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Background: Caregiver support is considered necessary after heart transplant (HT) and left ventricular assist device (LVAD) for patients with end‐stage heart failure (HF). Few studies have demonstrated how caregivers differ by gender and race, and whether that impacts therapy eligibility. Methods: We examined caregiver relationships among 674 patients (32% women, 55% Black) evaluated at Emory University from 2011 to 2017. Therapy readiness was assessed using the Stanford Integrated Assessment for Transplant (SIPAT). Evaluation outcome according to caregiver relationship was compared using χ2 analysis. Multivariable logistic regression determined the association between caregiver and eligibility according to gender and race. Results: Women and Black patients were less likely to have spouses as their support person (P <.001). Women were less likely to be considered eligible for advanced therapies (adjusted odds ratio [aOR].64, 95% confidence interval [CI].46–.89; P =.008), with Black women having lower eligibility than White women (aOR.28, 95% CI.11–.72; P =.008). Social support and SIPAT scores did not significantly influence eligibility by gender or race. Conclusion: Lack of caregiver support is considered a relative contraindication to advanced therapies. Type of caregiver in our cohort varied according to race and gender but did not explain differences in eligibility for advanced therapies. [ABSTRACT FROM AUTHOR]

Among the estimated 6.2 million Americans living with heart failure (HF), ≈5%/y may progress to advanced, or stage D, disease. Advanced HF has a high morbidity and mortality, such that early recognition of this condition is important to optimize care. Delayed referral or lack of referral in patients who are likely to derive benefit from an advanced HF evaluation can have important adverse consequences for patients and their families. A 2-step process can be used by practitioners when considering referral of a patient with advanced HF for consideration of advanced therapies, focused on recognizing the clinical clues associated with stage D HF and assessing potential benefits of referral to an advanced HF center. Although patients are often referred to an advanced HF center to undergo evaluation for advanced therapies such as heart transplantation or implantation of a left ventricular assist device, there are other reasons to refer, including access to the infrastructure and multidisciplinary team of the advanced HF center that offers a broad range of expertise. The intent of this statement is to provide a framework for practitioners and health systems to help identify and refer patients with HF who are most likely to derive benefit from referral to an advanced HF center. [ABSTRACT FROM AUTHOR]

Objectives: We investigated sex‐based differences in eligibility for and outcomes after receipt of advanced heart failure (HF) therapies. Background: Although women are more likely to die from HF than men, registry data suggest that women are less likely to receive heart transplant (HT) or left ventricular assist device (LVAD) for largely unknown reasons. Methods: We performed a single‐center retrospective cohort study of patients evaluated for advanced HF therapies from 2012 to 2016. Logistic regression was used to determine the association of sex with eligibility for HT/LVAD. Competing risks and Kaplan‐Meier analysis were used to examine survival. Results: Of 569 patients (31% women) evaluated, 223 (39.2%) were listed for HT and 81 (14.2%) received destination (DT) LVAD. Women were less likely to be listed for HT (adjusted odds ratio [OR] 0.36, 95% confidence interval [CI] 0.21‐0.61; P <.0001), based on allosensitization (P <.0001) and obesity (P =.02). Women were more likely to receive DT LVAD (adjusted OR 2.29, 95% CI 1.23‐4.29; P =.01). Survival was similar between men and women regardless of whether they received HT and DT LVAD or were ineligible for therapy. Conclusion: Women are less likely to be HT candidates, but more likely to receive DT LVAD. [ABSTRACT FROM AUTHOR]

