Changes in frailty among patients hospitalized for spine pathologies during the COVID-19 pandemic in Germany-a nationwide observational study.

PURPOSE: In spine care, frailty is associated with poor outcomes. The aim of this study was to describe changes in frailty in spine care during the coronavirus disease 2019 (COVID-19) pandemic and their relation to surgical management and outcomes. METHODS: Patients hospitalized for spine pathologies between January 1, 2019, and May 17, 2022, within a nationwide network of 76 hospitals in Germany were retrospectively included. Patient frailty, types of surgery, and in-hospital mortality rates were compared between pandemic and pre-pandemic periods. RESULTS: Of the 223,418 included patients with spine pathologies, 151,766 were admitted during the pandemic and 71,652 during corresponding pre-pandemic periods in 2019. During the pandemic, the proportion of high-frailty patients increased from a range of 5.1-6.1% to 6.5-8.8% (p < 0.01), while the proportion of low frailty patients decreased from a range of 70.5-71.4% to 65.5-70.1% (p < 0.01). In most phases of the pandemic, the Elixhauser comorbidity index (ECI) showed larger increases among high compared to low frailty patients (by 0.2-1.8 vs. 0.2-0.8 [p < 0.01]). Changes in rates of spine surgery were associated with frailty, most clearly in rates of spine fusion, showing consistent increases among low frailty patients (by 2.2-2.5%) versus decreases (by 0.3-0.8%) among high-frailty patients (p < 0.02). Changes in rates of in-hospital mortality were not associated with frailty. CONCLUSIONS: During the COVID-19 pandemic, the proportion of high-frailty patients increased among those hospitalized for spine pathologies in Germany. Low frailty was associated with a rise in rates of spine surgery and high frailty with comparably larger increases in rates of comorbidities.

Trends in frailty in brain tumor care during the COVID-19 pandemic in a nationwide hospital network in Germany.

PURPOSE: Among brain tumor patients, frailty is associated with poor outcomes. The COVID-19 pandemic has led to increased frailty in the general population. To date, evidence on changes in frailty among brain tumor patients during the pandemic is lacking. We aimed to compare frailty among brain tumor patients in Germany during the COVID-19 pandemic to the pre-pandemic era and to assess potential effects on brain tumor care. METHODS: In this retrospective observational study, we compared frailty among brain tumor patients hospitalized during the COVID-19 pandemic in years 2020 through 2022 to pre-pandemic years 2016 through 2019 based on administrative data from a nationwide network of 78 hospitals in Germany. Using the Hospital Frailty Risk Score (HFRS), frailty was categorized as low, intermediate, or high. We examined changes in frailty, patient demographics, the burden of comorbidity, rates of surgery, and mortality rates for different frailty groups during the pandemic and compared them to pre-pandemic levels. RESULTS: Of the 20,005 included hospitalizations for brain tumors, 7979 were during the pandemic (mean age 60.0 years (± 18.4); females: 49.8%), and 12,026 in the pre-pandemic period (mean age: 59.0 years [± 18.4]; females: 49.2%). Average daily admissions decreased from 8.2 (± 5.1) during pre-pandemic years to 7.3 (± 4.5) during the pandemic (p < 0.01). The overall median HFRS decreased from 3.1 (IQR: 0.9-7.3) during the pre-pandemic years to 2.6 (IQR: 0.3-6.8) during the pandemic (p < 0.01). At the same time, the Elixhauser Comorbidity Index (ECI) decreased from 17.0 (± 12.4) to 16.1 (± 12.0; p < 0.01), but to a larger degree among high compared to low frailty cases (by 1.8 vs. 0.3 points; p = 0.04). In the entire cohort, the mean length of stay was significantly shorter in the pandemic period (9.5 days [± 10.7]) compared with pre-pandemic levels (10.2 days [± 11.8]; p < 0.01) with similar differences in the three frailty groups. Rates of brain tumor resection increased from 29.9% in pre-pandemic years to 36.6% during the pandemic (p < 0.001) without differences between frailty levels. Rates of in-hospital mortality did not change during the pandemic (6.1% vs. 6.7%, p = 0.07), and there was no interaction with frailty. CONCLUSION: Even though our findings are limited in that the HFRS is validated only for patients ≥ 75 years of age, our study among patients of all ages hospitalized for brain tumors in Germany suggests a marked decrease in levels of frailty and in the burden of comorbidities during the COVID-19 pandemic.

Neurosurgical care for patients with high-grade gliomas during the coronavirus disease 2019 pandemic: Analysis of routine billing data of a German nationwide hospital network.

