Effectiveness of a New Fibrin Sealant (EVICEL) for Augmentation of Dural Closure: Results of a Preliminary Clinical Study

Abstract:

The authors prospectively evaluated the safety and efficacy of a new fibrin sealant in patients undergoing emergency and elective cranial/spinal surgery with documented cerebrospinal fluid (CSF) leakage after sutured dural repair. This study was designed as a prospective, nonrandomized clinical trial. EVICEL® Fibrin Sealant (Johnson & Johnson, Somerville, NJ) was used in 72 patients with documented intraoperative CSF leakage after neurosurgical dural repair for a variety of pathologies. Intraoperative CSF leakage was either spontaneous or induced by a Valsalva maneuver. Patients were monitored for 1 month postoperatively with physical examinations, clinical laboratory analyses, and diagnostic imaging (CT or MRI). The sealant was effective in closing intraoperative CSF leakage in all patients but one. There were no sealant-related adverse events, and all clinical outcomes were consistent with expectations for seriously ill patients undergoing prolonged neurosurgical procedures. EVICEL® Fibrin Sealant provides a safe and effective watertight closure when used as an adjunct to sutured dural repair during cranial surgery.

Authors:

Roberto Gazzeri, MD, Consultant Neurosurgeon, Department of Neurosurgery, San Giovanni Addolorata Hospital, Rome, Italy, Claudio Fiore, MD, Consultant Neurosurgeon, Department of Neurosurgery, San Giovanni Addolorata Hospital, Rome, Italy, Marcelo Galarza, MD, Consultant Neurosurgeon, Regional Service of Neurosurgery, Virgen de la Arrixaca University Hospital, Murcia, Spain

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Clinical and Radiographic Outcomes after Spinous Process Fixation and Posterior Fusion in an Elderly Cohort

Abstract:

Spinous process fixation (SPF) has gained attention as a less invasive option for lumbar fusion surgery. Minimally invasive techniques are of interest in an elderly population due to decreased surgical time and post-operative complications. Clinical outcomes and fusion rates have not been determined in a large cohort. Our objective was to describe significant predictors of visual analog scale (VAS), length of stay, blood loss, fusion rates, and complication rates for patients treated for degenerative lumbar spondolysis with ISP fixation with and without supplemental instrumentation. Charts were assessed for post-operative VAS vs. pre-operative VAS at: 1-3, >3-6, and >6-12 months. To control confounding variables, VAS scores were modeled as a repeated-measures linear-mixed-model. In a sub-cohort CT images were assessed for interspinous and interbody (IB) fusion. The images were reviewed by an independent radiologist to evaluate fusion status. Eighty-six SPF patients (91 levels, mean age 67 years) were identified. After determining the model, age and sex remained predictors of VAS. Adjusting for age and sex, patients saw a decrease of 3.6 VAS points from baseline to three months (95% CI: 2.9-4.4, p< 0.0001) that was maintained over the six to 12 month follow-up period. A sub-cohort of 50 patients with CT scans were identified and assessed for ISP and IB fusion at a mean of 181 days postoperatively. Ninety-four percent of levels demonstrated ISP fusion. Sixty-one percent of solid ISP fusion patients also had an interbody cage, but this did not impact fusion rates. Eighty-six percent of these levels showed solid IB fusion (BSF-3). Of the four pseudoarthrosed levels, two had pedicle screw fixation, and two were IB and ISP fixation. Only two patients went on to re-exploration and explantation due to pain secondary to spinous process and/or lamina fracture. This elderly cohort treated with SPF demonstrated significant improvement in VAS with reliable fusion rates.

Authors:

Amir Vokshoor, MD, Neurosurgeon, Providence Saint John’s Health Center, Chief of Spine Section, Santa Monica, CA, Sanjay Khurana MD, Orthopedic Spine Surgeon, Saint John’s Health Center, Santa Monica, CA, Dean Wilson, PA-C, Physician Assistant, West Hills Hospital, West Hills, CA, Peter Filsinger MD, Radiologist, Kaiser Permanente Health Center, Woodland Hills, CA

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Assessment of Stresses in the Cervical Spine Caused by Posture and Position of the Head

Abstract:

Preamble. Billions of people are using cell phone devices on the planet, essentially in poor posture. The purpose of this study is to assess the forces incrementally seen by the cervical spine as the head is tilted forward, into worsening posture. This data is also necessary for cervical spine surgeons to understand in the reconstruction of the neck.

Authors:

Kenneth K. Hansraj, MD, Chief of Spine Surgery, New York Spine Surgery & Rehabilitation Medicine, New York, New York

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Use of a Thrombin-gelatin Hemostatic Matrix (Surgiflo) in Spinal Surgery

Abstract:

A variety of techniques have been used to stop venous bleeding from the spinal epidural space. These generally consist of packing with Surgicel®, fibrillar collagen or Gelfoam®. Bipolar coagulation may also be used to control bleeding from spinal venous plexus, but it may bear the risk of healthy nervous tissue injury: dissipation of heat from the tips of the bipolar forceps may induce thermal injury to adjacent neural structures. In the case of intraspinal bleeding, quick and safe hemostasis is mandatory to ensure adequate visualization and safe preparation so as to avoid damaging nerves and spinal medulla. In addition, quick and safe hemostasis reduces the duration of surgery. Efficient control of bleeding can thereby reduce perioperative morbidity. During 6 months, the authors performed more than 170 major spinal surgeries, and in 67 procedures they used injection of thrombin-gelatin hemostatic matrix (Surgiflo, Johnson & Johnson Wound Management, Somerville, NJ) into spinal epidural space to assist in hemostasis. When the venous bleeding continued from the epidural space after packing with hemostatic agents as Surgicel and fibrillar collagen, gelatin matrix was used to stop venous bleeding. In all cases, the results were judged to be excellent, with immediate stoppage of epidural bleeding, or good. No complications related to the thrombin-gelatin hemostatic matrix were encountered. The thrombin-gelatin matrix could represent a valuable tool when other hemostatic strategies are ineffective or suboptimal. It is safe and biocompatible when compared with hemostatic agents currently in use. This is the first study reporting the use of Surgiflo hemostatic matrix in spinal surgery.

Authors:

Roberto Gazzeri, MD, Consultant Neurosurgeon, Department of Neurosurgery, San Giovanni Addolorata Hospital, Rome, Italy, Costanzo De Bonis, MD, Consultant Neurosurgeon, Department of Neurosurgery, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy, Marcelo Galarza, MD, Consultant Neurosurgeon, Regional Service of Neurosurgery, Virgen de la Arrixaca University Hospital, Murcia, Spain

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