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INTRODUCTION: Percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) is an attractive strategy for the treatment of obstructive coronary artery disease (CAD). The implantation technique strongly influences the outcome of DCB PCI: accurate and adequate lesion preparation, short delivery time and sufficient DCB inflation time are deemed crucial to warrant adequate drug transfer and mitigate the risk of immediate vessel recoil and flow-limiting dissections. However, the optimal DCB inflation time is unclear, current consensus documents suggesting 30-60 s based on Experts' opinion. However, clinical studies comparing the prognostic role of different inflation times are scarce and mainly involve paclitaxel-coated balloons. In this study we aimed to assess the impact of different inflation times in patients undergoing PCI with a sirolimus-coated balloon (SCB). METHODS: We conducted a post-hoc analysis of the prospective, multicenter, EASTBOURNE study, classified into two study groups according to balloon inflation time: long (>30 s) versus short (≤30 s). The primary endpoint was target lesion revascularization (TLR) at 24-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, non-fatal myocardial infarction (MI), and BARC 2-5 bleedings. Furthermore, angiographic endpoints (the rate of bailout stenting and post-procedural TIMI flow <3) were also addressed. RESULTS: A total of 2289 lesions (2092 in the long inflation group, 197 in the short inflation group) were included in the analysis. Median balloon inflation time was 60 s in the long inflation and 30 s in the short inflation group. The two study groups experienced a similar rate of TLR [6.2 % in the short versus 6.3 % in the long inflation group, p = 1.00] as well MACE (p = 0.683), death (p = 0.102), non-fatal MI (p = 0.822), and BARC 2-5 bleedings (p = 0.252). These results were consistent when considering subpopulations with different target lesion phenotypes (in-stent restenosis, de-novo lesions, large and small vessels). Interesting, the rate of bailout stent implantation and post-procedural TIMI flow <3 was higher in the short SCB inflation time, as compared to the standard strategy. CONCLUSIONS: Short vs. long SCB inflation time is associated with a higher need of bailout stenting after PCI with SCB, with similar clinical outcomes at 24-month follow-up.
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INTRODUCTION: Clinical trials, essential for medical advancement, vary significantly in methodology and regulatory pathways depending on the type of therapeutic intervention (i.e., drugs or devices). This study aimed to determine whether the drug or device intervention types influence the impact of randomized trials in cardiovascular medicine. METHODS: We analyzed late-breaking randomized controlled trials presented at major cardiology conferences from 2015 to 2021. The primary endpoint was the total number of citations obtained. Secondary endpoints included the number of citations at 1 and 2 years, number of total and 1-year mentions, and several metrics of study conduct and publication. Statistical analysis included tests for comparisons of continuous or categorical variables, based on their distribution, as appropriate. To adjust the results for potential confounders, univariable and multivariable regression models were utilized. Additionally, sensitivity analyses were conducted to explore both the effect of neutral or positive study outcomes on the comparative impact of drug versus device trials and the impact of the coronavirus disease 2019 (COVID-19) pandemic on the primary endpoint. RESULTS: Of 382 eligible randomized trials, 227 (59.4%) were trials of drugs and 155 (40.6%) were trials of devices. Drug trials had a higher median number of total citations compared to device studies (93 [interquartile range {IQR} 48-137] vs. 82 [IQR 39-192]; p = 0.025). This difference was consistent at 1 and 2 years and was also observed in the number of total mentions and mentions at 1 year. All the metrics of study conduct and publication were similar, except for drug studies being more often stopped prematurely (8.8 vs. 1.9%; p = 0.006). After adjusting for multiple potential confounders, the difference in citations and mentions was no longer statistically significant. However, drug trials remained more likely to be stopped prematurely (adjusted odds ratio = 1.15; 95% confidence interval 1.03-1.28; p = 0.009). Positive study outcomes significantly influenced the number of citations and the likelihood of a trial being stopped prematurely. CONCLUSIONS: Drug trials are often stopped early and receive more citations and mentions than device trials. However, these differences are mainly due to factors other than the treatment itself. Studies published simultaneously tend to get more attention, and drug trials with positive results are cited more often than those with neutral results.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , COVID-19 , Enfermedades Cardiovasculares/tratamiento farmacológico , Cardiología , Fármacos Cardiovasculares/uso terapéutico , Equipos y SuministrosRESUMEN