Background: Little is known about delivery of neurosurgical care, complication rate and outcome of patients with high-grade glioma (HGG) during the coronavirus disease 2019 (Covid-19) pandemic. Methods: This observational, retrospective cohort study analyzed routine administrative data of all patients admitted for neurosurgical treatment of an HGG within the Helios Hospital network in Germany. Data of the Covid-19 pandemic (March 1, 2020-May 31, 2022) were compared to the pre-pandemic period (January 1, 2016-February 29, 2020). Frequency of treatment and outcome (in-hospital mortality, length of hospital stay [LOHS], time in intensive care unit [TICU] and ventilation outside the operating room [OR]) were separately analyzed for patients with microsurgical resection (MR) or stereotactic biopsy (STBx). Results: A total of 1763 patients underwent MR of an HGG (648 patients during the Covid-19 pandemic; 1115 patients in the pre-pandemic period). 513 patients underwent STBx (182 [pandemic]; 331 patients [pre-pandemic]). No significant differences were found for treatment frequency (MR: 2.95 patients/week [Covid-19 pandemic] vs. 3.04 patients/week [pre-pandemic], IRR 0.98, 95% CI: 0.89-1.07; STBx (1.82 [Covid-19 pandemic] vs. 1.86 [pre-pandemic], IRR 0.96, 95% CI: 0.80-1.16, P > .05). Rates of in-hospital mortality, infection, postoperative hemorrhage, cerebral ischemia and ventilation outside the OR were similar in both periods. Overall LOHS was significantly shorter for patients with MR and STBx during the Covid-19 pandemic. Conclusions: The Covid-19 pandemic did not affect the frequency of neurosurgical treatment of patients with an HGG based on data of a large nationwide hospital network in Germany. LOHS was significantly shorter but quality of neurosurgical care and outcome was not altered during the Covid-19 pandemic.

Decompressive Surgery in the Treatment of Acute Ischemic Stroke during the First Four Waves of the COVID-19 Pandemic in Germany: A Nationwide Observational Cohort Study.

BACKGROUND: The COVID-19 pandemic has significantly affected acute ischemic stroke (AIS) care. In this study, we examined the effects of the pandemic on neurosurgical AIS care by means of decompressive surgery (DS). METHODS: In this retrospective observational study, we compared the characteristics, in-hospital processes, and in-hospital mortality rates among patients hospitalized for AIS during the first four waves of the pandemic (between January 1, 2020 and October 26, 2021) versus the corresponding periods in 2019 (prepandemic). We used administrative data from a nationwide hospital network in Germany. RESULTS: Of the 177 included AIS cases with DS, 60 were from 2019 and 117 from the first four pandemic waves. Compared with the prepandemic levels, there were no changes in weekly admissions for DS during the pandemic. The same was true for patient age (range: 51.7-60.4 years), the number of female patients (range: 33.3-57.1%), and the prevalence of comorbidity, as measured by the Elixhauser Comorbidity Index (range: 13.2-20.0 points). Also, no alterations were observed in transfer to the intensive care unit (range: 87.0-100%), duration of in-hospital stay (range: 14.6-22.7 days), and in-hospital mortality rates (range: 11.8-55.6%). CONCLUSION: In Germany, compared with the prepandemic levels, AIS patients undergoing DS during the first four waves of the pandemic showed no changes in demographics, rates of comorbidity, and in-hospital mortality rates. This is in contrast to previous evidence on patients with less critical types of AIS not requiring DS and underlines the uniqueness of the subgroup of AIS patients requiring DS. Our findings suggests that these patients, in contrast to AIS patients in general, were unable to forgo hospitalization during the COVID-19 pandemic. Maintaining the delivery of DS is an essential aspect of AIS care during a pandemic.

The spinal cord injury-induced immune deficiency syndrome: results of the SCIentinel study.

Infections are prevalent after spinal cord injury (SCI), constitute the main cause of death and are a rehabilitation confounder associated with impaired recovery. We hypothesize that SCI causes an acquired lesion-dependent (neurogenic) immune suppression as an underlying mechanism to facilitate infections. The international prospective multicentre cohort study (SCIentinel; protocol registration DRKS00000122; n = 111 patients) was designed to distinguish neurogenic from general trauma-related effects on the immune system. Therefore, SCI patient groups differing by neurological level, i.e. high SCI [thoracic (Th)4 or higher]; low SCI (Th5 or lower) and severity (complete SCI; incomplete SCI), were compared with a reference group of vertebral fracture (VF) patients without SCI. The primary outcome was quantitative monocytic Human Leukocyte Antigen-DR expression (mHLA-DR, synonym MHC II), a validated marker for immune suppression in critically ill patients associated with infection susceptibility. mHLA-DR was assessed from Day 1 to 10 weeks after injury by applying standardized flow cytometry procedures. Secondary outcomes were leucocyte subpopulation counts, serum immunoglobulin levels and clinically defined infections. Linear mixed models with multiple imputation were applied to evaluate group differences of logarithmic-transformed parameters. Mean quantitative mHLA-DR [ln (antibodies/cell)] levels at the primary end point 84 h after injury indicated an immune suppressive state below the normative values of 9.62 in all groups, which further differed in its dimension by neurological level: high SCI [8.95 (98.3% confidence interval, CI: 8.63; 9.26), n = 41], low SCI [9.05 (98.3% CI: 8.73; 9.36), n = 29], and VF without SCI [9.25 (98.3% CI: 8.97; 9.53), n = 41, P = 0.003]. Post hoc analysis accounting for SCI severity revealed the strongest mHLA-DR decrease [8.79 (95% CI: 8.50; 9.08)] in the complete, high SCI group, further demonstrating delayed mHLA-DR recovery [9.08 (95% CI: 8.82; 9.38)] and showing a difference from the VF controls of -0.43 (95% CI: -0.66; -0.20) at 14 days. Complete, high SCI patients also revealed constantly lower serum immunoglobulin G [-0.27 (95% CI: -0.45; -0.10)] and immunoglobulin A [-0.25 (95% CI: -0.49; -0.01)] levels [ln (g/l × 1000)] up to 10 weeks after injury. Low mHLA-DR levels in the range of borderline immunoparalysis (below 9.21) were positively associated with the occurrence and earlier onset of infections, which is consistent with results from studies on stroke or major surgery. Spinal cord injured patients can acquire a secondary, neurogenic immune deficiency syndrome characterized by reduced mHLA-DR expression and relative hypogammaglobulinaemia (combined cellular and humoral immune deficiency). mHLA-DR expression provides a basis to stratify infection-risk in patients with SCI.

