Mental health, COVID-19 burden and quality of life of kidney transplant recipients two years after the COVID-19 pandemic.

Introduction: Few studies have evaluated the psychological distress of COVID-19 in kidney transplantation and the psychological impact that the COVID-19 pandemic has had on kidney transplant recipients is not yet well understood. The present study aimed to investigate the change in symptom burden and health-related quality of life in the two years after initial assessment, by outlining the change over time of symptoms at 12 and 24 months of follow-up. Methods: This is a follow-up study. We performed a study published in 2021 (phase 1 of COVID-19); of the 89 kidney transplant recipients evaluated in this study, 60 completed the 12 months follow-up (March 2021 June 2021, phase 2 of COVID-19) and 57 completed the 24 months follow-up (March 2022 June 2022, post COVID-19). The same tools as in previous study were administered: the ad hoc questionnaire on emotional state and psychophysical well-being during COVID-19, the Middlesex Hospital Questionnaire (MHQ) to provide a simple and rapid quantification of the psychological and somatic symptoms and the Short Form Health Survey 36 (SF-36) was used to assess health-related quality of life. Results: Compared to the first and second phase of COVID-19, the mean score of quality of life variables were higher in the post COVID-19 phase; thus the recipients physical health, mental health and their perception of their general health improved. Regarding the psychopathology variables the levels of Anxiety, Depression and Phobia in the Post COVID-19 phase decreased, while the Somatization score was higher. Lastly, burden of COVID-19 scores in the third phase, significantly decreased. Discussion: Our study highlights a significant association between mental health and the burden of COVID-19 pandemic in kidney transplant recipients. This study showed, a significant worsening, over time, of some specific symptoms, such as somatization and phobias. However, the results showed that depressive symptoms improved during the study period. Long-term monitoring of kidney transplant recipients therefore remains fundamental. These results confirmed the need to provide integrated multidisciplinary services to adequately address the long-term effects of the COVID-19 pandemic on the mental health of the most vulnerable subjects.

Living-Donor Uterus Transplantation: A Clinical Review.

Uterus transplantation (UTx) is currently the only available treatment for absolute uterine factor infertility. More than 90 uterus transplantations have been performed worldwide, mostly from living donors. Living-donor (LD) UTx is a challenging surgical procedure since it poses ethical issues, and it is a high-risk and invasive surgery with higher hysterectomy-related risks compared to conventional hysterectomy. A total of 59 living-donor hysterectomies have been reported in the literature, including 35 performed with a laparotomic approach, 20 with a robotic approach and 4 with a laparoscopic approach. The mean donor age was 45.6 ± 9.1 years, and 22 were unrelated with the recipients, 34 were emotionally related (27 mothers, 5 sisters, 2 mother's sisters). The mean recipient age was 28.8 ± 4.5 years. Mayer-Rokitansky-Küster-Hauser syndrome was the most common indication for uterus transplant. Robotic living-donor hysterectomy had the longest operative time but resulted in a lower blood loss and postoperative stay compared to laparotomic and laparoscopic approaches. Twenty-nine births from LD-UTx have been reported, four after robotic living-donor hysterectomy and twenty-five after a laparotomic procedure. UTx is now an effective treatment for women with UFI. While living-donor UTx in some cases may be considered an experimental procedure, it offers the extraordinary possibility to give women the opportunity to have a pregnancy. Many efforts should be made to reduce the potential risks for donors, including the use of mini-invasive techniques, and the efficacy of UTx in the recipients, giving the potential harm of immunosuppression in a recipient of a non-life-saving organ.

Prevention of Delayed Graft Function in Kidney Transplant Recipients through a Continuous Infusion of the Prostaglandin Analogue Iloprost: A Single-Center Prospective Study.

