An open-label, randomized, parallel-group study of perioperative epoetin alfa versus standard of care for blood conservation in major elective spinal surgery: safety analysis.

STUDY DESIGN: Prospective, open-label, randomized, parallel-group study at 80 centers. OBJECTIVE: To demonstrate there is no clinically important additional risk for deep vein thrombosis with perioperative use of epoetin alfa versus standard of care in spine surgery without prophylactic anticoagulation. SUMMARY OF BACKGROUND DATA: Trials of epoetin alfa in orthopedic surgery that demonstrated no additional risk of thrombovascular events included perioperative pharmacologic anticoagulation. METHODS: Subjects received epoetin alfa 600 U/kg subcutaneously once weekly starting 3 weeks before spinal surgery plus standard of care for blood conservation, or standard of care alone. Perioperative anticoagulation therapy was not permitted; mechanical deep vein thrombosis prophylaxis was allowed. Doppler imaging for deep vein thrombosis was done on postoperative day 4 (or day of discharge), or for suspected deep vein thrombosis. Deep vein thrombosis was diagnosed by Doppler result or adverse event report. The criterion for no additional risk of deep vein thrombosis was a 1-sided 97.5% upper confidence limit < or =4% between groups. RESULTS: Of the 680 subjects analyzed (340 in each treatment group), 16 (4.7%) in the epoetin alfa group and 7 (2.1%) in the standard of care group had a diagnosis of deep vein thrombosis either by Doppler or by adverse event report with normal Doppler. The between-group difference was 2.6% (97.5% upper confidence limit, 5.4%). Deep vein thrombosis confirmed by Doppler (4.1% vs. 2.1%), other clinically relevant thrombovascular events (1.5% vs. 0.9%), and all adverse events combined (76.5% vs. 73.2%) occurred with similar frequency in the 2 treatment groups. CONCLUSION: This study documented a higher incidence of deep vein thrombosis and similar rates of other clinically relevant thrombovascular events with epoetin alfa versus standard of care for blood conservation in subjects who did not receive prophylactic anticoagulation before spinal surgery. Antithrombotic prophylaxis should be considered when erythropoietin is used in the surgical setting.

Use of somatosensory evoked potentials to detect peripheral ischemia and potential injury resulting from positioning of the surgical patient: case reports and discussion.

BACKGROUND: Somatosensory evoked potentials (SSEPs) have long been recognized as an excellent tool for detecting neural and vascular compromise during vascular, neurosurgical and orthopedic procedures. SSEPs have the ability to localize, central versus peripheral, the area of compromise. Many surgeons use only lower-limb SSEP monitoring when performing lumbar spinal surgery. The upper extremities are usually not monitored during such procedures, and monitoring oxygen saturation does not detect neural compromise. PURPOSE: To report that the expanded use of SSEP monitoring during surgery can be beneficial in detecting peripheral ischemia or neural compromise resulting from positioning. STUDY DESIGN: Three case reviews of orthopedic spine surgeries where SSEP monitoring provided early warnings of vascular and neural compression. METHODS: The cases review three different lumbar procedures in which evidence of peripheral ischemia and nerve compression were detected by SSEP monitoring. RESULTS: By the use of upper- and lower-extremity monitoring during lumbar procedures, early detection of ischemia and nerve compression were noted intraoperatively. These changes prompted examination of the patient and repositioning to correct the ischemia or compression. The repositioning in these cases corrected the problem, and no lasting effects were found. CONCLUSIONS: Including SSEP monitoring of the bilateral upper extremities should be considered during lumbar spinal procedures. Such monitoring can be offered for a slightly increased expense and only minimal time delay to place the additional required electrodes by the technician. As a direct result of the early warning of the SSEP monitoring, we were able to avoid potential ischemic injuries and improve patient outcomes.

Interpositional arthroplasty (Jones technique) for the treatment of herniated lumbar disks: a modification of the soft posterior lumbar interbody fusion.

Sixty-six patients underwent posterior lumbar interpositional arthroplasty using a combination of calcium sulfate pellets, decompression bone, and autologous growth factors. Patients who underwent this modification of the soft posterior lumbar interbody fusion (PLIF) (Jones technique) were evaluated using clinical and radiographic ratings. The Jones technique produced significantly improved clinical pain scores in all patients, reducing back pain by 71% and leg pain by 90%. Furthermore, 93% of patients achieved at least 50% opacity of the disk space area. The Jones technique for the soft PLIF provided reduction of pain and stabilized the disk space height in addition to decreasing morbidity and cost.