PURPOSE: Atelectasis otitis media (AtOM) is a chronic condition where the tympanic membrane (TM) becomes retracted towards the middle ear and the ossicular chain. Surgical treatment for this condition could be indicated based on stage of atelectasis, patient's clinical condition and hearing loss. Over the years, AtOM has been treated with various types of tympanoplasty under microscopic view. The aim of this study is to present the results of endoscopic ear surgery in AtOM. METHODS: Forty-five patients who underwent endoscopic trans-canal tympanoplasty were included in the study. Preoperative features, intraoperative findings and postoperative outcomes were collected. RESULTS: Preoperatively, none of the study's patients were classified with a Sadè Grade I, whereas grades II, III and IV were 3 (6.6%), 23 (32.1%) and 19 (67.8%) respectively. The 3 patients with Sadè grade II showed a conductive hearing loss higher than 20 dB and a continuous ear fullness, therefore they were surgically treated. The postoperative graft success rate was estimated at 95.5%. During follow-up, 2 patients showed a TM perforation (at 6 and 12 months after surgery) whereas 1 patient experienced a recurrence of atelectasis in the TM (16 months after surgery). The overall success rate at the final follow-up was calculated at 88.8%. The average preoperative air-conduction threshold was 51.1 ± 21.5, which reduced to 34.6 ± 22.1 (p = 0.04) at follow-up. The preoperative air-bone gap decreased from 28 ± 7.2 to 11.8 ± 10 (p = 0.002) after surgery. CONCLUSION: Atelectasis otitis media might be suitable for exclusive endoscopic surgical treatment, as it appears to exhibit a low recurrence rate and promising audiological outcomes.
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Background: Noninferiority trials are increasingly common in cardiovascular medicine, but their reporting and interpretation are challenging, particularly when an absolute risk difference is used as noninferiority margin. Objectives: This study aimed to investigate the effect of using absolute rather than relative noninferiority margins in cardiovascular trials. Methods: We reviewed noninferiority trials presented at major cardiovascular conferences from 2015 to 2022 and published within the same period. Based on the actual versus anticipated event rates in the control group, we recalculated the absolute noninferiority margin and re-assessed the trial results. The primary outcome of interest was the proportion of trials with a different interpretation after recalculation. Additionally, we analyzed the conclusion statements of these trials to determine if cautionary notes for the interpretation of study results were included. Results: We analyzed a total of 768 trials, of which 88 had a noninferiority design and 66 used an absolute noninferiority margin. Of 48 comparisons from 45 trials qualifying for the analysis, 11 (22.9%) had divergent results after recalculation of the absolute noninferiority margin based on the observed rather than anticipated event rate. Ten trials originally claiming noninferiority, did not meet it after the margin recalculation. All of them did not include statements suggesting cautionary interpretation of the study results in the conclusion section. Compared with the other trials, these displayed a larger median difference between anticipated and recalculated noninferiority margins (44.7% [IQR: 38.6%-56.7%] vs 15.3% [IQR: -1.5% to 28.9%]; P < 0.001). Conclusions: Recalculating noninferiority margins based on actual event rates, rather than anticipated ones, led to different outcomes in approximately 1 out of 4 cardiovascular trials, with most divergent trials lacking cautionary interpretation. These findings emphasize the importance of using or supplementing the relative noninferiority margin, particularly in studies with significant deviations between observed and expected event rates. This underscores the critical need for enhanced methodological and reporting standards in noninferiority trials, especially those employing absolute margins.
