A paired-kidney allocation study found superior survival with HLA-DR compatible kidney transplants in the Eurotransplant Senior Program.

The Eurotransplant Senior Program (ESP) has expedited the chance for elderly patients with kidney failure to receive a timely transplant. This current study evaluated survival parameters of kidneys donated after brain death with or without matching for HLA-DR antigens. This cohort study evaluated the period within ESP with paired allocation of 675 kidneys from donors 65 years and older to transplant candidates 65 years and older, the first kidney to 341 patients within the Eurotransplant Senior DR-compatible Program and 334 contralateral kidneys without (ESP) HLA-DR antigen matching. We used Kaplan-Meier estimates and competing risk analysis to assess all cause mortality and kidney graft failure, respectively. The log-rank test and Cox proportional hazards regression were used for comparisons. Within ESP, matching for HLA-DR antigens was associated with a significantly lower five-year risk of mortality (hazard ratio 0.71; 95% confidence interval 0.53-0.95) and significantly lower cause-specific hazards for kidney graft failure and return to dialysis at one year (0.55; 0.35-0.87) and five years (0.73; 0.53-0.99) post-transplant. Allocation based on HLA-DR matching resulted in longer cold ischemia (mean difference 1.00 hours; 95% confidence interval: 0.32-1.68) and kidney offers with a significantly shorter median dialysis vintage of 2.4 versus 4.1 yrs. in ESP without matching. Thus, our allocation based on HLA-DR matching improved five-year patient and kidney allograft survival. Hence, our paired allocation study suggests a superior outcome of HLA-DR matching in the context of old-for-old kidney transplantation.

Facial Allograft Donation: An Interpretative Phenomenological Analysis of the Experiences of Family Members.

Facial allograft transplantation can be regarded as a particular and complex type of donation because of its perceptibility and the importance of the face as an identity characteristic. As research on this topic is currently lacking, the objective of this study is to explore the experiences of the family members of the donor in facial allograft donation. In-depth, semi-structured interviews were conducted separately with the donor's family members and analyzed using interpretative phenomenological analysis. Six themes were identified: (1) Contrasting facial donation to that of more commonly donated organs; (2) Consenting to facial donation; (3) Expectations towards the recipient of the facial graft; (4) Expectations and consequences of restoration of the donor's face; (5) Relationship with the medical team during the process; and (6) Media attention. The findings of our study help to better support donor families through the facial donation process and to improve facial transplantation procedures.

5-Year outcomes of the prospective and randomized CISTCERT study comparing steroid withdrawal to replacement of cyclosporine with everolimus in de novo kidney transplant patients.

Withdrawal of either steroids or calcineurin inhibitors are two strategies to reduce treatment-related side effects and improve long-term outcomes of kidney transplantation. The CISTCERT study compared the efficacy and safety of these two strategies. In this multicenter, randomized controlled trial, 151 incident kidney transplant recipients received cyclosporine (CsA), mycophenolic acid (MPA), and steroids during three months, followed by either steroid withdrawal (CsA/MPA) or replacement of cyclosporine with everolimus (EVL) (EVL/MPA/steroids). 5-year patient survival (89% vs. 86%; P = NS) and death-censored graft survival (95% vs. 96%; P = NS) were comparable in the CsA/MPA and EVL/MPA/steroids arm, respectively. 51 CrEDTA clearance was comparable in the intention-to-treat analysis, but in the on-treatment population, the EVL/MPA/steroids arm exhibited a superior 51 CrEDTA clearance at 1 and 5 years after transplantation (61.6 vs. 52.4, P = 0.05 and 59.1 vs. 46.2ml/min/1.73 m2 , P = 0.042). Numerically more and more severe rejections were observed in the EVL/MPA/steroids arm, which also experienced a higher incidence of posttransplant diabetes (26% vs. 6%, P = 0.0016) and infections. No significant differences were observed in cardiovascular outcomes and malignancy. Both regimens provide an excellent long-term patient survival and graft survival. Regarding graft function, EVL/MPA/steroids is an attractive strategy for patients with good tolerability who remain free of rejection. (ClinicalTrials.gov number: NCT00903188; EudraCT Number 2007-005844-26).

Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data.

OBJECTIVE: The purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date. METHODS: Patients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak. RESULTS: Through 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up. CONCLUSIONS: In the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial.

PURPOSE: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial (ClinicalTrials.gov identifier NCT02211664). MATERIALS AND METHODS: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. RESULTS: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). CONCLUSION: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

Editor's Choice - Five Year Outcomes of the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair in the ENGAGE Registry.

OBJECTIVE/BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) is commonly used to treat abdominal aortic aneurysm (AAA). However, the incidence of long-term complications and the need for re-interventions after EVAR remain a concern. Newer generation stent grafts have encouraging short and mid-term outcomes, but thorough analysis of their long-term performance is necessary. METHODS: The ENGAGE registry includes a total of 1263 patients with AAA enrolled from March 2009 to April 2011 at 79 centres across 30 countries. The aim of this study is to present standard EVAR outcomes in the registry after five years. RESULTS: A significant proportion of the ENGAGE patients presented with challenging features, such as 15.2% with an AAA diameter >7 cm, 12.0% with proximal neck lengths <15 mm, and 10.2% with infrarenal neck angles >60°. Of the 1263 enrolled subjects, 17.8% were implanted outside of the instructions for use for the device. At the five year follow up, the Kaplan-Meier overall survival rate was 67.4% and the freedom from aneurysm related mortality was 97.8%. Freedom from aneurysm rupture, secondary procedures, and conversion to open repair at five years were 98.6%, 84.3%, and 97.9% respectively. The five year freedom from type IA endoleaks was 95.2% and for type III endoleaks 97.4%. Aneurysm sac diameter at five years was observed to have either decreased ≥5 mm in diameter or remained stable in 89.4% of the patients. CONCLUSION: Five year follow up of patients in the ENGAGE registry demonstrates sustained safety, effectiveness, and durability in an international cohort that is reflective of real world experience. Additional follow up is expected through to 10 years.

Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.

OBJECTIVES: The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB). BACKGROUND: DCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results. METHODS: The ILLUMENATE Global Study is a prospective, multicenter, single-arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio ≤2.5 or clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months. RESULTS: In total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD-TLR was 94.8% day 365 per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline. CONCLUSIONS: This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.

Nine-Month Outcomes of the DURABILITY Iliac Study on Self-Expanding Stents for Symptomatic Peripheral Artery Disease.

BACKGROUND: The DURABILITY Iliac clinical study evaluated the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic common and external iliac artery lesions up to 10 cm in length and >50% stenosis in subjects with Rutherford classification peripheral arterial disease stages 2-4. METHODS: DURABILITY Iliac was a prospective, multicenter, core lab adjudicated, nonrandomized clinical study enrolling 75 subjects from 15 sites in the United States and Europe. Clinical follow-up visits were at 30 days, 9 months, and 1, 2, and 3 years after procedure. The primary outcome measured was the major adverse event (MAE) rate at 9 months, defined as a composite of periprocedural death, in-hospital myocardial infarction (MI), clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb through 9 months after procedure. Secondary outcomes included primary patency rate at 9 months, clinically driven target vessel revascularization (CD-TVR), change in ankle-brachial index, and change in Walking Impairment Questionnaire score at 30 days and 9 months. Device success was defined as the ability to deploy the stent as intended at the treatment site. RESULTS: The MAE rate at 9 months was 1.3% (1/75), with 1 subject experiencing a CD-TLR. No periprocedural deaths, MIs, or amputations were reported. Primacy patency at 9 months was 95.8%. Freedom from CD-TVR was 98.6% at 9 months. Subjects improved in Walking Impairment Questionnaire scores for all categories (walking impairment, walking speed, walking distance, and stair climbing) at the 30-day and 9-month visit. Device success was 100%. CONCLUSIONS: The 9-month results of the DURABILITY Iliac study demonstrate the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic lesions of the common and external iliac arteries.

