The cost of serial cerebrospinal fluid aspirations between ventricular access device (VAD) and ventriculosubgaleal shunt (VSGS) for treatment of post-hemorrhagic ventricular dilatation (PHVD) in premature infants

Introduction: Ventriculosubgaleal shunts (VSGS) require fewer cerebrospinal (CSF) aspirations than ventricular access devices (VAD) for temporization of post-hemorrhagic ventricular dilatation (PHVD) in preterm infants. Cost of postoperative CSF aspiration has not been quantified. Methods: We reviewed CSF aspiration and laboratory studies obtained in preterm infants with PHVD and VAD at our institution between 2009-2020. Cost per aspiration was calculated for materials, labs, and Medicare fee schedule for ventricular puncture through implanted reservoir. We searched PubMed, Cochrane Library, Embase, CINAHL, and Web of Science for meta-analysis of pooled mean number of CSF aspirations and proportion of patients requiring aspiration. Results: Thirty-five preterm infants with PHVD had VAD placed with 22.2±18.4 aspirations per patient. Labs were obtained after every aspiration per local protocol. Cost per aspiration at our institution was $935.51. Of 269 published studies, 77 reported on VAD, 29 VSGS, and 13 both. Five studies on VAD (including the current study) had a pooled mean of 25.8 aspirations per patient (95%CI:16.7-34.8). One study on VSGS reported a mean of 1.6±1.7 aspirations. 3 studies on VAD (including the current study) had a pooled proportion of 97.4% of patients requiring aspirations (95%CI: 87.9-99.5). Four studies on VSGS had a pooled proportion of 36.5% requiring aspirations (95%CI:26.9-47.2). Frequency of lab draws ranged from weekly to daily. Based on costs at our institution, mean number of aspirations, and proportion of patients requiring aspirations, cost difference ranged between $4,243 to $23,235 per patient and $500,903 to 2.36 million per 100 patients depending on frequency of taps and Medicare locality. Discussion/Conclusion: Lower number of CSF aspirations using VSGS can be associated with considerably lower cost compared to VAD.

A survival analysis of ventricular access devices for delivery of cerliponase alfa

OBJECTIVE Late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) is a rare autosomal recessive disease caused by tripeptidyl peptidase 1 enzyme deficiency. At the authors’ center, the medication cerliponase alfa is administered every 2 weeks via the intracerebroventricular (ICV) route. This requires the placement of a ventricular access device (VAD) or reservoir and frequent percutaneous punctures of this device over the child’s lifetime. In this study, the authors audited the longevity and survival of these VADs and examined the causes of device failure. METHODS A single-center survival analysis of VAD insertions and revisions (January 2014 through June 2020) was conducted. All children received cerliponase alfa infusions through a VAD. Patient characteristics and complications were determined from a prospectively maintained surgical database and patient records. For the VAD survival analysis, the defined endpoint was when the device was removed or changed. Reservoir survival was assessed using Kaplan-Meier curves and the log-rank (Cox-Mantel) test. RESULTS A total of 17 patients had VADs inserted for drug delivery; median (range) age at first surgery was 4 years 4 months (1 year 8 months to 15 years). Twenty-six VAD operations (17 primary insertions and 9 revisions) were required among these 17 patients. Twelve VAD operations had an associated complication, including CSF infection (n = 6) with Propionibacterium and Staphylococcus species being the most prevalent organisms, significant surgical site swelling preventing infusion (n = 3), leakage/wound breakdown (n = 2), and catheter obstruction (n = 1). There were no complications or deaths associated with VAD insertion. The median (interquartile range) number of punctures was 59.5 (7.5–82.0) for unrevised VADs (n = 17) versus 2 (6–87.5) for revised VADs (n = 9) (p = 0.70). The median survival was 301 days for revisional reservoirs (n = 9) versus 2317 days for primary inserted reservoirs (n = 17) (p = 0.019). CONCLUSIONS In the context of the current interest in intrathecal drug delivery for rare metabolic disorders, the need for VADs is likely to increase. Auditing the medium- to long-term outcomes associated with these devices will hopefully result in their wider application and may have potential implications on the development of new VAD technologies. These results could also be used to counsel parents prior to commencement of therapy and VAD implantation.

