DOI QR코드

DOI QR Code

Blossom smart expander technology for tissue expander-based breast reconstruction facilitates shorter duration to full expansion: A pilot study

  • Choi, Youna K. (Division of Plastic and Reconstructive Surgery, Stanford University Medical Center) ;
  • Rochlin, Danielle H. (Division of Plastic and Reconstructive Surgery, Stanford University Medical Center) ;
  • Nguyen, Dung H. (Division of Plastic and Reconstructive Surgery, Stanford University Medical Center)
  • Received : 2020.03.30
  • Accepted : 2020.07.22
  • Published : 2020.09.15

Abstract

Background This study evaluated the Blossom system, an innovative self-filling, rate-controlled, pressure-responsive saline tissue expander (TE) system. We investigated the feasibility of utilizing this technology to facilitate implant-based and combined flap with implant-based breast reconstruction in comparison to conventional tissue expansion. Methods In this prospective, single-center, single-surgeon pilot study, participants underwent either implant-based breast reconstruction or a combination of autologous flap and implantbased breast reconstruction. Outcome measures included time to full expansion, complications, total expansion volume, and pain scores. Results Fourteen patients (TEs; n=22), were included in this study. The mean time to full expansion was 13.4 days (standard error of the mean [SEM], 1.3 days) in the combination group and 11.7 days (SEM, 1.4 days) in the implant group (P=0.78). The overall major complication rate was 4.5% (n=1). No statistically significant differences were found in the complication rate between the combination group and the implant group. The maximum patient-reported pain scores during the expansion process were low, but were significantly higher in the combination group (mean, 2.00±0.09) than in the implant group (mean, 0.29±0.25; P=0.005). Conclusions The reported average duration for conventional subcutaneous TE expansion is 79.4 days, but this pilot study using the Blossom system achieved an average expansion duration of less than 14 days in both groups. The Blossom system may accommodate single-stage breast reconstruction. The overall complication rate of this study was 4.5%, which is promising compared to the reported complication rates of two-stage breast reconstruction with TEs (20%-45%).

