Tag: Epidemiology

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Risk factors for reoperation after lumbar total disc replacement at short-, mid-, and long-term follow-up

DOI:https://doi.org/10.1016/j.spinee.2021.02.020

The reoperation rate following TDR (Total Disc replacement) has been established at short- and mid-term time points through the Food and Drug Administration Investigational Device Exemption (FDA IDE) trials. However, these trials include highly selected centers and surgeons with strict governance of indications. The utilization of TDR throughout the community needs further analysis.

PURPOSE

To identify the risk factors for lumbar spine reoperation in patients undergoing lumbar total disc replacement (TDR) at short-, mid-, and long-term follow-up.

STUDY DESIGN/SETTING

This study is a multi-center retrospective cohort study utilizing the New York Statewide Planning and Research Cooperative System database.

PATIENT SAMPLE

We identified 1,368 patients who underwent an elective primary lumbar TDR in New York State between January 1, 2005 and September 30, 2013.

OUTCOME MEASURES

The primary functional outcome of interest was lumbar reoperation, specifically the evaluation of independent risk factors for lumbar reoperation at a minimum of 2 years, with sub-analyses performed at 5 and ten years.

METHODS

International Classification of Diseases, Ninth revision codes were utilized to identify patients undergoing a primary lumbar TDR. We excluded patients with primary/revision lumbar fusion procedures and revision disc replacement procedures. Hospital academic status was determined by the Accreditation Council for Graduate Medical Education. Unique encrypted patient identifiers allowed for longitudinal follow-up for reoperation. Logistic regression models compared reoperation and no-reoperation cohorts, and were performed on sub-analyses for significant univariate predictors of reoperation.

RESULTS

Between January 2005 and September 2013, 1368 patients underwent a primary lumbar TDR. Reoperation occurred in 8.8% by 2 years, 15.8% by 5 years, and 19.5% by ten years. Diabetics were more likely to have reoperations (7.5% vs 3.8%, p=.013). Teaching hospitals experienced a decreased reoperation rate compared to nonteaching hospitals at 2-year (5.0% vs 10.5%, p=.002), 5-year (10.7% vs 17.9%, p=.002) and 10-year (11.7% vs 21.9%, p=.045) follow-up. Lumbar fusion was the most common reoperation (14.2%).

CONCLUSION

We identified an 8.8% reoperation rate after inpatient lumbar TDR at 2-years, 15.8% at 5-years, and 19.5% at 10-years. When stratifying by teaching status, reoperation rates at teaching centers align with those reported in FDA IDE studies. Diabetes was the only patient factor influencing reoperation rate. There is a growing consensus that lumbar TDR is a durable and appropriate surgical option for lumbar degenerative disc disease. Proper indications are crucial to obtaining good outcomes with lumbar TDR.

 

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Impact of temperature decline from the previous day as a trigger of spontaneous subarachnoid hemorrhage

J Neurosurg 133:374–382, 2020

Several environmental factors have been reported to correlate with incidence of spontaneous subarachnoid hemorrhage (SAH). However, because of different patient selection and study designs among these studies, meteorological factors that trigger the incidence of SAH in a short hazard period remain unknown. Among meteorological factors, daily temperature changes may disrupt and violate homeostasis and predispose to cerebrovascular circulatory disturbances and strokes. The authors aimed to investigate whether a decline in the temperature from the highest of the previous day to the lowest of the event day (temperature decline from the previous day [TDP]) triggers SAH in the prefecture-wide stroke database.

METHODS All 28 participating institutions with primary or comprehensive stroke centers located throughout Kochi Prefecture, Japan, were included in the study. Data collected between January 2012 and December 2016 were analyzed, and 715 consecutive SAH patients with a defined date of onset were enrolled. Meteorological data in this period were obtained from the Kochi Local Meteorological Observatory. A case-crossover study was performed to investigate association of TDP and other environmental factors with onset of SAH.

RESULTS The increasing TDP in 1°C on the day of the SAH event was associated with an increased incidence of SAH (OR 1.041, 95% CI 1.007–1.077) after adjustment for other environmental factors. According to the stratified analysis, a significant association between TDP and SAH was observed in women, patients < 65 years old, and patients with weekday onset. Among these factors, increasing TDP had a great impact on SAH onset in patients < 65 years old (p = 0.028, Mann-Whitney U-test).

CONCLUSIONS TDP, temperature decline from the highest of the previous day to the lowest of the day, was correlated with the incidence of spontaneous SAH, particularly in younger patients < 65 years old.

