Abstract: Evaluation of a New Concept in Two-Stage Breast Reconstruction: Patient Controlled Tissue Expansion Using the Aeroform CO2 Tissue Expander System (Plastic Surgery The Meeting)

Monday, September 26, 2016: 2:20 PM

Jeffrey A. Ascherman, MD , Division of Plastic Surgery, NewYork-Presbyterian/Columbia University Medical Center, New York, NY

Kamakshi R Zeidler, MD , Aesthetic Plastic and Reconstructive Surgery, Campbell, CA

Kerry A. Morrison, BS , Division of Plastic Surgery, NewYork-Presbyterian/Columbia University Medical Center, New York, NY

James Appel, MD , Presyterian Medical Center - Charlotte, Charlotte, NC

R. Laurence Berkowitz, MD , Aesthetic and Reconstructive Plastic Surgery, Campbell, CA

John Castle, MD , Plastic Surgery, University of Massachusetts Memorial Medical Center, Worcester, MA

Amy S Colwell, MD , Division of Plastic and Reconstructive Surgery, Massachusetts General Hospital/Harvard Medical School, Boston, MA

Yoon S. Chun, MD , Division of Plastic Surgery, Department of Surgery, Harvard Medical School, Brigham and Women's Hospital/Faulkner Hospital, Boston, MA

Debra J Johnson, MD , The Plastic Surgery Center, Sacramento, CA

Khashayar Mohebali, MD , Plastic Surgery Specialists, Corte Madera, CA

Presentation PDF file

Background: Two-stage breast reconstruction using saline tissue expanders is the standard of care utilized for greater than 50 years. Recently the status quo has been challenged by a CO₂filled, remote controlled tissue expander. The AeroForm expander (AirXpanders, Palo Alto, CA) has CE Mark certification and has been commercially available in Australia since 2015.

Data from multiple clinical studies have shown that this method can be used effectively and safely to prepare the surgical pocket for placement of a permanent implant.

Purpose: The purpose of this paper is to review the clinical data for latest generation AeroForm with regard to outcomes and management of patients implanted with this new technology.

Methods: Data from a US, prospective, multi-center, randomized, controlled study were analyzed for successful second stage surgery, time to complete expansion and reconstruction, and satisfaction. Patients were enrolled and randomized (2:1) to receive either the CO₂- expander or saline expander. Inclusion was limited by age (18-65), BMI (<33) and tissue suitability for expansion.

Results: Data were reviewed for 72 (44 CO₂/28 saline) patients implanted with the current generation of the AeroForm or a saline expander within the same time period. Data are presented by breast (AeroForm = 78, saline = 50) with the primary endpoint achieved in 97.3% (CO₂) and 97.8% (saline) patients. The treatment difference (-0.51) is within a margin of non-inferiority of -7.7. The study was a non-inferiority design and the protocol stated success range was a margin of < -10 %. The results with the CO₂ device versus earlier reported results reflect enhancements made to the design and manufacturing process during the trial. The average expansion and total reconstruction days were 17 and 111 respectively (CO₂) and 35 and 121 days respectively (saline). Overall satisfaction for the AeroForm was 84% (patient) and 89% (physician).

Conclusions: The AeroForm expander which uses CO₂ as the filling medium has been used successfully by patients for home dosing in clinical trials in the last five years. These results confirm earlier reports and demonstrate that the current generation of AeroForm is a viable alternative to saline for two-stage breast reconstruction. 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.

29171 Evaluation of a New Concept in Two-Stage Breast Reconstruction: Patient Controlled Tissue Expansion Using the Aeroform CO2 Tissue Expander System