Clinical and radiological course of intracerebral haemorrhage associated with the new non-vitamin K anticoagulants.

BACKGROUND: Clinical outcome and mortality in intracerebral haemorrhage (ICH) associated with anticoagulant treatment is poor. Novel direct oral anticoagulant drugs (NOACs) are increasingly prescribed. Management of NOAC-associated ICH might be more challenging. The aim of this study was to compare the clinical and radiological course of ICH patients being treated with different forms of oral anticoagulant drugs. METHOD: The study is a retrospective observational study. Haemorrhage in other intracranial compartments except the ventricular system were explicitly excluded. Four groups were categorised and compared with regard to their clinical and radiological course (NOACs, vitamin K antagonists [VKAs], platelet inhibitors and patients without anticoagulant/antiplatelet drugs). Clinical as well as radiological parameters were analysed. RESULTS: Overall, 182 patients were included (2011 to early 2016). Twenty-five patients with NOAC-associated ICH were included (47 with VKAs, 50 with platelet inhibitors and 60 patients without anticoagulant/antiplatelet drugs). The frequency of NOAC-associated ICH increased over the years. Diabetes was found significantly more often in the NOAC patients (p = 0.05). The clinical and radiological courses in the three different patient groups with impaired coagulation were similar. Mortality was significantly higher in patient groups with impaired coagulation (p = 0.04) compared to those without anticoagulant/antiplatelet drugs. Multivariate analysis revealed the Glasgow Coma Scale (GCS) score as a strong predictor for worse outcome and mortality. CONCLUSIONS: The frequency of NOAC-associated ICH increased in the last 5 years. Diabetes might be a risk factor for ICH when receiving NOACs. Clinical outcome in NOAC-associated ICH is poor and mortality is as high as in patients with other oral anticoagulant/antiplatelet drugs.

Surgical Experience and Complications in 50 Patients Treated with an Anular Closure Device Following Lumbar Discectomy.

OBJECTIVE: To examine the results of an anular closure device for prevention of lumbar disc reherniation in daily routine practice. METHODS: Fifty patients with large anular defects were treated with limited discectomy and a bone-anchored anular closure device. The device physically occludes the defect in the anulus fibrosus and is intended for prevention of lumbar disc reherniation. Pain scores on a visual analogue scale, back function on the Oswestry Disability Index, and neurological status were noted. Symptomatic reherniation and reoperation rates were assessed at each follow-up. Surgical findings and complications, device-related and/or procedure-related, were recorded. Follow-up was 6, 12, 26, and 52 weeks. RESULTS: Mean anular defect height/width was 4.6 mm/10.1 mm. The overall symptomatic reherniation and reoperation rate was 2%. During the 1-year follow-up period, mean back pain decreased from 43 to 8 (P < 0.001), leg pain decreased from 71 to 4 (P < 0.001), and the Oswestry Disability Index decreased from 46 to 5 (P < 0.001). Among 15 patients with preoperative neurological deficits, improvements in neurological function were noted in 14 (93%). There were no serious device-related complications. CONCLUSIONS: The presented study shows promising early results in using the anular closure device. The procedure is safe with significantly fewer reherniations than for patients with large anular defects without anular closure. Further studies with longer follow-up periods are warranted to prove these findings for long-term outcomes.

Challenges in the Analysis of Longitudinal Pain Data: Practical Lessons from a Randomized Trial of Annular Closure in Lumbar Disc Surgery.

Purpose. To analyze leg pain severity data from a randomized controlled trial (RCT) of lumbar disc surgery using integrated approaches that adjust pain scores collected at scheduled follow-up visits for confounding clinical events occurring between visits. Methods. Data were derived from an RCT of a bone-anchored annular closure device (ACD) following lumbar discectomy versus lumbar discectomy alone (Control) in patients with large postsurgical annular defects. Leg pain was recorded on a 0 to 100 scale at 6 weeks, 3 months, 6 months, 1 year, and 2 years of follow-up. Patients with pain reduction ≥20 points relative to baseline were considered responders. Unadjusted analyses utilized pain scores reported at follow-up visits. Since symptomatic reherniation signifies clinical failure of lumbar discectomy, integrated analyses adjusted pain scores following a symptomatic reherniation by baseline observation carried forward for continuous data or classification as nonresponders for categorical data. Results. Among 550 patients (272 ACD, 278 Control), symptomatic reherniation occurred in 10.3% of ACD patients and in 21.9% of controls (p < 0.001) through 2 years. There was no difference in leg pain scores at the 2-year visit between ACD and controls (12 versus 14; p = 0.33) in unadjusted analyses, but statistically significant differences favoring ACD (19 versus 29; p < 0.001) in integrated analyses. Unadjusted nonresponder rates were 6.0% with ACD and 6.7% with controls (p = 0.89), but 15.7% and 27.8% (p = 0.001) in integrated analyses. The probability of nonresponse was 16.4% with ACD and 18.3% with controls (p = 0.51) in unadjusted analysis, and 23.7% and 31.2% (p = 0.04) in integrated analyses. Conclusion. In an RCT of lumbar disc surgery, an integrated analysis of pain severity that adjusted for the confounding effects of clinical failures occurring between follow-up visits resulted in different conclusions compared to an unadjusted analysis of pain scores reported at follow-up visits only.

Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial.

