Results from the ASPIRE study for breast reconstruction utilizing the AeroForm™ patient controlled carbon dioxide-inflated tissue expanders.

摘要: Summary Background Therapeutic or prophylactic mastectomy is often indicated for women with breast cancer, those at a high risk of developing cancer due to familial history genetic mutations. Favorable aesthetic and psychological results make prosthetic reconstruction the placement tissue expanders followed by permanent implant popular choice diagnosed cancer. This study describes ASPIRE trial, objective which was provide supportive data demonstrate performance safety AeroForm™ System in population broader selection criteria than previous studies. Results earlier PACE clinical studies (PACE 1 2) demonstrated that could be used safely effectively achieve desired expansion necessary successful reconstruction. In current trial described paper, device evaluated exchange implant(s) unless precluded non-device related event. Safety based on reported adverse events. Methods: A prospective, single center, open-label subjects who met inclusion agreed participate were enrolled implanted AeroForm expander either time (immediate) sometime after (delayed). event bilateral procedure, each side. Subjects until explant expander(s) silicone saline implant(s). Thirty-four placed 21 trial; average age 49.7 ± 8.6 years BMI 26.1 ± 4.7. Bilateral procedures accounted 62% total 88% reconstructions completed latissimus dorsi flap (anterior approach) per investigators standard procedure. Four (12%) cases two using an inferior dermal flap. Overall success rate 94% (32/34 breasts) no failures. Two failed reconstruction, one infection wound healing issues, both requiring unilateral removal revision surgery. However, second stage delayed Conclusion The reports confirmatory more inclusive patient 2 trials, indicating Expander, provides time-saving, needle-free, safe effective method There complications from achieving goal exchange. Reported are similar literature procedures. Further development may enable dose controller operate increase size range offered this promising technology.