Does the Use of Acellular Dermal Matrix Increase Postoperative Complications of the First-Stage Reconstruction of Immediate Expander-Implant Breast Reconstruction

Woo, Kyong Je; Park, Jin-Woo; Mun, Goo‐Hyun; Pyon, Jai‐Kyong; Jeon, Byung-Joon; Bang, Sa Ik

doi:10.1097/sap.0000000000001067

Cited by 14 publications

(13 citation statements)

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“…However, ADMs are regularly used in many types of surgery, without any convincing evidence that they cause an adverse tissue response. Furthermore, using an ADM in a two‐stage reconstruction is not associated with an increased complication rate, implying that the high complication rate observed here is primarily associated with the surgical technique (direct placement of the definitive implant) and not the ADM. A prospective study comparing DTI breast reconstruction with and without the use of ADM is lacking.…”

Section: Discussionmentioning

confidence: 90%

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial

Negenborn

Dikmans

Bouman

et al. 2018

British Journal of Surgery

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BackgroundIn the multicentre randomized trial BRIOS (Breast Reconstruction In One Stage), direct‐to‐implant (DTI) breast reconstruction with an acellular dermal matrix (ADM) was associated with a markedly higher postoperative complication rate compared with two‐stage tissue expander/implant breast reconstruction. This study aimed to identify factors that contribute to the occurrence of complications after DTI ADM‐assisted breast reconstruction.MethodsData were obtained from the BRIOS study, including all patients treated with DTI ADM‐assisted breast reconstruction. Logistic regression analyses were performed to identify factors predictive of postoperative complications.ResultsFifty‐nine patients (91 breasts) were included, of whom 27 (35 breasts) developed a surgical complication. Reoperations were performed in 29 breasts (32 per cent), with prosthesis removal in 22 (24 per cent). In multivariable analyses, mastectomy weight was associated with complications (odds ratio (OR) 1·94, 95 per cent c.i. 1·33 to 2·83), reoperations (OR 1·70, 1·12 to 2·59) and removal of the implant (OR 1·55, 1·11 to 2·17). Younger patients (OR 1·07, 1·01 to 1·13) and those who received adjuvant chemotherapy (OR 4·83, 1·15 to 20·24) more frequently required reoperation. In univariable analyses, adjuvant radiotherapy showed a trend towards more complications (OR 7·23, 0·75 to 69·95) and removal of the implant (OR 5·12, 0·76 to 34·44), without reaching statistical significance.ConclusionBreast size appeared to be the most significant predictor of complications in DTI ADM‐assisted breast reconstruction. The technique should preferably be performed in patients with small to moderate sized breasts. Registration number: NTR5446 ( http://www.trialregister.nl).

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Section: Discussionmentioning

confidence: 90%

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial

Negenborn

Dikmans

Bouman

et al. 2018

British Journal of Surgery

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“…Despite increasing experience supporting the utility of ADMs in breast reconstruction, 16 , 17 there remains an unmet need for ADMs with more optimal clinical characteristics. AlloDerm has been used to support postmastectomy breast reconstruction for more than a decade and has demonstrated comparable clinical outcomes to other ADMs, with similar complication types and rates.…”

Section: Discussionmentioning

confidence: 99%

Comparison of 30-day Clinical Outcomes with SimpliDerm and AlloDerm RTU in Immediate Breast Reconstruction

Tierney

2021

Plastic and Reconstructive Surgery - Global Open

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Background: Acellular dermal matrix (ADM) is widely used in breast reconstruction, and outcomes of these procedures may be improved through optimized product design. SimpliDerm is a new human ADM designed to closely preserve the architecture of native dermis, with the goal of improving surgical outcomes. This study reports the initial (30-day) clinical experience with SimpliDerm compared with AlloDerm Ready-To-Use (RTU) in ADM-assisted breast reconstruction. Methods: Clinical characteristics and outcomes of 59 consecutive patients who underwent immediate 2-stage reconstruction with SimpliDerm (n = 28) or AlloDerm RTU (n = 31) following mastectomy are reported. Results: Fifty-nine women (108 breasts) underwent posmastectomy breast reconstruction with SimpliDerm or AlloDerm RTU. Mean patient age was 51.1 years, and mean body mass index was 28.2 kg/m 2 . Reconstructions were predominantly prepectoral (95.4%), used tissue expanders (100%), and followed a skin-sparing (64%) approach to mastectomy. Mean time to final drain removal did not differ between groups (17.0 days, SimpliDerm versus 17.7 days, AlloDerm RTU). Adverse events occurred in 13 (22%) patients; none considered serious—all were mild or moderate in intensity. Adverse event rates did not differ between groups. The observed adverse event profiles and rates are similar to those published for other ADMs in immediate breast reconstruction. Conclusions: There remains a clinical need for ADMs with more optimal characteristics. This case series describes comparable outcomes with SimpliDerm and AlloDerm RTU over 30 days after immediate 2-stage breast reconstruction.