Effects of the COVID-19 Pandemic on Spinal Fusion Procedures for Spinal Infections in a Nationwide Hospital Network in Germany.

BACKGROUND: The full impact of the COVID-19 pandemic on surgical spine care is difficult to assess due to a lack in nationwide evidence from more recent phases of the pandemic. We aimed to describe changes in in-hospital processes associated with spinal fusion procedures in the treatment of spinal infections (SI) during different phases of the pandemic. METHODS: In this retrospective observational study, we examined the in-hospital prevalence and outcomes of spinal fusion procedures for SI (along with patient characteristics, rates of transfer to intensive care units, and mortality rates) during the first four waves of the pandemic compared with the corresponding prepandemic periods in 2019. We used administrative data from a nationwide network of 76 hospitals managing 7% of all in-hospital cases in Germany. RESULTS: We observed no significant change in the prevalence of SI fusion procedures during the pandemic, neither in total numbers (349 vs. 373) nor for each wave separately. On a patient level, we found no differences in age, sex, and the prevalence of paresis, and no relevant differences in associated comorbidities. The rate of mechanical ventilation did not change during any of the examined pandemic waves: it ranged between 9.5 and 18.6% during the pandemic and 3.1 and 16.0% during the corresponding prepandemic control periods. The rate of transfer to intensive care changed only during wave 4 (from 70.4 to 54.8%; p = 0.046) but not in any other pandemic phases. We observed no changes in in-hospital mortality rates (range: 2.9-9.7% vs. 6.2-11.3%) or in duration of hospital stay (range: 26.2-30.8 days vs. 20.8-29.2 days). CONCLUSIONS: The main finding of our study is that within this nationwide network of spine care centers in Germany, the delivery of surgical treatment of SI by means of spinal fusion procedures was maintained throughout the first four waves of the pandemic. Furthermore, there were no relevant changes in patient demographics, in-hospital processes, and mortality rates.

Spontaneous ankylosis of the sacroiliac joint: prevalence and risk factors.

PURPOSE: Evidence on spontaneous sacroiliac joint (SIJ) ankylosis is lacking. The aim of this analysis was to assess the prevalence of spontaneous SIJ ankylosis and examined different ankylosis patterns and risk factors for spontaneous SIJ ankylosis. METHODS: Pelvic computed tomography (CT) data of 102 consecutive patients with spinal pathologies were compared to CT of a control group consisting of 102 consecutive patients without spinal pathologies. SIJ ankylosis patterns and risk factors for SIJ ankylosis, such as age, sex, and previous spinal fusion surgery were examined. RESULTS: Overall, 117 men and 86 women were examined between 2019 and 2020. Non-spinal patients were significantly older (mean age 70.5 years, standard deviation [SD] 11.4) than those in the spinal group (mean age 65.3 years, SD 14.3; p = 0.005). The prevalence of SIJ ankylosis was 24.5% in the non-spinal group and 23.5% in the spinal group. The anterior ankylosis type prevalence was 91.7% in the spinal group, compared to 48.0% in the non-spinal group. Factors associated with SIJ ankylosis were older age (odds ratio [OR] 1.04, 95% confidence interval [CI] 1.01-1.07, p = 0.004) and male sex (OR 5.14, 95% CI 2.29-11.55, p < 0.001). CONCLUSION: Spontaneous ankylosis of the SIJ was a frequent phenomenon in patients with and without spinal pathologies and more likely with older age and male sex. Anterior type SIJ ankylosis was substantially more frequent in patients with spinal pathologies. This may be due to strain exerted on the anterior SIJ aspects in patients with compromised posture due to spine degeneration.

Changes in nationwide in-hospital stroke care during the first four waves of COVID-19 in Germany.