Abstract Objective It remains unclear whether left ventricular assist device (LVAD) implantation in non-inotrope dependent patients is of clinical benefit. This study sought to evaluate cause of death in patients listed for heart transplant (HT) to determine the relative risks and benefits of implanting LVAD into patients who are less sick than those included in the original clinical trials. Methods We examined death as the primary outcome in 23,098 patients listed for HT from 2006 to 2014 using proportional subdistribution hazards modeling. Cause of death was examined as a secondary outcome using χ2 tests. Results 1859 (8.1%) patients were removed from the wait list for death, including 229 (2.7%) status 1A, 349 (4.6%) status 1B, 246 (13.2%) status 2, and 1035 (26.0%) status 7 patients (P < 0.0001). Status 2 patients who received LVAD while listed had a higher risk of death compared to those who did not (adjusted HR 1.68; 95% CI 1.09–2.59; P = 0.02), while there was no increased risk of death in status 1A (HR 1.02; 95% CI 0.68–1.51; P = 0.9) and status 1B (HR 0.89; 95% CI 0.65–1.23; P = 0.5) who received LVAD. Status 2 patients who received LVAD were more likely to die cerebrovascular causes (0.6% vs. 0.1%, P = 0.009) and organ failure (70.6% vs. 29.4%, P = 0.003). Conclusions LVAD implantation in status 2 patients listed for HT is associated with a higher risk of death. More research is needed to determine the impact LVAD implantation will have on mortality in patients with ambulatory, non-inotrope dependent HF. [ABSTRACT FROM AUTHOR]

Background There is increasing recognition that the risk of stroke after left ventricular assist device (LVAD) implantation varies based on gender, with a higher risk in female patients. We reviewed our own data to determine gender differences in the risk of stroke. Methods Frequency of stroke, including intracranial hemorrhage and ischemic stroke, was retrospectively evaluated in 110 heart failure patients (mean age 49.6 ± 13.6 years, 32% women) discharged from the hospital after implantation of a HeartMate II ( N = 74) or HeartWare ( N = 36) LVAD. Competing outcomes analysis was used to determine which clinical risk factors were associated with the risk of stroke and death, with the primary end-point being time to first stroke event. Results During a median follow-up of 1.3 years, 26 patients had a stroke (23.6%, 0.14 case per person-year). The median time to first stroke was 0.7 (interquartile range 0.3 to 1.4) years. After adjusting for covariates, risk of stroke was higher for women than for men (hazard ratio 3.1, 95% confidence interval 1.4 to 6.9; p = 0.007). There was no difference in overall survival between men and women. Conclusion The risk of stroke after LVAD varies based on gender, with a higher risk in female patients. More research is needed to fully understand these differences, and whether device management strategies should be tailored based on gender. [ABSTRACT FROM AUTHOR]

BACKGROUND: Dilated cardiomyopathy (DCM) can lead to advanced disease, defined herein as necessitating a durable left ventricular assist device or a heart transplant (LVAD/HT). DCM is known to have a genetic basis, but the association of rare variant genetics with advanced DCM has not been studied. METHODS: We analyzed clinical and genetic sequence data from patients enrolled between 2016 and 2021 in the US multisite DCM Precision Medicine Study, which was a geographically diverse, multiracial, multiethnic cohort. Clinical evaluation included standardized patient interview and medical record query forms. DCM severity was classified into 3 groups: patients with advanced disease with LVAD/HT; patients with an implantable cardioverter defibrillator (ICD) only; or patients with no ICD or LVAD/HT. Rare variants in 36 DCM genes were classified as pathogenic or likely pathogenic or variants of uncertain significance. Confounding factors we considered included demographic characteristics, lifestyle factors, access to care, DCM duration, and comorbidities. Crude and adjusted associations between DCM severity and rare variant genetic findings were assessed using multinomial models with generalized logit link. RESULTS: Patients' mean (SD) age was 51.9 (13.6) years; 42% were of African ancestry, 56% were of European ancestry, and 44% were female. Of 1198 patients, 347 had LVAD/HT, 511 had an ICD, and 340 had no LVAD/HT or ICD. The percentage of patients with pathogenic or likely pathogenic variants was 26.2%, 15.9%, and 15.0% for those with LVAD/HT, ICD only, or neither, respectively. After controlling for sociodemographic characteristics and comorbidities, patients with DCM with LVAD/HT were more likely than those without LVAD/HT or ICD to have DCM-related pathogenic or likely pathogenic rare variants (odds ratio, 2.3 [95% CI, 1.5-3.6]). The association did not differ by ancestry. Rare variant genetic findings were similar between patients with DCM with an ICD and those without LVAD/HT or ICD. CONCLUSIONS: Advanced DCM was associated with higher odds of rare variants in DCM genes adjudicated as pathogenic or likely pathogenic, compared with individuals with less severe DCM. This finding may help assess the risk of outcomes in management of patients with DCM and their at-risk family members. [ABSTRACT FROM AUTHOR]

