Influence of Gender in Advanced Heart Failure Therapies and Outcome Following Transplantation.
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ABSTRACT:
SUBMITTER: Garcia-Cosio MD
PROVIDER: S-EPMC7946818 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background Race influences medical decision making, but its impact on advanced heart failure therapy allocation is unknown. We sought to determine whether patient race influences allocation of advanced heart failure therapies. Methods and Results Members of a national heart failure organization were randomized to clinical vignettes that varied by patient race (black or white man) and were blinded to study objectives. Participants (N=422) completed Likert scale surveys rating factors for advanced therapy allocation and think-aloud interviews (n=44). Survey results were analyzed by least absolute shrinkage and selection operator and multivariable regression to identify factors influencing advanced therapy allocation, including interactions with vignette race and participant demographics. Interviews were analyzed using grounded theory. Surveys revealed no differences in overall racial ratings for advanced therapies. Least absolute shrinkage and selection operator regression selected no interactions between vignette race and clinical factors as important in allocation. However, interactions between participants aged ≥40 years and black vignette negatively influenced heart transplant allocation modestly (-0.58; 95% CI, -1.15 to -0.0002), with adherence and social history the most influential factors. Interviews revealed sequential decision making: forming overall impression, identifying urgency, evaluating prior care appropriateness, anticipating challenges, and evaluating trust while making recommendations. Race influenced each step: avoiding discussing race, believing photographs may contribute to racial bias, believing the black man was sicker compared with the white man, developing greater concern for trust and adherence with the black man, and ultimately offering the white man transplantation and the black man ventricular assist device implantation. Conclusions Black race modestly influenced decision making for heart transplant, particularly during conversations. Because advanced therapy selection meetings are conversations rather than surveys, allocation may be vulnerable to racial bias.
| S-EPMC6915287 | biostudies-literature
Project description:ImportanceRacial bias is associated with the allocation of advanced heart failure therapies, heart transplants, and ventricular assist devices. It is unknown whether gender and racial biases are associated with the allocation of advanced therapies among women.ObjectiveTo determine whether the intersection of patient gender and race is associated with the decision-making of clinicians during the allocation of advanced heart failure therapies.Design, setting, and participantsIn this qualitative study, 46 US clinicians attending a conference for an international heart transplant organization in April 2019 were interviewed on the allocation of advanced heart failure therapies. Participants were randomized to examine clinical vignettes that varied 1:1 by patient race (African American to white) and 20:3 by gender (women to men) to purposefully target vignettes of women patients to compare with a prior study of vignettes of men patients. Participants were interviewed about their decision-making process using the think-aloud technique and provided supplemental surveys. Interviews were analyzed using grounded theory methodology, and surveys were analyzed with Wilcoxon tests.ExposureRandomization to clinical vignettes.Main outcomes and measuresThematic differences in allocation of advanced therapies by patient race and gender.ResultsAmong 46 participants (24 [52%] women, 20 [43%] racial minority), participants were randomized to the vignette of a white woman (20 participants [43%]), an African American woman (20 participants [43%]), a white man (3 participants [7%]), and an African American man (3 participants [7%]). Allocation differences centered on 5 themes. First, clinicians critiqued the appearance of the women more harshly than the men as part of their overall impressions. Second, the African American man was perceived as experiencing more severe illness than individuals from other racial and gender groups. Third, there was more concern regarding appropriateness of prior care of the African American woman compared with the white woman. Fourth, there were greater concerns about adequacy of social support for the women than for the men. Children were perceived as liabilities for women, particularly the African American woman. Family dynamics and finances were perceived to be greater concerns for the African American woman than for individuals in the other vignettes; spouses were deemed inadequate support for women. Last, participants recommended ventricular assist devices over transplantation for all racial and gender groups. Surveys revealed no statistically significant differences in allocation recommendations for African American and white women patients.Conclusions and relevanceThis national study of health care professionals randomized to clinical vignettes that varied only by gender and race found evidence of gender and race bias in the decision-making process for offering advanced therapies for heart failure, particularly for African American women patients, who were judged more harshly by appearance and adequacy of social support. There was no associated between patient gender and race and final recommendations for allocation of advanced therapies. However, it is possible that bias may contribute to delayed allocation and ultimately inequity in the allocation of advanced therapies in a clinical setting.
