Maxwell Daniel, Estes Megan M, Walcott Jennifer McMillen, Canady John W, Hunter Tina D, Gache Larry, Wang-Ashraf Bernadette, Alexander Diane
Artisan Plastic Surgery, LLC, Atlanta, Ga.
Mentor Worldwide, LLC, Irvine, Calif.
Plast Reconstr Surg Glob Open. 2021 Mar 26;9(3):e3425. doi: 10.1097/GOX.0000000000003425. eCollection 2021 Mar.
In the United States, 2-stage expander-to-implant-based breast reconstruction accounts for more than half of all breast reconstruction procedures. Tissue expansion technology has undergone significant advancements in the past few decades. Previous reports suggest that the most common perioperative complications associated with breast tissue expanders are infection and skin flap necrosis. However, little clinical data are available for CPX4 Breast Tissue Expanders. The aim of the study was to measure real-world outcomes related to safety and effectiveness of the tissue expansion process, in patients who underwent primary breast reconstruction following the use of CPX4 Breast Tissue Expanders.
This was a single-arm retrospective cohort design looking at patients who underwent 2-stage, expander-to-implant-based primary breast reconstruction at a single site between April 2013 and December 2016 and who had a minimum of 2 years follow-up. Descriptive statistics were used to summarize baseline characteristics and safety outcomes.
A total of 123 patients were followed for an average of 3.73 ± 0.94 years. At least 1 complication during the time of tissue expansion, before the permanent implant, was reported in 39/123 (31.7%) patients [51/220 implants (23.2%)]. The most frequently reported complications were delayed wound healing (13.8%) and cellulitis/infection (9.7%).
Analyses of real-world data from a single site provide further support for the safety and effectiveness of the CPX4 Breast Tissue Expander for women undergoing 2-stage expander-to-implant primary breast reconstruction.
在美国，两阶段基于扩张器到植入物的乳房重建占所有乳房重建手术的一半以上。在过去几十年中，组织扩张技术取得了重大进展。先前的报告表明，与乳房组织扩张器相关的最常见围手术期并发症是感染和皮瓣坏死。然而，关于CPX4乳房组织扩张器的临床数据很少。本研究的目的是测量在使用CPX4乳房组织扩张器后接受一期乳房重建的患者中，与组织扩张过程的安全性和有效性相关的实际结果。
这是一项单臂回顾性队列设计，研究对象为2013年4月至2016年12月在单一地点接受两阶段、基于扩张器到植入物的一期乳房重建且至少随访2年的患者。描述性统计用于总结基线特征和安全结果。
共对123例患者进行了平均3.73±0.94年的随访。在39/123（31.7%）例患者[51/220个植入物（23.2%）]中报告了在组织扩张期间、永久植入前至少发生1种并发症。最常报告的并发症是伤口愈合延迟（13.8%）和蜂窝织炎/感染（9.7%）。
对来自单一地点的实际数据的分析为CPX4乳房组织扩张器在接受两阶段扩张器到植入物一期乳房重建的女性中的安全性和有效性提供了进一步支持。
