A Meta-Analysis of Human Acellular Dermis and Submuscular Tissue Expander Breast Reconstruction



A Meta-Analysis of Human Acellular Dermis and Submuscular Tissue Expander Breast Reconstruction


John Y. S. Kim, M.D.

Armando A. Davila, B.S.

Scott Persing, B.A., M.P.H.

Caitlin M. Connor, B.A.

Borko Jovanovic, Ph.D.

Seema A. Khan, M.D.

Neil Fine, M.D.

Vinay Rawlani, M.D.



Chicago and Maywood, Ill.

From the Division of Plastic and Reconstructive Surgery, the Department of Preventative Medicine, and the Lynn Sage Breast Center, Northwestern University, Feinberg School of Medicine, and Loyola University Chicago, Stritch School of Medicine.

Received for publication March 21, 2011; accepted June 16, 2011.

Copyright © 2011 by the American Society of Plastic Surgeons

DOI: 10.1097/PRS.0b013e3182361fd6




In the United States, approximately 57,000 tissue expander/implant–based reconstructions are performed annually, representing approximately 65 percent of all breast reconstructions.1 Acellular dermis has been an increasingly popular adjunct to traditional expander reconstruction with putative benefits including improved inframammary control, decreased incidence of migration, greater intraoperative fill (with decreased concomitant expansion time and number of postoperative visits), improved cosmesis, and amelioration of contracture.28 The basic technique involves releasing the pectoralis muscle along its inferior border and using the acellular dermis to reconstruct the ensuing lower pole defect.

The technique of using human acellular dermal matrix for soft-tissue reconstruction has existed since the early 1990s, and its use has been described in a myriad of clinical contexts from burn treatment and neourethra reconstruction to ameliorating contracture in hand and breast surgery.2,4,911 However, universal acceptance in these varying clinical indications has been tempered by concerns about surgical complications including seromas, infections, and loss of mechanical integrity.1214 The complication profile of human acellular dermal matrix in breast reconstruction ranges widely throughout the 6 years of published reports (range, 3.2 to 48.7 percent), making it difficult to develop generalized outcomes from study to study.2,3,5,7,12,1518 The central unknown remains regarding how outcomes of human acellular dermal matrix–assisted breast reconstruction compare with outcomes of traditional submuscular breast reconstruction. Our study attempts to collate recent studies in both treatment arms and determine general complication profiles and patterns by means of standard meta-analysis methodology.


Patients and Methods


Search Methods

A literature search was performed using PubMed to query the MEDLINE database (January 1, 2000, to February 6, 2011). Search terms included “tissue expander,” “implant,” “acellular dermis,” “acellular dermal matrix,” “AlloDerm” or “acellular matrix,” and “breast reconstruction.” Additional search methods included a manual review of reference lists of relevant studies.


Selection Criteria

Selection criteria were defined a priori. Eligible studies were limited to English-only and had to examine breast reconstruction in human patients. Study selection underwent two levels of review by two independent researchers (Fig. 1). Each study was required to clearly indicate the number of reconstructions performed. Studies reporting fewer than 25 tissue expander/implant reconstructions in at least one cohort were excluded. Titles and abstracts were screened for the following exclusion criteria: publications of brief communications, correspondence, discussions, letters, conference/lecture manuscripts, case reports, and reviews; publications containing only abstracts; novel modifications of surgical technique; outcomes related to breast augmentation; outcomes related solely to autogenous reconstruction; and outcomes about only a specific high-risk population.

Full articles were then retrieved for all studies that met the first level of criteria. Studies needed to report or provide data to calculate a total complication rate and report or provide data to calculate at least one of the following postoperative complications: seroma, hematoma, infection, and flap necrosis. In any studies that reported similar or overlapping cohorts, the publication with the greatest number of reconstructions was included.


Data Collection and Analysis

Data collection and analysis was performed following the guidelines set forth by the Cochrane Handbook for Systematic Reviews of Interventions and the “Meta-Analysis of Observational Studies in Epidemiology.”19,20 Two independent reviewers extracted data from all selected studies by using a standardized data abstraction form. This electronic data form included the lead author, publication year, type of reconstructive procedure, number of patients, number of reconstructions, number of unilateral and bilateral reconstructions, average patient age and body mass index, percentage of smokers and diabetic patients, percentage of patients who received radiation therapy before surgery, percentage of patients who received postoperative radiation therapy, percentage of patients who received chemotherapy, average tissue expander intraoperative fill, and average follow-up. Complication data included number of reconstructions with seromas, hematomas, infection, flap necrosis, and explantation.

