American Heart Association Council on cardiovascular nursing.

Background Tenofovir/emtricitabine (TDF/FTC) used as pre-exposure prophylaxis (PrEP) has proven benefits in preventing HIV infection. Widespread use of TDF/FTC can only be justified if the preventative benefits outweigh potential risks of adverse events. A previous meta-analysis of TDF/FTC compared to alternative tenofovir alafenamide (TAF)/FTC for treatment found no significant difference in safety endpoints when used without ritonavir or cobicistat, but more evidence around the safety of TDF/FTC is needed to address concerns and inform widespread use. Methods A systematic review identified 13 randomised trials of PrEP, using either TDF/FTC or TDF, versus placebo or no treatment: VOICE, PROUD, IPERGAY, FEM-PrEP, TDF-2, iPrEX, IAVI Kenya, IAVI Uganda, PrEPare, PARTNERS, US Safety study, Bangkok TDF study, W African TDF study. The number of participants with grade 3/4 adverse events or serious adverse events (SAEs) was compared between treatment and control in the meta-analysis. Further analyses of specific renal and bone markers were also undertaken, with fractures as a marker of bone effects and creatinine elevations as a surrogate marker for renal impairment. Analyses were stratified by study duration ( 1 year of follow up). Results The 13 randomised trials included 15,678 participants in relevant treatment and control arms. Three studies assessed TDF use only. The number of participants with grade 3/4 adverse events was 1306/7504 (17.4%) on treatment versus 1259/7502 (16.8%) on control (difference=0%, 95% confidence interval [CI] −1% to +2%). The number of participants with SAEs was 740/7843 (9.4%) on treatment versus 795/7835 (10.1%) on no treatment (difference=0%, 95% CI −1% to +1%). The number of participants with creatinine elevations was 8/7843 on treatment versus 4/7835 on control (difference=0%, 95% CI 0%–0%). The number of participants with bone fractures was 217/5789 on treatment versus 189/5795 on control (difference=0%, 95% CI 0% to 1%). There was no difference in outcome between studies with 1 year of randomised treatment. Conclusions In this meta-analysis of 13 randomised clinical trials of PrEP in 15,678 participants, there was no significant difference in risk of grade 3/4 clinical adverse events or SAEs between TDF/FTC (or TDF) and control. Furthermore, there was no significant difference in risk of specific renal or bone adverse outcomes. The favourable safety profile of TDF/FTC would support more widespread use PrEP in populations with a lower risk of HIV infection.

How safe is TDF/FTC as PrEP? A systematic review and meta-analysis of the risk of adverse events in 13 randomised trials of PrEP.

We surveyed 970 PrEPX study participants to evaluate interest in switching from daily to on-demand PrEP in a study setting. Interested respondents (n = 469, 48%) more commonly reported PrEP cessation (adjusted odds ratio [aOR], 3.0; P < .001), difficulty with adherence (aOR, 1.6; P = .029), infrequent sex (aOR, 3.7; P < .001), and toxicity concerns (aOR, 2.7; P < .001).

Interest in Switching to On-Demand HIV Pre-Exposure Prophylaxis (PrEP) Among Australian Users of Daily PrEP: An Online Survey

Sexual and gender minority (SGM) adolescents assigned male at birth who have sex with male partners are at increased risk for HIV. Daily oral pre-exposure prophylaxis (PrEP) is available for minor adolescents in the United States, who may have difficulty with adherence. Adolescents’ perspectives toward emerging PrEP delivery methods that would not require daily pill-taking have not been well-explored. We conducted online surveys and focus groups in November 2018–February 2019 with 59 SGM adolescents assigned male at birth who reported sex with or attraction to male partners. Questions assessed their perspectives on and preferences for biomedical (on-demand, injection, implant) and non-biomedical HIV prevention options (condoms). Data were analyzed thematically. Of all prevention options, the implant and condoms were rated highest, and participants preferred the implant over other biomedical options. Convenience, duration, and ease of access played important roles in adolescents’ preferences. Parents were viewed as a barrier to taking PrEP regardless of delivery method due to their role in adolescents’ ability to access healthcare. SGM adolescents are interested in long-acting PrEP, yet also perceive substantial obstacles to using biomedical prevention that reflect adolescents’ developmental contexts. State laws expanding adolescents’ access to HIV preventive services, sex education inclusive of PrEP information, and parent- and provider-initiated PrEP conversations can reduce barriers regardless of PrEP delivery method. Research to accelerate the availability of long-acting implants for adolescents is needed.

Perspectives on and preferences for on-demand and long-acting PrEP among sexual and gender minority adolescents assigned male at birth

Cardiovascular diseases are the leading cause of mortality rates throughout the world. Next to an insufficient number of healthy donors, this has led to increasing numbers of patients on heart transplant waiting lists with prolonged waiting times. Innovative technological advancements have led to the production of ventricular assist devices that play an increasingly important role in end stage heart failure therapy. This review is intended to provide an overview of current implantable left ventricular assist devices, different design concepts and implantation techniques. Challenges such as infections and thromboembolic events that may occur during LVAD implantations have also been discussed.

