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Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials

Neha Siddiqui, Ryan G. Chiu, Ravi S. Nunna, Georgia Glastris, and Ankit I. Mehta

OBJECTIVE

The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its effectiveness in the participant diversity of neurosurgical device trials.

METHODS

The FDA premarket approval (PMA) online database was queried for all original neurosurgical device submissions from January 1, 2006, to December 31, 2019. Endpoints of the study included racial and gender demographics of reported effectiveness trials, which were summated for each submission. Chi-square tests were performed on both endpoints for before and after years of FDASIA passage and implementation.

RESULTS

A total of 33 device approvals were analyzed, with 14 occurring before SIA implementation and 19 after. Most trials (96.97%) reported gender to the FDA, while 66.67% reported race and 63.64% reported ethnicity. Gender breakdown did not change significantly post-SIA (53.30% female, p = 0.884). Racial breakdown was significantly different from the 2010 US Census for all races (p < 0.001) both pre- and post-SIA. Only Native American race was significantly different in terms of representation post-SIA, increasing from 0% to 0.63% (p = 0.0187). There was no significant change in ethnicity.

CONCLUSIONS

The FDASIA, as currently written, does not appear to have had a significant impact on the racial or gender diversity of neurosurgical device clinical trial populations. This may be due to the noncompulsory nature of its guidance, or a lack of more stringent regulation on the composition of clinical trials themselves.

In Journal of Neurosurgery Publish Before Print

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The effectiveness of systemic therapies after surgery for metastatic renal cell carcinoma to the spine: a propensity analysis controlling for sarcopenia, frailty, and nutrition

Elie Massaad, Philip J. Saylor, Muhamed Hadzipasic, Ali Kiapour, Kevin Oh, Joseph H. Schwab, Andrew J. Schoenfeld, Ganesh M. Shankar, and John H. Shin

OBJECTIVE

The effectiveness of starting systemic therapies after surgery for spinal metastases from renal cell carcinoma (RCC) has not been evaluated in randomized controlled trials. Agents that target tyrosine kinases, mammalian target of rapamycin signaling, and immune checkpoints are now commonly used. Variables like sarcopenia, nutritional status, and frailty may impact recovery from spine surgery and are considered when evaluating a patient’s candidacy for such treatments. A better understanding of the significance of these variables may help improve patient selection for available treatment options after surgery. The authors used comparative effectiveness methods to study the treatment effect of postoperative systemic therapies (PSTs) on survival.

METHODS

Univariable and multivariable Cox regression analyses were performed to determine factors associated with overall survival (OS) in a retrospective cohort of adult patients who underwent spine surgery for metastatic RCC between 2010 and 2019. Propensity score–matched (PSM) analysis and inverse probability weighting (IPW) were performed to determine the treatment effect of PST on OS. To address confounding and minimize bias in estimations, PSM and IPW were adjusted for covariates, including age, sex, frailty, sarcopenia, nutrition, visceral metastases, International Metastatic RCC Database Consortium (IMDC) risk score, and performance status.

RESULTS

In total, 88 patients (73.9% male; median age 62 years, range 29–84 years) were identified; 49 patients (55.7%) had an intermediate IMDC risk, and 29 (33.0%) had a poor IMDC risk. The median follow-up was 17 months (range 1–104 months) during which 57 patients (64.7%) died. Poor IMDC risk (HR 3.2 [95% CI 1.08–9.3]), baseline performance status (Eastern Cooperative Oncology Group score 3 or 4; HR 2.7 [95% CI 1.5–4.7]), and nutrition (prognostic nutritional index [PNI] first tertile, PNI < 40.74; HR 2.69 [95% CI 1.42–5.1]) were associated with worse OS. Sarcopenia and frailty were not significantly associated with poor survival. PST was associated with prolonged OS, demonstrated by similar effects from multivariable Cox analysis (HR 0.55 [95% CI 0.30–1.00]), PSM (HR 0.53 [95% CI 0.29–0.93]), IPW (HR 0.47 [95% CI 0.24–0.94]), and comparable confidence intervals. The median survival for those receiving PST was 28 (95% CI 19–43) months versus 12 (95% CI 4–37) months for those who only had surgery (log-rank p = 0.027).

