A consecutive series of targeted muscle reinnervation (TMR) cases for relief of neuroma and phantom limb pain: UK perspective.

BACKGROUND: Studies have suggested that targeted muscle reinnervation (TMR) can improve symptoms of neuroma pain (NP) and phantom limb pain (PLP) in patients. OBJECTIVES: Our primary objective was to measure changes in NP and PLP levels following TMR surgery at 4-time points (baseline, 3, 6- and 12-months postoperatively). Secondary aims included identification of the character and rate of any surgical complications and patients' satisfaction with TMR. METHODS: A retrospective review of outcomes of 36 patients who underwent TMR surgery to treat intractable NP and/or PLP after major amputation of an upper (UL) or lower limb (LL) at a single centre in London, UK over 7 years. The surgical techniques, complications, and satisfaction with TMR are described. RESULTS: Forty TMR procedures were performed on 36 patients. Thirty patients had complete data for NP and PLP levels at all pre-defined time points. Significant improvements (p<0.01) in both types of pain were observed for both upper and LL amputees. However, there were varying patterns of recovery. For example, UL amputees experienced worsening of PLP in the first few months post-operatively whereas surgical complications were more common in LL cases. Patients were overwhelmingly satisfied with the improvements in their symptoms (90%). CONCLUSIONS: TMR surgery appeared to relieve both NP and PLP although the retrospective nature of this study limits the strength of this conclusion. However, complication rates were high, and it is crucial for surgeons and patients to fully understand the course and outcomes of this novel surgery prior to undertaking treatment.

Fat Grafting Improves Fibrosis and Scarring in Vulvar Lichen Sclerosus: Results From a Prospective Cohort Study.

OBJECTIVE: The aim of the study was to evaluate the effect of lipotransfer in women presenting with fibrosis and scarring due to lichen sclerosus. MATERIALS AND METHODS: This prospective cohort study included 33 women attending the vulvar clinic of a public hospital. Patients received one lipotransfer treatment. Validated measures were used prospectively to assess the sexual function (Female Sexual Function Index, Female Sexual Distress Scale); symptoms (visual analog scale for itching, burning, soreness), pain (Pain Anxiety Symptoms Scale 20); psychological status and quality of life (Hospital Anxiety and Depression Scale, Relationship Assessment Scale, Wound Management Questionnaire Revised); physician-based disease signs (Vulvar Architecture Severity Scale). Data were analyzed using paired t test with nonparametric Wilcoxon matched-pairs signed rank test and unpaired t test with nonparametric Mann-Whitney test (Prism6 Software). RESULTS: The mean (SD) follow-up was 12.9 (3.5) months. Sexual function improved after treatment (p < .001), as well as the distress associated with sexuality (p < .0001). A significant improvement was reported in itching (p < .001), burning (p < .05), soreness (p < .001), and pain (p < .0001). Patients reported a significant improvement in romantic relationship (p < .05), anxiety (p < .0001), and depression (p < .0001). Improvement was not significant in the self-care associated with self-disgust assessment (p = .42). The clinical physician-based score showed an overall improvement in all the treated areas to lesser or greater extent. CONCLUSIONS: The use of fat grafting in lichen sclerosus is promising. Further studies are required to rule out a potential placebo effect and to better understand the underlying molecular mechanism of action.

Stem cell enriched lipotransfer reverses the effects of fibrosis in systemic sclerosis.

