A Histological Assessment Tool for Breast Implant Capsules Validated in 480 Patients with and Without Capsular Contracture.

BACKGROUND: Understanding the impact of breast implants on the histological response in the surrounding fibrous capsule is important; however, consensus is lacking on how to analyze implant capsules histologically. We aimed to develop a standardized histological assessment tool to be used in research potentially improving diagnostic accuracy and treatment strategies for capsular contracture. METHODS: Biopsies of breast implant capsules from 480 patients who had undergone breast augmentation or reconstruction were collected and stained with hematoxylin and eosin. Initially, biopsies from 100 patients were analyzed to select histological parameters demonstrating the highest relevance and reproducibility. Then, biopsies from the remaining 380 patients were used to determine intra- and interobserver agreements of two blinded observers and agreement with a pathologist. Finally, we tested the association between the parameters and capsular contracture. RESULTS: The histological assessment tool included ten parameters assessing the inflammatory, fibrotic, and foreign-body reaction to breast implants, each graded on two-, three-, or four-point scales. Intra- and interobserver agreements were almost perfect (0.83 and 0.80), and agreement with the pathologist was substantial (0.67). Four parameters were significantly correlated with capsular contracture, namely chronic inflammation with lymphocyte infiltration (p < 0.01), thickness of the collagen layer (p < 0.0001), fiber organization (p < 0.01), and calcification (p < 0.001). CONCLUSIONS: This is the first validated histological assessment tool for breast implant capsules. The validated tool not only advances our understanding of capsular contracture but also sets a new standard for histological evaluation in breast implant research and clinical diagnostics. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Development and Validation of a Diagnostic Histopathological Scoring System for Capsular Contracture Based on 720 Breast Implant Capsules.

BACKGROUND: Capsular contracture is traditionally evaluated with the Baker classification, but this has notable limitations regarding reproducibility and objectivity. OBJECTIVES: The aim of this study was to develop and validate procedure-specific histopathological scoring systems to assess capsular contracture severity. METHODS: Biopsies of breast implant capsules were used to develop histopathological scoring systems for patients following breast augmentation and breast reconstruction. Ten histological parameters were evaluated by multivariable logistic regression to identify those most associated with capsular contracture. Significant parameters (P < .05) were selected for the scoring systems and assigned weighted scores (1-10). Validation was assessed from the area under the curve (AUC) and the mean absolute error (MAE). RESULTS: A total of 720 biopsies from 542 patients were included. Four parameters were selected for the augmentation scoring system, namely, collagen layer thickness, fiber organization, inflammatory infiltration, and calcification, providing a combined maximum score of 26. The AUC and MAE for the augmentation scoring system were 81% and 0.8%, which is considered strong. Three parameters were selected for the reconstruction scoring system, namely, fiber organization, collagen layer cellularity, and inflammatory infiltration, providing a combined maximum score of 19. The AUC and MAE of the reconstruction scoring system were 72% and 7.1%, which is considered good. CONCLUSIONS: The new histopathological scoring systems provide an objective, reproducible, and accurate assessment of capsular contracture severity. We propose these novel scoring systems as a valuable tool for confirming capsular contracture diagnosis in the clinical setting, for research, and for implant manufacturers and insurance providers in need of a confirmed capsular contracture diagnosis.

Deskinning in Inverted-T Mastopexy and Augmentation Mastopexy: A Retrospective Cohort Study.

BACKGROUND: Most surgeons choose to de-epithelialize when performing a mastopexy to minimize the risk of nipple-areola-complex (NAC) necrosis. Preservation of the dermis and thus the subdermal plexus is thought to be crucial for the survival of the NAC. However, this has never been scientifically proven. Deskinning involves resection of the epidermis and the dermis and is a timesaving alternative to de-epithelialization. In this study, we present data from mastopexy patients with or without implant surgery with total deskinning of the Wise pattern. METHODS: From September 2012 to March 2020, a single surgeon performed all inverted-T mastopexies using the deskinning technique. The patients were included retrospectively, and data were collected by reviewing the patients' medical records with emphasis on NAC necrosis. RESULTS: The cohort consisted of 274 consecutive patients who underwent bilateral mastopexy. Of these, 134 patients underwent mastopexy as the only procedure and 140 patients underwent mastopexy in combination with implant surgery. The median follow-up was 29 months (IQR 13-40 months). No complete NAC-necrosis occurred. Unilateral, partial NAC necrosis occurred in three patients who underwent mastopexy in combination with implant surgery. CONCLUSION: The NAC necrosis rate following inverted-T mastopexy using the deskinning technique is comparable to the rate of NAC-necrosis reported in the literature following mastopexy using the de-epithelialization technique. Our findings support that the use of deskinning is a safe and time-efficient method for patients undergoing inverted-T mastopexy. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the table of Contents or the online Instructions to Authors www.springer.com/00266.

