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Optical coherence tomography predictors of clinical outcomes after stent implantation: the ILUMIEN IV trial.
No full textObservational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial. ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions. A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length
Overnight stay in Spanish emergency departments and mortality in older patients.
No full text20.500.12530/87858To assess whether older adults who spend a night in emergency departments (ED) awaiting admission are at increased risk of mortality. This was a retrospective review of a multipurpose cohort that recruited all patients ≥ 75 years who visited ED and were admitted to hospital on April 1 to 7, 2019, at 52 EDs across Spain. Study groups were: patients staying in ED from midnight until 8:00 a.m. (ED group) and patients admitted to a ward before midnight (ward group). The primary endpoint was in-hospital mortality, truncated at 30 days, and secondary outcomes assessed length of stay for the index episode. The sample comprised 3,243 patients (median [IQR] age, 85 [81-90] years; 53% women), with 1,096 (34%) in the ED group and 2,147 (66%) in the ward group. In-hospital mortality for patients spending the night in the ED the ED group was 10.7% and 9.5% for patients transferred to a ward bed before midnight the ward group (adjusted OR: 1.12, 95%CI: 0.80-1.58). Sensitivity analyses rendered similar results (ORs ranged 1.06-1.13). Interaction was only detected for academic/non-academic hospitals (p 7 days), with adjusted OR of 1.16 (0.94-1.43) and 1.15 (0.94-1.42) depending on whether time spent in the ED was or was not taken into consideration. No increased risk of in-hospital mortality or prolonged hospitalization was found in older patients waiting overnight in the ED for admission. Nonetheless, all estimations suggest a potential harmful effect of staying overnight, especially if a proper bedroom and hospitalist ward bed and hospitalized care are not provided
Value of baseline PSA in predicting prostate cancer diagnosis and death. Spanish arm of the European Randomized Study of Screening for Prostate Cancer
No full text20.500.12530/87845Introduction Several studies have suggested that prostate-specific antigen (PSA) in young men may predict the risk of developing prostate cancer (PC). Our aim is to study baseline PSA as a prognostic factor in the lifetime risk of developing PC, clinically significant PC (csPC), and metastatic PC (mPC), as well as to assess its impact on long-term mortality. Material and methods This study was a retrospective analysis involving 2,415 men aged 45-70 years, all participants in the Spanish arm of the European Randomized Study of Screening for Prostate Cancer (ERSPC). These men underwent PSA testing, and prostate biopsies were performed if their PSA levels were >= 3 ng/ml. The follow-up period spanned from September 2, 1996, to February 11, 2021. Kaplan-Meier survival analysis was conducted to calculate the probability of prostate cancer diagnosis and death. The relationship between these probabilities and baseline PSA levels was assessed using the log-rank test. Results After 25 years of follow-up, the probability of being free of a diagnosis of PC was 95.5%, 89.6%, 80.0%, and 69.4%; and of PC death: 99.6%, 99.6%, 98.9%, and 98.3% for the categories of PSA = 3 ng/ml. The follow-up period spanned from September 2, 1996, to February 11, 2021. Kaplan-Meier survival analysis was conducted to calculate the probability of prostate cancer diagnosis and death. The relationship between these probabilities and baseline PSA levels was assessed using the log-rank test. Results After 25 years of follow-up, the probability of being free of a diagnosis of PC was 95.5%, 89.6%, 80.0%, and 69.4%; and of PC death: 99.6%, 99.6%, 98.9%, and 98.3% for the categories of PSA 3 ng/ml, respectively. There is an association between baseline PSA level and the probability of PC diagnosis (which is maintained in age stratification), csPC, mPC (
Perceived surgical difficulty of mandibular third molar extraction. A comparative cross-sectional study of dentists with postgraduate qualification in oral surgery and maxillofacial surgeons in a Spanish subpopulation.
