Usefulness of Modified Dindo-Clavien Scale to Evaluate the Correlation Between the Severity of Surgical Complications and Complications Related to the Renal and Pancreatic Grafts After Simultaneous Kidney and Pancreas Transplantation.

OBJECTIVE: Simultaneous pancreas and kidney transplantation (spktx) is the multiorgan transplantation. Thus various complications originated from transplanted organs and the complications that are not directly related to pancreatic or renal grafts could be developed at the same recipient. AIM: The aim of this study is to explore whether there is a correlation between the severity of complications originated from transplanted pancreas, transplanted kidney and general surgical complication developed at the same spktx recipient. METHODS: Complications which developed among 112 spktx recipients were divided into three groups: related to the pancreatic graft (PTXc), to the renal graft (KTXc) and the general surgical complication (GNc). Severity of postoperative complications using modified Dindo-Clavien scale recipients was evaluated for each group. The correlation of severity of coexisting complications from different complication groups was analyzed. RESULTS: There were 22 recipients who developed the coexistence of complication between different complication groups. Complication originated from two and three complication groups developed 15 (68.2%) and 7 (31.8%) patients, respectively. There was not found correlation of the complication severity between: KTXc and GNc group, GNc and PTXc group, KTXc and PTXc group. The correlation (r = 0.84) of complication severity in recipients who developed concurrently complication from transplanted kidney, transplanted pancreas and general surgery complication was found. CONCLUSION: The modified Dindo-Clavien scale is an useful methodology for the correlation description of complication severity in complex multiorgan transplantation such is spktx, especially when the complications originated from different, potentially independent from the pathophysiological point of view, sources.

Surgical Complications Not Related to the Renal and Pancreatic Grafts After Simultaneous Kidney and Pancreas Transplantation.

BACKGROUND: Simultaneous pancreas and kidney transplantation (SPKTx) is the most commonly performed multiorgan transplantation procedure worldwide. Transplanted organs are the main source of complication; however, some postoperative complications are not directly related to the pancreatic or renal grafts. The goal of this study was to evaluate the prevalence, type, and severity of postoperative complications not related to transplanted kidney or pancreas among SPKTx recipients. METHODS: Complications unrelated to transplanted pancreas and kidneys among 112 SPKTx recipients were analyzed. The cumulative freedom from general surgical complications was assessed, and it was compared with cumulative freedom from complications related to kidney and pancreatic grafts. Severity of complications was classified according to a modified Clavien-Dindo scale. RESULTS: The general surgery complication rate was 22.2%. Cumulative freedom from general surgical complications at days 60 and 90 after transplantation was 0.89 and 0.87, respectively. Cumulative freedom from general surgical complications was comparable with cumulative freedom from complications related to kidney grafts but significantly higher than cumulative freedom from complications related to pancreatic grafts (log-rank test, P < .001). The rates for grades of severity II, IIIa, IIIb, and IVb were 19.4%, 9.7%, 64.5%, and 6.4%, respectively. The most frequent cause of complications was intra-abdominal hematoma or abscess (25.8%). CONCLUSIONS: The general surgical complication rate was comparable to the rate of complications originating from the renal grafts but significantly lower than the complication rate related to the transplanted pancreas. The incidence of general surgical complications could be defined as moderate, and the severity of this type of complication was low.

Left ventricular hypertrophy in renal transplant recipients in the first year after transplantation.

BACKGROUND: Left ventricular hypertrophy (LVH) is a significant risk factor for cardiovascular complications in renal transplant recipients. The study objective here was to assess LVH and related factors in renal transplant recipients in the 1st year after transplantation. METHODS: Echocardiographic examinations were performed in the early post-transplantation period in 43 patients (age, 43.9 ± 12.4 years; male, 53.5%) and at 1 year after transplantation in 40 patients. At the same time, basic blood tests, N-terminal pro-B-type natriuretic peptide (NT-proBNP) level tests, and ambulatory blood pressure measurements were performed. LVH was diagnosed when LV mass index was >95 g/m(2) in women and >115 g/m(2) in men. Statistical analyses were performed with the use of the R Package. RESULTS: LVH (mainly concentric) was found in 51.2% of the patients in the early period and in 50% of the patients at 1 year. In 30% of the patients with baseline LVH it regressed at 1 year and in another 30% LVH developed de novo. In the early period, LV mass was influenced by age, sex, body mass index (BMI), estimated glomerular filtration rate (eGFR), and a history of cardiovascular disorders during dialysis therapy, whereas at 1 year after transplantation it was influenced by age, sex, BMI, 24-hour systolic blood pressure, a history of hypertension during dialysis therapy, and abnormal 24-hour blood pressure profile. Weight gain interfered with LVH regression during the 1st year after transplantation, whereas no improvement in blood pressure control contributed to de novo development of LVH. All other patients (those without LVH) had a morphologic abnormality of the left ventricle, the so-called concentric remodeling. Higher NT-proBNP levels were observed in patients with LVH. CONCLUSIONS: LVH is present in one-half of renal transplant recipients in the 1st year after transplantation, and concentric remodeling is present in the remaining patients of this group. An echocardiographic examination is indicated in every renal transplant recipient. Measurements of NT-proBNP levels are helpful in LVH diagnostics.

