BACKGROUND:The impact of regional differences on primary graft dysfunction (PGD) after heart transplantation (HT) has not been assessed. This study aims to compare differences in the incidence, risk factors, and outcomes of severe PGD in the US, Canada, and Europe. METHODS:This retrospective, observational study included consecutive adult HT recipients from 14 centers between 2010-2022. The primary outcome was severe PGD as defined by ISHLT criteria. Multivariable logistic regression analyses were conducted. Survival data were analyzed using a proportional hazards Cox model. RESULTS:4101 HT recipients were included in the analysis (2077 US, 730 Canada, 1294 Europe). Significant differences were observed in recipient cardiovascular risk factors, pre-HT mechanical circulatory support (MCS), ischemic time, and donor age. Severe PGD occurred in 8.6%, 9.0%, and 9.6% of HTs in the US, Canada, and Europe. There was an increasing trend in severe PGD incidence in the US and Canada over time. Risk factors for severe PGD were similar across regions and included pre-HT dialysis, durable LVAD or pre-HT MCS, and ischemic time. VA-ECMO was the preferred MCS strategy for PGD management in all three regions. Thirty-day (8.9%, 29.8%, 43.9%) and 1-year (26.3%, 50.8%, 48.5%) mortality after severe PGD in the US was significantly lower than in Canada and Europe. CONCLUSIONS:The incidence of severe PGD is similar across the US, Canada, and Europe, but with a lower mortality after severe PGD in the US. Analyzing regional differences in PGD can aid in development of best practices for survival after this devastating event.

Purpose: To analyze regional differences in the incidence of primary graft dysfunction (PGD) after heart transplantation (HT) in Europe, Canada and the United States (US), and its impact on 1-year mortality.

Purpose: Primary graft dysfunction (PGD) is the leading cause of early mortality after heart transplantation (HT). Our current local incidence rate of severe PGD is 15% per year, which is double the international average. The International Consortium on PGD was established to identify contemporary risk factors for PGD and as a part of this multicenter collaboration, we trained a multicenter machine learning (ML) algorithm to predict the risk of severe PGD. In this study, we aimed to validate the PGD-AI calculator in our local contemporary population and evaluate its potential as a tool for improving outcomes following HT.

Purpose: Primary Graft Dysfunction (PGD) is the leading cause of early mortality after heart transplantation (HT). To address this critical concern, the PGD Consortium was formed with the aim of developing a contemporary clinical risk prediction model. In 2022, an international collaborative effort involving 10 centers culminated in the development of an AI-powered PGD risk score. In the present study, this AI-PGD risk score will be validated utilizing data from an additional 6 centers.

Purpose: Consistent increase in number of sensitized patients at the waitlist requires strategies to prevent antibody-mediated rejection. In Vienna Daratumumab is used in this cohort, an antibody targeting CD38 at plasma cells, natural killer cells and T-regulatory cells. In the past short-term results confirmed its efficacy in heart transplantation (HT), however mid-term results are still missing.

Purpose: Allocation of donor organs is based on fair and equitable access to those most in need. However, there is a notable disparity with women representing less than 25% of heart transplant (HT) recipients. The International Consortium on Primary Graft Dysfunction (PGD) was established as a prospective registry designed to quantify the incidence and risk factors of PGD. In this study, we evaluate sex-based differences in severe PGD.

Purpose: In 2018, the allocation system for heart transplantation (HT) in the US was changed to decrease waitlist times for the sickest candidates. Prior studies have suggested that this change resulted in the transplantation of sicker recipients, with an increase in recipients bridged with temporary MCS. We investigated whether the allocation change has impacted the prevalence of severe primary graft dysfunction (PGD).

Purpose: In 2021, we presented the first report from the International Consortium on Primary Graft Dysfunction (PGD) inclusive of 2476 patients from 10 centers. Herein, we present an updated interim analysis and highlight key themes that have emerged from this multicenter collaboration.

Purpose: The HeartMate 3 (HM3) LVAD has shown remarkable outcomes, nonetheless the importance of pump speed optimization cannot be emphasized enough. This study aimed to delve into the heterogeneous left ventricular (LV) unloading observed during echocardiographic speed ramp tests.

