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

Purpose: 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 their mastectomy.

Methods and Materials: The investigational device in this prospective, open-label, single-site clinical study was an implantable tissue expander with an outer silicone shell, an anatomically shaped inner chamber containing a reservoir of compressed carbon dioxide, and a wireless handheld dosage controller that the patient and the surgeon used to add volume into the expander. All subjects underwent a latissimus dorsi pedicled flap procedure (per the standard practice of the investigator) to provide additional muscle coverage. Post-implant, subjects were followed until wound healing was adequate and then 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. After 6-8 weeks post full expansion, subjects underwent surgery to remove the expander and place an implant.

Experience: Nineteen women have enrolled in the study since July 2011. Eighteen of the enrolled subjects have undergone breast reconstruction with placement of a total of 33 small (400-cc) or medium (650-cc) patient controlled tissue expanders (15 bilateral and 3 unilateral).

Results: To date, thirteen subjects (11 bilateral and 2 unilateral) have successfully expanded and have exchanged to breast implants. Reconstructions for these 13 patients were completed in an average of 87 days (range, 68-109 days). No device-related adverse events or failures occurred.

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

1. Connell, AF. Patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide inflation: a feasibility study. Plast Reconstr Surg 2011;128(4):848-52.

 

Top: Patient-controlled expansion versus time, 23 days from the start of patient dosing until full expansion. Bottom: Same patient with bilateral patient-controlled expanders before exchange to permanent implants.