Twenty-Year Retrospective Analysis of Bone Morphogenetic Protein (BMP) Use in Anterior Cervical Fusion: Incidence of Severe Dysphagia and Airway Complications in a Single-Surgeon Study.

IF 1.9 4区 医学 Q3 CLINICAL NEUROLOGY
Brianna N Hebeka, Jennifer A Reilly, Amaya J Jones, Charles C Edwards
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引用次数: 0

Abstract

Study design: Retrospective, nonrandomized.

Objective: The objective of this study is to assess the incidence of severe swallowing and airway complications in patients who underwent anterior cervical discectomy and fusion (ACDF) with low-dose bone morphogenetic protein (BMP) by a single surgeon.

Summary of background data: The FDA released a black box warning against the use of BMP in ACDF surgeries in 2008, but few studies have reported the incidence of complications cited in the warning. Further, few studies have longitudinally tracked the use of low-dose BMP in the cervical spine and reported complication rates. This study aims to fill a gap in the literature by providing a 20-year longitudinal review of the use of low-dose BMP by a single surgeon.

Methods: The retrospective analysis assessed patients who underwent ACDF surgeries from 2003 to 2023 by a single surgeon. Patient demographics and surgical characteristics were identified. Complications, as defined by the FDA Black Box Warning, were prospectively recorded. Statistical analysis included binary logistic regressions to predict complications.

Results: One thousand ten patients were included in this study. 2.2% of the patients developed a Black Box Complication. In response to these complications, 1.5% of patients received intravenous steroids, 0.2% of patients were reintubated, 0.2% of patients underwent second surgeries to drain the surgical site, and 2.1% of patients were readmitted for swallowing or airway complications. No patients required a tracheostomy.

Conclusions: The complication rates of the current study are comparable to the published rates of ACDF procedures without BMP. Given the current study and the growing body of evidence supporting the safety and efficacy of low-dose BMP, categorical cautions against the use of BMP in the cervical spine should be reconsidered.

Level of evidence: Level III.

骨形态发生蛋白(BMP)用于颈椎前路融合术的20年回顾性分析:一项单外科医生研究中严重吞咽困难和气道并发症的发生率。
研究设计:回顾性、非随机。目的:本研究的目的是评估单个外科医生行低剂量骨形态发生蛋白(BMP)颈前路椎间盘切除术和融合(ACDF)患者严重吞咽和气道并发症的发生率。背景资料摘要:FDA在2008年发布了一个关于在ACDF手术中使用BMP的黑框警告,但很少有研究报道警告中提到的并发症的发生率。此外,很少有研究纵向追踪低剂量BMP在颈椎中的应用并报道并发症发生率。本研究旨在通过对单个外科医生使用低剂量BMP的20年纵向回顾来填补文献空白。方法:回顾性分析2003 ~ 2023年同一外科医生行ACDF手术的患者。确定患者人口统计学和手术特征。根据FDA黑盒警告定义的并发症被前瞻性记录。统计分析采用二元logistic回归预测并发症。结果:共纳入1010例患者。2.2%的患者出现黑箱并发症。针对这些并发症,1.5%的患者接受静脉注射类固醇,0.2%的患者重新插管,0.2%的患者进行第二次手术以引流手术部位,2.1%的患者因吞咽或气道并发症再次入院。没有病人需要气管切开术。结论:当前研究的并发症发生率与已发表的无BMP的ACDF手术的发生率相当。鉴于目前的研究和越来越多的证据支持低剂量BMP的安全性和有效性,应该重新考虑对颈椎使用BMP的明确警告。证据等级:三级。
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来源期刊
Clinical Spine Surgery
Clinical Spine Surgery Medicine-Surgery
CiteScore
3.00
自引率
5.30%
发文量
236
期刊介绍: Clinical Spine Surgery is the ideal journal for the busy practicing spine surgeon or trainee, as it is the only journal necessary to keep up to date with new clinical research and surgical techniques. Readers get to watch leaders in the field debate controversial topics in a new controversies section, and gain access to evidence-based reviews of important pathologies in the systematic reviews section. The journal features a surgical technique complete with a video, and a tips and tricks section that allows surgeons to review the important steps prior to a complex procedure. Clinical Spine Surgery provides readers with primary research studies, specifically level 1, 2 and 3 studies, ensuring that articles that may actually change a surgeon’s practice will be read and published. Each issue includes a brief article that will help a surgeon better understand the business of healthcare, as well as an article that will help a surgeon understand how to interpret increasingly complex research methodology. Clinical Spine Surgery is your single source for up-to-date, evidence-based recommendations for spine care.
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