Women with breast cancer or those at high risk of developing breast cancer because of familial history of the disease or genetic mutations are frequently indicated for therapeutic or prophylactic mastectomy. Prosthetic reconstruction of the breast with placement of tissue expanders followed by implants offers favorable aesthetic and psychological results while adding only minimal additional surgical intervention. This study describes the confirmatory phase of an earlier feasibility trial that involved seven women who successfully underwent patient-activated controlled expansion for breast reconstruction with 10 AeroForm patient-controlled tissue expanders.
A prospective, open-label, single-arm, single-surgeon confirmatory study in Perth, Australia, evaluated outcomes of two-stage breast reconstruction using the investigational device. Each subject administered a preset 10-cc dose of carbon dioxide gas using a remote dosage controller, three times each day, with a 3-hour lockout between doses until full expansion was achieved.
Thirty-three women with breast cancer, family history, or predisposition because of the BRCA1 or BRCA2 gene mutation underwent pedicled latissimus dorsi flap procedures with placement of 61 carbon dioxide–based tissue expanders. The mean number of days for subjects to achieve desired expansion was 17 ± 5. Operating the dosage controller was described by the surgeon as very easy in 94 percent of the cases and by 97 percent of the subjects. No serious adverse events were reported.
This study confirms that the AeroForm breast tissue expander has demonstrated the ability to provide, relative to saline expanders, a needle-free, patient-controlled, convenient, and time-saving method of tissue expansion.
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Subiaco, Western Australia, Australia
From private practice.
Received for publication December 13, 2013; accepted March 17, 2014.
This trial is registered under the name “Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation,” ClinicalTrials.gov identification number NCT01009008 (http://www.clinicaltrials.gov/ct2/show/NCT01009008).
Interim study results presented at the 17th World Congress of the International Confederation for Plastic, Reconstructive and Aesthetic Surgery, in Santiago, Chile, February 24 through March 1, 2013; and the 92nd Annual Meeting of the American Society of Plastic Surgeons, in San Diego, California, October 11 through 15, 2013.
Disclosure: Dr. Connell was the principal investigator for the study described in this article. He has no consulting, shareholder, or advisory relationship with the sponsor of the study. The sponsor, AirXpanders, Inc., supported the costs of conducting the study. Such costs included device and surgical materials; operating room, laboratory, and hospital expenses; surgeon’s fees; monitoring and follow-up of subjects; and other administrative costs associated with the study.
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Tony F. Connell, F.R.A.C.S., 3/200 Rokeby Road, Subiaco, Western Australia 6008, Australia, email@example.com