BACKGROUND: Skeletal muscle alterations are associated with higher mortality and morbidity in patients with liver cirrhosis. Assessing these changes seems to be a promising method for identifying patients at a high risk of poor outcomes following liver transplantation (LT). This is particularly important given the current global shortage of organ donors. However, evidence of the impact of these alterations on the prognosis of patients undergoing LT is inconclusive. The aim of our prospective study was to evaluate the impact of skeletal muscle changes, reflected in sarcopenia, myosteatosis and metabolic changes in the calf muscles, on perioperative outcomes and long-term survival after LT. We also sought to determine the posttransplant evolution of the resting muscle metabolism. METHODS: We examined 134 adult LT candidates. Of these, 105 underwent LT. Sarcopenia and myosteatosis were diagnosed by measuring the skeletal muscle index and mean psoas muscle radiation attenuation, respectively, which were obtained from computed tomography (CT) scans taken during pretransplant assessment. Additionally, patients underwent 31P MR spectroscopy (MRS) of the calf muscles at rest before LT and 6, 12 and 24 months thereafter. The median follow-up was 6 years. RESULTS: Patients with abnormal 31P MRS results and CT-diagnosed myosteatosis prior to LT had significantly worse long-term survival after LT (hazard ratio (HR), 3.36; 95% confidence interval (CI), 1.48-7.60; p = 0.0021 and HR, 2.58; 95% CI, 1.06-6.29; p = 0.03, respectively). Multivariable analysis showed that abnormal 31P MR spectra (HR, 3.40; 95% CI, 1.50-7.71; p = 0.003) were a better predictor of worse long-term survival after LT than myosteatosis (HR, 2.78; 95% CI, 1.14-6.78; p = 0.025). Patients with abnormal 31P MR spectra had higher blood loss during LT (p = 0.038), required a higher number of red blood cell transfusions (p = 0.006) and stayed longer in ICU (p = 0.041) and hospital (p = 0.007). Myosteatosis was associated with more revision surgeries following LT (p = 0.038) and a higher number of received red blood cell transfusion units (p = 0.002). Sarcopenia had no significant effect on posttransplant patient survival. An improvement in the resting metabolism of the calf muscles was observed at 12 and 24 months after LT. CONCLUSIONS: Abnormal 31P MRS results of calf muscles were superior to CT-based diagnosis of myosteatosis and sarcopenia in predicting perioperative complications and long-term survival after LT. Resting muscle metabolism normalized 1 year after LT in most recipients.
- MeSH
- dospělí MeSH
- kosterní svaly * diagnostické zobrazování metabolismus MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetická rezonanční spektroskopie * metody MeSH
- počítačová rentgenová tomografie * metody MeSH
- prognóza MeSH
- prospektivní studie MeSH
- sarkopenie etiologie metabolismus MeSH
- senioři MeSH
- transplantace jater * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) is an established treatment for achalasia with compelling midterm efficacy. In this study, we analyzed the long-term efficacy, sought predictors of failure, and comprehensively assessed post-POEM reflux. METHODS: We performed a retrospective analysis of a prospective database of patients undergoing POEM at a high-volume center from December 2012 to June 2023. Patients who had completed a 3-month follow-up were included. Efficacy was assessed at 3, 6, and 8 years using the Eckardt score (ES). An ES ≤2 was considered treatment success. At 3 months, gastroscopy, manometry, 24-hour pH monitoring, and fluoroscopy were performed, and gastroscopy was repeated at 2 and 3 years. At each visit, patients were assessed for reflux symptoms and quality of life. RESULTS: From 496 included patients, 3-, 6-, and 8-year follow-ups were completed in 302, 115, and 40 patients, respectively. The treatment success rates at 3, 6, and 8 years according to the Kaplan-Meier analysis were 90.2% (95% confidence interval [CI], 87.2-93.3), 82.3% (95% CI, 77.3-87.6), and 73.5% (95% CI, 64.8-83.5), respectively. Year of procedure was the only predictor of outcome. Fifty-three patients (10.7%) encountered failure or recurrence. Treatment success of redo-POEM (n = 20) at 1 year was significantly lower (62.9% [95% CI, 44.3-89.2] vs 96.9% [95% CI, 95.3-98.5], P < .001). At 3 months, 40.4% of patients had reflux esophagitis (RE), 43.6% of patients had an acid exposure time >4.5%, 39.2% of patients were using proton pump inhibitors (PPIs), but only 24.2% had reflux symptoms. At 2 to 3 years, 50.8% of patients took PPIs, whereas 39.6% were symptomatic. RE decreased to 20.2% at 6 years. CONCLUSIONS: The treatment success of POEM declines over time but remains sufficiently high in the long term. Experience with the procedure improves the outcome. Gastroesophageal reflux affects almost half of patients early after POEM and decreases substantially over time together with a rise in PPI use.
