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Background Coronavirus disease 2019 (COVID‐19) has significantly impacted the healthcare landscape in the United States in a variety of ways including a nation‐wide reduction in operative volume. The impact of COVID‐19 on the availability of donor organs and the impact on solid organ transplant remains unclear. We examine the impact of COVID‐19 on a single, large‐volume heart transplant program. Methods A retrospective chart review was performed examining all adult heart transplants performed at a single institution between March 2020 and June 2020. This was compared to the same time frame in 2019. We examined incidence of primary graft dysfunction, continuous renal replacement therapy (CRRT) and 30‐day survival. Results From March to June 2020, 43 orthotopic heart transplants were performed compared to 31 performed during 2019. Donor and recipient demographics demonstrated no differences. There was no difference in 30‐day survival. There was a statistically significant difference in incidence of postoperative CRRT (9/31 vs. 3/43; p = .01). There was a statistically significant difference in race (23 W/8B/1AA vs. 30 W/13B; p = .029). Conclusion We demonstrate that a single, large‐volume transplant program was able to grow volume with little difference in donor variables and clinical outcomes following transplant. While multiple reasons are possible, most likely the reduction of volume at other programs allowed us to utilize organs to which we would not have previously had access. More significantly, our growth in volume was coupled with no instances of COVID‐19 infection or transmission amongst patients or staff due to an aggressive testing and surveillance program.

Background Psychosocial evaluation of candidates for advanced heart failure (HF) therapies identifies risk factors for poor outcomes. The degree of psychosocial risk considered acceptable to proceed with advanced therapies varies between centers. We hypothesized that rates of patients declined for advanced therapies because of mental health disorders, substance abuse and inadequate social support would differ for urban versus rural candidates, as community resources to mitigate risk factors vary. Methods Medical records for 213 consecutive patients undergoing psychosocial evaluation for advanced HF therapies between May 2014 and October 2017 were reviewed. Patients were separated into rural or urban categories based on home zip codes and urban influence codes from the United States Department of Agriculture. Demographics, comorbidities and psychosocial characteristics were collected. Categorical variables were compared using Fisher's exact test and continuous variables using the Student's t-test. Results The overall population was 54 years old, 27% female, and 23.5% African American with prevalent comorbidities. Regional codes identified 62 patients as rural and 151 patients as urban. Demographics and prevalence of medical and psychosocial comorbidities were similar between the two cohorts. There were no significant differences in the frequency of cited medical or social barriers alone to advanced therapies between cohorts. The combination of medical and social barriers was more commonly cited as the reason for ineligibility for transplant in rural patients (p=0.04). Conclusion Rural patients are more often declined for transplant due to combinations of medical and psychosocial concerns, despite similar prevalence of individual stressors. Further study is required to describe the differences in resources available to heart failure patients, standardize criteria among centers, and improve disparities in access to advanced therapies.

Purpose CD3 monitoring has been shown to reduce thymoglobulin drug exposure and cost. There is limited data on the long term effects of this strategy on clinical outcomes and duration of CD3 suppression. Methods A retrospective chart review was completed for adult heart transplant recipients who received rabbit anti-thymocyte globulin (rATG) at our center in the last year. Patients were dosed with rATG daily at 1mg/kg at physician discretion for goal CD3 Results Of the six patients included in the analysis, 5 were treated with rATG for rejection and 1 for induction. The median absolute lymphocyte count at baseline was 0.72 × 103/mcL. The rATG treatment course is summarized in Figure 1. The median cumulative rATG dose was 3.4mg/kg, given over a median of 5 days. Median follow-up after treatment was 139 days. Post-treatment cell counts are depicted in Figure 2. The CD3 count remained suppressed for at least 90 days in most patients. Changes in the absolute lymphocyte count (ALC), CD4 subset, and CD8 subset paralleled that for CD3. No patient had an episode of rejection or infection requiring hospitalization during follow-up. One patient developed CMV viremia. Conclusion CD3 guided rATG dosing results in adequate persistent T-cell suppression with good clinical outcomes.

