Implications For Daily Clinical Practice Research Articles

Major vascular complications are reduced by ultrasound guided venous puncture compared to conventional technique in cardiac catheter ablation: a meta-analysis

Abstract Background Puncture site vascular complications are relatively common during invasive electrophysiology. One of the most promising measures to minimize these adverse events is the use of vascular ultrasound during puncture. Objective We aimed to carry out a meta-analysis comparing conventional, anatomically guided femoral venous puncture to ultrasound-guided puncture during electrophysiology procedures, which, in contrast to, the previous meta-analyses, used a uniform endpoint and involved novel trials resulting in higher patients numbers. Methods We conducted a systematic search in relevant electronic databases for articles reporting the rate of vascular complications during EP procedures both with and without ultrasound guidance. We defined major vascular complications (MVCs, as defined in the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus) as the primary endpoint. Secondary endpoints were arteriovenous fistula, pseudoanerurysm and major bleeding separately, and minor vascular complications and accidental arterial punctures. Statistical analysis was performed using a random effect model with the Mantel-Haenszel method. Results A total of 23605 patients were included in the 14 articles matching our selection criteria, and there were data on the primary outcome in 15160 of them (in 11 articles), with 236 (1.6%), who reached the primary endpoint of an MVC. Routine application of ultrasound guidance significantly reduced the incidence of major vascular complications (42/5645 vs. 194/9515, OR 0.36 [0.23–0.55], p<0.001). Furthermore, we found significantly lower incidence in several of our secondary endpoints: for total vascular complications the OR was 0.27 [0.13–0.53] (p<0.001), for major bleedings the OR was 0.42 [0.24–0.74] and for inadvertent artery puncture the OR was 0.24 [0.15–0.38] (p<0.001). Data was insufficiently reported in respect of arteriovenous fistulae and of pseudoanerurysms specifically. Conclusion With more than double of the number of patients compared to the previous meta-analyses, and with a more consistent MVC definition, we showed that ultrasound guidance for femoral venous puncture has significant benefits, most importantly reduces the incidence of major vascular complications and total vascular complications. Our results underscore the need for a randomized controlled trial in the question, with potentially important implications for daily clinical practice and patient safety. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Project no. NVKP_16-1–2016-0017 (“National Heart Program”) has been implemented with the support provided by the Ministry of Innovation and Technology of Hungary from the National Research, Development and Innovation Fund of Hungary, financed under the NVKP_16 funding scheme. -Project no. MEC_R-141548 has been implemented with the support provided by the Ministry of Innovation and Technology of Hungary from the National Research, Development and Innovation Fund, financed under the MEC_R_21 funding scheme.

Which hidradenitis suppurativa comorbidities should I take into account?

Hidradenitis suppurativa (HS) is a chronic, recurrent skin inflammatory disease associated with a variety of comorbidities, like metabolic syndrome, reduced quality of life, sexual dysfunction, working disability, inflammatory bowel disease, axial spondyloarthritis, depression and anxiety. Like psoriasis, HS patients have been found to have higher risk of cardiovascular death and suicide risk. Evidence suggests that for such a chronic, multi-comorbid disease, the use of validated outcomes to assess severity and effect of treatment, along with the use of clinically important patient reported outcomes, is essential. Clinicians should be informed about these comorbidities so that appropriate screening is implemented. The potential of available treatments to negatively and positively affect these comorbidities should also be taken into account when designing treatment strategies. This article aims to provide an outline of important HS comorbidities with emphasis on possible implications for daily clinical practice.

Impact of PET/CT for Assessing Response to Immunotherapy-A Clinical Perspective.