Oncoplastic breast surgery does not delay the onset of adjuvant chemotherapy: a population-based study.

BACKGROUND: Only a few studies of limited size have examined whether oncoplastic breast surgery delays the onset of adjuvant chemotherapy as compared to conventional breast surgery. We investigated whether oncoplastic breast surgery causes a delay in the onset of adjuvant chemotherapy in comparison to lumpectomy and mastectomy. MATERIAL AND METHODS: The study is a population-based cohort study. Within the nationwide registry of the Danish Breast Cancer Group (DBCG), we identified 1798 patients who received adjuvant chemotherapy following mastectomy, lumpectomy or oncoplastic breast surgery for early and unilateral invasive breast cancer. Women treated with neoadjuvant chemotherapy were excluded. RESULTS: We found no significant difference between the three groups (mastectomy, lumpectomy, oncoplastic breast surgery) in the time from biopsy to surgery (mean time 17.9, 17.0 and 18.3 days, respectively), the time from surgery to onset of adjuvant chemotherapy, nor total time from biopsy to the onset of adjuvant chemotherapy (mean time 52.7, 51.9 and 53.2 days, respectively). CONCLUSIONS: Our study shows that oncoplastic breast surgery does not delay the onset of adjuvant chemotherapy in comparison with mastectomy and lumpectomy. Accordingly, patients should not be excluded from treatment with oncoplastic breast surgery due to concerns of delay in adjuvant chemotherapy.

A review of forty five open tibial fractures covered with free flaps. Analysis of complications, microbiology and prognostic factors.

PURPOSE: Treatment of open fractures is complex and controversial. The purpose of the present study is to add evidence to the management of open tibial fractures, where tissue loss necessitates cover with a free flap. We identified factors that increase the risk of complications. We questioned whether early flap coverage improved the clinical outcome and whether we could improve our antibiotic treatment of open fractures. METHODS: From 2002 to 2013 we treated 56 patients with an open tibial fracture covered with a free flap. We reviewed patient records and databases for type of trauma, smoking, time to tissue cover, infection, amputations, flap loss and union of fracture. We identified factors that increase the risk of complications. We analysed the organisms cultured from open fractures to propose the optimal antibiotic prophylaxis. Follow-up was a minimum of one year. Primary outcome was infection, bacterial sensitivity pattern, amputation, flap failure and union of the fracture. RESULTS: When soft tissue cover was delayed beyond seven days, infection rate increased from 27 to 60 % (p < 0.04). High-energy trauma patients had a higher risk of amputation, infection, flap failure and non-union. Smokers had a higher risk of non-union and flap failure. The bacteria found were often resistant to Cefuroxime, aminoglycosides or amoxicillin, but sensitive to vancomycin or meropenem. CONCLUSION: Flap cover within one week is essential to avoid infection. High-energy trauma and smoking are important predictors of complications. We suggest antibiotic prophylaxis with vancomycin and meropenem until the wound is covered in these complex injuries.

Enrichment of autologous fat grafts with ex-vivo expanded adipose tissue-derived stem cells for graft survival: a randomised placebo-controlled trial.