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Enfermedades Cardiovasculares , Prevención Secundaria , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Prevención Secundaria/métodos , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéuticoRESUMEN
BACKGROUND: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. METHODS: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. RESULTS: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. CONCLUSIONS: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.
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Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Reestenosis Coronaria , Stents Liberadores de Fármacos , Sistema de Registros , Sirolimus , Humanos , Masculino , Femenino , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Reestenosis Coronaria/etiología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/mortalidad , Reestenosis Coronaria/terapia , Factores de Tiempo , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Factores de Riesgo , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Europa (Continente) , Infarto del Miocardio/mortalidad , Infarto del Miocardio/etiología , Catéteres Cardíacos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagenRESUMEN
Objective: The local spread of oral tongue squamous cell carcinoma (OTSCC) follows pathways of dissemination along areas of lesser resistance. In more advanced scenarios, the tumor can extend beyond the hemi-tongue of origin, by passing through the lingual septum and following the fibers of the transverse muscle. This can lead to the invasion of the contralateral extrinsic muscles, the first being the genioglossus and more laterally the hyoglossus. An anatomically guided surgical resection of the tumor can be planned to ensure both oncological safety and an acceptable functional outcome. This approach aims to preserve the hyo-styloglossus unit (HSU) whenever feasible. Methods: Between January 2019 and November 2022, six patients received extended glossectomy Type B (EG Type B), with preservation of the HSU. Preliminary oncological results and functional results in terms of swallowing (FOIS score) and quality of life (MDADI) are presented. Results: Five out of the six patients are alive and disease-free, while one patient died due to other causes. All patients who were candidates for an EG Type B underwent a swallowing assessment prior to surgery and followed daily postoperative swallowing training. At discharge, the patients continued swallowing training in an outpatient clinic. Five out of the six patients reached a full oral diet within 1 year of follow-up. Conclusion: The oncological results confirm the safety of this technique. The importance of preserving the HSU, the minimal functional unit, shows very encouraging results in terms of swallowing rehabilitation.
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The automatic detection of smoke by analyzing the video stream acquired by traditional surveillance cameras is becoming a more and more interesting problem for the scientific community thanks to the necessity to prevent fires at the very early stages. The adoption of a smart visual sensor, namely a computer vision algorithm running in real time, allows one to overcome the limitations of standard physical sensors. Nevertheless, this is a very challenging problem, due to the strong similarity of the smoke with other environmental elements like clouds, fog and dust. In addition to this challenge, data available for training deep neural networks is limited and not fully representative of real environments. Within this context, in this paper we propose a new method for smoke detection based on the combination of motion and appearance analysis with a modern convolutional neural network (CNN). Moreover, we propose a new dataset, called the MIVIA Smoke Detection Dataset (MIVIA-SDD), publicly available for research purposes; it consists of 129 videos covering about 28 h of recordings. The proposed hybrid method, trained and evaluated on the proposed dataset, demonstrated to be very effective by achieving a 94% smoke recognition rate and, at the same time, a substantially lower false positive rate if compared with fully deep learning-based approaches (14% vs. 100%). Therefore, the proposed combination of motion and appearance analysis with deep learning CNNs can be further investigated to improve the precision of fire detection approaches.