BACKGROUND: The purposes of the present study were to (1) confirm the risk of recurrent lumbar disc herniation in patients with a large anular defect who had undergone limited discectomy and (2) assess potential risk factors within this population. METHODS: The patient population was extracted from the control cohort of a prospective, randomized, multicenter controlled trial investigating the efficacy of an anular closure device following standard limited discectomy. All control patients underwent limited discectomy for the treatment of a single-level symptomatic posterior or posterolateral lumbar disc herniation. Only patients presenting with a large anular defect (6 to 10 mm wide by 4 to 6 mm long) were included in the study (n = 278). Baseline demographic, clinical, and surgical characteristics were recorded. Follow-up evaluations were performed at 6 weeks and at 3, 6, 12, and 24 months. Imaging modalities included magnetic resonance imaging, low-dose computed tomography, and radiographs. Symptomatic recurrent lumbar disc herniation was defined as any symptomatic postoperative herniation on either side of the index level. A multivariate logistic regression analysis of demographic and surgical variables associated with the incidence of recurrent lumbar disc herniation was performed. RESULTS: The mean anular defect area (and standard deviation) was 39.3 ± 9.1 mm2, and the mean excised nuclear tissue volume was 1.3 ± 0.8 mL. At 2 years, the incidence of symptomatic recurrent lumbar disc herniation was 25.3% (64 of 253), with the herniation occurring at a mean of 264 days after the index procedure. Of the 64 patients with recurrent lumbar disc herniation, 36 underwent a subsequent surgical procedure. Logistic regression analysis identified an increased risk for recurrent lumbar disc herniation in females (odds ratio, 2.2) and in patients with greater anular defect widths (odds ratio, 1.3). Furthermore, multivariate logistic regression analyses revealed a significant interaction between age and sex (p = 0.005). CONCLUSIONS: The outcomes of the present study provide the most substantial evidence to date in confirming previous reports of a high risk of reherniation among patients with large anular defects. Among those with large anular defects (width, ≥6 mm), females ≤50 years of age had the highest risk (up to ∼10 times higher) of recurrent lumbar disc herniation. It is recommended that an anular repair or closure should be performed after limited discectomies in patients with large anular defects. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial.

BACKGROUND CONTEXT: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. PURPOSE: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. DESIGN: This is a multicenter, randomized superiority study. PATIENT SAMPLE: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6-10 mm width) after lumbar microdiscectomy were included in the study. OUTCOME MEASURES: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. METHODS: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. RESULTS: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up. CONCLUSIONS: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted.

Intraparenchymal meningioma mimicking cavernous malformation: a case report and review of the literature.

INTRODUCTION: A primary intraparenchymal meningioma located in the subcortical region of the brain without a dural attachment is extremely rare. To the best of our knowledge, this is the first report showing that meningioma can mimic cavernous malformations. CASE PRESENTATION: We present the case of a 42-year-old German man who presented to our institution with seizure. Both computed tomography and magnetic resonance imaging scans showed characters of an intra-axial subcortical lesion with a 'popcorn' appearance and hemosiderin deposits in the right parietal lobe. The initial diagnosis was cavernous malformation. Intraoperatively, the lesion presented as a subcortical mass that had no connection to the dura or the ventricle. The histological diagnosis showed a WHO Grade 1 'raddled' psammomatous meningioma with extensive metaplastic ossification. A literature review of 29 cases of intraparenchymal meningiomas regarding their clinical presentations, location and management was performed. CONCLUSIONS: Meningiomas can be found in any region of the brain with and without dural attachment. Intraparenchymal meningiomas can have multiple entities mimicking their presentation. Caution must be used regarding the preoperative differential diagnosis.

A standardized protocol for the prevention of clinically relevant venous air embolism during neurosurgical interventions in the semisitting position.

OBJECTIVE: We report the results and complications associated with standardized intraoperative management designed for the prevention of hemodynamically relevant venous air embolism during surgery performed in the semisitting position. METHODS: A protocol for preoperative evaluation and intraoperative monitoring was developed and applied in 187 consecutive patients who underwent surgery in the semisitting position between 1999 and 2004. The protocol included preoperative transesophageal echocardiography examination (TEE), intraoperative TEE monitoring, catheterization of the right atrium and a combination of fluid input, positive end expiratory pressure, and standardized positioning aiming at a positive pressure in the transverse and sigmoid sinuses. Data were collected retrospectively from the charts and intraoperative anesthesiological protocols of the patients for the incidence of clinically relevant air embolism (i.e., TEE-diagnosed air embolism plus a decrease in end tidal CO2 or hemodynamic changes) and other complications related to the semisitting position. RESULTS: Three cases (1.6%) of relevant venous air embolism occurred in 187 patients. Only 1 case (0.5%) was hemodynamically relevant, with temporary arterial blood pressure decrease and heart rate increase. Pneumatocephalus leading to lethargy was a frequent postoperative finding, which resolved spontaneously in all except 1 patient with epileptic seizure and oculomotor nerve palsy attributable to space-occupying subdurally trapped air, which had to be treated surgically. There was no permanent morbidity or mortality related to the semisitting position. CONCLUSION: Fear of massive venous air embolism is one reason for dramatic decline in the use of the semisitting position in neurosurgical practice. We found that strict adherence to a standardized protocol using TEE monitoring before and during surgery; exclusion of patients with patent foramen ovale; and a combination of positive end expiratory pressure, fluid input, and a standardized position aiming a positive pressure in the transverse and sigmoid sinuses helped to greatly minimize this complication to a rate of 0.5% for hemodynamically relevant events.