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Matthew F. Gornet, J. Kenneth Burkus, Mark E. Shaffrey, Francine W. Schranck and Anne G. Copay

OBJECTIVE

Food and Drug Administration–approved investigational device exemption (IDE) studies have provided level I evidence supporting cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion (ACDF). Long-term CDA outcomes continue to be evaluated. Here, the authors present outcomes at 10 years postoperatively for the single-level CDA arm of an IDE study (postapproval study).

METHODS

The primary endpoint was overall success, a composite variable composed of five criteria: 1) Neck Disability Index score improvement ≥ 15 points; 2) maintenance or improvement in neurological status; 3) no decline in anterior or posterior functional spinal unit (FSU) height of more than 2 mm compared to 6 weeks postoperatively; 4) no serious adverse event (AE) caused by the implant or the implant and the surgical procedure; and 5) no additional surgery classified as a failure. Additional safety and effectiveness measures included numeric rating scales for neck pain and arm pain, SF-36 quality-of-life physical and mental components, patient satisfaction, range of motion, and AEs.

RESULTS

From the reported assessments at 7 years postoperatively to the 10-year postoperative follow-up, the scores for all patient-reported outcomes, rate of overall success (without FSU), and proportion of patients at least maintaining their neurological function remained stable for the CDA group. Nine patients had secondary surgery at the index level, increasing the secondary surgery cumulative rate from 6.6% to 10.3%. In that same time frame, four patients experienced a serious implant or implant/surgical procedure–related AE, for a 10-year cumulative rate of 7.8%. Seven patients had any second surgery at adjacent levels, for a 10-year cumulative rate of 13.8%. Average angular motion at both the index and adjacent levels was well maintained without creating hypermobility. Class IV heterotopic ossification increased from 1.2% at 2 years to 4.6% at 7 years and 9.0% at 10 years. Patient satisfaction was > 90% at 10 years.

CONCLUSIONS

CDA remained safe and effective out to 10 years postoperatively, with results comparable to 7-year outcomes and with high patient satisfaction.

Clinical trial registration no.: NCT00667459 (clinicaltrials.gov)

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Tsung-Hsi Tu, Chu-Yi Lee, Chao-Hung Kuo, Jau-Ching Wu, Hsuan-Kan Chang, Li-Yu Fay, Wen-Cheng Huang and Henrich Cheng

OBJECTIVE

The published clinical trials of cervical disc arthroplasty (CDA) have unanimously demonstrated the success of preservation of motion (average 7°–9°) at the index level for up to 10 years postoperatively. The inclusion criteria in these trials usually required patients to have evident mobility at the level to be treated (≥ 2° on lateral flexion-extension radiographs) prior to the surgery. Although the mean range of motion (ROM) remained similar after CDA, it was unclear in these trials if patients with less preoperative ROM would have different outcomes than patients with more ROM.

METHODS

A series of consecutive patients who underwent CDA at the level of C5–6 were followed up and retrospectively reviewed. The indications for surgery were medically refractory cervical radiculopathy, myelopathy, or both, caused by cervical disc herniation or spondylosis. All patients were assigned to 1 of 2 groups: a less-mobile group, which consisted of those patients who had an ROM of ≤ 5° at C5–6 preoperatively, or a more-mobile group, which consisted of patients whose ROM at C5–6 was > 5° preoperatively. Clinical outcomes, including visual analog scale, Neck Disability Index, and Japanese Orthopaedic Association Scale scores, were evaluated at each time point. Radiological outcomes were also assessed.

RESULTS

A total of 60 patients who had follow-up for more than 2 years were analyzed. There were 27 patients in the less-mobile group (mean preoperative ROM 3.0°) and 33 in the more-mobile group (mean ROM 11.7°). The 2 groups were similar in demographics, including age, sex, diabetes, and cigarette smoking. Both groups had significant improvements in clinical outcomes, with no significant differences between the 2 groups. However, the radiological evaluations demonstrated remarkable differences. The less-mobile group had a greater increase in ΔROM than the more-mobile group (ΔROM 5.5° vs 0.1°, p = 0.001), though the less-mobile group still had less segmental mobility (ROM 8.5° vs 11.7°, p = 0.04). The rates of complications were similar in both groups.