- MeSH
- achalázie jícnu * chirurgie patofyziologie MeSH
- časové faktory MeSH
- centra terciární péče MeSH
- dolní jícnový svěrač * chirurgie MeSH
- dospělí MeSH
- endoskopické operace přirozenými otvory * metody MeSH
- fluoroskopie MeSH
- gastroezofageální reflux * etiologie epidemiologie MeSH
- gastroskopie MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- manometrie MeSH
- monitorování jícnového pH MeSH
- následné studie MeSH
- pooperační komplikace * epidemiologie MeSH
- pyloromyotomie * metody MeSH
- recidiva MeSH
- retrospektivní studie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: In women with severe aortic stenosis, there are limited data regarding outcome differences following transcatheter (TAVR) vs surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to examine outcomes of TAVR vs SAVR in a patient-level pooled analysis of women in the RHEIA and PARTNER 3 trials. METHODS: Patients in both trials were randomly allocated to a balloon-expandable SAPIEN 3/Ultra valve or to surgical bioprostheses. Individual patient data of female participants in the 2 trials were pooled. The primary endpoint was all-cause mortality, all stroke, or rehospitalization at 1 year. RESULTS: A total of 376 women were randomized to TAVR and 336 to SAVR. The mean age was ∼73 years, and the mean Society of Thoracic Surgeons (STS) score was 2.1%. Kaplan-Meier estimates of event rates at 1 year with TAVR vs SAVR were 8.5% vs 16.8% for the composite of all-cause mortality, all stroke, or rehospitalization (absolute difference -8.2%; 95% CI: -13.1% to -3.3%; P < 0.001), 1.1% vs 2.1% (P = 0.27) for all-cause mortality, 2.7% vs 3.9% (P = 0.35) for all stroke, and 5.4% vs 11.9% (P = 0.002) for rehospitalization. The composite endpoint of all-cause death or stroke was similar between the 2 treatment groups: 3.5% vs 5.4% (absolute difference -1.9%; 95% CI: -5.0% to 1.1%; P = 0.21). CONCLUSIONS: Among women with symptomatic severe aortic stenosis, TAVR led to a reduction in the rate of the combined endpoint of all-cause mortality, stroke, or rehospitalization at 1-year follow-up, largely due to a significant reduction in the rate of rehospitalization.