 

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Outcome After Clipping and Coiling for Aneurysmal Subarachnoid Hemorrhage in Clinical Practice in Europe, USA, and Australia

Neurosurgery 84:1019–1027, 2019

Within randomized clinical trials (RCTs), coiling of the ruptured aneurysm to prevent rebleeding results in better outcomes than clipping in patients with aneurysmal subarachnoid hemorrhage (aSAH).

OBJECTIVE: To study the association of coiling and clipping with outcome after aSAH in daily clinical practice.

METHODS: In this controlled, nonrandomized study, we compared outcomes after endovascular coiling and neurosurgical clipping of ruptured intracranial aneurysms in an administrative dataset of 7658 aSAH patients (22 tertiary care hospitals from Europe, USA, Australia; 2007-2013). Because the results contradicted those of the randomized trials, findings were further explored in a large clinical dataset from 2 European centers (2006- 2016) of 1501 patients.

RESULTS: In the administrative dataset, the crude 14-d case-fatality rate was 6.4% (95% confidence interval [CI] 5.6%-7.2%) after clipping and 8.2% (95% CI 7.4%-9.1%) after coiling. After adjustment for age, sex, and comorbidity/severity, the odds ratio (OR) for 14-d casefatality after coiling compared to clipping was 1.32 (95% CI 1.10-1.58). In the clinical dataset crude 14-d case fatality ratewas 5.7% (95% CI 4.2%-7.8%) for clipping and 9.0% (95% CI 7.3%- 11.2%) for coiling. In multivariable logistic regression analysis, the OR for 14-d case-fatality after coiling compared to clipping was 1.7 (95% CI 1.1–2.7), for 90-d case-fatality 1.28 (95% CI 0.91–1.82) and for 90-d poor functional outcome 0.78 (95% CI 0.6–1.01).

CONCLUSION: In clinical practice, coiling after aSAH is associated with higher 14-d case-fatality than clipping and nonsuperior outcomes at 90 d. Both options need to be considered in aSAH patients. Further studies should address the reasons for the discrepancy between current data and those from the RCTs.

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Global hydrocephalus epidemiology and incidence: systematic review and meta-analysis

J Neurosurg 130:1065–1079, 2019

Hydrocephalus is one of the most common brain disorders, yet a reliable assessment of the global burden of disease is lacking. The authors sought a reliable estimate of the prevalence and annual incidence of hydrocephalus worldwide.

METHODS The authors performed a systematic literature review and meta-analysis to estimate the incidence of congenital hydrocephalus by WHO region and World Bank income level using the MEDLINE/PubMed and Cochrane Database of Systematic Reviews databases. A global estimate of pediatric hydrocephalus was obtained by adding acquired forms of childhood hydrocephalus to the baseline congenital figures using neural tube defect (NTD) registry data and known proportions of posthemorrhagic and postinfectious cases. Adult forms of hydrocephalus were also examined qualitatively.

RESULTS Seventy-eight articles were included from the systematic review, representative of all WHO regions and each income level. The pooled incidence of congenital hydrocephalus was highest in Africa and Latin America (145 and 316 per 100,000 births, respectively) and lowest in the United States/Canada (68 per 100,000 births) (p for interaction < 0.1). The incidence was higher in low- and middle-income countries (123 per 100,000 births; 95% CI 98–152 births) than in high-income countries (79 per 100,000 births; 95% CI 68–90 births) (p for interaction < 0.01). While likely representing an underestimate, this model predicts that each year, nearly 400,000 new cases of pediatric hydrocephalus will develop worldwide. The greatest burden of disease falls on the African, Latin American, and Southeast Asian regions, accounting for three-quarters of the total volume of new cases. The high crude birth rate, greater proportion of patients with postinfectious etiology, and higher incidence of NTDs all contribute to a case volume in low- and middle-income countries that outweighs that in high-income countries by more than 20-fold. Global estimates of adult and other forms of acquired hydrocephalus are lacking.

CONCLUSIONS For the first time in a global model, the annual incidence of pediatric hydrocephalus is estimated. Low and middle-income countries incur the greatest burden of disease, particularly those within the African and Latin American regions. Reliable incidence and burden figures for adult forms of hydrocephalus are absent in the literature and warrant specific investigation. A global effort to address hydrocephalus in regions with the greatest demand is imperative to reduce disease incidence, morbidity, mortality, and disparities of access to treatment.

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Hemorrhage from cerebral cavernous malformations

J Neurosurg 126:1079–1087, 2017

The aim of this paper is to define an overall cavernous malformation (CM) hemorrhage rate and risk factors for hemorrhage.

