A Systematic Review and Head-to-Head Meta-Analysis of Outcomes following Direct-to-Implant versus Conventional Two-Stage Implant Reconstruction.

BACKGROUND: Innovative approaches to reconstruction have ushered in an era of breast reconstruction in which direct-to-implant procedures can provide an immediately reconstructed breast. Balancing the benefits against its technical challenges is vital. The authors evaluated the safety and efficacy of using direct-to-implant versus conventional two-stage reconstruction through a systematic meta-analysis. METHODS: A literature search identified all articles published after 1999 involving prosthetic-based breast reconstruction as a two-stage tissue expander/implant or direct-to-implant technique. The primary outcomes of interest, including implant loss, capsular contracture, reoperation, and infection, were analyzed by means of head-to-head meta-analysis. RESULTS: Thirteen studies involving 5216 breast reconstructions were included. The average patient age was 47.2 ± 1.0 years, the average body mass index was 24.9 ± 0.8 mg/k, and the average follow-up was 40.8 months. Wound infection, seroma, and capsular contracture risk were similar between groups. However, direct-to-implant reconstruction was associated with a higher risk for skin flap necrosis (OR, 1.43; p = 0.01; I = 51 percent) and reoperation (OR, 1.25; p = 0.04; I = 43 percent). Ultimately, the risk for implant loss was nearly two-fold higher with direct-to-implant reconstruction compared with tissue expander/implant reconstruction (OR, 1.87; p = 0.04; I = 33 percent). CONCLUSIONS: Although direct-to-implant and two-stage tissue expander/implant reconstruction are successful approaches, this meta-analysis demonstrates significantly greater risk of flap necrosis and implant failure with direct-to-implant reconstruction. The authors' findings suggest that the critical component of patient selection is judgment of mastectomy flap tissue quality. These findings can enhance the risk counseling process and highlight the need for additional investigations to optimize outcomes. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.