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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

The 2018 Revised United Network for Organ Sharing Heart Allocation System (HAS) was proposed to reclassify status 1A candidates into groups of decreasing acuity; however, it does not take into account factors such as body mass index (BMI) and blood group which influence waitlist (WL) outcomes. We sought to validate patient prioritization in the new HAS at our center. We retrospectively evaluated patients listed for heart transplantation (n = 214) at Emory University Hospital from 2011 to 2017. Patients were reclassified into the 6-tier HAS. Multistate modeling and competing risk analysis were used to compare outcomes of transplantation and WL death/deterioration between new tiers. Additionally, a stratified sensitivity analysis by BMI and blood group was performed. Compared with tier 4 patients, there was progressively increasing hazard of WL death/deterioration in tier 3 (HR: 2.52, 95% CI: 1.37-4.63, P = .003) and tier 2 (HR: 5.03, 95% CI: 1.99-12.70, P < .001), without a difference in transplantation outcome. When stratified by BMI and blood group, this hierarchical association was not valid in patients with BMI ≥30 kg/m2 and non-O blood groups in our cohort. Therefore, the 2018 HAS accurately prioritizes the sickest patients in our cohort. Factors such as BMI and blood group influence this relationship and iterate that the system can be further refined.

Left ventricular assist devices improve survival prospects in patients with end-stage heart failure; however, infection complicates up to 59% of implantation cases. How many of these infections are caused by multidrug-resistant organisms is unknown. We sought to identify the incidence, risk factors, and outcomes of multidrug-resistant organism infection in patients who have left ventricular assist devices. We retrospectively evaluated the incidence of multidrug-resistant organisms and the independent risk factors associated with them in 57 patients who had permanent left ventricular assist devices implanted at our institution from May 2007 through October 2011. Outcomes included death, transplantation, device explantation, number of subsequent hospital admissions, and number of subsequent admissions related to infection. Infections were categorized in accordance with criteria from the Infectious Diseases Council of the International Society for Heart and Lung Transplantation. Multidrug-resistant organism infections developed in 18 of 57 patients (31.6%)—a high incidence. We found 3 independent risk factors: therapeutic goal (destination therapy vs bridging), P=0.01; body mass index, P=0.04; and exposed velour at driveline exit sites, P=0.004. We found no significant differences in mortality, transplantation, or device explantation rates; however, there was a statistically significant increase in postimplantation hospital admissions in patients with multidrug-resistant organism infection. To our knowledge, this is the first report in the medical literature concerning multidrug-resistant organism infection in patients who have permanent left ventricular assist devices.

Purpose The 2018 Revised UNOS Heart Allocation System was proposed to 1) address the rapid increase in status 1A candidates by re-classifying them into groups of decreasing acuity, and 2) reflect current prognosis for left ventricular assist device (LVAD) patients. The present study was designed to validate the rationale for the new guidelines by descriptively exploring their effect on patients listed for heart transplant (HT) at our center. Methods We retrospectively evaluated patients listed for HT at Emory University Hospital from 2011 to 2017. Patients were re-classified into the 6-tier Revised UNOS Heart Allocation System. Poisson regression was used to compare outcome rates (transplant and waitlist (WL) removal for death/deterioration) between tiers. Results There were 214 patients (mean age: 50.14 ± 11.9 yrs, 83% male, 57% black) listed for HT during the study period, 97 (45%) as status 1A and 117 (55%) as status 1B. Patients listed as status 1A would be re-classified as tiers 2 (12 [12.4%], 3 (83 [85.6%]), and 4 (2 [2.1%]), and those listed as status 1B would be re-classified as tiers 2 (5[4.3%]) and 4 (112 [95.7%]). Outcome rates by new tier: Patients re-listed as tier 2 had the highest rate of WL death/deterioration (p Conclusion The 2018 Revised UNOS Heart Allocation System accurately prioritizes those status 1A, 1Ab and 1B patients at the highest risk for WL mortality/deterioration in our cohort.