METHODS The authors performed a systematic, pooled analysis via the PubMed database through October 2015 using the terms “cavernoma,” “cavernous malformation,” “natural history,” “bleeding,” and “hemorrhage.” English-language studies providing annual rates and/or risk factors for CM hemorrhage were included. Data extraction, performed independently by the authors, included demographic data, hemorrhage rates, and hemorrhage risk factors.

RESULTS Across 12 natural history studies with 1610 patients, the mean age at presentation was 42.7 years old and 52% of patients (95% CI 49%–55%) were female. Presentation modality was seizure in 30% (95% CI 25%–35%), hemorrhage in 26% (95% CI 17%–37%), incidental in 17% (95% CI 9%–31%), and focal deficits only in 16% of cases (95% CI 11%–23%). CM location was lobar in 66% (95% CI 61%–70%), brainstem in 18% (95% CI 13%–24%), deep supratentorial in 8% (95% CI 6%–10%), and cerebellar in 8% (95% CI 5%–11%). Pooling 7 studies that did not assume CM presence since birth, the annual hemorrhage rate was 2.5% per patient-year over 5081.2 patient-years of follow-up (95% CI 1.3%–5.1%). Pooling hazard ratios across 5 studies that evaluated hemorrhage risk factors, prior CM hemorrhage was a significant risk factor for hemorrhage (HR 3.73, 95% CI 1.26–11.1; p = 0.02) while younger age, female sex, deep location, size, multiplicity, and associated developmental venous anomalies (DVAs) were not.

CONCLUSIONS Although limited by the heterogeneity of incorporated reports and selection bias, this study found prior hemorrhage to be a significant risk factor for CM bleeding, while age, sex, CM location, size, multiplicity, and associated DVAs were not. Future natural history studies should compound annual hemorrhage rate with prospective seizure and nonhemorrhagic neurological deficit rates.

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Morphological and clinical risk factors for the rupture of anterior communicating artery aneurysms

Anterior communicating artery aneurysm rupture

J Neurosurg 118:978–983, 2013

Patients with ruptured anterior communicating artery (ACoA) aneurysms have historically been observed to have poor neuropsychological outcomes, and ACoA aneurysms have accounted for a higher proportion of ruptured than unruptured aneurysms. Authors of this study aimed to investigate the morphological and clinical characteristics predisposing to ACoA aneurysm rupture.

Methods. Data from 140 consecutive patients with ACoA aneurysms managed at the authors’ facility between July 2003 and November 2011 were retrospectively reviewed. Patients with (78) and without (62) aneurysm rupture were divided into groups, and morphological and clinical characteristics were compared. Morphological characteristics were evaluated based on 3D CT angiography and included aneurysm location, dominance of the A1 portion of the anterior cerebral artery, direction of the aneurysm dome around the ACoA, aneurysm bleb(s), size of the aneurysm and its neck, aneurysm–parent artery angle, and existence of other intracranial unruptured aneurysms.

Results. Patients with ruptured ACoA aneurysms were significantly younger (a higher proportion were younger than 60 years of age) than those with unruptured lesions, and a significantly smaller proportion had hypercholesterolemia. A significantly larger proportion of patients with ruptured aneurysms showed an anterior direction of the aneurysm dome around the ACoA, had a bleb(s), and/or had an aneurysm size ≥ 5 mm. Multivariate logistic regression analysis showed that an anterior direction of the aneurysm dome around the ACoA (OR 6.0, p = 0.0012), the presence of a bleb(s) (OR 22, p < 0.0001), and an aneurysm size ≥ 5 mm (OR 3.16, p = 0.035) were significantly associated with ACoA aneurysm rupture.

Conclusions. Findings in the present study demonstrated that the anterior projection of an ACoA aneurysm may be related to rupturing. The authors would perhaps recommend treatment to patients with unruptured ACoA aneurysms that have an anterior dome projection, a bleb(s), and a size ≥ 5 mm.

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Differences in simple morphological variables in ruptured and unruptured middle cerebral artery aneurysms

J Neurosurg 117:913–919, 2012

Management of unruptured intracranial aneurysms remains controversial in neurosurgery. The contribution of morphological parameters has not been included in the treatment paradigm in a systematic manner or for any particular aneurysm location. The authors present a large sample of middle cerebral artery (MCA) aneurysms that were assessed using morphological variables to determine the parameters associated with aneurysm rupture.

