Luo Jessica, Moss Whitney D, Pires Giovanna R, Rhemtulla Irfan A, Rosales Megan, Stoddard Gregory J, Agarwal Jayant P, Kwok Alvin C
Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, Utah.
Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah.
Arch Plast Surg. 2022 Dec 13;49(6):716-723. doi: 10.1055/s-0042-1758638. eCollection 2022 Nov.
In March 2021, the United States Food and Drug Administration (FDA) safety communication cautioned against the use of acellular dermal matrix (ADM) products in breast reconstruction and reiterated that the FDA does not approve ADM use in breast surgery. This study aims to assess the safety of ADM use in breast reconstruction. Women who underwent ADM and non-ADM assisted tissue expander (TE)-based breast reconstruction were identified using the National Surgical Quality Improvement Program database (2012-2019). Trends of ADM use over time, and 30-day outcomes of surgical site infection (SSI), dehiscence, and unplanned reoperation were assessed. Of the 49,049 TE-based breast reconstructive cases, 42.4% were ADM assisted and 57.6% non-ADM assisted. From 2012 to 2019, the use of ADM increased from 26.1 to 55.6% (relative risk [RR] =1.10; < 0.01). Higher rates of SSI (3.9 vs. 3.4%; = 0.003) and reoperation (7.4 vs. 6.0%; < 0.001) were seen in the ADM cohort. There was no significant difference seen in dehiscence rates (0.7 vs. 0.7%; = 0.73). The most common reoperation within 30 days for the ADM group (17.6%) was removal of TE without insertion of implant (current procedural terminology: 11,971). ADM-assisted breast reconstruction was associated with increased relative risk of SSI by 10% (RR = 1.10, confidence interval [CI]: 1.01-1.21; = 0.03) and reoperation by 15% (RR = 1.15, CI: 1.08-1.23; < 0.001). ADM-assisted breast reconstruction more than doubled from 2012 to 2019. There are statistically higher complication rates of SSI (0.5%) and reoperation (1.4%) with ADM use in TE-based breast reconstruction, suggesting that reconstruction without ADM is safe when comparing immediate postoperative outcomes.
2021年3月，美国食品药品监督管理局（FDA）发布安全通告，警示不要在乳房重建中使用脱细胞真皮基质（ADM）产品，并重申FDA未批准在乳房手术中使用ADM。本研究旨在评估在乳房重建中使用ADM的安全性。
利用国家外科质量改进计划数据库（2012 - 2019年）确定接受ADM辅助和非ADM辅助的基于组织扩张器（TE）的乳房重建的女性。评估了ADM使用随时间的趋势以及手术部位感染（SSI）、伤口裂开和非计划再次手术的30天结局。
在49,049例基于TE的乳房重建病例中，42.4%为ADM辅助，57.6%为非ADM辅助。从2012年到2019年，ADM的使用从26.1%增加到55.6%（相对风险[RR]=1.10；<0.01）。ADM队列中SSI发生率（3.9%对3.4%；=0.003）和再次手术率（7.4%对6.0%；<0.001）更高。伤口裂开率无显著差异（0.7%对0.7%；=0.73）。ADM组30天内最常见的再次手术（17.6%）是取出TE而不植入假体（当前手术操作术语：11,971）。ADM辅助的乳房重建与SSI相对风险增加10%（RR = 1.10，置信区间[CI]：1.01 - 1.21；=0.03）和再次手术相对风险增加15%（RR = 1.15，CI：1.08 - 1.23；<0.001）相关。
从2012年到2019年ADM辅助的乳房重建增加了一倍多。在基于TE的乳房重建中使用ADM时SSI（0.5%）和再次手术（1.4%）并发症发生率在统计学上更高，这表明在比较术后即刻结局时，不使用ADM的重建是安全的。
