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Larry R Jackson II,1 Daniel J Friedman,1 Diane M Francis,2 Sonia Maccioni,2 Vincent C Thomas,3 Paul Coplan,4 Rahul Khanna,4 Charlene Wong,4 Neloufar Rahai,4 Jonathan P Piccini1 1Division of Cardiology, Duke University Medical Center & Duke Clinical Research Institute, Durham, NC, USA; 2Health Economics and Market Access, Johnson & Johnson Medical Devices, Irvine, CA, USA; 3Medical Safety, Biosense Webster, Irvine, CA, USA; 4Medical Device Epidemiology and Real-World Data Sciences, Johnson & Johnson, New Brunswick, NJ, USACorrespondence: Larry R Jackson II, Duke Clinical Research Institute, 300 W. Morgan Street, Durham, NC, 27701, USA, Tel +1 919-684-9940, Email larry.jackson@duke.eduBackground: Atrial fibrillation (AF) is associated with considerable morbidity and mortality. Timely management and treatment is critical in alleviating AF disease burden. Variation in treatment by race and ethnic and sex could lead to inequities in health outcomes.Objective: To identify racial and ethnic and sex differences in rhythm treatment for patients with incident AF.Methods: Using 2010– 2019 Optum Clinformatics database, an administrative claims data for commercially insured patients in the United States (US), incident AF patients ≥ 20 years old who were continuously enrolled 12-months pre- and post-index diagnosis were identified. Rhythm control treatment (ablation, antiarrhythmic drugs [AAD], and cardioversion) for AF were compared by patient race and ethnicity (Asian, Hispanic, Black vs White) and sex (female vs male). Multivariable regression analysis was used to examine the relationship of race and ethnicity and sex with rhythm control AF treatment.Results: A total of 77,932 patients were identified with incident AF. Black and Hispanic female patients had the highest CHA2DS2VASc scores (4.3 ± 1.8) and Elixhauser scores (4.1 ± 2.8 and 4.0 ± 6.7), respectively. Black males were less likely to receive AAD treatment (adjusted odds ratio [aOR] 0.87; 95% confidence interval [CI], 0.79– 0.96) or ablation (aOR, 0.72; 95% CI, 0.58– 0.90). Compared to White males, all groups had lower likelihood of receiving cardioversion with Asian females having the lowest [aOR, 0.48; 95% CI, (0.37– 0.63)].Conclusion: Black patients were less likely to receive pharmacologic and procedural rhythm control therapies. Further research is needed to understand the drivers of undertreatment among racial and ethnic groups and females with AF.Keywords: race, sex, atrial fibrillation, catheter ablation

Introduction: Endocrine therapy is an important and integral part of breast cancer management. Selective estrogen receptor modulators (SERMs), such as tamoxifen, remain a vital component in the endocrine therapy armamentarium. However the 'ideal SERM', which has antagonist effects on the breast and endometrium but beneficial agonistic effects on bone and lipid profile, remains to be found.Aim: The aim of this review is to examine the evidence for arzoxifene as the 'ideal SERM'Evidence review: Arzoxifene showed initial promise as the 'ideal SERM' in preclinical, phase I, and phase II clinical studies. It appeared to have powerful antiestrogenic effects on breast cancer and endometrium, with equally strong favorable estrogenic effects on bone and lipid profile, minimal side effects, and good oral bioavailability.However, phase III trial data found it to be inferior to tamoxifen, bringing an apparent end to its investigation as a breast cancer treatment.Clinical potential: Despite early promise as the 'ideal SERM', results from a phase III trial have relegated arzoxifene to research in breast cancer prevention and osteoporosis treatment. [ABSTRACT FROM AUTHOR]

Innate social behaviors like aggression are modulated by sex steroid hormones such as androgens and estrogens. However, we know little about how the same hormone regulates similar behaviors in both sexes. We investigated the role of androgenic signaling in the regulation of aggression in Astatotilapia burtoni, a social fish in which males and females perform similar aggressive behaviors. We used androgen receptor (AR) α knockout (KO) animals for this study since this gene was recently shown to be required for male-typical aggression and mating. Surprisingly, ARα KO females did not show deficits in aggression. We also determined that females lacking the other AR, ARβ, showed normal levels of aggression. Blocking both ARs pharmacologically confirmed that neither AR is necessary for aggression in females. However, ARα KO males showed clear deficits in attacks. Thus, in A. burtoni there appears to be a sexual dimorphism in the role of ARα in the control of aggression., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier B.V. All rights reserved.)

The rapid technological advancements in cardiac implantable electronic devices such as pacemakers, implantable cardioverter defibrillators, and loop recorders, coupled with a rise in the number of patients with these devices, necessitate an updated clinical framework for periprocedural management. The introduction of leadless pacemakers, subcutaneous and extravascular defibrillators, and novel device communication protocols underscores the imperative for clinical updates. This scientific statement provides an inclusive framework for the periprocedural management of patients with these devices, encompassing the planning phase, procedure, and subsequent care coordinated with the primary device managing clinic. Expert contributions from anesthesiologists, cardiac electrophysiologists, and cardiac nurses are consolidated to appraise current evidence, offer patient and health system management strategies, and highlight key areas for future research. The statement, pertinent to a wide range of health care professionals, underscores the importance of quality care pathways for patient safety, optimal device function, and minimization of hemodynamic disturbances or arrhythmias during procedures. Our primary objective is to deliver quality care to the expanding patient cohort with cardiac implanted electronic devices, offering direction in the era of evolving technologies and laying a foundation for sustained education and practice enhancement.

Competing Interests: Disclosures Dr Jackson serves as a consultant to Biosense Webster, Johnson & Johnson, Sanofi, Bristol Myers Squibb, and Pfizer and receives honoraria from Zoll LifeVest, CME Outfitters, Health Monitor, PRIME Education, and WebMD/Medscape. Dr Thomas is a consultant for Biosense Webster, Janssen, Zio, and Bristol Myers Squibb and receives honoraria from Medscape. The rest of the authors report no conflicts of interest.

Background: Black patients meeting indications for implantable cardioverter-defibrillators (ICDs) have lower rates of implantation compared with White patients. There is little understanding of how mental health impacts the decision-making process among Black patients considering ICDs. Our objective was to assess the association between depressive symptoms and ICD implantation among Black patients with heart failure., Methods and Results: This is a secondary analysis of the VIVID (Videos to Address Racial Disparities in ICD Therapy via Innovative Designs) randomized trial, which enrolled self-identified Black individuals with chronic systolic heart failure. Depressive symptoms were assessed by the Patient Health Questionnaire-2 and the Mental Component Summary of the 12-Item Short-Form Health Survey. Decisional conflict was measured by an adapted Decisional Conflict Scale (DCS). ANCOVA was used to assess differences in Decisional Conflict Scale scores. Multivariable logistic regression was used to examine the association between depressive symptoms and ICD implantation. Among 306 participants, 60 (19.6%) reported depressed mood, and 142 (46.4%) reported anhedonia. Participants with the lowest Mental Component Summary of the 12-Item Short-Form Health Survey scores (poorer mental health and higher likelihood of depression) had greater decisional conflict regarding ICD implantation compared with those with the highest Mental Component Summary of the 12-Item Short-Form Health Survey scores (adjusted mean difference in Decisional Conflict Scale score, 3.2 [95% CI, 0.5-5.9]). By 90-day follow-up, 202 (66.0%) participants underwent ICD implantation. There was no association between either the Patient Health Questionnaire-2 score or the Mental Component Summary of the 12-Item Short-Form Health Survey score and ICD implantation., Conclusions: Depressed mood and anhedonia were prevalent among ambulatory Black patients with chronic systolic heart failure considering ICD implantation. The presence of depressive symptoms did not impact the likelihood of ICD implantation in this population.