Multivariate analysis of complications after simultaneous pancreas and kidney transplantation.

OBJECTIVE: Identification of factors that have an impact on postoperative complications after simultaneous pancreas and kidney transplantation (SPKTx) could help overcome limitations of this kind of treatment. METHODS: Postoperative complications among 112 SPKTx recipients were divided into 3 groups: related to transplanted pancreas (n = 66), related to transplanted kidney (n = 23) and general surgical complications (n = 31) 120 refers to complications among 112 recipients. According to the modified Clavien-Dindo scale, complications were classified according to their severity for each group. Risk factors for complication development related to donor, recipient, surgical technique, and immunosuppression were included to establish the multivariable model using logistic regression. RESULTS: Multiple regression analysis showed the following independent factors influenced mortal complications due to transplanted pancreas: age of donor (OR, 1.07; P < .04), duration of vascular pancreas anastomosis above 35 minutes (OR, 3.94; P < .04) and duration of recipient dialysis above 24 months before transplantation (OR, 0.14; P < .01). Area under receiver operating characteristic curve for this model was 0.8. CONCLUSION: To improve results, the following modification of identified risk factors should be assumed: selection of donor in term of age, shortening of the second warm ischemia time, and adjustment of the waiting list to avoid prolongation of recipient dialysis before SPKTx.

Quality of pancreatic transplant program assessment using a risk-adjusted cumulative sum chart: experience from a single, small center.

BACKGROUND: The high rate of complication after pancreas transplantation not only had an impact on recipient quality of life and survival but also had significant financial implications. Thus, monitoring transplant center performance was crucial to indentifying changes in clinical practice that result in quality deterioration. OBJECTIVE: To evaluate retrospectively the quality of the single, small pancreatic transplant program and to establish prospective monitoring of the center using risk-adjusted cumulative sum (CUSUM). METHODOLOGY: From 1988 to 2014, 119 simultaneous pancreas and the kidney transplantations (SPKTx) were performed. The program was divided into 3 eras, based on surgical technique and immunosuppression. Analyses of the 15 fatal outcomes due to complication from pancreatic graft were performed. The risk model was developed using multivariable logistic regression analysis based on retrospective data of 112 SPKTx recipients. The risk-adjusted 1-sided CUSUM chart was plotted for retrospective and prospective events. The upper control limit was set to 2. RESULTS: There were 2 main causes of death: multiorgan failure (73.3%; 11/15) and septic hemorrhage (26.7%; 4/15). Quality analysis using the CUSUM chart revealed that the process was not homogeneous; however, no significant signal of program deterioration was obtained and the performance of the whole program was within the settled control limit. CONCLUSION: For a single pancreatic transplant center. The risk-adjusted CUSUM chart was a useful tool for quality program assessment. It could support decision making during traditional surgical morbidity and mortality conferences. For small transplant centers, increasing the sensitivity of the CUSUM method by lowering the upper control limit should be considered. However, an individual assessment approach of the for particular centers is recommended.

Early complications related to the transplanted kidney after simultaneous pancreas and kidney transplantation.

