Evaluation of smartphone-integrated magnetometers in detection of safe electromagnetic devices for use near programmable shunt valves: a proof-of-concept study

OBJECTIVE External magnetic forces can have an impact on programmable valve mechanisms and potentially alter the opening pressure. As wearable technology has begun to permeate mainstream living, there is a clear need to provide information regarding safety of these devices for use near a programmable valve (PV). The aim of this study was to evaluate the magnetic fields of reference devices using smartphone-integrated magnetometers and compare the results with published shunt tolerances. METHODS Five smartphones from different manufacturers were used to evaluate the magnetic properties of various commonly used (n = 6) and newer-generation (n = 10) devices using measurements generated from the internal smartphone magnetometers. PV tolerance testing using calibrated magnets of varying field strengths was also performed by smartphone magnetometers. RESULTS All tested smartphone-integrated magnetometers had a factory sensor saturation point at around 5000 µT or 50 Gauss (G). This is well below the threshold at which a magnet can potentially deprogram a shunt, based on manufacturer reports as well as the authors’ experimental data with a threshold of more than 300 G. While many of the devices did saturate the smartphone sensors at the source, the magnetic flux density of the objects decreases significantly at 2 inches. CONCLUSIONS The existence of an upper limit on the magnetometers of all the smartphones used, although well below the published deprogramming threshold for modern programmable valves, does not allow us to give precise recommendations on those devices that saturate the sensor. Based on the authors’ experimental data using smartphone-integrated magnetometers, they concluded that devices that measure < 40 G can be used safely close to a PV.

Outcomes and complications of different surgical treatments for idiopathic normal pressure hydrocephalus: a systematic review and meta-analysis

OBJECTIVEDifferent CSF diversion procedures (ventriculoperitoneal, ventriculoatrial, and lumboperitoneal shunting) have been utilized for the treatment of idiopathic normal pressure hydrocephalus. More recently, endoscopic third ventriculostomy has been suggested as a reasonable alternative in some studies. The purpose of this study was to perform a systematic review and meta-analysis to assess overall rates of favorable outcomes and adverse events for each of these treatments. An additional objective was to determine the outcomes and complication rates in relation to the type of valve utilized (fixed vs programmable).METHODSMultiple databases (PubMed, Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus) were searched for studies involving patients with idiopathic ventriculomegaly, no secondary cause of hydrocephalus, opening pressure < 25 mm Hg on high-volume tap or drainage trial, and age > 60 years. Outcomes included the proportion of patients who showed improvement in gait, cognition, and bladder function. Adverse events considered in the analysis included postoperative ischemic/hemorrhagic complications, subdural fluid collections, seizures, need for revision surgery, and infection.RESULTSA total of 33 studies, encompassing 2461 patients, were identified. More than 75% of patients experienced improvement after shunting, without significant differences among the different techniques utilized. Overall, gait improvement was observed in 75% of patients, cognitive function improvement in more than 60%, and improvement of incontinence in 55%. Adjustable valves were associated with a reduction in revisions (12% vs 32%) and subdural collections (9% vs 22%) as compared to fixed valves.CONCLUSIONSOutcomes did not differ significantly among different CSF diversion techniques, and overall improvement was reported in more than 75% of patients. The use of programmable valves decreased the incidence of revision surgery and of subdural collections after surgery, potentially justifying the higher initial cost associated with these valves.

A Cohort Comparison Analysis of Fixed Pressure Ventriculoperitoneal Shunt Valves With Programmable Valves for Hydrocephalus Following Nontraumatic Subarachnoid Hemorrhage

BACKGROUND Hydrocephalus after nontraumatic subarachnoid hemorrhage (SAH) is a common sequela that may require the placement of ventriculoperitoneal shunts (VPS). Adjustable-pressure valves (APVs) are being widely used in this situation though more expensive than differential-pressure valves (DPVs). OBJECTIVE To compare outcomes between APV and DPV in SAH-induced hydrocephalus. METHODS We performed a retrospective chart review of patients with nontraumatic SAH who underwent VPS placement for the treatment of hydrocephalus after SAH, between July 2007 and December 2016. Patients were classified according to the type of valve (APV vs DPV). We evaluated factors that could predict the type of valve used, outcomes in VPS revision/replacement rate, and complications. RESULTS A total of 66 patients underwent VPS placement who were equally distributed into the 2 groups of valves. VPS failure with the need for revision/replacement occurred in 13 (19.7%) cases. Ten (30.3%) patients with DPV had a VPS failure, while 3 (9.1%) patients with an APV had a similar failure with the need for revision/replacement (P = .03). VPS placement before discharge during the initial hospitalization (P = .02) was statistically significant associated with the use of a DPV, while the reason of external ventricular drain (EVD) failure (P = .03) was associated with the use of an APV. CONCLUSION APVs had a lower rate of surgical revisions compared to DPVs. Early placement of VPS was associated with the use of a DPV. The need for EVD replacement due to EVD infection or malfunction was associated with higher rates of APV use.