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OBJECTIVE: This study aims to evaluate the efficacy of the profunda artery perforator (PAP) flap in head and neck reconstruction. METHODS: A single arm meta-analysis was performed for flap survival rate (primary outcome), reoperation for major complication, and overall complication rates (secondary outcomes). RESULTS: The search strategy yielded a total of 295 potentially relevant publications, of which 13 were included. A total of 305 patients (males: 80.8%, n = 232/281), with a median age of 56.1 years (n = 305/305; 95% CI 53.9-63), who underwent a total of 307 PAP flap reconstructions for head and neck defects were included. Flap survival rate was 100% (n = 306/307; 95% CI 99.6%-100%), with a reoperation rate for major complications of 3.7% (n = 15/307; 95% CI 1.85%-6.1%) and an overall complication rate of 26.5% (n = 92/307; 95% CI 15.7%-38.9%). Notable postoperative complications included wound dehiscence (n = 15/307, 4.9%), delayed healing (n = 14/307, 4.6%), and wound infection (n = 12/307, 3.9%). Partial flap necrosis and hematoma occurred in 2.6% of cases (n = 8/307), while arterial and venous thrombosis were documented in 0.7% (n = 2/307) and 1.3%, respectively (n = 4/307). CONCLUSION: The application of the PAP flap in head and neck reconstructions showed several favorable aspects, such as an exceptionally low flap failure rate, versatility in achieving variable dimensions, and a relatively low incidence of complications. PAP flap might be considered as a compelling alternative to the traditionally employed soft tissue free flaps in head and neck reconstruction.
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Background: The introduction of biological drugs in the management of chronic rhinosinusitis with nasal polyps (CRSwNP) is allowing new and increasingly promising therapeutic options. This manuscript aims to provide a multicenter trial in a real-life setting on Mepolizumab treatment for severe uncontrolled CRSwNP with or without comorbid asthma. Methods: A retrospective data analysis was jointly conducted at the Otolaryngology-Head and Neck Surgery departments of La Sapienza University and San Camillo Forlanini Hospital in Rome. Both institutions participated by sharing clinical information on patients with CRSwNP treated with Mepolizumab. Patients were evaluated before starting Mepolizumab, at six months and at twelve months from the first drug administration. During follow-up visits, patients underwent endoscopic evaluation, quality of life assessment, nasal symptoms assessment, and blood tests to monitor mainly neutrophils, basophils, eosinophils, and IgG, IgA, and IgE assay. Results: Twenty patients affected by CRSwNP and treated with Mepolizumab were enrolled (12 females and 8 males with a mean age of 63.7 years). Sixteen patients (80%) had concomitant asthma. During follow-up, a gradual improvement in nasal polyp score, quality of life and nasal symptoms, assessed by SNOT-22 and VAS and loss of smell measured by olfactory VAS, was found. Regarding blood tests, eosinophils decreased gradually, while other blood parameters showed no statistically significant changes. Conclusions: Mepolizumab has been shown to be effective in the therapeutic management of patients with CRSwNP. Further studies are needed to support our findings and better understand the underlying immune pathways to predict patients' response to biological treatment in CRSwNP.
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BACKGROUND: Despite substantial progress in investigating its psychophysical complexity, tinnitus remains a scientific and clinical enigma. The present study, through an ecological and multidisciplinary approach, aims to identify associations between electroencephalographic (EEG) and psycho-audiological variables. METHODS: EEG beta activity, often related to stress and anxiety, was acquired from 12 tinnitus patients (TIN group) and 7 controls (CONT group) during an audio cognitive task and at rest. We also investigated psychological (SCL-90-R; STAI-Y; BFI-10) and audiological (THI; TQ12-I; Hyperacusis) variables using non-parametric statistics to assess differences and relationships between and within groups. RESULTS: In the TIN group, frontal beta activity positively correlated with hyperacusis, parietal activity, and trait anxiety; the latter is also associated with depression in CONT. Significant differences in paranoid ideation and openness were found between groups. CONCLUSIONS: The connection between anxiety trait, beta activity in the fronto-parietal cortices and hyperacusis provides insights into brain functioning in tinnitus patients, offering quantitative descriptions for clinicians and new multidisciplinary treatment hypotheses.
