Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.

BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Savviness of prey to introduced predators.

The prey naivety hypothesis posits that prey are vulnerable to introduced predators because many generations in slow gradual coevolution are needed for appropriate avoidance responses to develop. It predicts that prey will be more responsive to native than introduced predators and less responsive to introduced predators that differ substantially from native predators and from those newly established. To test these predictions, we conducted a global meta-analysis of studies that measured the wariness responses of small mammals to the scent of sympatric mammalian mesopredators. We identified 26 studies that met our selection criteria. These studies comprised 134 experiments reporting on the responses of 36 small mammal species to the scent of six introduced mesopredators and 12 native mesopredators. For each introduced mesopredator, we measured their phylogenetic and functional distance to local native mesopredators and the number of years sympatric with their prey. We used predator and prey body mass as a measure of predation risk. Globally, small mammals were similarly wary of the scent of native and introduced mesopredators; phylogenetic and functional distance between introduced mesopredators and closest native mesopredators had no effect on wariness; and wariness was unrelated to the number of prey generations, or years, since first contact with introduced mesopredators. Small mammal wariness was associated with predator-prey body mass ratio, regardless of the nativity. The one thing animals do not seem to recognize is whether their predators are native.

La hipótesis de la ingenuidad de la presa plantea que ésta es vulnerable a los depredadores introducidos porque se requiere que muchas generaciones atraviesen una coevolución lenta y gradual para que se desarrollen las respuestas de evasión adecuadas. La hipótesis supone que la presa será más sensible a los depredadores introducidos que difieren notoriamente de los nativos y de aquellos recién establecidos. Realizamos un metaanálisis global de estudios que midieron las respuestas cautelosas de mamíferos pequeños ante el rastro de meso depredadores simpátricos para probar estas suposiciones. Identificamos 26 estudios que cumplieron con nuestro criterio de selección. Estos estudios estuvieron conformados por 134 experimentos que reportaban las respuestas de 36 especies de mamíferos pequeños ante el rastro de seis meso depredadores introducidos y 12 nativos. Medimos la distancia funcional y filogenética entre cada meso depredador introducido y los meso depredadores locales nativos y el número de años simpátricos con su presa. Usamos la masa corporal del depredador y la presa como medida del riesgo de depredación. A nivel mundial, los mamíferos pequeños compartieron la cautela ante el rastro de los meso depredadores nativos e introducidos; la distancia funcional y la filogenética entre los meso depredadores introducidos y el meso depredador nativo más cercano no tuvieron efecto sobre la cautela; y la cautela no estuvo relacionada con el número de generaciones de la presa, o años, desde el primer contacto con los meso depredadores introducidos. La cautela de los mamíferos pequeños estuvo asociada con las proporciones de masa corporal entre el depredador y la presa, sin importar el origen. Lo único que los animales parecen no reconocer es si el depredador es nativo o no.

The effectiveness of a telephone smoking cessation program in mental health clinic patients by level of mental well-being and functioning: a secondary data analysis of a randomized clinical trial.

BACKGROUND: Few studies have examined the effectiveness of telephone smoking cessation interventions by severity of behavioral health symptoms. Using data from a telephone counseling study, we examined whether abstinence rates varied by level of behavioral health symptoms. METHODS: The parent study recruited adults who smoke cigarettes (N = 577) referred by mental health providers at six Veterans Health Administration facilities. Participants were randomized to specialized telephone counseling (intervention) or state Quitline referral (control). Participants completed assessments at baseline and 6 months, including the BASIS-24, a self-report measure of behavioral health symptoms and functioning. We used the BASIS-24 median to dichotomize participants as having high or low scores. The primary outcome was 30-day self-reported abstinence at 6 months. We compared groups on outcomes by logistic regression and performed an interaction effect analysis between treatment assignment and groups. RESULTS: At baseline, those with high behavioral health symptoms scores reported heavier nicotine dependence and more sedative and/or antidepressant use, compared to participants with low behavioral health symptoms. At 6 months, participants with low behavioral health symptoms scores in the intervention reported higher rates of 30-day abstinence compared to those in the control arm (26% vs 13%, OR = 2.3, 95% CI = 1.8, 2.9). People with high behavioral health symptoms scores reported no difference in 30-day abstinence between the treatment assignments at 6 months (12% vs. 13%, OR = 1.1, 95% CI = 0.6, 2.0). CONCLUSIONS: Only participants with low behavioral health symptoms scores reported higher abstinence rates in the intervention compared to the state Quitline. Future research can examine alternative approaches for people with worse mental well-being and functioning. TRIAL REGISTRATION: The parent study is registered at www. CLINICALTRIALS: gov NCT00724308.

Predictors of Counseling Participation Among Low-Income People Offered an Integrated Intervention Targeting Financial Distress and Tobacco Use.

