Patient Reported Outcome and cosmetic evaluation following implant-based breast-reconstruction with a titanized polypropylene mesh (TiLOOP® Bra): a prospective clinical study in 269 patients
Paepke S.1, Klein E.1, Faridi A.2, Meiré A.3, Gerber-Schäfer C.4, Baumann K.5, Blohmer J.-U.6, Mau C.7, Tofall S.8, Nolte E.8, Strittmatter H.-J.9, Ohlinger R.10, Thill M.11
1Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Frauenheilkunde, München, Deutschland, 2Universitätsklinikum Bonn, Bonn, Deutschland, 3St. Elisabeth Krankenhaus, Köln, Deutschland, 4Sankt Gertrauden Klinikum, Berlin, Deutschland, 5Universitätsklinikum Schleswig-Holstein, Lübeck, Deutschland, 6Campus Charité Mitte (CCM), Klinik für Gynäkologie mit Brustzentrum, Berlin, Deutschland, 7Helios Klinikum Berlin Buch, Berlin, Deutschland, 8pfm medical AG, Köln, Deutschland, 9Rems-Murr-Klinikum Winnenden, Winnenden, Deutschland, 10Universitätsmedizin Greifswald, Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde, Greifswald, Deutschland, 11AGAPLESION MARKUS KRANKENHAUS, Gynäkologisches Krebszentrum, Frankfurt am Main, Deutschland
Zielsetzung: Implant-based or expander-supported breast reconstruction is an established surgical method. In a prospective, single-arm, multi-center study the patient reported outcome (PRO) after breast reconstruction with a synthetic surgical mesh was investigated. The focus of this study was the analysis of patient reported outcome 12 months after breast reconstruction.
Materialien und Methoden: Primary or secondary implant-based breast reconstruction with support of a titanium-coated polypropylene mesh (TiLOOP® Bra) was performed in 269 patients in the course of the PRO-BRA study. Patient reported outcome 12 months after breast reconstruction was evaluated using the established Breast-Q questionnaire. Cosmetic outcome was evaluated by two independent experts.
Ergebnisse: The Breast-Q and 12 months FU were completed by 210 women. Patients without AE had a significantly higher Breast-Q score for “sexual well-being”; “psychosocial well-being” was negatively influenced by prior therapies, and patients > 40 years had significantly lower scores at 12 months FU for “ satisfaction with breasts (SwB)” while the opposite was true for patients ≤ 40 years. The BMI only influenced PRO preoperatively. Unilateral surgery resulted in reduced “satisfaction with breast”; a higher UICC stadium (II-IV) resulted in worse “SwB”. Radiotherapy negatively influenced “SwB”. The cosmetic evaluation showed a significant difference in the evaluation by the patients and experts with the patients' assessment being worse.
Zusammenfassung: Our trial showed that two years after implant-based breast reconstruction with support of TiLOOP® Bra PRO is influenced by different factors. This information can be used to improve the decision-making process for women who chose implant-based breast reconstruction.