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Clinical And Patient-reported Outcomes After Direct To Implant-based Breast Reconstruction With Acellular Dermal Matrix Versus Two-stage Breast Reconstruction: Results From A Multicenter, Randomized, Controlled Trial
Toni Zhong, M.D. M.H.S. FRCS(C)1, Han Zeng, M.D.
2, Anam Liaqat, PharmD, MPhil (Pharmacology), MSc Health Sciences
2, Claire Temple Oberle, M.D. MSc, FRCS(C)
3, Stefan O.P. Hofer, M.D. PhD. FRCS(C)
1, Anne O'Neill, MBBCh, MMedSci. FRCS(Plast), MSc, PhD
1, John Semple, BSc (AAM), M.D, MSc, FRCS(C), FACS
4, Mitchell H. Brown, M.D, MEd, FRCS(C)
4, Sheina A. Macadam, M.D., MSc Epi, FRCSC, FACS
5, Colleen M. McCarthy, M.D., FRCS(C)
6, Nancy Baxter, M.D, MBA, PhD, FRCS(C), FACS
7.
1University Health Network & University of Toronto, Toronto, ON, Canada,
2University Health Network, Toronto, ON, Canada,
3Tom Baker Cancer Centre, Alberta Health Services, Calgary, AB, Canada,
4University of Toronto, Toronto, ON, Canada,
5Vancouver General Hospital and University of British Columbia, Vancouver, BC, Canada,
6,Memorial Sloan-Kettering Cancer Center, New York, NY, USA,
7University of Sydney, Sydney, New South Wales, Australia.
PURPOSE:Acellular dermal matrices (ADMs) has widened the indications for implant-based breast reconstruction (IBBR). However, there is inconsistent evidence comparing the clinical and patient-reported outcomes (PROs) of direct to implant ADM-assisted IBBR and two-stage IBBR. The Multi Center Canadian Acellular Dermal Matrix Trial (MCCAT) compared PROs and complications between these two approaches.
METHODS:The trial was conducted in four hospitals in Canada. Eligible women undergoing mastectomy with IBBR were randomized to direct to implant ADM-assisted or two-stage IBBR group. The primary PROs were breast satisfaction, psychosocial, physical, and sexual well-being as measured by BREAST-Q prior to surgery, 2 weeks post-mastectomy, and 6 and 12 months after final reconstruction. Secondary outcomes included postoperative complications over a 12-month follow-up. The trial is registered at ClinicalTrials.gov: NCT00956384.
RESULTS:A total of 198 patients were randomly assigned to direct to implant ADM-assisted (n=102) or two-stage (n=96). At 2 weeks post-mastectomy, the direct to implant group reported higher satisfaction with breasts (mean difference:8.87,
p=0.03) and sexual well-being (mean difference:11.05,
p=0.02) but lower physical wellbeing (mean difference:-5.88,
p=0.02). There were no significant differences in PROs at 6 and 12 months post-reconstruction. A higher mastectomy weight was associated with increased risk of major complications (OR:1.24, 95% CI:1.01-1.54,
p=0.046). Complete reconstruction failure occurred only in direct to implant (10.5%).
CONCLUSION:Direct to implant ADM-assisted IBBR offers immediate aesthetic benefits, but it also increases the risk of early physical discomfort and reconstruction failure. Long term PROs were comparable in both groups, supporting informed choices in breast reconstruction.
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