No full text20.500.12530/87907Mandibular third molar (MTM) extraction is one of the most frequently performed surgeries in the oral cavity. Establishing the level of surgical difficulty pre-operatively is an essential step to ensure correct treatment planning. In Spain, MTM extraction - especially in cases presenting greater difficulty - is normally performed by doctors specializing in oral and maxillofacial surgery, or by dentists with postgraduate qualifications in oral surgery. The present work set out to analyze the extent to which perceptions of surgical difficulty of the said intervention vary in relation to professional training. This cross-sectional, descriptive, observational study took the form of a survey. Using a visual analog scale (VAS), participants evaluated both the perceived difficulty of 30 cases of MTM extraction described by means of digital panoramic radiographs and the perceived difficulty deriving from a series of factors conditioning MTM extraction. The results underwent statistical analysis with SPSS Statistics 28.0 software. Non-parametric tests (Mann Whitney test for independent samples and the Kruskal-Wallis test) were applied. A total of 213 surveys were available for analysis. Both groups awarded the greatest importance to clinical experience, followed by anatomical and radiographic factors, root morphology obtaining the highest score among anatomical factors (9.01±1.42), while proximity of the MTM to the inferior alveolar nerve was regarded as the least important anatomical factor (8.11±2.54). Significant differences were only found for patient age, whereby maxillofacial surgeons awarded this factor more importance than dentists. The different training received by dentists specialized in oral surgery and maxillofacial surgeons did not influence either perceptions of surgical difficulty of MTM extraction, or opinions as to the factors influencing surgical difficulty
Recent outcomes of liver transplantation for Budd-Chiari syndrome: A study of the European Liver Transplant Registry (ELTR) and affiliated centers.
No full text20.500.12530/87909Management of Budd-Chiari syndrome (BCS) has improved over the last decades. The main aim was to evaluate the contemporary post-liver transplant (post-LT) outcomes in Europe. Data from all patients who underwent transplantation from 1976 to 2020 was obtained from the European Liver Transplant Registry (ELTR). Patients LT for BCS results in excellent patient- and graft-survival. Older recipient or donor age and higher MELD are associated with poorer outcomes, while long-term anticoagulation improves both patient and graft outcomes
[Translated article] Trichotillomania Treatment Update.
No full text20.500.12530/87854Trichotillomania (TTM) is an obsessive-compulsive disorder in which affected individuals recurrently pull-out hair from any region of the body, causing hair loss or alopecia. The management of TTM is a therapeutic challenge for dermatologists and consists of a combination of pharmacological and non-pharmacological alternatives. Cognitive-behavioral therapy has successfully been used to treat TTM. However, not all patients are willing to follow this treatment strategy. Unconventional support tools are proposed, such as electronic devices, Internet therapies and microneedling. N-acetylcysteine and memantine are considered suitable first-line therapies thanks to their favorable safety and efficacy profile, low risk of adverse effects, and significant benefits. The use of other drugs, including fluoxetine, clomipramine, olanzapine, and naltrexone has limited evidence of variable efficacy. The present review illustrates the current treatment modalities for the management of TTM
A recommendation for the use of electrical biosensing technology in neonatology.
No full text20.500.12530/87913Non-invasive cardiac output monitoring, via electrical biosensing technology (EBT), provides continuous, multi-parameter hemodynamic variable monitoring which may allow for timely identification of hemodynamic instability in some neonates, providing an opportunity for early intervention that may improve neonatal outcomes. EBT encompasses thoracic (TEBT) and whole body (WBEBT) methods. Despite the lack of relative accuracy of these technologies, as compared to transthoracic echocardiography, the use of these technologies in neonatology, both in the research and clinical arena, have increased dramatically over the last 30 years. The European Society of Pediatric Research Special Interest Group in Non-Invasive Cardiac Output Monitoring, a group of experienced neonatologists in the field of EBT, deemed it appropriate to provide recommendations for the use of TEBT and WBEBT in the field of neonatology. Although TEBT is not an accurate determinant of cardiac output or stroke volume, it may be useful for monitoring longitudinal changes of hemodynamic parameters. Few recommendations can be made for the use of TEBT in common neonatal clinical conditions. It is recommended not to use WBEBT to monitor cardiac output. The differences in technologies, study methodologies and data reporting should be addressed in ongoing research prior to introducing EBT into routine practice. IMPACT STATEMENT: TEBT is not recommended as an accurate determinant of cardiac output (CO) (or stroke volume (SV)). TEBT may be useful for monitoring longitudinal changes from baseline of hemodynamic parameters on an individual patient basis. TEBT-derived thoracic fluid content (TFC) longitudinal changes from baseline may be useful in monitoring progress in respiratory disorders and circulatory conditions affecting intrathoracic fluid volume. Currently there is insufficient evidence to make any recommendations regarding the use of WBEBT for CO monitoring in neonates. Further research is required in all areas prior to the implementation of these monitors into routine clinical practice
Clinical outcomes and prognostic factors after HCV clearance with DAA in HIV/HCV-coinfected patients with advanced fibrosis/cirrhosis.