INTRODUCTION: Although prevalence of smoking in the USA has been decreasing for decades, smoking rates among low-income individuals remain elevated. Theories from behavioral economics and prior research suggest that financial stress may contribute to the difficulty that low-income smokers face in quitting. The present work is a secondary analysis of a randomized controlled trial that incorporated financial coaching and social services referrals into smoking cessation treatment. Primary analyses showed that participants randomized to the intervention (N = 208) were significantly more likely not to smoke, to have lower financial stress, and to be able to afford leisure activities (p < .05) than were control participants (N = 202). METHODS: This paper investigates subgroup discrepancies in attendance of intervention sessions and in uptake of various components of this intervention through exploratory analysis. RESULTS: Analysis using logistic regression indicated that decreased age, not having received higher education, and having income less than $1000 per month were predictive of decreased counseling attendance (p < .05). Few demographic factors were predictive of uptake of counseling components among those who attended counseling. CONCLUSIONS: These results can guide future efforts to increase participant engagement in the intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03187730.

Integrating Financial Coaching and Referrals into a Smoking Cessation Program for Low-income Smokers: a Randomized Waitlist Control Trial.

BACKGROUND: Financial distress is a barrier to cessation among low-income smokers. OBJECTIVE: To evaluate an intervention that integrated financial coaching and benefits referrals into a smoking cessation program for low-income smokers. DESIGN: Randomized waitlist control trial conducted from 2017 to 2019. PARTICIPANTS: Adult New York City residents were eligible if they reported past 30-day cigarette smoking, had income below 200% of the federal poverty level, spoke English or Spanish, and managed their own funds. Pregnant or breastfeeding people were excluded. Participants were recruited from two medical centers and from the community. INTERVENTION: The intervention (n = 208) offered smoking cessation coaching, nicotine replacement therapy, money management coaching, and referral to financial benefits and empowerment services. The waitlist control (n=202) was usual care during a 6-month waiting period. MAIN MEASURES: Treatment engagement, self-reported 7-day abstinence, and financial stress at 6 months. KEY RESULTS: At 6 months, intervention participants reported higher abstinence (17% vs. 9%, P=0.03), lower stress about finances (ß, -0.8 [SE, 0.4], P=0.02), and reduced frequency of being unable to afford activities (ß, -0.8 [SE, 0.4], P=0.04). Outcomes were stronger among participants recruited from the medical centers (versus from the community). Among medical center participants, the intervention was associated with higher abstinence (20% vs. 8%, P=0.01), higher satisfaction with present financial situation (ß, 1.0 [SE, 0.4], P=0.01), reduced frequency of being unable to afford activities (ß, -1.0 [SE, 0.5], P=0.04), reduced frequency in getting by paycheck-to-paycheck (ß, -1.0 [SE, 0.4], P=0.03), and lower stress about finances in general (ß, -1.0 [SE, 0.4], P = 0.02). There were no group differences in outcomes among people recruited from the community (P>0.05). CONCLUSIONS: Among low-income smokers recruited from medical centers, the intervention produced higher abstinence rates and reductions in some markers of financial distress than usual care. The intervention was not efficacious with people recruited from the community. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03187730.

Intimate Partner Violence and Preferences for Pre-exposure Prophylaxis (PrEP) Modes of Delivery Among A Sample of Gay, Bisexual, and Other Men Who Have Sex with Men.

While there is strong evidence that the experience of intimate partner violence (IPV) shapes PrEP use among heterosexual women, evidence for similar relationships among gay, bisexual and other men who have sex with men (GBMSM) is scant. In this paper we analyze baseline data from a large randomized controlled trial (RCT) of an HIV prevention intervention for GBMSM recruited from three cities (Atlanta, Detroit and New York City) to examine how the recent experience of IPV shapes their rankings of PrEP delivery options. Men were asked to rank from 1 to 8 PrEP taken by daily pill, event-based pill, injection, anal suppository (before sex), suppository (after sex), gel (penile or rectal) (before sex), and gel (after sex) and condoms. The analysis sample is 694 HIV-negative, sexually active GBMSM. Analysis considers an ordinal outcome measuring participant's ranked preferences for their future use of eight HIV prevention options. Men who experienced physical IPV preferred PrEP in pill form, while men who experienced partners monitoring their behaviors (monitoring IPV) preferred PrEP by injection. Men who experienced emotional IPV ranked PrEP by pill lower than other methods. Sexual and controlling IPV were not significantly associated with PrEP modality ranking. As more modes of PrEP delivery become available, providers should be encouraged to screen GBMSM seeking PrEP for IPV, and to provide men with the necessary information to facilitate an informed choice when deciding on a PrEP modality that will work for them and their relationship context.