Comparative durability and costs analysis of ventricular shunts

OBJECTIVEVentricular shunt (VS) durability has been well studied in the pediatric population and in patients with normal pressure hydrocephalus; however, further evaluation in a more heterogeneous adult population is needed. This study aims to evaluate the effect of diagnosis and valve type—fixed versus programmable—on shunt durability and cost for placement of shunts in adult patients.METHODSThe authors retrospectively reviewed the medical records of all patients who underwent implantation of a VS for hydrocephalus at their institution over a 3-year period between August 2013 and October 2016 with a minimum postoperative follow-up of 6 months. The primary outcome was shunt revision, which was defined as reoperation for any indication after the initial procedure. Supply costs, shunt durability, and hydrocephalus etiologies were compared between fixed and programmable valves.RESULTSA total of 417 patients underwent shunt placement during the index time frame, consisting of 62 fixed shunts (15%) and 355 programmable shunts (85%). The mean follow-up was 30 ± 12 (SD) months. The shunt revision rate was 22% for programmable pressure valves and 21% for fixed pressure valves (HR 1.1 [95% CI 0.6–1.8]). Shunt complications, such as valve failure, infection, and overdrainage, occurred with similar frequency across valve types. Kaplan-Meier survival curve analysis showed no difference in durability between fixed (mean 39 months) and programmable (mean 40 months) shunts (p = 0.980, log-rank test). The median shunt supply cost per index case and accounting for subsequent revisions was $3438 (interquartile range $2938–$3876) and $1504 (interquartile range $753–$1584) for programmable and fixed shunts, respectively (p < 0.001, Wilcoxon rank-sum test). Of all hydrocephalus etiologies, pseudotumor cerebri (HR 1.9 [95% CI 1.2–3.1]) and previous shunt malfunction (HR 1.8 [95% CI 1.2–2.7]) were found to significantly increase the risk of shunt revision. Within each diagnosis, there were no significant differences in revision rates between shunts with a fixed valve and shunts with a programmable valve.CONCLUSIONSLong-term shunt revision rates are similar for fixed and programmable shunt pressure valves in adult patients. Hydrocephalus etiology may play a significant role in predicting shunt revision, although programmable valves incur higher supply costs regardless of initial diagnosis. Utilization of fixed pressure valves versus programmable pressure valves may reduce supply costs while maintaining similar revision rates. Given the importance of developing cost-effective management protocols, this study highlights the critical need for large-scale prospective observational studies and randomized clinical trials of ventricular shunt valve revisions and additional patient-centered outcomes.

Parent/guardian knowledge regarding implanted shunt type, setting, and symptoms of malfunction/infection

OBJECTIVEPatients with shunts often interact with providers distant from their primary hospital, making it important that the parent(s)/guardian(s) is well versed in the type of shunt implanted and symptoms of malfunction/infection. This is particularly important with magnetic-sensitive programmable valves, as the use of MRI becomes more prevalent.METHODSOver a 6-month period, primary caregivers of 148 consecutive patients who received shunts were prospectively administered questionnaires at clinic visits. Caregivers were asked to do the following: 1) identify shunt valve name, type, and setting if applicable; 2) list symptoms of shunt malfunction/infection; and 3) indicate whether they had access to references regarding shunt type/setting, booklets from the Hydrocephalus Association, and quick reference cards with symptoms of shunt malfunction/infection. One cohort of caregivers (n = 75) was asked to carry informational cards with shunt valve/setting information (group I); this cohort was compared with another subgroup of caregivers (n = 73) not carrying cards (group II).RESULTSThe mean (± SD) age of patients at implantation/revision was 3.71 ± 4.91 years, and the age at follow-up was 6.12 ± 5.4 years. The average time from surgery to administration of the questionnaire was 2.38 ± 3.22 years. There were 86 new shunt insertions and 62 revisions. One hundred twenty-eight caregivers (87%) could identify the type of valve (programmable vs nonprogrammable). On the other hand, only 72 caregivers (49%) could identify the valve name. Fifty-four of 73 (74%) caregivers of patients who had shunts with programmable valves could correctly identify the valve setting. One hundred caregivers (68%) had a copy of the Hydrocephalus Association booklet, and 103 (70%) had quick reference cards. Eighty caregivers (54%) had references on shunt type/setting. Most caregivers (127 [86%]) could name ≥ 3 signs/symptoms of shunt malfunction, with vomiting (61%), headache (49%), and sleeps more/lethargic (35%) most frequently reported. Caregivers of patients in group I were more likely to have cards with symptoms of shunt infection or malfunction (p = 0.015); have information cards regarding shunt type/setting (p < 0.001); and correctly identify valve type (p = 0.001), name (p < 0.001), and setting if programmable (p = 0.0016). There were no differences in ability to list symptoms of shunt malfunction or infection (p = 0.8812) or in access to Hydrocephalus Association booklets (p = 0.1288). There were no significant demographic differences between the groups, except that group I patients had a shorter time from surgery to last follow-up (1.66 vs 3.17 years; p = 0.0001).CONCLUSIONSEducation regarding the care of patients with shunts by providing written cards with shunt type/setting and access to reference materials seems to be effective. Developing plans for guided instruction with assessment in the clinic setting of a caregiver’s knowledge is important for patient safety.