BACKGROUND: Autologous fat grafting is increasingly used in reconstructive surgery. However, resorption rates ranging from 25% to 80% have been reported. Therefore, methods to increase graft viability are needed. Here, we report the results of a triple-blind, placebo-controlled trial to compare the survival of fat grafts enriched with autologous adipose-derived stem cells (ASCs) versus non-enriched fat grafts. METHODS: Healthy participants underwent two liposuctions taken 14 days apart: one for ASC isolation and ex-vivo expansion, and another for the preparation of fat grafts. Two purified fat grafts (30 mL each) taken from the second liposuction were prepared for each participant. One graft was enriched with ASCs (20 × 10(6) cells per mL fat), and another graft without ASC enrichment served as a control. The fat grafts were injected subcutaneously as a bolus to the posterior part of the right and left upper arm according to the randomisation sequence. The volumes of injected fat grafts were measured by MRI immediately after injection and after 121 days before surgical removal. The primary goal was to compare the residual graft volumes of ASC-enriched grafts with those of control grafts. This study is registered at www.clinicaltrialsregister.eu, number 2010-023006-12. FINDINGS: 13 participants were enrolled, three of whom were excluded. Compared with the control grafts, the ASC-enriched fat grafts had significantly higher residual volumes: 23·00 (95% CI 20·57-25·43) cm(3) versus 4·66 (3·16-6·16) cm(3) for the controls, corresponding to 80·9% (76·6-85·2) versus 16·3% (11·1-21·4) of the initial volumes, respectively (p<0·0001). The difference between the groups was 18·34 (95% CI 15·70-20·98) cm(3), equivalent to 64·6% (57·1-72·1; p<0·0001). No serious adverse events were noted. INTERPRETATION: The procedure of ASC-enriched fat grafting had excellent feasibility and safety. These promising results add significantly to the prospect of stem cell use in clinical settings, and indicate that ASC graft enrichment could render lipofilling a reliable alternative to major tissue augmentation, such as breast surgery, with allogeneic material or major flap surgery. FUNDING: Danish Cancer Society, Centre of Head and Orthopaedics Rigshospitalet, and Moalem Weitemeyer Bendtsen.

Silicone Leakage from Breast Implants Is Determined by Silicone Cohesiveness: A Histological Study of 493 Patients.

BACKGROUND: Silicone leakage from breast implants is a concern with potential implications for patient health. This study aimed to quantify and model silicone leakage from implants to the breast implant capsule and to investigate whether silicone cohesiveness affected the silicone leakage rate. METHODS: Silicone content in the breast implant capsule was quantified histologically by measuring the area of silicone deposits. This was used to model silicone leakage over time based on the time of implantation. The effect of cohesiveness on silicone leakage was investigated across all implant brands with declared cohesiveness and in a subanalysis comparing only Mentor cohesive I implants with cohesive II and III implants. RESULTS: The study included 493 patients with 872 breasts and a median time of implantation of 13.0 years (range 0.4 to 51 years). The modeling of silicone leakage from intact implants showed that leakage and the acceleration of the leakage rate were significantly higher in low-cohesive implants than in highly cohesive implants (p<0.05). This was confirmed when analyzing only Mentor implants (p<0.05) and in the case of implant rupture (p<0.01) where low-cohesive implants also leaked significantly more than highly cohesive implants. CONCLUSIONS: Our results suggest that highly cohesive implants are superior to low-cohesive implants in preventing silicone leakage. Due to the accelerating rate of silicone leakage especially found in low-cohesive implants, we propose that exchange of low-cohesive implants could be discussed with patients 10 to 15 years after implantation to minimize silicone leakage even in the absence of implant rupture.

Identical effects of VEGF and serum-deprivation on phenotype and function of adipose-derived stromal cells from healthy donors and patients with ischemic heart disease.

