Multiple-Day Drainage when Using Bone Morphogenic Protein for Long-Segment Thoracolumbar Fusions Is Associated with Low Rates of Wound Complications

Saulle, Dwight; Fu, Kai-Ming; Shaffrey, Christopher I.; Smith, Justin S.

doi:10.1016/j.wneu.2012.08.003

Cited by 9 publications

(3 citation statements)

References 19 publications

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“…45,46 There have been numerous reports on adverse effects associated with the off-label use of rhBMP-2 in spine surgery: heterotopic ossification, osteolysis, seroma, infection, increased neurologic deficits, dysphagia in anterior cervical surgery, and cancer. 14,47,48 However, a multicenter study of 279 consecutive ASD surgeries suggested that rhBMP-2 did not increase acute major, neurologic, or wound complications. 49 Furthermore, The Scoliosis Research Society retrospectively reviewed a database of 55,862 spinal fusion surgeries and found no statistical difference in the overall complication rates or the rates of deep or superficial wound infections and hematoma/ seroma formation between the patients with or without BMP.…”

Section: Discussionmentioning

confidence: 99%

Trends of Posterior Long Segment Fusion with and without Recombinant Human Bone Morphogenetic Protein 2 in Patients with Scoliosis

Yin

Cohen

Buser

et al. 2015

Global Spine Journal

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Study Design Retrospective study.Objective Symptomatic scoliosis can be a source of severe pain and disability. When nonoperative treatments fail, spine fusion is considered as an effective procedure in scoliosis management. The purpose of this study was to evaluate the trends of patients with scoliosis undergoing posterior long segment fusion (PLSF) with and without recombinant human bone morphogenetic protein 2 (rhBMP-2).Methods Patients within the orthopedic subset of Medicare database undergoing PLSF from 2005 to 2011 were identified using the PearlDiver Patient Records Database. Both diagnosis and procedural International Classification of Diseases, ninth edition and Current Procedural Terminology codes were used. The year of procedure, age, sex, region, and rhBMP-2 use were recorded.Results In total, 1,265,591 patients with scoliosis were identified with 29,787 PLSF surgeries between 2005 and 2011. The incidence of PLSF procedures increased gradually from 2005 to 2009, decreased in 2010 (p < 0 0.01), and grew again in 2011. Patients over age 84 years had the highest incidence of PLSF. The lowest incidence of the procedures was in the Northeast, 5.96 per 100,000 patients. Sex differences were observed with a male-to-female ratio of 0.40 (p < 0.01). The use of rhBMP-2 for PLSF increased steadily from 2005 to 2009; the numbers dropped dramatically in 2010 and returned by 2011.Conclusions According to our study, patients with scoliosis demonstrated a 0.6575 average incidence increase of PLSF treatments annually. There were significant differences in incidence of PLSF procedure and patient demographics. Additionally, rhBMP-2 consumption significantly changed when we stratified it by sex, age, and region respectively.

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Section: Discussionmentioning

confidence: 99%

Trends of Posterior Long Segment Fusion with and without Recombinant Human Bone Morphogenetic Protein 2 in Patients with Scoliosis

Yin

Cohen

Buser

et al. 2015

Global Spine Journal

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“…The most commonly reported complications reflected the same proinflammatory and bone induction properties of BMP that led to fusion healing. There were reports of increased wound drainage [6], bony erosion around anterior fusion cages [7], and heterotopic ossification, sometimes causing radiculopathy [8,9]. The most serious concerns were related to anterior cervical fusion complicated by prevertebral edema, airway obstruction, re-intubation, and even death [10].…”

Section: Introductionmentioning

confidence: 99%

Changes in Recombinant Human Bone Morphogenetic Protein-2 Use in Posterior Fusion Over the Past Two Decades