Left Ventricular Assist Devices – A State of the Art Review

Objectives:We undertook the economic evaluation of the double-blind randomized ANRS-IPERGAY trial, which showed the efficacy of on-demand preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) in preventing HIV infection among high-risk MSM.Design and methods:The

Costs and benefits of on-demand HIV preexposure prophylaxis in MSM.

OBJECTIVES Heart transplantation (HT) and ventricular assist devices (VAD) for the management of end-stage heart failure have not been directly compared. We compare the outcomes and use of resources with these 2 strategies in 2 European countries with different allocation systems. METHODS We studied 83 patients managed by VAD as the first option in Bad Oeynhausen, Germany (Group I) and 141 managed with either HT or medical therapy, as the first option, in Paris, France (Group II). The primary end-point was 2-year survival. Kaplan-Meier analyses were performed after the application of propensity score weights to mitigate the effects of non-random group assignment. The secondary end-points were resource utilization and costs. Subgroup analyses were performed for patients undergoing HT and patients treated with inotropes at the enrolment time. RESULTS The Group I patients were more severely ill and haemodynamically compromised, and 28% subsequently underwent HT vs 55% primary HT in Group II, P < 0.001. The adjusted probability of survival was 44% in Group I vs 70% in Group II, P <0.0001. The mean cumulated 2-year costs were €281 361 ± 156 223 in Group I and €47 638 ± 35 061 in Group II, P < 0.0001. Among patients who underwent HT, the adjusted probability of survival in Group I (n = 23) versus Group II (n = 78) was 76% versus 68%, respectively (0.09), though it differed in the inotrope-treated subgroups (77% in Group I vs 67% in Group II, P = 0.04). CONCLUSIONS HT should remain the first option for end-stage heart failure patients, associated with improved outcomes and better cost-effectiveness profile. VAD devices represent an option when transplant is not possible or when patient presentation is not optimal.

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Management of end-stage heart failure patients with or without ventricular assist device: an observational comparison of clinical and economic outcomes.

IFNα and anti-IFNα autoantibodies have been implicated in susceptibility both for systemic lupus erythematosus (SLE) and viral infection. We aimed to analyze the SLE disease phenotype and risk for infection associated with anti-IFN-α IgG autoantibodies in SLE patients In this multidisciplinary retrospective single referral center study, all consecutive patients with SLE admitted between January 1st and November 30th 2020 were considered. All subjects fulfilled the ACR/EULAR 2019 criteria for SLE. Anti-IFNα IgG autoantibodies were quantified at admission by ELISA. Demographic, medical history, laboratory, treatment, and outcome data were extracted from electronic medical records using a standardized data collection form. 180 patients [female 87.2%, median age of 44.4 (34-54.2) years] were included. The median disease duration was 10 years [4-20] with a median SLEDAI score of 2 [0-4] at study time. Fifty-four (30%) patients had a past-history of lupus nephritis. One hundred and forty-four (80%) had received long-term glucocorticoids and 99 (55%) immunosuppressive drugs. Overall, 127 infections-mostly bacterial and viral-were reported in 95 (52.8%) patients. Twenty SLE patients (11.1%) had positive anti-IFNα IgG autoantibodies with a titer ranging from 10 to 103 UA/mL. Age, sex, SLE phenotype and treatment did not significantly differ between SLE patients with or without anti-IFNα. Infection rate was similar in both groups except for tuberculosis which was more frequent in patients with anti-IFNα (20% vs. 3.1%, p = 0.01). The prevalence of autoantibodies against IFNα is high in SLE and associated with a higher frequency of tuberculosis. 

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Autoantibodies against IFNα in patients with systemic lupus erythematosus and susceptibility for infection: a retrospective case-control study

(1) Background: Cephalosporins (CA) are the first-line antibiotic prophylaxis recommended to prevent surgical site infection (SSI) after cardiac surgery. The combination of vancomycin/gentamicin (VGA) might represent a good alternative, but few studies have evaluated its efficacy in SSI prevention. (2) Methods: A single-centre retrospective study was conducted over a 13-year period in all consecutive adult patients undergoing elective cardiac surgery. Patients were stratified according to the type of antibiotic prophylaxis. CA served as the first-line prophylaxis, and VGA was used as the second-line prophylaxis. The primary endpoint was SSI occurrence at 90 days, which was defined as the need for reoperation due to SSI. (3) Results: In total, 14,960 adult patients treated consecutively from 2006 to 2019 were included in this study, of whom 1774 (12%) received VGA and 540 (3.7%) developed SSI. VGA patients had higher severity with increased 90-day mortality. Nevertheless, the frequency of SSI was similar between CA and VGA patients. However, the microbiological aetiologies were different, with more Gram-negative bacteria noted in the VGA group. (4) Conclusions: VGA seems to be as effective as CA in preventing SSI.

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Pierre Mutuon

Papers

Costs and benefits of on-demand HIV preexposure prophylaxis in MSM.

Management of end-stage heart failure patients with or without ventricular assist device: an observational comparison of clinical and economic outcomes.

Autoantibodies against IFNα in patients with systemic lupus erythematosus and susceptibility for infection: a retrospective case-control study

Impact of Antibiotic Prophylaxis on Surgical Site Infections in Cardiac Surgery