TROPHY registry — status report

Introduction The TROPHY registry has been established to conduct an international multicenter prospective data collection on the surgical management of neonatal intraventricular hemorrhage (IVH)-related hydrocephalus to possibly contribute to future guidelines. The registry allows comparing the techniques established to treat hydrocephalus, such as external ventricular drainage (EVD), ventricular access device (VAD), ventricular subgaleal shunt (VSGS), and neuroendoscopic lavage (NEL). This first status report of the registry presents the results of the standard of care survey of participating centers assessed upon online registration. Methods On the standard of treatment forms, each center indicated the institutional protocol of interventions performed for neonatal post-hemorrhagic hydrocephalus (nPHH) for a time period of 2 years (Y1 and Y2) before starting the active participation in the registry. In addition, the amount of patients enrolled so far and allocated to a treatment approach are reported. Results According to the standard of treatment forms completed by 56 registered centers, fewer EVDs (Y1 55% Y2 46%) were used while more centers have implemented NEL (Y1 39%; Y2 52%) to treat nPHH. VAD (Y1 66%; Y2 66%) and VSGS (Y1 42%; Y2 41%) were used at a consistent rate during the 2 years. The majority of the centers used at least two different techniques to treat nPHH (43%), while 27% used only one technique, 21% used three, and 7% used even four different techniques. Patient data of 110 infants treated surgically between 9/2018 and 2/2021 (13% EVD, 15% VAD, 30% VSGS, and 43% NEL) were contributed by 29 centers. Conclusions Our results emphasize the varying strategies used for the treatment of nPHH. The international TROPHY registry has entered into a phase of growing patient recruitment. Further evaluation will be performed and published according to the registry protocol.

Ventriculosubgaleal shunt and neuroendoscopic lavage: refining the treatment algorithm of neonatal post-hemorrhagic hydrocephalus

Background The optimal management of neonatal post-hemorrhagic hydrocephalus (PHH) is still debated, though several treatment options have been proposed. In the last years, ventriculosubgaleal shunt (VSgS) and neuroendosdcopic lavage (NEL) have been proposed to overcome the drawbacks of more traditional options, such as external ventricular drainage and ventricular access device. Methods We retrospectively reviewed neonates affected by PHH treated at our institution since September 2012 to September 2020. Until 2017 patients received VSgS as initial treatment. After the introduction of NEL, this treatment option was offered to patients with large intraventricular clots. After NEL, VSgS was always placed. Primary VSgS was reserved to patients without significant intraventricular clots and critically ill patients that could not be transferred to the operating room and undergo a longer surgery. Results We collected 63 babies (38 males and 25 females) with mean gestational age of 27.8 ± 3.8SD weeks (range 23–38.5 weeks) and mean birthweight of 1199.7 ± 690.6 SD grams (range 500–3320 g). In 6 patients, hemorrhage occurred in the third trimester of gestation, while in the remaining cases hemorrhage complicated prematurity. This group included 37 inborn and 26 outborn babies. Intraventricular hemorrhage was classified as low grade (I–II according to modified Papile grading scale) in 7 cases, while in the remaining cases the grade of hemorrhage was III to IV. Mean age at first neurosurgical procedure was 32.2 ± 3.6SD weeks (range 25.4–40 weeks). Death due to prematurity occurred in 5 patients. First-line treatment was VSgS in 49 patients and NEL in the remaining 14 cases. Mean longevity of VSgS was 30.3 days (range 10–97 days) in patients finally requiring an additional treatment of hydrocephalus. Thirty-two patients required one to three redo VSgS. Interval from initial treatment to permanent shunt ranged from 14 to 312 days (mean 70.9 days). CSF infection was observed in 5 patients (7.9%). Shunt dependency was observed in 51 out of 58 surviving patients, while 7 cases remained shunt-free at the last follow-up. Multiloculated hydrocephalus was observed in 14 cases. Among these, only one patient initially received NEL and was complicated by isolated trapped temporal horn. Conclusions VSgS and NEL are two effective treatment options in the management of PHH. Both procedures should be part of the neurosurgical armamentarium to deal with PHH, since they offer specific advantages in selected patients. A treatment algorithm combining these two options may reduce the infectious risk and the risk of multiloculated hydrocephalus.