Facing a New Face: An Interpretative Phenomenological Analysis of the Experiences of a Blind Face Transplant Patient and His Partner.

Increasing evidence points to good functional, aesthetic, and psychosocial outcomes after face transplantation. However, research investigating how patients and their families subjectively experience the transplantation process is lacking thus far. This study aims to investigate the personal experiences of a blind face transplant patient and his partner. In-depth interviews exploring different experiences were conducted with both partners separately 20 months after face transplantation. The interviews were analyzed using interpretative phenomenological analysis. Seven themes were identified in both interviews: coping with the facial trauma, motivation for the face transplantation, outcomes of the face transplantation, acceptance of the new face, gratitude toward the donor family, relation to the medical team, and dealing with the media. Two further themes were only mentioned by the patient (coping with complications and coping with blindness) and one theme only by the partner (loss of choices). The results of this study increase our understanding of the transplantation process as experienced by a face transplant recipient and his partner. They may help to better inform professionals to optimize transplantation procedures or supportive interventions.

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months.

PURPOSE: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. METHODS: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. RESULTS: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. CONCLUSION: Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.

PURPOSE: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. METHODS: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). RESULTS: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. CONCLUSION: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Former smoking and early and long-term graft outcome in renal transplant recipients: a retrospective cohort study.

Smoking is associated with unfavourable outcome in solid-organ transplant recipients. Nicotine may predispose to kidney injury by increasing oxidative stress. We hypothesized that former smoking negatively affects graft outcome in kidney transplant recipients and especially those with delayed graft function (DGF). We included adult recipients of a kidney transplant between 1 January 2003 and 1 October 2015 at Ghent University Hospital and recorded outcomes until 31 October 2015. We used Kaplan-Meier and multivariable Cox proportional hazard analysis to examine the relationship between former smoking at the time of transplantation and the incidence of 10-year graft loss with and without censoring for death in 1013 participants. We evaluated mean differences in eGFR over time by a random intercept and slope model, considering a linear time effect. After adjusting for potential confounders, a history of smoking was associated with an increased hazard of graft loss (adjusted hazard ratio (aHR) 1.60; 95% CI: 1.17-2.17; P = 0.003) and death-censored graft loss (aHR 2.29; 95% CI: 1.41-3.72; P = 0.001). The linear time trend of eGFR was different between former and never smokers (P = 0.001). To conclude, former smoking exerts long-lasting negative effects on graft outcome and this independent of DGF.

Post Surgical Pyoderma Gangrenosum in flap surgery: diagnostic clues and treatment recommendations.

BACKGROUND: Post Surgical Pyoderma Gangrenosum (PSPG) is a neutrophilic dermatosis causing aseptic necrotic ulcerations within surgical sites. It is often misdiagnosed as infection or ischemia and worsened by the inappropriate treatment. Therefore diagnostic clues must be identified and awareness for PSPG raised. METHODS: We present two cases of PSPG after flap surgery and a review of the literature. RESULTS: Seventeen cases of PSPG after flap surgery were found. Fever, pain and redness are the most common initial symptoms. In 63%, lesions were on the flap and the adjacent skin. In 63%, the donor site is also involved. Time to diagnosis was nine days to four years. Frequent debridement (89%) and administration of antibiotics (74%) illustrate the misdiagnosis of infection or ischemia. PSPG in flap surgery seems to be less associated with underlying diseases, than other forms of Pyoderma Gangrenosum. Corticoids are the most commonly used treatment. Of the 19 cases, 10 experienced partial or total flap loss. CONCLUSION: PSPG must be included in the differential diagnosis of postoperative wound problems. Recognizing the diagnostic clues can lead to early diagnosis and treatment with systemic immunotherapy. Associated diseases should be investigated and additional surgery can only be successful when associated with immunotherapy.

Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty.

OBJECTIVE: The mechanism of angioplasty is disruption of atherosclerotic plaque, which often results in dissections. Dissection after percutaneous transluminal angioplasty (PTA) remains a significant clinical problem and untreated may cause acute occlusion or later restenosis. Stents are used to manage dissections, which is often followed by in-stent restenosis and occasionally stent fracture. Tack (Intact Vascular, Wayne, Pa) implants have minimal metal and low radial force and are specifically designed for dissection repair. This study evaluated Tack implants for treatment of dissections resulting from standard balloon PTA for femoral-popliteal arterial disease. Twelve-month outcomes after Tack treatment of post-PTA dissections are described. METHODS: This prospective, single-arm study evaluated patients with ischemia (Rutherford clinical category 2-4) caused by lesions of the superficial femoral and popliteal arteries. Patients were treated with standard balloon angioplasty, and post-PTA dissections were treated with Tacks. The primary end points were core laboratory-adjudicated device technical success, defined as the ability of the Tack implants to resolve post-PTA dissection, and device safety, defined as the absence of new-onset major adverse events. Patients were followed up to 12 months after implantation. RESULTS: Tacks were used in 130 patients with post-PTA dissections (74.0% ≥ grade C). Technical success was achieved in 128 (98.5%) patients with no major adverse events at 30 days. The 12-month patency was 76.4%, and freedom from target lesion revascularization was 89.5%. Significant improvement from baseline was observed in Rutherford clinical category (82.8% with grade ≤1) and ankle-brachial index (0.68 ± 0.18 to 0.94 ± 0.15; P < .0001). CONCLUSIONS: Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization. Tack treatment represents a new, minimal metal paradigm for dissection repair that can safely improve the clinical results associated with PTA.

High-urgency kidney transplantation in the Eurotransplant Kidney Allocation System: success or waste of organs? The Eurotransplant 15-year all-centre survey.

BACKGROUND: In the Eurotransplant Kidney Allocation System (ETKAS), transplant candidates can be considered for high-urgency (HU) status in case of life-threatening inability to undergo renal replacement therapy. Data on the outcomes of HU transplantation are sparse and the benefit is controversial. METHODS: We systematically analysed data from 898 ET HU kidney transplant recipients from 61 transplant centres between 1996 and 2010 and investigated the 5-year patient and graft outcomes and differences between relevant subgroups. RESULTS: Kidney recipients with an HU status were younger (median 43 versus 55 years) and spent less time on the waiting list compared with non-HU recipients (34 versus 54 months). They received grafts with significantly more mismatches (mean 3.79 versus 2.42; P < 0.001) and the percentage of retransplantations was remarkably higher (37.5 versus 16.7%). Patient survival (P = 0.0053) and death with a functioning graft (DwFG; P < 0.0001) after HU transplantation were significantly worse than in non-HU recipients, whereas graft outcome was comparable (P = 0.094). Analysis according to the different HU indications revealed that recipients listed HU because of an imminent lack of access for dialysis had a significantly worse patient survival (P = 0.0053) and DwFG (P = 0.0462) compared with recipients with psychological problems and suicidality because of dialysis. In addition, retransplantation had a negative impact on patient and graft outcome. CONCLUSIONS: Facing organ shortages, increasing wait times and considerable mortality on dialysis, we question the current policy of HU allocation and propose more restrictive criteria with regard to individuals with vascular complications or repeated retransplantations in order to support patients on the non-HU waiting list with a much better long-term prognosis.

External Validation of a risk stratification model to assist shared decision making for patients starting renal replacement therapy.