Background: The VIVID (Videos for Addressing Racial Disparities in Implantable Cardioverter Defibrillator Therapy via Innovative Designs) study was a multicenter, randomized controlled trial aimed at evaluating the effectiveness of a video-based decision support tool in enhancing informed consent for implantable cardioverter defibrillator (ICD) implantation among Black patients who met guideline criteria for primary prevention ICDs. Within the broader VIVID randomized trial, a qualitative investigation was conducted to elucidate the decisional factors among Black individuals considering ICD implantation for the primary prevention of sudden cardiac arrest., Methods: Between October 2016 and July 2019, in-depth interviews were conducted at 2 time points from randomization, ≈7 days (time interval for the decision) and at 90 days; the time interval for determining ICD implantation. Interview findings were categorized by randomized groups, those assigned to 1 of the 2 encounter-based video decision support tools or standard care (without video). Interview participants were purposefully selected to ensure diversity across gender, age, educational background, research site, and randomization group; participants were sampled from 14 academic and community-based electrophysiology clinics in the United States. Data analysis employed applied thematic analysis techniques., Results: A diverse sample of Black individuals were interviewed at 1 week (n=59; female, 37.3%) and 90 days (n=48; female, 39.6%). The primary factors influencing the decisions of Black individuals considering a primary prevention ICD implantation were (1) their clinicians' recommendations for ICD implantation; (2) their perception of their cardiac health status; and (3) a desire to prolong their lives for the sake of their families., Conclusions: These findings offer valuable insights that may guide clinicians in their communication with Black patients during shared decision-making encounters related to ICD implantation., Competing Interests: Dr Jackson reports research grants from the National Institutes of Health, specifically the National Institute on Minority Health and Health Disparities, is currently supported by 1K01HL159041 from the National Heart, Lung and Blood Institute and the American Association under award number 851386. Dr Jackson serves as a consultant to Biosense Webster Inc, Johnson and Johnson, Sanofi, Bristol Myers Squibb, and Pfizer and receives honoraria from Zoll LifeVest, continuing medical education outfitters, Health Monitor, PRIME Education, and WebMD/Medscape. Dr Thomas reports on consulting with Biosense Webster Inc. The other authors report no conflicts.

Competing Interests: Dr Jackson also serves as a consultant to Biosense Webster, Johnson and Johnson, Pfizer, and Sanofi and receives honoraria from PRIME Education. The other authors report no conflicts.

A key challenge in animal behavior is disentangling the social stimuli that drive conspecific behaviors. For some species, like teleost fish, putative sexual signaling cues are inextricably linked to others, making it difficult to parse the precise roles distinct signals play in driving conspecific behaviors. In the African cichlid Astatotilapia burtoni, males are either dominant or subordinate, wherein bright coloration, territoriality, and courtship behavior inextricably correlate positively with rank. Here, we leveraged androgen receptor (AR) mutant male A. burtoni that lack dominance-typical coloration but not behavior to isolate the role of male coloration in driving female mating behaviors in this species. We found in independent behavioral assays that females behave aggressively towards AR mutant but not WT males, yet still mated with both types of males. Females showed enhanced activation of esr2b + cells in the hypothalamus when housed with either mutant or WT males and this activation scaled with spawning activities. Therefore, there is not a simple relationship between male coloration and female mating behaviors in A. burtoni, suggesting independent sensory mechanisms converge on hypothalamic esr2b cells to coordinate behavioral output., Competing Interests: Declaration of competing interest The authors declare no competing or financial interests., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Many have found racial differences in clinician-patient communication using validated codebooks that represent effective communication. No codebooks used for examining racial differences, however, have included patient input. In this paper, we describe creating codebook with Black patient advocates to determine if we could reliably code discriminatory/valuing communication and assess racial differences in these behaviors., Methods: We created a codebook for discriminatory/valuing communication behaviors with the input of Black patient advocates. We used the codebook to analyze data from 101 audio recorded encounters between White cardiologists and Black and White patients. We examined the differences in the prevalence of behaviors in cardiology encounters., Results: In comparison to White patients, cardiologists made fewer tailoring statements to their Black patients (68% vs. 49%, p = 0.07). Coders found 4 instances of stereotyping behaviors and only Black patients (p = 0.12). We found no significant associations between any of the other outcomes and patient race. Black patients had a lower incidence of tailoring statements (p = 0.13), lower incidence of interrupting statements (p = 0.16), and higher rushed global score (p = 0.14)., Conclusion and Practice Implications: We found that coders can reliably identify discriminatory/valuing behaviors in cardiology encounters. Future work should apply these codes to other datasets to assess their validity and generalizability., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Purpose of Review: Pharmacoequity refers to the goal of ensuring that all patients have access to high-quality medications, regardless of their race, ethnicity, gender, or other characteristics. The goal of this article is to review current evidence on disparities in access to cardiovascular drug therapies across sociodemographic subgroups, with a focus on heart failure, atrial fibrillation, and dyslipidemia., Recent Findings: Considerable and consistent disparities to life-prolonging heart failure, atrial fibrillation, and dyslipidemia medications exist in clinical trial representation, access to specialist care, prescription of guideline-based therapy, drug affordability, and pharmacy accessibility across racial, ethnic, gender, and other sociodemographic subgroups. Researchers, health systems, and policy makers can take steps to improve pharmacoequity by diversifying clinical trial enrollment, increasing access to inpatient and outpatient cardiology care, nudging clinicians to increase prescription of guideline-directed medical therapy, and pursuing system-level reforms to improve drug access and affordability., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose of Review: Sudden cardiac arrest is associated with high morbidity and mortality. Despite having a disproportionate burden of sudden cardiac death (SCD), rates of primary and secondary prevention of SCD with implantable cardioverter-defibrillator (ICD) therapy are lower among eligible racially minoritized patients. This review highlights the racial and ethnic disparities in ICD utilization, associated barriers to ICD care, and proposed interventions to improve equitable ICD uptake., Recent Findings: Racially minoritized populations are disproportionately eligible for ICD therapy but are less likely to see cardiac specialists, be counseled on ICD therapy, and ultimately undergo ICD implantation, fueling disparate outcomes. Racial disparities in ICD utilization are multifactorial, with contributions at the patient, provider, health system, and structural/societal level., Summary: Racial and ethnic disparities have been demonstrated in preventing SCD with ICD use. Proposed strategies to mitigate these disparities must prioritize care delivery and access to care for racially minoritized patients, increase the diversification of clinical and implementation trial participants and the healthcare workforce, and center reparative justice frameworks to rectify a long history of racial injustice., Competing Interests: Conflict of Interest Larry R. Jackson II reports consulting fees from Sanofi, Johnson and Johnson, Inc., Pfizer, Bristol-Myers Squibb, and Biosense Webster, Inc. Dr. Jackson also reports payment or honoraria from Zoll Life Vest, CME Outfitters, Prime Education, Health Monitor, and WebMD/Medscape. Lauren Eberly reports speaking fees from Pfizer, and Virtual Advisory Board: Understanding Native American/Alaskan Native Population and Cardiac Amyloidosis (Pfizer). The other authors have nothing to disclose.

Background: There is evidence to suggest that colchicine reduces the risk of recurrent atrial fibrillation (AF) after catheter ablation; however, the tolerability and safety of colchicine in routine practice is unknown., Methods: Patients undergoing catheter ablation for AF who received colchicine after ablation were matched 1:1 to patients who did not by age, sex, and renal function. Recurrent AF was compared between groups categorically at 12 months and via propensity weighted Cox proportional hazards models with and without a 3-month blanking period., Results: Overall, 180 patients (n = 90 colchicine and n = 90 matched controls) were followed for a median (Q1, Q3) of 10.3 (7.0, 12.0) months. Mean age was 65.3 ± 9.1 years, 33.9% were women, mean CHA 2 DS 2 -VASc score was 2.9 ± 1.5, and 51.1% had persistent AF. Most patients (70%) received colchicine 0.6 mg daily for a median of 30 days. In the colchicine group, 55 patients (61.1%) were receiving at least one known interacting medication with colchicine. After ablation, one patient required colchicine dose reduction and four patients required discontinuation. After adjusting for covariate imbalance using propensity weighting, no significant association between colchicine use and AF recurrence was identified (adjusted hazard ratio 0.94, 95% confidence interval [CI] 0.48-1.85; p = 0.853). No significant association was found between colchicine use and all-cause hospitalizations (adjusted odds ratio 0.74, 95% CI 0.28-1.96; p = 0.548)., Conclusion: Despite the frequent presence of drug-drug interactions, a 30-day course of colchicine is well-tolerated after AF ablation; however, we did not observe any association between colchicine and lower rates of AF recurrence or hospitalization., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Traditional transvenous pacemakers are associated with worsening tricuspid valve function due to lead-related leaflet impingement, as well as ventricular dysfunction related to electromechanical dyssynchrony from chronic right ventricular (RV) pacing. The association of leadless pacing with ventricular and valvular function has not been well established. We aimed to assess the association of leadless pacemaker placement with changes in valvular regurgitation and ventricular function., Methods and Results: Echocardiographic features before and after leadless pacemaker implant were analyzed in consecutive patients who received a leadless pacemaker with pre- and postprocedure echocardiography at Duke University Hospital between November 2014 and November 2019. Valvular regurgitation was graded ordinally from 0 (none) to 3 (severe). Among 54 patients, the mean age was mean age was 70.1 ± 14.3 years, 24 (44%) were women, and the most frequent primary pacing indication was complete heart block in 24 (44%). The median RV pacing burden was 45.4 (interquartile range [IQR] 3.5-97.0). On echocardiogram performed 8.9 months (IQR 4.5-14.5) after implant, there was no change in the average severity of tricuspid regurgitation (mean change 0.07 ± 1.15, p = .64) from pre-procedure echocardiogram. We observed a decrease in the average left ventricular ejection fraction (LVEF) (52.3 ± 9.3 to 47.9 ± 12.1, p = .0019) and tricuspid annular plane systolic excursion (TAPSE) (1.8 ± 0.6 to 1.6 ± 0.4, p = .0437). Thirteen patients (24%) had absolute drop in LVEF of ≥10%., Conclusion: We did not observe short term worsening valvular function in patients with leadless pacemakers. However, consistent with the pathophysiologic impact of RV pacing, leadless pacing was associated with a reduction in biventricular function., (© 2023 Wiley Periodicals LLC.)

