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Complications, revision fusions, readmissions, and utilization over a 1-year period after bone morphogenetic protein
Adam P Goode1, William J Richardson2, Robin M Schectman3
1Department of Community and Family Medicine, Duke University School of Medicine, 2200 West Main Street, Durham, NC 27705, USA.
Insights
Bone morphogenetic protein (BMP) use in cervical spine fusions increased complication risks and revision surgeries. This study questions the safety and effectiveness of off-label BMP in primary cervical fusions.
Area of Science:
- Spine surgery
- Biomaterials
- Health outcomes research
Background:
- Nationwide data on bone morphogenetic protein (BMP) use in cervical spine fusions primarily focused on perioperative outcomes.
- Limited understanding exists regarding the long-term risks associated with BMP in these procedures.
Purpose of the Study:
- To assess the 1-year risk of complications, revision cervical spine fusions, and hospital readmissions.
- To evaluate health care services utilization following primary cervical spine fusions with and without BMP.
Main Methods:
- Retrospective cohort study utilizing a nationwide claims database (2002-2009).
- Included 61,937 primary cervical spine fusions (C2-C7), with 1,677 receiving BMP.
- Outcomes analyzed included complications, revision fusions, 30-day readmissions, and healthcare utilization, defined by ICD-9-CM and CPT codes.
Main Results:
- Patients receiving BMP had a significantly higher risk of overall complications (aRR=1.29) and nervous system complications (aRR=1.42).
- BMP use was associated with increased likelihood of cervical revision fusions (aRR=1.69) and 30-day hospital readmissions (aRR=1.37), occurring sooner.
- BMP recipients were more likely to undergo CT scans and receive epidurals, particularly with anterior approaches.
Conclusions:
- Findings suggest increased risks of complications and revision surgeries with BMP use in primary cervical spine fusions.
- The study raises concerns about the safety and effectiveness of off-label bone morphogenetic protein utilization in this patient population.
Background Context:
Nationwide estimates examining bone morphogenetic protein (BMP) use with cervical spine fusions have been limited to perioperative outcomes.
Purpose:
To determine the 1-year risk of complications, cervical revision fusions, hospital readmissions, and health care services utilization.
Study Design:
A retrospective cohort study from 2002 to 2009 using a nationwide claims database.
Patient Sample:
There were 61,937 primary cervical spine fusions of which 1,677 received BMP.
Outcome Measures:
Complications, revision fusions, 30-day hospital readmission, and health care utilization.
Methods:
Data for these analyses come from the Thomson Reuters MarketScan Commercial Claims and Encounters Database 2010. Patients were aged 18 to 64 years, receiving and not receiving BMP with a primary (C2-C7) cervical spine fusion. All outcomes were defined by International Classification of Diseases, 9th edition Clinical Modification and Current Procedural and Terminology, 4th edition codes. Complications were analyzed as any complication and stratified by nervous system, wound, and dysphagia or hoarseness. Cervical revision fusions were determined in the 1-year follow-up. Hospital readmission discharge records defined 30-day hospital readmission and reason for the readmission. The utilization of at least one health care service of cervical spine imaging, epidural usage or rehabilitation service was examined. Poisson regression models were used to estimate the relative risk and 95% confidence interval (CI). Linear regression was used to determine the time to hospital readmission. Results were stratified by anterior or posterior and circumferential approaches.
Results:
Patients receiving BMP were 29% more likely to have a complication (adjusted relative risk [aRR]=1.29 [95% CI, 1.14-1.46]) and a nervous system complication (aRR=1.42 [95% CI, 1.10-1.83]). Cervical revision fusions were more likely among patients receiving BMP (aRR=1.69 [95% CI, 1.35-2.13]). The risk of 30-day readmission was greater with BMP use (aRR=1.37 [95% CI, 1.07-1.73]) and readmission occurred 27.4% sooner on an average. Patients receiving BMP were more likely to receive computed tomography scans (aRR=1.34 [95% CI, 1.06-1.70]) and epidurals with anterior surgical approaches (aRR=1.29 [95% CI, 1.00-1.65]).
Conclusions:
These findings question both the safety and effectiveness of off-label BMP use in primary cervical spine fusions.
