Touching up post-mastectomy breast reconstructions with autologous fat grafts made women happier with the results, improving their satisfaction, psycho-social well-being, and sexual well-being, a longitudinal prospective cohort study found.
Prior to undergoing fat grafting, women who chose to have the procedure reported significantly lower breast satisfaction (adjusted mean difference −4.74; 95% CI −8.21 to −1.28; P=0.008), psycho-social well-being (AMD −3.87; 95% CI −7.33 to −0.40; P=0.03), and sexual well-being (AMD −5.59; 95% CI −9.70 to −1.47; P=0.008), compared with women who felt they didn't need fat grafting, reported researchers led by Dr Katelyn Bennett of the University of Michigan Health System in Ann Arbor.
After the grafting, these women had "caught up" to the others, reporting similar breast satisfaction (AMD −0.68; 95% CI −4.42 to 3.06; P=0.72), psycho-social well-being (AMD −0.59; 95% CI −3.92 to 2.74; P=0.73), and sexual well-being (AMD −2.94; 95% CI −7.01 to 1.12; P=0.15), Bennett's group said.
"During the past 2 decades, fat grafting has revolutionized breast reconstruction, enabling plastic surgeons to significantly improve aesthetic outcomes. Contour irregularities and volume deficits in both autologous and implant-based reconstructions can both be addressed with autologous fat transfer," the researchers wrote.
Initial concerns about the possibilities of fat necrosis and an increased risk for breast cancer recurrence were not substantiated by studies, and guidelines from the American Society of Plastic Surgeons now endorse fat grafting, Bennett and colleagues noted.
However, concerns still remain, and the US Food and Drug Administration (FDA) recently proposed new guidance for autologous fat grafting, they said.
"Thus, well-designed research assessing the efficacy of fat grafting is essential not only for high-quality patient care, but also to meet growing regulatory concerns over these procedures," Bennett and colleagues wrote. "Despite the widespread assumption that patients are pleased with the results of fat grafting, there have been few studies assessing the effects of these techniques on patient reported outcomes."
In an accompanying editorial, Dr Scott Hollenbeck and Dr Shelley Hwang, both of Duke University in Durham, North Carolina, said, "The study is notable, as it is the first in the literature to provide patient-reported outcomes regarding fat grafting in the setting of a prospective trial… These data support that fat grafting can be a useful adjunct in the reconstructive process and may help those patients struggling with their overall reconstruction."
The Mastectomy Reconstruction Outcomes Consortium Study included 2,048 women enrolled from 2012 to 2016. Their mean age was 49. Most (89.5%) underwent mastectomy for cancer treatment. More than half (60%) received implant-based reconstruction, 38% received autologous procedures, and the rest underwent mixed procedures.
All participants had completed breast mound reconstruction by the first year of the study. Between the first and second year, 165 women chose to have fat grafting. Patient reported outcomes were assessed at years one and two with the BREAST-Q survey, a validated survey with scores ranging from 0 to 100. Higher scores indicated better satisfaction or health-related quality of life. The survey assessed patient satisfaction with the reconstructed breast as well as psychosocial, physical, and sexual well-being. Rates of cancer recurrence did not differ between groups in the study (1.8% in the grafted patients versus 2.0% for those ungrafted), confirming the previous studies that found no significant risk, Hollenbeck and Hwang noted.
"We hope that this study will contribute to the ongoing discussion with payers and regulators over the safety and effectiveness of these procedures," the study authors wrote.
An important limitation of the study was that significantly more women who chose fat grafting also chose to have other revision procedures, compared to women who did not elect to have fat grafting (75% versus 17%; P<0.001).
"Bennett et al. account for this in their analysis," the editorialists observed. "However, it is difficult to ascertain how much of the improvement in breast satisfaction can be attributed to fat grafting itself rather than to the other revisions," they said.
Abstract
Importance: Fat grafting has proven to be a useful adjunct to breast reconstruction for the treatment of contour irregularities and volume deficits, but the proposed US Food and Drug Administration regulations may severely limit the ability of plastic surgeons to continue its use in this clinical context.
Objective: To determine whether fat grafting is associated with patient-reported outcomes (PROs) in patients undergoing breast reconstruction.
Design, Setting, and Participants: A longitudinal, multicenter, prospective cohort study was conducted between February 1, 2012, and July 31, 2016, at the 11 sites associated with the Mastectomy Reconstruction Outcomes Consortium Study. Eligible patients included women 18 years or older presenting for breast reconstruction after mastectomy with 2 years or more of follow-up. All primary procedure types (implant based and flap based) were eligible. Patients were excluded if they had not completed breast mound reconstruction by 1 year after starting reconstruction.
Interventions: Fat grafting as an adjunct to breast mound reconstruction.
Main Outcomes and Measures: Primary end points were patient-reported outcome measures as assessed by the validated BREAST-Q survey, with higher scores on a 0- to 100-point scale indicating better health-related quality of life. Survey subscales included breast satisfaction, as well as psychosocial, physical, and sexual well-being. Patient-reported outcomes were compared between those who received and did not receive fat grafting.
Results :A total of 2048 women were included (mean [SD] age, 49.4 [10] years), with 165 (8.1%) undergoing fat grafting between years 1 and 2. One year postoperatively, patients who later underwent fat grafting reported significantly lower breast satisfaction (adjusted mean difference [AMD], −4.74; 95% CI, −8.21 to −1.28; P = .008), psychosocial well-being (AMD, −3.87; 95% CI, −7.33 to −0.40; P = .03), and sexual well-being (AMD, −5.59; 95% CI, −9.70 to −1.47; P = .008), compared with those who did not receive subsequent fat grafting. Following the procedure, the fat-grafted cohort reported similar breast satisfaction (AMD, −0.68; 95% CI, −4.42 to 3.06; P = .72), psychosocial well-being (AMD, −0.59; 95% CI, −3.92 to 2.74; P = .73), and sexual well-being (AMD, −2.94; 95% CI, −7.01 to 1.12; P = .15) 2 years postoperatively.
Conclusions and Relevance :Fat grafting may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients undergoing breast reconstruction.
Authors
Katelyn G Bennett, Ji Qi, Hyungjin M Kim, Jennifer B Hamill, Edwin G Wilkins, Babak J Mehrara, Jeffrey H Kozlow
[link url="http://www.medpagetoday.com/hematologyoncology/breastcancer/66392"]Medpage Today report[/link]
[link url="http://jamanetwork.com/journals/jamasurgery/fullarticle/2634512"]JAMA Surgery abstract[/link]
[link url="http://jamanetwork.com/journals/jamasurgery/article-abstract/2634506"]JAMA Surgery invited comment[/link]
[link url="https://www.plasticsurgery.org/Documents/Health-Policy/Principles/principle-2015-post-mastectomy-fat-grafting.pdf"]American Society of Plastic Surgeons guidelines[/link]
[link url="https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm427811.pdf"]FDA guidance[/link]