Short-term safety outcomes of mastectomy and immediate pre-pectoral implant-based breast reconstruction: Pre-BRA prospective multicentre cohort study

Introduction: Pre-pectoral breast reconstruction (PPBR) has recently been introduced to reduce post-operative pain and improve cosmetic outcomes in women having implant-based procedures. High-quality evidence to support the practice of PPBR, however, is lacking. Pre-BRA is an IDEAL stage 2a/2b study that aimed to establish the safety, effectiveness and stability of PPBR prior to definitive evaluation in a randomised controlled trial (RCT). This manuscript reports the short-term safety endpoints at 3-months following surgery.

Methods: Consecutive patients electing to undergo immediate PPBR at participating UK centres between July 2019 - December 2020 were invited to participate. Demographic, operative, oncology and complication data were collected. The primary outcome was implant loss at 3 months. Other outcomes of interest included readmission, reoperation and infection. The study received full ethical approval (Ref:19/SC/0129).

Results: 347 women underwent 424 immediate implant-based reconstructions at 40 centres. Most were single-stage direct-to-implant (n=357, 84.2%) biological mesh-assisted procedures (n=341, 80.4%). Conversion to subpectoral reconstruction was necessary in 4 cases (0.9%) due to poor skin-flap quality. Of the 343 women undergoing PPBR, 144 (42.0%) experienced at least one post-operative complication. Implant loss occurred in 8.2% (n=28) women; almost
20% (n=67) experienced an infection; 17.5% (n=60) were readmitted for a complication and 16% (n=55) required reoperation within 3-months of their reconstruction.

Conclusions: Complication rates following pre-pectoral reconstruction are high and implant loss is comparable to subpectoral mesh-assisted implant-based techniques. These findings support the need for a well-designed RCT comparing pre and subpectoral reconstruction to establish best-practice for IBBR.