- MeSH
- aortální chlopeň * chirurgie patofyziologie diagnostické zobrazování MeSH
- aortální stenóza * mortalita chirurgie patofyziologie diagnostické zobrazování MeSH
- bioprotézy MeSH
- časové faktory MeSH
- cévní mozková příhoda mortalita etiologie terapie MeSH
- chirurgická náhrada chlopně * škodlivé účinky mortalita přístrojové vybavení MeSH
- hodnocení rizik MeSH
- lidé MeSH
- protézy - design MeSH
- randomizované kontrolované studie jako téma MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sexuální faktory MeSH
- srdeční chlopně umělé MeSH
- stupeň závažnosti nemoci MeSH
- transkatetrální implantace aortální chlopně * škodlivé účinky mortalita přístrojové vybavení MeSH
- výsledek terapie MeSH
- znovupřijetí pacienta MeSH
- Check Tag
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
BACKGROUND AND AIMS: Although women with severe symptomatic aortic stenosis have more complications than men when undergoing surgical valve replacement, they are under-represented in clinical trials. The Randomized researcH in womEn all comers wIth Aortic stenosis (RHEIA) trial investigates the balance of benefits and risks of transcatheter aortic valve implantation (TAVI) vs. surgery in women. METHODS: Women were randomized 1:1 to transfemoral TAVI with a balloon-expandable valve or surgery. The primary composite endpoint was death, stroke, or (valve, procedure or heart failure related) rehospitalization at 1 year. Non-inferiority testing with a pre-specified 6% margin and superiority testing were performed in the as-treated population. RESULTS: At 48 European centres, 443 women underwent randomization, and 420 were treated as randomized. Mean age was 73 years, and the mean estimated surgical risk of death was 2.1% (Society of Thoracic Surgeons risk score). Kaplan-Meier estimates of the primary endpoint event rates at 1 year were 8.9% in the TAVI and 15.6% in the surgery group. This difference of -6.8% with an upper 95% confidence limit of -1.5% demonstrated the non-inferiority of TAVI (P < .001). The two-sided 95% confidence interval of -13.0% to -.5% further resulted in superiority (P = .034). The 1-year incidence of the primary endpoint components was: .9% with TAVI vs. 2.0% with surgery for death from any cause, 3.3% vs. 3.0% for stroke, and 5.8% vs. 11.4% for rehospitalization. CONCLUSIONS: Among women with severe aortic stenosis, the incidence of the composite of death, stroke, or rehospitalization at 1 year was lower with TAVI than with surgery. CLINICALTRIALS.GOV NUMBER: NCT04160130.
- MeSH
- aortální chlopeň * chirurgie MeSH
- aortální stenóza * chirurgie mortalita MeSH
- cévní mozková příhoda etiologie epidemiologie MeSH
- chirurgická náhrada chlopně * metody mortalita škodlivé účinky MeSH
- lidé MeSH
- pooperační komplikace mortalita epidemiologie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční chlopně umělé MeSH
- transkatetrální implantace aortální chlopně * metody mortalita škodlivé účinky MeSH
- výsledek terapie MeSH
- znovupřijetí pacienta statistika a číselné údaje MeSH
- Check Tag
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
Intravenous immunoglobulins (IVIG) are commonly used in peri-transplant desensitization, but evidence supporting their efficacy is limited. We conducted a prospective, randomized single-center, open-label, Phase IIIb non-inferiority clinical pilot trial to compare the efficacy of IVIG (administered at a dose of 3 × 0.5 g/kg) versus no IVIG, in conjunction with rabbit anti-thymocyte globulin (5-7 mg/kg) induction, in pre-sensitized patients with donor-specific antibodies who had negative pre-transplantation Flow- and CDC-crossmatches, between July 2020 and November 2022. The primary endpoint was the rate of efficacy failure, defined as biopsy-proven rejection within 12-month post-transplant. Secondary endpoints included the incidence of rejection at protocol biopsies, evaluated by histology and biopsy-based transcripts diagnostics. Of the screened patients, 53 (72.6%) were excluded due to crossmatch positivity. Ten patients were randomized to the IVIG+, and 7 to the IVIG-arm. The trial was prematurely terminated due to futility at interim analysis. In the IVIG-arm, 3 patients (43%) experienced the primary endpoint compared to none in the IVIG+ arm (p = 0.026). MMDx identified one molecular ABMR in the IVIG+ and 2 in the IVIG-arm in 12-month protocol biopsies. There was one graft loss in the IVIG-arm. The results of this pilot study, although not definitive, do not support the use of IVIG-sparing regimens in HLA-incompatible kidney transplantation (NCT04302805). This study is registered on ClinicalTrials.gov under the identifier NCT04302805.
