Hoque Sheymonti S, Zhou Jieyun, Gartoulla Pragya, Hansen Jessy, Farrell Gillian, Hopper Ingrid
From the Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University.
Plastic and Reconstructive Surgery Unit, Peter MacCallum Cancer Centre.
Plast Reconstr Surg. 2023 May 1;151(5):927-937. doi: 10.1097/PRS.0000000000010066. Epub 2022 Dec 19.
There remains a lack of clarity surrounding the benefits, risks, and outcomes between two-stage expander/implant reconstruction and single-stage direct-to-implant (DTI) reconstruction. This study used a national data set to examine real-world outcomes of two-stage and DTI reconstructions.
A cohort study was conducted examining patients in the Australian Breast Device Registry (ABDR) from 2015 to 2018 who underwent prosthetic breast reconstruction following mastectomy. DTI and two-stage cohorts after definitive implant insertion were compared. Rate of revision surgery, reasons for revision, and patient-reported outcome measures were recorded. Statistical analysis was undertaken using Fisher exact or chi-square, Wilcoxon rank sum, or t tests; Nelson-Aalen cumulative incidence estimates; and Cox proportional hazards regression.
A total of 5152 breast reconstructions were recorded, including 3093 two-stage and 2059 DTI reconstructions. Overall revision surgery rates were 15.6% for DTI (median follow-up, 24.7 months), compared with 9.7% in the two-stage cohort (median follow-up, 26.5 months; P < 0.001). The most common reasons for revision for DTI and two-stage reconstruction were capsular contracture (25.2% versus 26.7%; P = 0.714) and implant malposition (26.7% versus 34.3%; P = 0.045). Multivariate analysis found acellular dermal matrix use ( P = 0.028) was significantly associated with a higher risk of revision. The influence of radiotherapy on revision rates was unable to be studied. Patient satisfaction levels were similar between reconstructive groups; however, patient experience was better in the DTI cohort than in the two-stage cohort.
The ABDR data set demonstrated that DTI reconstruction had a higher revision rate than two-stage, but with comparable patient satisfaction and better patient experience. Capsular contracture and device malposition were leading causes of revision in both cohorts.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
在两阶段扩张器/植入物重建与单阶段直接植入（DTI）重建之间，其益处、风险和结果仍不明确。本研究使用全国性数据集来研究两阶段重建和DTI重建的实际结果。
进行了一项队列研究，调查2015年至2018年澳大利亚乳房装置登记处（ABDR）中接受乳房切除术后假体乳房重建的患者。比较了DTI组和确定植入后的两阶段队列。记录了翻修手术率、翻修原因和患者报告的结局指标。使用Fisher精确检验或卡方检验、Wilcoxon秩和检验或t检验、Nelson-Aalen累积发病率估计以及Cox比例风险回归进行统计分析。
共记录了5152例乳房重建，其中包括3093例两阶段重建和2059例DTI重建。DTI组的总体翻修手术率为15.6%（中位随访时间为24.7个月），而两阶段队列中的翻修手术率为9.7%（中位随访时间为26.5个月；P<0.001）。DTI重建和两阶段重建最常见的翻修原因是包膜挛缩（25.2%对26.7%；P = 0.714）和植入物位置不当（26.7%对34.3%；P = 0.045）。多变量分析发现，使用脱细胞真皮基质（P = 0.028）与更高的翻修风险显著相关。无法研究放疗对翻修率的影响。重建组之间的患者满意度水平相似；然而，DTI队列中的患者体验优于两阶段队列。
ABDR数据集表明，DTI重建的翻修率高于两阶段重建，但患者满意度相当，且患者体验更好。包膜挛缩和装置位置不当是两个队列中翻修的主要原因。
临床问题/证据水平：治疗性，III级。