OBJECTIVE: Simultaneous pancreas and kidney transplantation (SPKTx) is the most often performed multiorgan transplantation. The main source of complication is transplanted pancreas; as a result, early complications related to kidney transplant are rarely assessed. The aim of this study was to evaluate prevalence, types, and severity of postoperative complications due to kidney graft among the simultaneous pancreas and kidney recipients. METHODS: Complications related to transplanted kidney among 112 SPKTx recipients were analyzed. The indication for SPKTx was end-stage diabetic nephropathy due to long-lasting diabetes type 1. The cumulative survival rates for kidney graft function and cumulative freedom from complication on days 60 and 90 after transplantation were assessed. Severity of complications was classified according to the modified Dindo-Clavien scale. RESULTS: The 12-month cumulative survival rate for kidney graft was 0.91. Cumulative freedom from complication on the 60th day after transplantation was 0.84. The rates for II, IIIA, IIIB, IVA, and IVB severity grades were: 34.9%, 4.3%, 26.1%, 26.1%, and 8.6%, respectively. Acute tubular necrosis and rejection were the most frequent (43.4%) cause of complication. The most frequent reasons for graft nephrectomy were infections (2/7; 28.6%) and vascular thrombosis due to atherosclerosis of recipient iliac arteries (2/7; 28.6%). The most severe (IVB) complications were caused by fungal infection. CONCLUSION: Rate and severity of complications due to renal graft after SPKTx was low; however, to prevent the most serious ones reduction of fungal infection was necessary.

Surgical complications related to transplanted pancreas after simultaneous pancreas and kidney transplantation.

OBJECTIVE: Simultaneous pancreas and kidney transplantation (SPTKx) is characterized by the high rate and variability of postoperative complications, which could be a limitation of this treatment. The aim of this study was to evaluate prevalence, types, and severity of postoperative complications due to pancreas graft among the simultaneous pancreas and kidney recipients. METHODS: Postoperative complications related to transplanted pancreas among 112 SPTKx recipients were analyzed. The cumulative survival rates for pancreas graft function and cumulative freedom from complication on day 60 after transplantation were assessed. Severity of complications was classified according to a modified Clavien-Dindo scale. RESULTS: The 12-month cumulative survival rate for pancreatic graft was 0.74. Cumulative freedom from complication on the 60th day after transplantation was 0.57. The rates for II, IIIA, IIIB, IVA, and IVB severity grades were 10,6%, 4,5%, 19,7%, 44%, and 21,2%, respectively. The most severe (IVB) transplanted pancreas complications were due to graft inflammation, infection, pancreatic abscess, and local or diffuse necrosis. The most frequent reason for graft pancreatectomy was vascular thrombosis 35.9% (14/39). The mortality rate after graft pancreatectomy was significantly lower for vascular thrombosis than for infection (0/14 vs 11/25; P < .05). CONCLUSION: Reducing vascular thrombosis could preserve graft function rate. Preventing graft inflammation and infection would reduce mortality.

Role of 16-multidetector computerized tomography in evaluation of graft failure risk in patients with pancreatic graft thrombosis after simultaneous pancreas and kidney transplantation.

BACKGROUND: Thrombosis of the pancreatic graft vessels is a common complication in patients after pancreas transplantation. The aim of this study was to evaluate the usefulness of 16-multidetector computerized tomography (16-MDCT) with volume rendering (VR) and maximum intensity projection (MIP) reconstruction as a predicting method of pancreatic graft loss after simultaneous pancreas and kidney transplantation. METHODS: Within 6-8 days after combined kidney-pancreas transplantation, MDCT was performed in 60 patients. Secondary reconstructions were obtained with the application of VR and MIP algorithms. Vessel anastomosis, extra- and intrapancreatic arteries, venous morphology, and enhancement of graft's parenchyma were evaluated. The stenosis grade of pancreatic graft vessels and the areas of graft parenchyma malperfusion were evaluated. RESULTS: Thrombosis of pancreatic graft vessels was recognized in 26 patients (43%), however only one-half of them required graftectomy. There were 17 cases of large vessel thrombosis and 9 cases of small intragraft vessel thrombosis. In 13 (86.6%) out of 15 recipients parenchymal malperfusion resulted in graft lost. It appeared that vessel narrowing >40% was a threshold for pancreatic graft loss with sensitivity and false positive values of 100% and 9%, respectively. For parenchyma nonenhancement >60% the sensitivity and false positive values of 100% and 0% were significantly associated with pancreatic graft loss (P < .0001). CONCLUSIONS: Vascular occlusion of >40% and necrosis >60% of parenchymal volume correspond with pancreatic graft loss.

When less is more--case report of successful renal transplantation from a living unrelated donor to a high-risk female recipient.