Aims Despite improved outcomes and lower right ventricular failure (RVF) rates with continuous-flow left ventricular assist devices (LVADs), RVF still occurs in 20-40% of LVAD recipients and leads to worse clinical and patient-centred outcomes and higher utilization of healthcare resources. Preoperative quantification of RV function with echocardiography has only recently been considered for RVF prediction, and RV mechanics have not been prospectively evaluated. Methods and results In this single-centre prospective cohort study, we plan to enroll a total of 120 LVAD candidates to evaluate standard and mechanics-based echocardiographic measures of RV function, obtained within 7 days of planned LVAD surgery, for prediction of (i) RVF within 90 days; (ii) quality of life (QoL) at 90 days; and (iii) RV function recovery at 90 days post-LVAD. Our primary hypothesis is that an RV echocardiographic score will predict RVF with clinically relevant discrimination ( C >0.85) and positive and negative predictive values (>80%). Our secondary hypothesis is that the RV score will predict QoL and RV recovery by 90 days. We expect that RV mechanics will provide incremental prognostic information for these outcomes. The preliminary results of an interim analysis are encouraging. Conclusion The results of this study may help improve LVAD outcomes and reduce resource utilization by facilitating shared decision-making and selection for LVAD implantation, provide insights into RV function recovery, and potentially inform reassessment of LVAD timing in patients at high risk for RVF.

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.

Purpose Clinical scores for right ventricular failure (RVF) risk after left ventricular assist device implantation (LVAD) were developed in mostly pulsatile-flow LVAD populations, whereas most patients currently receive continuous-flow LVADs. Methods and Materials We evaluated the Michigan, Penn, and Utah scores and multiple pre-operative echocardiographic parameters for 90-day RVF prediction in 69 patients who underwent HeartMate-II (N=58) or HeartWare (N=11) implantation in 2007-2011. Results Baseline characteristics are presented in Table 1 . Overall 18 patients (26.1%) experienced RVF (defined as ≥48h NO use; multi-organ failure due to RVF; inotropes for ≥14 days post-LVAD; or re-institution of inotropes). Among clinical scores, only Michigan predicted RVF (OR per point: 1.29; 95% CI: 1.04, 1.59; P=0.02) but discrimination was modest (C=0.64, P=0.093; sensitivity: 50%; specificity: 78.4%). Penn (C=0.50; P=0.99) and Utah (C=0.52; P=0.78) scores did not discriminate RVF. Among echocardiographic parameters, only a smaller left atrial diameter (OR per -10 mm: 2.36; 95% CI: 1.01, 5.45; P=0.045) was associated with RVF and, when added to, improved discrimination of Michigan score to C=0.76 (P Conclusions RVF risk prediction scores developed for pulsatile LVADs are suboptimal for patients with continuous-flow LVADs. Baseline clinical and echocardiographic characteristics (N=69) Patients with RVF (N=18) Patients without RVF (N=51) P Age, yrs 55.2±9.4 48.9±13.9 0.078 Male, % 61.1 47.1 0.56 Ischemic HF, % 27.8 29.4 1.00 Intra-aortic balloon pump pre-op, % 38.9 25.5 0.37 Inotropes pre-op, % 100 96.1 1.00 Pressors pre-op, % 11.1 5.9 0.60 Bilirubin, mg/dL 1.6±0.9 1.6±1.1 0.77 AST, U/L 58 (35, 127) 30 (23, 39) 0.002 Creatinine, mg/dL 2.0±0.7 1.6±1.0 0.014 Cardiac index, L/m 2 1.75±0.50 1.75±0.43 0.86 RV stroke work index, mmHg a l/min 0.52±0.26 0.49±0.24 0.50 LV ejection fraction, % 18.8±4.8 19.1±5.1 0.54 Left atrial diameter, mm 47±6 52±8 0.034 RV fractional area change, % 30.0±6.0 27.8±8.0 0.14