Usage of recombinant human bone morphogenetic protein in cervical spine procedures: analysis of the MarketScan longitudinal database

J Bone Joint Surg Am. 2014 Sep 3;96(17):1409-16. doi: 10.2106/JBJS.M.01016.

Abstract

Background: Usage of recombinant human bone morphogenetic protein (rhBMP) in anterior cervical discectomy and fusion (ACDF) procedures is controversial. Studies suggest increased rates of dysphagia, hematoma or seroma, and severe airway compromise in anterior cervical spine procedures using rhBMP. The purpose of the present study was to determine and describe national utilization trends and complication rates associated with rhBMP usage in anterior cervical spine procedures.

Methods: The MarketScan database from 2006 to 2010 was retrospectively queried to identify 91,543 patients who underwent ACDF with or without cervical corpectomy. Patient selection and outcomes were ascertained with use of ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) and CPT (Current Procedural Terminology) coding. A total of 3197 patients were treated with rhBMP intraoperatively. Mean follow-up was 588 days (interquartile range [IQR], 205 to 886 days) in the non-treated cohort and 591 days (IQR, 203 to 925 days) in the rhBMP-treated cohort. Multivariate logistic regression as well as propensity score analysis were used to evaluate the association of rhBMP usage with postoperative complications.

Results: In propensity score-adjusted models, rhBMP usage was associated with an increased risk of any complication (odds ratio [OR] = 1.34, 95% confidence interval [CI] = 1.2 to 1.5) and specific complications such as hematoma or seroma (OR = 1.8, 95% CI = 1.4 to 2.3), dysphagia (OR = 1.3, 95% CI = 1.1 to 1.5), and any pulmonary complication (OR = 1.5, 95% CI = 1.2 to 1.8) within thirty days postoperatively. There were no significant differences in the rates of readmission, in-hospital mortality, referral to pain management, new malignancy, or reoperation between the two cohorts. Usage of rhBMP was associated with a mean increase of $5545 (19%) in total payments to the hospital and primary physician (p < 0.001).

Conclusions: We found an increased overall rate of postoperative complications in patients receiving rhBMP for cervical spinal fusion procedures compared with patients not receiving rhBMP. Hematoma or seroma, pulmonary complications, and dysphagia were also more common in the rhBMP cohort. Usage of rhBMP in a case was associated with $311 greater payments to the surgeon and $4213 greater payments to the hospital.

Level of evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adult
  • Aged
  • Bone Morphogenetic Proteins / adverse effects*
  • Bone Morphogenetic Proteins / therapeutic use
  • Cervical Vertebrae / drug effects*
  • Cervical Vertebrae / physiopathology
  • Cervical Vertebrae / surgery*
  • Combined Modality Therapy
  • Databases, Factual
  • Diskectomy / adverse effects
  • Diskectomy / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Logistic Models
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Postoperative Complications / epidemiology
  • Postoperative Complications / physiopathology
  • ROC Curve
  • Recombinant Proteins / therapeutic use
  • Spinal Diseases / drug therapy
  • Spinal Diseases / surgery
  • Spinal Fusion / adverse effects
  • Spinal Fusion / methods*
  • Treatment Outcome

Substances

  • Bone Morphogenetic Proteins
  • Recombinant Proteins