AeroForm CO2 tissue expander comparable to saline in two-stage breast reconstruction

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.”

Jeffrey Ascherman

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.

Reference:

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.