Introduction: In the early stages of the global COVID-19 pandemic hospital admissions for acute ischemic stroke (AIS) decreased substantially. As health systems have become more experienced in dealing with the pandemic, and as the proportion of the population vaccinated rises, it is of interest to determine whether the prevalence of AIS hospitalization and outcomes from hospitalization have returned to normal. Patients and methods: In this observational, retrospective cohort study, we compared the prevalence and outcomes of AIS during the first four waves of the pandemic to corresponding pre-pandemic periods in 2019 using administrative data collected from a nationwide network of 76 hospitals that manages 7% of all in-hospital cases in Germany. Results: We included 25,821 AIS cases in the study period (2020/2021) and used 26,295 AIS cases as controls (2019). Compared to pre-pandemic numbers, mean daily AIS admissions decreased only during wave 1 (from 39.6 to 34.1; p < 0.01) and wave 2 (from 39.9 to 38.3; p = 0.03) and returned to normal levels during waves 3 and 4. AIS case fatality increased in wave 1 only (from 6.0% to 7.6%; p = 0.03). We observed a consistent decrease in the prevalences of arterial hypertension, diabetes, and obesity among AIS cases throughout the pandemic and no changes in rates of systemic thrombolysis, mechanical thrombectomy, or decompressive craniectomy. The rate of transfer to stroke units increased only during waves 2 (by 4.6%; p < 0.01) and 3 (by 3.0%; p < 0.01). The proportion of patients with coinciding SARS-CoV-2 and AIS was low, peaking at 3.4% in wave 2 and subsequently decreasing to 0.4% in wave 4. Conclusion: In Germany, the COVID-19 pandemic seems to have had a larger effect on nationwide in-hospital AIS care during the early pandemic stages, in which AIS case numbers decreased and case fatality rose. This may reflect a nationwide "learning curve" within health care systems in providing AIS care in times of a pandemic.

Sex Differences in Clinical Course and Intensive Care Unit Admission in a National Cohort of Hospitalized Patients with COVID-19.

Males have a higher risk for an adverse outcome of COVID-19. The aim of the study was to analyze sex differences in the clinical course with focus on patients who received intensive care. Research was conducted as an observational retrospective cohort study. A group of 23,235 patients from 83 hospitals with PCR-confirmed infection with SARS-CoV-2 between 4 February 2020 and 22 March 2021 were included. Data on symptoms were retrieved from a separate registry, which served as a routine infection control system. Males accounted for 51.4% of all included patients. Males received more intensive care (ratio OR = 1.61, 95% CI = 1.51-1.71) and mechanical ventilation (invasive or noninvasive, OR = 1.87, 95% CI = 1.73-2.01). A model for the prediction of mortality showed that until the age 60 y, mortality increased with age with no substantial difference between sexes. After 60 y, the risk of death increased more in males than in females. At 90 y, females had a predicted mortality risk of 31%, corresponding to males of 84 y. In the intensive care unit (ICU) cohort, females of 90 y had a mortality risk of 46%, equivalent to males of 72 y. Seventy-five percent of males over 90 died, but only 46% of females of the same age. In conclusion, the sex gap was most evident among the oldest in the ICU. Understanding sex-determined differences in COVID-19 can be useful to facilitate individualized treatments.

The rationale and development of a CyberKnife© registry for pediatric patients with CNS lesions.

BACKGROUND: CyberKnife© Radiosurgery (CKRS) is a recognized treatment concept for CNS lesions in adults due to its high precision and efficacy beside a high patient comfort. However, scientific evidence for this treatment modality in pediatric patients is scarce. A dedicated registry was designed to document CyberKnife© procedures in children, aiming to test the hypothesis that it is safe and efficient for the treatment of CNS lesions. METHODS: The CyberKnife© registry is designed as a retrospective and prospective multicenter observational study (German Clinical Trials Register ( https://www.drks.de ), DRKS-ID 00016973). Patient recruitment will be ongoing throughout a 5-year period and includes collection of demographic, treatment, clinical, and imaging data. Follow-up results will be monitored for 10 years. All data will be registered in a centralized electronic database at the Charité-Universitätsmedizin. The primary endpoint is stable disease for benign and vascular lesions at 5 years of follow-up and local tumor control for malign lesions at 1- and 2-year follow-up. Secondary endpoints are radiation toxicity, side effects, and neurocognitive development. CONCLUSION: The CyberKnife© registry intends to generate scientific evidence for all treatment- and outcome-related aspects in pediatric patients with treated CNS lesions. The registry may define safety and efficacy of CKRS in children and serve as a basis for future clinical trials, inter-methodological comparisons and changes of treatment algorithms.

Diagnostic reliability of the Berlin classification for complex MCA aneurysms-usability in a series of only giant aneurysms.