Behavioral Efficacy of a Sexual Health Mobile App for Men Who Have Sex With Men: Randomized Controlled Trial of Mobile Messaging for Men.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) face the highest burden of HIV in the United States, and there is a paucity of efficacious mobile health (mHealth) HIV prevention and care interventions tailored specifically for GBMSM. We tested a mobile app combining prevention messages and access to core prevention services for GBMSM. OBJECTIVE: This study aims to measure the efficacy of the Mobile Messaging for Men (M-cubed) app and related services to increase HIV prevention and care behaviors in diverse US GBMSM. METHODS: We conducted a randomized open-label study with a waitlist control group among GBMSM in 3 groups (low-risk HIV-negative group, high-risk HIV-negative group, and living-with-HIV [LWH] group) recruited online and in venues in Atlanta, Detroit, and New York City. Participants were randomly assigned to receive access to the app immediately or at 9 months after randomization. The app provided prevention messages in 6 domains of sexual health and offered ordering of at-home HIV and sexually transmitted infection test kits, receiving preexposure prophylaxis (PrEP) evaluations and navigation, and service locators. Serostatus- and risk-specific prevention outcomes were evaluated at baseline, at the end of the intervention period, and at 3, 6, and 9 months after the intervention period. RESULTS: In total, 1226 GBMSM were enrolled and randomized; of these 611 (49.84%) were assigned to the intervention group and 608 (99.51%) were analyzed, while 615 (50.16%) were assigned to the control group and 612 (99.51%) were analyzed. For high-risk GBMSM, allocation to the intervention arm was associated with higher odds of HIV testing during the intervention period (adjusted odds ratio [aOR] 2.02, 95% CI 1.11-3.66) and with higher odds of using PrEP in the 3 months after the intervention period (aOR 2.41, 95% CI 1.00-5.76, P<.05). No changes in HIV prevention or care were associated with allocation to the intervention arm for the low-risk HIV-negative and LWH groups. CONCLUSIONS: Access to the M-cubed app was associated with increased HIV testing and PrEP use among high-risk HIV-negative GBMSM in 3 US cities. The app could be made available through funded HIV prevention providers; additional efforts are needed to understand optimal strategies to implement the app outside of the research setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/16439.

Comparing the Prevalence of Alcohol, Combustible and Electronic Cigarettes, Hookah, and Marijuana, in Music Videos across 6 Genres of Popular Music from 2014-2020.

OBJECTIVES: To determine the frequency of alcohol, marijuana, cigarettes/cigars, e-cigarettes, and hookah portrayals in popular music lyrics and videos on YouTube across 6 genres over 7 years; assess percent change over the years, document brand placement, and determine frequency of promotion of substances/devices by Teen Choice Award celebrities. METHODS: We analyzed 699 songs from the Billboard Hot 100 between 2014 and 2020. Two raters coded 10% of the songs to establish inter-rater reliability and remaining songs were reviewed by one rater. RESULTS: The majority of songs (59.2%) on YouTube included either lyrical or video depictions and 20.6% included both. Songs that featured substances/devices were viewed 148 billion times on YouTube as of February 2021. Nearly 25% of videos depicting substances/devices featured branding. Forty-three (18.22%) of the music celebrities who featured substances/devices in their videos received one or more Teen Choice Awards during the study period. CONCLUSIONS: Popular music celebrities promote substance use in their lyrics and music videos, which are easily accessible to children and adolescents. Some of these celebrities are highly popular and influential among adolescents.Policy Implications. Findings support the need to limit promotion of these substances to youth by influencers to reduce substance use and misuse.

Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial.

BACKGROUND: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). METHODS: The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories. RESULTS: The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg; P=0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm2; P=0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year. CONCLUSIONS: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.

Tobacco Screening and Treatment during Outpatient Urology Office Visits in the United States.

PURPOSE: Tobacco use is a causative or exacerbating risk factor for benign and malignant urological disease. However, it is not well known how often urologists screen for tobacco use and provide tobacco cessation treatment at the population level. We sought to evaluate how often urologists see patients for tobacco-related diagnoses in the outpatient setting and how often these visits include tobacco use screening and treatment. MATERIALS AND METHODS: We used the National Ambulatory Medical Care Survey public use files for the years 2014-2016 to identify all outpatient urology visits with adults 18 years old or older. Clinic visit reasons were categorized according to diagnoses associated with the encounter: all urological diagnoses, a tobacco-related urological condition or a urological cancer. Our primary outcome was the percentage of visits during which tobacco screening was reported. Secondary outcomes included reported delivery of cessation counseling and provision of cessation pharmacotherapy. RESULTS: We identified 4,625 unique urological outpatient encounters, representing a population-weighted estimate of 63.9 million visits over 3 years. Approximately a third of all urology visits were for a tobacco-related urological diagnosis and 15% were for urological cancers. An estimated 1.1 million visits over 3 years were with patients who identified as current tobacco users. Of all visits, 70% included tobacco screening. However, only 7% of visits with current smokers included counseling and only 3% of patients were prescribed medications. No differences in screening and treatment were observed between visit types. CONCLUSIONS: Urologists regularly see patients for tobacco-related conditions and frequently, although not universally, screen patients for tobacco. However, urologists rarely offer counseling or cessation treatment. These findings may represent missed opportunities to decrease the morbidity associated with tobacco use.