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PACE 2 — Prospective Study of Patient Activated Controlled Expansion for Breast Reconstruction Following Mastectomy

Connell, Anthony F. MBBS, BSc

Plastic & Reconstructive Surgery: November 2012 - Volume 130 - Issue 5S-1 - p 82
doi: 10.1097/01.prs.0000421797.07455.eb
Sunday, October 28
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To confirm the results of the PACE 1 Study (1) in a larger population. The PACE 1 Study demonstrated that a patient-controlled tissue expander could perform tissue expansion in women who elected to have breast reconstruction following mastectomy.

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The investigational device in this prospective, open-label, single-site clinical study was a remote-controlled tissue expander containing a reservoir of compressed carbon dioxide. All subjects underwent a latissimus dorsi pedicled flap procedure (per the standard practice of the investigator). Post-implant, subjects were instructed to use the remote dosage controller to administer 10-cc doses of carbon dioxide based on their comfort level up to three times daily. Post full expansion, the expander was exchanged for a permanent implant.

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Thirty-three women have enrolled in the study since July 2011. All enrolled subjects have undergone breast reconstruction with placement of a total of 62 small (400-cc) or medium (650-cc) patient controlled tissue expanders (29 bilateral and 4 unilateral). To date, 24 subjects (20 bilateral and 4 unilateral) have successfully expanded and have exchanged to breast implants. Mean expansion occurred in 17 ± 5.4 days, and reconstructions for the 33 expanders were completed in an average of 86 ± 16 days (Figures 1 and 2). Ninety-two percent (12/13) of reporting patients were moderately-to-very satisfied overall; surgeon-reported satisfaction with expansion results in all patients was moderate-to-very satisfied. No device-related adverse events or failures occurred.

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The short time to complete the expansion and reconstruction process, the absence of device-related adverse events, and the high patient and physician satisfaction reports confirm the need to provide mastectomy patients with immediate or delayed reconstruction the option of needle-free, gradual and comfort-guided tissue expansion that they can control.

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Materials and administrative support for the study were supplied by the study sponsor: AirXpanders, Inc., Palo Alto, CA USA. The author does not have a financial interest in any of the products, devices, or drugs mentioned in this manuscript.

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1. Connell A. F. Patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide inflation: A feasibility study. Plast Reconstr Surg 2011; 128:848–852, 2011.
©2012American Society of Plastic Surgeons