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Aims: TOMM40 single nucleotide polymorphism (SNP) rs2075650 consists of allelic variation c.275-31A > G and it has been linked to Alzheimer disease, apolipoprotein and cholesterol levels and other risk factors. However, data on its role in cardiovascular disorders are lacking. The first aim of the study is to evaluate mortality according to TOMM40 genotype in a cohort of selected patients affected by advanced atherosclerosis. Second aim was to investigate the relationship between Xg and AA alleles and the presence of conduction disorders and implantation of defibrillator (ICD) or pacemaker (PM) in our cohort. Materials and Methods: We enrolled 276 patients (mean age 70.16 ± 7.96 years) affected by hemodynamic significant carotid stenosis and/or ischemia of the lower limbs of II or III stadium Fontaine. We divided the population into two groups according to the genotype (Xg and AA carriers). We evaluated several electrocardiographic and echocardiographic parameters, including heart rate, rhythm, presence of right and left bundle branch block (LBBB and RBBB), PR interval, QRS duration and morphology, QTc interval, and left ventricular ejection fraction (LVEF). We clinically followed these patients for 82.53 ± 30.02 months and we evaluated the incidence of cardiovascular events, number of deaths and PM/ICD implantations. Results: We did not find a difference in total mortality between Xg and AA carriers (16.3 % vs. 19.4%; p = 0.62). However, we found a higher mortality for fatal cardiovascular events in Xg carriers (8.2% vs. 4.4%; HR = 4.53, 95% CI 1.179-17.367; p = 0.04) with respect to AA carriers. We noted a higher percentage of LBBB in Xg carriers (10.2% vs. 3.1%, p = 0.027), which was statistically significant. Presence of right bundle branch block (RBBB) was also higher in Xg (10.2% vs. 4.4%, p = 0.10), but without reaching statistically significant difference compared to AA patients. We did not observe significant differences in heart rate, presence of sinus rhythm, number of device implantations, PR and QTc intervals, QRS duration and LVEF between the two groups. At the time of enrolment, we observed a tendency for device implant in Xg carriers at a younger age compared to AA carriers (58.50 ± 0.71 y vs. 72.14 ± 11.11 y, p = 0.10). During the follow-up, we noted no statistical difference for new device implantations in Xg respect to AA carriers (8.2% vs. 3.5%; HR = 2.384, 95% CI 0.718-7.922; p = 0.156). The tendency to implant Xg at a younger age compared to AA patients was confirmed during follow-up, but without reaching a significant difference(69.50 ± 2.89 y vs. 75.63 ± 8.35 y, p = 0.074). Finally, we pointed out that Xg carriers underwent device implantation 7.27 ± 4.43 years before AA (65.83 ± 6.11 years vs. 73.10 ± 10.39 years) and that difference reached a statistically significant difference (p = 0.049) when we considered all patients, from enrollment to follow-up. Conclusions: In our study we observed that TOMM40 Xg patients affected by advanced atherosclerosis have a higher incidence of developing fatal cardiovascular events, higher incidence of LBBB and an earlier age of PM or ICD implantations, as compared to AA carriers. Further studies will be needed to evaluate the genomic contribution of TOMM40 SNPs to cardiovascular deaths and cardiac conduction diseases.
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Anticoagulation is indicated for treatment and prevention of arterial and venous thrombosis. Targeting different steps of the coagulation process, currently available anticoagulants entail an increased risk of bleeding, which detrimentally impacts on prognosis and hinders the administration of an effective antithrombotic regimen. Factor XI (FXI) inhibition has emerged as a strategy to uncouple prevention of thrombosis from bleeding. Indeed, while FXI is crucial for the amplification phase in pathological thrombosis, it is ancillary in physiological hemostasis. A comprehensive search in several scientific databases has been performed to identify relevant studies in the field. In addition, ongoing trials have been searched for in proper datasets to provide an updated and comprehensive assessment of the current state of investigations on FXI inhibition. Many compounds have been tested to inhibit FXI at different stages (i.e., synthesis, activation, or interactions with target molecules and coagulation factors). These include antisense oligonucleotides, monoclonal antibodies, small molecules, natural peptides and aptamers. In phase 2 studies, FXI inhibitors reduced thrombotic complications without any corresponding increase in bleeding. FXI inhibitors were noninferior and potentially superior to low-molecular-weight heparin in orthopedic surgery and reduced bleeding compared to apixaban in patients with atrial fibrillation. FXI inhibition is also under testing in other conditions, including end-stage renal disease, cancer, or noncardioembolic stroke. FXI inhibition represents a promising and rapidly emerging approach for a number of clinical indications. This article reviews the rationale, evidence, pharmacology, and future applications of FXI inhibition.