Keywords

References

  1. American Society of Plastic Surgeons (ASPS). Plastic surgery statistics [Internet]. Arlington Heights, IL: ASPS; c2019 [cited 2020 Aug 27]. Available from: https://www.plasticsurgery.org/news/plastic-surgery-statistics.
  2. Radovan C. Breast reconstruction after mastectomy using the temporary expander. Plast Reconstr Surg 1982;69:195-208. https://doi.org/10.1097/00006534-198202000-00001
  3. Austad ED, Rose GL. A self-inflating tissue expander. Plast Reconstr Surg 1982;70:588-94. https://doi.org/10.1097/00006534-198211000-00011
  4. Han RS, Jacobs D, Jones CS et al. Tissue expander. Munich, Germany: 2016. European Patent Office Patent No. EP3023-075A1.
  5. Widgerow AD, Murdoch M, Edwards G, et al. Patient-controlled expansion: applying a new technique to breast reconstruction. Aesthetic Plast Surg 2007;31:299-305. https://doi.org/10.1007/s00266-006-0229-y
  6. Bertozzi N, Pesce M, Santi P, et al. Tissue expansion for breast reconstruction: methods and techniques. Ann Med Surg (Lond) 2017;21:34-44. https://doi.org/10.1016/j.amsu.2017.07.048
  7. Zhu L, Mohan AT, Abdelsattar JM, et al. Comparison of subcutaneous versus submuscular expander placement in the first stage of immediate breast reconstruction. J Plast Reconstr Aesthet Surg 2016;69:e77-86. https://doi.org/10.1016/j.bjps.2016.01.006
  8. Eltahir Y, Werners LL, Dreise MM, et al. Quality-of-life outcomes between mastectomy alone and breast reconstruction: comparison of patient-reported BREAST-Q and other health-related quality-of-life measures. Plast Reconstr Surg 2013;132:201e-209e. https://doi.org/10.1097/PRS.0b013e31829586a7
  9. Al-Ghazal SK, Sully L, Fallowfield L, et al. The psychological impact of immediate rather than delayed breast reconstruction. Eur J Surg Oncol 2000;26:17-9. https://doi.org/10.1053/ejso.1999.0733
  10. Le NK, Garcia-Molina C, Kumar A, et al. Pain and anxiety levels of patients undergoing tissue expansion after mastectomies: a case series study. Cancer Control 2017;24:1073274817729893.
  11. Azzi AJ, Zammit D, Lessard L. Single-stage breast reconstruction using an all-in-one adjustable expander/implant. Plast Reconstr Surg Glob Open 2018;6:e1609. https://doi.org/10.1097/GOX.0000000000001609
  12. Wilkins EG, Hamill JB, Kim HM, et al. Complications in postmastectomy breast reconstruction: one-year outcomes of the Mastectomy Reconstruction Outcomes Consortium (MROC) Study. Ann Surg 2018;267:164-70. https://doi.org/10.1097/SLA.0000000000002033
  13. Bennett KG, Qi J, Kim HM, et al. Comparison of 2-year complication rates among common techniques for postmastectomy breast reconstruction. JAMA Surg 2018;153:901-8. https://doi.org/10.1001/jamasurg.2018.1687
  14. Corban J, Shash H, Safran T, et al. A systematic review of complications associated with direct implants vs. tissue expanders following Wise pattern skin-sparing mastectomy. J Plast Reconstr Aesthet Surg 2017;70:1191-9. https://doi.org/10.1016/j.bjps.2017.02.028
  15. Chopra K, Singh D, Hricz N, et al. Two-stage prosthetic prepectoral breast reconstruction: comparing tissue expansion with carbon dioxide and saline. Plast Reconstr Surg Glob Open 2019;7:e2051. https://doi.org/10.1097/GOX.0000000000002051
  16. Ascherman JA, Zeidler K, Morrison KA, et al. Carbon dioxide-based versus saline tissue expansion for breast reconstruction: results of the XPAND prospective, randomized clinical trial. Plast Reconstr Surg 2016;138:1161-70. https://doi.org/10.1097/PRS.0000000000002784
  17. Azadgoli B, Fahradyan A, Wolfswinkel EM, et al. External port tissue expansion in the pediatric population: confirming its safety and efficacy. Plast Reconstr Surg 2018;141:883e-890e. https://doi.org/10.1097/PRS.0000000000004372
  18. Azouz V, Lopez S, Wagner DS. Surgeon-controlled comparison of direct-to-implant and 2-stage tissue expander-implant immediate breast reconstruction outcomes. Ann Plast Surg 2018;80:212-6. https://doi.org/10.1097/SAP.0000000000001220
  19. Srinivasa DR, Garvey PB, Qi J, et al. Direct-to-implant versus two-stage tissue expander/implant reconstruction: 2-year risks and patient-reported outcomes from a prospective, multicenter study. Plast Reconstr Surg 2017;140:869-77. https://doi.org/10.1097/PRS.0000000000003748
  20. McCarthy CM, Mehrara BJ, Riedel E, et al. Predicting complications following expander/implant breast reconstruction: an outcomes analysis based on preoperative clinical risk. Plast Reconstr Surg 2008;121:1886-92. https://doi.org/10.1097/PRS.0b013e31817151c4
  21. Viola GM, Selber JC, Crosby M, et al. Salvaging the infected breast tissue expander: a standardized multidisciplinary approach. Plast Reconstr Surg Glob Open 2016;4:e732. https://doi.org/10.1097/GOX.0000000000000676
  22. U.S. Food & Drug Administration. 510(k) Premarket Notification [Internet]. Silver Spring, MD: U.S. Food & Drug Administration; c1985 [cited 2020 Sep 9]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K853014.
  23. Tseng WH, Stevenson TR, Canter RJ, et al. Sacramento area breast cancer epidemiology study: use of postmastectomy breast reconstruction along the rural-to-urban continuum. Plast Reconstr Surg 2010;126:1815-24. https://doi.org/10.1097/PRS.0b013e3181f444bc
  24. DeCoster RC, Bautista RF Jr, Burns JC, et al. Rural-urban differences in breast reconstruction utilization following oncologic resection. J Rural Health 2020;36:347-54. https://doi.org/10.1111/jrh.12396
  25. Alderman AK, Hawley ST, Janz NK, et al. Racial and ethnic disparities in the use of postmastectomy breast reconstruction: results from a population-based study. J Clin Oncol 2009;27:5325-30. https://doi.org/10.1200/JCO.2009.22.2455