BACKGROUND: Delayed graft function (DGF) is common after kidney transplantation from deceased donors and may significantly affect post-transplant outcomes. This study aimed to evaluate whether an innovative approach, based on the administration of the intravenous prostaglandin analogue iloprost, could be beneficial in reducing the incidence of DGF occurring after kidney transplantation from deceased donors. METHODS: This prospective, randomized (1:1), placebo-controlled study enrolled all consecutive patients who received a kidney transplant from a deceased donor from January 2000 to December 2012 and who were treated in the peri-transplant period with the prostaglandin analogue iloprost at 0.27 µg/min through an elastomeric pump (treatment group) or with a placebo (control group). RESULTS: A total of 476 patients were included: DGF was reported in 172 (36.1%) patients in the entire cohort. The multivariate analysis showed that the donor's age > 70 years (OR 2.50, 95% confidence interval (CI): 1.40-3.05, p < 0.001), cold ischemia time > 24 h (OR 2.60, 95% CI: 1.50-4.51, p < 0.001), the donor's acute kidney injury (OR 2.71, 95% CI: 1.61-4.52, p = 0.021) and, above all, the recipient's arterial hypotension (OR 5.06, 95% CI: 2.52-10.1, p < 0.0001) were the strongest risk factors for developing post-transplant DGF. The incidence of DGF was 21.4% in the treatment group and 50.9% in the control group (p < 0.001). Interestingly, among patients who developed DGF, those who received iloprost had a shorter duration of post-transplant DGF (10.5 ± 8.3 vs. 13.4 ± 6.7, days, p = 0.016). CONCLUSIONS: This study showed that the use of a continuous infusion of iloprost could safely and effectively reduce the incidence of DGF in recipients of deceased-donor kidneys, allowing a better graft functionality as well as a better graft survival.

Nonadherence to Immunosuppressants Among Transplant Recipients: Emotional Intelligence as a Predictive Factor During COVID-19 Pandemic.

Purpose: To evaluate the association between emotional intelligence and fear of COVID-19 on self-reported adherence, based on a cross-sectional design. Patients and Methods: Transplants recipient of both sexes aged 23-75 years old were evaluated at the Organ Transplant Unit, University Hospital of Catania, Italy. Data were analyzed using frequency, descriptives, Spearman and Pearson correlations, Chi-square goodness of fit test, and linear regression. Self-reported adherence was estimated with the Basel Assessment of Adherence with Immunosuppressive Medication Scale (BAASIS). Emotional intelligence and fear of COVID were, respectively, measured with the Emotional Intelligence Scale (EIS) and Multidimensional Assessment of COVID-19 Related Fears Scale (MAC-RF). This was a cross-sectional study of kidney transplant recipients. In reporting this study the authors followed the STROBE guidelines. Results: A correlation was found between EIS and MAC and between EIS and adherence but there was no correlation between MAC and adherence. A linear regression model was also conducted using a stepwise method, which indicated that EIS was a significant predictor of adherence (p <0.05). Conclusion: This study was found that EIS is a predictor of adherence to treatment in transplant patients. Fear of COVID, while positively correlated to EIS, is not correlated to the adherence's outcome, possibly due to the proper follow-up performed to the patients. Indeed, according to these results, we suggest to provide good follow-ups with recipients, with interviews also based on self-regulation and awareness.

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

PURPOSE: To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions. MATERIALS AND METHODS: Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed. RESULTS: 220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503). CONCLUSION: Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions.

Attachment and parental bond: impact on psychopathology, mental health and quality of life of hemodialysis patients: a cross-sectional study.

BACKGROUND: Attachment theory represents a reference model for understanding better how pre-existing personality factors can influence the coping with some chronic conditions. The onset of a chronic disease can represent a "threat" to the relationships between the subject and parental figures according to the type of bond that already exists. The aim of our study was to explore attachment styles in a sample of hemodialysis patients, hypothesizing that a secure attachment bond can constitute a protective factor for the quality of life and mental health in this type of patients. DESIGN: We used a cross-sectional design. METHODS: Fifty hemodialysis patients were given the following tests: Attachment Style Questionnaire (ASQ) to assess attachment styles, Parental Bonding Instrument (PBI) to assess parental bonding, Short Form Health Survey-36 (SF-36) for perceived quality of life and Middlesex Hospital Questionnaire (MHQ) to detect key psychological symptoms and relevant traits. RESULTS: The results showed that secure attachment style correlated with good general health (r = 0.339; p < 0.05), good mental health (r = 0.547; p < 0.001) and mental component scale (r = 0.373; p < 0.05) of SF-36. Secure attachment was also significantly associated with mental health (B = 1.104; p = .002) of the SF-36. CONCLUSIONS: The results confirmed the positive role of a secure attachment style for adequate psychological health. Early identification of patients with dysfunctional attachment styles will make it possible to offer them targeted interventions to improve their ability to accept, adapt and manage the disease and to maintain adequate psychological well-being.

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

BACKGROUND: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities. METHODS: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA. RESULTS: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186). CONCLUSIONS: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Quality of Life and Mental Health in Kidney Transplant Recipients During the COVID-19 Pandemic.

