Scheflan Michael, Grinberg-Rashi Helena, Hod Keren
Tel Aviv, Israel.
From private practice; MedTech Industries; and the Research Division, Epidemiological Service, Assuta Medical Center.
Plast Reconstr Surg. 2018 Jan;141(1):1e-10e. doi: 10.1097/PRS.0000000000003982.
Acellular dermal matrices can be combined with implant-based breast reconstruction to help optimize outcomes. SurgiMend PRS is a fetal bovine dermis-derived acellular dermal matrix composed of type I collagen and approximately 30 percent type III collagen, sharing many of the properties of human cadaveric acellular dermal matrix.
This was a retrospective, single-center analysis of 111 adult patients (147 breasts) undergoing one-stage (83.7 percent) or two-stage (16.3 percent) immediate breast reconstruction after mastectomy. The aims were to characterize the safety profile of SurgiMend and investigate associations between risk factors and complications.
The mean age of the patients was 47.9 years and the mean body mass index was 24.7 kg/m. After a median follow-up of 24.3 months, the overall rates of minor and major complications were 25.2 percent (n = 37 of 147) and 12.9 percent (n = 19 of 147), respectively. The most common major complications were seroma [n = 12 (8.2 percent)] and necrosis [n = 9 (6.1 percent)]. All occurred within 3 months after surgery. The rate of capsular contracture was 2.7 percent (n = 4). A total of 2.7 percent of implanted breasts (n = 4) required explantation. In a univariate analysis, smokers had a greater risk of major complications (p = 0.013), and postoperative radiation therapy and obesity were associated with an increased risk of capsular contracture (p = 0.006) and explantation (p = 0.006), respectively. In a multivariate analysis, several factors were associated with complications or explantation, including obesity (p < 0.05), preoperative chemotherapy (p < 0.001), and mastectomy weight (p < 0.05). These associations align with other studies of implant-based reconstruction and do not appear to be specific to this acellular dermal matrix.
The results are consistent with previous analyses of SurgiMend, and support its value in implant-based breast reconstruction.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
脱细胞真皮基质可与植入物乳房重建相结合，以帮助优化手术效果。SurgiMend PRS是一种源自胎牛真皮的脱细胞真皮基质，由I型胶原蛋白和大约30%的III型胶原蛋白组成，具有许多人尸体脱细胞真皮基质的特性。
这是一项对111例成年患者（147个乳房）进行的回顾性单中心分析，这些患者在乳房切除术后接受一期（83.7%）或二期（16.3%）即刻乳房重建。目的是描述SurgiMend的安全性，并调查危险因素与并发症之间的关联。
患者的平均年龄为47.9岁，平均体重指数为24.7kg/m²。中位随访24.3个月后，轻微和严重并发症的总体发生率分别为25.2%（147例中的37例）和12.9%（147例中的19例）。最常见的严重并发症是血清肿[n = 12（8.2%）]和坏死[n = 9（6.1%）]。所有并发症均发生在术后3个月内。包膜挛缩率为2.7%（n = 4）。共有2.7%的植入乳房（n = 4）需要取出植入物。单因素分析显示，吸烟者发生严重并发症的风险更高（p = 0.013），术后放疗和肥胖分别与包膜挛缩风险增加（p = 0.006）和取出植入物风险增加（p = 0.006）相关。多因素分析显示，几个因素与并发症或取出植入物相关，包括肥胖（p < 0.05）、术前化疗（p < 0.001）和乳房切除重量（p < 0.05）。这些关联与其他基于植入物重建的研究一致，似乎并非这种脱细胞真皮基质所特有。
结果与之前对SurgiMend的分析一致，并支持其在基于植入物乳房重建中的价值。
临床问题/证据水平：治疗性，IV级。
