Introduction: Recombinant human bone morphogenetic protein (BMP) is used within the lumbar spine at substantial rates, with most utilization off label. BMP use in anterior cervical discectomy and fusions (ACDF) is controversial. Studies suggest increased rates of dysphagia, soft-tissue hematoma, and severe airway compromise in cervical procedures using BMP. An FDA “black box” warning cautioning the use of BMP in cervical cases was issued in 2008. This study describes national utilization trends and incidence of complications associated with BMP use in anterior cervical spine procedures.
Methods: Between 2006-2010, 91,543 patients were recorded for ACDF and/or cervical corpectomy in the Thomson Reuters Marketscan database. Patient selection and outcome measures were ascertained using ICD-9 and CPT coding. 3,197 patients were treated with BMP intra-operatively. Mean follow-up was 588 days in the non-treated group and 591 days in the BMP-treated group.
Results: BMP was utilized at higher rates in multi-level (OR:1.2,95%CI 1.1-1.8,p<0.0001) and instrumented cervical procedures (OR:1.7,95%CI 1.4-2.1,p<0.0001). At 30-days post-operation BMP utilization increased the risk of any complication (OR:1.4,95%CI 1.2-1.5,p<0.0001) and specific complications such as wound hematoma (OR1.7 95%CI 1.3-2.3, p=0.0007), dysphagia (OR:1.3,95%CI 1.1-1.6,p=0.002), new chronic pain (OR:1.4,95%CI 1.0-1.9,p=0.04), and any pulmonary complication (OR:1.5,95%CI 1.2-1.8,p=0.0005). There was no statistical difference in re-admission rates, mortality, referrals to pain management, new malignancies or overall re-operation rates between the two groups. The BMP-treated group demonstrated higher rates of pseudoarthrosis (OR:1.5,95%CI 1.3-1.8,p<0.0001) and a mean increase in total case payment of $5,546 (19% increase,p<0.001)
Conclusions: In this national database study on cervical spine procedures, we report higher rates of post-operative complications in ACDF patients receiving BMP. Adverse events including pseudoarthrosis, wound hematoma, and dysphagia were more common in the BMP cohort. BMP did not reduce the need for revision procedures. BMP effectiveness in the cervical spine remains controversial, although increased costs with its use appear clear.
Patient Care: Use of BMP in anterior cervical spine procedures is controversial and has recently been associated with increased risk of dysphagia, soft-tissue hematoma, and new malignancies. A nationwide, administrative database study has yet been completed and will shed light on utilization rates and complication rates from data in the United States.
Learning Objectives: By the conclusion of this session, participants should be able to: 1) Describe the importance of BMP usage in anterior cervical spine procedures, 2) Discuss, in small groups, the pros and cons, as well as indications and complications, associated with BMP use in ACDF, from national data, 3) Identify an effective treatment that may not involve BMP usage for anterior cervical spine fusion.