Jan Maerten Smit

Autologous fat grafting in onco-plastic breast reconstruction: A systematic review on oncological and radiological safety, complications, volume retention and patient/surgeon satisfaction.

OBJECTIVE This study presents an up-to-date overview of the literature on autologous fat grafting (AFG) in onco-plastic breast reconstruction, with respect to complications, oncological and radiological safety, volume retention and patient/surgeon satisfaction. BACKGROUND Although AFG is increasingly being applied in onco-plastic breast reconstruction, a comprehensive overview of the available evidence for this procedure is still lacking. METHODS A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement was conducted. Case series, cohort studies and randomized controlled trials (RCTs) reporting on relevant outcomes of breast reconstruction with supplemental AFG were included. RESULTS In total, 43 studies were included reporting on 6260 patients with a follow-up period ranging from 12 to 136 months. The average locoregional and distant oncological recurrence rates after breast reconstruction with AFG were 2.5% (95% confidence interval (CI) 1.7-3.7) and 2.0% (95% CI 1.1-3.5), respectively. Fewer cysts and calcifications were seen on radiological images for this procedure than for other types of breast surgery. However, more biopsies were performed based on radiological findings (3.7% vs. 1.6%), and more cases of fat necrosis (9.0% vs 4.7%) were seen after treatment with AFG. The total complication rate of 8.4% (95% CI 7.6-9.1) is lower than those reported following other reconstructive breast procedures. The mean volume retention was 76.8% (range 44.7-82.6%) with a satisfaction rate of 93.4% for patients and 90.1% for surgeons. CONCLUSIONS AFG in breast reconstruction is a promising technique. Safety is not compromised as cancer recurrence and complications are not observed. Whether AFG interferes with radiological follow-up remains to be elucidated. Randomized trials with sound methodology are needed to confirm these conclusions.

The Use of Autologous Fat Grafting for Treatment of Scar Tissue and Scar-Related Conditions: A Systematic Review.

Background: Scar tissue can cause cosmetic impairments, functional limitations, pain, and itch. It may also cause emotional, social, and behavioral problems, especially when it is located in exposed areas. To date, no gold standard exists for the treatment of scar tissue. Autologous fat grafting has been introduced as a promising treatment option for scar tissue-related symptoms. However, the scientific evidence for its effectiveness remains unclear. This systematic review aims to evaluate the available evidence regarding the effectiveness of autologous fat grafting for the treatment of scar tissue and scar-related conditions. Methods: A systematic literature review was performed using MEDLINE, Cochrane Library, EMBASE, and Web of Science. No language restrictions were imposed. Results: Twenty-six clinical articles were included, reporting on 905 patients in total. Meta-analysis was not performed because of the heterogeneous methodology demonstrated among the articles. Main outcome measures were scar appearance and skin characteristics, restoration of volume and/or (three-dimensional) contour, itch, and pain. All publications report a beneficial effect of autologous fat grafting on scar tissue. There is statistical significant improvement of the scar appearance, skin characteristics, and pain. Itch and restoration of volume and three-dimensional contour also improved. Conclusions: Autologous fat grafting is used to improve a variety of symptoms related to scar tissue. This systematic review suggests that autologous fat grafting provides beneficial effects with limited side effects. However, the level of evidence and methodological quality are quite low. Future randomized controlled trials with a methodologically strong design are necessary to confirm the effects of autologous fat grafting on scar tissue and scar-related conditions.

Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial

BACKGROUND The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. METHODS We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. FINDINGS 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. INTERPRETATION Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. FUNDING Pink Ribbon, Nuts-Ohra, and LifeCell.

Quality of life and patient satisfaction after one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage breast reconstruction (BRIOS): primary outcome of a randomised, controlled trial

BACKGROUND There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR. METHODS This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446. FINDINGS Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17·0 months [SD 7·8]) in the one-stage group and 44 women (17·2 months [SD 6·7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78·0 [SD 14·1] vs two-stage 79·3 [12·2], p=0·60), psychosocial wellbeing (72·6 [17·3] vs 72·8 [19·6], p=0·95), and sexual wellbeing (58·0 [17·0] vs 57·1 [19·5], p=0·82), or in the patient-reported satisfaction domains: satisfaction with breasts (63·4 [15·8] vs 60·3 [15·4], p=0·35) and satisfaction with outcome (72·8 [19·1] vs 67·8 [16·3], p=0·19). INTERPRETATION Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis. FUNDING Pink Ribbon, Nuts-Ohra, and LifeCell.

Intraoperative evaluation of perfusion in free flap surgery: A systematic review and meta-analysis

Free flap survival relies on adequate tissue perfusion. We aim to give an overview of the available literature of all objective methods to intraoperatively assess free flap tissue perfusion, and the effects on (partial) flap loss.

Reply: Surgical Outcome after Penile Inversion Vaginoplasty

237e Reply: Surgical Outcome after Penile Inversion Vaginoplasty: A Retrospective Study of 475 Transgender Women Sir: We sincerely thank Massie et al. for their interest in our article1 and valuable recommendations. This letter emphasizes the importance of more research in this field. The main aim of gender-confirming surgery is to relieve the distress caused by a discrepancy between the biological gender identity and the gender identity perceived by the transgender person. In transgender women, vaginoplasty is one of the surgical procedures in the comprehensive treatment to alleviate this distress. Worldwide, the method of choice for vaginoplasty in trans women is the penile inversion vaginoplasty. However, few articles report on the outcomes of this procedure.2 Jonathan Massie and colleagues connect with the worldwide awareness that the outcome of a treatment as experienced by the patient is central for evaluating its success. Development of patient-reported outcome measures has really taken off. We agree that patient-reported outcomes are central for evaluation of treatment, especially if the treatment is aimed at alleviation of distress. In fact, we were one of the first to measure patientreported outcomes after vaginoplasty in trans women.3–5 We also established that there is a need for transgenderspecific questionnaires, because existing questionnaires are not very appropriate for this population.3 Massie and colleagues argue that knowledge about surgical outcomes is most important for providers, whereas patient-reported outcomes are more important for the patients and that a study reporting on just one of these outcomes would be incomplete. We propose that both surgical outcomes and patient-reported outcomes are important to evaluate. Of course it is great if you can assess both at the same time; nevertheless, information about either of these outcomes remains valuable. Knowledge about surgical outcomes is important for optimizing the technique and for adequately informing the patient. We suggest that a well-informed patient will be more satisfied with the outcome of treatment. The need for transgender-specific questionnaires has been recognized in recent years. Because of 3. De Cuypere G, T’Sjoen G, Beerten R, et al. Sexual and physical health after sex reassignment surgery. Arch Sex Behav. 2005;34:679–690. 4. Vyas KS, Johnson K, Mardini S. The role of patient-centered outcomes research in plastic surgery. Ann Plast Surg. 2016;77:585–586. 5. Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: The BREAST-Q. Plast Reconstr Surg. 2009;124:345–353. 6. Bouman MB, van der Sluis WB, van Woudenberg Hamstra LE, et al. Patient-reported esthetic and functional outcomes of primary total laparoscopic intestinal vaginoplasty in transgender women with penoscrotal hypoplasia. J Sex Med. 2016;13:1438–1444. increasing cooperation between gender health care providers, development of validated patient-reported measures for this growing population has now become feasible. DOI: 10.1097/PRS.0000000000003487