Purpose The prevalence of end stage heart failure and patients that could benefit from heart transplantation requires expansion of the donor pool, relying on the transplant community to continually re-evaluate and expand the use of marginal donor organs. Introduction of new technologies such as the Paragonix SherpaPak Cardiac Transport System (CTS) aids in this shift. We seek to analyze the impact of the CTS system on recipient outcomes who receive extended criteria organs in the GUARDIAN Heart Registry. Methods Between October 2015-August 2022, 761 adults from 9 US centers receiving donor hearts utilizing either CTS (N=419) or conventional ice storage (ICE, N=342) were analyzed from the GUARDIAN Heart registry using summary statistics. A modified EXPAND OCS Trial criteria was used to delineate cohorts of extended criteria donors, which included 176 CTS and 132 ICE (see Table). Results Forty percent of the total US donors in the registry population met the extended criteria definition. There were few baseline differences among recipients in the 2 cohorts, most notably both distance traveled and total ischemic time was significantly greater in CTS, and significantly more donor hearts in the CTS cohort had >4 hours total ischemia time, although baseline VAD was higher in the ICE cohort. Post-transplant MCS utilization and New ECMO/VAD was significantly reduced, and the rate of severe PGD was significantly reduced by over 50% in hearts preserved using CTS. Survival between cohorts was similar. Conclusion This subgroup analysis demonstrates that SherpaPak CTS can be safely used to utilize extended criteria donors, with low severe PGD rates. This is encouraging toward use of extended criteria donors in European transplant programs, though further clinical evaluation in Europe is warranted.

The radial artery (RA) is a frequently used conduit in coronary artery bypass grafting (CABG). Endothelial injury incurred during graft harvesting promotes oxidative damage, which leads to graft disease and graft failure. We evaluated the protective effect of DuraGraft®, an endothelial damage inhibitor (EDI), on RA grafts. We further compared the protective effect of the EDI between RA grafts and saphenous vein grafts (SVG). Samples of RA (n = 10) and SVG (n = 13) from 23 patients undergoing CABG were flushed and preserved with either EDI or heparinized Ringer's lactate solution (RL). The effect of EDI vs. RL on endothelial damage was evaluated ex vivo and in vitro using histological analysis, immunofluorescence staining, Western blot, and scanning electron microscopy. EDI-treated RA grafts showed a significant reduction of endothelial and sub-endothelial damage. Lower level of reactive oxygen species (ROS) after EDI treatment was correlated with a reduction of hypoxic damage (eNOS and Caveolin-1) and significant increase of oxidation-reduction potential. Additionally, an increased expression of TGFβ, PDGFα/β, and HO-1 which are indicative for vascular protective function were observed after EDI exposure. EDI treatment preserves functionality and integrity of endothelial and intimal cells. Therefore, EDI may have the potential to reduce the occurrence of graft disease and failure in RA grafts in patients undergoing CABG.

Purpose During the global COVID-19 pandemic heart transplantation in Europe was affected due to difficultly traveling internationally and greater delays associated with crossing borders. During a similar time frame our center also adopted the Paragonix SherpaPak Cardiac Transport System (SHRP) for regular use rather than conventional ice storage (ICE). This study aims to compare heart transplant baseline characteristics and outcomes for the 18 months prior to the global pandemic with the 18 months since the pandemic began. Methods The Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN) study is a retrospective, multi-institutional registry. We analyzed patients transplanted in Austria pre-pandemic, from 1 SEP 2018 to 1 MAR 2020 (PRE), with patients transplanted during the pandemic, from 1 MAR 2020 to 1 SEP 2021 (C19). Results 83 patients (42 PRE, 41 C19) met these criteria to be included in the analysis. The PRE cohort utilized donor organs from statistically longer travel distances (PRE=323 v C19=179 miles, p=0.02). Despite the shorter travel distances, ischemic times were same (PRE=195 v C19=189 min, p=0.60), likely indicating the additional burdens for traveling across borders. During the PRE period the SHRP was only used for marginal cases and in the C19 period it was adopted for regular use. The proportion of cases utilizing SHRP was statistically higher in the C19 cohort (PRE=19% v C19=80%, p<0.001). The PRE cohort showed numerically higher rates of newly placed ECMO post-transplant (16.1% v 11.8% p=0.18), incidence of PGD (16.7% v 4.9%, p=0.08), incidence of severe PGD (4.8% v 2.4%, p=0.57), and rates of the use of cardioversion intra-operatively to start the donor heart (19.0% v 9.8%, p=0.32) for PRE v C19 respectively. In-hospital survival was similar (92.9% v 90.2%, p=0.67). Conclusion The global COVID-19 pandemic caused a substantial impact on the access to donor hearts in Europe due to the ability to travel internationally. Despite this limitation on donor heart access, we saw trends towards improved outcomes in this period compared to the pre-pandemic period. This period was also highly correlated with the implementation of the Paragonix SherpaPak Cardiac Transport System as a preservation method which may have helped mitigate some of the negative effects of reduced donor access.

