Insights into complication rates, reoperation rates, and healthcare utilization associated with use of recombinant human bone morphogenetic protein–2 in patients with spine infections

Abstract

<jats:sec><jats:title>OBJECTIVE</jats:title><jats:p>Use of recombinant human bone morphogenetic protein–2 (rhBMP-2) in patients with spine infections is controversial. The purpose of this study was to identify long-term complications, reoperations, and healthcare utilization associated with rhBMP-2 use in patients with spine infections.</jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p>This retrospective study extracted data using ICD-9/10 and CPT codes from MarketScan (2000–2016). Patients were dichotomized into 2 groups (rhBMP-2, no rhBMP-2) based on whether rhBMP-2 was used during fusion surgery for spinal infections. Outcomes of interest were reoperation rates (index level, other levels), readmission rates, discharge disposition, length of stay, complications, and healthcare resource utilization at the index hospitalization and 1, 3, 6, 12, and 24 months following discharge. Outcomes were compared using nonparametric 2-group tests and generalized linear regression models.</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>The database search identified 2762 patients with &gt; 24 months’ follow-up; rhBMP-2 was used in 8.4% of their cases. The patients’ median age was 53 years, 52.43% were female, and 15.11% had an Elixhauser Comorbidity Index ≥ 3. Patients in the rhBMP-2 group had higher comorbidity indices, incurred higher costs at index hospitalization, were discharged home in most cases, and had lower complication rates than those in the no–rhBMP-2 group. There was no statistically significant between-groups difference in complication rates 1 month following discharge or in reoperation rates at 3, 6, 12, and 24 months following the procedure. Patients in the no–rhBMP-2 group incurred higher utilization of outpatient services and medication refill costs at 1, 3, 6, 12, and 24 months following surgery.</jats:p></jats:sec><jats:sec><jats:title>CONCLUSIONS</jats:title><jats:p>In patients undergoing surgery for spine infection, rhBMP-2 use was associated with lower complication rates and higher median payments during index hospitalization compared to cases in which rhBMP-2 was not used. There was no significant between-groups difference in reoperation rates (index and other levels) at 3, 6, 12, and 24 months after the index operation. Patients treated with rhBMP-2 incurred lower utilization of outpatient services and overall payments. These results indicate that rhBMP-2 can be used safely in patients with spine infections with cost-effective utilization of healthcare resources and without an increase in complications or reoperation rates.</jats:p></jats:sec>

Demographics and Outcomes of Spine Surgery in Octogenarians and Nonagenarians: A Comparison of the National Inpatient Sample, MarketScan and National Surgical Quality Improvement Program Databases

“…Incorporation of national databases into research has substantially increased in the past few years [2,3,6,13,14]. Although these large sample sizes offer researchers opportunities to investigate rare diseases, the statistically significant results are nevertheless susceptible to type I errors, or false-positive results [1].…”

BMP and TGFβ use and release in bone regeneration

“…There are also various applications of BMPs and TGFβs in clinics with carrier molecules [51,[75][76][77][78][79][80][81][82][83][84]. However, the locally applied supraphysiological BMP-2 doses during surgery is reported to be connected with hematoma formation in soft tissue, increased inflammatory response, bone cysts and infection [85] which also increase the importance of clinical follow-up studies.…”

“…Also, the delayed healing rate was reported to be in the range of 16%-60% for less severe fractures and 43%-10% for more severe fractures and the nonunion rate is reported to be 4%-10% [89]. In addition to postoperative problems or complications, the economic side of these surgeries and instrumentations as well as composites is another problem that we have to face in clinic [79,91].…”

“…Nevertheless, these complications did not prevent the use of these cytokines in the clinics because the clinical studies showed better results with BMP-2 than autogenous bone grafting alone [20,92]. The advantage of increased rate in spinal fusion with the combination of BMPs [20,56,76,78,79,91] and BMPs' having high capacity for bone regeneration and capability of fracture healing keep them popular in bone regeneration studies and make them a popular research area also in basic science in order to find suitable carriers for these cytokines to be released in a sustained manner with a decrease in required dose for bone regeneration. Thus, it is an important research area to find new materials to fill bone defects and/or to support the instruments that are used to stabilize the bone while supporting bone regeneration and the sustained release of the cytokine and/or to understand the signaling pathways of cytokines, how they work in cellular level on differentiation and proliferation in order to prevent the probable progression of a disease before it needs a replacement surgery.…”

Health Care Utilization in Patients Undergoing Repeat Stereotactic Radiosurgery for Vestibular Schwannoma with 5-Year Follow-up: A National Database Analysis

“…19 The MarketScan database represents a substantial clinical population with longitudinal analysis capability as previously described. 20,21 However, one limitation is the generalizability of study results because the cohort is a nonrandom sample and a retrospective observational study. The window of analysis is also limited given resources of the MarketScan search that does not include data beyond 2016.…”