- MeSH
- antilymfocytární sérum * aplikace a dávkování MeSH
- desenzibilizace imunologická * metody MeSH
- dospělí MeSH
- intravenózní imunoglobuliny * aplikace a dávkování MeSH
- lidé středního věku MeSH
- lidé MeSH
- pilotní projekty MeSH
- prospektivní studie MeSH
- rejekce štěpu * prevence a kontrola imunologie MeSH
- transplantace ledvin * škodlivé účinky MeSH
- výsledek terapie MeSH
- zvířata MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Effective diabetes management requires a multimodal approach involving lifestyle changes, pharmacological treatment, and continuous patient education. Self-management demands can be overwhelming for patients, leading to lowered motivation, poor adherence, and compromised therapeutic outcomes. In this context, digital health apps are emerging as vital tools to provide personalized support and enhance diabetes management and clinical outcomes. OBJECTIVE: This study evaluated the impact of the digital health application Vitadio on glycemic control in patients with type 2 diabetes mellitus (T2DM). Secondary objectives included evaluating its effects on cardiometabolic parameters (weight, BMI, waist circumference, blood pressure, and heart rate) and self-reported measures of diabetes distress and self-management. METHODS: In this 6-month, 2-arm, multicenter, unblinded randomized controlled trial, patients aged 18 years or older diagnosed with T2DM were randomly assigned (1:1) to an intervention group (IG) receiving standard diabetes care reinforced by the digital health app Vitadio or to a control group (CG) provided solely with standard diabetes care. Vitadio provided a mobile-based self-management support tool featuring educational modules, motivational messages, peer support, personalized goal setting, and health monitoring. The personal consultant was available in the app to provide technical support for app-related issues. The primary outcome, assessed in the intention-to-treat population, was a change in glycated hemoglobin (HbA1c) levels at 6 months. Secondary outcomes included changes in cardiometabolic measures and self-reported outcomes. Data were collected in 2 study centers: diabetologist practice in Dessau-Roßlau and the University of Dresden. RESULTS: Between November 2022 and June 2023, a total of 276 patients were screened for eligibility, with 149 randomized to in intervention group (IG; n=73) and a control group (CG; n=76). The majority of participants were male (91/149, 61%). The dropout rate at month 6 was 19% (121/149). While both groups achieved significant HbA1c reduction at 6 months (IG: mean -0.8, SD 0.9%, P<.001; CG: mean -0.3, SD 0.7%, P=.001), the primary confirmatory analysis revealed statistically significant advantage of the IG (adjusted mean difference: -0.53%, SD 0.15, 95% CI -0.24 to -0.82; P<.001; effect size [Cohen d]=0.67, 95% CI 0.33-1). Significant between-group differences in favor of the IG were also observed for weight loss (P=.002), BMI (P=.001) and systolic blood pressure (P<.03). In addition, Vitadio users experienced greater reduction in diabetes-related distress (P<.03) and obtained more pronounced improvements in self-care practices in the areas of general diet (P<.001), specific diet (P<.03), and exercise (P<.03). CONCLUSIONS: This trial provides evidence for the superior efficacy of Vitadio in lowering the HbA1c levels in T2DM patients compared to standard care. In addition, Vitadio contributed to improvements in cardiometabolic health, reduced diabetes-related distress, and enhanced self-management, highlighting its potential as an accessible digital tool for comprehensive diabetes management. TRIAL REGISTRATION: German Clinical Trials Registry DRKS00027405; https://drks.de/search/de/trial/DRKS00027405.
