Complications of rhBMP-2 utilization for posterolateral lumbar fusions requiring reoperation: a single practice,retrospective case series report

Background context

Recombinant human bone morphogenetic protein-2 (rhBMP-2) (INFUSE, Medtronic, Memphis, TN, USA) has been used off-label for posterolateral lumbar fusions for many years.

Purpose

The goal of this study was to evaluate the complications requiring reoperation associated with rhBMP-2 application for posterolateral lumbar fusions.

Study design/setting

During a 7-year period of time (2002–2009), all patients undergoing lumbar posterolateral fusion using rhBMP-2 (INFUSE) were retrospectively evaluated within a large orthopedic surgery private practice.

Patient sample

A total of 1,158 consecutive patients were evaluated with 468 (40.4%) males and 690 (59.6%) females.

Outcome measures

Complications related to rhBMP were defined as reoperation secondary to symptomatic failed fusion (nonunion), symptomatic seroma formation, symptomatic reformation of foraminal bone, and infection.

Methods

Inclusion criteria were posterolateral fusion with rhBMP-2 implant and age equal to or older than 18 years. Surgical indications and treatment were performed in accordance with the surgeon's best knowledge, discretion, and experience. Patients consented to lumbar decompression and arthrodesis using rhBMP-2. All patients were educated and informed of the off-label utilization of rhBMP-2. Patient follow-up was performed at regular intervals of 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and later if required or indicated.

Results

Average age was 59.2 years, and body mass index was 30.7 kg/m². Numbers of levels fused were 1 (414, 35.8%), 2 (469, 40.5%), 3 (162, 14.0%), 4 (70, 6.0%), 5 (19, 1.6%), 6 (11, 0.9%), 7 (7, 0.6%), 8 (4, 0.3%), and 9 (2, 0.2%). Patients having complications requiring reoperation were 117 of 1,158 (10.1%): symptomatic nonunion requiring redo fusion and instrumentation 41 (3.5%), seroma with acute neural compression 32 (2.8%), excess bone formation with delayed neural compression 4 (0.3%), and infection requiring debridement 26 (2.2%). Nonunion was related to male sex and previous BMP exposure. Seroma formation was significantly higher in patients with higher doses of rhBMP-2 (p=.050) and with more than 12 mg of rhBMP-2 (χ²=0.025). Bone reformation and neural compression at the laminectomy and foraminotomy sites occurred in a delayed fashion. Infection was associated with obesity and respiratory disease. Infections were noted with a greater BMP dose (p<.001), more than 12 mg (χ²<0.001), fusion more than three levels (χ²<0.001), and reexposed to BMP (χ²=0.023).

Conclusions

rhBMP-2 utilization for posterolateral lumbar fusions has a low symptomatic nonunion rate. Prior rhBMP-2 exposure and male sex were related to symptomatic nonunion formation. rhBMP-2–associated neural compression acutely with seroma formation and delayed with foraminal bone formation is concerning and associated with higher rhBMP-2 concentrations.     

多次手术与腹股沟疝术后血清肿关系的临床分析

目的探讨血清肿的发生与手术创伤的关系。方法选取腹股沟疝手术患者93例,所有患者均完整剥除疝囊,分成3组。A组:应用普里灵疝修补装置的无张力修补术38例;B组:复发疝2次手术组,第1次手术采用前入路传统疝修补术而复发,第2次采用前入路采用普里灵疝修补装置,共30例;C组:复发疝3次手术,第1次及第2次手术采用前入路传统疝修补术而复发,本次采用前入路手术应用普里灵疝修补装置的无张力修补术,共25例;以手术次数代表手术创伤大小,观察与血清肿发生率的关系。结果A组无血清肿发生,B组血清肿发生率为26.7%,C组血清肿发生率为40%。结论手术次数增加导致的腹股沟解剖结构紊乱使手术创伤增加,并与血清肿的发生有关。     

乳腺癌术后皮下积液的预防及护理

目的 探讨乳腺癌患者术后皮下积液的预防及护理.方法 回顾性分析我院2004年6月～2006年10月间103例乳腺癌患者术后皮下积液情况.结果 103例乳腺癌患者术后出现皮下积液20例（19.4%）,最短半月,最长4月.经对症处理,皮下积液均消失.结论 乳腺癌术后皮下积液是常见并发症,护理人员的水平对预防乳腺癌术后皮下积液的发生有重要作用.     

聚桂醇治疗腹腔镜经腹腹膜前疝修补术后Ⅳ型血清肿及残壁囊肿的疗效

目的观察聚桂醇在腹腔镜经腹腹膜前疝修补术（laparoscopic trans-abdominal preperitoneal hernia repair，TAPP）后并发Ⅳ型血清肿及残壁囊肿的疗效。 方法选取2013年3月至2016年3月，贵阳中医学院第二附属医院腹股沟疝术后并发Ⅳ型血清肿或疝囊残壁囊肿患者10例，经抽净液体后注入适量聚桂醇注射液，并留置囊内或术区，术区加压。 结果本组10例患者注药治疗后出现1例阴囊疼痛、注射针孔少量渗血，通过对症处理后24 h症状消失。9例患者未发生注药后出血、疼痛、感染、补片与聚桂醇相互反应及不缓解等症状及现象。分别于治疗1、3、6、12个月后复查，均未见复发。 结论聚桂醇在腹股沟疝术后并发Ⅳ型血清肿或残壁囊肿具有效果好、不良反应少、安全性高、复发率低的特点，是治疗腹股沟疝术后并发血清肿或残壁囊肿的有效方法。     

The achilles heel of minimally invasive inguinal lymph node dissection: Seroma formation