Background: Implantable cardioverter-defibrillator (ICD) placement in heart failure (HF) patients during or early after (≤90 days) unplanned cardiovascular hospitalizations has been associated with poor outcomes. Racial and ethnic differences in this "peri-hospitalization" ICD placement have not been well described., Methods: Using a 20% random sample of Medicare beneficiaries, we identified older (≥66 years) patients with HF who underwent ICD placement for primary prevention from 2008 to 2018. We investigated racial and ethnic differences in frequency of peri-hospitalization ICD placement using modified Poisson regression. We utilized Kaplan-Meier analyses and Cox regression to investigate the association of peri-hospitalization ICD placement with differences in all-cause mortality and hospitalization (HF, cardiovascular and all-cause) within and between race and ethnicity groups for up to 5-year follow-up., Results: Among the 61,710 beneficiaries receiving ICDs (35% female, 82% White, 10% Black, 6% Hispanic), 44% were implanted peri-hospitalization. Black [adjusted rate ratio (RR) 95% Confidence Interval (95% CI): 1.16 (1.12, 1.20)] and Hispanic [RR (95% CI): 1.10 (1.06, 1.14)] beneficiaries were more likely than White beneficiaries to have ICD placement peri-hospitalization. Peri-hospitalization ICD placement was associated with an at least 1.5× increased risk of death, 1.5× increased risk of re-hospitalization and 1.7× increased risk of HF hospitalization during 3-year follow-up in fully adjusted models. Although beneficiaries with peri-hospitalization placement had the highest mortality and readmission rates 1- and 3-year post-implant (log-rank p  < 0.0001), the magnitude of the associated risk did not differ significantly by race and ethnicity ( p  = NS for interaction)., Conclusions: ICD implantation occurring during the peri-hospitalization period was associated with worse prognosis and occurred at higher rates among Black and Hispanic compared to White Medicare beneficiaries with HF during the period under study. The risk associated with peri-hospitalization ICD placement did not differ by race and ethnicity. Future paradigms aimed at enhancing real-world effectiveness of ICD therapy and addressing disparate outcomes should consider timing and setting of ICD placement in HFrEF patients who otherwise meet guideline eligibility., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Akhabue, Kuhrt, Gandhi, Rua, Shalmon, Visaria, Jackson and Setoguchi.)

In 1929, August Krogh wrote that for every question in biology, there is a species or collection of species in which pursuing such questions is the most appropriate for achieving the deepest insights. Referred to as "Krogh's Principle," these words are a guiding force for many biologists. In practice, Krogh's principle might guide a biologist interested in studying bi-parental care to choose not to use lab mice, in which the female does most of the parenting, but instead study species in which bi-parental care is present and clearly observable, such as in certain poison dart frogs. This approach to pursuing biological questions has been fruitful, with more in-depth insights achievable with new technologies. However, up until recently, an important limitation of Krogh's principle for biologists interested in the functions of certain genes, was certain techniques were only available for a few traditional model organisms such as lab mice, fruit flies (Drosophila melanogaster), zebrafish (Danio rerio) and C. elegans (Caenorhabditis elegans), in which testing the functions of molecular systems on biological processes can be achieved using genetic knockout (KO) and transgenic technology. These methods are typically more precise than other approaches (e.g., pharmacology) commonly used in nontraditional model organisms to address similar questions. Therefore, some of the most in-depth insights into our understanding of the molecular control of these mechanisms have come from a small number of genetically tractable species. Recent advances in gene editing technology such as CRISPR (Clustered Regularly Interspersed Short Palindromic Repeats)/Cas9 gene editing as a laboratory tool has changed the insights achievable for biologists applying Krogh's principle. In this review, we will provide a brief summary on how some researchers of nontraditional model organisms have been able to achieve different levels of experimental precision with limited genetic tractability in their non-traditional model organism in the field of behavioral neuroendocrinology, a field in which understanding tissue and brain-region specific actions of molecules of interest has been a major goal. Then, we will highlight the exciting potential of Krogh's principle using discoveries made in a popular model species of social behavior, the African cichlid fish Astatotilapia burtoni. Specifically, we will focus on insights gained from studies of the control of social status by sex steroid hormones (androgens and estrogens) in A. burtoni that originated during field observations during the 1970s, and have recently culminated in novel insights from CRISPR/Cas9 gene editing in laboratory studies. Our review highlighting discoveries in A. burtoni may function as a roadmap for others using Krogh's principle aiming to incorporate gene editing into their research program. Gene editing is thus a powerful complimentary laboratory tool researchers can use to yield novel insights into understanding the molecular mechanisms of physiology and behavior in non-traditional model organisms., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Integrative and Comparative Biology.)

Purpose of Review: To assess contemporary epidemiological trends in AF incidence and prevalence in the LatinX population after the Hispanic Community Health Study/Study of Latinos., Recent Findings: Atrial fibrillation (AF) remains the most abnormal heart rhythm condition globally and disproportionately impacts morbidity and mortality of communities that have been historically disadvantaged. The incidence and prevalence of AF is lower in the LatinX population compared to White individuals despite a higher burden of classic risk factors associated with AF. Since the Hispanic Community Health Study/Study of Latinos study on AF, recent data continues to demonstrate a similar lower burden of AF in the LatinX population compared to White individuals. However, the rates of incident AF may be accelerating faster in the LatinX population compared to their White counterparts. Furthermore, studies have found environmental and genetic risk factors that are associated with the development of AF within LatinX individuals, which may help explain the rising development of AF among the LatinX community. Recent research continues to show that LatinX populations are less likely to be treated with stroke reduction and rhythm control strategies and have a disproportionately higher burden of poor outcomes associated with AF compared to White patients. Our review illuminates that further inclusion of LatinX individuals in AF randomized control trials and observational studies is imperative to understand the incidence and prevalence of AF in the LatinX community and improve overall morbidity and mortality., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