Qualification for kidney transplantation for patients with a long history of renal replacement therapy and numerous medical complications requires individual analysis of all contraindications and limitations as well as advantages of the procedure. In this case report, we analyze the qualification process and posttransplantation course of a 28-year-old female patient with end-stage renal failure due to reflux nephropathy, treated with renal replacement therapy since early childhood, who received her second kidney transplant with glomerular filtration rate <40 mL/min/1.73 m(2) from a living, unrelated donor in 2009. Despite the high risk of immunological and surgical complications, transplanting organs of borderline excretory capacity, and no human leukocyte antigen matching, significant health benefits were achieved. Procurement of a kidney with borderline filtering function reduces the risk of potential negative consequences of impaired remnant filtration in the living donor. Following the principle of procuring a kidney with worse parameters from the living donors, it is necessary to perform an examination evaluating the function of each kidney. Procurement of a kidney with significantly worse parameters requires an individual assessment of benefits for the recipient.

Characteristics of potential living kidney donors and recipients: donor disqualification reasons--experience of a Polish center.

INTRODUCTION: Kidney transplantation is efficacious as a renal replacement, particularly pre-emptive living donation. In Poland, the rate of transplantation of living donor kidneys is only 3%. The aim of the study was to identify the most common reasons to disqualify a potential living kidney donor. METHODS: We evaluated 124 kidney donor candidates for 111 potential recipients at 1 medical center for genders and ages of donor and recipient; thus relation, donor disqualification reasons, number of potential donors for a particular recipient, prior transplantations, and kidney vasculature. RESULTS: The 111 recipients of ages 2-62 years had, 1, 2, or 3 potential donors were tested in 101, 1, and 7, cases respectively. We had 18.9% recipients referred for pre-emptive transplantation; 59.5% were on haemodialysis and 21.6% on peritoneal dialysis. In all, 89% recipients sought first kidney transplantations. Kidneys were procured from 49/124 (39.5%) of the initially evaluated donors. The full examination was completed by 92 potential donors with 68/124 donors disqualified early. Single and multiple renal arteries were detected in 56 and 36 potential donors, respectively. Donor disqualification was due to medical contraindications (39.7%), earlier transplantation from a deceased donor (25%), immunologic constraints (23.5%), donor consent withdrawn (6%) or psychological and social reasons (4.4%). CONCLUSIONS: A considerable number of donor candidates are disqualified for medical reasons.

Antiphospholipid antibodies in renal allograft recipients.

BACKGROUND: Antiphospholipid antibodies (APLAs) are associated with an increased risk of thrombosis. The role of APLAs as a marker of thrombosis in renal recipients has not been established. We sought to determine the prevalence of APLAs in renal recipients and investigate their association with thrombosis. MATERIAL: The study included 37 renal recipients: 17 women and 20 men of ages 22-69 years. The 2 subgroups were one of patients without (n = 27; T-) and a second, with a history of severe thrombosis (n = 10; T+) subgroups, We determined lupus anticoagulant (coagulation methods) and anticardiolipin antibodies (ACL), anti-Beta2GlicoproteinI antibodies (anti-B2GPI), antiprothrombin antibodies (anti-PT) in immunoglobulin (Ig)G and IgM isotype using enzyme-linked immunosorbent assay. The determinations were made twice at a 6-months interval. The mean duration of follow-up was 12 months. RESULTS: The most commonly detected antibodies were anti-ß2GPI IgM (16.22%) and aCL IgG (13.8%). No differences were identified when the prevalence APLA was compared between T- and T+. A significant correlation was found between anti-ß2GPI IgM and aCL IgM (P = .0328); anti-ß2GPI IgM and aCL IgG (P = .0198) and aCL IgM and aCL IgG (P = .0252). No differences in serum creatinine were observed between the T- and T+ cohorts. During the follow-up, 2 female patients in the T+ produced APLAs and were treated with low-molecular-weight heparin. During follow-up one patient developed thrombosis (TMA), which led to graft loss. The other patient with normal renal graft function did not experience a recurrence of thrombosis. CONCLUSIONS: The prevalence of APLAs in renal transplant recipients was higher than in the general population. The study did not demonstrate any predictive value of APLAs as markers of thrombosis in renal recipients. Routine determination of APLAs is not necessary in all transplant recipients.