CONCLUSIONS

This comparative analysis demonstrated that PST is associated with improved survival in specific cohorts with metastatic spinal RCC after adjusting for frailty, sarcopenia, and malnutrition. The marked differences in survival should be taken into consideration when planning for surgery.

In Journal of Neurosurgery: Spine Publish Before Print

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Evaluation of nonaccidental trauma in infants presenting with skull fractures: a retrospective review

Abhilasha P. Boruah, Tamia O. Potter, Berje H. Shammassian, Byron B. Hills, Michael W. Dingeldein, and Krystal L. Tomei

OBJECTIVE

Nonaccidental trauma (NAT) is one of the leading causes of serious injury and death among young children in the United States, with a high proportion of head injury. Numerous studies have demonstrated the safety of discharge of infants with isolated skull fractures (ISFs); however, these same studies have noted that those infants with suspected abuse should not be immediately discharged. The authors aimed to create a standardized protocol for evaluation of infants presenting with skull fractures to our regional level I pediatric trauma center to best identify children at risk.

METHODS

A protocol for evaluation of NAT was developed by our pediatric trauma committee, which consists of evaluation by neurosurgery, pediatric surgery, and ophthalmology, as well as the pediatric child protection team. Social work evaluations and a skeletal survey were also utilized. Patients presenting over a 2-year period, inclusive of all infants younger than 12 months at the time of presentation, were assessed. Factors at presentation, protocol compliance, and the results of the workup were evaluated to determine how to optimize identification of children at risk.

RESULTS

A total of 45 infants with a mean age at presentation of 5.05 months (SD 3.14 months) were included. The most common stated mechanism of injury was a fall (75.6%), followed by an unknown mechanism (22.2%). The most common presenting symptoms were swelling over the fracture site (25 patients, 55.6%), followed by vomiting (5 patients, 11.1%). For the entire population of patients with skull fractures, there was suspicion of NAT in 24 patients (53.3% of the cohort). Among the 30 patients with ISFs, there was suspicion of NAT in 13 patients (43.3% of the subgroup).

CONCLUSIONS

Infants presenting with skull fractures with intracranial findings and ISFs had a substantial rate of concern for the possibility of nonaccidental skull fracture. Although prior studies have demonstrated the relative safety of discharging infants with ISFs, it is critical to establish an appropriate standardized protocol to evaluate for infants at risk of abusive head trauma.

In Journal of Neurosurgery: Pediatrics Publish Before Print

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Fourth ventricle roof angle as a measure of fourth ventricle bowing and a radiographic predictor of brainstem dysfunction in Chiari malformation type I

Scott C. Seaman, Luyuan Li, Arnold H. Menezes, and Brian J. Dlouhy

OBJECTIVE

Chiari malformation type I (CM-I) is a congenital and developmental abnormality that results in tonsillar descent 5 mm below the foramen magnum. However, this cutoff value has poor specificity as a predictor of clinical severity. Therefore, the authors sought to identify a novel radiographic marker predictive of clinical severity to assist in the management of patients with CM-I.

METHODS

The authors retrospectively reviewed 102 symptomatic CM-I (sCM-I) patients and compared them to 60 age-matched normal healthy controls and 30 asymptomatic CM-I (aCM-I) patients. The authors used the fourth ventricle roof angle (FVRA) to identify fourth ventricle “bowing,” a configuration change suggestive of fourth ventricle outlet obstruction, and compared these results across all three cohorts. A receiver operating characteristic (ROC) curve was used to identify a predictive cutoff for brainstem dysfunction. Binary logistic regression was used to determine whether bowing of the fourth ventricle was more predictive of brainstem dysfunction than tonsillar descent, clival canal angle, or obex position in aCM-I and sCM-I patients.