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BACKGROUND: Olfactory dysfunction is a well-known phenomenon in neurological diseases with anosmia and hyposmia serving as clinical or preclinical indicators of Alzheimer's disease, Parkinson's disease, and other neurodegenerative disorders. Since glaucoma is a neurodegenerative disease of the visual system, it may also entail alterations in olfactory function, warranting investigation into potential sensory interconnections. METHODS: A review of the current literature of the last 15 years (from 1 April 2008 to 1 April 2023) was conducted by two different authors searching for topics related to olfaction and glaucoma. RESULTS: three papers met the selection criteria. According to these findings, patients with POAG appear to have worse olfaction than healthy subjects. Furthermore, certain predisposing conditions to glaucoma, such as pseudoexfoliation syndrome and primary vascular dysregulation, could possibly induce olfactory changes that can be measured with the Sniffin Stick test. CONCLUSIONS: the scientific literature on this topic is very limited, and the pathogenesis of olfactory changes in glaucoma is not clear. However, if the results of these studies are confirmed by further research, olfactory testing may be a non-invasive tool to assist clinicians in the early diagnosis of glaucoma.
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Introducción y objetivos: Los ensayos clínicos aleatorizados a menudo se presentan en conferencias médicas y se publican al mismo tiempo o después. Los predictores de publicación simultánea y sus consecuencias no están determinados. Nuestro objetivo es caracterizar la práctica de la publicación simultánea, identificar sus predictores y evaluar su impacto. Métodos: En este estudio transversal se incluyeron ensayos clínicos aleatorizados presentados en sesiones de ciencia de última hora de importantes conferencias cardiovasculares desde 2015 hasta 2021. Se analizó la asociación entre las características del ensayo y el momento de la publicación. Se investigó el impacto de la publicación simultánea frente a la no simultánea en el número de citas a 1 año y menciones a 1 mes, así como en el total de citas y menciones en el seguimiento más largo observado. Resultados: De los 478 ensayos incluidos en el análisis, el 48,7% se publicó simultáneamente. Las publicaciones simultáneas tenían mayor probabilidad de presentarse en la sala principal de la conferencia (OR=6,09; IC95%, 1,34-36,92; p=0,029) y se caracterizaban por un tiempo de revisión más corto (OR=0,95; IC95%, 0,91-0,96; p<0,001). Las publicaciones simultáneas se asociaron con un mayor número de citas a 1 año (R2=43,81; IC95%, 23,89-63,73; p<0,001), menciones a 1 mes (R2=132,32; IC95%, 85,42-179,22; p<0,001) y total de citas (R2=222,89; IC95%, 127,98-317,80; p<0,001) en el seguimiento. Conclusiones: Los ensayos clínicos aleatorizados presentados en la sala principal de la conferencia y con un tiempo de revisión más corto tienen mayor probabilidad de publicarse simultáneamente. Las publicaciones simultáneas se asocian con más citas y menciones que las publicaciones no simultáneas. (AU)
Introduction and objectives: Randomized trials are often presented at medical conferences and published simultaneously or later. Predictors of simultaneous publication and its consequences are undetermined. Our aim was to characterize the practice of simultaneous publication, identify its predictors, and evaluate its impact. Methods: In this cross-sectional study, we included randomized trials presented at late-breaking science sessions of major cardiovascular conferences from 2015 to 2021. The association of trial characteristics with the timing of publication was analyzed. The impact of simultaneous vs nonsimultaneous publication was investigated on the number of 1-year citations and 1-month mentions, and the total citations and mentions at the longest observation follow-up. Results: Of 478 trials included in the analysis, 48.7% were published simultaneously. Simultaneous publications were more likely to be presented in the main conference room (OR, 6.09; 95%CI, 1.34-36.92; P=.029) and were characterized by a shorter review time (OR, 0.95; 95%CI, 0.91-0.96; P<.001). Simultaneous publications were associated with higher 1-year citations (R2, 43.81; 95%CI, 23.89-63.73; P<.001), 1-month mentions (R2, 132.32; 95%CI, 85.42-179.22; P<.001) and total citations (R2, 222.89; 95%CI, 127.98-317.80; P<.001). Conclusions: Randomized trials presented in the main conference room and with shorter review time were more likely to be published simultaneously. Simultaneous publications were associated with more citations and mentions than nonsimultaneous publications. (AU)
