Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

The "boatman's knot": a new option for renal hilum ligation during laparoscopic nephrectomy O "nó de barqueiro": nova opção para ligadura do hilo renal durante a nefrectomia laparoscópica

PURPOSE: The authors present and describe an original adaptation for the use of "boatman's knot" in renal vein ligation during laparoscopic nephrectomy. This procedure may replace the need for the endovascular stapler, which is considered the standard of care, but not available in several institutions in Brazil. The knot presented is also known as the " pig's knot" in several farms in Brazil. METHODS: Fourteen laparoscopic nephrectomies were performed by the same surgeon in a standard fashion in seven female pigs. Both the renal artery and vein were ligated using the "boatman's knot" as the only method for hemostasis with conventional intracorporeal technique. Two knots were applied in each artery and vein; one knot was tied proximally and the other distally. The vessels were then sectioned in between both knots. This technique is based on the intracorporeal confection of two loops by the right hand pair of dissectors with the help of the left hand. The arteries and the veins were then sectioned and the capability to accomplish full hemostasis was observed. RESULTS: All the laparoscopic nephrectomies were performed successfully. The "boatman's knot" was performed by the same surgeon with neither complications nor difficulties during the confection of the knot. In all cases hemostasis was fully achieved using only the "boatman's knot" as the hemostatic method. CONCLUSION: The "boatman's knot" is feasible and safe for hilum control during laparoscopic nephrectomy in pigs and total hemostasis can be achieved using it as the only method of hemostasis. However, the safety and the capacity of others to learn how to apply it should be tested before it may be advised to use it routinely.<br>OBJETIVO: Os autores apresentam e descrevem uma adaptação original para o uso do nó de barqueiro na ligadura da veia renal durante a nefrectomia laparoscópica. O procedimento pode substituir a necessidade da sutura mecânica endovascular, considerada o tratamento padrão, mas não disponível em muitas instituições no Brasil. Este nó é tembém conhecidocomo "nó de porco" em várias fazendas no Brasil. MÉTODOS: Quatorze nefrectomias laparoscópicas foram realizadas pou um único cirurgião utilizando a técnica padrão em sete porcas. A veia e a artéria renal foram ligadas utilizando o "nó de barqueiro" como o único método de hemostasia. Dois nós foram colocados tanto na artéria quanto na veia renal, um deles proximal e o outro distal, e os vasos seccionados entre os nós. Esta técnica é baseada a confecção intra-corpórea de duas alças pela mão direito com um par de pinças, com o auxílio da mão esquerda. Após a secção dos vasos, as condições da hemostasia foram observadas. RESULTADOS: Todas as nefrectomias laparoscópicas foram realizadas com sucesso. O "nó de barqueiro" foi realizado pelo mesmo cirurgião sem complicações nem dificuldades, obtendohemostasia completa em todos os casos como técnica única. CONCLUSÃO: O nó de barqueiro é uma técnica factível e segura para o controle do hilo renal durante a nefrectomia laparoscópica em porcos. Entretanto, a eficácia e segurança desta técnica deve ser avaliada por outros cirurgiões antes da recomendadção do emprego na prática clínica

Evaluation of renal defect healing, hemostasis, and urinary fistula after Laparoscopic partial nephrectomy with oxidized cellulose

Background and Purpose: Laparoscopic partial nephrectomy (LPN) has been performed at several institutions using oxidized cellulose ( OC) as a means of bleeding and urinary fistula (UF) prevention. However, a foreign-body reaction mimicking either abscess or tumor recurrence has been associated with the use of OC. We evaluated renal-defect healing after LPN with and without OC.Materials and Methods: Sixteen female Landrace pigs underwent lower-pole excision; all the collecting systems were entered and then closed with absorbable running suture. in group 1, hemostatic U-shaped stitches were the only method of hemostasis. in group 2, a bolster of OC was added to the renal defect. the pigs were sacrificed at 1, 4, 7, or 21 days, and gross findings such as perirenal collection were observed. A catheter was advanced up to the kidney, and methylene blue was injected with collecting system pressure observation; burst pressure was defined as the appearance of extravasation. High risk for UF was defined as burst pressure <10 mm Hg.Results: Neither hemorrhage nor urinoma was observed during sacrifice. One pig from group 2 had a burst pressure of 4 mm Hg at 7 days ( high risk for UF). At 21 days in group 2, the tissue was grossly solid, apparently a granuloma. Suppuration tended to be greater in group 2. the foreign-body reaction was more intense in group 2 and was strongly present at 4, 7, and 21 days.Conclusions: the use of OC is associated with higher scores of suppuration and foreign-body reaction. After LPN with OC, postoperative day 7 might be a critical time for the development of urinary leakage.Universidade Federal de São Paulo, Div Urol, São Paulo, BrazilUniversidade Federal de São Paulo, Dept Pathol, São Paulo, BrazilUniversidade Federal de São Paulo, Div Expt Surg, São Paulo, BrazilUniversidade Federal de São Paulo, Div Urol, São Paulo, BrazilUniversidade Federal de São Paulo, Dept Pathol, São Paulo, BrazilUniversidade Federal de São Paulo, Div Expt Surg, São Paulo, BrazilWeb of Scienc