PR prolongation is defined primarily as delayed conduction through the AV node, but can also signify delayed electrical impulse propagation through any part of the conduction system. The prevalence of PR prolongation ranges from 1% to 5% in patients younger than 50 years, with increasing prevalence, after the sixth decade of life and in patients with organic heart disease. Contemporary studies have documented increased risk of atrial arrhythmias, heart failure, and mortality in patients with PR prolongation. Future studies are needed to more accurately risk stratify elderly patients with PR prolongation who may be at increased risk of adverse outcomes., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Importance: Communication between cardiologists and patients can significantly affect patient comprehension, adherence, and satisfaction. To our knowledge, a coaching intervention to improve cardiologist communication has not been tested., Objective: To evaluate the effect of a communication coaching intervention to teach evidence-based communication skills to cardiologists., Design, Setting, and Participants: This 2-arm randomized clinical trial was performed at outpatient cardiology clinics at an academic medical center and affiliated community clinics, and from February 2019 through March 2020 recruited 40 cardiologists and audio recorded 161 patients in the preintervention phase and 240 in the postintervention phase. Data analysis was performed from March 2022 to January 2023., Interventions: Half of the cardiologists were randomized to receive a coaching intervention that involved three 1:1 sessions, 2 of which included feedback on their audio-recorded encounters. Communication coaches taught 5 skills derived from motivational interviewing: (1) sitting down and making eye contact with all in the room, (2) open-ended questions, (3) reflective statements, (4) empathic statements, and (5) "What questions do you have?", Main Outcomes and Measures: Coders unaware of study arm coded these behaviors in the preintervention and postintervention audio-recorded encounters (objective communication). Patients completed a survey after the visit to report perceptions of communication quality (subjective communication)., Results: Analysis included 40 cardiologists (mean [SD] age, 47 [9] years; 7 female and 33 male) and 240 patients in the postintervention phase (mean [SD] age, 58 [15] years; 122 female, 118 male). When controlling for preintervention behaviors, cardiologists in the intervention vs control arm were more likely to make empathic statements (intervention: 52 of 117 [44%] vs control: 31 of 113 [27%]; P = .05); to ask, "What questions do you have?" (26 of 117 [22%] vs 6 of 113 [5%]; P = .002); and to respond with empathy when patients expressed negative emotions (mean ratio of empathic responses to empathic opportunities, 0.50 vs 0.20; P = .004). These effects did not vary based on patient or cardiologist race or sex. We found no arm differences for open-ended questions or reflective statements and were unable to assess differences in patient ratings due to ceiling effects., Conclusions and Relevance: In this randomized clinical trial, a communication coaching intervention improved 2 key communication behaviors: expressing empathy and eliciting questions. Empathic communication is a harder-level skill that may improve the patient experience and information comprehension. Future work should explore how best to assess the effect of communication coaching on patient perceptions of care and clinical outcomes and determine its effectiveness in larger, more diverse samples of cardiologists., Trial Registration: ClinicalTrials.gov Identifier: NCT03464110.

Background: Racial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates., Objective: To assess the effectiveness of a video decision support tool for Black patients eligible for an ICD., Design: Multicenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973)., Setting: Fourteen academic and community-based electrophysiology clinics in the United States., Participants: Black adults with heart failure who were eligible for a primary prevention ICD., Intervention: An encounter-based video decision support tool or usual care., Measurements: The primary outcome was the decision regarding ICD implantation. Additional outcomes included patient knowledge, decisional conflict, ICD implantation within 90 days, the effect of racial concordance on outcomes, and the time patients spent with clinicians., Results: Of the 330 randomly assigned patients, 311 contributed data for the primary outcome. Among those randomly assigned to the video group, assent to ICD implantation was 58.6% compared with 59.4% in the usual care group (difference, -0.8 percentage point [95% CI, -13.2 to 11.1 percentage points]). Compared with usual care, participants in the video group had a higher mean knowledge score (difference, 0.7 [CI, 0.2 to 1.1]) and a similar decisional conflict score (difference, -2.6 [CI, -5.7 to 0.4]). The ICD implantation rate within 90 days was 65.7%, with no differences by intervention. Participants randomly assigned to the video group spent less time with their clinician than those in the usual care group (mean, 22.1 vs. 27.0 minutes; difference, -4.9 minutes [CI, -9.4 to -0.3 minutes]). Racial concordance between video and study participants did not affect study outcomes., Limitation: The Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study., Conclusion: A video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation., Primary Funding Source: Patient-Centered Outcomes Research Institute., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-2934.

Cardiovascular disease remains one of the most prominent global health problems and has been demonstrated to disproportionally affect certain communities. Despite an increasing collective effort to improve health inequalities, a multitude of disparities continue to affect cardiovascular outcomes. Among the most prominent disparities within cardiovascular disease prevention are with the use and distribution of sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists. Several landmark trials have demonstrated the efficacy of these novel agents, not only in cardiovascular disease prevention among those with diabetes, but also in heart failure and chronic kidney disease. However, the use of these agents remains limited by disparities in certain racial/ethnic, sex, and socioeconomic groups. This review works to highlight and understand these differences on the use and prescribing patterns of pivotal agents in cardiovascular disease prevention, SGLT-2 inhibitors and GLP-1 agonists. Our aim is to enrich understanding and to inspire efforts to end disparities in cardiovascular morbidity and mortality due to race, sex and income inequality., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Neha Pajidipati reports a relationship with Eli Lilly and Company that includes: consulting or advisory and funding grants. Neha Pajidipati reports a relationship with Novo Nordisk Pharmaceuticals SA that includes: consulting or advisory and funding grants. Neha Pajidipati reports a relationship with AstraZeneca Pharmaceuticals LP that includes: consulting or advisory and funding grants. Neha Pajidipati reports a relationship with Boehringer Ingelheim Corp USA that includes: consulting or advisory and funding grants. Schulyer Jones reports a relationship with Boehringer Ingelheim Corp USA that includes: funding grants., (© 2023 The Author(s).)

Background: Catheter ablation is recommended for the treatment of symptomatic atrial fibrillation (AF) refractory to medical therapy., Objective: The study sought to examine racial/ethnic and sex differences in complications and AF/atrial flutter (AFL)-related acute healthcare utilization following catheter ablation for AF., Methods: We performed a retrospective analysis using data from the Centers for Medicare and Medicaid Services Medicare Standard Analytical Files (October 1, 2014, to September 30, 2019) among patients ≥65 years of age with AF who underwent catheter ablation for rhythm control. The risk of any complication within 30 days and AF/AFL-related acute healthcare utilization within 1 year of ablation by race, ethnicity, and sex were assessed using multivariable Cox regression modeling., Results: We identified 95,394 patients for analysis of postablation complications and 68,408 patients for analysis of AF/AFL-related acute healthcare utilization. Both cohorts were ∼95% White and 52% male. Female patients had a slightly elevated risk of complications compared with male patients (adjusted hazard ratio [aHR] 1.07, 95% confidence interval [CI] 1.03-1.12). Black (aHR 0.78, 95% CI 0.77-1.00) and Asian (aHR 0.67, 95% CI 0.50-0.89) patients had lower utilization compared with White patients. Specifically, Asian men (aHR 0.58, 95% CI 0.38-0.91) had lower utilization compared with White men., Conclusion: Differences in safety and healthcare utilization after catheter ablation for AF were observed by race/ethnicity and sex groups. Underrepresented racial and ethnic groups with AF had a lower risk of AF/AFL-related acute healthcare utilization postablation., (© 2023 Heart Rhythm Society. Published by Elsevier Inc.)