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Humanos , Cardiología , Congresos como Asunto , Publicaciones , Factor de Impacto , Estudios TransversalesRESUMEN
PURPOSE: Otology and neuro-otology surgeries pose significant challenges due to the intricate and variable anatomy of the temporal bone (TB), requiring extensive training. In the last years 3D-printed temporal bone models for otological dissection are becoming increasingly popular. In this study, we presented a new 3D-printed temporal bone model named 'SAPIENS', tailored for educational and surgical simulation purposes. METHODS: The 'SAPIENS' model was a collaborative effort involving a multidisciplinary team, including radiologists, software engineers, ENT specialists, and 3D-printing experts. The development process spanned from June 2022 to October 2023 at the Department of Sense Organs, Sapienza University of Rome. Acquisition of human temporal bone images; temporal bone rendering; 3D-printing; post-printing phase; 3D-printed temporal bone model dissection and validation. RESULTS: The 'SAPIENS' 3D-printed temporal bone model demonstrated a high level of anatomical accuracy, resembling the human temporal bone in both middle and inner ear anatomy. The questionnaire-based assessment by five experienced ENT surgeons yielded an average total score of 49.4 ± 1.8 out of 61, indicating a model highly similar to the human TB for both anatomy and dissection. Specific areas of excellence included external contour, sigmoid sinus contour, cortical mastoidectomy simulation, and its utility as a surgical practice simulator. CONCLUSION: We have designed and developed a 3D model of the temporal bone that closely resembles the human temporal bone. This model enables the surgical dissection of the middle ear and mastoid with an excellent degree of similarity to the dissection performed on cadaveric temporal bones.
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Modelos Anatómicos , Impresión Tridimensional , Hueso Temporal , Hueso Temporal/anatomía & histología , Hueso Temporal/cirugía , Humanos , Otolaringología/educación , Procedimientos Quirúrgicos Otológicos/educación , Procedimientos Quirúrgicos Otológicos/métodos , Entrenamiento Simulado/métodos , Imagenología TridimensionalRESUMEN
Despite the proven effectiveness of cochlear implant (CI) in the hearing restoration of deaf or hard-of-hearing (DHH) children, to date, extreme variability in verbal working memory (VWM) abilities is observed in both unilateral and bilateral CI user children (CIs). Although clinical experience has long observed deficits in this fundamental executive function in CIs, the cause to date is still unknown. Here, we have set out to investigate differences in brain functioning regarding the impact of monaural and binaural listening in CIs compared with normal hearing (NH) peers during a three-level difficulty n-back task undertaken in two sensory modalities (auditory and visual). The objective of this pioneering study was to identify electroencephalographic (EEG) marker pattern differences in visual and auditory VWM performances in CIs compared to NH peers and possible differences between unilateral cochlear implant (UCI) and bilateral cochlear implant (BCI) users. The main results revealed differences in theta and gamma EEG bands. Compared with hearing controls and BCIs, UCIs showed hypoactivation of theta in the frontal area during the most complex condition of the auditory task and a correlation of the same activation with VWM performance. Hypoactivation in theta was also observed, again for UCIs, in the left hemisphere when compared to BCIs and in the gamma band in UCIs compared to both BCIs and NHs. For the latter two, a correlation was found between left hemispheric gamma oscillation and performance in the audio task. These findings, discussed in the light of recent research, suggest that unilateral CI is deficient in supporting auditory VWM in DHH. At the same time, bilateral CI would allow the DHH child to approach the VWM benchmark for NH children. The present study suggests the possible effectiveness of EEG in supporting, through a targeted approach, the diagnosis and rehabilitation of VWM in DHH children.
