ABSTRACT
BACKGROUND: Cardiovascular diseases and (infarct-related) cardiogenic shock are among the most frequent causes of death in Germany. Adequate clinical care often poses great challenges for hospitals. The complex care of patients in a multi-professional team places high demands on all those involved in the care process. Since nurses in particular are in close contact with patients and play a decisive role in shaping and controlling therapy, a national (intensive) care guideline is urgently needed. METHODS: Within the framework of the guideline programme of the Association of the Scientific Medical Societies in Germany (AWMF), an S1 guideline was developed with the participation of six professional societies and published in May 2022. The guideline group defined relevant topics, which were processed through a systematic literature search in peer-reviewed journals. Based on the S1 classification, no separate evidence review was conducted. A formal consensus-building process was used to classify the recommendations. RESULTS: The guideline contains 36 recommendations ranging from nursing care in the central emergency department to the cardiac catheterisation laboratory, intensive care unit and follow-up care. In addition, recommendations are made on the necessary qualifications and structural requirements in the respective areas in order to ensure a high-quality (nursing) care process. CONCLUSION: This is the first national intensive care guideline. It is aimed at nurses involved in the care of patients with (infarct-related) cardiogenic shock. The guideline is valid until 30.12.2026.
Subject(s)
Critical Care , Shock, Cardiogenic , Germany , Humans , Peer Review , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/therapy , Societies, MedicalABSTRACT
PURPOSE: To investigate focal therapy using High Intensity Focused Ultrasound (HIFU) for the treatment of localized prostate cancer (CaP), we analyzed the safety and complications of this procedure. METHODS: Patients (pts) eligible for this multicenter prospective cohort study suffered from low to intermediate risk localized CaP with no prior treatment. After tumor identification on multiparametric MRI and in prostate biopsy, the lesions were treated with HIFU observing a safety margin of 8 to 10 mm. Adverse events (AE) after 30 and 90 days, as well as the required interventions were assessed and stratified for treatment localizations. RESULTS: Of the 98 men included in the study in two European centers, 35 (35.7%) experienced AEs in the first 30 days after HIFU intervention with Clavien-Dindo grade ≤ II: 15 pts (15.3%) had a postoperative urinary tract infection and 26 pts (26.5%) a urinary retention. Four pts (4.1%) underwent subsequent intervention (Clavien-Dindo grade IIIa/b). The number of late postoperative complications occurring between 30 and 90 days after intervention was low (2.0%). The highest complication rate was associated with tumors located at the anterior base (50.0%). The inclusion of the urethra in the ablation zone led to AEs in 20 out of 41 cases (48.8%) and represented a significant risk factor for complications within 30 days (odds ratioâ¯=â¯2.53; 95% confidence interval: 1.08-5.96; Pâ¯=â¯0.033). CONCLUSIONS: Focal therapy of CaP lesions with a robotic HIFU-probe is safe and renders an acceptable rate of minor early AEs. The inclusion of the urethra in the ablation zone leads to an increase in early complications and should be avoided whenever possible.
Subject(s)
Prostatic Neoplasms/diagnostic imaging , Ultrasound, High-Intensity Focused, Transrectal/methods , Aged , Cohort Studies , Humans , Male , Middle Aged , Prospective Studies , Prostatic Neoplasms/pathology , Treatment OutcomeABSTRACT
PURPOSE: Irreversible electroporation (IRE) is a new potential ablation modality for small renal masses. Animal experiments have shown preservation of the urine-collecting system (UCS). The purpose of this clinical study was to perform the first evaluation and comparison of IRE's effects on the renal UCS by using urinary cytology, magnetic-resonance imaging, and resection histology in men after IRE of pT1a renal-cell carcinoma (RCC). METHODS: Seven patients with biopsy-proven RCC pT1a cN0cM0 underwent IRE in a phase 2a pilot ablate-and-resect study (IRENE trial). A contrast-enhanced, diffusion-weighted MRI and urinary cytology was performed 1 day before and 2, 7, and 27 days after IRE. Twenty-eight days after IRE the tumour region was completely resected surgically. RESULTS: Technical feasibility was demonstrated in all patients. In all cases, MRI revealed complete coverage of the tumour area by the ablation zone with degenerative change. The urographic late venous MRI phase (urogram scans) demonstrated normal morphological appearances. Urine cytology showed a temporary vacuolisation of the cyto- and caryoplasmas after IRE. Whereas the urothelium showed signs of regeneration 28 days after IRE-ablation, the tumour and parenchyma below it showed necrosis and permanent tissue destruction. CONCLUSIONS: Renal percutaneous IRE appears to be a safe treatment for pT1a RCC. The preservation of the UCS with unaltered normal morphology as well as urothelial regeneration and a phenomenon (new in urinary cytology) of temporary degeneration with vacuolisation of detached transitional epithelium cells were demonstrated in this clinical pilot study.