Research across species has led to important discoveries on the functions of steroid hormones in the regulation of behavior. However, like in many fields, advancements in transgenic and mutagenic technology allowed mice to become the premier genetic model for conducting many experiments to understand how steroids control social behavior. Since there has been a general lack of parallel methodological developments in other species, many of the findings cannot be generalized. This is especially the case for teleost fish, in which a whole-genome duplication produced novel paralogs for key steroid hormone signaling genes. In this review, we summarize technical advancements over the history of the field of neuroendocrinology that have led to important insights in our understanding of the control of social behavior by steroids. We demonstrate that early mouse genetic models to understand these mechanisms suffered from several issues that were remedied by more precise transgenic technological advancements. We then highlight the importance of CRISPR/Cas9 gene editing tools that will in time bridge the gap between mice and non-traditional model species for understanding principles of steroid hormone action in the modulation of social behavior. We specifically highlight the role of teleost fish in bridging this gap because they are 1) highly genetically tractable and 2) provide a novel advantage in achieving precise genetic control. The field of neuroendocrinology is entering a new "gene editing revolution" that will lead to novel discoveries about the roles of steroid hormones in the regulation and evolutionary trajectories of social behavior., Competing Interests: Competing interest The authors declare no competing or financial interests., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Racial and ethnic differences in treatment-cardiovascular and otherwise-have been documented in many aspects of the American health care system and can be seen in implantable cardioverter-defibrillator (ICD) patient selection, counseling, and management. ICDs have been demonstrated to be a powerful tool in the prevention of sudden cardiac death, yet uptake across all eligible patients has been modest. Although patients who do not identify as White are disproportionately eligible for ICDs in the United States, they are less likely to see specialists, be counseled on ICDs, and ultimately have an ICD implanted. This review explores racial and ethnic differences demonstrated in ICD patient selection, outcomes including shock effectiveness, and postimplantation monitoring for both primary and secondary prevention devices. It also highlights barriers for uptake at the health system, physician, and patient levels and suggests areas of further research needed to clarify the differences, illuminate the driving forces of these differences, and investigate strategies to address them., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Objectives: Examine the association of coder ratings of cardiologist behaviors and global scores of cardiologist communication style with patient participation in clinic encounters., Methods: We coded transcripts of clinic encounters for patient participatory behaviors: asking questions, assertive statements, and expressing negative emotions; clinician behavior counts: reflective statements, open-ended questions, empathic statements, and eliciting questions. We used general linear regression models to examine associations of mean number of patient participatory behaviors with clinician behaviors., Results: Our sample included 161 patients of 40 cardiologists. Patient female gender was associated with on average 2.1 (CI: 0.06, 4.1; p = 0.04) more patient participatory behaviors. In an adjusted model, clinician reflective statements were associated with on average 0.3 (CI: 0.04, 0.4; p = 0.02) more patient participatory behaviors. A clinician making at least one empathic statement was associated with on average 3.7 (CI: 0.2, 7.1; p = 0.04) more patient participatory behaviors., Conclusions: These results demonstrate that some individual clinician behaviors are associated with higher patient participation in cardiology encounters., Practice Implications: Clinician reflective and empathic statements may be important targets in communication training to increase patient participation., Section: Communication Studies., Competing Interests: Declaration of Competing Interest The authors declare no competing interests., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Many drugs that show potential in animal models of glioblastoma (GBM) fail to translate to the clinic, contributing to a paucity of new therapeutic options. In addition, animal model development often includes histologic assessment, but multiparametric/multimodality imaging is rarely included despite increasing utilization in patient cancer management. This study developed an intracranial recurrent, drug-resistant, human-derived glioblastoma tumor in Sprague-Dawley Rag2 - Rag2 tm1Hera knockout rat and was characterized both histologically and using multiparametric/multimodality neuroimaging. Hybrid 18 F-fluoroethyltyrosine positron emission tomography and magnetic resonance imaging, including chemical exchange saturation transfer ( 18 F-FET PET/CEST MRI), was performed for full tumor viability determination and characterization. Histological analysis demonstrated human-like GBM features of the intracranially implanted tumor, with rapid tumor cell proliferation (Ki67 positivity: 30.5 ± 7.8%) and neovascular heterogeneity (von Willebrand factor VIII:1.8 to 5.0% positivity). Early serial MRI followed by simultaneous 18 F-FET PET/CEST MRI demonstrated consistent, predictable tumor growth, with exponential tumor growth most evident between days 35 and 49 post-implantation. In a second, larger cohort of rats, 18 F-FET PET/CEST MRI was performed in mature tumors (day 49 post-implantation) for biomarker determination, followed by evaluation of single and combination therapy as part of the model development and validation. The mean percentage of the injected dose per mL of 18 F-FET PET correlated with the mean %CEST (r = 0.67, P < 0.05), but there was also a qualitative difference in hot spot location within the tumor, indicating complementary information regarding the tumor cell demand for amino acids and tumor intracellular mobile phase protein levels. Finally, the use of this glioblastoma animal model for therapy assessment was validated by its increased overall survival after treatment with combination therapy (temozolomide and idasanutlin) (P < 0.001). Our findings hold promise for a more accurate tumor viability determination and novel therapy assessment in vivo in a recently developed, reproducible, intracranial, PDX GBM., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Jackson, Masi, Selman, Sandusky, Zarrinmayeh, Das, Maharjan, Wang, Zheng, Pollok, Snyder, Sun, Hutchins, Butch and Veronesi.)

Objectives: Clinician burnout poses risks not just to clinicians but also to patients and the health system. Cardiologists might be especially prone to burnout due to performing high-risk procedures, having to discuss serious news, and treating diseases that incur significant morbidity and mortality. Few have attempted to examine which cardiologists might be at higher risk of burnout. Knowing at-risk cardiologists can help frame resilience interventions., Methods: We enrolled 41 cardiologists across five ambulatory cardiology clinics into a randomized controlled trial where we assessed the Maslach Burnout Inventory at baseline. We used bivariate analyses to assess associations between cardiologist demographics and burnout., Results: Cardiologists reported low burnout for depersonalization and personal accomplishment and moderate levels for emotional exhaustion. Female cardiologists reported emotional exhaustion scores in the "low" range (M = 12.3; SD = 10.06), compared to male cardiologists whose score was in the "moderate" range 19.6 (SD = 9.59; p = 0.113). Cardiologists who had greater than 15 years in practice reported higher mean scores of emotional exhaustion, indicating moderate burnout (M = 20.0, SD = 10.63), compared to those with less than 15 years in practice (M = 16.6, SD = 9.10; p = 0.271)., Conclusions: In this sample, unlike prior studies, male cardiologists reported more burnout. Consistent with prior work, mid-level cardiologists might be at highest risk of emotional exhaustion.

Background: Pulmonary vein (PV) isolation using radiofrequency ablation (RFA) to treat atrial fibrillation (AF) requires delivery of contiguous transmural lesions at the PV antra while avoiding injury to the esophagus. Continuous 2-dimensional phased-array intracardiac echocardiography (ICE) from within the left atrium (LA) can provide consistent high-resolution images of catheter tip contact and location during ablation., Objective: The purpose of this study was to compare near-term safety outcomes of therapeutic AF ablation with and without ICE imaging from within the LA., Methods: The study cohort included 590 consecutive patients undergoing RFA for AF including continuous ICE imaging during ablation from within either the right atrium (RA) or the LA. Subjects were followed prospectively, and periprocedural complications within 30 days were identified and recorded., Results: All subjects had RA ICE imaging to guide transseptal catheterization. Ultrasound imaging from both RA and LA was used in 243 (41.2%). Respectively, the LA vs RA only imaging cohorts were comparable with respect to age (median 64 [interquartile range 57.4-71.2] years vs 64 [56.2-70.6] years; P = .425); history of hypertension (64.0% vs 67.2%; P = .421); diabetes mellitus (23.1% vs 19.4%; P = .268); previous cerebrovascular accident/transient ischemic attack (10.8% vs 8.4%; P = .331); and AF type ( P = .241). There were no significant differences in major complications within 30 days between the 2 cohorts ( P = .649) and no identified cases of esophageal or phrenic nerve injury or PV stenosis., Conclusions: Routine continuous LA ICE imaging seems to be safe and holds potential to facilitate lesion delivery during RFA for AF., (© 2022 Published by Elsevier Inc. on behalf of Heart Rhythm Society.)

Background: Cardiac implanted electronic device (CIED) pocket and systemic infection remain common complications with traditional CIEDs and are associated with high morbidity and mortality. Leadless pacemakers may be an attractive pacing alternative for many patients following complete hardware removal for a CIED infection by eliminating surgical pocket-related complications as well as lower risk of recurrent complications., Objective: To describe use and outcomes associated with leadless pacemaker implantation following extraction of a CIED system due to infection., Methods: Patient characteristics and postprocedural outcomes were described in patients who underwent leadless pacemaker implantation at Duke University Hospital between November 11, 2014 and November 18, 2019, following CIED infection and device extraction. Outcomes of interest included procedural complications, pacemaker syndrome, need for system revision, and recurrent infection., Results: Among 39 patients, the mean age was 71 ± 17 years, 31% were women, and the most frequent primary pacing indication was complete heart block (64.1%) with 9 (23.1%) patients being pacemaker dependent at the time of Micra implantation. The primary organism implicated in the CIED infection was Staphylococcus aureus (43.6%). Nine of the 39 patients had a leadless pacemaker implanted before or on the same day as their extraction procedure, and the remaining 30 patients had a leadless pacemaker implanted after their extraction procedure. During follow-up (mean 24.8 ± 14.7 months) after leadless pacemaker implantation, there were a total of 3 major complications: 1 groin hematoma, 1 femoral arteriovenous fistula, and 1 case of pacemaker syndrome. No patients had evidence of recurrent CIED infection after leadless pacemaker implantation., Conclusions: Despite a prior CIED infection and an elevated risk of recurrent infection, there was no evidence of CIED infection with a mean follow up of over 2 years following leadless pacemaker implantation at or after CIED system removal. Larger studies with longer follow-up are required to determine if there is a long-term advantage to implanting a leadless pacemaker versus a traditional pacemaker following temporary pacing when needed during the periextraction period in patients with a prior CIED infection., (© 2022 Wiley Periodicals LLC.)