Programmable shunt valve interactions with osseointegrated hearing devices

OBJECTIVE Patients with ventriculoperitoneal (VP) shunts with programmable valves who would benefit from osseointegrated hearing devices (OIHDs) represent a unique population. The aim of this study was to evaluate the magnetic field strengths of 4 OIHDs and their interactions with 5 programmable VP shunt valves. METHODS Magnetic field strength was measured as a function of distance for each hearing device (Cochlear Baha 5, Cochlear Baha BP110, Oticon Ponto Plus Power, and Medtronic Sophono) in the following modes: inactive, active in quiet, and active in 60 decibels of background noise in the sound booth. The hearing devices were introduced to each shunt valve (Aesculap proGAV, Aesculap proGAV 2.0, Codman Hakim, Codman Certas, and Medtronic Strata II) also as a function of distance in these identical 3 settings. Each trial was repeated 5 times. Between each trial, the valves were assessed for a change in setting. Finally, using a skull model, the devices were introduced to each other in standard anatomical locations and the valves were assessed for a change in settings. RESULTS The maximum magnetic field strengths generated by the Cochlear Baha 5, BP110, and Oticon OIHDs were 1.1, 36.2, and 48.7 gauss (G), respectively. The maximum strength generated by the Sophono device was > 800 G. The magnetic field strength of the hearing devices decreased markedly with increasing distance from the device. The strength of the Sophono's magnetic attachment decreased to 34.8 G at 5 mm. The Codman Hakim, Codman Certas, and Medtronic Strata II valve settings changed when rotating the valves next to the Sophono abutment. No other changes in valve settings occurred in the distance or anatomical models for any other trials. CONCLUSIONS This is the first study evaluating the interaction between OIHDs and programmable VP shunt valves. The findings suggest that it is safe to use these devices together without having to switch to a nonprogrammable valve or move the shunt valve to a more distant location. Still, care should be taken if the Sophono device is used to ensure that the valve is ≥ 5 mm away from the magnetic attachment.

One-year outcome in patients with idiopathic normal-pressure hydrocephalus: comparison of lumboperitoneal shunt to ventriculoperitoneal shunt

OBJECTIVE Idiopathic normal pressure hydrocephalus (iNPH) is treated with cerebrospinal fluid shunting, and implantation of a ventriculoperitoneal shunt (VPS) is the current standard treatment. The objective of this study was to compare the efficacy and safety of VPSs and lumboperitoneal shunts (LPSs) for patients with iNPH. METHODS The authors conducted a prospective multicenter study of LPS use for patients with iNPH. Eighty-three patients with iNPH (age 60 to 85 years) who presented with ventriculomegaly and high-convexity and medial subarachnoid space tightness on MR images were recruited from 20 neurological or neurosurgical centers in Japan between March 1, 2010, and October 19, 2011. The primary outcome was the modified Rankin Scale (mRS) score 1 year after surgery, and the secondary outcome included scores on the iNPH grading scale (iNPHGS). A previously conducted VPS cohort study with the same inclusion criteria and primary and secondary end points was used as a historical control. RESULTS The proportion of patients who achieved a favorable outcome (i.e., improvement of at least 1 point in their mRS score) was 63% (95% CI 51%–73%) and was comparable to values reported with VPS implantation (69%, 95% CI 59%–78%). Using the iNPHGS, the 1-year improvement rate was 75% (95% CI 64%–84%) and was comparable to the rate found in the VPS study (77%, 95% CI 68%–84%). The proportion of patients experiencing serious adverse events (SAEs) and non-SAEs did not differ significantly between the groups at 1 year after surgery (SAEs: 19 [22%] of 87 LPS patients vs 15 [15%] of 100 VPS patients, p = 0.226; non-SAEs: 24 [27.6%] LPS patients vs 20 [20%] VPS patients, p = 0.223). However, shunt revisions were more common in LPS-treated patients than in VPS-treated patients (6 [7%] vs 1 [1%]). CONCLUSIONS The efficacy and safety rates for LPSs with programmable valves are comparable to those for VPSs for the treatment of patients with iNPH. Despite the relatively high shunt failure rate, an LPS can be the treatment of choice because of its minimal invasiveness and avoidance of brain injury.