Purpose Non-dialysis dependent patients with renal impairment undergoing heart transplantation (HT) alone are at significantly higher risk of mortality and poor renal outcomes compared with those undergoing heart-kidney transplantation (HKT). It remains unclear what parameters might identify patients who may benefit from HKT compared to HT alone. We investigated whether blood urea nitrogen to creatinine ratio (BCR) at time of HT listing among those with stage 3 chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) between 30 and 59 ml/min/1.73 m2) is associated with higher risk of post-HT death or dialysis. Methods We identified 159 patients who underwent HT alone at our institution between 1/2009 and 2/2018. Univariate and multivariate Cox-proportional regression analyses were used to investigate the association between BCR and composite risk of post-HT death or dialysis at 1 year. Results At listing, average age was 55±10 years (74% male and 28% African American) and eGFR was 47 ± 8. Mean eGFR did not differ between those with the composite outcome (46 ± 8) and those without (47 ± 8; p = 0.60). Overall, 14 patients (9%) died and 25 (16%) needed dialysis by 1 year post-HT. The univariate and multivariate adjusted hazard ratios for continuous variable BCR as a predictor of the composite outcome were 1.05 [95% confidence interval (CI): 1.02, 1.09; p Conclusion Heart transplant candidates with stage 3 CKD and elevated BCR at time of listing are at increased risk of post-HT mortality or dialysis. Further investigation of HKT outcomes among those with stage 3 CKD and elevated BCR at listing is warranted.

Purpose Inhibition of the renin angiotensin-aldosterone system (RAAS) improves survival and reduces adverse cardiac events in heart failure with reduced ejection fraction, but the benefit is not well-defined following left ventricular assist device (LVAD). Methods We analyzed the ISHLT IMACS registry for adults with a primary, continuous-flow LVAD from January 2013 to September 2017 who were alive at post-operative month 3 without a major adverse event, and categorized patients according to treatment at month 3 with an angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB), mineralocorticoid receptor antagonist (MRA), or neither (noRAAS). Results Of 11,494 patients included, 50% were treated with ACEI/ARB and 38% with MRA. Propensity score matching was performed separately for ACEI/ARB versus noRAAS (n=2,853 each) and MRA versus noRAAS (n=2,670 each). Kaplan-Meier survival was significantly better for patients receiving ACEI/ARB (Figure A, p Conclusion These findings suggest a benefit for ACEI/ARB as tolerated in patients with heart failure after LVAD implantation.

Purpose Non-dialysis dependent patients with renal impairment undergoing heart transplantation (HT) alone are at significantly higher risk of mortality and poor renal outcomes compared with those undergoing heart-kidney transplantation (HKT). It remains unclear what parameters might identify patients who may benefit from HKT compared to HT alone. The Model for End-Stage Liver Disease Excluding INR (MELD-XI) score at the time of HT has been shown to predict early post-HT mortality. We investigated whether trends in the MELD-XI score between listing and transplant among those with stage 3 chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) between 30 and 59 ml/min/1.73 m2) are associated with higher risk of post-HT death or dialysis. Methods We identified 159 patients undergoing HT at our institution between 1/2009 and 2/2018. The following groups were created: Group 1 - MELD-XI ≤ 16 at listing and HT, Group 2 - MELD-XI ≤ 16 at listing and > 16 at HT, Group 3 - MELD-XI > 16 at listing and ≤ 16 at HT, Group 4 - MELD-XI > 16 at listing and HT. A cutoff of 16 was chosen based on the 75th percentile in a normal distribution among those without a composite outcome of post-HT death or dialysis at 1 year. Cox-proportional regression and survival analyses were performed to assess risk of this outcome. Results Average MELD-XI at listing was 14.0 ± 4.9 and at HT was 12.8 ± 4.5 (p 16 was present in 51 (32.1%) at listing and 38 (23.9%) at HT. Group 4 incurred highest risk of composite outcome relative to Group 1 (adjusted hazard ratio 3.67 (95% confidence interval: 1.38-9.76, p Conclusion Changes in MELD-XI between listing and transplantation offer additional risk stratification beyond absolute MELD-XI at time of transplant for death or dialysis at 1 year in patients with stage 3 CKD.

