LOS ANGELES — The AeroForm expander, an investigational device that uses CO2 as a filling medium, was comparable to a saline expander, with a faster average expansion time, in two-stage breast reconstruction, according to research presented at Plastic Surgery The Meeting.
“This is an investigational device that uses CO2 rather than saline to fill up an expander for reconstruction, but the preliminary results have been excellent,” Jeffrey Ascherman, MD, of Columbia University, told Healio.com/Aesthetics. “The expansion itself occurred twice as fast with the CO2 device. The most recent version [of the device] had a very good safety profile, so we’re just waiting to hear from the FDA.”
Ascherman and colleagues conducted a prospective, multicenter, randomized control study (XPAND) of 72 patients who were implanted with the AeroForm CO2 expander (AirXpanders; n = 44) or saline expander (n = 28). Patients aged 18 to 70 years, those with a BMI less than 33, and those with breast tissue suitable for expansion were included in the study.
Analysis was conducted for successful second-stage surgery, time to complete expansion and reconstruction and satisfaction.
The AeroForm expander is patient-controlled, and is dispensed in 10 cc doses of CO2 into the expander via a handheld wireless device. Patients can only give one dose every 3 hours for a maximum of three doses daily, and a control limits dosing once the expander is full, Ascherman explained during his presentation. This allows for a needle-free system and eliminates the need for office visits for expansion.
With data presented by breast treated, including 78 for AeroForm and 50 for saline, 97.3% of patients in the AeroForm cohort and 97.8% in the saline cohort achieved the primary endpoint.
The patients in the CO2 device cohort experienced a mean of 17 expansion days vs. a mean of 35 days for saline patients. Patients in the CO2 device group had a mean of 111 days of total reconstruction compared with 121 days in the saline group.
Eighty-four percent of patients and 89% of physicians reported overall satisfaction with the CO2 device.
“These results confirm earlier reports and demonstrate the current generation of AeroForm is a viable alternative to saline for two-stage breast reconstruction,” the researchers concluded. “With the planned introduction of this novel technology in the U.S., patient management and training for home use will be required for its success.” – by Bruce Thiel
Disclosure: Ascherman reports being a principal investigator in the XPAND and XPAND2 studies, and having received research support and being a consultant for AirXpanders.
Ascherman J, et al. Breast Session 3. Evaluation of a New Concept in Two-Stage Breast Reconstruction: Patient-Controlled Tissue Expander System. Presented at: Plastic Surgery The Meeting; Sept. 23-27, 2016; Los Angeles.