Abstract: One-stage implant-based breast reconstruction with the use of an acellular dermal matrix: One step forward or two steps back? (Plastic Surgery The Meeting)

Sunday, September 25, 2016: 2:25 PM

Rieky EG Dikmans, MD , Plastic, reconstructive and hand surgery, VU University Medical Center, Amsterdam, Netherlands

Vera L Negenborn, MD , Plastic, reconstructive and hand surgery, VU University Medical Center, Amsterdam, Netherlands

Mark-Bram Bouman, MD , Plastic, reconstructive and hand surgery, VU University Medical Center, Amsterdam, Netherlands

Hay A.H. Winters, MD, PhD , Plastic, reconstructive and hand surgery, VU University Medical Center, Amsterdam, Netherlands

Jos WR Twisk, PhD , Department of Epidemiology & Biostatistics, VU University Medical Center, Amsterdam, Netherlands

Quinten P Ruhe, MD, PhD , Plastic, reconstructive and hand surgery, Meander Medical Center, Amersfoort, Netherlands

Marc A.M. Mureau, MD, PhD , Plastic, Reconstructive and Hand Surgery, Erasmus Medical Center Rotterdam, Rotterdam, Netherlands

Jan-Maerten Smit, MD , Plastic, reconstructive and hand surgery, Alexander Monro Hospital, Bilthoven, Netherlands

Stefania Tuinder, MD, PhD , Plastic, reconstructive and hand surgery, Maastricht University Medical Center, Maastricht, Netherlands

Yassir Eltahir, MD , Plastic, reconstructive and hand surgery, University Medical Center Groningen, Groningen, Netherlands

Nicole Posch, MD , Plastic, reconstructive and hand surgery, Haga Hospital, Den Haag, Netherlands

Jose van Steveninck-Barends , Plastic, reconstructive and hand surgery, Haga Hospital, Den Haag, Netherlands

Marleen Meesters-Caberg, MD , Plastic, reconstructive and hand surgery, Orbis Hospital, Sittard, Netherlands

Rene Van der Hulst , Plastic, reconstructive and hand surgery, Maastricht University Medical Center, Maastricht, Netherlands

Marco J.PF. Ritt, MD, PhD , Department of Epidemiology & Biostatistics, VU University Medical Center, Amsterdam, Netherlands

Margriet G. Mullender, PhD , VU University Medical Center, Amsterdam, Netherlands

Presentation PDF file

BACKGROUND: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. The aim of this prospective randomized trial was to compare the outcomes of direct IBBR augmented with an ADM (Strattice™, LifeCell Cooperation) with those of two-stage IBBR. We report on the first results on the safety outcomes of the two procedures.

METHODS: A non-blinded randomized controlled trial was conducted at eight hospitals in the Netherlands. Patients who intended to undergo skin-sparing mastectomy and immediate IBBR were randomized to one of two procedures for IBBR: one-stage ADM-assisted IBBR or two-stage IBBR. The primary endpoint was quality of life. In the present article, we assessed the effect of the procedure on the occurrence of adverse outcomes. Analyses were performed with logistic regression and the general linear model. The trial is registered in the Dutch National Trial Register (NTR TC 5446 ) and the public CCMO register in the Netherlands (NL41125.029.12). The inclusion of patients is completed.

FINDINGS: Between April 14, 2013, and May 29, 2015, 140 patients were enrolled in the study. Eventually, 59 patients (91 breasts) in the one-stage IBBR group and 59 (87 breasts) in the two-stage IBBR group were included for analysis. The overall medical complication rates (38.5% vs 10.3%, OR=6.28, p=0.001), the medical re-operation rates (32.6% vs 9.6%, OR=3.96, p=0.009) and the implant explantation rates (27.0% vs 2.4%, OR=15.17, p=0.001) were significantly higher in the one-stage group. This remained the case after controlling for multiple confounding factors (p <.001).

CONCLUSIONS: Immediate one-stage ADM-assisted IBBR was associated with a significantly higher rate of post-operative complications compared with two-stage IBBR. There was no evidence of adverse tissue reactions to the ADM itself. These results indicate that immediate one-stage ADM-assisted IBBR should be considered very carefully.

30536 One-stage implant-based breast reconstruction with the use of an acellular dermal matrix: One step forward or two steps back?