Direct-to-Implant versus Two-Stage Tissue Expander/Implant Reconstruction: 2-Year Risks and Patient-Reported Outcomes from a Prospective, Multicenter Study

Abstract

Background Direct-to-implant breast reconstruction offers time-saving advantages over two-stage techniques. However, use of direct-to-implant reconstruction remains limited, in part, because of concerns over complication rates.1,2 The authors’ aim was to compare 2-year complications and patient-reported outcomes for direct-to-implant versus tissue expander/implant reconstruction. Methods Patients undergoing immediate direct-to-implant or tissue expander/implant reconstruction were enrolled in the Mastectomy Reconstruction Outcomes Consortium, an 11-center prospective cohort study. Complications and patient-reported outcomes (using the BREAST-Q questionnaire) were evaluated. Outcomes were compared using mixed-effects regression models, adjusting for demographic and clinical characteristics. Results Of 1427 patients, 99 underwent direct-to-implant reconstruction and 1328 underwent tissue expander/implant reconstruction. Two years after reconstruction and controlling for covariates, direct-to-implant and tissue expander/implant reconstruction patients did not show statistically significant differences in any complications, including infection. Multivariable analyses found no significant differences between the two groups in patient-reported outcomes, with the exception of sexual well-being, where direct-to-implant patients fared better than the tissue expander/implant cohort (p = 0.047). Conclusions This prospective, multi-institutional study showed no statistically significant differences between direct-to-implant and tissue expander/implant reconstruction, in either complication rates or most patient-reported outcomes at 2 years postoperatively. Direct-to-implant reconstruction appears to be a viable alternative to expander/implant reconstruction. This analysis provides new evidence on which to base reconstructive decisions.

Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study

“…Increased numbers of re-operations could reflect more aggressive management of complications when mesh is used, but the use of mesh does not seem to translate into a reduced percentage of implant loss. Although the proportions of patients with implant loss and return to theatre in this study are much lower than those reported in a 2017 randomised trial,11, 13 they are much higher than those reported in other large prospective observational studies14, 15, 28 and summarised in recent systematic reviews 8, 9. This large, multicentre study is likely to reflect real-world outcomes of immediate implant-based breast reconstruction, and highlights the need for improvement in this area.…”

“…The study was criticised because the participating surgeons had limited experience with the technique, 12 but further analysis did not identify a learning curve effect 13 . However, other large multicentre prospective studies have not shown a significant difference in incidence of complications or patient-reported outcomes between single-stage direct-to-implant and two-stage techniques, 14 or between two-stage expander-implant reconstruction done with and without acellular dermal matrix 15 . Although these findings are supportive of the technique, there remains the need for high-quality evidence from a randomised study to support practice.…”

Beyond 30 Days: A Risk Calculator for Longer Term Outcomes of Prosthetic Breast Reconstruction

“…One-year risk of complications in our cohort are comparable to other long-term follow-up values reported in the literature (Table 2). 23–26,50–52 Although these rates are useful as benchmark figures for the population, they have limited utility as risk estimates for most individual patients. That is, the mean incidence of a complication is not representative of most patients, because the distribution of risk is so positively skewed (skewness = 2.027, Fig.…”

Safe and Efficient Implant-based Breast Reconstruction

“…A strength of this approach is the ability to complete the reconstruction in a single-stage, while maintaining similar rates of revision and complications as well as patient-reported outcomes compared with tissue expander/implant reconstruction. 13 , 14 Optimal candidates for DP-DTI reconstruction are patients with relatively smaller breasts who wish to maintain the same size. 10 , 15 In addition, it is best performed in patients who demonstrate well-perfused mastectomy flaps because ADM is fundamentally a graft that relies on revascularization by the overlying tissues.…”