Purpose Non-dialysis dependent patients with renal impairment undergoing heart transplantation (HT) alone are at higher risk of mortality and poor renal outcomes compared to those undergoing heart-kidney transplantation (HKT). It remains unclear what parameters might identify patients who may benefit from HKT compared to HT. We investigated whether interval changes in blood urea nitrogen to creatinine ratio (BCR) between listing and transplant in those with stage 3 chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) 30 - 59 ml/min/1.73 m2) are associated with higher risk of post-HT death or worsening renal function (WRF). Methods We identified 159 patients undergoing HT at our institution between 1/2009 and 2/2018. Absolute changes in BCR between listing and transplant were categorized as improved (BCR decreased) or worsened (BCR increased). Next, the following groups were created: Group 1 - improved BCR and BCR ≤ 21 at HT, Group 2 - worsened BCR but remained ≤21 at HT, Group 3 - worsened BCR and BCR >21 at HT, and Group 4 - improved BCR but remained >21 at HT. WRF was defined as a decrease in eGFR by >25% or need for dialysis between HT and 1-year follow up. One-year composite risk of death or dialysis was our primary outcome of interest; WRF in survivors was our secondary outcome of interest. Results By 1 year, a total of 14 patients died and 43 had WRF, including 15 who needed dialysis. The BCR improved in 98 patients (62%) and worsened in 61 (38%); BCR was >21 at HT in 25 patients (16%). Group 4 incurred highest risk of both the primary and secondary outcomes (see figure) with adjusted hazard ratio of 3.81 (95% confidence interval (CI): 1.45-10.00; p Conclusion High BCR at listing that remained >21 at HT despite interval improvement was associated with increased risk of death or dialysis and WRF. These findings warrant further pathophysiologic explanation.

Obesity is very common in heart failure (HF) and heart failure hospitalizations (HFH) but complicates clinical assessment of volume in the office by exam and BNP levels, and at home by monitoring of daily weight and peripheral edema. Management guided by pulmonary artery pressure monitoring with the

Purpose Circulating levels of b-type natriuretic peptide (BNP) are elevated following heart transplantation (HT), peak at 1-2 months post-HT, and decline over the course of several months but rarely return to normal. We sought to determine the time course of BNP level following combined heart-kidney transplantation (HKT) compared to HT alone. Methods Between July, 2014 and August, 2017, 11 patients underwent HKT; they were matched based on age, gender, race and body mass index (BMI) to 22 patients undergoing isolated HT. Baseline demographics, serial BNP levels, and estimated glomerular filtration rate (eGFR; ml/min/1.73 m 2 ) were monitored in patients at post-transplant days 30, 60, 90, 180 and 365. Wilcoxon rank-sum test was used to compared median BNP levels at different time points between the groups. Results Average age of HKT recipients was 54±18 years (82% females, 27% black Americans, BMI 25±5 kg/m2) and that of HT recipients was 55±14 years (82% females, 27% black Americans, BMI 26±3 kg/m2). As shown in the Figure, BNP values decreased significantly among HKT recipients by 90-days, and remained significantly lower at 1-year post-transplantation (p Conclusion Unlike HT alone, BNP levels were found to be near normal in the majority of HKT recipients within a much shorter period of time and remained low up to 1-year post-transplant. This finding can potentially be explained by improved renal function with kidney transplant ; although, the effect of KT on lusitropic properties of transplanted heart cannot be ruled out.

Introduction The formation of de novo donor specific antibodies (dDSAs) has been implicated in the development of antibody-mediated rejection (AMR) and coronary allograft vasculopathy (CAV) after cardiac transplantation. dDSAs can develop at any time following transplantation and are associated with a poor prognosis, but the reason dDSAs develop after the initial injury of the transplant surgery is unknown. Since the detection of dDSAs often triggers the use of potentially toxic therapies to reduce these antibodies, it is important to understand whether dDSAs are a mediator of poor outcomes or a marker of a harmful underlying process. Hypothesis In some cases, the development of dDSAs is precipitated by the development of CAV or other myocardial injury which can expose myocardial cell epitopes. Methods We reviewed the medical record of 217 patients followed at our institution who underwent heart transplantation between 2014 and 2017, were not desensitized prior to transplant and did not have pre-transplant donor specific antibodies. Of these, we identified 36 patients with dDSAs, 16 of whom did not develop dDSAs until ≥ 6 months post-transplant, as detected by the modern bead-based multiplex assay on routine measurement every 3 months. Results Major findings are shown in Figure 1. In 10 of 16 patients with dDSAs but without evidence of AMR, CAV diagnosis or significant elevation in BNP suggestive of myocardial injury preceded dDSA development. Conclusions These findings suggest that CAV or other myocardial injury may precede the development of dDSAs in some cardiac transplant recipients and would explain why dDSAs signal a poor prognosis. These findings may shift the therapeutic focus from direct suppression of dDSAs to earlier detection, prevention and therapy of CAV or other injury that may trigger these antibodies' delayed appearance.