Background Several clinical prediction schemes for right ventricular failure (RVF) risk after left ventricular assist device (LVAD) implantation have been developed in both the pulsatile- and continuous-flow LVAD eras. The performance of these models has not been evaluated systematically in a continuous-flow LVAD cohort. Methods We evaluated 6 clinical RVF prediction models (Michigan, Penn, Utah, Kormos et al, CRITT, Pittsburgh Decision Tree) in 116 patients (age 51 ± 13 years; 41.4% white and 56.0% black; 66.4% men; 56.0% bridge to transplant, 37.1% destination therapy, 17.4% bridge to decision) who received a continuous-flow LVAD (HeartMate II: 79 patients, HeartWare: 37 patients) between 2008 and 2013. Results Overall, 37 patients (31.9%) developed RVF, defined: as pulmonary vasodilator use for ≥48 hours or inotrope use for ≥14 days post-operatively; re-institution of inotropes; multi-organ failure due to RVF; or need for mechanical RV support. Median (Quartile 1 to Quartile 3) time to initial discontinuation of inotropes was 6 (range 4 to 8) days. Among scores, the Michigan score reached significance for RVF prediction but discrimination was modest (C = 0.62 [95% CI 0.52 to 0.72], p = 0.021; positive predictive value [PPV] 60.0%; negative predictive value [NPV] 75.8%), followed by CRITT (C = 0.60 [95% CI 0.50 to 0.71], p = 0.059; PPV 40.5%; NPV 72.2%). Other models did not significantly discriminate RVF. The newer, INTERMACS 3.0 definition for RVF, which includes inotropic support beyond 7 days, was reached by 57 patients (49.1%). The Kormos model performed best with this definition (C = 0.62 [95% CI 0.54 to 0.71], p = 0.005; PPV 64.3%; NPV 59.5%), followed by Penn (C = 0.61), Michigan (C = 0.60) and CRITT (C = 0.60), but overall score performance was modest. Conclusion Current schemes for post-LVAD RVF risk prediction perform only modestly when applied to external populations. [ABSTRACT FROM AUTHOR]

Introduction: Right ventricular failure (RVF) still occurs in >20% of left ventricular assist device (LVAD) recipients. In this prospective, single-center study, we evaluated the potential of echocardiography to predict 90-day RVF in LVAD recipients. Methods: We performed standard and speckle-tracking echocardiography, with focus on right ventricular (RV) function and mechanics, within 7 days of scheduled LVAD implantation in adults with INTERMACS ≥2 profile, excluding those with planned RV support or pulmonary vascular resistance >6 Wood units. The primary endpoint was RVF by 90 days, defined per INTERMACS 4.0 protocol as elevated central venous pressure (CVP) >16 mmHg and manifestations of elevated CVP accompanied by (1) RVF-related death or mechanical RV support (severe); (2) inotropes or inhaled/IV pulmonary vasodilators any time >7 days post-implant (>14 days: severe; ≤14: moderate); or (3) readmission(s) for RVF (≥2: severe; 1: moderate). Results: Between 7/2012 and 12/2016, 83 patients were enrolled (Table 1). At 90 days, 35 patients (42.2%) developed RVF (22 [26.5%] severe, 13 [15.7%] moderate). Five patients (6.0%) died, 3 from RVF. Median length of stay (LoS) in intensive care was 7 days (6, 10) and total LoS was 15 days (12, 21). Postoperative inotropes were used for 7 days (5, 12) and 14 (16.9%) of patients were readmitted for RVF. Among echo parameters (Table 2), height-indexed inferior vena cava diameter (OR per mm/m 1.24; 95% CI: 1.03-1.49; P=0.025) and pulmonary valve acceleration time (OR per -10ms 1.42; 95% CI: 1.02-1.97; P=0.039) best predicted RVF using best-subset selection. Preoperative pulmonary wedge pressure (OR per mmHg 1.11; 95% CI: 1.03-1.20; P=0.008) was the only independent clinical predictor of RVF. These 3 variables combined had C=0.78 for RVF prediction. RV mechanics did not improve risk assessment. Conclusions: Standard echocardiography helps predict short-term post-LVAD RVF. However, RV mechanics do not improve predictive accuracy. [ABSTRACT FROM AUTHOR]