Kilmer Lee H, Challa Sanjana, Stranix John T, Campbell Christopher A
From the Department of Plastic Surgery, University of Virginia, Charlottesville, Va.
University of Virginia School of Medicine, Charlottesville, Va.
Plast Reconstr Surg Glob Open. 2024 Mar 13;12(3):e5660. doi: 10.1097/GOX.0000000000005660. eCollection 2024 Mar.
Acellular dermal matrix (ADM) is commonly used in implant-based breast reconstruction due to improved soft-tissue support and control of the implant pocket and decreased capsular contracture. However, concerns about complications have prompted the FDA to request more clinical data. This large-scale study aims to examine perioperative outcomes of ADM use in breast reconstruction.
This study utilized a national insurance-based database to identify patients who underwent mastectomy between 2011 and 2019, with and without ADM. The groups were matched for age, region, and comorbidities. Complications within 90 days were compared using univariate and multivariate analyses.
A total of 49,366 patients were identified with 26,266 patients in the ADM group and 23,100 in the non-ADM group. Infection rates (4.7% ADM versus 4.4% no ADM) and seroma rates (3.9% ADM versus 4% no ADM) were similar. However, the ADM group had a 1% higher rate of implant removal (4.9% ADM versus 3.9% no ADM, < 0.001). In direct-to-implant procedures, ADM use was associated with higher explantation rates (8.2% versus 6.3%, = 0.002). Multivariate analysis identified tobacco use, hypertension, depression, obesity, ADM usage, and direct-to-implant surgery as risk factors for implant removal.
This study found comparable infection and seroma rates in implant-based breast reconstruction with and without ADM. ADM use was associated with a 1% higher risk of implant removal, with risk factors including tobacco use, obesity, hypertension, depression, and direct-to-implant procedures. Multicenter studies and registry data on prepectoral breast reconstruction are warranted to help interpret these findings.
脱细胞真皮基质(ADM)因能改善软组织支撑、控制植入腔隙并降低包膜挛缩,常用于基于植入物的乳房重建。然而,对并发症的担忧促使美国食品药品监督管理局(FDA)要求提供更多临床数据。这项大规模研究旨在探讨ADM在乳房重建中的围手术期结果。
本研究利用基于国家保险的数据库,识别2011年至2019年间接受乳房切除术的患者,分为使用ADM组和未使用ADM组。两组在年龄、地区和合并症方面进行匹配。采用单因素和多因素分析比较90天内的并发症情况。
共识别出49366例患者,其中ADM组26266例,非ADM组23100例。感染率(ADM组为4.7%,非ADM组为4.4%)和血清肿发生率(ADM组为3.9%,非ADM组为4%)相似。然而,ADM组的植入物取出率高1%(ADM组为4.9%,非ADM组为3.9%,P<0.001)。在直接植入手术中,使用ADM与更高的取出率相关(8.2%对6.3%,P = 0.002)。多因素分析确定吸烟、高血压、抑郁症、肥胖、ADM使用和直接植入手术是植入物取出的危险因素。
本研究发现,在基于植入物的乳房重建中,使用和不使用ADM的感染率和血清肿发生率相当。使用ADM与植入物取出风险高1%相关,危险因素包括吸烟、肥胖、高血压、抑郁症和直接植入手术。有必要开展多中心研究和关于胸前乳房重建的登记数据,以帮助解读这些发现。