BACKGROUND: Shared decision making is nowadays acknowledged as an essential step when deciding on starting renal replacement therapy. Valid risk stratification of prognosis is, besides discussing quality of life, crucial in this regard. We intended to validate a recently published risk stratification model in a large cohort of incident patients starting renal replacement therapy in Flanders. METHODS: During 3 years (2001-2003), the data set collected for the Nederlandstalige Belgische Vereniging voor Nefrologie (NBVN) registry was expanded with parameters of comorbidity. For all incident patients, the abbreviated REIN score(aREIN), being the REIN score without the parameter "mobility", was calculated, and prognostication of mortality at 3, 6 and 12 month after start of renal replacement therapy (RRT) was evaluated. RESULTS: Three thousand four hundred seventy-two patients started RRT in Flanders during the observation period (mean age 67.6 ± 14.3, 56.7 % men, 33.6 % diabetes). The mean aREIN score was 4.1 ± 2.8, and 56.8, 23.1, 12.6 and 7.4 % of patients had a score of ≤4, 5-6, 7-8 or ≥9 respectively. Mortality at 3, 6 and 12 months was 8.6, 14.1 and 19.6 % in the overall and 13.2, 21.5 and 31.9 % in the group with age >75 respectively. In RoC analysis, the aREIN score had an AUC of 0.74 for prediction of survival at 3, 6 and 12 months. There was an incremental increase in mortality with the aREIN score from 5.6 to 45.8 % mortality at 6 months for those with a score ≤4 or ≥9 respectively. CONCLUSION: The aREIN score is a useful tool to predict short term prognosis of patients starting renal replacement therapy as based on comorbidity and age, and delivers meaningful discrimination between low and high risk populations. As such, it can be a useful instrument to be incorporated in shared decision making on whether or not start of dialysis is worthwhile.

Right-sided Cockett's syndrome.

Background Cockett and Thomas described and named Cockett's syndrome in 1965, commonly referred to as iliac vein compression syndrome (IVCS). It is often found as underlying cause in iliofemoral deep venous thrombosis (DVT). They described the syndrome mostly seen on the left side and predominantly in women during the second to the fourth decade of life. In this article, we present a patient with a Cockett's syndrome on the right side. Case presentation Our patient is a 52-year old female with edema of the right leg since 4 months. She had no signs of a DVT and did not benefit from a 3-month compression therapy. She was diagnosed using a CT-scan. Endovascular treatment was performed with a venous stent in the right common iliac vein (CIV). No postoperative complications were seen. After a 6-month follow-up, patient was free of pain and had no residual edema of the right leg. Conclusions Our patient presented with a non-complicated right-sided Cockett's syndrome. She was successfully treated with balloon dilatation and additional stenting of the right common iliac vein. Because of the clinical improvement of the patient together with the excellent long-term results and good patency results of the stenting, guidelines nowadays advise more and more venous stenting to prevent DVT and to relieve symptoms in case of vein compression syndromes.

Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial.

PURPOSE: To evaluate the short- and midterm outcomes of the Viabahn endoprosthesis with Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery. METHODS: Between June 2010 and February 2012, 83 patients with superficial femoral artery in-stent and Rutherford category 2 to 5 ischemia were enrolled at 7 sites participating in this prospective randomized controlled study (RELINE; ClinicalTrials.gov; identifier NCT01108861). The patients were randomized to treatment with either the heparin-bonded Viabahn endoprosthesis (n = 39: 29 men; mean age 67.7 ± 9.8 years) or a standard angioplasty balloon (n = 44: 32 men; mean age 69.0 ± 9.7 years). The primary effectiveness outcome was primary patency at 12 months, defined as no restenosis/occlusion within the target lesion based on duplex ultrasound and no target lesion revascularization. The primary safety endpoint was the incidence of serious device-related adverse events within 30 days of the procedure. RESULTS: All patients randomized to receive dilation or the Viabahn stent-graft were treated according to their assignment. The technical success was 100% for the Viabahn group and 81.8% for the angioplasty group (p = 0.002) owing to 9 patients requiring a bailout procedure after unsuccessful angioplasty. The 12-month primary patency rates were 74.8% for the Viabahn group and 28.0% for the angioplasty group (p < 0.001). Excluding the 9 angioplasty patients who received bailout stenting, the primary patency for optimal balloon angioplasty was 37.0% (p < 0.001). Three patients experienced device-related adverse events within 30 days: occlusion of the target lesion (Viabahn group), peripheral embolization (angioplasty group), and reocclusion of the target lesion (angioplasty group). CONCLUSION: In this study, the treatment of femoropopliteal in-stent restenosis with a Viabahn endoprosthesis showed significantly better results than treatment with a standard balloon at 1 year.