BACKGROUND: Adipose-derived stromal cells (ASCs) stimulated with vascular endothelial growth factor (VEGF) and serum-deprived, are applied in the first in-man double-blind placebo-controlled MyStromalCell Trial, as a novel therapeutic option for treatment of ischemic heart disease (IHD). This in vitro study explored the effect of VEGF and serum deprivation on endothelial differentiation capacity of ASCs from healthy donors and IHD patients. METHODS: ASCs stimulated with rhVEGF(A165) in serum-deprived medium for one to three weeks were compared with ASCs in serum-deprived (2% fetal bovine serum) or complete medium (10% fetal bovine serum). Expression of VEGF receptors, endothelial and stem cell markers was measured using qPCR, flow cytometry and immunocytochemistry. In vitro tube formation and proliferation was also measured. RESULTS: ASCs from VEGF-stimulated and serum-deprived medium significantly increased transcription of transcription factor FOXF1, endothelial marker vWF and receptor VEGFR1 compared with ASCs from complete medium. ASCs maintained stem cell characteristics in all conditions. Tube formation of ASCs occurred in VEGF-stimulated and serum-deprived medium. The only difference between healthy and patient ASCs was a variation in proliferation rate. CONCLUSIONS: ASCs from IHD patients and healthy donors proved equally inclined to differentiate in endothelial direction by serum-deprivation, however with no visible additive effect of VEGF stimulation. The treatment did not result in complete endothelial differentiation, but priming towards endothelial lineage.

Pooled human platelet lysate versus fetal bovine serum-investigating the proliferation rate, chromosome stability and angiogenic potential of human adipose tissue-derived stem cells intended for clinical use.

BACKGROUND AIMS: Because of an increasing focus on the use of adipose-derived stem cells (ASCs) in clinical trials, the culture conditions for these cells are being optimized. We compared the proliferation rates and chromosomal stability of ASCs that had been cultured in Dulbecco's modified Eagle's Medium (DMEM) supplemented with either pooled human platelet lysate (pHPL) or clinical-grade fetal bovine serum (FBS) (DMEM(pHPL) versus DMEM(FBS)). METHODS: ASCs from four healthy donors were cultured in either DMEM(pHPL) or DMEM(FBS), and the population doubling time (PDT) was calculated. ASCs from two of the donors were expanded in DMEM(pHPL) or DMEM(FBS) and cultured for the final week before harvesting with or without the addition of vascular endothelial growth factor. We assessed the chromosomal stability (through the use of array comparative genomic hybridization), the expression of ASC and endothelial surface markers and the differentiation and angiogenic potential of these cells. RESULTS: The ASCs that were cultured in pHPL exhibited a significantly shorter PDT of 29.6 h (95% confidence interval, 22.3-41.9 h) compared with those cultured in FBS, for which the PDT was 123.9 h (95% confidence interval, 95.6-176.2 h). Comparative genomic hybridization analyses revealed no chromosomal aberrations. Cell differentiation, capillary structure formation and cell-surface marker expression were generally unaffected by the type of medium supplement that was used or by the addition of vascular endothelial growth factor. CONCLUSIONS: We observed that the use of pHPL as a growth supplement for ASCs facilitated a significantly higher proliferation rate compared with FBS without compromising genomic stability or differentiation capacity.

Delayed breast implant reconstruction: is radiation therapy associated with capsular contracture or reoperations?

We evaluated the association between radiation therapy and severe capsular contracture or reoperation after 717 delayed breast implant reconstruction procedures (288 1- and 429 2-stage procedures) identified in the prospective database of the Danish Registry for Plastic Surgery of the Breast during the period between 1999 and 2006. A history of radiation therapy was associated with increased risk of severe capsular contracture for 1- and 2-stage procedures, with adjusted hazard ratios (HR) of 3.3 (95% confidence interval [CI]: 0.9-12.4) and 7.2 (95% CI: 2.4-21.4), respectively. Similarly, a history of radiation therapy was associated with a non-significantly increased risk of reoperation after both 1-stage (HR = 1.4; 95% CI: 0.7-2.5) and 2-stage (HR = 1.6; 95% CI: 0.9-3.1) procedures. Reconstruction failure was highest (13.2%) in the 2-stage procedures with a history of radiation therapy. Breast reconstruction approaches other than implants should be seriously considered among women who have received radiation therapy.

Hematoma and deep surgical site infection following primary breast augmentation: A retrospective review of 1128 patients.