RESULTS

The FVRA had excellent interrater reliability (intraclass correlation 0.930, 95% CI 0.905–0.949, Spearman r2 = 0.766, p < 0.0001). The FVRA was significantly greater in the sCM-I group than the aCM-I and healthy control groups (59.3° vs 41.8° vs 45.2°, p < 0.0001). No difference was observed between aCM-I patients and healthy controls (p = 0.347). ROC analysis indicated that an FVRA of 65° had a specificity of 93% and a sensitivity of 50%, with a positive predictive value of 76% for brainstem dysfunction. FVRA > 65° was more predictive of brainstem dysfunction (OR 5.058, 95% CI 1.845–13.865, p = 0.002) than tonsillar herniation > 10 mm (OR 2.564, 95% CI 1.050–6.258, p = 0.039), although increasing age was also associated with brainstem dysfunction (OR 1.045, 95% CI 1.011–1.080, p = 0.009). A clival canal angle < 140° (p = 0.793) and obex below the foramen magnum (p = 0.563) had no association with brainstem dysfunction.

CONCLUSIONS

The authors identified a novel radiographic measure, the FVRA, that can be used to assess fourth ventricular bowing in CM-I and is more predictive of brainstem dysfunction than tonsillar herniation. The FVRA is easy to measure, has excellent interrater variability, and can be a reliable universal radiographic measure. The FVRA will be useful in further describing CM-I radiographically and clinically by identifying patients more likely to be symptomatic as a result of brainstem dysfunction.

In Journal of Neurosurgery: Pediatrics Publish Before Print

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Intermediate-grade brain arteriovenous malformations and the boundary of operability using the supplemented Spetzler-Martin grading system

Joshua S. Catapano, Fabio A. Frisoli, Candice L. Nguyen, Mohamed A. Labib, Tyler S. Cole, Jacob F. Baranoski, Helen Kim, Robert F. Spetzler, and Michael T. Lawton

OBJECTIVE

Supplemented Spetzler-Martin grading (Supp-SM), which is the combination of Spetzler-Martin and Lawton-Young grades, was validated as being more accurate than stand-alone Spetzler-Martin grading, but an operability cutoff was not established. In this study, the authors surgically treated intermediate-grade AVMs to provide prognostic factors for neurological outcomes and to define AVMs at the boundary of operability.

METHODS

Surgically treated Supp-SM intermediate-grade (5, 6, and 7) AVMs were analyzed from 2011 to 2018 at two medical centers. Worsened neurological outcomes were defined as increased modified Rankin Scale (mRS) scores on postoperative examinations. A second analysis of 2000–2011 data for Supp-SM grade 6 and 7 AVMs was performed to determine the subtypes with improved or unchanged outcomes. Patients were separated into three groups based on nidus size (S1: < 3 cm, S2: 3–6 cm, S3: > 6 cm) and age (A1: < 20 years, A2: 20–40 years, A3: > 40 years), followed by any combination of the combined supplemented grade: low risk (S1A1, S1A2, S2A1), intermediate risk (S2A2, S1A3, S3A1, or high risk (S3A3, S3A2, S2A3).

RESULTS

Two hundred forty-six patients had intermediate Supp-SM grade AVMs. Of these patients, 102 had Supp-SM grade 5 (41.5%), 99 had Supp-SM grade 6 (40.2%), and 45 had Supp-SM grade 7 (18.3%). Significant differences in the proportions of patients with worse mRS scores at follow-up were found between the groups, with 24.5% (25/102) of patients in Supp-SM grade 5, 29.3% (29/99) in Supp-SM grade 6, and 57.8% (26/45) in Supp-SM grade 7 (p < 0.001). Patients with Supp-SM grade 7 AVMs had significantly increased odds of worse postoperative mRS scores (p < 0.001; OR 3.7, 95% CI 1.9–7.3). In the expanded cohort of 349 Supp-SM grade 6 AVM patients, a significantly higher proportion of older patients with larger Supp-SM grade 6 AVMs (grade 6+, 38.6%) had neurological deterioration than the others with Supp-SM grade 6 AVMs (22.9%, p = 0.02). Conversely, in an expanded cohort of 197 Supp-SM grade 7 AVM patients, a significantly lower proportion of younger patients with smaller Supp-SM grade 7 AVMs (grade 7–, 19%) had neurological deterioration than the others with Supp-SM grade 7 AVMs (44.9%, p = 0.01).

CONCLUSIONS

Patients with Supp-SM grade 7 AVMs are at increased risk of worse postoperative neurological outcomes, making Supp-SM grade 6 an appropriate operability cutoff. However, young patients with small niduses in the low-risk Supp-SM grade 7 group (grade 7−) have favorable postoperative outcomes. Outcomes in Supp-SM grade 7 patients did not improve with surgeon experience, indicating that the operability boundary is a hard limit reflecting the complexity of high-grade AVMs.