Facial transplantation in a blind patient: psychologic, marital, and family outcomes at 15 months follow-up.

BACKGROUND: Quality of life has frequently been reported to improve after vascularized composite allotransplantation of the face. However, psychosocial functioning of the partner or of particular patient groups such as blind patients are until now less well investigated. OBJECTIVE: The aim of this study is to investigate psychologic, marital, and family functioning of a blind 54-year-old patient, Mr. A, and his partner after facial transplantation. METHODS: Depressive and anxiety symptoms, hopelessness, personality, coping, resilience, illness cognitions, marital support, dyadic adjustment, family functioning, and quality of life of Mr. A and his partner were assessed before and after facial transplantation and at 15 months follow-up. Reliable change index (RCI) was further calculated to evaluate the magnitude of change. RESULTS: Most psychologic, marital, and family scores of both Mr. A and his partner were within a normative and healthy range before and after transplant and at 15 months follow-up. Resilience (RCI: 3.6), affective responsiveness (RCI: -3.6), and disease benefits (RCI: 2.6) of Mr. A further improved at 15 months follow-up whereas the physical quality of life (RCI: -14.8) strongly decreased. Only marital support (RCI: -2.1) and depth (RCI: -2.0) of the partner decreased at 15 months. CONCLUSIONS: The results of this study point to positive psychosocial outcomes in a blind patient after facial transplantation. Further, they may underscore the importance of good psychosocial functioning before transplantation of both partners and of their involvement in psychologic and psychiatric treatment. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

24-Month Data from the BRAVISSIMO: A Large-Scale Prospective Registry on Iliac Stenting for TASC A & B and TASC C & D Lesions.

BACKGROUND: To evaluate the 24-month outcome of stenting in Trans-Atlantic Inter-Society Consensus (TASC) A & B and TASC C & D iliac lesions in a controlled setting. METHODS: The BRAVISSIMO study is a prospective, nonrandomized, multicenter, multinational, monitored registry including 325 patients with aortoiliac lesions. The end point is the primary patency at 24 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio >2.0). A separate analysis for TASC A & B versus TASC C & D population is performed. RESULTS: Between July 2009 and September 2010, 190 patients with TASC A or B and 135 patients with TASC C or D aortoiliac lesions were included. The demographic data were comparable for TASC A & B cohort and TASC C & D cohort. Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A & B lesions, and considerably more self-expanding stents were placed in TASC C & D (P = 0.01). The 24-month primary patency rate after 24 months for the total population was 87.9% (88.0% for TASC A, 88.5% for TASC B, 91.9% for TASC C, and 84.8% for TASC D). No statistically significant difference was shown when comparing these groups. The 24-month primary patency rates were 92.1% for patients treated with the self-expanding stent, 85.2% for patients treated with the balloon-expandable stent, and 75.3% for patients treated with a combination of both stents (P = 0.06). Univariate and multivariable regression analyses using Cox proportional hazards model identified only kissing stent configuration (P = 0.0012) and obesity (P = 0.0109) as independent predictors of restenosis (primary patency failure). Interestingly, as all TASC groups enjoyed high levels of patency, neither TASC category nor lesion length was predictive of restenosis. CONCLUSION: The 24-month data from this large, prospective, multicenter study confirm that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category.