All rates used in the analysis were based on the number of reconstructions in each study. Two levels of analysis were performed. Cumulative pooled estimates were calculated from the standard error of complication rates based on the binomial distribution.21 In instances where a study specified a zero occurrence rate of an outcome, the standard error was estimated using a constant continuity correction.22 If a study did not specifically report an outcome, no correction was used, and the study was not included in the analysis of that outcome. Total complications for both analyses were retrieved for only defined postoperative complications (i.e., seroma, hematoma,
infection/cellulitis, and flap necrosis). Relative risks were calculated from studies that examined complications in both human acellular dermal matrix and submuscular cohorts specifically. For both analyses, the DerSimonian and Laird random-effects method was used based on interstudy heterogeneity.23,24 Heterogeneity was assessed using the Q statistic and the I2 statistic.25 Small Q statistic p values are indicative of statistically significant heterogeneity, whereas I2 percentages indicate the amount of heterogeneity between studies. For any heterogeneity of statistical significance, sources of heterogeneity were explored by means of an exclusion sensitivity analysis. Funnel plots, Egger’s regression test, and Begg’s rank correlation test were used to assess publication bias.26,27 Statistical analysis was performed using MIX 2.0, Professional Software for Meta-analysis plug-in for Microsoft Excel, version 2.0.1.2 (BiostatXL, Sunnyvale, Calif.), and corroborated with RevMan5.0 (Cochrane Collaboration Information Management System, Oxford, United Kingdom).28,29






Fig. 1. Study attrition diagram. TE/I, tissue expander/implant; HADM, human acellular dermal matrix.





Discussion

The advent of any new technology—and specifically, its integration with a new technique—generates uncertainty about outcomes and questions about benefits vis-à-vis risks. With human acellular dermal matrix–assisted tissue expander breast reconstruction, the potential for improvement in cosmetic and reconstructive outcomes has been promulgated with little consensus on cumulative risks. The variance in total complication profiles reported in the literature (range, 3.2 to 48.7 percent)


suggests the need for pooled analysis.2,3,5,7,12,1518 The aim of our meta-analysis was to focus on complication profiles and perform both a risk analysis and pooled summary estimates using the most recent literature. We did not specifically address the underlying rationale for using human acellular dermal matrix or validate the potential advantages of this technique, as these topics have been discussed elsewhere in the literature.2,4,5,6,15








Table 1. Characteristics of Study Populations Reporting Human Acellular Dermal Matrix Reconstruction Outcomes



















































































































































































































































































































Reference Patient Characteristics Complications
No. of Reconstructions Mean Age (yr) Mean BMI Previous XRT (%) Postoperative XRT (%) Mean Intraoperative Fill (ml) Mean Follow-Up (mo) Total Complications Seroma Hematoma Infection Flap Necrosis Reconstructive Failure
Antony et al., 201016 153 44.5 23.8 10.5 9.2 NA NA 32 11 3 11 7 9
Becker et al., 200930 50 50.9 26.3 0.0 NA 40.0 14.3 2 1 NA 1 NA NA
Bindingnavele et al., 200731 65 50.0 NA NA 12.2 NA 10.0 6 3 1 2 NA 1
Breuing and Colwell, 200715 67 46.0 NA 7.4 7.4 NA 16.1 2 NA NA 2 NA 1
Buck et al., 20103 58 53.3 NA 4.0 10.0 213.5 4.6 5 1 1 2 1 2
Chun et al., 201012 269 47.0 25.5 8.7 6.5 322.7 NA 131 38 6 24 63 16
Lanier et al., 201065 52 51.0 29.8 5.8 5.8 256.0 6.7 31 8 0 15 8 10
Liu et al., 201117 266 NA 24.9 NA 9.8 187.8 NA 75 19 1 18 37 13
Losken, 20097 31 48.0 26.7 NA 25.8 NA 10.2 1 0 NA 0 1 0
Margulies et al., 200532 50 46.0 NA NA NA NA 7.9 2 NA NA 1 1 NA
Nahabedian, 20096 100 48.2 NA 11.8 18.4 NA 17.0 13 5 NA 5 3 2
Namnoum, 200933 29 NA NA NA 3.4 170.0 21.0 3 1 NA 1 1 NA
Preminger et al., 200866 45 NA NA NA NA 223.8 NA 7 3 1 3 NA NA
Rawlani et al., 20112 121 50.2 NA 2.5 19.0 256.6 10.2 19 2 0 9 8 11
Salzberg et al., 201118 466 NA NA 2.4 2.1 412.8 28.9 11 NA 5 1 5 6
Sbitany et al., 200913 92 48.6 26.4 NA 12.0 412.5 NA 11 3 NA 8 NA 4
Spear et al., 20085 58 50.3 NA 5.2 13.8 242.0 18.1 7 1 NA 4 2 1
Topol et al., 200834 35 NA NA NA NA NA 9.5 3 NA NA 3 NA 2
Zienowicz and Karacaoglu, 200735 30 NA NA NA NA 441.0 18.0 6 NA NA NA 6 NA
NA, not applicable; XRT, radiotherapy.

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