BACKGROUND: Breast augmentation is one of the most frequently performed cosmetic surgery worldwide. Some of the most severe short-term complications after breast augmentation are hematoma and deep surgical site infection. However, these complications are relatively rare; therefore, large patient populations are required to perform statistical analyses. In this study, we provide a detailed analysis of the complications after primary breast augmentation with an emphasis on deep surgical site infection and hematoma. METHOD: We retrospectively reviewed the medical records of women who underwent primary breast augmentation without the use of pocket irrigation between 2012 and 2019 in a single private clinic. A cumulative hazard function and a multivariate analysis on the risk of hematoma were performed. RESULTS: We included 1128 patients in the study. Thirty patients (2.7%) developed postoperative hematoma after a median time of 14 h (IQR 5 h-9 days). Six patients (0.5%) contracted a deep surgical site infection after a median time of 14 days (range 4-41 days). Age, BMI, implant volume, or implant placement was not significantly associated with hematoma. CONCLUSION: Our findings support that the risk of hematoma after primary breast augmentation is highest within the first 24 h after the surgery. This time period should be considered when planning postoperative care for these patients. We did not find an increased rate of deep surgical site infection compared with studies of breast augmentations with pocket irrigation. Further studies and meta-analyses are needed to explore the effect of pocket irrigation and other risk factors.

The clinical course of immediate breast implant reconstruction after breast cancer.

BACKGROUND: The number of women suitable for breast conserving treatment as well as immediate reconstruction after breast cancer has been increasing, and studies of complications hereafter are needed. MATERIAL AND METHODS: The cohort was identified in the prospective database of the Danish Registry for Plastic Surgery of the Breast during the period 1999 to 2006; 167 women with 189 immediate breast reconstructions (40 one-stage and 149 two-stage procedures) after breast cancer without a history of radiation therapy. The women were followed for complications until November 2009. Cumulative incidence risks were computed for infection, hematoma, seroma, severe capsular contracture (modified Baker III and IV), extrusion of the implant, implant rupture, asymmetry/displacement of the implant, any complication, and reoperation. In addition, we compared the postoperative course of immediate two-stage procedures with delayed two-stage procedures. RESULTS: The overall eight-year risk estimates for the immediate procedures were 76.4% for any complication, 5.3% for severe capsular contracture, 29.5% for displacement/asymmetry of the implant and 40.6% for reoperation. Significantly higher risk for reoperation was observed after immediate one-stage than after two-stage procedures. For immediate two-stage procedures acute complications such as infection, seroma and hematoma were higher in the expansion period than after the second planned surgery. Higher risks for acute complications were observed after immediate than after delayed two-stage procedures. CONCLUSION: Immediate breast implant reconstruction was found to have substantial risks of complications in non-radiated women, which should be considered in the guidance of breast cancer patients before choosing reconstructive procedure.

Vascularized fibula grafts for reconstruction of bone defects after resection of bone sarcomas.

We evaluated the results of limb-sparing surgery and reconstruction of bone defects with vascularized fibula grafts in 8 consecutive patients (mean age at operation 13.6 years (range 4.1-24.2 years), female/male = 6/2) with bone sarcomas (BS) (osteosarcoma/Ewing's sarcoma/chondrosarcoma= 4/3/1) operated on form 2000 to 2006. The bone defects reconstructed were proximal femoral diaphysis and epiphysis (n = 2), humeral diaphysis (n = 2), humeral proximal diaphysis and epiphysis (n = 1), femoral diaphysis (n = 1), ulnar diaphysis (n = 1), and tibial diaphysis (n = 1). One patient with Ewing's sarcoma had an early hip disarticulation, developed multiple metastases, and died 9 months after the operation. The remaining patients (n = 7) are all alive 50 months (range 26-75 months) after surgery. During the follow-up the following major complications were seen: 1-2 fractures (n = 4), pseudarthrosis (n = 2), and hip dislocation (n = 1). Limb-sparing surgery with reconstruction of bone defects using vascularized fibular grafts in BS cases is feasible with acceptable clinical results, but fractures should be expected in many patients.

Breast Reduction with Deskinning of a Superomedial Pedicle: A Retrospective Cohort Study.