Cancer immunotherapy using immune-checkpoint inhibitors (ICI) has revolutionized the therapeutic landscape of various malignancies like non-small-cell lung cancer or melanoma. Pre-therapy response prediction and assessment during ICI treatment is challenging due to the lack of reliable biomarkers and the possibility of atypical radiological response patterns. Positron emission tomography/computed tomography (PET/CT) enables the visualization and quantification of metabolic lesion activity additional to conventional CT imaging. Various biomarkers derived from PET/CT have been reported as predictors for response to ICI and may aid to overcome the challenges clinicians currently face in the management of ICI-treated patients. In this narrative review, experts in nuclear medicine, thoracic oncology, dermatooncology, hemato- and internal oncology, urological and head/neck tumors performed literature reviews in their respective field and a joint discussion on the use of PET/CT in the context of ICI treatment. The aims were to give a clinical overview on present standards and evidence, to identify current challenges and fields of research and to enable an outlook to future developments and their possible implications. Multiple promising studies concerning ICI response assessment or prediction using biomarkers derived from PET/CT alone or as composite biomarkers have been identified for various malignancies and disease stages. Of interest, additional major incentives in the field may evolve from novel tracers specifically targeting immune-checkpoint molecules which could allow not only response assessment and prognosis, but also visualization of histological tumor cell properties like programmed death-ligand (PD-L1) expression in vivo. Despite the broad range of existing literature on PET/CT-derived biomarkers in ICI therapy, implications for daily clinical practice remain elusive. High-quality prospective data are urgently warranted to determine whether patients benefit from the application of PET/CT in terms of prognosis. At the moment, the lack of such evidence as well as the absence of standardized imaging methods and biomarkers still precludes PET/CT imaging to be included in the relevant clinical practice guidelines.

Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial

BackgroundIn oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings.MethodsThe trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated.DiscussionThe presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries.Trial registrationClinicalTrials.gov NCT04066868. Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)

Review of Comorbidities of Hidradenitis Suppurativa: Implications for Daily Clinical Practice.

Hidradenitis suppurativa (HS) is a chronic, recurrent skin inflammatory disease associated with a variety of comorbidities, like reduced quality of life, metabolic syndrome, sexual dysfunction, working disability, axial spondyloarthritis, inflammatory bowel disease, depression, and anxiety. Like psoriasis, HS patients have been found to have higher risk of cardiovascular death and suicide risk. Clinicians should be informed about these comorbidities so that appropriate screening is implemented. All this evidence suggests that for such a chronic, multi-comorbid disease, the use of validated outcomes to assess severity and effect of treatment, along with the use of clinically important patient reported outcomes, is essential. The potential of available treatments to negatively and positively affect these comorbidities should also be taken into account when designing treatment strategies. This review provides an outline of important HS comorbidities with emphasis on possible implications for daily clinical practice.

Impact of PET reconstruction protocols on quantification of lesions that fulfil the PERCIST lesion inclusion criteria

BackgroundThe aim of this study was to compare liver and oncologic lesion standardized uptake values (SUV) obtained through two different reconstruction protocols, GE’s newest clinical lesion detection protocol (Q.Clear) and the EANM Research Ltd (EARL) harmonization protocol, and to assess the clinical relevance of potential differences and possible implications for daily clinical practice using the PERCIST lesional inclusion criteria.NEMA phantom recovery coefficients (RC) and SUV normalized for lean body mass (LBM), referred to as SUV normalized for LBM (SUL), of liver and lesion volumes of interest were compared between the two reconstruction protocols. Head-to-toe PET/CT examinations and raw data from 64 patients were retrospectively retrieved. PET image reconstruction was carried out twice: once optimized for quantification, complying with EARL accreditation requirements, and once optimized for lesion detection, according to GE’s Q.Clear reconstruction settings.ResultsThe two reconstruction protocols showed different NEMA phantom RC values for different sphere sizes. Q.Clear values were always highest and exceeded the EARL accreditation maximum for smaller spheres. Comparison of liver SULmean showed a statistically significant but clinically irrelevant difference between both protocols. Comparison of lesion SULpeak and SULmax showed a statistically significant, and clinically relevant, difference of 1.64 and 4.57, respectively.ConclusionsFor treatment response assessment using PERCIST criteria, the harmonization reconstruction protocol should be used as the lesion detection reconstruction protocol using resolution recovery systematically overestimates true SUL values.

Achieving recovery in patients with schizophrenia through psychosocial interventions: A retrospective study.