CONCLUSIONS

Preoperative segmental mobility did not alter the clinical outcomes of CDA. The preoperatively less-mobile (ROM ≤ 5°) discs had similar clinical improvements and greater increase of segmental mobility (ΔROM), but remained less mobile, than the preoperatively more-mobile (ROM > 5°) discs at 2 years postoperatively.

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Trista Reid, Joanna Grudziak, Nidia Rodriguez-Ormaza, Rebecca G. Maine, Nelson Msiska, Carolyn Quinsey and Anthony Charles

OBJECTIVE

Hydrocephalus is the most common pediatric neurosurgical condition, with a high prevalence in low- and middle-income countries. Untreated, hydrocephalus leads to neurological disability or death. The epidemiology and outcomes of hydrocephalus treated by ventriculoperitoneal (VP) shunts in Sub-Saharan Africa are not well defined and vary by region. The aim of the present study was to examine the mortality and morbidity rates and predictors of mortality in children treated by VP shunt placement for hydrocephalus at Kamuzu Central Hospital in Lilongwe, Malawi.

METHODS

This is a prospective study of 100 consecutive children presenting with hydrocephalus who were treated with VP shunt placement from January 2015 to August 2017. Demographics, nutritional status, maternal characteristics, developmental delay, shunt complications, readmissions, and in-hospital and 3-month mortality data were collected. Multivariate logistic regression was used to identify predictors of death within 3 months of surgery.

RESULTS

Overall, 46% of participants were female, with an average age of 5.4 ± 3.7 months at the time of surgery. The majority of patients were term deliveries (87.8%) and were not malnourished (72.9%). Only 10.8% of children were diagnosed with meningitis before admission. In-hospital and 3-month mortality rates were 5.5% and 32.1%, respectively. The only significant association with mortality was maternal age, with older maternal age demonstrating decreased odds of 3-month mortality (OR 0.9, 95% CI 0.8–1.0, p = 0.045).

CONCLUSIONS

Surgical management of hydrocephalus with VP shunts portends a high mortality rate in Malawi. The association of younger maternal age with mortality is likely a proxy for social determinants, which appear to contribute as much to mortality as patient factors. VP shunting is inadequate as a sole surgical management of hydrocephalus in resource-limited settings.

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Michael Kogan, David J. Caldwell, Shahin Hakimian, Kurt E. Weaver, Andrew L. Ko and Jeffery G. Ojemann

OBJECTIVE

Electrocorticography is an indispensable tool in identifying the epileptogenic zone in the presurgical evaluation of many epilepsy patients. Traditional electrocorticographic features (spikes, ictal onset changes, and recently high-frequency oscillations [HFOs]) rely on the presence of transient features that occur within or near epileptogenic cortex. Here the authors report on a novel corticography feature of epileptogenic cortex—covariation of high-gamma and beta frequency band power profiles. Band-limited power was measured from each recording site based on native physiological signal differences without relying on clinical ictal or interictal epileptogenic features. In this preliminary analysis, frequency windowed power correlation appears to be a specific marker of the epileptogenic zone. The authors’ overall aim was to validate this observation with the location of the eventual resection and outcome.

METHODS

The authors conducted a retrospective analysis of 13 adult patients who had undergone electrocorticography for surgical planning at their center. They quantified the correlation of high-gamma (70–200 Hz) and beta (12–18 Hz) band frequency power per electrode site during a cognitive task. They used a sliding window method to correlate the power of smoothed, Hilbert-transformed high-gamma and beta bands. They then compared positive and negative correlations between power in the high-gamma and beta bands in the setting of a hand versus a tongue motor task as well as within the resting state. Significant positive correlations were compared to surgically resected areas and outcomes based on reviewed records.

RESULTS

Positive high-gamma and beta correlations appeared to predict the area of eventual resection and, preliminarily, surgical outcome independent of spike detection. In general, patients with the best outcomes had well-localized positive correlations (high-gamma and beta activities) to areas of eventual resection, while those with poorer outcomes displayed more diffuse patterns.