Is severe atherosclerosis in the aortoiliac region a contraindication for kidney transplantation?

BACKGROUND: Atherosclerosis is common in end-stage renal disease patients on dialysis. However, it has previously been considered to be a relative contraindication to kidney transplantation. Currently, patients with extended indications are accepted onto the waiting list, including those with severe atherosclerosis. These patients require vascular procedures before or during kidney transplantation. The aim of this study was to present our experience with vascular reconstruction before kidney transplantation. MATERIAL AND METHODS: Twelve atherosclerotic, uremic patients referred to be candidates for kidney transplantation were refused because of occlusive lesions of the iliac arteries or the distal aorta. The 10 males and 2 females had an age range of 45 to 68 years. Preoperative assessments consisted of a Doppler ultrasound and an angio computed tomography scan. The reconstructions were performed with aorto-biliac, aorto-bifemoral, or ilio-femoral dacron grafts in 7, 4, and 1 patient, respectively, under general anesthesia. RESULTS: There were no major postoperative complications; the patients were discharged and placed on a special waiting list. Eight patients received kidney allografts, including one living-related transplantation. All procedures were performed with arterial anastomosis of the transplanted kidney to the side of the prosthesis. No patient developed signs of arterial graft infection. In the postoperative period, there were no arterial or transplanted kidney-related complications, except for delayed graft function in four cases. The remaining four patients are still on the waiting list. CONCLUSION: In end-stage renal disease patients with severe atherosclerosis in the aortoiliac region, vascular reconstruction allows kidney transplantation.

Dietary supplements and herbal preparations in renal and liver transplant recipients.

BACKGROUND: Dietary supplements (DS) and herbal preparations (HP) are advertised to be safe and have therapeutic potential. They are sold over the counter. Therefore, a considerable increase in the frequency of their use has been observed; for example in the United States one in four persons taking medicines uses DS. The use of DS and HP in renal and liver transplant recipients remains unknown. OBJECTIVES: The aim of our study was to determine the proportion of patients who used DS or HP, as well as to assess their awareness of the benefits and risks related to ingestion of these products. METHODS: We enrolled 100 renal, liver, or combined renal and heart transplant patients into the study. They underwent a survey consisting of 14 multiple-choice questions, concerning demographic features, transplant-related data, and information about the use of DS and HP, including the frequency of use, the reasons for the purchase, the knowledge of risks and benefits, as well as the sources of information about these products. RESULTS: Among the 58 (58%) patients who admitted their use of DS and/or HP, 20 (34.5%) ingested more than one preparation. Among liver patients, 51%, and among renal, 44%, of patients took these products for a variety of indications. Vitamins, minerals, diuretics, gastrointestinal tract-regulating, and sedative herbs were chosen most frequently. While 27% of respondents alleged to have obtained the information on DS and HP from a physician, 14% were from a pharmacist, 9% from a friend, acquaintance or neighbor, 8% from an attached leaflet, 4% from an advertisement, and 4% from the internet. CONCLUSIONS: A high proportion of patients use DS and HP. Most preparations were taken without medical consultation. Awareness of their toxicity or drug interactions was low. Therefore, a tailored education program should be proposed for this group of patients.

Lymphocyte counts in kidney allograft recipients are associated with IMPDH2 3757T>C gene polymorphism.

Inosine monophosphate dehydrogenase (IMPDH), the rate-limiting enzyme for de novo synthesis of guanine nucleotides, is required for lymphocyte proliferation. Inhibition of IMPDH by mycophenolic acid (MPA) constitutes part of an immunosuppressive therapy in kidney allograft recipients. The 3757T>C polymorphic variant (rs11706052) of the IMPDH2 gene, which encodes 1 of 2 IMPDH isoenzymes, has been associated with increased IMPDH activity and reduced ability of MPA to exert antiproliferative effects on lymphocytes. The association of IMPDH2 3757T>C SNP with posttransplant courses of kidney allograft recipients remains unclear. Therefore, the aim of the present study was to evaluate associations between this single nucleotide polymorphism and common posttransplant complications among Polish kidney allotransplant recipients. We observed that the frequency of IMPDH2 3757C allele in this group (n=177) did not differ significantly from a control cohort representing the background population of Poland (n=550). There were no significant differences between patients carrying the IMPDH2 3757CT and TT genotypes with respect to acute rejection risk, neutropenia, or incidences of serious infections or gastrointestinal side effects. However, we noted that the 3757C allele was associated with higher lymphocyte counts and a reduced incidence of lymphopenia among kidney allograft recipients. Our findings may be of practical significance to tailor immunosuppressive regimens in kidney transplant recipients.

