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Ali Chahlavi, Michael P. Steinmetz, Thomas J. Masaryk, and Peter A. Rasmussen

✓ Cerebral venous sinus thrombosis is often difficult to manage. Treatment options include systemically delivered anticoagulation therapy or chemical thrombolysis. Targeted endovascular delivery of thrombolytic agents is currently a popular option, but it carries an increased risk of hemorrhage. These strategies require significant time to produce thrombolysis, often in a patient with a rapidly deteriorating neurological condition. Rapid mechanical recanalization with thrombectomy is therefore very attractive; this procedure provides rapid recanalization with no increased risk of hemorrhage from use of thrombolytic agents. Nevertheless, the rheolytic catheter is large and stiff and may not be able to navigate tortuous intracranial vascular anatomy. The authors present their experience with direct dural sinus mechanical thrombectomy performed using the rheolytic catheter via a transcranial route.

Two patients with dural sinus thrombosis and rapidly deteriorating levels of consciousness underwent unsuccessful attempts at mechanical thrombolysis via the usual transfemoral route. Through a burr hole over the dural sinus, mechanical thrombectomy was subsequently performed using the thrombectomy catheter. Sinus patency was restored following treatment and both patients demonstrated neurological recovery.

Hemorrhage or a rapidly deteriorating neurological condition may preclude the use of systemic or locally delivered thrombolytic agents for the treatment of cerebral venous sinus thrombosis. Mechanical thrombectomy may be the treatment of choice in these circumstances. In patients with limited transfemoral access, a transcranial approach may be used to access the cerebral dural sinuses and thrombectomy may be safely and effectively performed. Further evaluation of this therapy is warranted.

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Domagoj Coric, Ahmad Nassr, Paul K. Kim, William C. Welch, Stephen Robbins, Steven DeLuca, Donald Whiting, Ali Chahlavi, Stephen M. Pirris, Michael W. Groff, John H. Chi, Jason H. Huang, Roland Kent, Robert G. Whitmore, Scott A. Meyer, Paul M. Arnold, Ashvin I. Patel, R. Douglas Orr, Ajit Krishnaney, Peggy Boltes, Yoram Anekstein, and Michael P. Steinmetz

OBJECTIVE

The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial.

METHODS

The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory.

RESULTS

A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°).

CONCLUSIONS

This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.