Recovery, or functional remission, represents the ultimate treatment goal in schizophrenia. Despite its importance, a standardized definition of remission is still lacking, thus reported rates significantly vary across studies. Moreover, the effects of rehabilitative interventions on recovery have not been thoroughly investigated. This study aimed to evaluate recovery in a sample of patients with chronic schizophrenia engaged in rehabilitation programs and to explore contributing factors, with a focus on sociocognitive rehabilitative interventions. Data from 104 patients with schizophrenia treated either with a standard rehabilitation program, including cognitive remediation (n = 46), or the latter plus a specific sociocognitive intervention (n = 58), and assessed for psychopathology, cognition, social cognition, and Quality of Life Scale, were retrospectively analyzed for this study. Recovery, evaluated with the Quality of Life Scale, was achieved by 56.76% of patients in our sample. While no effects were observed for clinical, cognitive, or sociocognitive variables, participation in the sociocognitive rehabilitative interventions was positively associated with recovery. Our results indicate that high rates of recovery can be achieved in patients treated with psychosocial interventions and suggest that rehabilitative programs targeting social cognition may further facilitate the process of recovery. If confirmed, these results may have relevant implications for daily clinical practice and service provision, allowing clinicians to develop and optimize specific rehabilitation programs in order to promote recovery.

The year in cardiology 2015: arrhythmias and device therapy

The year 2015 was once more filled with exciting and important novel developments in the field of invasive electrophysiology and implantable cardiac devices. These include technical innovation, novel molecular and cellular insights, and presentation of large randomized clinical trials as well as important ‘real-world’ registries. In addition, several new guidelines surfaced in 2015, including those for the treatment of ventricular arrhythmias and prevention of sudden cardiac death. It is virtually impossible to cover all novel developments that would merit discussion in this type of overview; as a result, the authors had to make a selection, focusing on several important developments with direct implications for daily clinical practice.

The year in cardiology 2015: arrhythmias and device therapy.

The year 2015 was once more filled with exciting and important novel developments in the field of invasive electrophysiology and implantable cardiac devices. These include technical innovation, novel molecular and cellular insights, and presentation of large randomized clinical trials as well as important ‘real-world’ registries. In addition, several new guidelines surfaced in 2015, including those for the treatment of ventricular arrhythmias and prevention of sudden cardiac death. It is virtually impossible to cover all novel developments that would merit discussion in this type of overview; as a result, the authors had to make a selection, focusing on several important developments with direct implications for daily clinical practice. ### Atrial fibrillation Catheter ablation of atrial fibrillation (AF) remained in focus of clinical studies and large-scale trials. The use of force-sensing ablation catheter technologies seems to improve the induction of durable atrial lesions and was shown to significantly reduce AF recurrence rate after catheter ablation in a meta-analysis mainly made of non-randomized trials.1 This technology will become standard for AF catheter ablation in the future. A word of caution: there is growing evidence that more extensive ablation in the atria does not per se improve the rhythm outcome after AF catheter ablation. The Minimax Trial compared two ablation strategies for pulmonary vein isolation (PVI) in 234 patients who underwent catheter ablation of paroxysmal AF: circumferential antral PVI alone (‘minimal’) vs. PVI with intravenous ridge ablation to achieve individual PVI (‘maximal’). After a mean follow-up of 17 ± 8 months, freedom from AF after limited ‘minimal’ ablation was not worse compared with more extensive ‘maximal’ ablation (70 vs. 62%; P = 0.25).2 Previous data indicated that adenosine-guided detection of …

Systemic lupus erythematosus and fractures

Since survival of patients with systemic lupus erythematosus (SLE) has improved over the past decades, increasing attention is focused on complications of the disease. Osteoporosis and fractures contribute to damage...

SP0183 Multifactorial Pathogenesis of Osteoporosis in Sle

Systemic Lupus Erythematosus (SLE) is a chronic multisystem autoimmune disease that usually affects women during the childbearing ages. Because survival of SLE patients has improved dramatically over the last decades,...

HIV testing and antiretroviral treatment strategies for prevention of HIV infection: impact on antiretroviral drug resistance

'Test and treat' is a strategy in which widespread screening for human immunodeficiency virus (HIV) is followed by immediate antiretroviral therapy for those testing positive, thereby potentially reducing infectiousness in larger cohorts of infected patients. However, there is a concern that test and treat could lead to increased the levels of transmissible drug-resistant HIV, especially if viral load and/or drug resistance is not routinely monitored. Reviews of the existing literature show that up to now, even in the absence of laboratory tests, drug resistance has not created major problems in sub-Saharan Africa. Here, we discuss the current evidence for the effectiveness of a preventive test and treat approach and the challenges and implications for daily clinical practice and public health.

