Effectiveness of an annular closure device in a "real-world" population: stratification of registry data using screening criteria from a randomized controlled trial.

PURPOSE: Increased focus has been put on the use of "'real-world" data to support randomized clinical trial (RCT) evidence for clinical decision-making. The objective of this study was to assess the performance of an annular closure device (ACD) after stratifying a consecutive series of "real-world" patients by the screening criteria of an ongoing RCT. MATERIALS AND METHODS: This was a single-center registry analysis of 164 subjects who underwent limited discectomy combined with ACD for symptomatic lumbar disc herniation. Patients were stratified into two groups using the selection criteria of a pivotal RCT on the same device: Trial (met inclusion; n=44) or non-Trial (did not meet inclusion; n=120). Patient-reported outcomes, including Oswestry Disability Index (ODI) and visual analog scale (VAS) for leg and back pain, and adverse events were collected from baseline to last follow-up (mean: Trial - 15.6 months; non-Trial - 14.6 months). Statistical analyses were performed with significance set at p<0.05. RESULTS: Patient-reported outcomes were not significantly different between groups at last (p≥0.15) and clinical success (≥15-point improvement in ODI score; ≥20-point improvement in VAS scores) was achieved in both the groups. Three non-Trial (2.5%) and three Trial (6.8%) patients experienced symptomatic reherniation (p=0.34). Rates of reoperation, ACD mesh dislocation/separation, and other radiographic findings were similar between groups (p=1.00). CONCLUSION: Outcomes with the ACD appeared advantageous in both the groups, particularly in comparison with historical reherniation rates reported in the same high-risk, large annular defect population. Stratification of this "real-world" series on the basis of RCT screening criteria did not result in significant between-group differences. These findings suggest that the efficacy of the ACD extends beyond the strictly defined patient population being studied in the RCT of this device. Furthermore, reducing the reherniation rate following lumbar discectomy has positive clinical and economic implications.

Cost Comparison of Surgical and Endovascular Treatment of Unruptured Giant Intracranial Aneurysms.

BACKGROUND: Giant intracranial aneurysms (GIAs), which are defined as intracranial aneurysms (IAs) with a diameter of ≥25 mm, are most likely associated with the highest treatment costs of all IAs. However, the treatment costs of unruptured GIAs have so far not been reported. OBJECTIVE: To examine direct costs of endovascular and surgical treatment of unruptured GIAs. METHODS: We retrospectively examined 55 patients with unruptured GIAs treated surgically (37 patients) or endovascularly (18 patients) between April 2004 and March 2014. We analyzed the costs of all hospital stays, interventions, and imaging with a median follow-up of 46 months. RESULTS: There was no difference in the costs of hospital stay between surgical and endovascular treatment groups ($10,565 vs. $14,992; P = .37). Imaging costs were significantly higher in the surgical group than in the endovascular treatment group ($2890 vs. $1612; P < .01), as were the costs of the intervention room and personnel involved in the intervention ($5566 vs. $1520; P < .01). Implants used per patient were more expensive in the endovascular group than in the surgical treatment group ($20,885 vs. $167). The total direct treatment costs were higher in the endovascular group ($52,325) than in the surgical treatment group ($20,619; P < .01). Treatment costs were associated with the type of treatment and GIA location but not with patient age, sex, or GIA size. CONCLUSION: Endovascular GIA treatment produced higher direct costs than surgical GIA treatment mainly due to higher implant costs. Reducing endovascular implant costs may be the most effective tool to decrease direct costs of GIA treatment.

Accuracy of pedicle screw insertion in the cervical spine for internal fixation using frameless stereotactic guidance.

OBJECT: Although transpedicular fixation is a biomechanically superior technique, it is not routinely used in the cervical spine. The risk of neurovascular injury in this region is considered high because the diameter of cervical pedicles is very small and their angle of insertion into the vertebral body varies. This study was conducted to analyze the clinical accuracy of stereotactically guided transpedicular screw insertion into the cervical spine. METHODS: Twenty-seven patients underwent posterior stabilization of the cervical spine for degenerative instability resulting from myelopathy, fracture/dislocation, tumor, rheumatoid arthritis, and pyogenic spondylitis. Fixation included 1-6 motion segments (mean 2.2 segments). Transpedicular screws (3.5-mm diameter) were placed using 1 of 2 computer-assisted guidance systems and lateral fluoroscopic control. The intraoperative mean deviation of frameless stereotaxy was < 1.9 mm for all procedures. RESULTS: No neurovascular complications resulted from screw insertion. Postoperative computed tomography (CT) scans revealed satisfactory positioning in 104 (90%) of 116 cervical pedicles and in all 12 thoracic pedicles. A noncritical lateral or inferior cortical breach was seen with 7 screws (6%). Critical malplacement (4%) was always lateral: 5 screws encroached into the vertebral artery foramen by 40-60% of its diameter; Doppler sonographic controls revealed no vascular compromise. Screw malplacement was mostly due to a small pedicle diameter that required a steep trajectory angle, which could not be achieved because of anatomical limitation in the exposure of the surgical field. CONCLUSIONS: Despite the use of frameless stereotaxy, there remains some risk of critical transpedicular screw malpositioning in the subaxial cervical spine. Results may be improved by the use of intraoperative CT scanning and navigated percutaneous screw insertion, which allow optimization of the transpedicular trajectory.