Citations

Abstract The pharmacological provocation test is a pivotal tool in cardiac electrophysiology for the diagnosis of potential causes of sudden cardiac death, sudden cardiac arrest (SCA), arrhythmias, symptoms, or ECG abnormalities. The 2022 European Society of Cardiology Guidelines for the Treatment of Ventricular Arrhythmias and Prevention of Sudden Cardiac Death offered guidance on provocation testing but did not describe the indications and requirements in depth. This clinical consensus statement, led by the European Heart Rhythm Association and approved by major international stakeholders, aims to advise the general cardiologist and the arrhythmia expert who to test and when, where, and how to do it. The statement focuses on current practice for the diagnosis of subclinical arrhythmia syndromes and the causes of SCA, building upon the recommendations of the Guidelines. We address the sodium channel blocker provocation test for patients suspected of Brugada syndrome as well as the use of epinephrine, isoproterenol, adenosine, ergonovine, and acetylcholine.

Abstract Background: Prior studies have evaluated the efficacy of subchondroplasty for the management of subchondral cysts of the knee, yet few studies to date evaluate minimum 2-year outcomes following subchondroplasty of the acetabulum. Purpose: The purpose of this study was to evaluate minimum two-year outcomes following arthroscopic subchondroplasty for the treatment of acetabular subchondral cysts and to identify variables associated with total hip arthroplasty (THA) conversion following subchondroplasty. Study Design: Cases Series, Level of Evidence IV. Methods: A retrospective review of prospectively maintained data was performed on patients who underwent primary hip arthroscopy May 2019 to September 2021 by a single surgeon. Consecutive patients who underwent subchondroplasty for acetabular subchondral cysts with minimum two-year follow-up were identified. Demographics, magnetic resonance imaging (MRI), intraoperative findings, and clinical outcomes were evaluated. Cross-sectional area of the subchondral cysts was measured on MRI. Clinical outcomes included Hip Outcome Score–Activities of Daily Living (HOS-ADL), HOS–Sports Subscale (HOS-SS), international Hip Outcome Score-12 (iHOT-12), and visual analog scale for pain (VAS-Pain). Conversion to THA was recorded. The patients who converted to THA were compared to those who did not. Continuous variables associated with THA conversion were analyzed with receiver operating characteristic (ROC) curves to identify thresholds associated with THA conversion. Results: Twenty-nine patients underwent subchondroplasty for acetabular subchondral cysts with minimum two-year follow up (age: 48.2±11.1 years, body mass index: 29.9±6.6kg/m2, 52.0% female). The THA-free survivorship rate was 62.1%. Patients who achieved THA-free survivorship had smaller subchondral cysts (88.5±59.2 mm2 vs. 147.1±54.8, P=0.013) and a lower prevalence of high-grade femoral head chondral defects (16.7% vs. 54.5%, P=0.048) compared to patients who converted to THA. ROC analysis identified patients with a subchondral cyst <133 mm2 were 21.3 times more likely to achieve THA-free survivorship (P=0.001). The THA-free survivors demonstrated significant improvements across all measured PROs (P≤0.015). Conclusions: Subchondroplasty for acetabular subchondral cysts demonstrated a 62.1% THA-free survivorship at minimum 2-year follow-up, with survivors demonstrating significantly improved PROs. Patients with cysts <133 mm2 were 21.3 times more likely to achieve THA-free survivorship than patients with larger cysts. Keywords: Hip, Acetabulum, Subchondral Cysts, Subchondroplasty

OBJECTIVE Core outcome sets (COSs) are needed to promote data consistency across studies as well as data synthesis and comparability. The goal of the current study was to utilize a modified Delphi process to develop a COS–sciatic injury and neuropathy evaluation (COS-SINE). METHODS A five-stage approach was utilized to develop the COS-SINE: stage 1, consortium development; stage 2, literature review to identify potential outcome measures; stage 3, Delphi survey to develop consensus on outcomes for inclusion; stage 4, Delphi survey to develop definitions; and stage 5, consensus meeting to finalize the COS and definitions. The study followed the Core Outcome Set–STAndards for Development recommendations. RESULTS The Core Outcomes in Nerve Surgery (COINS) Consortium comprised 23 participants, all neurological surgeons, representing 13 countries. Three participants were excluded on the basis of agreed upon participation rules. The final COS-SINE consisted of 36 data points/outcomes covering the domains of demographics, diagnostics, patient-reported outcomes, motor and sensory outcomes, and complications. Appropriate instruments, methods of testing, and definitions were set. The consensus minimum duration of follow-up was 24 months, with consensus optimal time points for assessment identified as preoperatively and 3, 6, 12, 24, and 36 months postoperatively. CONCLUSIONS The COINS Consortium developed a consensus COS and provided definitions, methods of implementation, and time points for assessment. The COS-SINE should serve as a minimum set of data that should be collected in all future neurosurgical studies on sciatic nerve injury and neuropathy. Incorporation of this COS should help improve consistency in reporting and data synthesis and comparability and should minimize outcome-reporting bias.