BACKGROUND AND OBJECTIVE: The main challenge of bypass surgery of complex MCA aneurysms is not the selection of the bypass type but the initial decision-making of how to exclude the affected vessel segment from circulation. To this end, we have previously proposed a classification for complex MCA aneurysms based on the preoperative angiography. The current study aimed to validate this new classification and assess its diagnostic reliability using the giant aneurysm registry as an independent data set. METHODS: We reviewed the pretreatment neuroimaging of 51 patients with giant (> 2.5 cm) MCA aneurysms from 18 centers, prospectively entered into the international giant aneurysm registry. We classified the aneurysms according to our previously proposed Berlin classification for complex MCA aneurysms. To test for interrater diagnostic reliability, the data set was reviewed by four independent observers. RESULTS: We were able to classify all 51 aneurysms according to the Berlin classification for complex MCA aneurysms. Eight percent of the aneurysm were classified as type 1a, 14% as type 1b, 14% as type 2a, 24% as type 2b, 33% as type 2c, and 8% as type 3. The interrater reliability was moderate with Fleiss's Kappa of 0.419. CONCLUSION: The recently published Berlin classification for complex MCA aneurysms showed diagnostic reliability, independent of the observer when applied to the MCA aneurysms of the international giant aneurysm registry.

Clinical course and factors associated with outcomes among 1904 patients hospitalized with COVID-19 in Germany: an observational study.

OBJECTIVES: In Germany the coronavirus disease 2019 (COVID-19) pandemic situation is unique among large European countries in that incidence and case fatality rate are distinctly lower. We describe the clinical course and examine factors associated with outcomes among patients hospitalized with COVID-19 in Germany. METHODS: In this retrospective cohort study we included patients with COVID-19 admitted to a national network of German hospitals between February 12 and June 12, 2020. We examined demographic characteristics, comorbidities and clinical outcomes. RESULTS: We included 1904 patients with a median age of 73 years, 48.5% (924/1904) of whom were female. The mortality rate was 17% (317/1835; 95% confidence interval (95%CI) 16-19), the rate of admission to the intensive care unit (ICU) was 21% (399/1860; 95%CI 20-23), and the rate of invasive mechanical ventilation was 14% (250/1850: 95%CI 12-15). The most prominent risk factors for death were male sex (hazard ratio (HR) 1.45; 95%CI 1.15-1.83), pre-existing lung disease (HR 1.61; 95%CI 1.20-2.16), and increased patient age (HR 4.11 (95%CI 2.57-6.58) for age >79 years versus <60 years). Among patients admitted to the ICU, the mortality rate was 29% (109/374; 95%CI 25-34) and higher in ventilated (33% [77/235; 95%CI 27-39]) than in non-ventilated ICU patients (23%, 32/139; 95%CI 16-30; p < 0.05). CONCLUSIONS: In this nationwide series of patients hospitalized with COVID-19 in Germany, in-hospital and ICU mortality rates were substantial. The most prominent risk factors for death were male sex, pre-existing lung disease, and greater patient age.

Recurrent Laryngeal Nerve Palsy after Anterior Cervical Discectomy and Fusion - Prevalence and Risk Factors.

BACKGROUND AND STUDY AIMS: Recurrent laryngeal nerve palsy (RLNP) is a potential complication of anterior discectomy and fusion (ACDF). There still is substantial disagreement on the actual prevalence of RLNP after ACDF as well as on risk factors for postoperative RLNP. The aim of this study was to describe the prevalence of postoperative RLNP in a cohort of consecutive cases of ACDF and to examine potential risk factors. MATERIALS AND METHODS: This retrospective study included patients who underwent ACDF between 2005 and 2019 at a single neurosurgical center. As part of clinical routine, RLNP was examined prior to and after surgery by independent otorhinolaryngologists using endoscopic laryngoscopy. As potential risk factors for postoperative RLNP, we examined patient's age, sex, body mass index, multilevel surgery, and the duration of surgery. RESULTS: 214 consecutive cases were included. The prevalence of preoperative RLNP was 1.4% (3/214) and the prevalence of postoperative RLNP was 9% (19/211). The number of operated levels was 1 in 73.5% (155/211), 2 in 24.2% (51/211), and 3 or more in 2.4% (5/211) of cases. Of all cases, 4.7% (10/211) were repeat surgeries. There was no difference in the prevalence of RLNP between the primary surgery group (9.0%, 18/183) versus the repeat surgery group (10.0%, 1/10; p = 0.91). Also, there was no difference in any characteristics between subjects with postoperative RLNP compared with those without postoperative RLNP. We found no association between postoperative RLNP and patient's age, sex, body mass index, duration of surgery, or number of levels (odds ratios between 0.24 and 1.05; p values between 0.20 and 0.97). CONCLUSIONS: In our cohort, the prevalence of postoperative RLNP after ACDF was 9.0%. The fact that none of the examined variables was associated with the occurrence of RLNP supports the view that postoperative RLNP may depend more on direct mechanical manipulation during surgery than on specific patient or surgical characteristics.

Radiofrequency denervation for treatment of sacroiliac joint pain-comparison of two different ablation techniques.