ObjectiveTo describe the incidence of post-operative seroma and interventions attempted to reduce this complication in patients undergoing minimally invasive inguinal lymph node dissection (MILND).BackgroundMILND has resulted in fewer wound complications, hospital readmissions, and shorter length of stay; unfortunately, seroma formation remains a major source of morbidity.MethodsA retrospective study of MILNDs performed from 2010 to 2017 was conducted. Different interventions were trialed attempting to combat this problem. We report the analysis with respect to seroma formation.ResultsForty-one patients underwent 44 MILND. Twenty-two (50%) patients developed symptomatic seroma requiring aspiration and/or drain placement. Risk factors associated with seroma on univariate analysis were increased number of metastatic nodes (p = 0.028), increasing BMI (p = 0.046), increasing age (p = 0.056), and larger suction drain bulbs (p = 0.013). There was an association with postoperative seroma formation and post-operative lymphedema (p = 0.001). Multiple interventions trialed to reduce seroma formation were unsuccessful in reducing the seroma rate.ConclusionSeromas formation continues to be a common morbidity following MILND. Further research is needed to determine how seroma incidence can be reduced in patients undergoing MILND.     

四维CT测得部分乳腺外照射者基于金属夹与血清肿确定术腔体积及位置关系比较研究

目的 比较部分乳腺外照射患者四维CT (4DCT)测得的基于金属夹与血清肿所确定的术腔体积及位置关系。方法 在15例乳腺癌患者4DCT 图像上分别基于术腔各边界金属夹、血清肿、结合金属夹和血清肿勾画大体肿瘤体积并定义为GTV_C、GTV_S和GTV_C+S。测定GTV_C、GTV_S和GTV_C+S的体积、适形指数(CI)及三者间包含度(DI)。三者间体积、CI值比较行方差分析,DI值比较采用配对t检验,DI、CI值与靶区中心间距相关分析用Pearson法。结果 GTV_C、GTV_S和GTV_C+S的体积分别为23.15、19.27 cm³和24.60 m³(P=0.000)。GTV_C与GTV_S、GTV_C与GTV_C+S、GTV_S与GTV_C+S间的CI分别为0.36、0.60、0.53(P=0.000)。DI显示GTV_S对GTV_C的优于GTV_C对GTV_S的(0.67比0.48,P=0.000),GTV_C对GTV_C+S的优于GTV_C+S对GTV_C的(0.82比0.71, P=0.000),GTV_S对GTV_C+S的优于GTV_C+S对GTV_S的(0.91比0.52,P=0.000)。DI、CI值与靶区中心间距均呈负相关(所有P=0.000)。结论 基于金属夹与血清肿及结合金属夹和血清肿勾画术腔靶区既存在体积差异又存在空间错位。     

腹腔镜腹股沟疝修补术后血清肿发生原因及对策

【摘要】 目的 探讨腹腔镜腹股沟疝修补术后血清肿的发生原因及对策。方法〓选取我科从2012年4月到2016年6月间采用腹腔镜术式治疗成年男性腹股沟疝患者共251例,观察术后1个月内血清肿的发生率及严重程度,找出其原因及探讨处理对策。结果〓4年间共发生血清肿42例,大多数无需处理,仅3例需抽液并加压治疗,全部42例患者未发生感染。血肿可能与年龄、手术方式和伴随较严重的疾病有关。结论〓腹腔镜腹股沟疝修补术术后血清肿可能涉及到年龄、手术方法及严重的伴随疾病有关。     

腹腔镜腹股沟疝修补术后浆液肿的预防措施

腹腔镜腹股沟疝修补术后的浆液肿发生率较高,浆液肿是腹腔镜腹股沟疝修补术后常见的现象。关于如何预防腹腔镜疝术后浆液肿的发生,尚无一致意见。本文阐述了腹腔镜疝术后浆液肿发生的机理,易发因素及预防措施,并介绍了我们在这方面的临床经验。腹股沟直疝及大的斜疝或者阴囊疝术后浆液肿发生率较高。对于腹股沟直疝,可以在腹腔镜疝直疝修补术时将疝囊关闭（采用倒刺缝线或者endoloop）值得推荐,对于较大的腹股沟斜疝,可以尝试采用倒刺缝线悬吊远端疝囊,对于某些特殊情况,可以选择性放置引流管,早期拔出引流。     

猪小肠黏膜下层脱细胞基质补片在不同术式治疗青壮年腹股沟疝中的应用效果

目的:探讨猪小肠黏膜下层脱细胞基质(SIS)补片用于腹腔镜经腹腹膜前(TAPP)疝修补术与开放无张力疝修补术(Lichtenstein手术)治疗青壮年腹股沟疝临床效果。方法:回顾性分析2015年2月—2018年2月期间首都医科大学附属北京朝阳医院疝和腹壁外科采用SIS补片行疝修补术的268例青壮年腹股沟疝的患者临床资料,其中152例行Lichtenstein手术(Lichtenstein组),116例行TAPP手术(TAPP)。比较两组患者的相关临床指标。结果:Lichtenstein组手术时间、住院费用明显少于TAPP组,但围术期疼痛评分明显高于TAPP组(均P0.05);两组在术中出血量、住院时间方面差异均无统计学意义(均P0.05)。Lichtenstein组术后1周及1、3个月血清肿的发生率均低于TAPP组(均P0.05)。所有患者均未发生异物感、肠梗阻、肠瘘等并发症。结论:SIS补片应用于青壮年腹股沟疝的开放和腹腔镜疝修补术均有确切的效果,但该补片用于两种术式均有各自的优缺点。