Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol, UK; Bristol Breast Care Centre, North Bristol NHS Trust, Bristol, UK.
Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.
Lancet Oncol. 2019 Feb;20(2):254-266. doi: 10.1016/S1470-2045(18)30781-2. Epub 2019 Jan 9.
Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction-breast reconstruction with implants or expanders at the time of mastectomy-but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques.
In this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281.
Between Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 (99%) patients. Of these patients, 182 (9%, 95% CI 8-10) experienced implant loss, 372 (18%, 16-20) required re-admission to hospital, and 370 (18%, 16-20) required return to theatre for complications within 3 months of their initial surgery. 522 (25%, 95% CI 23-27) patients required treatment for an infection. The rates of all of these complications are higher than those in the National Quality Standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection).
Complications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomised clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction.
National Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons.
使用生物或合成网可能会改善即刻植入物乳房重建的结果-乳房切除术时同时植入或扩张器-但缺乏高质量的证据来支持该技术的安全性或有效性。我们旨在确定即刻植入物乳房重建的短期安全性，无论是否使用网片，为未来比较不同乳房重建技术的随机临床试验提供依据。
在这项前瞻性，多中心队列研究中，我们连续招募了在英国 81 个参与乳房和整形手术单位接受任何类型的即刻植入物乳房重建的年龄在 16 岁或以上的恶性肿瘤或降低风险的女性，任何技术均可。收集了手术前和手术后患者的人口统计学和手术，肿瘤学和并发症详细信息。研究的主要结局是植入物丢失（定义为计划外移除扩张器或植入物），需要用抗生素或手术治疗的感染，计划外再次手术，以及计划外因重建手术并发症而再次住院，至重建后 3 个月，通过临床评估或患者自我报告进行评估。随访已完成。该研究在 ISRCTN 注册中心注册，编号 ISRCTN37664281。
在 2014 年 2 月 1 日至 2016 年 6 月 30 日期间，在英国的 81 个单位中，有 2108 名患者进行了 2655 例乳房切除术并进行了即刻植入物乳房重建。1650 名（78％）患者计划进行单阶段重建（包括 12 名每个乳房采用不同技术的患者）。1376 名（65％）患者接受了生物（1133 名[54％]）或合成（243 名[12％]）网片重建，181 名（9％）患者接受了非网片胸肌下或筋膜下植入物，440 名（21％）患者接受了真皮吊带植入物，42 名（2％）患者接受了胸肌前植入物，79 名（4％）患者接受了其他或多种植入物。有 2081 名（99％）患者可获得 3 个月的结局数据。在这些患者中，182 名（9％，95％CI 8-10）发生植入物丢失，372 名（18％，16-20）需要再次住院，370 名（18％，16-20）需要因手术并发症而再次手术。522 名（25％，95％CI 23-27）患者需要治疗感染。所有这些并发症的发生率均高于国家质量标准（<5％用于再次手术，再次住院和植入物丢失，<10％用于感染）。
即刻植入物乳房重建后的并发症发生率高于国家标准建议。需要进行随机临床试验以确定即刻植入物乳房重建的最佳方法。
英国国民健康保险制度，乳房外科协会和英国整形，重建和美容外科医师协会。