In Journal of Neurosurgery Publish Before Print

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Letter to the Editor. Age at death: a neglected outcome measure in oncology

Michael D. Cusimano and Paul J. Muller

In Journal of Neurosurgery Publish Before Print

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Long-term stability of Onyx: is there any indication for repeated angiography after dural arteriovenous fistula embolization?

Richard Voldřich, David Netuka, František Charvát, and Vladimír Beneš

OBJECTIVE

The natural course of dural arteriovenous fistulas (DAVFs) is unfavorable. Transarterial embolization with Onyx is currently the therapeutic method of choice, although the long-term stability of Onyx has been questioned. The literature reports a significant difference in the recurrence rate after complete DAVF occlusion and lacks larger series with long-term follow-up. The authors present the largest series to date with a long-term follow-up to determine the stability of Onyx, prospectively comparing magnetic resonance angiography (MRA) and digital subtraction angiography (DSA) as follow-up diagnostic methods.

METHODS

Demographics, clinical symptomatology, length of follow-up, diagnostic methods, and angiographic findings of DAVFs were recorded and retrospectively evaluated in 112 patients. A prospective group of 15 patients with more than 5 years of follow-up after complete DAVF occlusion was established. All 15 patients in the prospective group underwent a clinical examination and MRA; 10 of these patients also underwent DSA. The recurrences and the correlation between the two diagnostic methods were evaluated.

RESULTS

Among the 112 patients, 71 were men and 41 were women, with an average age of 60 years. Intracranial hemorrhage (40%) was the most common clinical presentation of DAVF. At the last follow-up, 73% of the patients experienced clinical improvement, 21% remained unchanged, and 6% worsened. Overall, 87.5% of the DAVFs were occluded entirely with endovascular treatment, and 93% of the DAVFs were classified as cured at the last follow-up (i.e., completely embolized DAVFs and DAVFs that thrombosed spontaneously or after Gamma Knife surgery). Two recurrences of DAVFs were recorded in the entire series. Both were first diagnosed by MRA and confirmed with DSA. The mean follow-up was 27.7 months. In the prospective group, a small asymptomatic recurrence was diagnosed. The mean follow-up of the prospective group was 96 months.

CONCLUSIONS

Onyx is a stable embolic material, although recurrence of seemingly completely occluded DAVFs may develop because of postembolization hemodynamic changes that accentuate primarily graphically absent residual fistula. These residuals can be diagnosed with MRA at follow-up. The authors’ data suggest that MRA could be sufficient as the follow-up diagnostic method after complete DAVF occlusion with Onyx. However, larger prospective studies on this topic are needed.

In Journal of Neurosurgery Publish Before Print

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Navigated transcranial magnetic stimulation mapping of the motor cortex for preoperative diagnostics in pediatric epilepsy

Severin Schramm, Aashna Mehta, Kurtis I. Auguste, and Phiroz E. Tarapore

OBJECTIVE

Navigated transcranial magnetic stimulation (nTMS) is a noninvasive technique often used for localization of the functional motor cortex via induction of motor evoked potentials (MEPs) in neurosurgical patients. There has, however, been no published record of its application in pediatric epilepsy surgery. In this study, the authors aimed to investigate the feasibility of nTMS-based motor mapping in the preoperative diagnostic workup within a population of children with medically refractory epilepsy.

METHODS

A single-institution database was screened for preoperative nTMS motor mappings obtained in pediatric patients (aged 0 to 18 years, 2012 to present) with medically refractory epilepsy. Patient clinical data, demographic information, and mapping results were extracted and used in statistical analyses.

RESULTS

Sixteen patients met the inclusion criteria, 15 of whom underwent resection. The median age was 9 years (range 0–17 years). No adverse effects were recorded during mapping. Specifically, no epileptic seizures were provoked via nTMS. Recordings of valid MEPs induced by nTMS were obtained in 10 patients. In the remaining patients, no MEPs could be elicited. Failure to generate MEPs was associated significantly with younger patient age (r = 0.8020, p = 0.0001863). The most frequent seizure control outcome was Engel Epilepsy Surgery Outcome Scale class I (9 patients).

