Revision Incidence after Immediate Direct-to-Implant versus Two-Stage Implant-Based Breast Reconstruction Using National Real-World Data

Background: In immediate implant-based breast reconstruction (IBBR), large variation is observed in current practices between a direct-to-implant and a two-stage approach (insertion of a breast implant after a tissue expander). This population-based study aimed to compare unplanned short- and long-term revision incidence between direct-to-implant and two-stage IBBR in The Netherlands. Methods: All patients who underwent immediate IBBR following a mastectomy between 2015 and 2019 were selected from the nationwide Dutch Breast Implant Registry. Short- and long-term unplanned revision incidences were studied per immediate IBBR, including revision indications and the total number of additional operations. Confounding by indication was limited using propensity score matching. Results: A total of 4512 breast implants (3948 women) were included, of which 2100 (47%) were for direct-to-implant IBBR and 2412 (53%) were for two-stage IBBR. Median (IQR) follow-up was 29 months (range, 16 to 45 months) and 33 months (range, 21 to 47 months), respectively. Short-term revision incidence was 4.0% and 11.7%, respectively (conditional OR, 0.31; 95% CI, 0.23 to 0.42%). Long-term revision incidence was 10.6% (95% CI, 9.2 to 12.1%) and 16.4% (95% CI, 14.8 to 17.9%), respectively. In the propensity score-matched cohort, similar results were found. In the direct-to-implant group, more breasts were reconstructed within the planned number of operations than in the two-stage group. Conclusions: Unplanned revision surgery occurred less often after direct-to-implant IBBR, and more breasts were reconstructed within the planned number of operations compared to two-stage IBBR. These results, based on real-world data, are important for improving patient counseling and shared decision-making. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.