A Novel Approach for 2-Stage Breast Reconstruction: Patient-Controlled Tissue Expansion Using the AeroForm CO2 Tissue Expander System

Objectives: The tissue expansion process using standard of care, saline-filled expanders is lengthy, inconvenient, and uncomfortable and may lead women to make the decision to decline breast reconstruction. The efficacy and safety of a novel, needle-free, patient-controlled tissue expander using CO₂ as the filling medium was compared with the standard of care in the US-based XPAND study. Data from this multicenter, prospective, randomized clinical trial are presented to inform care providers of this new development in breast reconstruction.

Methods: One hundred fifty women were enrolled and randomized (2:1) to the AeroForm expander or traditional saline expander control group. Inclusion was restricted by age (18-65 years), BMI (<33), and tissue suitability for expansion. Women randomized to the AeroForm group self-administered 10-cc doses of CO₂ up to 3 times daily, whereas the saline group underwent serial injections of saline. Upon reaching full expansion, the expanders in both groups were exchanged to standard breast implants. This paper presents data for the latest generation of the device from 72 patients: 44 CO₂ and 28 saline implanted within the same time period. The protocol was designed as a noninferiority study, and the protocol-stated success for the primary end point (successful second-stage surgery) was a margin of _10%. Additional end points analyzed include successful second-stage surgery, time to complete expansion, time to reconstruction, and satisfaction.

Results: Data are presented by breasts implanted with an expander (AeroForm = 78, saline = 50), with the successful exchange to breast implant achieved in 97.3% (CO₂) and 97.8% (saline) of patients. The primary end point was met with the treatment difference (_0.51) within a margin of noninferiority of _7.7. The average number of expansion days were 17 for CO₂ and 35 for saline, and total reconstruction days were 111 for CO₂ and 121 for saline. Overall satisfaction for the AeroForm was 84% (patients) and 89% (physicians).

Conclusions: The results of the XPAND study demonstrate that patient-controlled, needle-free CO₂ expansion using the AeroForm expander is a viable alternative to saline expansion for 2-stage breast recon__struction. Management of patients receiving this device will be critical to successful adoption of the technology when it becomes available for general use in the United States.