Purpose Donor-derived hepatitis C infection (dd-HCV) infection may increase risk of renal impairment (RI) among heart transplant (HT) recipients. Sofosbuvir, an integral component of anti-HCV direct-acting antivirals (DAAs), has also been linked to RI. To date, no prior study has examined the trends in renal function for HT recipients of dd-HCV infection, and assessed safety and efficacy of sofosbuvir-based DAAs. Methods Between September 2016 and June 2018, 46 HCV-naive patients and 1 with a history of treated-HCV pre-HT underwent HT from HCV-positive donors (follow-up through October 10th, 2018). Patients were treated with ledipasvir-sofosbuvir (genotype 1) or sofosbuvir-velpatasvir (genotype 3) for 12 or 24 weeks; no dose adjustments were made for renal function. Data on renal function were available for 23 patients who achieved a sustained virologic response at 12 weeks after the end of treatment (SVR12; cohort A) and 18 patients who completed 1-year of follow-up (cohort B). Results Treatment of dd-HCV infection was initiated after a median of 6 weeks post-HT. In both cohorts, a non-significant change in median eGFR was noted (Cohort A: pre-transplant eGFR: 62 (IQR 51,84) to SVR12 eGFR: 49 ((IQR: 37, 82), p=0.43); Cohort B: pre-transplant eGFR: 65 (IQR: 54, 84) to 1-year post-HT eGFR: 56 ((IQR: 39, 75); p=0.29). Pre-treatment renal function or early initiation of DAAs post-transplant had no significant impact on changes in renal function during treatment. All patients tolerated DAAs well with 100% completion rate to the assigned therapy and duration, and 100% success at achieving SVR12. Conclusion In this first and largest reported case series to date of HT recipients with dd-HCV infection, we observed that neither the dd-HCV infection nor its treatment with Sofosbuvir-based DAAs increased the risk of RI. Sofosbuvir-based DAAs appear safe, tolerable and effective for HCV treatment even in presence of severe RI.

Purpose Prior to the advent of direct-acting antivirals (DAAs), donor-derived hepatitis C (dd-HCV) viremia predicted poor post-heart transplant (HT) outcomes, including a higher risk of coronary allograft vasculopathy (CAV) and death. Considering the success of DAAs to treat HCV and the shortage of organs for HT, we institutionalized a clinical protocol of using HCV+ donors. Using intracoronary ultrasound (ICUS) in patients acquiring post-HT HCV infection, we examined the risk of CAV in the current era. Methods Between September 1st 2016 and October 2nd 2018, 54 HCV-naive patients and 1 with a history of treated-HCV pre-transplant, underwent HT from HCV-positive donors (follow-up available through October 10th, 2018). Patients were treated with ledipasvir-sofosbuvir (genotype 1) or sofosbuvir-velpatasvir (genotype 3) for 12 or 24 weeks. ICUS of left anterior descending artery was performed at 6-months and 1-year post-HT for those developing donor-derived HCV (dd-HCV) infection using an automated, mechanical pullback at a rate of 1 mm/ second. Results The ICUS data were available for 20 patients at 6-months (cohort A) and 16 patients at 1-year (cohort B); 14 patients had serial data available at 6-months and 1-year (cohort C). Figures A and B show changes in maximum intima thickness (MIT) for the overall sample and cohort C. For cohort C, absolute change in MIT from 6-months to 1-year was +0.15 (median) (Inter-quartile range: -0.03, 0.42) and only one patient had an increase in MIT by >0.5mm. Two patients in cohort A (10%) and 4 patients in cohort B (25%) had angiographic CAV grade 1; one patient in each cohort had known coronary artery disease in the donor heart. None required percutaneous coronary intervention or re-transplant for CAV at 1-year. Conclusion Utilization of HCV-positive donors may represent a viable strategy to expand the donor pool in era of DAAs. Larger scale data on changes in MIT is required to appropriately assess the effect of dd-HCV infection on incident CAV.