The Nocebo Effect and Its Relevance for Clinical Practice

Negative expectations deriving from the clinical encounter can produce negative outcomes, known as nocebo effects. Specifically, research on the nocebo effect indicates that information disclosure about potential side effects can itself contribute to producing adverse effects. Neurobiological processes play a role in the nocebo effect, and this article provides a selective review of mechanistic research on the nocebo effect. Comparatively little attention has been directed to clinical studies and their implications for daily clinical practice. The nocebo response is influenced by the content and the way information is presented to patients in clinical trials in both the placebo and active treatment conditions. Nocebo effects adversely influence quality of life and therapy adherence, emphasizing the need for minimizing these responses to the extent possible. Evidence further indicates that the informed consent process in clinical trials may induce nocebo effects. This article concludes with ethical directions for future patient-oriented research and routine practice.

Glycemic Control in the Intensive Care Unit and during the Postoperative Period

Glycemic Control in the Intensive Care Unit and during the Postoperative Period

Genetic testing in the epilepsies—Report of the ILAE Genetics Commission

In this report, the International League Against Epilepsy (ILAE) Genetics Commission discusses essential issues to be considered with regard to clinical genetic testing in the epilepsies. Genetic research on the epilepsies has led to the identification of more than 20 genes with a major effect on susceptibility to idiopathic epilepsies. The most important potential clinical application of these discoveries is genetic testing: the use of genetic information, either to clarify the diagnosis in people already known or suspected to have epilepsy (diagnostic testing), or to predict onset of epilepsy in people at risk because of a family history (predictive testing). Although genetic testing has many potential benefits, it also has potential harms, and assessment of these potential benefits and harms in particular situations is complex. Moreover, many treating clinicians are unfamiliar with the types of tests available, how to access them, how to decide whether they should be offered, and what measures should be used to maximize benefit and minimize harm to their patients. Because the field is moving rapidly, with new information emerging practically every day, we present a framework for considering the clinical utility of genetic testing that can be applied to many different syndromes and clinical contexts. Given the current state of knowledge, genetic testing has high clinical utility in few clinical contexts, but in some of these it carries implications for daily clinical practice.

Joint National Committee VII and European Society of Hypertension/European Society of Cardiology Guidelines for Evaluating and Treating Hypertension

During the first half of the past year, guidelines for hypertension management issued by the Joint National Committee (JNC VII) and by the European Society of Hypertension in conjunction to the European Society of Cardiology (ESH/ESC) have been published in major scientific journals. This article reviews the main features and elements of novelty of these authoritative recommendations. It also highlights the major agreements and disagreements between the two sets of guidelines and their implications for daily clinical practice.

Acute Inflammatory Events and Ischemic Stroke Subtypes

Background: Recent studies have suggested that previous infection may be a risk factor for ischemic stroke mainly in young and middle-aged patients. The present study sought to further investigate the association between recent inflammatory events (IE) and ischemic stroke without age restriction and to determine the role of recent IE in different ischemic stroke subtypes. Methods: We performed a case-control study with 93 consecutive hospitalized stroke patients and 200 (107 hospital and 93 community) controls. Acute IE, both infective and non-infective, occurring in the previous 30 days were assessed using a standard questionnaire. The TOAST criteria were used for ischemic stroke subtypes classification. Results: Acute IE in the previous 30 and 7 days were significantly and independently associated with ischemic stroke (37/93 vs. 47/200; OR 2.23, 95% CI 1.26–3.96 and 17/93 vs.16/200; OR 2.45, 95% IC 1.11–5.39, respectively). Stratifying for stroke subtypes, acute IE significantly and independently increased the risk of atherothrombotic (OR 5.72, 95% CI 2.14–15.25) and cardioembolic stroke (OR 3.02, 95%CI 1.20–7.63). Conclusions: Acute IE increase the risk of acute ischemic stroke of atherothrombotic and cardioembolic type independently of other predisposing factors. Implications for daily clinical practice, in relation to prevention and treatment of IE in patients at risk, have to be explored.