Bedside placement of ventricular access devices under local anaesthesia in neonates with posthaemorrhagic hydrocephalus: preliminary experience

Purpose Posthaemorrhagic ventricular dilatation in preterm infants is primarily treated using temporising measures, of which the placement of a ventricular access device (VAD) is one option. Permanent shunt dependency rates are high, though vary widely. In order to improve the treatment burden and lower shunt dependency rates, we implemented several changes over the years. One of these changes involves the setting of the surgery from general anaesthesia in the OR to local anaesthesia in bed at the neonatal intensive care unit (NICU), which may seem counterintuitive to many. In this article, we describe our surgical technique and present the results of this regimen and compare it to our previous techniques. Methods Retrospective study of a consecutive series of 37 neonates with posthaemorrhagic ventricular dilatation (PHVD) treated using a VAD, with a cohort I (n = 13) treated from 2004 to 2008 under general anaesthesia in the OR, cohort II (n = 11) treated from 2009 to 2013 under general anaesthesia in the NICU and cohort III (n = 13) treated from December 2013 to December 2017 under local anaesthesia on the NICU. Results The overall infection rate was 14%; the VAD revision rate was 22% and did not differ significantly between the cohorts. Procedures under local anaesthesia never required conversion to general anaesthesia and were well tolerated. After an average of 33 tapping days, 38% of the neonates received a permanent ventriculoperitoneal (VP) shunt. The permanent VP shunt rate was 9% with VAD placement under local anaesthesia and 52% when performed under general anaesthesia (p = 0.02). Conclusion Bedside placement of VADs for PHVD under local anaesthesia in neonates is a low-risk, well-tolerated procedure that results in at least equal results to surgery performed under general anaesthesia and/or performed in an OR.

P94 Ventricular subgaleal shunting is a safe and effective temporising measure for the treatment of neonatal post haemorrhagic hydrocephalus

ObjectivesThe use of a temporising device to facilitate neonatal maturation prior to permanent ventricular peritoneal shunt (VPS) remains gold standard treatment for neonatal posthaemorrhagic hydrocephalus (PHH). The relative superiority of ventricular access device (VAD) or ventricular subgaleal shunt (VSG) remains contentious.DesignRetrospective case note review.Subjects49 neonates born between Sept 2012 to April 2018: (M:F 34:15); Average: gestation 26+3 (23 to 32+5); birth weight 870 g (±355 g); Papile grade 3:4 (ratio ≈ 1:2).MethodsComputer records from neonatal VSG at a single tertiary care children’s hospital reviewed.ResultsEarly complications associated with VSG seen in 13 cases (27%). Migration of shunt n=3, infection n=2, inadequate control of ventricular volume n=5, decompression haemorrhage n=2, wound leak n=1. All patients managed on NICU with an average inpatient stay of 5 days (range 2 to 15). 5 outcome groups defined: 1. Patient died (non neurological cause) (n=4) 2. VSG in situ for <1 year (n=7) 3. VSG and no VPS (n=6 16%) 4. VSG and VPS X1 never revised (n=17 45%) 5. VSG and VPS with revisions (n=15 39%) Rate of shunting in patients with VSG >1 year=84%. All patients that needed permanent VPS were operated within the first year. The average time elapsed prior to VPS was 86 days with over 80% of cases shunted within 100 days.ConclusionsVSG remains a safe method of temporary CSF drainage for the treatment of neonatal PHH with rates of shunting in line with the published literature.

