (P = .0127). In pediatric patients, 5 obstructions were observed in the regular catheter group (5/26, 19.2%) compared with none in the flow group (0/30, P = .0172). Five of the 7 obstructions occurred in children aged 10 years or younger, mainly in occipital placements, with rates slightly higher in Grade II (21.43%) than in Grade I (17.39%) according to Schaumann and Thomale classification.
Conclusion: The flow catheter, representing the next generation of ventricular catheters with a homogeneous flow pattern, can be inserted safely in hydrocephalic patients of all types. This comparative study still showed possible obstruction-free functionality.
