Revisiting aortic valve prosthesis choice in patients younger than 50 years: 10 years results of the AUTHEARTVISIT study.

OBJECTIVES: This population-based cohort study investigated mid-term outcome after surgical aortic valve replacement with a bioprosthetic or mechanical valve prosthesis in patients aged <50 years in a European social welfare state. METHODS: We analysed patient data from the main social insurance carriers in Austria (2010-2020). Subsequent patient-level record linkage with national health data provided patient characteristics and clinical outcome. Survival, reoperation, myocardial infarction, heart failure, embolic stroke or intracerebral haemorrhage, bleeding other than intracerebral haemorrhage and major adverse cardiac events were evaluated as outcomes. RESULTS: A total of 991 patients were analysed. Regarding demographics, no major differences between groups were observed. Multivariable Cox regression revealed no significant difference in overall survival (P = 0.352) with a median follow-up time of 6.2 years. Reoperation-free survival was decreased (hazard ratio = 1.560 [95% CI: 1.076-2.262], P = 0.019) and the risk for reoperation was increased (hazard ratio = 2.770 [95% CI: 1.402-5.472], P = 0.003) in patients who received bioprostheses. Estimated probability of death after reoperation was 0.23 (CL: 0.08-0.35) after 2 years and 0.34 (CL: 0.06-0.53) after 10 years over both groups. Regarding further outcomes, no significant differences between the two groups were observed. CONCLUSIONS: In patients below 50 years of age receiving aortic valve replacement, implantation of bioprostheses when compared to mechanical heart valve prostheses was associated with a significantly higher rate of reoperations and reduced reoperation-free survival. Nevertheless, we could not observe a difference in overall survival. However, long-term follow-up has to evaluate that a significantly lower rate of reoperations may translate in consistently improved long-term survival.

PerIoperative iNflammatory reSponse assessment In hiGH-risk patienTs undergoing non-cardiac surgery (INSIGHT): study protocol of a prospective non-interventional observational study.

INTRODUCTION: Increased inflammatory processes after non-cardiac surgery are very common. The association between postoperative inflammation and the occurrence of cardiovascular complications after non-cardiac surgery are still not entirely clear. Therefore, we will evaluate the association between postoperative inflammation and the occurrence of major cardiovascular complications in patients at-risk for cardiovascular complications undergoing non-cardiac surgery. We will further evaluate the association of postoperative inflammation and days-at-home within 30 days after surgery (DAH30), the incidence of acute kidney injury, postoperative N-terminal probrain natriuretic peptide (NT-proBNP) concentrations and neurocognitive decline. METHODS AND ANALYSIS: In this multicentre study, we will include 1400 patients at-risk for cardiovascular complications undergoing non-cardiac surgery. Our primary aim is to evaluate the association of postoperative maximum C-reactive protein concentration and the occurrence of a composite of five major cardiovascular complications (myocardial infarction, myocardial injury after non-cardiac surgery, new onset of atrial fibrillation, stroke and death) within 30 days after surgery using a Mann-Whitney-U test as well as a logistic regression model. As our secondary aim, we will evaluate the association of a composite of three inflammatory biomarkers (interleukin 6, procalcitonin and copeptin) on the occurrence of our composite of five cardiovascular complications within 30 days and 1 year after surgery, acute kidney injury, DAH30 and NT-proBNP concentrations using linear or logistic regression models. We will measure inflammatory biomarkers before surgery, and on the first, second, third and fifth postoperative day. We will check medical records and conduct a telephone survey 30 days and 1 year after surgery. We evaluate neurocognitive function, using a Montreal Cognitive Assessment, before and 1 year after surgery. ETHICS AND DISSEMINATION: This study was approved by the ethics committees at the Medical University of Vienna (2458/2020) and at the Medical University of Graz (33-274 ex 20/21). TRIAL REGISTRATION NUMBER: NCT04753307.

Mechanical aortic valve prostheses offer a survival benefit in 50-65 year olds: AUTHEARTVISIT study.

BACKGROUND: The present population-based cohort study investigated long-term mortality after surgical aortic valve replacement (AVR) with bioprosthetic (B) or mechanical aortic valve prostheses (M) in a European social welfare state. METHODS: We analysed patient data from health insurance records covering 98% of the Austrian population between 2010 and 2018. Subsequent patient-level record linkage with national health data provided patient characteristics and clinical outcomes. Further reoperation, myocardial infarction, heart failure and stroke were evaluated as secondary outcomes. RESULTS: A total of 13,993 patients were analysed and the following age groups were examined separately: <50 years (727 patients: 57.77% M, 42.23% B), 50-65 years (2612 patients: 26.88% M, 73.12% B) and >65 years (10,654 patients: 1.26% M, 98.74% B). Multivariable Cox regression revealed that the use of B-AVR was significantly associated with higher mortality in patients aged 50-65 years compared to M-AVR (HR = 1.676 [1.289-2.181], p < 0.001). B-AVR also performed worse in a competing risk analysis regarding reoperation (HR = 3.483 [1.445-8.396], p = 0.005) and myocardial infarction (HR = 2.868 [1.255-6.555], p = 0.012). However, the risk of developing heart failure and stroke did not differ significantly after AVR in any age group. CONCLUSIONS: Patients aged 50-65 years who underwent M-AVR had better long-term survival, and a lower risk of reoperation and myocardial infarction. Even though anticoagulation is crucial in patients with M-AVR, we did not observe significantly increased stroke rates in patients with M-AVR. This evident survival benefit in recipients of mechanical aortic valve prostheses aged <65 years critically questions current guideline recommendations.