Purpose Right heart failure (RHF) is a crucial risk factor in the development of acute kidney injury. By decreasing the right-ventricular filling pressures and increasing cardiac output, right ventricular assist devices (RVAD) may prevent the development of cardiorenal syndrome. We report our institutional experience on the development of renal function and outcome after left ventricular assist device (LVAD) and temporary RVAD implantation in congestive heart failure patients. Methods We retrospectively reviewed the data of 72 consecutive patients who received a continuous-flow LVAD and temporary RVAD due to terminal heart failure at our center from 12/ 2001 and 12/ 2019. Mean age of patient population was 58 ± 12 years, with 86.1% of the patients being male. Sixty-three patients (87.5%) were able to be successfully weaned from temporary RVAD support. However, two patients (2.8%) required an RVAD to be re-implanted due to progressive RHF. Median time of temporary RVAD support was 13 days (4 - 90 days). Renal function was determined by the Modification of Diet in Renal Disease (MDRD)-derived glomerular filtration rates (GFR), and patients were categorized into two groups based on pre-implant GFR: (1) normal renal function, defined by GFR > 60 (n=29), and (2) impaired renal function, defined by GFR Results The patient group with impaired renal function (RF) experienced a significant improvement of GFR: GFR at time of implant to month six, 41.94 ± 11.37 to 65.21± 39.52 (p=0.003), and after one-year GFR improved from 41.94 ± 11.37 to 55.73 ± 23.22 (p=0.012). Post-implant renal replacement therapy was indicated in eighteen patients (41.86%) of the impaired RF group vs. ten patients (34.48%) in the normal RF group. Post-implant survival after LVAD and temporary RVAD support at one, six, and 12 months for GFR 60 group, 89.7%, 72.4% and 72.4%, respectively (p=0.576). Conclusion LVAD and temporary RVAD support improves renal function in patients with renal dysfunction prior to implantation. Our data indicates that impaired renal function prior to implantation does not guarantee a worsened outcome.

