Intraoperative MRI-Guided Resection Is Not Superior to 5-Aminolevulinic Acid Guidance in Newly Diagnosed Glioblastoma: A Prospective Controlled Multicenter Clinical Trial.

PURPOSE: Prospective data suggested a superiority of intraoperative MRI (iMRI) over 5-aminolevulinic acid (5-ALA) for achieving complete resections of contrast enhancement in glioblastoma surgery. We investigated this hypothesis in a prospective clinical trial and correlated residual disease volumes with clinical outcome in newly diagnosed glioblastoma. METHODS: This is a prospective controlled multicenter parallel-group trial with two center-specific treatment arms (5-ALA and iMRI) and blinded evaluation. The primary end point was complete resection of contrast enhancement on early postoperative MRI. We assessed resectability and extent of resection by an independent blinded centralized review of preoperative and postoperative MRI with 1-mm slices. Secondary end points included progression-free survival (PFS) and overall survival (OS), patient-reported quality of life, and clinical parameters. RESULTS: We recruited 314 patients with newly diagnosed glioblastomas at 11 German centers. A total of 127 patients in the 5-ALA and 150 in the iMRI arm were analyzed in the as-treated analysis. Complete resections, defined as a residual tumor ≤0.175 cm³, were achieved in 90 patients (78%) in the 5-ALA and 115 (81%) in the iMRI arm (P = .79). Incision-suture times (P < .001) were significantly longer in the iMRI arm (316 v 215 [5-ALA] minutes). Median PFS and OS were comparable in both arms. The lack of any residual contrast enhancing tumor (0 cm³) was a significant favorable prognostic factor for PFS (P < .001) and OS (P = .048), especially in methylguanine-DNA-methyltransferase unmethylated tumors (P = .006). CONCLUSION: We could not confirm superiority of iMRI over 5-ALA for achieving complete resections. Neurosurgical interventions in newly diagnosed glioblastoma shall aim for safe complete resections with 0 cm³ contrast-enhancing residual disease, as any other residual tumor volume is a negative predictor for PFS and OS.

Prospective Multicenter Trial of Cervical Arthroplasty with the ROTAIO® Cervical Disc Prosthesis.

STUDY DESIGN: Clinical observational study. OBJECTIVE: The ROTAIO® cervical disc prosthesis is a novel unconstrained implant with a variable center of rotation aiming at physiological motion. The objective of this multicenter prospective trial was to evaluate clinical outcome and complications within 2 years. MATERIAL AND METHODS: 120 patients (72 females and 48 males with median age of 43.0 years [23-60 yrs] underwent ACDA (ROTAIO®, SIGNUS Medical, Alzenau, Germany) and were prospectively followed for 24 months. Preoperative complaints were mainly associated with radiculopathy (n = 104) or myelopathy (n=16). There were 108 monosegmental and 12 bisegmental procedures including 6 hybrid constructs. Clinical outcome was evaluated at 3, 12 and 24 months in 100%, 96% and 77% of the cohort by VAS, NDI, WL-26, Patient`s Satisfaction Index (PSI), SF-36, Nurick Score, mJOA, Composite Success Rate, complications, patient`s overall satisfaction and analgesics use. RESULTS: Highly significant clinical improvements were observed according to NDI and VAS (P < .0001 (arm); P < .001 (neck); P = .002 (head)) at all time points. Analgetic use could be reduced in 87.1 to 95.2%. Doctor`s visits have been reduced in 93.8% after 24 months. Patient`s overall satisfaction was high with 78.4 to 83.5% of patients. The composite success rate was 77.5% after 12 months and 76.9% after 24 months. There were no major complications in this series. Slight subsidence of the prosthesis was observed in 2 patients and 3 patients demonstrated fusion after 24 months. 2 patients developed symptomatic foraminal stenosis, so that implant removal and fusion was performed resulting in a revision rate of 1.7% in 2 years. CONCLUSION: The ROTAIO® cervical disc prosthesis is a safe and efficient treatment option for symptomatic degenerative disc disease demonstrating highly significant clinical improvement and high patient`s overall satisfaction with very low revision rates at 2 years.

Influence of iMRI-guidance on the extent of resection and survival of patients with glioblastoma multiforme.

Intraoperative MRI (iMRI) is used in glioma surgery mainly to determine the extent of resection, allowing surgeons to immediately continue resection in case of residual tumor tissue. The aim of this study is to report on the influence of the use of iMRI on the extent of resection and survival of patients with glioblastoma multiforme (GBM). We analyzed our prospectively collected database of patients with GBM operated upon during the initial period after installation of an iMRI; between July 2004 and December 2005, all patients with GBM undergoing intended complete tumor resection were included in this study, while patients undergoing mere tumor biopsy or intended incomplete resection were not. In total, 43 Patients met the inclusion criteria. Of these, 10 patients (23.3%) were operated upon with the help of iMRI while 33 underwent conventional tumor resection. All patients underwent postoperative high-field MR imaging at 1.5 Tesla to determine the extent of resection. Subsequently, all patients received adjuvant treatment. Median patient age was 60.0 years; median overall survival was 70.7 weeks. Radiologically complete tumor resection (P < 0.001) and the administration of temozolomide chemotherapy (P < 0.01) were statistically significant prognostic factors in a multivariate analysis. The rate of complete tumor resections was significantly higher in the iMRI group than in the conventional surgery group (P < 0.05). Patient age was not a prognostic factor in our series of patients (P = 0.22). Intraoperative MRI is a helpful tool to increase the extent of resection in GBM surgery and thereby improve patient survival.