- MeSH
- diabetes mellitus 2. typu * krev terapie MeSH
- dospělí MeSH
- glykovaný hemoglobin analýza MeSH
- lidé středního věku MeSH
- lidé MeSH
- mobilní aplikace * MeSH
- péče o sebe MeSH
- self-management MeSH
- senioři MeSH
- telemedicína MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
Kazuistika představuje pacienta s roztroušenou sklerózou, který byl nejprve léčen pro izolovanou monokulární poruchou visu, a to kortikosteroidy s dobrým účinkem, následně žádné potíže neměl a dostavil se v důsledku nových klinických příznaků po 15 letech k neurologickému vyšetření, které na základě klinických a laboratorních vyšetření prokázalo definitivní diagnózu relabující formy roztroušené sklerózy. Na základě zahájení adekvátní imunomodulační léčby se podařilo onemocnění stabilizovat.
The case report presents a patient with multiple sclerosis who was initially treated for an isolated visual impairment in one eye. This condition was managed with corticosteroids, which proved effective. Subsequently, the patient had no further issues and presented for a neurological examination with after 15 years. Based on clinical and laboratory findings, a definitive diagnosis of the relapsing form of multiple sclerosis was established. With the initiation of appropriate immunomodulatory treatment, the disease was successfully stabilized.
- Klíčová slova
- ozanimod,
- MeSH
- lidé středního věku MeSH
- lidé MeSH
- modulátory receptorů sfingosin-1-fosfátu farmakologie terapeutické užití MeSH
- relabující-remitující roztroušená skleróza * diagnóza farmakoterapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
OBJECTIVE: Diabetic foot (DF), especially DF ulcers (DFUs) are a relatively frequent and financially burdensome late-stage complication of diabetes. However, data on the costs of podiatric care in the Czech Republic are scarce. The aim of this prospective multicenter study was to determine the total costs associated with long-term podiatric care in selected foot clinics across the Czech Republic. RESEARCH DESIGN AND METHODS: A total of 119 patients with DFUs (mean age of 68 ± 11 years, diabetes duration of 19 ± 11 years, HbA1c level of 62 ± 14 mmol/mol, composite WIfI score of 3 ± 2, 33 % had new DFUs, 37 % previous amputations, and 50 % had peripheral artery disease (PAD)) from 10 podiatric foot clinics in the Czech Republic were enrolled in our financial analysis. Direct and indirect costs associated with podiatric care - diagnostic and treatment methods - including angiological, radiological, and microbiological examinations, blood sampling, prescribed materials for local therapy, antibiotics, surgical procedures, offloading devices, hospital services and additional expenses such as patient transportation, doctors' visits, home care assistance, and work incapacity - were monitored over a 6-month period using an electronic database. RESULTS: The average cost of podiatric care per patient over a 6-month period was €2,506 with median €1,320. The largest expenses were spent on therapeutic procedures (51.4 %). Costs for patients hospitalized during the study period were significantly higher than for outpatients (€7,923 vs. €1,304 on average; P < 0.001). Among hospitalized patients, the main costs were hospital services (32 %), therapeutic procedures (26 %), and antibiotic and local therapies (20 %). Among outpatients, therapeutic procedures accounted for 74 % of the total costs. Newly developed DFUs or PAD were not linked to significantly increased costs. The composite WIfI score, primarily the wound component, was the only parameter that significantly positively correlated with the total podiatric costs (r = 0.434; 95 % CI 0.279-0.559; P < 0.0001). Other patient characteristics such as age, diabetes duration, DFU duration, and HbA1c level did not show significant cost correlations. CONCLUSIONS: On average, podiatric care for patients with DFUs in the Czech Republic is 3 to 9 times more expensive than standard diabetes healthcare. The expenses for hospitalized patients are almost 6 times higher than for outpatients. The composite WIfI score was the most significant indicator of podiatric financial burden.
- MeSH
- diabetická noha * ekonomika terapie epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- náklady na zdravotní péči * MeSH
- osobní újma zaviněná nemocí * MeSH
- podiatrie * ekonomika MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Česká republika MeSH