The acceptability and feasibility of a pilot study examining the impact of a mobile technology-based intervention informed by behavioral economics to improve HIV knowledge and testing frequency among Latinx sexual minority men and transgender women.

BACKGROUND: We developed a novel intervention that uses behavioral economics incentives and mobile-health text messages to increase HIV knowledge and testing frequency among Latinx sexual minority men and Latinx transgender women. Here we provide a theoretically-grounded assessment regarding the intervention's acceptability and feasibility. METHODS: We conducted 30-min exit interviews with a stratified sample of participants (n = 26 Latinx sexual minority men, 15 Latinx transgender women), supplemented with insights from study staff (n = 6). All interviews were recorded, transcribed, and translated for a content analysis using Dedoose. Cohen's Kappa was 89.4% across coded excerpts. We evaluated acceptability based on how participants cognitively and emotionally reacted to the intervention and whether they considered it to be appropriate. We measured feasibility based on resource, scientific and process assessments (e.g., functionality of text messaging service, feedback on study recruitment procedures and surveys). RESULTS: Regarding acceptability, most participants clearly understood the intervention as a program to receive information about HIV prevention methods through text messages. Participants who did not complete the intervention shared they did not fully understand what it entailed at their initial enrollment, and thought it was a one-time engagement and not an ongoing program. Though some participants with a higher level of education felt the information was simplistic, most appreciated moving beyond a narrow focus on HIV to include general information on sexually transmitted infections; drug use and impaired sexual decision-making; and differential risks associated with sexual positions and practices. Latinx transgender women in particular appreciated receiving information about Pre-Exposure Prophylaxis. While participants didn't fully understand the exact chances of winning a prize in the quiz component, most enjoyed the quizzes and chance of winning a prize. Participants appreciated that the intervention required a minimal time investment. Participants shared that the intervention was generally culturally appropriate. Regarding feasibility, most participants reported the text message platform worked well though inactive participants consistently said technical difficulties led to their disengagement. Staff shared that clients had varying reactions to being approached while being tested for HIV, with some unwilling to enroll and others being very open and curious about the program. Both staff and participants relayed concerns regarding the length of the recruitment process and study surveys. CONCLUSIONS: Our theoretically-grounded assessment shows the intervention is both acceptable and feasible. TRIAL REGISTRATION: The trial was registered on May 5, 2017 with the ClinicalTrials.gov registry [ NCT03144336 ].

Brief Report: Using Behavioral Economics to Increase HIV Knowledge and Testing Among Latinx Sexual Minority Men and Transgender Women: A Quasi-Experimental Pilot Study.

OBJECTIVE: To determine how weekly text messages and small incentives impact HIV knowledge and frequency of HIV testing among Latinx sexual minority men (LSMM) and transgender women (LTGW). DESIGN: Prospectively randomized participants into 2 intervention arms compared with a nonrandomized comparison group. SETTING: Bienestar, a primarily Latinx focused HIV service provider located across Los Angeles County. SUBJECTS, PARTICIPANTS: Two hundred eighteen participants self-identifying as LSMM or LTGW, HIV negative, having regular mobile phone access, ≥18 years, and fluent in English or Spanish. INTERVENTION: The "information only" (IO) group received text messages with HIV prevention information. The "information plus" (IP) group additionally could win incentives by answering weekly quiz questions correctly and testing for HIV once every 3 months. We followed participants for 12 months. MAIN OUTCOME MEASURE(S): HIV knowledge and frequency of HIV testing. RESULTS: We found no effect on HIV knowledge in the IO group but a statistically significant improvement in the IP group (79.2%-88.1%; P = 0.007). The frequency of HIV testing was higher in both intervention groups relative to the comparison group: On average, 22.0% of IO participants and 24.9% of IP participants tested at a Bienestar site within a given 3-month period, compared with 13.0% in the comparison group. This represents unadjusted relative risk ratios of 1.69 for the IO group (95% CI: 1.25 to 2.1; P < 0.01) and 1.91 for the IP group (95% CI: 1.51 to 2.31; P < 0.01), respectively. CONCLUSIONS: This study demonstrates that a simple, low-cost intervention may help increase HIV testing frequency among LSMM and LTGW, 2 groups at high HIV risk.

A randomized controlled trial study of the acceptability, feasibility, and preliminary impact of SITA (SMS as an Incentive To Adhere): a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda.