Influence of simultaneous pancreas and preemptive kidney transplantation on severity of postoperative complications.

BACKGROUND: Simultaneous pancreas and preemptive kidney transplantation (SPpreKT) seems to be the optimal treatment for the patients with diabetes type 1 who are progressing to end-stage renal disease. On the other hand, surgical complications with a high rate of relaparatomy are a limiting factor in pancreas transplantation. OBJECTIVE: Comparison of severity of surgical complications was performed between a group of preemptive (SPpreKT group) and nonpreemptive recipients of SPKT (SPKT group). METHODS: Between 1988 and 2010, we performed 112 SPKTs including 25 preemptive recipients (22.3%). The SPKT Group included 87 recipients (77.7%). The severity of complications was classified according to a modified Clavien scale: grade I, no complication; grade II, drug therapy; grade IIIA, invasive intervention not requiring general anesthesia; grade IIIB, invasive intervention requiring general anesthesia; grade IVA, graft failure; and grade IVB, death. RESULTS: Among the SPpreKT group, 64% of recipients were free from postoperative complications compared with 40.3% of the SPKT group (P<.01). Among the SPKT group, 52 recipients (59.7%) developed 58 postoperative complications, including 15 (17.3%) deaths due to graft pancreatitis (80%) or pancreatic fistula (20%). Among the SPpreKT group, 9 recipients developed 9 complications. None of the preemptively transplanted group subjects experienced a lethal complication. Among the SPpreKT group, the most severe complication was graft pancreatitis leading to graft removal in 2 recipients. CONCLUSIONS: Recipients of preemptive SPKT developed significantly fewer postoperative complications, especially deaths. However the rates of mild (II, IIIA) and moderate (IIIB) complications as well as graft failures (IVA) were similar to the nonpreemptive group.

Vascular access for haemodialysis in patients with central vein thrombosis.

OBJECTIVES: Dialysis-dependent patients often have central venous drainage complications. In patients with functioning arm arteriovenous fistula, this may result in venous hypertension, arm oedema and vascular access failure. Percutaneous angioplasty and stent implantation might be inadequate to resolve these issues. In these cases, new access can potentially be created with anastomosis to the subclavian vein, iliac vein or vena cava or by making a veno-venous graft to bypass the thrombosis. The aim of this study was to assess the utility of unusual bypasses in vascular access in patients with the central vein thrombosis. MATERIALS: A total of 49 patients were treated. The mean number of previous vascular access surgery procedures was 7.6 (3-17). We performed 19 axillo-iliac, 14 axillo-axillary bypasses and 16 conduits from the arm fistula to the jugular (nine conduits) or subclavian (seven conduits) vein for haemodialysis purposes. RESULTS: All fistulas except one were used for haemodialysis. One patient died before the first use of the fistula. At 12 months, the primary, primary assisted and secondary patency rates were 85.4%, 89.6% and 95.8%, respectively. The follow-up period ranged from 1 to 84 months. CONCLUSION: Unusual grafts are an efficient option as a permanent vascular access for haemodialysis purposes in patients with central vein occlusion.

Use of high-dose human immune globulin in highly sensitized patients on the kidney transplant waiting list: one center's experience.

