Cortiva versus AlloDerm in Prepectoral and Partial Submuscular Implant-Based Breast Reconstruction: A Randomized Clinical Trial

Abstract

Background: Several acellular dermal matrices (ADMs) are used for soft-tissue support in prosthetic breast reconstruction. Little high-level evidence supports the use of one ADM over another. The authors sought to compare Cortiva 1-mm Allograft Dermis with AlloDerm RTU (ready to use), the most studied ADM in the literature.

Methods: A single-blinded randomized controlled trial comparing Cortiva with AlloDerm in prepectoral and subpectoral immediate prosthetic breast reconstruction was performed at 2 academic hospitals from March of 2017 to December of 2021. Reconstructions were direct to implant (DTI) or tissue expander (TE). Primary outcome was reconstructive failure, defined as TE explantation before planned further reconstruction, or explantation of DTI reconstructions before 3 months postoperatively. Secondary outcomes were additional complications, patient-reported outcomes (PROs), and cost.

Results: There were 302 patients included: 151 AlloDerm (280 breasts), 151 Cortiva (277 breasts). The majority of reconstructions in both cohorts consisted of TE (62% versus 38% DTI), smooth device (68% versus 32% textured), and prepectoral (80% versus 20% subpectoral). Reconstructive failure was no different between ADMs (AlloDerm 9.3% versus Cortiva 8.3%; P = 0.68). There were no additional differences in any complications or PROs between ADMs. Seromas occurred in 7.6% of Cortiva but 12% of AlloDerm cases, in which the odds of seroma formation were two-fold higher (odds ratio, 1.93 [95% CI, 1.01 to 3.67]; P = 0.047). AlloDerm variable cost was 10% to 15% more than Cortiva, and there were no additional cost differences.

Conclusion: When assessing safety, clinical performance, PROs, and cost, Cortiva is noninferior to AlloDerm in immediate prosthetic breast reconstruction, and may be less expensive, with lower risk of seroma formation.

Clinical question/level of evidence: Therapeutic, I.

Fig. 1.

Consolidated Standards of Reporting Trials diagram. Existing data did not inform how prepectoral reconstruction would influence outcomes, so we amended the trial protocol to recruit an additional 180 patients for prepectoral reconstruction beyond those recruited for the subpectoral approach. No additional patients chose subpectoral reconstruction once prepectoral was offered, despite keeping the trial open for an additional year to optimize recruitment. Furthermore, no patient who selected prepectoral reconstruction was converted to a postpectoral approach for clinical reasons. Based on these trends, we continued overall trial enrollment to 302 patients (n = 61 subpectoral, n = 241 prepectoral). The research coordinator screened and enrolled all patients, who were blinded to the intervention; performed block randomization; notified surgeons which ADM would be used for each patient, disclosed in sealed envelopes; coordinated follow-up; administered the BREAST-Q to measure PROs; and ensured study protocol compliance.

Fig. 2.

Cost of subpectoral TE or prepectoral TE or DTI breast reconstructions using AlloDerm or Cortiva in unilateral or bilateral settings. Mean variable costs generated from actual patients are presented in bar graphs and exclude the cost of ADM. Costs with ADM assuming $28 to $31/cm² for AlloDerm (blue) and $23 to $26/cm² for Cortiva (red) are depicted as circles. The use of an ADM increases variable cost from 1.7 times (unilateral, subpectoral TE with Cortiva) to 4.2 times (bilateral, prepectoral DTI with AlloDerm) at the time of primary immediate reconstruction.