PR prolongation is defined primarily as delayed conduction through the AV node, but can also signify delayed electrical impulse propagation through any part of the conduction system. The prevalence of PR prolongation ranges from 1% to 5% in patients younger than 50 years, with increasing prevalence, after the sixth decade of life and in patients with organic heart disease. Contemporary studies have documented increased risk of atrial arrhythmias, heart failure, and mortality in patients with PR prolongation. Future studies are needed to more accurately risk stratify elderly patients with PR prolongation who may be at increased risk of adverse outcomes., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Patients with sudden cardiac arrest occurring in the acute phase of myocardial infarction (MI-SCA) are believed to be at similar risk of death after revascularization compared with MI patients without SCA (MI-no SCA). Among patients with anterior MI, we examined whether those with MI-SCA were at greater risk of all-cause mortality or sudden cardiac death (SCD) than MI-no SCA patients., Methods: The Home Automated External Defibrillator Trial enrolled patients with anterior MI who had not received or were candidates for an implantable cardioverter defibrillator (ICD). Our cohort included patients with a reported SCA event, in the acute phase of an MI, prior to HAT trial enrollment. Cox proportional hazards models examined the adjusted association between MI-SCA versus MI-no SCA patients and all-cause mortality and sudden cardiac death (SCD). We also determined whether the relationship between prior SCA and outcomes changed with subsequent events (syncope, revascularization, and recurrent MI) during follow-up., Results: Of 6849 patients, 650 (9.5%) had MI-SCA before trial enrollment. Approximately 48% of patients had the MI-SCA event ≤1 year prior to enrollment; 71% of SCA events were in-hospital. MI-SCA patients were younger, more frequently white, and had higher rates of prior PCI versus MI-no SCA patients. There were no differences in adjusted all-cause mortality (hazard ratio [HR 0.95; 95% CI 0.65-1.38]) or SCD (HR 1.12; 95% CI 0.68-1.83) for MI-SCA vs. MI-no SCA. After ICD implantation, MI-SCA patients experienced higher all-cause mortality risk (HR 5.01, 95% CI 1.05-23.79) versus MI-no SCA patients; there was no mortality difference between MI-SCA and MI-no SCA patients without ICD implantation (HR 0.89, 95% CI 0.60-1.31), [interaction p = 0.035]., Conclusions: Patients with MI-SCA had similar adjusted risk of all-cause mortality and SCD compared with MI-no SCA. After ICD implantation, MI-SCA patients had higher mortality compared with MI-no SCA patients., (Copyright © 2021. Published by Elsevier B.V.)

Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Dr. Mendys is an employee of Pfizer, Inc as a Senior Director, North American Medical Affairs Dr. Ferdinand serves as a consultant for Amgen, Novartis, Medtronic ,Pfizer

Introduction: Direct oral anticoagulants (DOACs) have partial renal clearance and generally require dosage adjustments based on renal function. While current US and European guidance recommends dose adjustments in patients with moderate chronic kidney disease (CKD), it is unclear how often this is done appropriately in routine clinical practice., Methods: We examined rates of appropriate and inappropriate dosing in patients with atrial fibrillation (AF) and moderate CKD, as determined by creatinine clearance (CrCl) of 30-50 mL/min calculated with the Cockcroft-Gault formula. Descriptive statistics were used to describe the rate of appropriate and inappropriate dosing as well as event rates., Results: Among 1134 patients (8.5% of the overall ORBIT-AF II registry) with AF and CrCl 30-50 mL/min, the median age was 82 (25th, 75th percentile: 78, 86), 38% were male, and the median CHA 2 DS 2 VASC score was 4 (25th, 75th percentile: 4, 5). At baseline, more than one-third (34%) of patients with moderate CKD were inappropriately dosed with DOACs. When evaluating the specific prescribed doses in those with moderate CKD, 15% (N = 170/1134) were underdosed, 66% (743/1134) were appropriately dosed, and 20% (N = 221/1134) were overdosed. There were no significant differences in comorbid medical conditions between patients with moderate CKD who were appropriately and inappropriately dosed with a DOAC., Conclusion: In routine clinical practice, prescribing of DOACs in patients with AF with moderate CKD is often inconsistent with drug labeling, with up to one-third of patients being inappropriately dosed., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature.)

Background: Atrioventricular (AV)-synchronous single-chamber leadless pacing using a mechanical atrial sensing algorithm produced high AV synchrony in clinical trials, but clinical practice experience with these devices has not yet been described., Objective: To describe pacing outcomes and programming changes with AV-synchronous leadless pacemakers in clinical practice., Methods: Consecutive patients without persistent atrial fibrillation who received an AV-synchronous leadless pacemaker and completed follow-up between February 2020 and April 2021 were included. We evaluated tracking index (atrial mechanical sense followed by ventricular pace [AM-VP] divided by total VP), total AV synchrony (sum of AM-ventricular sense [AM-VS], AM-VP, and AV conduction mode switch), use of programming optimization, and improvement in AV synchrony after optimization., Results: Fifty patients met the inclusion criteria. Mean age was 69 ± 16.8 years, 24 (48%) were women, 24 (48%) had complete heart block, and 17 (34%) required ≥50% pacing. Mean tracking index was 41% ± 34%. Thirty-five patients (70%) received ≥1 programming change. In 36 patients with 2 follow-up visits, tracking improved by +9% ± 28% ( P value for improvement = .09) and +18% ± 19% ( P = .02) among 15 patients with complete heart block. Average total AV synchrony increased from 89% [67%, 99%] to 93% [78%, 100%] in all patients ( P = .22), from 86% [52%, 98%] to 97% [82%, 99%] in those with complete heart block ( P = .04), and from 73% [52%, 80%] to 78% [70%, 85%] in those with ≥50% pacing ( P = .09)., Conclusion: In patients with AV-synchronous leadless pacemakers, programming changes are frequent and are associated with increased atrial tracking and increased AV synchrony in patients with complete heart block., (© 2021 Published by Elsevier Inc. on behalf of Heart Rhythm Society.)