BACKGROUND: In most breast reduction techniques, the pedicle of the nipple-areola complex (NAC) is de-epithelialized to preserve the subdermal plexus, thereby decreasing the risk of NAC necrosis. However, deskinning the pedicle is faster and makes it more pliable, which potentially improves the aesthetic outcome. There is no scientific evidence regarding the beneficial effects of de-epithelialization. In this study, we present data from patients undergoing breast reduction with deskinning of a superomedial pedicle. METHODS: In the period June 2013 to March 2019, a single surgeon performed all breast reductions using a superomedial glandular pedicle. The patients were included retrospectively and data were collected by reviewing the medical records. The NAC necrosis rate was compared with data from the literature through a systematic review. RESULTS: The cohort consisted of 142 consecutive patients. The median resection weight was 287 g (interquartile range (IQR), 197-399) per breast. No complete NAC necroses occurred during the follow-up period, but two patients (1.4%) developed partial NAC necrosis. In the literature, the rate of NAC necrosis (complete or partial) was 1.5% of patients undergoing breast reduction with de-epithelialization. CONCLUSION: The rate of NAC necrosis after breast reduction with deskinning of the pedicle was comparable with breast reductions with de-epithelialization that has been reported in the literature. Our findings support that the pedicle in breast reduction surgery can be deskinned safely in patients with low resection weights.

Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.

BACKGROUND: In 2006, a single-center Swedish study demonstrated a low rupture rate and high patient satisfaction with the Style 410 shaped, form-stable gel implant. The current study aimed to validate the accuracy of the previously published results across multiple European sites. METHODS: A total of 163 subjects (approximately 70% had augmentation [n = 112], 15% had reconstruction [n = 25], and 15% had revision [n = 26]) underwent a physical examination followed by breast magnetic resonance imaging (MRI) for rupture detection. These subjects had been implanted for 5 to 11 years with at least one Style 410 shaped gel breast implant before examination. The secondary end points included lactation, reproductive and breast disease history before and after implantation, and quality-of-life measurements and complications after implantation. RESULTS: The implant rupture rate was 1.7% a median of 8 years after implantation. Capsular contracture was the most common complication noted at the physical examination, occurring for 5.3% of implants, and there were no cases of grade 4 capsular contracture. The postimplantation rates for lactation and reproductive problems and breast disease were lower than the preimplantation rates. Breast implantation surgery was considered advantageous by 91% of the subjects, demonstrating high patient satisfaction. CONCLUSIONS: The Style 410 anatomically shaped, form-stable gel breast implants demonstrated long-term safety and effectiveness.

Clinical outcome and health-related quality-of-life following microsurgical reconstruction in patients with oral and oropharyngeal cancer.

CONCLUSION: Radial forearm free flap (RFFF) and fibula free flap (FFF) provide high safety and reliability with low incidence of free flap failure and an acceptable level of complications and health-related quality-of-life (HRQoL). OBJECTIVES: To determine the clinical outcomes and long-term HRQoL in patients with oral or oropharyngeal cancer following free flap reconstruction. METHODS: A retrospective review of medical records and self-administered HRQoL questionnaires, EORTC QLQ-C30, and -H&N35. All patients who underwent surgery for oral or oropharyngeal cancer followed by primary reconstruction by RFFF or FFF at Rigshospitalet between September 2001 and November 2011 were included. RESULTS: The study comprised 19 patients still alive out of 61 patients. The free flap success rate was 94.7%. Early post-operative complications occurred in 11 patients (57.9%); however, only three cases (15.8%) required re-surgery. Nine patients (47.4%) developed late complications, including mandibular osteoradionecrosis in six cases (31.6%). Most patients obtained acceptable values of global quality-of-life and relatively high scores on the functional scales.

Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study.

We aimed to evaluate the effect of intramyocardial injections of autologous VEGF-A165-stimulated adipose-derived stromal cells (ASCs) in patients with refractory angina. MyStromalCell trial is a randomized double-blind placebo-controlled study including sixty patients with CCS/NYHA class II-III, left ventricular ejection fraction > 40%, and at least one significant coronary artery stenosis. Patients were treated with ASC or placebo in a 2 : 1 ratio. ASCs from the abdomen were culture expanded and stimulated with VEGF-A165. At 6 months follow-up, bicycle exercise tolerance increased significantly in time duration 22 s (95%CI -164 to 208 s) (P = 0.034), in watt 4 (95%CI -33 to 41, 0.048), and in METs 0.2 (95%CI -1.4 to 1.8) (P = 0.048) in the ASC group while there was a nonsignificant increase in the placebo group in time duration 9 s (95%CI -203 to 221 s) (P = 0.053), in watt 7 (95%CI -40 to 54) (P = 0.41), and in METs 0.1 (95%CI -1.7 to 1.9) (P = 0.757). The difference between the groups was not significant (P = 0.680, P = 0.608, and P = 0.720 for time duration, watt, and METs, resp.). Intramyocardial delivered VEGF-A165-stimulated ASC treatment was safe but did not improve exercise capacity compared to placebo. However, exercise capacity increased in the ASC but not in the placebo group. This trial is registered with ClinicalTrials.gov NCT01449032.