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Estimulación Acústica , Percepción Auditiva , Implantación Coclear , Implantes Cocleares , Electroencefalografía , Memoria a Corto Plazo , Personas con Deficiencia Auditiva , Percepción Visual , Humanos , Niño , Femenino , Implantación Coclear/instrumentación , Masculino , Personas con Deficiencia Auditiva/rehabilitación , Personas con Deficiencia Auditiva/psicología , Estudios de Casos y Controles , Ritmo Teta , Estimulación Luminosa , Ritmo Gamma , Adolescente , Percepción del Habla , Corrección de Deficiencia Auditiva/instrumentación , Corteza Cerebral/fisiopatología , Corteza Cerebral/fisiología , Sordera/fisiopatología , Sordera/rehabilitación , Sordera/cirugía , AudiciónRESUMEN
Pulmonary embolism (PE) ranks as a leading cause of in-hospital mortality and the third most common cause of cardiovascular death. The spectrum of PE manifestations varies widely, making it difficult to determine the best treatment approach for specific patients. Conventional treatment options include anticoagulation, thrombolysis, or surgery, but emerging percutaneous interventional procedures are being investigated for their potential benefits in heterogeneous PE populations. These novel interventional techniques encompass catheter-directed thrombolysis, mechanical thrombectomy, and hybrid approaches combining different mechanisms. Furthermore, inferior vena cava filters are also available as an option for PE prevention. Such interventions may offer faster improvements in right ventricular function, as well as in pulmonary and systemic haemodynamics, in individual patients. Moreover, percutaneous treatment may be a valid alternative to traditional therapies in high bleeding risk patients and could potentially reduce the burden of mortality related to major bleeds, such as that of haemorrhagic strokes. Nevertheless, the safety and efficacy of these techniques compared to conservative therapies have not been conclusively established. This review offers a comprehensive evaluation of the current evidence for percutaneous interventions in PE and provides guidance for selecting appropriate patients and treatments. It serves as a valuable resource for future researchers and clinicians seeking to advance this field. Additionally, we explore future perspectives, proposing "percutaneous primary pulmonary intervention" as a potential paradigm shift in the field.
Asunto(s)
Embolia Pulmonar , Terapia Trombolítica , Humanos , Terapia Trombolítica/métodos , Trombectomía/métodos , Embolia Pulmonar/terapia , Resultado del Tratamiento , Fibrinolíticos/uso terapéuticoRESUMEN
Periprocedural myocardial infarction (PMI) and injury, pertinent to both cardiac and non-cardiac procedures, have gained increasing recognition in clinical practice. Over time, diverse definitions for diagnosing PMI have been developed and validated among patient populations undergoing coronary revascularization. However, this variety in definitions presents considerable challenges in clinical settings and complicates both the design and interpretation of clinical trials. The necessity to accurately diagnose PMI has spurred significant interest in establishing universally accepted and prognostically meaningful thresholds for cardiac biomarkers elevation and supportive ancillary criteria. In fact, elevations in cardiac biomarkers in line with the 4th Universal Definition of Myocardial Infarction, have been extensively confirmed to be associated with increased mortality and cardiovascular events. In the context of non-coronary cardiac procedures, such as Transcatheter Aortic Valve Implantation, there is a growing acknowledgment of both the high incidence rates and the adverse impact of PMI on patient outcomes. Similarly, emerging research underscores the significance of PMI and injury in non-cardiac surgery, highlighting the urgent need for effective prevention and risk management strategies in this domain.