Given the role of effective communication in improving patient adherence and satisfaction, high quality patient-clinician communication is critical. Building on previous communication interventions in oncology and pediatrics, we developed a tailored communication coaching intervention to improve empathic communication quality and patient-centered care. In this randomized controlled trial, cardiologists record their patient encounters for review by a communication coach who provides tailored feedback. We are recruiting 40 cardiologists and 400 patients, or 4 patients per cardiologist in the Pre-intervention phase and 6 patients per cardiologists in the Post-intervention phase, from outpatient cardiology clinics within the Duke Health System. The primary goal of the trial is to determine the efficacy of the clinician communication coaching versus usual care in the post-intervention phase (240 patient encounters). In this paper, we describe the development of the communication coaching intervention. We also describe the details of the methods and outcomes of the ongoing trial. Finally, we discuss the challenges, solutions, and lessons learned during the start-up phase of the study., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Stroke is a major driver of increased morbidity and mortality in patients with non-valvular atrial fibrillation (NVAF). While systemic oral anticoagulation (OAC) continues to be the mainstay for stroke reduction therapy in patients with NVAF, several barriers prevent the sustained long-term use of OAC, including increased risk of bleeding, non-compliance, cost, drug-drug interactions, and the need for ongoing laboratory testing. Given the need for continued stroke reduction therapies in patients who are intolerant of or non-compliant with OAC, percutaneous left atrial appendage (LAA) occlusion (LAAO) has emerged as a nonpharmacologic alternative to OAC. The development of percutaneous LAAO techniques is based on data suggesting that more than 90% of thrombi in patients with NVAF originate in the LAA. Two percutaneous LAAO devices are currently in widespread clinical use: Watchman (United States and Europe) and the Amplatzer type of devices (Europe); randomized trial data exist only for the Watchman device. Multiple randomized and nonrandomized trials and registries have demonstrated the safety and effectiveness of LAAO in patients who are suitable for short-term anticoagulation using a variety of post-procedural antithrombotic strategies. Ongoing randomized clinical trials on LAAO are focused on OAC-ineligible patients to compare efficacy of LAAO devices against a multitude of antithrombotic options. This review aims to discuss the rationale and evidence for LAAO and post procedural antithrombotic strategies and opportunities for research examination. In addition, we discuss the need for continued investigation of LAAO in populations not well represented in clinical trials or registries, including women, older patients, and underrepresented racial and ethnic groups., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Among patients with severe aortic stenosis (AS), there are limited data on aortic valve replacement (AVR), reasons for nonreceipt and mortality by race., Methods: Utilizing the Duke Echocardiography Laboratory Database, we analyzed data from 110,711 patients who underwent echocardiography at Duke University Medical Center between 1999 and 2013. We identified 1,111 patients with severe AS who met ≥1 of 3 criteria for AVR: ejection fraction ≤50%, diagnosis of heart failure, or need for coronary artery bypass surgery. Logistic regression models were used to assess the association between race, AVR and 1-year mortality. χ2 testing was used to assess potential racial differences in reasons for AVR nonreceipt., Results: Among the 1,111 patients (143 AA and 968 CA) eligible for AVR, AA were more often women, had more diabetes, renal insufficiency, aortic regurgitation and left ventricular hypertrophy. CA were more often smokers, had more ischemic heart disease, hyperlipidemia and higher median income levels. There were no racial differences in surgical risk utilizing logistic euroSCORES. Relative to CA, AA had lower rates of AVR (adjusted odds ratio 0.46, 95% CI 0.3-0.71, P < .001) yet similar 1-year mortality (aHR 0.81, 95% CI 0.57-1.17, P = .262). There were no significant differences in reasons for AVR nonreceipt., Conclusions: We identified 143 African Americans (AA) and 968 Caucasian Americans(CA) with severe AS who met prespecified criteria for AVR.. AA relative to CA were more often women, had more diabetes, renal insufficiency, and left ventricular hypertrophy, however had less tobacco use, ischemic heart disease, hyperlipidemia and lower median income levels. Among patients with severe AS, AA relative to CA had lower rates of AVR (adjusted odds ratio 0.46, 95% CI 0.3-0.71, P < .001) without significant differences in reasons for AVR nonreceipt and similar 1-year mortality., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: The proportion of women and underrepresented racial and ethnic groups (UREGs) matriculating into general cardiology fellowships remains low., Objective: To assess a systematic recruitment initiative aimed at ensuring adequate matriculation of women and UREGs in a general cardiology fellowship., Design, Setting, and Participants: This quality improvement study took place at a large, tertiary academic medical center and associated Accreditation Council for Graduate Medical Education Cardiovascular Disease fellowship. Participants included cardiology fellowship and divisional leadership and general cardiology fellow applicants to the Duke Cardiovascular Disease Fellowship Program from 2017 to 2019. Data analysis was performed from December 2019 to May 2020., Exposure: Multipronged initiative that created an environment committed to ensuring equity of opportunity. This included the creation of a fellowship diversity and inclusivity task force that drafted recommendations, which included reorganization of the fellowship recruitment committee, and changes to the applicant screening process, the interview day, applicant ranking process, and postmatch interventions., Main Outcomes and Measures: The percentage of matriculating and overall women and UREGs before and after the interventions were recorded., Results: The fellowship received a mean (SD) of 462 (55) applications annually before the interventions (2006-2016) and 611 (27) applications annually after the interventions (2017-2019). Between the 10-year period before the interventions and the 3-year period during the interventions, there was a significant increase in the annual mean (SD) percentage of women (22.4% [2.9%] vs 26.4% [0.07%]; P < .001) and UREG applicants (10.5% [1.1%] vs 12.5% [1.9%]; P = .01) to the program. Among applicants interviewed, the percentage of women increased from 20.0% to 33.5% (P = .01) and that of and UREGs increased from 14.0% to 20.0% (P = .01). Before the interventions, a mean (SD) of 23.2% (16.2%) women and 9.7% (7.8%) UREGs matriculated as first-year fellows, whereas after the interventions, a mean (SD) of 54.2% (7.2%) women and 33.3% (19.0%) UREGs matriculated as first-year fellows. The proportion of the entire fellowship who were women increased from a 5-year mean (SD) of 27.0% (8.8%) to 54.2% (7.2%) after 3 years of interventions, and that of UREGs increased from 5.6% (4.6%) to 33.3% (19.0%). Overall, the proportion of applicants in the entire population who were either women or from UREGs increased from 27.8% to 66.7%., Conclusions and Relevance: After implementing interventions to promote equity of opportunity in the cardiovascular disease fellowship, the percentage of women and UREGs significantly increased in the fellowship over a 3-year time period. These interventions may be applicable to other cardiovascular disease fellowships seeking to diversify training programs.

While oral anticoagulation is a cornerstone of stroke prevention therapy in atrial fibrillation (AF), few studies have evaluated comparative discontinuation rates in clinical practice. The objective of this study is to evaluate discontinuation rates among patients on warfarin and direct oral anticoagulants (DOACs) in clinical practice., Methods: The ORBIT-AF II Registry enrolled 10,005 total AF patients with a CHA 2 DS 2 VASc score of ≥2 on warfarin or DOACs from 235 clinical practices across the US from February 13, 2013 and July 12, 2017. Descriptive statistics and multivariable Cox regression modeling were used to describe baseline characteristics and predictors of discontinuation. Unadjusted and adjusted discontinuation rates and 95% confidence intervals (CI) were calculated using Cox proportional hazards models and propensity score adjustment, respectively., Results: At baseline, 16.4% (N = 1642/10,005) were treated with warfarin, 83.6% (N = 8363/10,005) with DOACs and 1498/10,005 patients (15.0%) discontinued therapy [warfarin = 236/1642 (14.4%) vs DOACs = 1262/8363 (15.1%)]. At 6 and 12 months respectively, among 7049 patients with a new diagnosis of AF within 6 months, adjusted discontinuation rates for warfarin versus DOACs were as follows: [6 months: 7.9%, 95%CI (6.8%-9.0%) vs 9.6% (8.4%-10.7%), P = .16]; [12 months: 12.7% (11.0%-14.3%) vs 15.3% (13.6%-16.9%), P = .02)]. Patients who discontinued therapy with warfarin or DOACs had higher risk of adverse clinical outcomes including: all-cause mortality and cardiovascular death (CV) than those who continued treatment., Conclusion: In a community based AF cohort, adjusted rates of discontinuation at 12-months were higher in DOAC-treated versus VKA-treated patients. Discontinuation of oral anticoagulation was associated with increased absolute risk of all-cause mortality and CV death., Clinical Trial Registration: URL:https://clinicaltrials.gov. Unique Identifier: NCT01701817., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Diabetes mellitus (DM) is an independent risk factor for atrial fibrillation (AF). Few studies have compared clinical outcomes after catheter ablation between patients with and those without DM., Objective: The purpose of this study was to compare AF ablation outcomes in patients with and those without DM., Methods: We performed a retrospective analysis of 351 consecutive patients who underwent first-time AF ablation. Clinical outcomes included freedom from recurrent atrial arrhythmia, symptom burden (Mayo AF Symptom Inventory score), cardiovascular and all-cause hospitalizations, and periprocedural complications., Results: Patients with DM (n = 65) were older, had a higher body mass index, more persistent AF, more hypertension, and larger left atrial diameter ( P <.05 for all). Median (Q1, Q3) total radiofrequency duration [64.0 (43.6, 81.4) minutes vs 54.3 (39.2, 76.4) minutes; P = .132] and periprocedural complications ( P = .868) did not differ between patients with and those without DM. After a median follow-up of 29.5 months, arrhythmia recurrence was significantly higher in the DM group compared to the no-DM group after adjustment for baseline differences (adjusted hazard ratio [HR] 2.24; 95% confidence [CI] 1.42-3.55; P = .001). There was a nonsignificant trend toward higher AF recurrence with worse glycemic levels (HR 1.29; 95% CI 0.99-1.69; P = .064)., Conclusion: Although safety outcomes associated with AF ablation were similar between patients with and those without DM, arrhythmia-free survival was significantly lower among patients with DM. Poor glycemic control seems to an important risk factor for AF recurrence., (© 2020 Heart Rhythm Society. Published by Elsevier Inc.)