| S-EPMC7412827 | biostudies-literature
Project description:This in-depth review of sex differences in advanced heart failure therapy summarizes the existing literature on implantable cardioverter defibrillators, biventricular pacemakers, mechanical circulatory support, and transplantation with a focus on utilization, efficacy/clinical effectiveness, adverse events, and controversies. One will learn about the controversies regarding efficacy/clinical effectiveness of implantable cardioverter defibrillators and understand why these devices should be implanted in women even if there are sex differences in appropriate shocks. Individuals will learn about the sex differences with biventricular pacemakers with respect to ventricular remodeling and reduction in heart failure hospitalizations/mortality, as well as, possible mechanisms. We will demonstrate sex differences in heart transplantation and waitlist survival. Despite similar survival for women and men with left ventricular assist devices, there are sex differences in adverse events. These devices do successfully bridge women and men to transplant, yet women are less likely than men to have a left ventricular assist at time of listing and time of transplantation. Finally, one will learn about the concerns regarding poor outcome for men who receive female donor hearts and discover this may not be due to sex, but rather size. More research is needed to better understand sex differences and further improve advanced heart failure therapy for both women and men.
| S-EPMC6383806 | biostudies-literature
Project description:Background US regulatory framework for advanced heart failure therapies (AHFT), ventricular assist devices, and heart transplants, delegate eligibility decisions to multidisciplinary groups at the center level. The subjective nature of decision-making is at risk for racial, ethnic, and gender bias. We sought to determine how group dynamics impact allocation decision-making by patient gender, racial, and ethnic group. Methods and Results We performed a mixed-methods study among 4 AHFT centers. For ≈ 1 month, AHFT meetings were audio recorded. Meeting transcripts were evaluated for group function scores using de Groot Critically Reflective Diagnoses protocol (metrics: challenging groupthink, critical opinion sharing, openness to mistakes, asking/giving feedback, and experimentation; scoring: 1 to 4 [high to low quality]). The relationship between summed group function scores and AHFT allocation was assessed via hierarchical logistic regression with patients nested within meetings nested within centers, and interaction effects of group function score with gender and race, adjusting for patient age and comorbidities. Among 87 patients (24% women, 66% White race) evaluated for AHFT, 57% of women, 38% of men, 44% of White race, and 40% of patients of color were allocated to AHFT. The interaction between group function score and allocation by patient gender was statistically significant (P=0.035); as group function scores improved, the probability of AHFT allocation increased for women and decreased for men, a pattern that was similar irrespective of racial and ethnic groups. Conclusions Women evaluated for AHFT were more likely to receive AHFT when group decision-making processes were of higher quality. Further investigation is needed to promote routine high-quality group decision-making and reduce known disparities in AHFT allocation.
| S-EPMC10111441 | biostudies-literature
Project description:BackgroundAs survival and neuromuscular function in Duchenne Muscular Dystrophy (DMD) improve with glucocorticoid therapy and respiratory advances, the proportion of cardiac deaths is increasing. Little is known about the use and outcomes of advanced heart failure (HF) therapies in this population.MethodsA retrospective cohort study of 436 males with DMD was performed, from January 1, 2005-January 1, 2018, with the primary outcome being use of advanced HF therapies including: implantable cardioverter defibrillator (ICD), left ventricular assist device (LVAD), and heart transplantation (HTX).ResultsNine subjects had an ICD placed, 2 of whom (22.2%) had appropriate shocks for ventricular tachycardia; 1 and 968 days after implant, and all of whom were alive at last follow-up; median 18 (IQR: 12.5-25.5) months from implant. Four subjects had a LVAD implanted with post-LVAD survival of 75% at 1 year; 2 remaining on support and 1 undergoing HTX. One subject was bridged to HTX with ICD and LVAD and was alive at last follow-up, 53 months after HTX.ConclusionAdvanced HF therapies may be used effectively in select subjects with DMD. Further studies are needed to better understand risk stratification for ICD use and optimal candidacy for LVAD implantation and HTX, with hopes of improving cardiac outcomes.