Abstract Excessively restrictive inclusion and exclusion criteria in clinical trials are one of many barriers to clinical trial enrollment for patients with myelodysplastic syndromes/neoplasms (MDSs). Many organizations are developing efforts to increase clinical trial eligibility; yet, several recent publications focused on patients with MDS suggest that many patients with this disease may be excluded from clinical trials unnecessarily. Clinical trial eligibility should reflect the phase of the study and risks of the agent being studied. Phase 3 trials should be less restrictive than early-phase trials to represent the real-world population as closely as possible. We hypothesize that many clinical trials, particularly phase 3 trials, have unnecessarily restrictive eligibility criteria. This study aims to evaluate the most common eligibility criteria according to phase of trial and to determine whether criteria correspond with drug safety signals. We identified MDS clinical trials registered on ClinicalTrials.gov from 1 January 2000 to 1 September 2023 and analyzed the eligibility criteria of 191 therapeutic MDS trials. We found that categorical inclusion and exclusion criteria are remarkably similar in representation across trial phases. Additionally, only 13% of trials are concordant with drug safety signals, suggesting that the eligibility criteria are often arbitrary. On behalf of the icMDS (International Consortium for Myelodysplastic Syndromes), an association of international MDS experts, we provide a position statement on restrictive eligibility criteria for MDS clinical trials that should be avoided with the aim of removing barriers to clinical trial enrollment.

BACKGROUND: Patients presenting with cervical artery dissection (CAD) are at risk for subsequent ischemic events. We aimed to identify characteristics that are associated with increased risk of ischemic stroke after initial presentation of CAD and to evaluate the differential impact of anticoagulant versus antiplatelet therapy in these high-risk individuals. METHODS: This was a preplanned secondary analysis of the STOP-CAD study (Antithrombotic Treatment for Stroke Prevention in Cervical Artery Dissection), a multicenter international retrospective observational study (63 sites from 16 countries in North America, South America, Europe, Asia, and Africa) that included patients with CAD predominantly between January 2015 and June 2022. The primary outcome was subsequent ischemic stroke by day 180 after diagnosis. Clinical and imaging variables were compared between those with versus without subsequent ischemic stroke. Significant factors associated with subsequent stroke risk were identified using stepwise Cox regression. Associations between subsequent ischemic stroke risk and antithrombotic therapy type (anticoagulation versus antiplatelets) among patients with identified risk factors were explored using adjusted Cox regression. RESULTS: In all, 4023 patients (mean age was 47.4 years; 44.5% were women) were included. By day 180, subsequent ischemic stroke occurred in 5.3% of the cohort. In adjusted Cox regression, factors associated with increased risk of subsequent ischemic stroke were prior history of ischemic stroke (adjusted hazard ratio [aHR], 7.31 [95% CI, 1.61–33.13]; P =0.010), presentation within 7 days from first symptoms (aHR, 3.04 [95% CI, 1.04–8.91]; P =0.043), infarct on baseline imaging (aHR, 9.85 [95% CI, 3.65–26.58]; P <0.001), and occlusive dissection (aHR, 2.34 [95% CI, 1.03–5.34]; P =0.043). Only patients with occlusive dissection demonstrated a reduced risk of subsequent ischemic stroke when treated with anticoagulation versus antiplatelets (aHR, 0.36 [95% CI, 0.16–0.80]; P =0.01). CONCLUSIONS: In this post hoc analysis of the STOP-CAD study, several factors associated with subsequent ischemic stroke were identified among patients with CAD. Furthermore, we identified a potential benefit of anticoagulation in patients with CAD with occlusive dissection. These findings require validation by meta-analyses of prior studies to formulate optimal treatment strategies for specific high-risk CAD subgroups.