Abstract

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

Dr Stefan Paepke
Klinikum Rechts der Isar, Klinik und Poliklinik fuer Frauenheilkunde, Technische, Universitaet Muenchen, Germany

Introduction:

In the majority of interdisciplinary breast centres of Germany, implant-based, mesh-supported operations constitute a total of approximately 50-60% of reconstructive techniques. The vast majority of mesh-supported reconstructive breast surgery is performed with the titanised polypropylene mesh TiLoop®Bra [ Zoche H; 2014]. The BreastQ [Pusic AL; 2006] is the most valid and reliable measurement of quality of life aspects in important domains used in clinical routine.

Material and Methods:

Because the patient reported outcome is the most relevant factor reflecting the overall satisfaction from a patient perspective a prospective single arm non-randomised surveillance study with BreastQ-scales at 12 months as primary endpoint was conducted (2013). 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 (secondary endpoint) was done.

Results:

Most frequent indication was BC. Almost all surgeries were primary reconstructions (96.6%) and nipple-skin-sparing mastectomies (97.1%). A expander exchange is planned for 20 pts. The most frequent incision was inframammary (n=115), followed by T-shaped (n=45). The average of the pts. was 50 y (19-77); BMI was 22 (17-33), 77.3% were non-smokers. Percentage of neoadjuvant chemotherapy 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 score of BreastQ was equal 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 satisfaction with surgeon 90+/-15. 88.3% were very satisfied, 10.0% somewhat satisfied, only 1.7% somewhat dissatisfied, 0% very dissatisfied.

Conclusion:

The first analysis of the PROBra-study shows positive results in all outcome parameters. The study will continue until the complete recruitment of the pre-planned 267 pts. within a follow up of at least two years.