| S-EPMC6663084 | biostudies-literature
Project description:INTRODUCTION:Patients with advanced heart failure (HF) experience many burdensome symptoms that increase patient suffering. METHODS:Comparative secondary analysis of 347 patients with advanced HF. Symptom burden was measured with the Memorial Symptom Assessment Scale-HF. Depression was measured using the Patient Health Questionnaire-9. RESULTS:Mean number of symptoms was 13.6. The three most frequent symptoms were non-cardiac pain, shortness of breath, and lack of energy. Patients with depression reported higher symptom burden. Symptom burden differed when compared by gender. Women reported higher symptom burden for other pain, dry mouth, swelling of the arms and legs, sweats, feeling nervous, nausea, and vomiting. Men reported higher symptom burden with sexual problems. CONCLUSIONS:Given the high rates of symptoms and distress, interventions are needed to alleviate the symptom burden of patients with advanced HF. Reported symptom burden in patients with advanced heart failure was higher when depressive symptoms were present. Women reported varied number and severity of symptoms than men.
| S-EPMC7582916 | biostudies-literature
Project description:IntroductionArtificial intelligence can recognize complex patterns in large datasets. It is a promising technology to advance heart failure practice, as many decisions rely on expert opinions in the absence of high-quality data-driven evidence.MethodsWe searched Embase, Web of Science, and PubMed databases for articles containing "artificial intelligence," "machine learning," or "deep learning" and any of the phrases "heart transplantation," "ventricular assist device," or "cardiogenic shock" from inception until August 2022. We only included original research addressing post heart transplantation (HTx) or mechanical circulatory support (MCS) clinical care. Review and data extraction were performed in accordance with PRISMA-Scr guidelines.ResultsOf 584 unique publications detected, 31 met the inclusion criteria. The majority focused on outcome prediction post HTx (n = 13) and post durable MCS (n = 7), as well as post HTx and MCS management (n = 7, n = 3, respectively). One study addressed temporary mechanical circulatory support. Most studies advocated for rapid integration of AI into clinical practice, acknowledging potential improvements in management guidance and reliability of outcomes prediction. There was a notable paucity of external data validation and integration of multiple data modalities.ConclusionOur review showed mounting innovation in AI application in management of MCS and HTx, with the largest evidence showing improved mortality outcome prediction.
| S-EPMC9999024 | biostudies-literature
Project description:AimsThe role of donor/recipient gender matching on the long-term rejection process and clinical outcomes following heart transplantation (HT) outcomes is still controversial. We aim to investigate the impact of gender matching on early and long-term outcome HT.Methods and resultsThe study population comprised 166 patients who underwent HT between 1991 and 2013 and were prospectively followed up in a tertiary referral centre. Early and late outcomes were assessed by the type of donor-recipient gender match (primary analysis: female donor-male recipient [FD-MR, n = 36] vs. male donor-male recipient [MD-MR, n = 109]). Early mortality, need for inotropic support, length of hospital stay, and major perioperative adverse events did not differ between the FD-MR and MD-MR groups. However, the FD-MR group experienced significantly higher rates of early major rejections per patient as compared with the MD-MR group (1.2 ± 1.6 vs. 0.4 ± 0.8; P = 0.001), higher rates of overall major rejections (16 vs. 5.5 per 100 person years; P < 0.05), and higher rate of cardiac allograft vasculopathy (43% vs. 20%; P = 0.01). Kaplan-Meier survival analysis showed that the cumulative probabilities of survival free of rejections and major adverse events were significantly higher in MD-MR group (P = 0.002 and 0.001, respectively). Multivariate analysis showed that FD-MR status was associated with >2.5-fold (P = 0.03) increase in the risk for rejections and with a >3-fold (P = 0.01) increase in the risk for major adverse events during follow-up.ConclusionsDonor-recipient gender mismatch is a powerful independent predictor of early and late rejections and long-term major adverse events following HT.