CONCLUSIONS

Data in this study suggest that positive high-gamma and beta correlations independent of any behavioral metric may have clinical applicability in surgical decision-making. Further studies are needed to evaluate the clinical potential of this methodology. Additional work is also needed to relate these results to other methods, such as HFO detection or connectivity with other cortical areas.

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Jillian E. Urban, William C. Flood, Barret J. Zimmerman, Mireille E. Kelley, Mark A. Espeland, Liam McNamara, Elizabeth M. Davenport, Alexander K. Powers, Christopher T. Whitlow, Joseph A. Maldjian and Joel D. Stitzel

OBJECTIVE

There is a growing body of literature informing efforts to improve the safety of football; however, research relating on-field activity to head impacts in youth football is limited. Therefore, the objective of this study was to compare head impact exposure (HIE) measured in game plays among 3 youth football teams.

METHODS

Head impact and video data were collected from athletes (ages 10–13 years) participating on 3 youth football teams. Video analysis was performed to verify head impacts and assign each to a specific play type. Each play was categorized as a down, punt, kickoff, field goal, or false start. Kickoffs and punts were classified as special teams. Downs were classified as running, passing, or other. HIE was quantified by play type in terms of mean, median, and 95th percentile linear and rotational acceleration. Mixed-effects models were used to assess differences in acceleration among play types. Contact occurring on special teams plays was evaluated using a standardized video abstraction form.

RESULTS

A total of 3003 head impacts over 27.5 games were analyzed and paired with detailed video coding of plays. Most head impacts were attributed to running (79.6%), followed by passing (14.0%), and special teams (6.4%) plays. The 95th percentile linear acceleration measured during each play type was 52.6g, 50.7g, and 65.5g, respectively. Special teams had significantly greater mean linear acceleration than running and passing plays (both p = 0.03). The most common kick result on special teams was a deep kick, of which 85% were attempted to be returned. No special teams plays resulted in a touchback, and one resulted in a fair catch. One-third of all special teams plays and 92% of all nonreturned kicks resulted in athletes diving toward the ball.

CONCLUSIONS

The results demonstrate a trend toward higher head impact magnitudes on special teams than for running and passing plays, but a greater number of impacts were measured during running plays. Deep kicks were most common on special teams, and many returned and nonreturned kicks resulted in athletes diving toward the ball. These results support policy changes to youth special teams plays, including modifying the yard line the ball is kicked from and coaching proper return technique. Further investigation into biomechanical exposure measured during game impact scenarios is needed to inform policy relevant to the youth level.

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Kazunori Hayashi, Louis Boissière, Fernando Guevara-Villazón, Daniel Larrieu, Susana Núñez-Pereira, Anouar Bourghli, Olivier Gille, Jean-Marc Vital, Ferran Pellisé, Francisco Javier Sánchez Pérez-Grueso, Frank Kleinstück, Emre Acaroğlu, Ahmet Alanay and Ibrahim Obeid

OBJECTIVE

Achieving high patient satisfaction with management is often one of the goals after adult spinal deformity (ASD) surgery. However, literature on associated factors and their correlations with patient satisfaction is limited. The aim of this study was to determine the clinical and radiographic factors independently correlated with patient satisfaction in terms of management at 2 years after surgery.

METHODS

A multicenter prospective database of ASD surgery was retrospectively reviewed. The demographics, complications, health-related quality of life (HRQOL) subdomains, and radiographic parameters were examined to determine their correlation coefficients with the Scoliosis Research Society-22 questionnaire (SRS-22R) satisfaction scores at 2 years (Sat-2y score). Subsequently, factors determined to be independently associated with low satisfaction (Sat-2y score ≤ 4.0) were used to construct 2 types of multivariate models: one with 2-year data and the other with improvement (score at 2 years − score at baseline) data.

