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Background and Purpose- The WEAVE trial (Wingspan Stent System Post Market Surveillance) is a postmarket surveillance trial mandated by the Food and Drug Administration to assess the periprocedural safety of the Wingspan Stent system in the treatment of symptomatic intracranial atherosclerotic disease. Methods- A total of 152 consecutive patients who met the Food and Drug Administration on-label usage criteria were enrolled at 24 hospitals and underwent angioplasty and stenting with the Wingspan stent. On-label criteria included age 22 to 80 years, symptomatic intracranial atherosclerotic stenosis of 70% to 99%, baseline modified Rankin Scale score ≤3, ≥2 strokes in the vascular territory of the stenotic lesion with at least 1 stroke while on medical therapy, and stenting of the lesion ≥8 days after the last stroke. The primary analysis assessed the periprocedural stroke, bleed, and death rate within 72 hours of the procedure with adjudication by a core study Stroke Neurologist. Results- The trial was stopped early after interim analysis of 152 consecutive patients demonstrated a lower than expected 2.6% (4/152 patients) periprocedural stroke, bleed, and death rate. This was lower than the 4% periprocedural primary event safety benchmark set for the interim analysis in the study. A total of 97.4% (148/152) patients were event-free at 72 hours, 1.3% (2/152) had nonfatal strokes, and 1.3% (2/152) of patients died. Conclusions- With experienced interventionalists, and proper patient selection following the on-label usage guidelines, the use of the Wingspan stent for intracranial atherosclerotic disease demonstrated a low periprocedural complication rate and excellent safety profile. This is the largest on-label, multicenter, prospective trial of the Wingspan stent system to date with the lowest reported complication rate. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02034058.

Study Design:Retrospective, multicenter review of adult scoliosis patients with minimum 2-year follow-up. Objective:Because the fractional curve (FC) of adult scoliosis can cause radiculopathy, we evaluated patients treated with either circumferential minimally invasive surgery (cMIS) or open surgery. Methods:A multicenter retrospective adult deformity review was performed. Patients included: age >18 years with FC >10°, ≥3 levels of instrumentation, 2-year follow-up, and one of the following: coronal Cobb angle (CCA) > 20°, pelvic incidence and lumbar lordosis (PI-LL) > 10°, pelvic tilt (PT) > 20°, and sagittal vertical axis (SVA) > 5 cm. Results:The FC was treated in 118 patients, 79 open and 39 cMIS. The FCs had similar coronal Cobb angles preoperative (17° cMIS, 19.6° open) and postoperative (7° cMIS, 8.1° open), but open had more levels treated (12.1 vs 5.7). cMIS patients had greater reduction in VAS leg (6.4 to 1.8) than open (4.3 to 2.5). With propensity matching 40 patients for levels treated (cMIS: 6.6 levels, N = 20; open: 7.3 levels, N = 20), both groups had similar FC correction (18° in both preoperative, 6.9° in cMIS and 8.5° postoperative). Open had more posterior decompressions (80% vs 22.2%, P < .001). Both groups had similar preoperative (Visual Analogue Scale [VAS] leg 6.1 cMIS and 5.4 open) and postoperative (VAS leg 1.6 cMIS and 3.1 open) leg pain. All cMIS patients had interbody grafts; 35% of open did. There was no difference in change of primary CCA, PI-LL, LL, Oswestry Disability Index, or VAS Back. Conclusion:Patients' FCs treated with cMIS had comparable reduction of leg pain compared with those treated with open surgery, despite significantly fewer cMIS patients undergoing direct decompression.

BackgroundEndovascular treatment with mechanical thrombectomy (MT) is beneficial for patients with acute stroke suffering a large-vessel occlusion, although treatment efficacy is highly time-dependent. We hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared with direct presentation.MethodsSTRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke because of anterior-circulation large-vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without intravenous tissue plasminogen activator and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0-2) at 90 days. We assessed (1) real-world time metrics of stroke care delivery, (2) outcome differences between direct and transfer patients undergoing MT, and (3) the potential impact of local hospital bypass.ResultsA total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct versus 311.5 minutes for transfer patients (P

Study designRetrospective review.ObjectivesThe goal of this study was to evaluate the baseline characteristics of patients chosen to undergo traditional open versus minimally invasive surgery (MIS) for adult spinal deformity (ASD).MethodsA multicenter review of 2 databases including ASD patients treated with surgery. Inclusion criteria were age >45 years, Cobb angle minimum of 20°, and minimum 2-year follow-up. Preoperative radiographic parameters and disability outcome measures were reviewed.ResultsA total of 350 patients were identified: 173 OPEN patients and 177 MIS. OPEN patients were significantly younger than MIS patients (61.5 years vs 63.74 years, P = .013). The OPEN group had significantly more females (87% vs 76%, P = .006), but both groups had similar body mass index. Preoperative lumbar Cobb was significantly higher for the OPEN group (34.2°) than for the MIS group (26.0°, P < .001). The mean preoperative Oswestry Disability Index was significantly higher in the MIS group (44.8 in OPEN patients and 49.8 in MIS patients, P < .011). The preoperative Numerical Rating Scale value for back pain was 7.2 in the OPEN group and 6.8 in the MIS group preoperatively, P = .100.ConclusionsPatients chosen for MIS for ASD are slightly older and have smaller coronal deformities than those chosen for open techniques, but they did not have a substantially lesser degree of sagittal malalignment. MIS surgery was most frequently utilized for patients with an sagittal vertical axis under 6 cm and a baseline pelvic incidence and lumbar lordosis mismatch under 30°.

In this study the authors compare the radiographic findings of patients undergoing 1-3 level ACDF a rigid CFRP plate and a translational titanium plate system with a focus on radiographic alignment. A retrospective review 70 consecutive patients undergoing a 1 to 3 level ACDF for cervical spondylosis was conducted. 2 groups depending on the cervical plating system were created including 38 patients in group 1 (dynamic plate) and 32 in group 2 (rigid CFRP plate). Plain neutral radiographs preoperatively, immediately after surgery and at most recent follow-up were used to assess parameters on sagittal alignment, fusion height, adjacent segment ossification (ASO), fusion rate and implant failure. There were no significant differences between groups preoperatively. Both groups had a more than 12 months follow-up (p = 0.327). Improvement of C2-7 lordosis was seen in both groups but only in group 1 it reached statistical significance at final follow-up. Significant improvement in sagittal segmental alignment was noted in both groups following surgery. A significant sagittal correction of 5.5 ± 9.1 degrees (p = 0.002) was maintained through follow-up only in group 2. No significantly different was seen for segmental fusion rates and loss of fusion height. There were no instances of implant failure within both groups. Worsening of ASO was 20% for both groups. ACDF allows for correction and maintenance of cervical alignment. Rigid rigid plate appears more effective at maintaining segmental lordotic correction. The fusion rate and implant failure was not different for both groups. [ABSTRACT FROM AUTHOR]