Background: Despite a higher prevalence of sudden cardiac death (SCD), black individuals are less likely than whites to have an implantable cardioverter defibrillator (ICD) implanted. Racial differences in ICD utilization is in part explained by higher refusal rates in black individuals. Decision support can assist with treatment-related uncertainty and prepare patients to make well-informed decisions., Methods: The Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) study will randomize 350 black individuals with a primary prevention indication for an ICD to a racially concordant/discordant video-based decision support tool or usual care. The composite primary outcome is (1) the decision for ICD placement in the combined video groups compared with usual care and (2) the decision for ICD placement in the racially concordant relative to discordant video group. Additional outcomes include knowledge of ICD therapy and SCD risk; decisional conflict; ICD receipt at 90 days; and a qualitative assessment of ICD decision making in acceptors, decliners, and those undecided., Conclusions: In addition to assessing the efficacy of decision support on ICD acceptance among black individuals, VIVID will provide insight into the role of racial concordance in medical decision making. Given the similarities in the root causes of racial/ethnic disparities in care across health disciplines, our approach and findings may be generalizable to decision making in other health care settings., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Aortic stenosis (AS) is among the most common valvular heart diseases encountered in the United States. In this review the authors examine differences between racial and ethnic groups in the epidemiology and management of severe AS, explore potential explanations for these findings, and discuss the implications for improving the delivery of care to racially and ethnically diverse populations. Underrepresented racial and ethnic groups experience a paradoxically lower prevalence or incidence of AS relative to white subjects, despite having a higher prevalence of traditional risk factors. Historically, UREGs with severe AS have had lower rates of both surgical and transcatheter aortic valve replacement and experienced more post-surgical complications, including, bleeding, worsening heart failure, and rehospitalization. Last, UREGs with severe AS have an increased risk for morbidity and mortality relative to white patients. To date much of the research on AS has examined black-white differences, so there is a need to understand how other racial and ethnic groups with severe AS are diagnosed and treated, with examination of their resulting outcomes. Overall, racial and ethnic disparities in health care access and care delivery are a public health concern given the changing demographics of the U.S. population. These differences in AS management and outcomes highlight the need for additional research into contributing factors and appropriate interventions to address the lower rates of aortic valve replacement and higher morbidity and mortality among UREGs., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Catheter ablation is an important rhythm control therapy in patients with atrial fibrillation (AF) with concomitant heart failure (HF). The objective of this study was to assess the comparative efficacy of AF ablation patients with ischemic vs nonischemic heart failure., Methods: We conducted a retrospective, observational cohort study of patients with HF who underwent AF ablation. Outcomes were compared based on HF etiology and included in-hospital events, symptoms (Mayo AF Symptom Inventory [MAFSI]), and functional status (New York Heart Association class) and freedom from atrial arrhythmias at 12 months., Results: Among 242 patients (n = 70 [29%] ischemic, n = 172 [71%] nonischemic), patients with nonischemic cardiomyopathy were younger (mean age 64 ± 11.5 vs 69 ± 9.1, P  = .002), more often female (36% vs 17%, P  = .004), and had higher mean left-ventricular ejection fraction (47% vs 42%, P  = .0007). There were no significant differences in periprocedural characteristics, including mean procedure time (243 ± 74.2 vs 259 ± 81.8 minutes, P  = .1) and nonleft atrial ablation (17% vs 20%, P  = .6). All-cause adverse events were similar in each group (15% vs 17%, P  = .7). NYHA and MAFSI scores improved significantly at follow-up and did not differ according to HF etiology ( P  = .5; P  = .10-1.00 after Bonferroni correction). There were no significant differences in freedom from recurrent atrial arrhythmia at 12-months between ischemic (74%) and nonischemic patients (78%): adjusted RR 0.63, 95% confidence interval 0.33-1.19., Conclusions: Catheter ablation in patients with AF and concomitant heart failure leads to significant improvements in functional and symptom status without significant differences between patients with ischemic vs nonischemic HF etiology., Competing Interests: E. Black‐Maier: None. BA Steinberg: Fellowship Support; Medtronic, Inc, St. Jude Medical, Biotronik, Boston Scientific Corp. Fellowship Support; Biosense Webster, Inc.; Boston Scientific Corp., Janssen Pharmaceuticals. Other; Bristol Meyers Squibb. K. Trulock: None. F. Wang: None.. Y. Lokhnygina: None. W. O 'Neal: None. SM Al‐Khatib: None. BD Atwater: Research Grants; St. Jude Medical. JP Daubert: consulting fees/honoraria from Medtronic, St. Jude Medical, Boston Scientific, Sorin Group, and CardioFocus' research grants from Boston Scientific, Biosense Webster, Medtronic, and Gilead Sciences. C. Frazier‐M ills: None. DD Hegland: None. KP Jackson: None. LR Jackson: None. JI Koontz: None. RK Lewis: None. AY Sun: None. KL Thomas: None. TD Bahnson: Research Grants: Medtronic; St. Jude Medical; Consultant to Boehringer Ingelheim, ChanRX, Sequel Pharma, and Sanofi‐Aventis. JP Piccini: research grants from Abbott, American Heart Association, Bayer, Boston Scientific, Gilead, Janssen Pharmaceuticals, NHLBI, and Philips and consultant fees from Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, Johnson & Johnson, LivaNova, Medtronic, Milestone, Sanofi, and Philips., (© 2020 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Heart Rhythm Society.)

Background: Compared with medical therapy, catheter ablation of atrial fibrillation (AF) in patients with heart failure (HF) improves cardiovascular outcomes. Risk scores (CAAP-AF and APPLE) have been developed to predict the likelihood of AF recurrence after ablation, have not been validated specifically in patients with AF and HF., Methods: We analyzed baseline characteristics, risk scores, and rates of AF recurrence 12 months postablation in a cohort of 230 consecutive patients with AF and HF undergoing PVI in the Duke Center for Atrial Fibrillation registry from 2009-2013., Results: During a follow-up period of 12 months, 76 of 230 (33%) patients with HF experienced recurrent AF after ablation. The median APPLE and CAAP-AF scores were 1.5 ([Q1, Q3]: [1.0, 2.0]) and 4.0 ([Q1, Q3]: [3.0, 5.0]), respectively and were not different from those patients with and without recurrent AF. Freedom from AF was not different according to APPLE and CAAP-AF scores. Discrimination for recurrent AF with the CAAP-AF score was modest with a C-statistic of 0.60 (95% CI 0.52-0.67). Discrimination with the APPLE score was similarly modest, with a C-statistic of 0.54 (95% CI: 0.47-0.62)., Conclusions: Validated predictive risk scores for recurrent AF after catheter ablation exhibit limited predictive ability in cohorts of AF and HF. Additional tools are needed to facilitate risk stratification and patient selection for AF ablation in patients with concomitant HF., (© 2019 Wiley Periodicals, Inc.)

Background: Cluster-randomized trials (CRTs) are being increasingly used to test a range of interventions, including medical interventions commonly used in clinical practice. Policies created by the NIH and the Food and Drug Administration (FDA) require the reporting of demographics and the examination of demographic heterogeneity of treatment effect (HTE) for individually randomized trials. Little is known about how frequent demographics are reported and HTE analyses are conducted in CRTs., Objectives: We sought to understand the prevalence of HTE analyses and the statistical methods used to conduct them in CRTs focused on treating cardiovascular disease, cancer, and chronic lower respiratory diseases. Additionally, we also report on the proportion of CRTs that reported on baseline demographics of its populations and conducted demographic HTE analyses., Data Sources: We searched PubMed and Embase for CRTs published between 1/1/2010 and 3/29/2016 that focused on treating the top 3 Center for Disease Control causes of death (cardiovascular disease, chronic lower respiratory disease, and cancer). Evidence Screening And Review: Of 1,682 unique titles, 117 abstracts were screened. After excluding 53 articles, we included 64 CRT publications and abstracted information on study characteristics and demographic information, statistical analysis, HTE analysis, and study quality., Results: Age and sex were reported in greater than 95.3% of CRTs, while race and ethnicity were reported in only 20.3% of CRTs. HTE analyses were conducted in 28.1% (n = 18) of included CRTs and 77.8% (n = 12) were prespecified analyses. Four CRTs conducted a demographic subgroup analysis. Only 6/18 CRTs used interaction testing to determine whether HTE existed., Conclusions: Baseline demographic reporting was high for age and sex in CRTs, but was uncommon for race and ethnicity. HTE analyses were uncommon and was rare for demographic subgroups, which limits the ability to examine the extent of benefits or risks for treatments tested with CRT designs., Competing Interests: MA Starks - none; GD Sanders - none; RR Coeytaux - none; IL Riley - none; LR Jackson - education support from Medtronic and Biotronik; honoraria from Biotronik; AM Brooks - none; KL Thomas - Consultant: Pfizer, BMS, Janssen; KR Choudhury - none; RM Califf - sits on the corporate board for Cytokinetics and is board chair for the People-Centered Research Foundation. He receives personal fees for consulting from Merck, Amgen, Biogen, Genentech, Eli Lilly, and Boehringer Ingelheim. He is also employed as an advisor by Verily Life Sciences (Alphabet); AF Hernandez - consulting fees from Sanofi, Johnson & Johnson, AstraZeneca, and Cortera; research support from Amylin and Scios/Johnson & Johnson. This does not alter our adherence to PLOS ONE policies on sharing data and materials.