Introduction The most recent meta-analysis published, containing only studies from 2011 onwards, reports acellular dermal matrix (ADM) assisted breast reconstructions are associated with a significant increase in risk of infection, seroma and mastectomy flap necrosis but not implant loss when compared to submuscular reconstructions. We hypothesised that implant loss associated with ADM-assisted reconstruction did not exclusively occur within the first 30 days after surgery and studies with short-term follow-up may underestimate the risk. We aimed to determine with long-term follow-up at what time point explantation occurs after Strattice™ ADM-assisted reconstruction and if it differs from traditional submuscular implant based reconstruction. Methods A retrospective case note review was completed for all immediate implant based reconstructions performed between 1st January 2009 and 31st December 2015 in a single tertiary centre in England. Implant losses, the timings and causes of loss were determined. Results In total there were 510 immediate implant based reconstructions performed in 373 patients, of which 135 were submuscular and 375 ADM-assisted. In the ADM group a total of 22 (5.9%) implants were lost as a complication of their primary surgery. 14 implants were lost due to infection and eight due to wound breakdown. Implants were lost over a range of 14-661 days, median 76 days. Implant loss occurred within 30 days in six (27%), <90 days in 13 (59%) and over 90 days in nine breasts (41%). There were seven unplanned explantations, six were changed to autologous reconstructions (three for cosmetic reasons and three as a result of radiotherapy damage); one patient had a completion mastectomy for recurrent cancer. In the submuscular group a total of 11 (8.1%) implants were lost as a complication of their primary surgery. Six implants were lost due to infection and five due to wound breakdown. Implants were lost over a range of 12-274 days, median 49 days. Implant loss occurred within 30 days in four (36%), <90 days in seven (64%) and over 90 days in nine breasts (36%). There were a further six unplanned explantations, two for pain and four for cosmetic reasons. Comparing the two groups there were no differences in total implant loss rate or time to implant loss. Conclusions Implant loss within the first 3 months of ADM-assisted breast reconstruction is 3.5%; however, implant loss can occur more than 90 days after ADM-assisted breast reconstruction. Patients and clinicians should be aware that the risk of explantation continues for up to two years post-operatively with an ADM-assisted reconstruction whereas with submuscular coverage there were no implant losses beyond nine months follow-up. There were no differences in explantation rates between submuscular and ADM-assisted breast reconstructions. Citation Format: Wilson RL, Kirwan CC, Johnson RK, Harvey JR. Long term risk of explantation with Strattice™ assisted breast reconstruction, is it any different to submuscular reconstruction? [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-14-05.
Introduction Implant based reconstruction accounts for approximately 85% of reconstructions in the UK and 80% in the US with an increase in use of acellular dermal matrices (ADM) e.g. Strattice™. There is little long-term data on the outcomes of ADM reconstructions and its efficacy. Our aim was to establish the most comprehensive long-term surgical, cost-effectiveness, quality of life and cosmetic outcomes in three large UK reconstructive centres. Methods All women who had undergone immediate implant based breast reconstruction with Strattice™ or a submuscular technique between 2009 and 2015 across three tertiary centres in the UK were invited for prospective clinical (examination and tonometry), cosmetic and quality of life assessment. An eight year retrospective review of case notes, theatre database and implant log was performed. Results 601 patients underwent 837 reconstructions. 589 Strattice™-assisted (331 therapeutic, 258 risk reduction) and 248 submuscular (152 therapeutic, 96 risk reduction). Revision surgery was performed in 43% of Strattice™-assisted reconstructions and 35% of submuscular within the follow-up period (p=0.034). Strattice™-assisted reconstructions were revised significantly sooner than submuscular, median time to first revision of 12 months vs. 21 months (p<0.0001).There was a significant reduction in the need for revision surgery for capsular contracture in the Strattice™-assisted group (Strattice™ n=19, submuscular n=16, p=0.04). Revision rates for capsular contracture in those having prior or adjuvant radiotherapy were 33% (n=9) in the Strattice™-assisted group and 66% (n=2) in the submuscular. At a median time of 58 months from initial procedure, 10% in the Strattice™-assisted group and 14% in the submuscular had significant capsular contracture (Baker 3/4). At the time of assessment 7% of the Strattice™-assisted group and 17% of the submuscular had already undergone revision surgery for capsular contracture. Therefore, overall there was significantly more capsular contracture in the submuscular group (17% vs. 31%, p=0.047). There was no difference between the mean (of the four quadrant readings) breast tonometry reading between the two groups (0 hard – 10 soft). The median reading was 5.3 in the Strattice™-assisted group, 5.4 in the submuscular and 6.6 in native breasts. Those with Baker 1/2 had a median reading of 5.4 compared to 4.8 in those with a Baker 3/4 capsule. Quality of life was equivalent between the two groups at a median time of 58 months. There was no difference in median Breast Q score for satisfaction with breasts, Strattice™-assisted 62 vs. submuscular 58 or satisfaction with outcome 67 vs. 75. The mean cost of the index reconstructive procedure was less in the Strattice™-assisted group (£3634 vs. £4230) but there were no significant differences in long-term cost. Conclusion Long-term clinical outcomes support the use of Strattice™ in breast reconstruction. It reduces capsular contracture and enables patients to have their surgery in one rather than two procedures. The increased revision rate in the Strattice-assisted group was multi-faceted e.g. patient request to upsize and correction of contouring defects. Strattice™ reduces healthcare cost. Citation Format: Wilson RL, Kirwan CC, O'Donoghue JM, Linforth RA, Johnson RK, Harvey JR. The long-term outcomes of the BROWSE multicentre cohort study comparing Strattice™-assisted implant based reconstruction and submuscular reconstruction [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-16-03.
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