Reconstruction of irradiated mandible after segmental resection of osteoradionecrosis-a technique employing a microvascular latissimus dorsi flap and subsequent particulate iliac bone grafting.

The fibula osteocutaneous flap has revolutionized the options of mandibular segmental defect bridging in osteoradionecrosis (ORN). In selected cases, however, the fibula flap is not an option because of atherosclerosis or other features that compromise the vascularity of the lower leg and foot. The aim of this study is to present an alternative method of mandibular segmental reconstruction employing a latissimus dorsi (LD) flap and subsequent particulate iliac free bone graft reconstruction. In 15 patients with ORN, a mandibular segmental defect was bridged with a reconstruction plate, and the defect site was primed with a LD musculocutaneous flap wrapped around the reconstruction plate to bring in vascularized tissue and optimize healing conditions for a subsequent particulate iliac free bone graft reconstruction. The management of defect closure was successful in all 15 patients. Twelve patients had a subsequent bone grafting from the posterior ileum for repair of defects up to 14 cm length. Three patients had no bone graft for various reasons. In three patients dental rehabilitation was achieved with implant supported prosthodontic appliances. Ten patients met the success criteria of uneventful graft healing with restitution of osseous continuity, mandibular height, symmetry and function, and avoidance of reconstruction plate fracture.

[Oncoplastic breast surgery in Denmark].

With improved survival rates after breast cancer treatment, more attention is drawn to improve the cosmetic outcome after surgical treatment of breast cancer. In this process the oncoplastic breast surgery was conceived. It supplements the traditional surgical treatments (mastectomy and breast conserving surgery) with increased focus on individualized therapy. The ambition is to obtain the best possible cosmetic outcome without compromising recurrence rates and survival. This article provides an overview of the current oncoplastic breast surgery treatment offered in Denmark.

Breast reconstruction with an expander prosthesis following mastectomy does not cause additional persistent pain: a nationwide cross-sectional study.

INTRODUCTION: Few studies have examined the prevalence of persistent pain after breast reconstruction with an implant after tissue expansion in comparison to mastectomy without breast reconstruction. Our primary objective was to evaluate the prevalence of persistent pain after breast reconstruction with a subpectoral implant after tissue expansion in a population-based study. Secondary objectives were to evaluate sensory disturbances, lymphoedema and functional impairment. METHOD: This was a nationwide cross-sectional questionnaire study of breast cancer patients aged 18-69 years who were treated with or without reconstruction after mastectomy for primary breast cancer in Denmark between 1 January 2005 and 31 December 2006. The response rate was 84% for mastectomy without reconstruction and 83% for patients treated with breast reconstruction. RESULTS: A total of 129 patients treated with mastectomy and breast reconstruction with a subpectoral implant were compared with 1131 patients treated with mastectomy without reconstruction. Prevalence of persistent pain for patients treated with mastectomy followed by reconstruction with an implant was 40% compared to 48% of patients treated only with mastectomy. We found no increased risk of persistent pain in patients having a reconstruction with an implant compared with mastectomy without reconstruction (odds ratio (OR) 0.82, 95% confidence interval (CI) 0.55-1.22, P=0.33) when adjusting for age, axillary procedure, radiotherapy and chemotherapy. We observed no difference in the prevalence of pain between patients treated with immediate or delayed breast reconstruction (P=0.116). CONCLUSION: Breast reconstruction with a subpectoral implant after tissue expansion does not confer increased prevalence of persistent pain.