The 6 month interim analysis of a randomized controlled trial assessing the quality of life in patients with breast cancer related lymphedema undergoing lymphaticovenous anastomosis vs. conservative therapy.

Breast cancer related lymphedema (BCRL) is a chronic condition with a detrimental impact on psychosocial and physical well-being. Lymphaticovenous anastomosis has shown promising results in alleviating physical symptoms and increasing quality of life in patients with BCRL. The aim of the study is to evaluate the effect on health related quality of life (HrQol) after LVA surgery versus conservative treatment in patients with BCRL. The study is a prospective, multicenter randomized controlled trial. Adult women with unilateral BCRL, with early stage lymphedema and viable lymphatic vessels were included. The primary outcome measure was HrQol measured by the lymphedema functioning disability and health (Lymph-ICF) questionnaire. The secondary outcomes were volume difference measured by the water displacement method; the Upper Extremity Lymphedema (UEL) index; and daily use of the compression garments after 3 and 6 months. For this interim analysis 46 patients per group were included. There was a significant improvement in the domains in physical and mental function in the Lymph-ICF questionnaire in the LVA group after 6 months, (- 16.46 ± 18.5, p < 0.05, - 10.12 ± 29.5, p < 0.05 respectively). However, there was no statistical difference in the total score of the Lymph-ICF after 6 months in both groups (LVA-group; - 8.57 ± 22.6, p > 0.05, CDT-group; - 2.65 ± 18.2, p < 0.05). Furthermore, there was no significant volume reduction in both groups (LVA-group: 20.04 ± 196.40, p = 0.497, CDT: 33.98 ± 189.87, p = 0.236). In the LVA group, 41% partially of completely stopped wearing the compression garments after six months whereas in the CDT group 0% discontinued to use of compression garments. LVA resulted in improvement of the domains physical and mental function of the Lymph-ICF. Limb volume did not significantly improve after 6 months. However, around 42% could completely or partially stopped with the use of compression garments in the LVA group. The current results are promising, however longer follow up is required to assess long term effect of LVA for secondary lymphedema. Clinical Trial Registration: NCT02790021 registered on 03/06/2016.

The impact of using the internal mammary artery as a recipient vessel on medial mastectomy skin flap perfusion in autologous breast reconstruction: An observational study using indocyanine green.

BACKGROUND: The internal mammary artery (IMA) is the preferred recipient vessel for microvascular anastomosis in immediate autologous breast reconstruction following skin-sparing mastectomy (SSM). Although the IMA accounts for approximately 60% of the blood supply to the breast, the exact contribution to the mastectomy skin flap perfusion is unclear. The aim of this observational study was to investigate the impact of using the IMA as a recipient vessel on medial mastectomy skin flap perfusion assessed with indocyanine green angiography (ICGA). METHODS: This observational study included ten consecutive women who underwent immediate autologous breast reconstructions following SSM. Two intraoperative indocyanine green (ICG) assessments were performed to assess tissue perfusion of the upper and lower part of the medial mastectomy skin flap: the first following the SSM and the second after clamping the IMA. During a 120-second angiography, three additional images were made after 60, 90, and 120 s. The ICG inflow time and mean, minimum, and maximum fluorescence intensities (FIs) were obtained. RESULTS: Four unilateral and six bilateral autologous breast reconstructions were included. There was no difference in tissue perfusion when comparing the inflow time (24.1 s vs. 23.0 s, P = 0.348), the mean FI (131.4 vs. 124.0, P = 0.126), minimum FI (28.6 vs. 33.4, P = 0.086), and maximum FI (253.1 vs. 247.6, P = 0.166) before and after clamping the IMA. CONCLUSION: According to this study, the use of the IMA as a recipient vessel does not reduce medial mastectomy skin flap perfusion in patients undergoing immediate autologous breast reconstructions following SSM.

Risk of major postoperative complications in breast reconstructive surgery with and without an acellular dermal matrix: A development of a prognostic prediction model.

Introduction: Acellular dermal matrices (ADM) have been suggested to allow for different approaches and reduce the risk of postoperative complications in implant-based breast surgery. Surgeons seem to embrace ADMs around the world, although a lack of consistent evidence regarding the factors that increase the risk of major postoperative complications remains. Purpose: To develop and internally validate a model to predict the risk of a major postoperative complication in breast reconstructive surgery with and without an ADM. Methodology: The DBIR is an opt-out registry that holds characteristics of all breast implant surgeries in the Netherlands since 2015. Using a literature-driven preselection of predictors, multivariable mixed-effects logistic regression modelling was used to develop the prediction model. Results: A total of 2939 breasts were eligible, of which 11% underwent an ADM-assisted procedure (single-stage or two-stage). However, 31% underwent a two-stage procedure (with or without the use of ADM). Of all breasts, 10.2% developed a major postoperative complication. Age (OR 1.01), delayed timing (OR 0.71), and two-stage technique (OR 4.46) were associated with the outcome. Conclusion: The data suggest that ADM use was not associated with a major postoperative complication, while two-stage reconstructions were strongly associated with an increased risk of major complications. Despite these findings, ADMs are not as popular in the Netherlands as in the USA. The predictive capabilities of the developed model are mediocre to poor, but because of the above findings, we believe that the role of the two-stage technique as a golden standard should be put up for debate.

