Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.

While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines.

Intraoperative MRI with a rotating, tiltable surgical table: a time use study and clinical results in 122 patients.

OBJECTIVE: The objective of our study was to evaluate intraoperative low-field MRI for the frequency and duration of imaging sessions needed during surgery, the direct additional procedure time attributable to imaging, and the proportion of cases in which information provided by intraoperative MRI led to a change in the procedure or otherwise was deemed valuable by operating surgeons. MATERIALS AND METHODS: One hundred twenty-two patients (65 males, 57 females; age range, 6-77 years; mean age, 43.8 years) underwent 130 neurosurgical and ENT procedures (106 craniotomies, 17 transsphenoidal pituitary resections, three biopsies, three intracranial cyst aspirations or injections, and one skull base resection) in a specially designed surgical MRI suite equipped with a 0.2-T imager and a prototype rotating, tiltable surgical table. The intraoperative MR sequences included free induction with steady-state precession (fast imaging with steady-state precession [FISP]), steady-state free precession T2-weighted, reverse fast imaging with steady-state free precession (PSIF), FLASH, spin-echo T1-weighted, turbo spin-echo (TSE) T2-weighted, and TSE FLAIR. Each case was analyzed for the number of imaging sessions, duration of each session, total imaging time during surgery, and impact of imaging information on procedure. RESULTS: Each patient underwent between one and five intraor postoperative imaging sessions. Imaging times were 1.7 seconds-8 minutes 31 seconds per sequence. The mean total imaging time was 35 minutes 17 seconds per surgical procedure. Imaging was continuous during biopsy and cyst aspiration procedures and averaged 200.67 and 54.66 minutes, respectively. Additional surgical resection based on intraoperative imaging findings was performed in 72.8% of the cases. CONCLUSION: Intraoperative low-field MRI provides valuable information for surgical decision making that is predominantly related to detection of residual tumor and the exclusion of complications. The benefits of this technology surpass the time cost associated with its implementation when using proper imaging strategies.

Cervicomedullary junction compression caused by vertebral artery dolichoectasia and requiring surgical treatment. Case report.

A case of progressive brainstem syndrome secondary to vertebral artery (VA) dolichoectasia is reported. The patient presented with partial bilateral abduction paralysis, which progressed to quadriparesis, ataxia, and areflexia. The initial diagnosis was stroke, but because of the patient's deterioration, a diagnosis of Miller-Fisher syndrome was made. Neuroimages obtained at that time revealed an ectatic left VA with minimal cervicomedullary compression. The patient continued to deteriorate despite medical management. Follow-up imaging demonstrated worsened cervicomedullary compression. An emergency posterior fossa neurovascular decompression was performed using a Gore-Tex sling and resulted in mild neurological improvement. This case emphasizes that early recognition and surgical intervention to prevent progressive neurological sequelae are crucial in symptomatic VA dolichoectasia.