Introduction: The COVID-19 pandemic has led to an increase in mental distress such as phobic anxieties, depressive reactions, hypochondriac concerns, and insomnia. Among the causes are risk of infection and prolonged isolation. This study aimed to analyze psychopathological variables and dysfunctional lifestyles related to adequate therapeutic compliance in kidney transplant recipients. Methods: Eighty-nine kidney transplant recipients were evaluated using an online protocol including a questionnaire concerning habits, lifestyle and psychophysical well-being in the COVID-19 period, the Middlesex Hospital Questionnaire (MHQ) and the SF-36 Health Survey to evaluate the perception of their physical and emotional health. Results: Of these recipients, 28.6% reported changes in their emotional state. Sleep quality deteriorated for 16.1%. Anxiety (M = 5.57, r = 0.33; p < 0.05) and phobia (M = 6.28, r = 0.26; p < 0.05) correlated with concerns related to physical health. There was no negative impact on relational and socialization aspects, which were likely well compensated by the use of remote technologies such as video phone calls, Zoom meetings and use of computers (r = 0.99; r = 0.80; p < 0.05). Conclusions: It would be interesting to maintain this remote visit and interview mode to monitor, on a clinical and psychological level, kidney transplant recipients in subsequent follow-ups (12-18 months), to check for any psychopathological disorders and/or changes in their resilience capacity in the Coronavirus emergency.

An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation.

BACKGROUND: Vascular complications still represent an important issue after transcatheter aortic valve implantation (TAVI). AIMS: The aim of this study was to evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) plug-based system on top of suture-based devices (SBDs) for endovascular haemostasis after transfemoral (TF) TAVI. METHODS: From January 2019 to April 2020, 332 consecutive patients with preprocedural computed tomography angiography (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 30-day major vascular complications and major or life-threatening (LT) bleeding due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 pairs), undergoing either isolated SBD or SBD+AS, were matched using the propensity-score method. RESULTS: At 30 days, patients receiving SBD+AS had lower rates of major/LT bleeding (1.6% vs 8.9%, odds ratio [OR] 0.17, 95% confidence interval [CI]: 0.04-0.78; p<0.01) and major vascular complications (1.6% vs 8.9%, OR 0.17, 95% CI: 0.04-0.78; p<0.01). In addition, the use of SBD+AS was associated with a significant cost saving related to the vascular event (mean difference -315.3 € per patient, 95% CI: -566.4 € to -64.1 €; p=0.01), and a higher probability of next-day discharge (NDD) after TAVI (30.9% vs 16.3%, OR 2.30, 95% CI: 1.25-4.25; p<0.01). No difference in all-cause 30-day mortality was observed (3.3% vs 1.6% for SBD and SBD+AS groups, respectively, OR 0.49, 95% CI: 0.09-2.74; p=0.41). CONCLUSIONS: An upfront combined strategy with an additional AS plug-based device on top of SBDs was shown to reduce major vascular complications and major/LT bleeding due to closure system failure after TF-TAVI. This approach was associated with a cost saving and with a higher probability of NDD compared to the use of isolated SBD. Visual summary. Effectiveness of the upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation using Angio-Seal on top of a suture-based device (SBD) versus the isolated use of SBD. LT: life-threatening; TF-TAVI: transfemoral transcatheter aortic valve implantation.

Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study.

OBJECTIVES: The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment. BACKGROUND: Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking. METHODS: RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR. RESULTS: Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV-sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01). CONCLUSIONS: Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV-sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204).

Heme-Oxygenase and Kidney Transplantation: A Potential for Target Therapy?

Kidney transplantation is a well-established therapy for patients with end-stage renal disease. While a significant improvement of short-term results has been achieved in the short-term, similar results were not reported in the long-term. Heme-oxygenase (HO) is the rate-limiting enzyme in heme catabolism, converting heme to iron, carbon monoxide, and biliverdin. Heme-oxygenase overexpression may be observed in all phases of transplant processes, including brain death, recipient management, and acute and chronic rejection. HO induction has been proved to provide a significant reduction of inflammatory response and a reduction of ischemia and reperfusion injury in organ transplantation, as well as providing a reduction of incidence of acute rejection. In this review, we will summarize data on HO and kidney transplantation, suggesting possible clinical applications in the near future to improve the long-term outcomes.

Critical Behavior and Psychopathologic Variables of the Parent-Child Couple in Living Kidney Transplantation.