| S-EPMC5292637 | biostudies-literature
Project description:BACKGROUND:Although hospital readmission for heart failure (HF) is an issue for both men and women, little is known about differences in readmission rates by sex. Consequently, strategies to optimize readmission reduction programs and care strategies for women and men remain unclear. Our study aims were: (1) to identify studies examining readmission rates according to sex, and (2) to provide a qualitative overview of possible considerations for the impact of sex or gender. METHODS:We conducted a scoping review using the Arksey and O'Malley framework to include full text articles published between 2002 and 2017 drawn from multiple databases (MEDLINE, EMBASE), grey literature (i.e. National Technical information, Duck Duck Go), and expert consultation. Eligible articles included an index heart failure episode, readmission rates, and sex/gender-based analysis. RESULTS:The search generated 5887 articles, of which 746 underwent full abstract text consideration for eligibility. Of 164 eligible articles, 34 studies addressed the primary outcome, 103 studies considered sex differences as a secondary outcome and 25 studies stratified data for sex. Good inter-rater agreement was reached: 83% title/abstract; 88% full text; kappa: 0.69 (95%CI: 0.53-0.85). Twelve of 34 studies reported higher heart failure readmission rates for men and six studies reported higher heart failure readmission rates for women. Using non composite endpoints, five studies reported higher HF readmission rates for men compared to three studies reporting higher HF readmission rates for women. Overall, there was heterogeneity between studies when examined by sex, but one observation emerged that was related to the timing of readmissions. Readmission rates for men were higher when follow-up duration was longer than 1 year. Women were more likely to experience higher readmission rates than men when time to event was less than 1 year. CONCLUSIONS:Future studies should consider different time horizons in their designs and avoid the use of composite measures, such as readmission rates combined with mortality, which are highly skewed by sex. Co-interventions and targeted post-discharge approaches with attention to sex would be of benefit to the HF patient population.
| S-EPMC7222562 | biostudies-literature
Project description:J Clin Hypertens (Greenwich). 2009;11:466-474. (c)2009 Wiley Periodicals, Inc.Lower heart failure (HF) rates in individuals taking chlorthalidone vs amlodipine, lisinopril, or doxazosin were unanticipated in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). HF differences appeared early, leading to questions about the possible influence of pre-enrollment antihypertensive drugs. A post hoc study evaluated hospitalized HF events. During year 1479 individuals had HF, with pre-entry antihypertensive medication data obtained on 301 patients (63%). Case-only analysis examined interactive effects (interaction odds ratio [OR, ratio of ORs]) of previous medication and ALLHAT treatment on HF outcomes, eg, did treatment effect differ by pre-entry antihypertensive class? Among cases, 39%, 37%, 17%, and 47% were taking pre-entry diuretics, angiotensin-converting enzyme inhibitors, beta-blockers, and calcium channel blockers, respectively. Interaction OR for year 1 HF for amlodipine vs chlorthalidone for patients taking vs not taking diuretics pre-entry was 1.08 (95% confidence interval [CI], 0.53-2.21; P=.83); for lisinopril vs chlorthalidone, 1.33 (95% CI, 0.65-2.74; P=.44); and for doxazosin vs chlorthalidone, 1.13 (95% CI, 0.57-2.25; P=.73). Controlling for other pre-entry antihypertensives yielded similar results. There was no significant evidence that pre-entry drug type explained observed hospitalized HF differences by ALLHAT treatment.
| S-EPMC2788785 | biostudies-literature