Methods. Preoperative CT angiography (CTA) studies were evaluated using Slicer software to generate 3D models of the aneurysms and their surrounding vascular architecture. Morphological parameters examined in each model included 5 variables already defined in the literature (aneurysm size, aspect ratio, aneurysm angle, vessel angle, and size ratio) and 3 novel variables (flow angle, distance to the genu, and parent-daughter angle). Univariate and multivariate statistical analyses were performed to determine statistical significance.

Results. Between 2005 and 2008, 132 MCA aneurysms were treated at a single institution, and CTA studies of 79 aneurysms (40 ruptured and 39 unruptured) were analyzed. Fifty-three aneurysms were excluded because of reoperation (4), associated AVM (2), or lack of preoperative CTA studies (47). Ruptured aneurysms were associated with larger size, greater aspect ratio, larger aneurysm and flow angles, and smaller parent-daughter angle. Multivariate logistic regression revealed that aspect ratio, flow angle, and parent-daughter angle were the strongest factors associated with ruptured aneurysms.

Conclusions. Aspect ratio, flow angle, and parent-daughter angle are more strongly associated with ruptured MCA aneurysms than size. The association of parameters independent of aneurysm morphology with ruptured aneurysms suggests that these parameters may be associated with an increased risk of aneurysm rupture. These factors are readily applied in clinical practice and should be considered in addition to aneurysm size when assessing the risk of aneurysm rupture specific to the MCA location.

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The transorbital keyhole approach: early and long-term outcome analysis of approach-related morbidity and cosmetic results

J Neurosurg 114:852–856, 2011. DOI: 10.3171/2010.9.JNS1095

In 2003 the authors introduced a minimally invasive transorbital keyhole approach. Because this approach requires removal of the orbital rim and orbital roof, there have been concerns regarding perioperative morbidity, long-term morbidity, and cosmetic results. The authors evaluated approach-related morbidity and cosmetic results in their patients to determine the rate of complications and compared this to published reports of similar approaches.

Material. Seventy-one patients (41 female, 30 male) underwent operations using this approach between 2004 and 2008. Immediate approach-related morbidity was recorded after the operation. Late morbidity was determined after 7 months by an independent examiner while cosmetic results were self-rated by the patient using a questionnaire.

Results. Fifty-one (72%) of 71 patients had no postoperative complications and 12 (16.9%) had minor complications, the most common of which was subgaleal CSF collection (7.0%). Other minor complications included facial nerve palsy (2.8%), hyposphagma (2.8%), periorbital swelling due to periorbital hematoma (2.8%), and subdural hematoma (1.4%). Major complications requiring surgical revision occurred in 4 patients (5.6%); these were CSF fistulas in 2 patients, pneumocephalus in 1 patient, and a hematoma in 1 patient. Forty-nine (90.7%) of all 54 examined patients rated the cosmetic results as very good or good. Major long-term morbidity was hyposmia or anosmia (14 patients) followed by hypoesthesia around the scar (9 patients).

Conclusions. The transorbital keyhole approach is a feasible approach with a low-risk profile for postoperative or long-term morbidity and excellent cosmetic outcome.

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The Association Between Weather and Spontaneous Subarachnoid Hemorrhage: An Analysis of 155 US Hospitals

Neurosurgery 68:132–139, 2011 DOI: 10.1227/NEU.0b013e3181fe23a1

A seasonal and meteorological influence on the incidence of spontaneous subarachnoid hemorrhage (SAH) has been suggested, but a consensus in the literature has yet to emerge.

OBJECTIVE: This study examines the impact of weather patterns on the incidence of SAH using a geographically broad analysis of hospital admissions and represents the largest study of the topic to date.

METHODS: We retrospectively analyzed SAH admissions to 155 US hospitals during the calendar years 2004 to 2008 (N = 7758). Daily weather readings for temperature, pressure, and humidity were obtained for the same period from National Oceanic and Atmospheric Administration weather stations located near each hospital. The daily values of each weather variable were associated with the daily volume of SAH admissions using a combination of correlation and time-series analyses.

RESULTS: No seasonal trends were observed in the monthly volume of SAH admissions during the study period. No significant correlation was detected between the daily SAH admission volume and the day’s weather, the previous day’s weather, or the 24-hour weather change.

CONCLUSION: This study represents the most comprehensive investigation of the association between weather and spontaneous SAH to date. The results suggest that neither season nor weather significantly influences the incidence of SAH.