Oro-facial fibrosis in systemic sclerosis (Scleroderma;SSc) has a major impact on mouth function, facial appearance, and patient quality of life. Lipotransfer is a method of reconstruction that can be used in the treatment of oro-facial fibrosis. The effect of this treatment not only restores oro-facial volume but has also been found to reverse the effects of oro-facial fibrosis. Adipose derived stem cells (ADSCs) within the engrafted adipose tissue have been shown to be anti-fibrotic in SSc and are proposed as the mechanism of the anti-fibrotic effect of lipotransfer. A cohort of 62 SSc patients with oro-facial fibrosis were assessed before and after stem cell enriched lipotransfer treatment. Clinical evaluation included assessment of mouth function using a validated assessment tool (Mouth Handicap in Systemic Sclerosis Scale-MHISS), validated psychological measurements and pre and post-operative volumetric assessment. In addition, to understand the mechanism by which the anti-fibrotic effect of ADSCs occur, SSc derived fibroblasts and ADSCs from this cohort of patients were co-cultured in direct and indirect culture systems and compared to monoculture controls. Cell viability, DNA content, protein secretion of known fibrotic mediators including growth factor- ß1 (TGF ß-1) and connective tissue growth factor (CTGF) using ELISA analysis and fibrosis gene expression using a fibrosis pathway specific qPCR array were evaluated. Mouth function (MHISS) was significantly improved (6.85±5.07) (p<0.0001) after treatment. All psychological measures were significantly improved: DAS 24 (12.1±9.5) (p<0.0001); HADS-anxiety (2.8±3.2) (p<0.0001), HADS-depression (2.0±3.1) (p<0.0001); BFNE (2.9 ± 4.3) (p<0.0001); VAS (3.56±4.1) (p<0.0001). Multiple treatments further improved mouth function (p<0.05), DAS (p<0.0001) and VAS (p = 0.01) scores. SSc fibroblast viability and proliferation was significantly reduced in co-culture compared to monoculture via a paracrine effect over 14 days (p < 0.0001). Protein secretion of transforming growth factor (TGF-ß1) and connective tissue growth factor (CTGF) was significantly reduced in co-culture compared to monoculture (p < 0.0001). Multiple fibrosis associated genes were down regulated in SSc co-culture compared to monoculture after 14 days including Matrix metalloproteinase-8 (MMMP-8), Platelet derived growth factor-ß (PDGF-ß) and Integrin Subunit Beta 6 (ITG-ß6). Autologous stem cell enriched lipotransfer significantly improved the effects of oro-facial fibrosis in SSc in this open cohort study. Lipotransfer may reduce dermal fibrosis through the suppression of fibroblast proliferation and key regulators of fibrogenesis including TG-ß1 and CTGF. Our findings warrant further investigation in a randomised controlled trial.

Assessing the effects of changes in care commissioning guidelines at a tertiary centre in London on the provision of NHS-funded procedures of limited clinical effectiveness: an 11-year retrospective database analysis.

OBJECTIVES: The main objective of this study was to assess the impact of changes in care commissioning policies on National Health Service (NHS)-funded cosmetic procedures over an 11-year period at our centre. SETTING: The setting was a tertiary care hospital in London regulated by the North Central London Hospitals NHS Trust care commissioning group. PARTICIPANTS: We included all patients logged on to our database at the time of the study which was 2087 but later excluded 61 from analysis due to insufficient information. PRIMARY AND SECONDARY OUTCOME MEASURES: The main outcome measures were the results of tribunal assessment for different cosmetic surgeries which were either accepted, rejected or inconclusive based on the panel meeting. RESULTS: There were a total of 2087 patient requests considered between 2004 and 2015, of which 715 (34%) were accepted, 1311 (63%) were declined and 61 (3%) had inconclusive results. The implementation of local care commissioning guidelines has reduced access to cosmetic surgeries. Within this period, the proportion of procedures accepted has fallen from 36% in 2004 to 21% in 2015 (χ2; p<0.05, 95% CI). CONCLUSION: Local guidance on procedures of limited clinical effectiveness is a useful, although not evidence-based selection process to reduce access to cosmetic surgery in line with increasing financial constraints. However, patients with a physical impairment may not receive treatment in comparison to previous years, and this can have a negative impact on their quality of life.

The acceptability of PEGASUS: an intervention to facilitate shared decision-making with women contemplating breast reconstruction.

Good practice guidelines recommend that women who undergo mastectomy are offered reconstructive surgery. However, many who choose this option report a degree of decisional regret and dissatisfaction because their pre-surgical expectations were not met. This paper reports an acceptability study of a new intervention (PEGASUS) that aims to support shared decision-making by eliciting women's pre-surgical expectations and setting patient-centred goals. Eighteen women contemplating breast reconstruction completed the PEGASUS intervention. Semi-structured interviews were conducted with 12 women and 3 health professionals to explore their experiences of using PEGASUS. Interview transcripts were subjected to a thematic analysis, and a content analysis was conducted on 79 goals that the 18 women identified. Feedback was extremely positive--women found that completing PEGASUS alongside a discussion with a specially trained health professional helped them prepare for the surgical consultation and increased their trust in their surgeon. Staff reported that PEGASUS facilitated patient-centred discussions and informed the decisions made about potential surgery. This preliminary study suggests that this novel intervention is acceptable to patients and health professionals alike. Further work is needed to evaluate its efficacy and then its effectiveness with a larger sample of women, and its potential use with other patient groups.