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“…Five NRCSs, reported in 10 articles, [192][193][194][195][196][197][198][199][200][201] evaluated the timing of radiation therapy relative to IBR in a total of 2,834 patients. The studies are detailed in Appendix Tables C-3, D-2, and D-3.…”

Section: Overall Summary For Key Questionmentioning

confidence: 99%

“…Nine studies (both RCTs and seven NRCSs) reported on any or undefined infections. Seven studies, comprising both RCTs (McCarthy 2012 and Wendel 2013) and five NRCSs (Chun 2010, Nealon 2020b, Seth 2012, Sobti 2018, and Woo 2017, reported effect sizes that adequately accounted for confounders and were thus included in a meta-analysis (Figure 9). Effect sizes ranged from 0.88 to 5.37.…”

Section: Any or Undefined Infectionsmentioning

confidence: 99%

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Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis

Saldanha¹,

Cao²,

Broyles³

et al. 2021

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Objectives. This systematic review evaluates breast reconstruction options for women after mastectomy for breast cancer (or breast cancer prophylaxis). We addressed six Key Questions (KQs): (1) implant-based reconstruction (IBR) versus autologous reconstruction (AR), (2) timing of IBR and AR in relation to chemotherapy and radiation therapy, (3) comparisons of implant materials, (4) comparisons of anatomic planes for IBR, (5) use versus nonuse of human acellular dermal matrices (ADMs) during IBR, and (6) comparisons of AR flap types. Data sources and review methods. We searched Medline®, Embase®, Cochrane CENTRAL, CINAHL®, and ClinicalTrials.gov from inception to March 23, 2021, to identify comparative and single group studies. We extracted study data into the Systematic Review Data Repository Plus (SRDR+). We assessed the risk of bias and evaluated the strength of evidence (SoE) using standard methods. The protocol was registered in PROSPERO (registration number CRD42020193183). Results. We found 8 randomized controlled trials, 83 nonrandomized comparative studies, and 69 single group studies. Risk of bias was moderate to high for most studies. KQ1: Compared with IBR, AR is probably associated with clinically better patient satisfaction with breasts and sexual well-being but comparable general quality of life and psychosocial well-being (moderate SoE, all outcomes). AR probably poses a greater risk of deep vein thrombosis or pulmonary embolism (moderate SoE), but IBR probably poses a greater risk of reconstructive failure in the long term (1.5 to 4 years) (moderate SoE) and may pose a greater risk of breast seroma (low SoE). KQ 2: Conducting IBR either before or after radiation therapy may result in comparable physical well-being, psychosocial well-being, sexual well-being, and patient satisfaction with breasts (all low SoE), and probably results in comparable risks of implant failure/loss or need for explant surgery (moderate SoE). We found no evidence addressing timing of IBR or AR in relation to chemotherapy or timing of AR in relation to radiation therapy. KQ 3: Silicone and saline implants may result in clinically comparable patient satisfaction with breasts (low SoE). There is insufficient evidence regarding double lumen implants. KQ 4: Whether the implant is placed in the prepectoral or total submuscular plane may not be associated with risk of infections that are not explicitly implant related (low SoE). There is insufficient evidence addressing the comparisons between prepectoral and partial submuscular and between partial and total submuscular planes. KQ 5: The evidence is inconsistent regarding whether human ADM use during IBR impacts physical well-being, psychosocial well-being, or satisfaction with breasts. However, ADM use probably increases the risk of implant failure/loss or need for explant surgery (moderate SoE) and may increase the risk of infections not explicitly implant related (low SoE). Whether or not ADM is used probably is associated with comparable risks of seroma and unplanned repeat surgeries for revision (moderate SoE for both), and possibly necrosis (low SoE). KQ 6: AR with either transverse rectus abdominis (TRAM) or deep inferior epigastric perforator (DIEP) flaps may result in comparable patient satisfaction with breasts (low SoE), but TRAM flaps probably increase the risk of harms to the area of flap harvest (moderate SoE). AR with either DIEP or latissimus dorsi flaps may result in comparable patient satisfaction with breasts (low SoE), but there is insufficient evidence regarding thromboembolic events and no evidence regarding other surgical complications. Conclusion. Evidence regarding surgical breast reconstruction options is largely insufficient or of only low or moderate SoE. New high-quality research is needed, especially for timing of IBR and AR in relation to chemotherapy and radiation therapy, for comparisons of implant materials, and for comparisons of anatomic planes of implant placement.

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Does the Use of Acellular Dermal Matrix Increase Postoperative Complications of the First-Stage Reconstruction of Immediate Expander-Implant Breast Reconstruction

Abstract: A matched cohort analysis demonstrated that ADM usage is not associated with an increased risk of complications, including skin flap complications, seroma, and infection. Our result suggests that ADM can be safely used in immediate expander-implant breast reconstruction when necessary.

Cited by 14 publications

References 30 publications

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial

Comparison of 30-day Clinical Outcomes with SimpliDerm and AlloDerm RTU in Immediate Breast Reconstruction

Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis

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