The radiofrequency treatment (RFD) for sacroiliac joint pain (SIP) is well-established, but there is still scarce evidence on its clinical outcome. The classical monopolar RFD is limited by a high recurrence rate. This might be caused by an incomplete denervation of the dorsal rami. The Simplicity III probe was invented to optimise pain fibre recruitment by its multi-electrode design. However, the clinical superiority of this procedure was never proven. The aim of this study was to illustrate the effectiveness of RFD and to compare both denervation techniques. One hundred twenty-one patients were included, and their clinical course was analysed. Fifty-seven patients received conventional treatment with multiple percutaneous monopolar RFDs (monolesion probe group, MoLG) and 64 patients with the Simplicity III probe (multilesion probe group, MuLG). All patients were followed 1, 3, 6 and 12 s after RFD. Clinical outcome scores were analysed (numeric pain rating scale (NPRS), Roland-Morris Disability Questionnaire, Oswestry Disability Index (ODI), Odom's criteria, Short Form 36 score). The MuLG showed a clearly advanced improvement concerning the clinically relevant pain relief (≥ 50%) (1 month/3 months /6 months/12 months = 72%, 55%, 36%, 27% vs. 1 month/3 months/6 months/12 months = 39%, 28%, 16%, 11%) as well as an advanced improvement of pain-associated disability and a higher satisfaction rating compared to the MoLG (NPRSMuLG_preop = 8,3; NPRSMuLG_12months = 5.8; NPRSMoLG_preop = 7,7; NPRSMoLG_12months = 5.8; ODIMuLG_preop = 52; ODIMuLG_12months = 42; ODIMoLG_preop = 52; ODIMoLG_12months = 47; ODOMSMuLG_good/excellent = 54%; ODOMSMoLG_good/excellent = 28%). RFD of the SIP with the Simplicity III probe is effective and delivers a distinct pain reduction even after 1 year of treatment. This technique shows clear advantages compared to the conventional monolesion technique and is a useful treatment for patients with recurrent SIP.

Giant intracranial aneurysms: natural history and 1-year case fatality after endovascular or surgical treatment.

OBJECTIVE: Clinical evidence on giant intracranial aneurysms (GIAs), intracranial aneurysms with a diameter of at least 25 mm, is limited. The authors aimed to investigate the natural history, case fatality, and treatment outcomes of ruptured and unruptured GIAs. METHODS: In this international observational registry study, patients with a ruptured or unruptured GIA received conservative management (CM), surgical management (SM), or endovascular management (EM). The authors investigated rupture rates and case fatality. RESULTS: The retrospective cohort comprised 219 patients with GIAs (21.9% ruptured GIAs and 78.1% unruptured GIAs) whose index hospitalization occurred between January 2006 and November 2016. The index hospitalization in the prospective cohort (362 patients with GIAs [17.1% ruptured and 82.9% unruptured]) occurred between December 2008 and February 2017. In the retrospective cohort, the risk ratio for death at a mean follow-up of 4.8 years (SD 2.2 years) after CM, compared with EM and SM, was 1.63 (95% CI 1.23-2.16) in ruptured GIAs and 3.96 (95% CI 2.57-6.11) in unruptured GIAs. In the prospective cohort, the 1-year case fatality in ruptured GIAs/unruptured GIAs was 100%/22.0% during CM, 36.0%/3.0% after SM, and 39.0%/12.0% after EM. Corresponding 1-year rupture rates in unruptured GIAs were 25.0% during CM, 1.2% after SM, and 2.5% after EM. In unruptured GIAs, the HR for death within the 1st year in patients with posterior circulation GIAs was 6.7 (95% CI 1.5-30.4, p < 0.01), with patients with a GIA at the supraclinoid internal carotid artery as reference. Different sizes of unruptured GIAs were not associated with 1-year case fatality. CONCLUSIONS: Rupture rates for unruptured GIAs were high, and the natural history and treatment outcomes for ruptured GIAs were poor. Patients undergoing SM or EM showed lower case fatality and rupture rates than those undergoing CM. This difference in outcome may in part be influenced by patients in the CM group having been found poor candidates for SM or EM.Clinical trial registration no.: NCT02066493 (clinicaltrials.gov).

Clinical implications and radiographic characteristics of the relation between giant intracranial aneurysms of the posterior circulation and the brainstem.

