First results of pre-planned interim analysis of national multicenter Patient Reported Outcome Study (PRO-Bra) in breast reconstruction following mastectomy with titaniferously coated polypropylene mesh (TiloopBra)

Introduction: Implant based, mesh-supported operations constitute a total of 50 – 60% of reconstructive techniques. The BreastQ [Pusic AL; 2006] is the most valid and reliable measurement of quality of life aspects used in clinical routine.

Patients and Method: A prospective single arm non-randomized surveillance study with BreastQ-scales at 12 months as primary endpoint was conducted. Overall 205 breasts of 153 pts. were treated between 12/2013 and 9/2015. A pre-planned analysis of the first 60 pts. with completion of the BreastQ after 6 months was done.

Results: Most frequent indication was BC, in 96,6% were primary reconstructions and nipple-skin-sparing mastectomies (97.1%). An expander exchange is planned for 20 pts. The most frequent incision was inframammary, followed by T-shaped. The average of the pts. was 50 y; BMI was 22 (17 – 33), 77.3% were non-smokers. Percentage of PST was 23%, of prior radiotherapy was 12%. Radiotherapy showed no significant influence of the BreastQ. Severe events occurred in 46 cases. The most frequent complications were necrosis (n = 12), hematoma (n = 12); 9 pts. dropped out. The mean BreatQ-score was identicaly pre- and postoperative after 6 months (67 ± 16 to 65 ± 15); satisfaction with breast from 67 ± 22 to 61 ± 14; psycho-social well-being from 71 ± 17 to 73 ± 18; sexual well-being from 62 ± 17 to 60 ± 19; satisfaction with outcome was 75 ± 18 and with surgeon 90 ± 15. 88.3% were very satisfied, 10.0% somewhat satisfied, only 1.7% somewhat dissatisfied.

Conclusion: The first analysis of the PROBra-study shows positive results in all outcome parameters.