Risk factors for infection and the effect of an institutional shunt protocol on the incidence of ventricular access device infections in preterm infants

OBJECT Intraventricular hemorrhage in premature infants often leads to progressive ventricular dilation and the need for ventricular reservoir placement. Unfortunately, these reservoirs have a higher rate of infection than ventriculoperitoneal shunts in premature babies. The authors analyzed the risk factors for infection in this population and studied whether the implementation of an institutional protocol for shunt placement had a corollary effect on ventricular access device (VAD) infection rates in premature neonates with intraventricular hemorrhage. METHODS The authors conducted a retrospective cohort review of consecutive premature neonates in whom VADs were inserted in the operating room at Primary Children's Hospital between June 2003 and June 2011 to identify risk factors for infection. Medical records were reviewed for information on infection (culture proven or eroded hardware at 90 days), gestational age at birth, weight, gestational age at surgery, intrathecal antibiotics, hemorrhage, death, and surgeon. The institution used a pilot protocol for shunt infection reduction in 2006–2007, and then the full Hydrocephalus Clinical Research Network protocol from June 2007 to 2011, and the rates of infection during these periods were analyzed. Confounding factors such as sepsis, necrotizing enterocolitis, and a history of meningitis were also analyzed. RESULTS The overall infection rate was 10.5% (11 patients) in the 105 patients identified. Gestational age at procedure was a significant risk factor for infection (p = 0.05). Meningitis was significantly associated with infection, with 63% of the infected group having had prior meningitis compared with 7% for the noninfected group (p < 0.001). Concurrent with the implementation of the protocol to reduce shunt infection, the VAD infection rate decreased from 14.7% to 5.4% (p = 0.2). CONCLUSIONS Gestational age at procedure and previous meningitis were significant risk factors for VAD infections. In addition, the implementation of an institutional standardized shunt protocol for ventriculoperitoneal shunts may have altered the operating room team's behavior, indicated by a nonmandated use of intrathecal antibiotics in VAD surgeries, contributing to a reduced VAD infection rate. Although the observed difference was not statistically significant with the small sample size, the authors believe that these findings deserve further study.

Poor correlation between head circumference and cranial ultrasound findings in premature infants with intraventricular hemorrhage

Object Intraventricular hemorrhage (IVH) is the most common cause of hydrocephalus in the pediatric population and is particularly common in preterm infants. The decision to place a ventriculoperitoneal shunt or ventricular access device is based on physical examination findings and radiographic imaging. The authors undertook this study to determine if head circumference (HC) measurements correlated with the Evans ratio (ER) and if changes in ventricular size could be detected by HC measurements. Methods All cranial ultrasound (CUS) reports at the authors' institution between 2008 and 2011 were queried for terms related to hydrocephalus and IVH, from which a patient cohort was determined. A review of radiology reports, HC measurements, operative interventions, and significant clinical events was performed for each patient in the study. Additional radiographic measurements, such as an ER, were calculated by the authors. Significance was set at a statistical threshold of p < 0.05 for this study. Results One hundred forty-four patients were studied, of which 45 (31%) underwent CSF diversion. The mean gestational age and birth weight did not differ between patients who did and those who did not undergo CSF diversion. The CSF diversion procedures were reserved almost entirely for patients with IVH categorized as Grade III or IV. Both initial ER and HC were significantly larger for patients who underwent CSF diversion. The average ER and HC at presentation were 0.59 and 28.2 cm, respectively, for patients undergoing CSF diversion, and 0.34 and 25.2 cm for those who did not undergo CSF diversion. There was poor correlation between ER and HC measurements regardless of gestational age (r = 0.13). Additionally, increasing HC was not found to correlate with increasing ERs on consecutive CUSs (φ = −0.01, p = 0.90). Patients who underwent CSF diversion after being followed with multiple CUSs (10 of 45 patients) presented with smaller ERs and HC than those who underwent CSF diversion after a single CUS. Just prior to CSF diversion surgery, the patients who received multiple CUSs had ERs, but not HC measurements, that were similar to those in patients who underwent CSF diversion after a single CUS. Conclusions The HC measurement does not correlate with the ER or with changes in ER and therefore does not appear to be an adequate surrogate for serial CUSs. In patients who are followed for longer periods of time before CSF shunting procedures, the ER may play a larger role in the decision to proceed with surgery. Clinicians should be aware that the ER and HC are not surrogates for one another and may reflect different pathological processes. Future studies that take into account other physical examination findings and long-term clinical outcomes will aid in developing standardized protocols for evaluating preterm infants for ventriculoperitoneal shunt or ventricular access device placement.