Results of an pre-planned interim analysis of a national multicenter Patient Reported Outcome Study (PRO-Bra) in breast reconstruction with titaniferously coated polypropylene mesh (TiloopBra)

Introduction: Implant based, mesh-supported reconstructive breast surgery is routinely performed with the titanized polypropylene mesh TiLoop®Bra. The BreastQ [Pusic AL; 2006] is the most valid and reliable measurement of quality of life aspects used in clinical routine.

Material and method: Because PRO is the most relevant factor reflecting the overall satisfaction from a patient perspective a prospective single arm non-randomized surveillance study with BreastQ-scales as primary endpoint was conducted (2013). A pre-planned analysis of the first 60 pts. with completion after 6 months (secondary endpoint) was done.

Results: Most frequent indication was BC – primary reconstructions in 96.6% and nipple-skin-sparing mastectomies (97.1%). A expander exchange is planned for 20 pts. Incision were inframammary in 115 pts., T-shaped in 45. The average of the pts. was 50 y (19 – 77); BMI was 22 (17 – 33), 77.3% were non-smokers. In 23% PST, in 12% prior radiotherapy were given. Radiotherapy showed no significant influence of the BreastQ. Severe events occurred in 46 cases, in 12 pts. necrosis as well as hematoma; 9 pts. dropped out. Mean score of BreastQ was equal pre- and postoperative after 6 months (67 ± 16 to 65 ± 15); satisfaction with breast 67 ± 22 to 61 ± 14; psycho-social well-being 71 ± 17 to 73 ± 18; sexual well-being 62 ± 17 to 60 ± 19; satisfaction with outcome was 75 ± 18 and satisfaction with surgeon 90 ± 15. 88.3% were very satisfied.

Conclusion: The first analysis of the PROBra-study shows positive results in all outcome parameters. The study completed recruitment in 7/2017 with the pre-planned 267 pts. within a follow up of at least 2 years.