BACKGROUND: Living kidney donation is a complex emotional experience for donor candidates and recipients. The international literature underlines the importance of the type of donor-recipient bond to understand specific problems of donor candidates and optimize psychosocial evaluation and support for these patients. METHODS: The aim of our study was to analyze the emotional experience of donating in the living couple according to the type of donor-recipient bond (parental/nonparental) and the possible presence of psychopathologic symptoms in the couples pretransplantation and post-transplantation. RESULTS: Thirty donor-recipient couples (8 nonparental, emotionally linked couples [husband-wife or wife-husband], 22 genetically linked parental couples [16 parent-son or parent-daughter, 6 siblings]), recruited at the Organ Transplant Unit (University Hospital of Catania), were evaluated with a questionnaire (prepared ad hoc by the authors) to investigate the experience of donation in the couple and the aspects of the donor-recipient relationship in pre- and post-transplantation, and with the SCL-90-R to study the couples' possible psychopathologic variables before the donation and in the follow-up 24 months post-transplant. CONCLUSIONS: The authors have seen in their study how, in particular, the parent-child bond complicates the donation process, especially when the sons are young subjects. The "mental distress" that emerged and the "unpredictability" of behaviors of these subjects makes the adaptation process more complicated with difficulty in accepting the organ received. It is certainly necessary for transplant psychiatrists and psychologists to keep them "hooked" and work with them to increase awareness and therefore clarity of their behaviors.

Study of Defense Mechanisms in Kidney Transplanted Subjects.

Defenses mechanisms are defined as the tools an individual uses to manage instincts, drives, and affects. Transplantation is a stressful event that requires the body to mobilize its internal and external defenses and implement coping and adaptation strategies, which can be essential for overcoming the painful and potentially dangerous environmental, existential, and relational situations that may occur after transplantation. The aim of our study was to analyze the defense styles in 50 kidney transplanted subjects and to correlate the latter with any psychopathology and the quality of life subjectively perceived. The Defense Style Questionnaire was administered to evaluate the defense mechanisms. The Symptom Checklist-90-R (SCL-90-R) was used for the evaluation of any psychopathology. Quality of life was studied using the Complete Form Health Survey (SF-36). The "somatization" (SOM) and "anxiety" (ANX) dimensions of the SCL-90 R correlated significantly with the "reaction formation" (RF) neurotic defense (RF/SOM r = .893; RF/ANX r = .966; P < .05). A good perception of one's "general health" (GH) correlated significantly with the "humor" (HU) and "sublimation" (SU) mature defenses (HU/GH r = .681; SU/GH r = .524; P < .05). Kidney transplanted subjects are exposed to persistent physical and psychosocial stress and each transplanted subject uses their own defense mechanisms to contain the mental pain and reduce the emotional stress derived from the transplantation experience. Identifying the different kinds of defenses (mature, immature, or neurotic) can be an effective way to search for predictive indices of a good quality of life and adherence to treatments.

Psychological and Psychopathological Aspects of Kidney Transplantation: A Systematic Review.

Kidney transplantation is a serious event that involves profound psychological, relational and social changes both for the patient and his family context. Assessment of personality profile, awareness of disease, family and social support of the patient candidate for kidney transplantation are necessary because factors not adequately considered, can influence the success of the transplant and alter the psychological stability of the patient. The present study aims to provide a systematic review of the literature of the last twelve years (2006-2018), focusing in particular on patient's readiness level and illness management and on possible psychopathology. Sixty-two studies were examined. Based on the Downs and Black checklist, most studies (n = 32) were of high quality; 15 of which related to lifestyle, health education, and therapeutic adherence in post-renal transplantation, 17 studies concerned the possible existence of psychopathology and cognitive impairment of renal deceased transplanted subjects. The literature used has shown that the population of kidney transplant patients is exposed to a high risk of psychiatric disorders with repercussions on the quality of life and the risk of rejection. Therefore, an adequate pre-transplant psychosocial assessment is necessary, which allows a more in-depth knowledge of the candidate to plan coping strategies and possible post-transplant psychotherapy.

ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions.

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial.

PURPOSE: To evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI). MATERIALS AND METHODS: The Brave Dreams trial ( ClinicalTrials.gov identifier NCT01371760) was a multicenter, randomized, parallel group, double-blind, sham-controlled trial to assess the efficacy of jugular venoplasty in MS patients with CCSVI. Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS were randomized 2:1 to venography plus angioplasty (n=86) or venography (sham; n=44). Patients and study personnel (except the interventionist) were masked to treatment assignment. MRI data acquired at 6 and 12 months after randomization were compared to the preoperative scan for new and/or >30% enlargement of T2 lesions plus new gadolinium enhancement of pre-existing lesions. The relative risks (RR) with 95% confidence interval (CI) were estimated and compared. In a secondary assessment, venograms of patients who underwent venous angioplasty were graded as "favorable" (n=38) or "unfavorable" (n=30) for dilation according to the Giaquinta grading system by 4 investigators blinded to outcomes. These subgroups were also compared. RESULTS: Of the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005). CONCLUSION: Expanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. Secondary analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from accumulation of new cerebral lesions at MRI.