The combination of semi-sitting position and intraoperative MRI--first report on feasibility.

INTRODUCTION: Intraoperative MRI (iMRI) has been established as a routine imaging modality with a remarkable impact on specific neurosurgical procedures. The technological advancement continuously extends the spectrum of iMRI, leading to an increasing number of installations. Yet, procedures in which a semi-sitting position would be advantageous were beyond the reach of iMRI. MATERIALS AND METHODS: We performed an iMRI-guided surgical procedure in a patient with a cystic lesion of the inferior parieto-occipital lobe while the patient was placed in a semi-sitting position, employing a mobile 0.15-T intraoperative MRI system. For that purpose, we adapted a standard OR table according to the needs of iMRI. FINDINGS: Patient positioning could be accomplished easily. For intraoperative scanning, the OR table was tilted backwards so as to position the patient's head in the magnet's aperture. Obtained images were used for neuronavigated cyst evacuation via burr hole trephination after repositioning the OR table. Subsequent intraoperative imaging documented collapse of the cyst at the end of the procedure. There were no adverse effects resulting from the combination of semi-sitting position and iMRI guidance. CONCLUSION: This report demonstrates for the first time that the combination of iMRI and the semi-sitting position is feasible and that this procedure bears specific benefits. Issues such as brain shift due to table tilting warrant further investigations in order to expand this technique to posterior fossa craniotomies.

A standardised evaluation of pre-surgical imaging of the corticospinal tract: where to place the seed ROI.

The aim of the study was to compare the different approaches of pre-operative diffusion-tensor-imaging-based fibre tracking (FT) of the corticospinal tract (CST) focusing on the positioning of the seeding region of interest (seed ROI). Thirty-nine patients with brain lesions in the vicinity of the CST were evaluated pre-operatively. Imaging comprised a 3D T1-weighted sequence, a gradient echo echo-planar imaging sequence for functional magnetic resonance imaging (fMRI), and a diffusion-weighted sequence for diffusion tensor (DT) tractography. DT tractography was performed with two different procedures to track the corticospinal fibres: one downwards and one upwards. Downward FT was started with the seed ROI in the pre-central gyrus subjacent to the maximal fMRI activity while for the upward FT seed ROI was placed in the cerebral peduncle. In 16 patients, tracking results were individually compared with the unaffected contralateral hemisphere. Results were correlated with fractional anisotropy (FA) values and other factors potentially influencing fibre tracking results. On the side with the space-occupying lesion, downward FT yielded more positive tracking results (tracked fibres > 0) than the upward FT. On both the affected and the unaffected side, downward FT reconstructed fewer fibres than upward FT. For none of the two methods did the tracking results (number and volume of fibres) correlate with FA values or with other clinical data. FA values for tracts ipsilateral to the lesion correlated with age and lesion entity. We conclude that the sequence of ROI positioning influences significantly the tracking results. Upward FT may fail to track fibres, whereas the successful tracking results may be superior to downward FT. Hence, upward FT of the CST should be preferred in patients with space-occupying lesions. Downward FT should be performed if upward FT fails.

Comparison between clipping and coiling on the incidence of cerebral vasospasm after aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis.

Cerebral vasospasm is one of the most important complications of aneurysmal subarachnoid hemorrhage. The effect of aneurysm occlusion technique on incidence of vasospasm is not exactly known. The objective was to analyze surgical clipping versus endovascular coiling on the incidence of cerebral vasospasm and its consequences. Using the MEDLINE PubMed (1966-present) database, all English-language manuscripts comparing patients treated by surgical clipping with patients treated by endovascular coiling, regarding vasospasm incidence after aneurysmal subarachnoid hemorrhage, were analyzed. Data extracted from eligible studies included the following outcome measures: incidence of total vasospasm, symptomatic vasospasm, ischemic infarct vasospasm-induced and delayed ischemic neurological deficit (DIND). A pooled estimate of the effect size was computed and the test of heterogeneity between studies was carried out using The Cochrane Collaboration's Review Manager software, RevMan 4.2. Nine manuscripts that fulfilled the eligibility criteria were included and analyzed. The studies differed substantially with respect to design and methodological quality. The overall results showed no significant difference between clipping and coiling regarding to outcome measures. According to the available data, there is no significant difference between the types of technique used for aneurysm occlusion (clipping or coiling) on the risk of cerebral vasospasm development and its consequences.