Subject(s)
Carcinoma, Renal Cell/therapy , Electroporation/methods , Kidney Neoplasms/therapy , Urinary Tract/diagnostic imaging , Animals , Carcinoma, Renal Cell/diagnostic imaging , Carcinoma, Renal Cell/surgery , Diffusion Magnetic Resonance Imaging/methods , Humans , Kidney/diagnostic imaging , Kidney/surgery , Kidney Neoplasms/diagnostic imaging , Kidney Neoplasms/surgery , Male , Pilot Projects , Treatment OutcomeABSTRACT
A more than 100-year period, where the prostate was only seen and treated as a whole is coming to an end right now. Finally, high resolution imaging is providing deep insights and detailed information so that new therapeutic procedures can aim for the smallest targets within the gland. The long-standing wish of patients for individual noninvasive diagnostics and treatment of prostate diseases can now be fulfilled by providing new tailored concepts; however, in order to transfer the enormous amount of new information into the specific clinical patient situation, a closely knit interdisciplinary approach is required. In this setting, the traditional outpatient consultation service is overstretched in every aspect. It is now the time for new innovative constructs. The current one-sided service concept for urologists, radiologists and radiation therapists is therefore behind the times and the development of a "prostate management team" with equally cooperating partners from each specialty is the task for the future.
Subject(s)
Patient Care Team , Prostate/diagnostic imaging , Prostatic Neoplasms/diagnostic imaging , Prostatic Neoplasms/therapy , Radiologists , Urologists , Humans , Magnetic Resonance Imaging , MaleABSTRACT
The tyrosine kinase inhibitor sunitinib is used as first-line therapy in patients with metastasized renal cell carcinoma (mRCC), given in fixed-dose regimens despite its high variability in pharmacokinetics (PKs). Interindividual variability of drug exposure may be responsible for differences in response. Therefore, dosing strategies based on pharmacokinetic/pharmacodynamic (PK/PD) models may be useful to optimize treatment. Plasma concentrations of sunitinib, its active metabolite SU12662, and the soluble vascular endothelial growth factor receptors sVEGFR-2 and sVEGFR-3, were measured in 26 patients with mRCC within the EuroTARGET project and 21 patients with metastasized colorectal cancer (mCRC) from the C-II-005 study. Based on these observations, PK/PD models with potential influence of genetic predictors were developed and linked to time-to-event (TTE) models. Baseline sVEGFR-2 levels were associated with clinical outcome in patients with mRCC, whereas active drug PKs seemed to be more predictive in patients with mCRC. The models provide the basis of PK/PD-guided strategies for the individualization of anti-angiogenic therapies.
Subject(s)
Antineoplastic Agents/pharmacology , Antineoplastic Agents/pharmacokinetics , Indoles/pharmacology , Indoles/pharmacokinetics , Models, Biological , Protein Kinase Inhibitors/pharmacology , Protein Kinase Inhibitors/pharmacokinetics , Pyrroles/pharmacology , Pyrroles/pharmacokinetics , ATP Binding Cassette Transporter, Subfamily B/genetics , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/blood , Antineoplastic Agents/therapeutic use , Carcinoma, Renal Cell/blood , Carcinoma, Renal Cell/drug therapy , Carcinoma, Renal Cell/genetics , Colorectal Neoplasms/blood , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/genetics , Cytochrome P-450 CYP3A/genetics , Female , Genotype , Humans , Indoles/blood , Indoles/therapeutic use , Interleukin-8/genetics , Kidney Neoplasms/blood , Kidney Neoplasms/drug therapy , Kidney Neoplasms/genetics , Male , Middle Aged , Polymorphism, Single Nucleotide , Protein Kinase Inhibitors/blood , Protein Kinase Inhibitors/therapeutic use , Pyrroles/blood , Pyrroles/therapeutic use , Sunitinib , Treatment Outcome , Vascular Endothelial Growth Factor A/genetics , Vascular Endothelial Growth Factor Receptor-2/blood , Vascular Endothelial Growth Factor Receptor-2/genetics , Vascular Endothelial Growth Factor Receptor-3/blood , Vascular Endothelial Growth Factor Receptor-3/geneticsABSTRACT