CONCLUSIONS

Navigated TMS is a feasible, effective, and well-tolerated method for mapping the motor cortex of the upper and lower extremities in pediatric patients with epilepsy. Patient age modulates elicitability of MEPs, potentially reflecting various stages of myelination. Successful motor mapping has the potential to add to the existing presurgical diagnostic workup in this population, and further research is warranted.

In Journal of Neurosurgery: Pediatrics Publish Before Print

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Neuroophthalmological manifestations of congenital aqueductal stenosis

Aneek Patel, Hussam Abou-Al-Shaar, Michael C. Chiang, Hanna N. Algattas, Michael M. McDowell, Jeremy G. Stone, Ellen B. Mitchell, Stephen P. Emery, and Stephanie Greene

OBJECTIVE

Congenital aqueductal stenosis (CAS) is a common etiology of hydrocephalus that occurs in a subset of infants and may be linked to an increased incidence of ophthalmological abnormalities and delayed developmental milestones. Although hydrocephalus is common and widely studied, sparse literature exists on patients with isolated (no identifiable genetic link) CAS along with analysis of ophthalmological manifestations. In this study, the authors sought to describe the ophthalmological abnormalities and delayed developmental milestones of patients with isolated CAS.

METHODS

Data of patients with CAS were prospectively entered and monitored in a surgical database maintained by the Department of Neurological Surgery at Children’s Hospital of Pittsburgh from January 2005 to October 2016. Patients with a family history of congenital hydrocephalus, positive testing for genetic forms of aqueductal stenosis, other congenital abnormalities suggesting an underlying genetic syndrome, and stenosis/obstruction due to secondary causes were excluded from this study. Prenatal and perinatal history, CSF diversion history, and a variety of outcomes, including ophthalmological deficits and developmental milestones, were collected and analyzed.

RESULTS

A total of 41 patients with isolated CAS were identified, with a mean follow-up duration of 6 years. Among that cohort, 26 patients (63.4%) developed neuroophthalmological complications, which were further stratified. Fourteen patients (34.1%) developed strabismus and 11 (26.8%) developed astigmatism, and 1 patient (2.4%) with papilledema was recorded. Among patients with ophthalmological abnormalities, 76.9% had delayed developmental milestones (p = 0.045).

CONCLUSIONS

Patients with CAS were found to have increased risk of ophthalmological abnormalities requiring correction, along with an increased risk of delayed developmental milestones. Importantly, there was a significant correlation between the development of ophthalmological abnormalities and delayed developmental milestones that was independent of CSF diversion history. Larger patient cohort studies are required to explore whether earlier development of hydrocephalus, as is the case in CAS, causes elevated rates of neurological and ophthalmological complications, and if earlier CSF diversion correlates with improved outcomes.

In Journal of Neurosurgery: Pediatrics Publish Before Print

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Neurosurgery at UT Southwestern Medical Center: 1956–2020

Christopher L. Taylor

The history of neurosurgery at UT Southwestern Medical Center in Dallas, Texas, is reviewed. Kemp Clark, MD, started the academic neurosurgical practice at Parkland Hospital in 1956. Clark developed a robust training program that required the resident to operate early. In 1972, the Dallas Veterans Affairs Hospital was added to the training program. Duke Samson, MD, became chair in 1988. He emphasized technical excellence and honest reporting of surgical outcomes. In 1989, Zale Lipshy University Hospital opened and became a center for neurosurgical care, and Hunt Batjer, MD, became chair in 2012. The program expanded significantly. Along with principles established by his predecessors, Batjer emphasized the need for all neurosurgeons to engage the community and to be active in policy leadership through local and national organizations. During his tenure, the pediatric neurosurgery group at Children’s Medical Center Dallas was integrated with the department, and a multidisciplinary spine service was developed. In 2014, the Peter O’Donnell Jr. Brain Institute was established, and the William P. Clements Jr. University Hospital opened. For 64 years, UT Southwestern Medical Center has been fertile ground for academic neurosurgery, with a strong emphasis on excellence in patient care.

In Journal of Neurosurgery Publish Before Print