RESULTS

A total of 422 patients who underwent ASD surgery (mean age 53.1 years) were enrolled. All HRQOL subdomains and several coronal and sagittal radiographic parameters had significantly improved 2 years after surgery. The Sat-2y score was strongly correlated with the SRS-22R self-image (SI)/appearance subdomain (r = 0.64), followed by moderate correlation with subdomains related to standing (r = 0.53), body pain (r = 0.49–0.55), and function (r = 0.41–0.55) at 2 years. Conversely, the correlation between radiographic or demographic parameters with Sat-2y score was weak (r < 0.4). Multivariate analysis to eliminate confounding factors revealed that a worse Oswestry Disability Index (ODI) score for standing (≥ 2 points; OR 4.48) and pain intensity (≥ 2 points; OR 2.07), SRS-22R SI/appearance subdomain (< 3 points; OR 2.70) at 2 years, and a greater sagittal vertical axis (SVA) (> 5 cm; OR 2.68) at 2 years were independent related factors for low satisfaction. According to the other model, a lower improvement in ODI for standing (< 30%; OR 2.68), SRS-22R pain (< 50%; OR 3.25) and SI/appearance (< 50%; OR 2.18) subdomains, and an inadequate restoration of the SVA from baseline (< 2 cm; OR 3.16) were associated with low satisfaction.

CONCLUSIONS

Self-image, pain, standing difficulty, and sagittal alignment restoration may be useful goals in improving patient satisfaction with management at 2 years after ASD surgery. Surgeons and other medical providers have to take care of these factors to prevent low satisfaction.

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Mariangela Piano, Luca Valvassori, Emilio Lozupone, Guglielmo Pero, Luca Quilici, Edoardo Boccardi and the FRED Italian Registry Group

OBJECTIVE

The introduction of flow-diverter devices (FDDs) has revolutionized the endovascular treatment of intracranial aneurysms. Here the authors present their Italian multicenter experience using the flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms, evaluating both short- and long-term safety and efficacy of this device.

METHODS

Between February 2013 and December 2014, 169 consecutive aneurysms treated using FRED in 166 patients were entered into this study across 30 Italian centers. Data collected included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and posttreatment modified Rankin Scale scores, as well as angiographic and cross-sectional CT/MRI follow-up at 3–6 months and/or 12–24 months per institutional standard of care. All images were reviewed and adjudicated by an independent core lab.

RESULTS

Of the 169 lesions initially entered into the study, 4 were later determined to be extracranial or nonaneurysmal by the core lab and were excluded, leaving 165 aneurysms in 162 patients treated in 163 procedures. Ninety-one (56.2%) patients were asymptomatic with aneurysms found incidentally. Of the 165 aneurysms, 150 (90.9%) were unruptured. One hundred thirty-four (81.2%) were saccular, 27 (16.4%) were fusiform/dissecting, and the remaining 4 (2.4%) were blister-like. One hundred thirty-seven (83.0%) arose from the anterior circulation.

FRED deployment was impossible in 2/163 (1.2%) cases, and in an additional 4 cases (2.5%) the device was misdeployed. Overall mortality and morbidity rates were 4.3% and 7.3%, respectively, with rates of mortality and morbidity potentially related to FRED of up to 2.4% and 6.2%, respectively. Neuroimaging follow-up at 3–6 months showed complete or nearly complete occlusion of the aneurysm in 94% of cases, increasing to 96% at 12–24 months’ follow-up. Aneurysmal sac shrinkage was observed in 78% of assessable aneurysms.

CONCLUSIONS

This preliminary experience using FRED for endovascular treatment of complex unruptured and ruptured aneurysms showed a high safety and efficacy profile that is comparable to those of other FDDs currently in use.

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Justice O. Agyei, Jingxin Qiu and Andrew J. Fabiano

The Fusarium species are one of the most common opportunistic fungal infections occurring in immunocompromised patients and are associated with high morbidity and mortality. Common sites of infection include blood, skin, nasal passages, lungs, bone, and other visceral organs. There is a paucity of literature on Fusarium infections in the brain, and the true nature and extent of central nervous system involvement is not well described. To the authors’ knowledge, there have been no reported cases of Fusarium infection of the spine. The authors report the case of a man with acute myeloblastic leukemia and resultant pancytopenia who presented with fungal sinusitis, upper- and lower-extremity weakness, and cardiopulmonary arrest. Imaging studies revealed a spinal cervical intramedullary ring-enhancing lesion. Because of the progressive nature of his symptoms, neurosurgical intervention involving a C2–3 laminectomy and drainage of the lesion was performed. Intraoperative cultures and histopathology results were positive for Fusarium species and, along with intraoperative findings, were consistent with a fungus ball. The patient was placed on a regimen of intravenous and intrathecal antifungal therapy. Unfortunately, his clinical condition declined postoperatively, and he ultimately died of disseminated infection.