De Novo Cancer Incidence and Prognosis After Kidney Transplantation: A Single Center Analysis.

BACKGROUND: Malignancy is an important cause of mortality in renal transplants recipients. The aim of this study was to evaluate the incidence, prognosis, and survival of patients developing a de novo post-transplant cancer. METHODS: Using a retrospective cohort design, we evaluated the incidence of de novo cancers among kidney transplants patients in our hospital from January 2000 to December 2012. We also evaluated the patient survival after tumor diagnosis. RESULTS: We included 535 kidney transplants recipients with a mean follow-up of 7.8 years; among them, 39 (7.2%) developed malignancies. Median time from transplant to cancer diagnosis was 3 years, with a median age at diagnosis of 60 years. Male patients were significantly older at time of cancer diagnosis (68.5 years) compared with women (38 years, P < .05), and cancer diagnosis occurred significantly earlier in men (3.5 years since transplantation) than in women (8.5 years, P < .05). Among 39 patients affected by a de novo post-transplant cancer, 18 patients (46.2%) died, with an average age at death of 58.5 years. The average time from cancer diagnosis to death was 1.5 years. Among the group of patients who did not develop a post-transplant cancer, 83 patients (16.7%) died, with a median age at time of death of 54.5 years (P < .05). CONCLUSIONS: Kidney transplant recipients are at higher risk of developing a post-transplant cancer. Prognosis after cancer diagnosis is poor, probably as a consequence of a more aggressive behavior of cancer in transplant recipients. Intensive screening protocols could allow for an earlier diagnosis thereby improving the long-term outcome of these patients.

Nonverbal Communication and Psychopathology in Kidney Transplant Recipients.

Transplant recipients have difficulty expressing, identifying, and describing their emotional experiences. The Machover human figure test allows us to bring out the deepest contents of a patient's personality, which are normally hidden and not explained to structured quantitative tests. The study analyzed possible situations of distress and possible symptoms of psychopathology in kidney transplant recipients, emerged from the projective test of the human figure and not easily verbalized to the common standardized tests. The sample included 80 kidney transplant patients (51 men and 29 women; mean age, 47.74 [SD, 12.39] years) during follow-up visits at 12 months after transplant. The Machover test was used to evaluate body image, affective aspects, and personality variables by projective method; the Symptom Checklist-90-R was used for the evaluation of possible psychopathology, and the 36-Item Short Form Health Survey was used for the assessment of perceived quality of life. RESULTS: showed that the more anxiety there is in the human figure test, the less somatization dimensions (ANX/SOM R = -331, P < .05), depression (ANX/DEP R = -326, P < .05), and the global index of psychic symptomatology (ANX/GSI R = -367, P < .05) of the Symptom Checklist-90-R are present. This research has confirmed the hypothesis that the spontaneous graphic production of the recipients, through the projective methods, allows them to identify and deepen their psychological contents and to activate and maintain a good psychophysical balance post transplant.

Impact of Incidental Findings During the Evaluation of Live Kidney Donors on Post-Transplant Outcomes: A Single Center Analysis.

BACKGROUND: A careful assessment of a living donor is mandatory to minimize the short- and long-term risk related to kidney donation. In this study, we evaluated the incidence of incidental findings (IFs) in a large population of potential living kidney donors. Moreover, this study evaluated if the presence of IFs could influence the chance of living kidney donation and post-transplant outcomes. METHODS: One hundred and sixty consecutive potential prospective living kidney transplant donors, who underwent a multidetector computed tomography angiography (MDCTA), were included in the study. An IF was defined as an incidentally discovered mass or lesion, detected by computed tomography angiography during the imaging evaluation of potential living donors. Clinical outcomes of living donors with IF were compared with those without IF. RESULTS: In 10 patients (6.2%) an incidental finding was detected at MDCTA assessment. Among the 10 patients presenting with an IF, 7 patients (4.3%) were excluded from the living donation: 2 patients with an adrenal lesion, 3 patients with cancer, and 2 patients with a large (>8 cm) renal cyst. Graft and patient survival of kidney transplant recipients of donors with IFs were not significantly different to those receiving a kidney from living donors without IFs. CONCLUSIONS: Incidental findings are frequently discovered during living kidney donor evaluation. Whereas most are asymptomatic or not clinically relevant, predonation screening could identify potentially life-threatening diseases at an earlier stage, allowing for a more radical treatment.