CODMAN CERTAS® Plus Programmable Valve
The Codman CertasTM valve for treatment of hydrocephalus was introduced into clinical practice in January 2011. It has 8 different settings with an opening pressure varying from 36 to over 400 mm H2O at a flow rate of 20 mL/h. The 8th setting is designed to provide a “virtual off” function.
Czosnyka et al. described the initial clinical experience with the CertasTM valve and evaluate clinical usage with the main focus on the portable adjustment device - Therapeutic Management System (TMS), the “virtual off” setting and compatibility with magnetic resonance imaging (MRI).
In the laboratory the Certas valve appears to be a reliable differential-pressure programmable valve. Laboratory evaluation should be supplemented by results of a clinical audit in the future 1).
Configuration
With SiphonGuard® Anti-Siphon Device
Without SiphonGuard® Anti-Siphon Device
Interactions
The Codman CERTAS Plus electronic programmer detects the magnetic field emitted from an Apple Watch and mistakes it for the valve, rendering programming difficult. These smartwatches and similar electronic devices should be kept away from the programmer and not worn by health care providers to avoid inappropriate readings and setting changes 2)
Smartphones exert reversible effects on Strata programmable valves without producing remarkable radiologic findings and irreversible effects on Codman Certas valves 3)
He et al. tested: Strata NSC Adjustable Pressure Valve, Strata NSC Burr Hole Valve, Strata II small valve, Sophysa Polaris model SPV, Aesculap valve proGAV, and Codman Certas Programmable Valve. The left front edge of the iPad 3 with Smart Cover was found to have the strongest magnetic flux, measuring approximately 1,200 G and was moved linearly directly over the tested valve and then parallel to the first path at approximately 30 cm/s. Also, this area was rotated once at varying distances above the valve at approximately 1 rad/s.
Almost all shunt valves were immune to reprogramming by the iPad 3 at varying distances (including direct contact) except for the Strata II small valve, where rotating the peak flux location 4 mm above the valve changed the valve pressure settings every time.
The iPad 3 can change pressure settings of the Strata II small valve at a distance comparable to the thickness of certain regions of the scalp. Although the specific rotational motion described here may be uncommon in real life, it is nevertheless recommended that children with hydrocephalus, caregivers, educators, and therapists are informed of the now-apparent risks of close contact with this increasingly popular technology 4).
Case series
The valve setting of two different programmable shunts (Codman Certas Plus® and Sophysa Polaris®) were assessed by two blinded observers in 24 patients using 65 head CT scans (slice thickness ≤2 mm). Using multi-planar reconstruction (MPR) tools, images were resliced according to the direction of the valve, allowing a direct readout of the valve settings. We validated our CT based method against 32 available skull X-rays.
Results: For all CT scans it was possible to assess the valve setting. No interobserver variability was found and there was a 100 % concordance between the CT based method and skull X-rays.
Discussion: CT based assessment of programmable shunt valve settings is feasible and reliable. It may obviate the need for additional skull x-rays when a head CT scan is available.
Conclusions: This technique can reduce radiation exposure and can be applied to historical CT imaging with unknown valve settings 5).
Forty-two patients with hydrocephalus from different etiologies were treated with the CertasTM adjustable shunt system. Data regarding implantation procedures, the use of the TMS system, x-ray imaging, and MRI procedures were recorded prospectively. All patients had clinical follow-up at four weeks after implantation and every three months until a stable clinical condition was obtained.The mean time for follow-up was 8.6 months (1-16.6). Seventy-one adjustments were performed with the TMS, 12 were problematic. Twenty-nine MRI procedures were performed and did not cause accidental resetting. Five patients were treated with the “virtual off” function for a period.
Watt et al. found the CertasTM valve valuable in the treatment of hydrocephalus, usability of the TMS was high because it is small and portable, but in some cases we experienced adjustment problems with the first procedures performed by a surgeon, indicating that there is a learning curve. The “virtual off” function provided a possibility of treating over-drainage without the need for shunt ligation or other invasive procedures 6).
Case reports
A 50-year-old man presented with daily headaches, visual loss (right > left), and increased lumbar opening pressure consistent with IIH. A VPS was inserted using a Strata II valve with a pressure setting of 1.5, lowering ICP into the normal range. The patient initially had a normal postoperative course, but then became comatose and developed imaging signs consistent with intracranial hypotension. A Codman Certas valve was placed at a setting of 7 and a distal slit-cut peritoneal catheter was used (as opposed to standard open output). This custom system drained at pressure >26 mm Hg based on intraoperative manometry. The patient tolerated this well and is currently planned for a gradual reduction in ICP with valve setting adjustments as an outpatient.
In patients with chronic IIH, reduction to normal ICP may unexpectedly lead to encephalopathic changes. Personalized shunts may facilitate reduction of ICP to still elevated but tolerable levels in these patients 7)