BACKGROUND: Giant intracranial aneurysms of the posterior circulation (GPCirA) are rare entities compressing the brainstem and adjacent structures. Previous evidence has shown that the amount of brainstem shift away from the cranial base is not associated with neurological deficits. This raises the question whether other factors may be associated with neurological deficits. METHODS: All data were extracted from the Giant Intracranial Aneurysm Registry, an international multicenter prospective study on giant intracranial aneurysms. We grouped GPCirA according to the mass effect on the brainstem (lateral versus medial). Brainstem compression was evaluated with two indices: (a) brainstem compression ratio (BCR) or diameter of the compressed brainstem to the assumed normal diameter of the brainstem and (b) aneurysm to brainstem ratio (ABR) or diameter of the aneurysm to the diameter of the compressed brainstem. We examined associations between neurological deficits and GPCirA characteristics using binary regression analysis. RESULTS: Twenty-eight GPCirA were included. Twenty GPCirA showed medial (71.4%) and 8 lateral compression of the brainstem (28.6%). Baseline characteristics did not differ between the groups for patient age, aneurysm diameter, aneurysm volume, modified Rankin Scale (mRS), motor deficit (MD), or cranial nerve deficits (CND). Mean BCR was 53.0 in the medial and 54.0 in the lateral group (p = 0.92). The mean ABR was 2.9 in the medial and 2.3 in the lateral group (p = 0.96). In the entire cohort, neither BCR nor ABR nor GPCirA volumes were associated with the occurrence of CND or MD. In contrast, disability (mRS) was significantly associated with ABR (OR 1.94 (95% CI 1.01-3.70; p = 0.045) and GPCirA volumes (OR 1.21 (95% CI 1.01-1.44); p = 0.035), but not with BCR. CONCLUSION: In this cohort of patients with GPCirA, neither the degree of lateral projection nor the amount of brainstem compression predicted neurological deficits. Disability was associated only with aneurysm volume. When designing treatment strategies for GPCirA, aneurysm laterality or the amount of brainstem compression should be viewed as less relevant while the high risk of rupture of such giant lesions should be emphasized. TRIAL REGISTRATION: The registry is listed at clinicaltrials.gov under the registration no. NCT02066493.

Blood Flow Assessment of Arteriovenous Malformations Using Intraoperative Indocyanine Green Videoangiography.

Intraoperative indocyanine green (ICG) videoangiography is widely used in patients undergoing neurosurgery. FLOW800 is a recently developed analytical tool for ICG videoangiography to assess semi-quantitative flow dynamics; however, its efficacy is unknown. In this study, we evaluated its functionality in the assessment of flow dynamics of arteriovenous malformation (AVM) through ICG videoangiography under clinical settings. ICG videoangiography was performed in the exposed AVM in eight patients undergoing surgery. FLOW800 analysis was applied directly, and gray-scale and color-coded maps of the surgical field were obtained. After surgery, a region of interest was placed on the individual vessels to obtain time-intensity curves. Parameters of flow dynamics, including the maximum intensity, transit time, and cerebral blood flow index, were calculated using the curves. The color-coded maps provided high-resolution images; however, reconstruction of colored images was restricted by the depth, approach angle, and brain swelling. Semi-quantitative parameters were similar among the feeders, niduses, and drainers. However, a higher cerebral blood flow index was observed in the feeders of large AVM (>3 cm) than in those of small AVM (P < 0.05). Similarly, the cerebral blood flow index values were positively correlated with the nidus volume (P < 0.01). FLOW800 enabled visualization of the AVM structure and safer resection, except in case of deep-seated AVM. Moreover, semi-quantitative values in the individual vessels through using ICG intensity diagram showed different patterns according to size of the AVM. ICG videoangiography showed good performance in evaluating flow dynamics of the AVM in patients undergoing surgery.

Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint.

BACKGROUND: Sacroiliac joint pain is increasingly recognized as a cause of low back pain. We compared the safety and effectiveness of minimally invasive sacroiliac joint arthrodesis using triangular titanium implants and conservative management in patients with chronic sacroiliac joint pain. METHODS: This study was a prospective, multicenter randomized controlled trial of adults with chronic sacroiliac joint pain assigned to either conservative management or sacroiliac joint arthrodesis with triangular titanium implants. The study end points included self-rated low back pain (visual analog scale [VAS]), back dysfunction (Oswestry Disability Index [ODI]), and quality of life. Ninety percent of subjects in both groups completed the study. RESULTS: Between June 6, 2013, and May 15, 2015, 103 subjects were randomly assigned to conservative management (n = 51) or sacroiliac joint arthrodesis (n = 52). At 2 years, the mean low back pain improved by 45 points (95% confidence interval [CI], 37 to 54 points) after sacroiliac joint arthrodesis and 11 points (95% CI, 2 to 20 points) after conservative management, with a mean difference between groups of 34 points (p < 0.0001). The mean ODI improved by 26 points (95% CI, 21 to 32 points) after sacroiliac joint arthrodesis and 8 points (95% CI, 2 to 14 points) after conservative management, with a mean difference between groups of 18 points (p < 0.0001). Parallel improvements were seen in quality of life. In the sacroiliac joint arthrodesis group, the prevalence of opioid use decreased from 56% at baseline to 33% at 2 years (p = 0.009), and no significant change was observed in the conservative management group (47.1% at baseline and 45.7% at 2 years). Subjects in the conservative management group, after crossover to the surgical procedure, showed improvements in all measures similar to those originally assigned to sacroiliac joint arthrodesis. In the first 6 months, the frequency of adverse events did not differ between groups (p = 0.664). By month 24, we observed 39 severe adverse events after sacroiliac joint arthrodesis, including 2 cases of sacroiliac joint pain, 1 case of a postoperative gluteal hematoma, and 1 case of postoperative nerve impingement. The analysis of computed tomographic (CT) imaging at 12 months after sacroiliac joint arthrodesis showed radiolucencies adjacent to 8 implants (4.0% of all implants). CONCLUSIONS: For patients with chronic sacroiliac joint pain due to joint degeneration or disruption, minimally invasive sacroiliac joint arthrodesis with triangular titanium implants was safe and more effective throughout 2 years in improving pain, disability, and quality of life compared with conservative management. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Risk Factors for Continued Opioid Use in Conservative Versus Surgical Management of Low Back Pain Originating From the Sacroiliac Joint.