Nabizadeh

Glassman

Djurasovic

et al. 2021

Cureus

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BackgroundIn 2011, studies suggested that complications and cancer rates associated with bone morphogenetic protein (BMP) were greater than previously reported. However, later studies reported complication rates similar to prior literature and no increased cancer rate. We evaluated the pattern of clinical utilization of BMP in posteriorly based lumbar fusion by comparing two periods: 2002-2004 and 2017-2019. MethodsPatients who received BMP from 2002-2004 (Early) and 2017-2019 (Late) from a single multi-surgeon institution who had a lumbar fusion were identified. One hundred patients from each cohort were randomly selected. Mean total BMP used at each level and the proportion of BMP placed in the interbody space versus posterolateral gutters were evaluated. ResultsIn the transforaminal lumbar intebody fusion (TLIF) cohort, the total BMP dose in the Late group (6.15 mg) was nearly half of that used in the Early group (12.04 mg, p<0.000). The amount of BMP used in the posterolateral gutters remained similar (Early: 4.01 mg vs Late: 3.38 mg, p=0.222). The amount of BMP used in the interbody space was less in the Late group (2.76 mg) compared to the Early group (8.03 mg, p<0.000). In the posterior spinal fusion (PSF) cohort, the total BMP dose remained similar between the Early (11.96 mg) and the Late groups (10.82 mg, p=0.007). ConclusionChange in the use of BMP in TLIF cases was driven by the complications reported in the literature with no change in outcome. A similar impetus was not seen for PSF.

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“…4 Other authors have also reviewed the literature and reported similar findings, highlighting the increasing trend of off-label rhBMP-2 usage for spinal arthrodesis. [8][9][10] When off-label rhBMP-2 is used in the anterior cervical spine, some authors have hypothesized that the putative inflammatory effect (which contributes to the effectiveness of rhBMP-2 for arthrodesis) may spread to adjacent cervical structures and lead to increased postoperative morbidity (e.g., hematoma/seroma, cervical swelling, dysphagia). 2 Notably, a study by Shields et al demonstrated high complication rates in patients undergoing ACF with high-dose rhBMP-2 (2.1 mg/level).…”

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confidence: 99%

Editorial. Anterior cervical fusion and rhBMP-2: a prospective study is needed to assess optimal dosing and delivery

Buell¹,

Shaffrey²

2021

Neurosurgical Focus

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Some prior reports have suggested that the use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in anterior cervical fusion (ACF) may be beneficial in select patients with risk factors for developing pseudarthrosis. 1 However, other reports have provided evidence to suggest that there is potential for high complication rates (e.g., hematoma/seroma, cervical swelling, dysphagia) when using rhBMP-2 for ACF. 2 As such, there are currently no clear guidelines or definitive recommendations regarding the usage of rhBMP-2 in patients undergoing ACF. The explanation for some of the discrepancies from prior rhBMP-2/ACF reports is likely multifactorial but could potentially be attributed to nonstandardized dosing and delivery of rhBMP-2. [1][2][3][4] To address this important topic, Mendenhall et al. performed a retrospective study to evaluate the safety and efficacy of low-dose rhBMP-2 for use in patients undergoing ACF (both anterior cervical discectomy and corpectomy). 5 The authors hypothesized that the higher doses of rhBMP-2 used in prior ACF studies may have led to the higher complication rates observed.In this study, Mendenhall and colleagues included a total of 198 patients (62 [31%] were smokers) who underwent stand-alone ACF (median of 2 levels fused; mean rhBMP-2 dose 0.50 ± 0.09 mg/level; both contained and noncontained delivery devices were used). The authors reported associated complications and fusion rates with a minimum of 1 year of radiographic follow-up. Briefly, 22 (11%) patients experienced dysphagia, 11 (6%) patients experienced cervical swelling, 2 (1%) patients underwent washout for hematoma, 1 (0.5%) patient had washout for seroma, 2 (1%) patients had pseudarthrosis requiring posterior cervical fusion, and 3 (2%) patients experienced a new postoperative neurological deficit (which was reported to have recovered by the last follow-up). Regarding rates of arthrodesis, study results demonstrated that 190 (96%) patients had solid arthrodesis over an average of 15 months of follow-up (with no statistically significant difference in fusion rates between smokers and nonsmokers). After carefully analyzing these study results, the authors

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Multiple-Day Drainage when Using Bone Morphogenic Protein for Long-Segment Thoracolumbar Fusions Is Associated with Low Rates of Wound Complications

Cited by 9 publications

References 19 publications

Trends of Posterior Long Segment Fusion with and without Recombinant Human Bone Morphogenetic Protein 2 in Patients with Scoliosis

Trends of Posterior Long Segment Fusion with and without Recombinant Human Bone Morphogenetic Protein 2 in Patients with Scoliosis

Changes in Recombinant Human Bone Morphogenetic Protein-2 Use in Posterior Fusion Over the Past Two Decades

Editorial. Anterior cervical fusion and rhBMP-2: a prospective study is needed to assess optimal dosing and delivery

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