CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) update 2022

Primary Percutaneous Coronary Intervention (PCI) has significantly contributed to reducing the mortality of patients with ST-segment elevation myocardial infarction (STEMI) even in cardiogenic shock and is now the standard of care in most of Japanese institutions. The Task Force on Primary PCI of the Japanese Association of Cardiovascular Interventional and Therapeutics (CVIT) society proposed an expert consensus document for the management of acute myocardial infarction (AMI) focusing on procedural aspects of primary PCI in 2018. Updated guidelines for the management of AMI were published by the European Society of Cardiology (ESC) in 2017 and 2020. Major changes in the guidelines for STEMI patients included: (1) radial access and drug-eluting stents (DES) over bare-metal stents (BMS) were recommended as a Class I indication, (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. In 2020, updated guidelines for Non-ST-Elevation Myocardial Infarction (NSTEMI) patients, the followings were changed: (1) an early invasive strategy within 24 h is recommended in patients with NSTEMI as a Class I indication, (2) complete revascularization in NSTEMI patients without cardiogenic shock is considered as Class IIa recommendation, and (3) in patients with atrial fibrillation following a short period of triple antithrombotic therapy, dual antithrombotic therapy (e.g., DOAC and single oral antiplatelet agent preferably clopidogrel) is recommended, with discontinuation of the antiplatelet agent after 6 to 12 months. Furthermore, an aspirin-free strategy after PCI has been investigated in several trials those have started to show the safety and efficacy. The Task Force on Primary PCI of the CVIT group has now proposed the updated expert consensus document for the management of AMI focusing on procedural aspects of primary PCI in 2022 version.

Eligibility criteria for pediatric patients who may benefit from anti SARS-CoV-2 monoclonal antibody therapy administration: an Italian inter-society consensus statement

The fast diffusion of the SARS-CoV-2 pandemic have called for an equally rapid evolution of the therapeutic options.The Human recombinant monoclonal antibodies (mAbs) have recently been approved by the Food and Drug Administration (FDA) and by the Italian Medicines Agency (AIFA) in subjects aged ≥12 with SARS-CoV-2 infection and specific risk factors.Currently the indications are specific for the use of two different mAbs combination: Bamlanivimab+Etesevimab (produced by Eli Lilly) and Casirivimab+Imdevimab (produced by Regeneron).These drugs have shown favorable effects in adult patients in the initial phase of infection, whereas to date few data are available on their use in children.AIFA criteria derived from the existing literature which reports an increased risk of severe COVID-19 in children with comorbidities. However, the studies analyzing the determinants for progression to severe disease are mainly monocentric, with limited numbers and reporting mostly generic risk categories.Thus, the Italian Society of Pediatrics invited its affiliated Scientific Societies to produce a Consensus document based on the revision of the criteria proposed by AIFA in light of the most recent literature and experts’ agreement.This Consensus tries to detail which patients actually have the risk to develop severe disease, analyzing the most common comorbidities in children, in order to detail the indications for mAbs administration and to guide the clinicians in identifying eligible patients.

Transition of adolescents with severe asthma from pediatric to adult care in Spain: the STAR consensus

Objective: To assess the consensus level among a multidisciplinary expert panel on the transition of adolescents with severe asthma from pediatric to adult care. Methods: A 61-item survey was developed based on guidelines for other chronic pathologies, covering transition planning, preparation, effective transfer, and follow-up. A two-round Delphi process assessed the consensus level among 98 experts (49 pediatricians, 24 allergists and 25 pulmonologists). Consensus was established with ≥70% agreement. Results: Forty-two items (70%) reached consensus. No age range to initiate the transition was agreed upon by the panelists. The main goal to achieve during the transition identified by the experts is that adolescents gain autonomy to manage their severe asthma and prescribed treatments. The panelists agreed on the importance of developing an individualized plan, promoting patient’s autonomy, and identifying home environment factors. They agreed that the adult healthcare team should have expertise in severe asthma, biologics and management of adolescent patients. Pediatric and adult healthcare teams should share clinical information, agree on the criteria to maintain the biological therapy, and have an on-site joint visit with the patient before the effective transfer. Adult healthcare professionals should closely follow the patient after the effective transfer to ensure correct inhaler technique, treatment adherence and attendance to healthcare appointments. Conclusions: This consensus document provides the first roadmap for Spanish pediatric and adult teams to ensure that key aspects of the transition process in severe asthma are covered. The implementation of these recommendations will improve the quality of care offered to the patient.

Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups

PURPOSE As prostate-specific membrane antigen (PSMA) positron emission tomography (PET) becomes increasingly available in the United States, the greater sensitivity of the technology in comparison to conventional imaging poses challenges for clinical trials. The NCI Clinical Imaging Steering Committee (CISC) PSMA PET Working Group was convened to coordinate the identification of these challenges in various clinical scenarios and to develop consensus recommendations on how best to integrate PSMA PET into ongoing and upcoming National Clinical Trials Network (NCTN) trials. METHODS NCI CISC and NCI Genitourinary Steering Committee members and leadership nominated clinicians, biostatisticians, patient advocates, and other imaging experts for inclusion in the PSMA PET Working Group. From April to July 2021, the working group met independently and in conjunction with the CISC to frame challenges, including stage migration, response assessment, trial logistics, and statistical challenges, and to discuss proposed solutions. An anonymous, open-ended survey was distributed to members to collect feedback on challenges faced. Representatives from each NCTN group were invited to present an overview of affected trials. From these discussions, the consensus document was developed and circulated for the inclusion of multiple rounds of feedback from both the Working Group and CISC. RESULTS The current consensus document outlines the key challenges for clinical prostate cancer trials resulting from the increasing availability of PSMA PET. We discuss implications for patient selection and definition of end points and provide guidance and potential solutions for different clinical scenarios, particularly with regard to best practices in defining eligibility criteria and outcome measures. RECOMMENDATIONS This article provides guidance regarding clinical trial design and conduct, and the interpretation of trial results.

Consensus on COVID-19 vaccination in pediatric oncohematological patients, on behalf of infectious working group of Italian Association of Pediatric Hematology Oncology

Vaccines represent the best tool to prevent the severity course and fatal consequences of pandemic by new Coronavirus 2019 infection (SARS CoV 2). Considering the limited data on vaccination of pediatric oncohematological patients, we develop a Consensus document to support the Italian pediatric hematological oncological (AIEOP) centers in a scientifically correct communication with families and patients and to promote vaccination. The topics of the Consensus were: SARS CoV 2 infection and disease (COVID 19) in the pediatric subject s; COVID 19 vaccines (type, schedule); which and when to vaccinate; contraindications and risk of serious adverse events; rare adverse events; third dose and vaccination after COVID 19; and other general prevention measures. Using the Delphi methodology fo r Consensus, 21 statements and their corresponding rationale were elaborated and discussed with the representatives of 31 centers, followed by voting. AIEOP Centers showed an overall agreement on all the statements that were therefore approved. This consensus document highlights that children and adolescents affected by hematological and oncological diseases are a fragile category. Vaccination plays an important role to prevent COVID19, to permit the regular administration of chemotherapy or other treatmen ts, to perform control visits and hospital admissions, and to prevent treatment delays.

Pramoxine containing topical formulation of eberconazole in the management of dermatophytosis in India: a consensus statement

<p>Dermatophytosis, a superficial fungal infection has attained significant extents among Indian population. Its clinical presentation is diverse, often in terms of morphology, severity type and involvement of all age groups. Management of dermatophytosis has become an important public health issue in India. Cases of steroid modified dermatophytosis are being encountered frequently, mostly caused due to the inadvertent use of steroid in combination with topical antifungal agents. This combination is available over the counter and is often used for the management of inflammation and pruritis associated with the disease. Current treatment recommendations must be reviewed as per the current clinical scenario of the disease. Thus, a topical formulation of an anti-itch agent like pramoxine and antifungal agent with an anti-inflammatory property like eberconazole holds a promising treatment approach for dermatophytosis. This article focuses on the challenges encountered in the management of dermatophytosis and strategies for optimizing treatment for better patient outcomes. An expert’s panel discussion was conducted involving fifteen dermatologists all over India, during which modified Delphi method was executed for a set of nine statements. Agreement of more than 75% was set to reach the consensus. This consensus document was developed to review the available evidence and make recommendation based on the expert group’s opinion for the use of pramoxine containing topical formulation of eberconazole, as it provides the benefit of having an anti-inflammatory and anti-pruritic activity in a single formulation, where pramoxine can be utilised as an excipient to combat pruritis associated with dermatophytosis.</p><p><strong> </strong></p>