How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch Breast Implant Registry (2015-2017).

BACKGROUND: Although the use of breast implants is generally considered to be safe, breast implants are associated with short- and long-term complications. To evaluate and improve the quality of breast implant surgery, and increase our knowledge of implant performance, the national Dutch Breast Implant Registry (DBIR) was established in 2015. DBIR is one of the first up-and-running breast implant registries worldwide and follows an opt-out structure. OBJECTIVE: This article provides an overview of the first outcomes and experiences of the DBIR. METHODS: The national coverage of DBIR was studied using data from the Dutch Health and Youth Care Inspectorate. The incidence rate of breast implants was calculated for 2016 and 2017, and patient, device, and surgery characteristics were compared between cosmetic breast augmentations or reconstructive indications. Four infection control, measures were selected to demonstrate the variation in the Dutch clinical practice. RESULTS: In 2016, 95% of the hospitals and 78% of the private clinics participated in DBIR. Between 2015 and 2017, a total of 15,049 patients and 30,541 breast implants were included. A minimum breast implant incidence rate of 1 per 1,691 women could be determined for 2017. The majority of devices were inserted for a cosmetic indication (85.2%). In general, patient, device, and surgery characteristics differed per indication group. Substantial variation was seen in the use of infection control measures (range 0-100%). CONCLUSION: Preliminary results obtained from DBIR show high national participation rates and support further developments toward the improvement of breast implant surgery and patient safety.

Prospective evaluation of ischemia in brachial-basilic and forearm prosthetic arteriovenous fistulas for hemodialysis.

UNLABELLED: Ischemia is a devastating complication after arteriovenous fistula (AVF) creation. When not timely corrected, it may lead to amputation. Symptomatic ischemia occurs in 3.7-5% of the hemodialysis population. Upper arm AVFs have a higher incidence of ischemia compared to forearm AVFs. As more patients may need upper arm AVFs in the growing and older hemodialysis population, occurrence of symptomatic ischemia may increase. The purpose of this study is to identify predictors for occurrence of ischemia. METHODS: A prospective evaluation of ischemia was performed in patients randomised for either a brachial-basilic (BB-) AVF or a prosthetic forearm loop AVF. Clinical parameters, preoperative vessel diameters, access flows, digital blood pressures, digit-to-brachial indices (DBI) and interventions for ischemia were recorded. RESULTS: Sixty-one patients (BB-AVF 28) were studied. Seventeen patients (BB-AVF 8) developed ischemic symptoms. Six patients (BB-AVF 3) needed interventions for severe symptoms. Age, history of peripheral arterial reconstruction and radial artery volume flow were significant predictors for the occurrence of ischemia. CONCLUSION: Symptomatic ischemia occurred in 28% of patients with brachial-basilic and prosthetic forearm AVFs. Age, history of peripheral arterial reconstruction and radial artery volume flow might be important for prediction of ischemia.

Effect of upper arm brachial basilic and prosthetic forearm arteriovenous fistula on left ventricular hypertrophy.

BACKGROUND: Creation of an arteriovenous fistula (AVF) may increase left ventricular hypertrophy in the hemodialysis population. Aim of this study was to compare the effects of a brachial-basilic (BB) AVF and the prosthetic brachial-antecubital forearm loop access (PTFE) on cardiac performance. METHODS: Patients were randomized to receive BB-AVF or prosthetic brachial-antecubital forearm loop access. Before and three months after AVF creation patients underwent an echocardiographic examination. Mann-Whitney U-test was used to compare relative increase between the measured cardiac parameters for the two groups. RESULTS: Twenty-seven patients participated in the study. The relative increase in left ventricular parameters was not significantly different between the two groups. Only left ventricular end-diastolic diameter tended to be of significance. Mean blood flow through the brachial artery was 1680+/-156 and 1450+/-221 mL/min three months after surgery for the PTFE and the BB-AVF group, respectively. CONCLUSION: After three months of follow-up, changes in cardiac structure were comparable between patients with BB and PTFE AVFs. Also access flow was comparable at this time. In general, the effects of creation of a fistula on LV structure were limited. Longer follow up time may be needed to explore the long term effects of different vascular accesses on cardiac function.