BACKGROUND: In patients with low-risk prostate cancer (PCa) the standard therapies carry a risk of overtreatment with potentially preventable side effects whereas restrained therapeutic strategies pose a risk of underestimation of the individual cancer risk. Alternative treatment options include thermal ablation strategies such as high-intensity focused ultrasound (HIFU). PATIENTS AND METHODS: 96 patients with low-risk PCa (D'Amico) were treated at 2 HIFU centres with different expertise (n=48, experienced centre Lyon/France; n=48 inexperienced centre Charité Berlin/Germany). Matched pairs were formed and analysed with regard to biochemical disease-free survival (BDFS) as well as postoperative functional parameters (micturition, erectile function). The matched pairs were discriminated as to whether they had received HIFU treatment alone or a combination of HIFU with transurethral resection of the prostate (TURP). Patients of the Lyon group were retrospectively matched through the @-registry database whereas patients of the Berlin group were prospectively evaluated. In the latter patients quality of life assessment was additionally inquired. RESULTS: Postoperative PSA-Nadir was lower in the Berlin group for patients with HIFU only (0.007 vs. Lyon 0.34 ng/ml; p=0.037) and HIFU+TURP (0.25 vs. Lyon 0.42 ng/ml; p=0.003). BDFS was comparable in both groups for HIFU only (Berlin 4.77, Lyon 5.23 years; p=0.741) but patients with combined HIFU+TURP in the Berlin group showed an unfavourable BDFS as compared to the Lyon group (Berlin 3.02, Lyon 4.59 years; p=0.05). In an analysis of Berlin subgroups especially patients who had received HIFU and TURP (n=4) within the same narcosis had an unfavourable BDFS (p=0.009). Median follow-up was 3.36 years for HIFU only and 2.26 years for HIFU+TURP. Neither HIFU only (p=0.117) nor HIFU+TURP (p=0.131) showed an impact on postoperative micturition. Erectile function was negatively influenced (HIFU: p=0.04; HIFU+TURP: p=0.036). There was no measurable change in quality of life after the treatment. CONCLUSION: The 4-year BDFS after HIFU and HIFU+TURP is comparable to that of the standard therapies. The erectile function is sustainably negatively influenced whereas postoperative micturition and quality of life were not affected by HIFU or HIFU+TURP. These results are strongly limited by the low patient count and the short follow-up period and require validation in prospective multicentre studies with higher number of cases.
Subject(s)
Clinical Competence , Learning Curve , Prostatic Neoplasms/surgery , Quality of Life , Aged , Berlin , Biomarkers, Tumor/blood , Cohort Studies , Combined Modality Therapy , Disease-Free Survival , Female , France , High-Intensity Focused Ultrasound Ablation , Humans , Kaplan-Meier Estimate , Male , Matched-Pair Analysis , Neoplasm Grading , Neoplasm Staging , Prostate-Specific Antigen/blood , Prostatic Neoplasms/blood , Prostatic Neoplasms/pathology , Transurethral Resection of Prostate , Tumor BurdenABSTRACT
Magnetic resonance urography (MRU) provides high resolution imaging of the urogenital system and the use of paramagnetic contrast agents enables a functional depiction. This review summarizes existing data concerning this diagnostic procedure in pediatric urology. A systematic search and assessment of the literature was performed.A total of 12 studies were reviewed in detail. In mostly small study populations a great heterogeneity concerning methodology, use of comparative examinations and standards of reference was noted. Besides the quality of anatomical imaging, the functional study of renal excretory function and differential renal function was also assessed. Only a few studies performed statistical analyses.The authors' rating of MRU was mostly positive. Due to methodical weaknesses, lack of independent standards of reference and statistical analyses the overall level of evidence was low. Further high quality studies will be necessary to assess the value of MRU for the diagnostic workup in pediatric urology.
Subject(s)
Magnetic Resonance Imaging/statistics & numerical data , Pediatrics/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Urography/statistics & numerical data , Urologic Diseases/epidemiology , Urologic Diseases/pathology , Urology/statistics & numerical data , Child , Humans , Prevalence , Reproducibility of Results , Sensitivity and SpecificityABSTRACT
BACKGROUND: Local ablation techniques are a major focus of current developments in oncology. The primary aim is to retain organs and preserve organ functions without compromising the oncological outcome. METHOD: Irreversible electroporation (IRE) is a novel ablation technique that involves the application of high-voltage pulses to induce cell apoptosis without causing thermal damage to the target tissue or adjacent structures. AIM: First published in 2005 IRE is currently undergoing preclinical and clinical trials in several areas of oncology and the initial results have been promising. The IRE technique could be a significant development in ablation treatment for renal cell carcinoma (RCC) but decisive proof of its effectiveness for local RCC has not yet been provided. This study presents the results of preclinical and initial clinical trials which are discussed and compared with those of other ablation techniques in order to demonstrate the current value of IRE.