BACKGROUND: Studies report serious adherence problems among youth (individuals age 15-24 years of age) in Uganda. Recent growth in mobile phone ownership has highlighted the potential of using text-based interventions to improve antiretroviral treatment (ART) adherence among Ugandan youth. We piloted a randomized controlled trial of a text-based intervention providing weekly real-time antiretroviral adherence feedback, based on information from a smart pill box, to HIV-positive Ugandan youth. In this paper, we report the acceptability, feasibility, and preliminary impact of the intervention. METHODS: We randomized participants to a control group, or to receive messages with information on either their own adherence levels (Treatment 1 - T1), or their own adherence and peer adherence levels (Treatment 2 - T2). We conducted six focus groups from December 2016 to March 2017 with providers and youth ages 15-24, double coded 130 excerpts, and achieved a pooled Cohen's Kappa of 0.79 and 0.80 based on 34 randomly selected excerpts. RESULTS: The quantitative and qualitative data show that the intervention was deemed acceptable and feasible. After controlling for baseline adherence, the T1 group had 3.8 percentage point lower adherence than the control group (95% CI -9.9, 2.3) and the T2 group had 2.4 percentage points higher adherence than the control group (95% CI -3.0, 7.9). However, there was an increasing treatment effect over time for the T2 group with the largest effect towards the end of the study; a 2.5 percentage point increase in the initial 9-weeks that grows steadily to 9.0 percentage points by the last 9-weeks of the study. We find negative treatment effects for T1 in 3 of the 4 9-week intervals. This pilot study was not designed to detect statistically significant differences. CONCLUSIONS: Improving youth's adherence by supplementing information about their adherence with information about the adherence of peers is a promising new strategy that should be further evaluated in a fully-powered study. Providing one's own adherence information alone appears to have less potential. TRIAL REGISTRATION: NCT02514356 07/30/2015.

Lessons learned from a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda.

Evidence suggests that simple text messaging interventions may not suffice to improve ART adherence among youth in low-resource settings. To address this shortcoming, we developed an intervention that shared weekly real-time adherence feedback to youth in Uganda using short message services (SMS), based on information tracked by an electronic device (Wisepill). We present results from 7 formative and 6 exit focus groups (FGs) in Mulago and Entebbe, Uganda with youth ages 15-24, providers, and Community Advisory Board members. Participants consistently conveyed positive impressions of Wisepill, noting that it helped store their medications, facilitated travel, served as a reminder, and motivated adherence. Participants raised phone-related issues before the study; most were addressed but some remained (e.g., limited network access, electricity for powering phones). Further, they highlighted the importance of carefully crafting text messages (e.g., use slang rather than potentially stigmatizing words) and viewed personalizing messages favorably but were divided on the desirability of including their name in study-related texts. Exit FGs confirmed that sharing group adherence levels with participants tapped into the competitive spirit common among youth. Our results suggest future mobile technology-based interventions can be improved by providing messages that go beyond simple reminders to provide individual and group-level adherence feedback.

Assessment of urban microbiome assemblies with the help of targeted in silico gold standards.

BACKGROUND: Microbial communities play a crucial role in our environment and may influence human health tremendously. Despite being the place where human interaction is most abundant we still know little about the urban microbiome. This is highlighted by the large amount of unclassified DNA reads found in urban metagenome samples. The only in silico approach that allows us to find unknown species, is the assembly and classification of draft genomes from a metagenomic dataset. In this study we (1) investigate the applicability of an assembly and binning approach for urban metagenome datasets, and (2) develop a new method for the generation of in silico gold standards to better understand the specific challenges of such datasets and provide a guide in the selection of available software. RESULTS: We applied combinations of three assembly (Megahit, SPAdes and MetaSPAdes) and three binning tools (MaxBin, MetaBAT and CONCOCT) to whole genome shotgun datasets from the CAMDA 2017 Challenge. Complex in silico gold standards with a simulated bacterial fraction were generated for representative samples of each surface type and city. Using these gold standards, we found the combination of SPAdes and MetaBAT to be optimal for urban metagenome datasets by providing the best trade-off between the number of high-quality genome draft bins (MIMAG standards) retrieved, the least amount of misassemblies and contamination. The assembled draft genomes included known species like Propionibacterium acnes but also novel species according to respective ANI values. CONCLUSIONS: In our work, we showed that, even for datasets with high diversity and low sequencing depth from urban environments, assembly and binning-based methods can provide high-quality genome drafts. Of vital importance to retrieve high-quality genome drafts is sequence depth but even more so a high proportion of the bacterial sequence fraction too achieve high coverage for bacterial genomes. In contrast to read-based methods relying on database knowledge, genome-centric methods as applied in this study can provide valuable information about unknown species and strains as well as functional contributions of single community members within a sample. Furthermore, we present a method for the generation of sample-specific highly complex in silico gold standards. REVIEWERS: This article was reviewed by Craig Herbold, Serghei Mangul and Yana Bromberg.