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Reinfection following initial cerebrospinal fluid shunt infection

J Neurosurg Pediatrics 6:000–000, 2010. DOI: 10.3171/2010.5.PEDS09457

Significant variation exists in the surgical and medical management of CSF shunt infection. The objectives of this study were to determine CSF shunt reinfection rates following initial CSF shunt infection in a large patient cohort and to determine management, patient, hospital, and surgeon factors associated with CSF shunt reinfection.

Methods. This retrospective cohort study included children who were in the Pediatric Health Information System (PHIS) database, who ranged in age from 0 to 18 years, and who underwent uncomplicated initial CSF shunt placement in addition to treatment for initial CSF shunt infection between January 1, 2001, and December 31, 2008. The outcome was CSF shunt reinfection within 6 months. The main predictor variable of interest was surgical approach to treatment of first infection, which was determined for 483 patients. Covariates included patient, hospital, surgeon, and other management factors.

Results. The PHIS database includes 675 children with initial CSF shunt infection. Surgical approach to treatment of the initial CSF shunt infection was determined for 483 children (71.6%). The surgical approach was primarily shunt removal/new shunt placement (in 286 children [59.2%]), but a substantial number underwent externalization (59 children [12.2%]), of whom a subset went on to have the externalized shunt removed and a new shunt placed (17 children [3.5% overall]). Other approaches included nonsurgical management (64 children [13.3%]) and complete shunt removal without shunt replacement (74 children [15.3%]). The 6-month reinfection rate was 14.8% (100 of 675 patients). The median time from infection to reinfection was 21 days (interquartile range [IQR] 5–58 days). Children with reinfection had less time between shunt placement and initial infection (median 50 vs 79 days, p = 0.06). No differences between those with and without reinfection were seen in patient factors (patient age at either shunt placement or initial infection, sex, race/ethnicity, payer, indication for shunt, number of comorbidities, distal shunt location, and number of shunt revisions at first infection); hospital volume; surgeon volume; or other management factors (for example, duration of intravenous antibiotic use). Nonsurgical management was associated with reinfection, and complete shunt removal was negatively associated with reinfection. However, reinfection rates did not differ between the 2 most common surgical approaches: shunt removal/new shunt placement (44 [15.4%] of 286; 95% CI 11.4%–20.1%) and externalization (total 12 [20.3%] of 59; 95% CI 11.0%–32.8%). Externalization followed by shunt removal/new shunt placement (5 [29.4%] of 17; 95% CI 10.3%–56.0%) and nonsurgical management (15 [23.4%] of 64; 95% CI 13.8%–35.7%) had higher, but nonstatistically significant, reinfection rates. The length of stay was shorter for nonsurgical management.

Conclusions. Surgical approach to treatment of initial CSF shunt infection was not associated with reinfection in this large cohort of patients.

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Trends in Case-Fatality Rates in Hospitalized Nontraumatic Subarachnoid Hemorrhage: Results of a Population-Based Study in Dijon, France, From 1985 to 2006

Neurosurgery 66:1039-1043, 2010 DOI: 10.1227/01.NEU.0000369512.58898.99

Subarachnoid hemorrhage accounts for 2% to 5% of all strokes and is associated with high morbidity and mortality rates. Reports in the literature show that case-fatality rates vary with time and according to geographical area.

OBJECTIVE: The objective of the study was to evaluate the case-fatality rates in subarachnoid hemorrhage at 1 and 6 months and to determine trends in these rates over 22 years using a population-based registry.

METHODS: The Dijon Stroke Registry has enabled us to perform a comprehensive analysis of subarachnoid hemorrhage diagnosed in a population of >150 000 inhabitants hospitalized between 1985 and 2006 in the Dijon University Hospital, which has both a neurosurgery unit and a neuroradiology unit. Diagnosis was based on clinical and neuroimaging features and, when necessary, on lumbar puncture.

RESULTS: Case-fatality rates for hospitalized subarachnoid hemorrhages at 1 and 6 months were 15.59% (95% confidence interval [CI], 9.37-25.34) and 16.84% (95% CI, 10.33-26.78), respectively. From 1985 to 1995, case-fatality rates for SAH at 1 and 6 months were 17.1% (95% CI, 8.1-34.2) and 17.7% (95% CI, 9.6-31.3), whereas from 1996 to 2006, they were 20.2% (95% CI, 10.2-37.8) and 19.7% (95% CI, 11.1-33.6), respectively.

CONCLUSION: Case-fatality rates for hospitalized subarachnoid hemorrhages in this population- based study remained stable over 22 years, suggesting that this stroke subtype is still a very severe disease despite early management. Most deaths occurred during the first 30 days. Further work is necessary to evaluate levels of prehospital case-fatality in our population-based registry.

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