Subject(s)
Ablation Techniques/methods , Carcinoma, Renal Cell/therapy , Electrochemotherapy/methods , Liver Neoplasms/therapy , HumansABSTRACT
BACKGROUND: Percutaneous nephrostomy (PCN) tube placement under combined ultrasound and fluoroscopic guidance is a standard procedure in urology. The use of a 1 Tesla open magnetic resonance imaging (MRI) scanner enables PCN placement under real-time guidance. METHOD: In the present series 51 patients underwent a total of 79 MRI-guided procedures between 2008 and 2012 and 52 interventions were performed after failure of conventional urological manipulation. Of the procedures 55 involved only a minor urine transport disorder (UTD) or none at all. RESULTS: Puncture and subsequent PCN tube placement were successful in all patients. Extravasation was found in four patients and renal pelvic clots in three. All complications healed without sequelae or further interventions. CONCLUSION: The MRI-guided PCN tube placement is an optimal alternative, particularly in cases of limited conventional imaging.
Subject(s)
Magnetic Resonance Imaging/methods , Magnetic Resonance Imaging/trends , Nephrostomy, Percutaneous/methods , Nephrostomy, Percutaneous/trends , Surgery, Computer-Assisted/methods , Surgery, Computer-Assisted/trends , Adolescent , Adult , Female , Humans , Male , Middle Aged , Treatment Outcome , Urology/trends , Young AdultABSTRACT
A new fluorescent reagent based on aluminum phthalocyanine has been developed for general application to immunoassay. This highly sensitive fluorophore, Ultralite 680, may be covalently attached to a variety of biological entities for use as a tracer. We report the use of an Ultralite 680-streptavidin-digoxin conjugate as a tracer in a direct, competitive, heterogeneous, fluorescent immunoassay of digoxin. The assay is performed manually with 50 microL of serum and no sample pre-treatment. Primary anti-digoxin antibody is incubated with a serum sample containing digoxin and Ultralite 680-streptavidin-digoxin. Bound and free tracer are separated, and the bound fluorescence is released and quantified with a commercially available spectrofluorometer. Assay precision was good (CV = 7.05% at a digoxin concentration of 2.00 micrograms/L) and results by our method correlated well with those by a conventional RIA (r = 0.9650, n = 24).
Subject(s)
Bacterial Proteins , Digoxin/blood , Fluorescent Antibody Technique , Fluorescent Dyes , Indoles , Organometallic Compounds , Aluminum , Antibodies, Monoclonal , HumansABSTRACT
Solid-state 2H NMR spectroscopy has been used to investigate the dynamics of a DNA oligonucleotide with a defined sequence, [d(CGCGAATTCGCG)]2, which contains the EcoRI binding site. Quadrupole echo line shapes and spin-lattice relaxation times were obtained as a function of hydration on two different deuterated samples, both in the form of the Na salt. In one sample, the C8 protons of all purines in the self-complementary dodecamer were exchanged for deuterons. In the other sample, a specifically labeled thymidine (C6 deuterated) was synthetically incorporated at the seventh position (counting 5' to 3') in the sequence. The general trends for both samples were quite similar. At all levels of hydration, the data reveal the presence of a rapid, small-amplitude libration of the bases (tau c less than or equal to 1 ns, 6 degrees-10 degrees amplitude). At the higher hydration levels (80% relative humidity or higher), the results indicate the presence of a much slower motion (tau c approximately 10-100 microseconds), which at 80% relative humidity is of small amplitude (approximately 5 degrees) and at higher hydration levels may be of larger amplitude. There is no evidence for large-amplitude (greater than +/- 10 degrees) motion on a nanosecond or faster time scale under any hydration condition. The 2H NMR results were analyzed with a dynamical model which treats the oligonucleotide as a deformable filament and which can include collective torsional fluctuations. The slow motion observed at high hydration levels is attributed to the uniform twisting mode (of the entire helix).(ABSTRACT TRUNCATED AT 250 WORDS)