STUDY DESIGN: Secondary analysis of data from a randomized controlled trial. OBJECTIVES: To identify risk factors for continued opioid use after conservative management (CM) or minimally invasive surgical management (MISM) of low back pain (LBP) originating from the sacroiliac joint. METHODS: Patients were randomized either to CM (n = 49) or MISM (n = 52). We documented opioid use, pain intensity (visual analogue scale [VAS]), Oswestry Disability Index (ODI), and the Zung depression score (Zung Self-Rating Depression Scale) at baseline and at months 3 and 6 after treatment initiation. RESULTS: Compared with opioid nonusers, opioid users at baseline had higher mean levels of disability (ODI 61.5, standard deviation [SD] 13.3 vs ODI 51.5, SD 12.8; P < .01) and higher depression scores (Zung 48.5, SD 8.5, vs Zung 42.2, SD 7.2; P < .01). At 6 months, opioid users had higher 6-month pain levels (VAS 60.4, SD 24.0, vs VAS 42.4, SD 28.2; P < .01), higher disability scores (ODI 50.5, SD 16.2, vs ODI 32.7, SD 19.3; P < .01) and higher depression scores (Zung 47.6, SD 8.0, vs Zung 38.8, SD 8.9; P < .01). Risk factors for continued opioid use at 6 months were patient age (odds ratio [OR] for age = 0.91; P = .02) and an increase in LBP (OR 1.08; P = .02) in the CM group and a lack of improvement in depression scores (OR 1.12; P = .03) in the MISM group. CONCLUSIONS: In our patient cohort, the risk of continued opioid use in the treatment of LBP increased not only with pain intensity but also with levels of depression during the course of treatment.

Giant intracranial aneurysms of the posterior circulation and their relation to the brainstem: analysis of risk factors for neurological deficits.

OBJECTIVE: Giant posterior circulation aneurysms (GPCirAs) usually cause substantial mass effect on the brainstem, which may lead to neurological deficits. So far, there has been no systematic investigation of factors associated with such deficits in GPCirA. The authors aim to examine the risk factors for cranial nerve deficit (CND), motor deficit, and disability in patients with GPCirA. METHODS: Using MR images obtained in 30 patients with unruptured GPCirA, the authors examined GPCirA volume, presence of hydrocephalus or partial thrombosis (PT) of the aneurysm, and the degree of brainstem displacement measured by the distance between the McRae line and the tip of the GPCirA (∆MT). They evaluated associations between these factors and neurological deficits. RESULTS: Thirty GPCirAs in 30 patients were included. The prevalence of CNDs was 50%. Patients with CNDs significantly differed from those without CNDs in terms of age (mean 51.0 years [SD 15.0 years] vs 69.0 years [SD 21.0 years], p = 0.01) and in ∆MT (median 50.7 mm [IQR 39.2-53.9 mm] vs 39.0 mm [IQR 32.3-45.9 mm], p = 0.02). The prevalence of motor deficits was 33.3%. Patients with motor deficits showed a larger ∆MT (median 50.5 mm [IQR 40.8-54.6 mm]) compared with those without (∆MT: median 39.1 mm [IQR 32.8-50.5 mm], p = 0.04). GPCirA volume was larger in patients with poor modified Rankin Scale (mRS) scores (median 14.9 cm3 [IQR 8.6-18.7 cm3]) than in those with mRS scores of 0-2 (median 6.8 cm3 [IQR 4.4-11.7 cm3], p = 0.03). After adjusting for patient age and the occurrence of hydrocephalus or PT, the authors found that higher degrees of disability were significantly associated with aneurysm volume (OR 1.13, 95% CI 1.0-1.3; p = 0.04), but not with ∆MT. The occurrence of CND or motor deficit was not associated with any of the examined variables. There was no correlation between GPCirA volume and ∆MT (rs = 0.01, p = 0.96). The prevalence of neurological deficits did not differ between GPCirA at the basilar apex, the basilar trunk, the vertebrobasilar junction, or the vertebral artery. CONCLUSIONS: In this study, the neurological condition of the patients was associated only with GPCirA volume and not with the degree of brainstem displacement, the occurrence of PT or hydrocephalus, or the exact location of the GPCirA. These findings highlight the clinical relevance of GPCirA volume and suggest that factors such as brainstem displacement or PT should play less of a role when finding arguments for or against treatment of GPCirA.Clinical trial registration no.: NCT02066493 (clinicaltrials.gov).