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Mehdi Chihi, Oliver Gembruch, Marvin Darkwah Oppong, Bixia Chen, Thiemo Florin Dinger, Lennart Barthel, Daniela Pierscianek, Karsten H. Wrede, Neriman Özkan, Ulrich Sure and Ramazan Jabbarli

OBJECTIVE

Tuberous sclerosis complex (TSC) is a rare multisystem genetic disease. Arterial wall developmental disorders, such as aneurysms, in association with TSC have been well described for extracranial vasculature. The characteristics of intracranial aneurysms (IAs) in TSC have not previously been addressed in the literature. This systematic review was performed to identify and assess the distinct characteristics of IAs in patients with TSC.

METHODS

The authors searched PubMed, Scopus, and Web of Science for publications describing cases of TSC and IA reported before August 7, 2018. They also report 2 cases of IAs in TSC patients treated at their own institution.

RESULTS

Thirty-three TSC patients with a total of 42 IAs were included in this review. Three individuals presented with subarachnoid hemorrhage. The IAs were large or giant in 57.1% and fusiform in 45.2% of the cases. Most of the IAs (61.9%, 26 of 42) originated from the internal carotid artery. There was a higher prevalence of pediatric cases (66.7%) and male patients (63.6%, 21 of 32 individuals with known sex) among the collected series.

CONCLUSIONS

TSC patients with IAs are characterized with a higher proportion of large/giant and fusiform IAs and young age, suggesting rapid aneurysmal growth. Furthermore, there is a distinct location pattern of IAs and an inverse sex ratio than in the healthy population. Large population-based patient registers are required to improve the understanding of epidemiology and pathophysiology of IA formation in TSC.

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Man Kyu Choi, Dae Jean Jo and Chang Kyu Park

OBJECTIVE

Late-onset neurological deficits are a rare complication of spinal tuberculosis that may be caused by proximal adjacent segment degeneration (ASD) above the kyphus. The objective of this study was to report several cases of neurological deficits due to proximal ASD in patients with post-tuberculous kyphotic deformity and discuss the characteristics of the authors’ corrective surgical technique.

METHODS

The inclusion criteria in this study were severe angular kyphosis due to a post-tuberculous kyphotic deformity and a late-onset neurological deficit. The cause of these deficits was related to a lesion in the proximal cephalad portion of the kyphotic deformity. Surgical intervention, including decompression and compromised restoration of the sagittal imbalance, was performed in all patients. Preoperative surgical planning with a radiological evaluation included CT, plain radiograph, and MRI studies. Clinical outcomes were evaluated using the American Spinal Injury Association Impairment Scale and the Oswestry Disability Index (ODI).

RESULTS

The main goal of our surgical technique was the correction of sagittal malalignment by positioning the patient’s head above the kyphotic deformity on the sagittal plane, excluding aggressive osteotomy. The neurological symptoms showed immediate improvements postoperatively, except in 1 patient. Compared to the preoperative value of 66.9, the mean ODI score improved to 42.6 at the final follow-up for all patients. Preoperatively, the mean values of the angles of deformity and the sagittal vertical axis were 99.7° and 157.7 mm, respectively, and decreased to 75.3° and 46.0 mm, respectively, at the final follow-up. No major complications were observed, and the patients’ self-satisfaction was high with respect to both cosmetic and functional outcomes.

CONCLUSIONS

Clinicians should be aware of the degeneration of the vertebrae above the kyphotic segment in patients with post-tuberculosis deformity. Successful neurological recovery and compromised sagittal balance could be obtained by using our “head on kyphus” surgical concept.