No full text20.500.12530/87913We assessed long-term clinical outcomes and prognostic factors for liver disease progression after sustained viral response with direct-acting antivirals in patients coinfected with HIV/HCV with advanced fibrosis or cirrhosis. A total of 1300 patients who achieved sustained viral response with direct-acting antivirals from 2014 to 2017 in Spain were included: 1145 with compensated advanced chronic liver disease (384 advanced fibrosis and 761 compensated cirrhosis) and 155 with decompensated cirrhosis. The median follow-up was 40.9 months. Overall, 85 deaths occurred, 61 due to non-liver non-AIDS-related causes that were the leading cause of death across all stages of liver disease. The incidence (95% CI) of decompensation per 100 person-years (py) was 0 in patients with advanced fibrosis, 1.01 (0.68-1.51) in patients with compensated cirrhosis, and 8.35 (6.05-11.53) in patients with decompensated cirrhosis. The incidence (95% CI) of HCC per 100 py was 0.34 (0.13-0.91) in patients with advanced fibrosis, 0.73 (0.45-1.18) in patients with compensated cirrhosis, and 1.92 (1.00-3.70) per 100 py in patients with decompensated cirrhosis. Prognostic factors for decompensation in patients with compensated advanced chronic liver disease included serum albumin, liver stiffness measurement (LSM), and fibrosis 4. In this population, LSM and LSM-based posttreatment risk stratification models showed their predictive ability for decompensation and HCC. Non-liver non-AIDS-related events were the leading causes of morbidity and mortality after direct-acting antiviral cure among coinfected patients with advanced fibrosis/cirrhosis. Among those with compensated advanced chronic liver disease, baseline LSM and posttreatment LSM-based models helped to assess decompensation and HCC risk
The overlap with metabolic dysfunction-associated steatotic liver disease negatively affects outcomes of primary biliary cholangitis.
No full text20.500.12530/87887The relationship between primary biliary cholangitis (PBC) and metabolic dysfunction-associated steatotic liver disease, and its impact on treatment response and prognosis, remains underexplored. Patient cohort from two centres comprising long-term follow-up data. All patients had histologically confirmed PBC. Biopsies were classified according to Non-Alcoholic Steatohepatitis Clinical Research Network. Diagnosis of metabolic dysfunction-associated steatotic liver disease was established when steatosis exceeded 5%, along with at least one metabolic risk factor. Patients with specific aetiologies of steatosis, other liver diseases, incomplete results and inadequate treatment with ursodeoxycholic acid were excluded. Data from patients initiating second-line treatment were censored. Treatment response was assessed using the Toronto, Paris II and AST-to-platelet at 12-month criteria. The UK PBC and Globe scores, and liver events were utilized as outcome measures. The study included 129 patients, 36 showing histologically confirmed overlap between PBC and steatosis. Patients with overlap showed worse prognosis according to Paris II (61.1% vs. 33.3%, p = 0.004), Toronto (52.5% vs. 24.7%, p = 0.002), AST-to-platelet 12-month >0.54 (36.1% vs. 17.2%, p = 0.021), Globe >0.30 (49.2% vs. 29.2%, p = 0.033) and UK PBC at 5, 10 and 15 years (p ≤ 0.001). Liver-related mortality and liver transplant were more prevalent in the overlap group (p = 0.001). In the multivariate analysis, steatosis, dyslipidaemia and advanced fibrosis were independently associated to worse outcomes. Our findings suggest that metabolic dysfunction-associated steatotic liver disease worsens the prognosis of PBC
Safety and outcome of children, adolescents and young adults participating in phase I/II clinical oncology trials: a 9-year center experience.
No full textEnrolling children with cancer in early phase trials is crucial to access innovative treatments, contributing to advancing pediatric oncology research and providing tailored therapeutic options. Our objective is to analyze the impact of these trials on patient outcomes and safety, and to examine the evolution and feasibility of trials in pediatric cancer over the past decade. All patients recruited in pediatric anticancer phase I/II clinical trials from January 2014 to December 2022 were included. Clinical records and trial protocols were analyzed. A total of 215 patients (median age 11.2 years, range 1-29.5) were included in 52 trials (258 inclusions). Patients with extracranial solid tumors (67%), central nervous system (CNS) tumors (24%), and leukemia (9%) were included. The most common investigational drugs were small molecules (28.3%) and antibodies (20.5%). Serious adverse events were experienced by 41% of patients, 4.4% discontinued treatment because of toxicity and two had toxic deaths. Median event-free survival was 3.7 months (95%CI: 2.8-4.5), longer in phase II trials than in phase I (2 vs. 6.3 months; p ≤ 0.001). Median overall survival was 12 months (95%CI: 9-15), higher in target-specific vs. non-target-specific trials (14 vs. 6 months; p ≤ 0.001). A significant and increasing number of patients have been included in early clinical trials, suggesting that both oncologists and families consider it valuable to be referred to specialized Units to access new therapies. Moreover, our data suggests that participation in early clinical trials, although not without potential toxicities, might have a positive impact on individual outcomes