AGA technical review: Malnutrition and cachexia, chronic diarrhea, and hepatobiliary disease in patients with human immunodeficiency virus infection

Disorders of the gastrointestinal tract and hepatobiliary system are among the most common complications associated with human immunodeficiency virus (HIV) infection. These disorders not only result in major morbidity but mortality as well. With increasing use of prophylaxis against Pneumocystis carinii pneumonia, the incidence of opportunistic gastrointestinal disorders has increased. ^{[1] , [2] and [3]} Significant progress has been made in the last decade in characterizing the spectrum of pathogens involving the gastrointestinal and hepatobiliary systems, determining the pathophysiological mechanisms of these diverse processes, and defining management options. Despite these encouraging advancements, many questions remain unanswered. The purpose of this review is to evaluate and synthesize the published clinical research pertaining to three important HIV-related complications: malnutrition and cachexia, chronic diarrhea, and hepatobiliary disease. A separate review addresses disorders of the esophagus.⁴ Attention here is focused on etiology and pathogenesis, clinical features, diagnostic strategies, and efficacy of current treatment options. Recommendations for managing patients with these complications are provided based on the weight of the clinical evidence.GASTROENTEROLOGY 1996;111:1724-1752     

Outcomes of Veterans Undergoing TAVR Within Veterans Affairs Medical Centers: Insights From the Veterans Affairs Clinical Assessment,Reporting, and Tracking Program

ObjectivesThis study sought to describe clinical and procedural characteristics of veterans undergoing transcatheter aortic valve replacement (TAVR) within U.S. Department of Veterans Affairs (VA) centers and to examine their association with short- and long-term mortality, length of stay (LOS), and rehospitalization within 30 days.BackgroundVeterans with severe aortic stenosis frequently undergo TAVR at VA medical centers.MethodsConsecutive veterans undergoing TAVR between 2012 and 2017 were included. Patient and procedural characteristics were obtained from the VA Clinical Assessment, Reporting, and Tracking system. The primary outcomes were 30-day and 1-year survival, LOS >6 days, and rehospitalization within 30 days. Logistic regression and Cox proportional hazards analyses were performed to evaluate the associations between pre-procedural characteristics and LOS and rehospitalization.ResultsNine hundred fifty-nine veterans underwent TAVR at 8 VA centers during the study period, 860 (90%) by transfemoral access, 50 (5%) transapical, 36 (3.8%) transaxillary, and 3 (0.3%) transaortic. Men predominated (939 of 959 [98%]), with an average age of 78.1 years. There were 28 deaths within 30 days (2.9%) and 134 at 1 year (14.0%). Median LOS was 5 days, and 141 veterans were rehospitalized within 30 days (14.7%). Nonfemoral access (odds ratio: 1.74; 95% confidence interval [CI]: 1.10 to 2.74), heart failure (odds ratio: 2.51; 95% CI: 1.83 to 3.44), and atrial fibrillation (odds ratio: 1.40; 95% CI: 1.01 to 1.95) were associated with increased LOS. Atrial fibrillation was associated with 30-day rehospitalization (hazard ratio: 1.79; 95% CI: 1.22 to 2.63).ConclusionsVeterans undergoing TAVR at VA centers are predominantly elderly men with significant comorbidities. Clinical outcomes of mortality and rehospitalization at 30 days and 1-year mortality compare favorably with benchmark outcome data outside the VA.     

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC,and TVT Registry

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 “core” data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.     

Opportunities and challenges in heart rhythm research: Rationale and development of an electrophysiology collaboratory

There are many challenges in the current landscape of electrophysiology (EP) clinical and translational research, including increasing costs and complexity, competing demands, regulatory requirements, and challenges with study implementation. This review seeks to broadly discuss the state of EP research, including challenges and opportunities. Included here are results from a Heart Rhythm Society (HRS) Research Committee member survey detailing HRS members’ perspectives regarding both barriers to clinical and translational research and opportunities to address these challenges. We also provide stakeholder perspectives on barriers and opportunities for future EP research, including input from representatives of the U.S. Food and Drug Administration, industry, and research funding institutions that participated in a Research Collaboratory Summit convened by HRS. This review further summarizes the experiences of the heart failure and heart valve communities and how they have approached similar challenges in their own fields. We then explore potential solutions, including various models of research ecosystems designed to identify research challenges and to coordinate ways to address them in a collaborative fashion in order to optimize innovation, increase efficiency of evidence generation, and advance the development of new therapeutic products. The objectives of the proposed collaborative cardiac EP research community are to encourage and support scientific discourse, research efficiency, and evidence generation by exploring collaborative and equitable solutions in which stakeholders within the EP community can interact to address knowledge gaps, innovate, and advance new therapies.     

Dietary assessment methods in surveillance systems targeted to adolescents: A review of the literature

AimsThe present paper aims to identify ongoing multinational surveillance systems (SURSYSs) assessing diet and nutrition targeted to adolescents, including European surveys involving multiple countries and similar initiatives conducted in non-European countries with developed economies, and to describe the dietary assessment methods used.Data synthesisA total of 13 SURSYSs conducted in Europe, USA, Canada, Australia and New Zealand were identified. Dietary assessment methods commonly used include 24-h recalls (24H-Rs) and questionnaires or interviews. Food frequency questionnaires (FFQs) are used in combination with 24H-Rs in six SURSYSs: only FFQs are used in four SURSYSs; 24H-Rs only in one system and a 24H-R in combination with a general questionnaire/interview in one SURSYS. Eleven systems collect information also on some dietary habits and ten systems on other nutritional indicators such as anthropometric and/or biochemical measures. The FFQs used are not homogeneous and often include limited food or beverage items such as fruits and vegetables or sugar-sweetened beverages. In seven systems, foods specifically consumed by adolescents, such as fast food or snacks, are not assessed; instead, a total of seven systems collect data on supplement intake and just in very few cases on fats, legumes and/or water.ConclusionsThis study detected considerable variability across the systems identified, suggesting the need for a SURSYS targeted to adolescents that gathers as much as possible complete dietary information, with standardised methodology and regular periodicity. The detailed information provided by this review could be useful to national authorities for the choice of protocols to be applied in their own national surveys.