INTRODUCTION: Transplant rates are low among highly sensitized patients with preformed anti-HLA antibodies, because of the additional immunologic barrier, the increased risk of rejection, and the greater chance of early graft loss. Intravenous infusion of pooled human immune globulin (IVIG) is immunomodulatory, neutralizing circulating antibodies and reducing rejection rates, two factors that may improve long-term transplantation outcomes. METHODS: We selected for high-dose IVIG treatment (1 g/kg monthly for 4 months) 10 adult, stage V, highly HLA-sensitized (PRA, historical >80% and current 56%-100%) chronic kidney disease patients listed for kidney transplantation with a mean waiting time of 7.5 years. They spanned age of 29-52 years. Anti-HLA titers were monitored monthly before each treatment and 1 month after the last IVIG dose; afterwards, patients were placed on an urgent list and followed for their transplant renal function and rejection episodes. RESULTS: Although 1 subject was transplanted after the first dose of IVIG, 9 patients completed the study, but their PRA decreased only insubstantially, namely, 14.4% (range, 8%-28%). During 6-12 months follow-up, 6 patients were considered for transplantation (negative crossmatch); 5 received kidneys and 1 was disqualified due to infection. The recipients were treated with antithymocyte globulin (n = 3) or basiliximab (n = 2) as well as tacrolimus/mycophenolate/steroids for baseline immunosuppression. Protocol biopsies (months 1, 3, and 6) in 4 patients (1 denied consent) revealed subclinical acute rejection and C4d positivity in most cases, either repeatedly or in the final biopsy. However at 6-12 months the mean serum creatinine concentration averaged 1.5 +/- 0.4 mg/dL. CONCLUSION: High-dose human IVIG reduced PRA poorly, but short-term transplantation outcomes were encouraging. Surveillance biopsies are advised for sensitized kidney recipients due to the frequent appearance of rejection, particularly of the antibody mediated type.

Safety and tolerance of sodium mycophenolate in patients after renal transplantation--an observational study.

BACKGROUND: Enteric-coated mycophenolate sodium (EC-MPS) was developed as an alternative agent to mycophenolate mofetil (MMF), aimed at reduction of gastrointestinal (GI) complications. METHODS: Seventy-four patients (mean age 42.3 years) switched from MMF to MPS were included in the study and followed-up for 3 months (Visit 0, Visit 2 after 1 month and Visit 3 after 3 months). The mean time from transplantation to switch was 3.7 years. During Visit 2 and 3 the following were recorded: impact of treatment change on the severity of GI symptoms (4 point scale: 1-worsening, 2-no change, 3-improvement, 4-resolution), EC-MPS tolerance, adverse events (AEs), patient compliance and physician satisfaction with treatment (4 point scale: 1-bad, 2-fair, 3-good, 4-very good). RESULTS: Sixty-three patients completed the study (85.1%). EC-MPS dose ranged from 720 to 1440 mg. GI symptom severity score averaged at 3.41. Symptoms most commonly compelling a conversion were: abdominal pain, diarrhea, abdominal colic, nausea, anorexia and vomiting. Out of 175 complaints, 144 (82%) either improved or resolved, 5 (2.86%) aggravated, and 25 (14.86%) persisted. Patient compliance and mean physician satisfaction score averaged at 3.70 and 3.02 at Visit 3, respectively. 9 AEs (2 severe) were reported. Causal relationship with the medication was suspected in 5 cases (1 case of SAE). The most common AEs were: anemia, infection (including sepsis), GI symptoms (abdominal pain, diarrhea). CONCLUSIONS: The following was concluded in our study: (1) sodium mycophenolate is well tolerated; (2) after switching from MMF to EC-MPS, gastrointestinal symptoms alleviated; (3) EC-MPS is a safe medication, with a low adverse events rate.

Serum 1-84 and 7-84 parathyroid hormone concentrations and bone in patients with primary hyperparathyroidism.

BACKGROUND AND AIMS: Parathyroid hormone (PTH) acts on bone as both anabolic and catabolic factor. It includes two fractions: 1-84 (cyclase activating PTH, CAP) which increases bone turnover and serum calcium, and 7-84 (cyclase inactivating PTH, CIP) acting the opposite way. The aim of this study was to establish whether bone mineral density (BMD) and turnover in patients' primary hyperparathyroidism (HPT) are dependent on CAP and CIP concentrations. PATIENTS/METHODS: Thirty-one patients with HPT and 29 appropriately matched controls were examined. Parameters of calcium-phosphate homeostasis and BMD were estimated. RESULTS: BMD of radius shaft was lower in patients with HPT as compared with controls, whereas BMD of spine and ultradistal radius were similar. Serum calcium, bone alkaline phosphatase, total PTH, 1-84 PTH, and 7-84 PTH were higher in HPT patients, whereas serum phosphate was lower and beta cross-laps similar. Both total PTH and CAP correlated significantly with BMD of radius shaft and serum calcium concentration, but not with other examined parameters. CONCLUSION: Total and 1-84 PTH are similarly associated with examined parameters in patients with HPT. Thus, determination of serum CAP concentration does not seem to have advantages over total PTH with regard to bone mineral density and bone turnover assessment in those patients.