Journal of plastic, reconstructive & aesthetic surgery : JPRAS · 2026
External vacuum expansion in autologous fat transfer as total breast reconstruction: Is it worth it? The interim analysis of the multicentre randomised controlled EVE trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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van der Venne Wessel B W, Smeins Nieke N P M, Kuijlaars Zoë M A, Van Kuijk Sander M J, Rijkx Maud E P, Bernardi Ella, Houwers Janneke B, Heuts Esther M, EVE trial investigators, Van der Hulst René R W J, Piatkowski A
Аннотация
BACKGROUND: Autologous fat transfer (AFT) is an emerging option for total breast reconstruction. To improve graft survival, perioperative external vacuum expansion (EVE) is used to optimise recipient-site environment. However, the efficacy of EVE and its treatment burden on women needs consideration. This interim analysis of a multicentre randomised controlled trial (RCT) evaluates the effect of EVE on volumetric outcomes and safety.
METHODS: Women undergoing total breast reconstruction with AFT were randomised 2:1 to perioperative EVE or no EVE. All participants underwent three AFT sessions followed by magnetic resonance imaging (MRI)-based volumetric assessment at six months. Primary outcomes were percentage augmentation and graft retention. Secondary outcomes included (serious) adverse events (SAEs). Quality-of-life (QoL) outcomes were not analysed in this interim analysis, as reconstruction was ongoing.
RESULTS: Fifty-three participants were included (EVE, N = 32; control, N = 21). Mean augmentation was 190.7% with EVE versus 176.4% without (adjusted difference 14.6%; 95% CI -80.0 to 109.1; p = 0.757). Graft retention was 39.3% and 34.9%, respectively (difference 4.5%; 95% CI -6.4 to 15.4; p = 0.405). Both outcomes showed no statistically significant between-group differences. The EVE group experienced more AEs (22 AEs and 5 SAEs) compared with the control group (three AEs and two SAEs), which were predominantly skin-related complications.
CONCLUSIONS: Perioperative EVE use did not yield significant improvements in augmentation or graft retention; however, it was associated with higher treatment burden and more (S)AEs. Final analyses of our ongoing RCT, incorporating patient-reported QoL outcomes are still awaited. Based on this interim analysis, the clinical benefit of EVE in reconstructive settings remains uncertain and warrants additional research.
METHODS: Women undergoing total breast reconstruction with AFT were randomised 2:1 to perioperative EVE or no EVE. All participants underwent three AFT sessions followed by magnetic resonance imaging (MRI)-based volumetric assessment at six months. Primary outcomes were percentage augmentation and graft retention. Secondary outcomes included (serious) adverse events (SAEs). Quality-of-life (QoL) outcomes were not analysed in this interim analysis, as reconstruction was ongoing.
RESULTS: Fifty-three participants were included (EVE, N = 32; control, N = 21). Mean augmentation was 190.7% with EVE versus 176.4% without (adjusted difference 14.6%; 95% CI -80.0 to 109.1; p = 0.757). Graft retention was 39.3% and 34.9%, respectively (difference 4.5%; 95% CI -6.4 to 15.4; p = 0.405). Both outcomes showed no statistically significant between-group differences. The EVE group experienced more AEs (22 AEs and 5 SAEs) compared with the control group (three AEs and two SAEs), which were predominantly skin-related complications.
CONCLUSIONS: Perioperative EVE use did not yield significant improvements in augmentation or graft retention; however, it was associated with higher treatment burden and more (S)AEs. Final analyses of our ongoing RCT, incorporating patient-reported QoL outcomes are still awaited. Based on this interim analysis, the clinical benefit of EVE in reconstructive settings remains uncertain and warrants additional research.