Purpose Previous studies have shown a correlation between improved renal function and ventricular assist device implantation, resulting in improved survival rates. This study aims to strengthen this correlation and establish long term findings by increasing the size of the study cohort as well as study period. Methods We retrospectively reviewed the data of 389 patients who received ventricular assist device implantation due to terminal heart failure at our center from 12/2003 to 03/2018. Median duration of LVAD support was 307 days (range 1 to 2849 days). Renal function was assessed using the Modification of Diet in Renal Disease study-derived Glomerular Filtration Rates (MDRD-GFR; mL x min(-1) x 1.73m(-2)). According to pre-implantation measured GFR rates patients were categorized in three groups: normal renal function (GFR>90, n= 52); moderately impaired renal function (GFR 30-90; n=295) and severely impaired renal function (GFR<30; n=42). Results Mean GFR showed a significant increase of renal function in both the moderately impaired and severely impaired kidney function groups at week 1 post-implantation (moderately: 56.0 ± 15.6 to 81.6 ± 39.0; severely: 22.7 ± 5.0 to 43.5 ± 19.0; p<.001), at week 4 post-implantation (moderately: 56.1 ± 15.4 to 89.5 ± 41.5; severely: 22.4 ± 5.2 to 64.8 ± 40.5; p<.001), and at week 12 post-implantation (moderately: 56.8 ± 15.2 to 76.6 ± 29.3; severely: 22.8 ± 4.8 to 64.0 ± 48.1; p<.001). However, further renal function improvement stopped as demonstrated by the study cohort's mean GFR decreasing significantly in the moderately impaired group at both 6 months (moderately: 76.1 ± 29.1 to 65.0 ± 25.4; p< .001; severely: 54.7 ± 36.9 to 52.1 ± 40.2; p= .784) and one-year post-implantation (moderately: 76.7 ± 29.2 to 62.5 ± 21.3; p=<.001 severely: 50.0 ± 21.2 to 39.9 ± 15.1; p=.046). Survival after 3, 6 and 12 months post LVAD implantation was significantly higher (p=.042) in patients with normal renal function compared to patients with moderately to severe impaired renal function (normal: 88,5%, 64.6%, 82.7%; moderate: 82.0%, 76.9%, 70.8%; severe: 76.2%, 60.5%, 52.4%, respectively). Conclusion Ventricular assist device implantation improves the renal function in terminal heart failure patients with moderate to severe kidney dysfunction. Normal renal function is correlated with better outcomes post LVAD implantation. Previous studies have shown a correlation between improved renal function and ventricular assist device implantation, resulting in improved survival rates. This study aims to strengthen this correlation and establish long term findings by increasing the size of the study cohort as well as study period. We retrospectively reviewed the data of 389 patients who received ventricular assist device implantation due to terminal heart failure at our center from 12/2003 to 03/2018. Median duration of LVAD support was 307 days (range 1 to 2849 days). Renal function was assessed using the Modification of Diet in Renal Disease study-derived Glomerular Filtration Rates (MDRD-GFR; mL x min(-1) x 1.73m(-2)). According to pre-implantation measured GFR rates patients were categorized in three groups: normal renal function (GFR>90, n= 52); moderately impaired renal function (GFR 30-90; n=295) and severely impaired renal function (GFR<30; n=42). Mean GFR showed a significant increase of renal function in both the moderately impaired and severely impaired kidney function groups at week 1 post-implantation (moderately: 56.0 ± 15.6 to 81.6 ± 39.0; severely: 22.7 ± 5.0 to 43.5 ± 19.0; p<.001), at week 4 post-implantation (moderately: 56.1 ± 15.4 to 89.5 ± 41.5; severely: 22.4 ± 5.2 to 64.8 ± 40.5; p<.001), and at week 12 post-implantation (moderately: 56.8 ± 15.2 to 76.6 ± 29.3; severely: 22.8 ± 4.8 to 64.0 ± 48.1; p<.001). However, further renal function improvement stopped as demonstrated by the study cohort's mean GFR decreasing significantly in the moderately impaired group at both 6 months (moderately: 76.1 ± 29.1 to 65.0 ± 25.4; p< .001; severely: 54.7 ± 36.9 to 52.1 ± 40.2; p= .784) and one-year post-implantation (moderately: 76.7 ± 29.2 to 62.5 ± 21.3; p=<.001 severely: 50.0 ± 21.2 to 39.9 ± 15.1; p=.046). Survival after 3, 6 and 12 months post LVAD implantation was significantly higher (p=.042) in patients with normal renal function compared to patients with moderately to severe impaired renal function (normal: 88,5%, 64.6%, 82.7%; moderate: 82.0%, 76.9%, 70.8%; severe: 76.2%, 60.5%, 52.4%, respectively). Ventricular assist device implantation improves the renal function in terminal heart failure patients with moderate to severe kidney dysfunction. Normal renal function is correlated with better outcomes post LVAD implantation.

Limited incision left ventricular assist device (LVAD) implantation has evolved as an alternative to standard median sternotomy. We present our long-term outcomes with this innovative approach regarding survival, perioperative adverse events and post transplantation outcomes.

Objectives: Pump thrombus formation (PT) is a frequent complication after left ventricular assist device (LVAD) implantation. Treatment options include thrombolytic therapy (TL), augmentation of anticoagulation or antiplatelet therapy, pump exchange or urgent heart transplantation. We reviewed our institutional experience using Alteplase for thrombolytic therapy in LVAD patients with pump thrombus formation.

Since its invention in 2012 the Eurotransplant Heart Donor Score (HDS) reflects the likehood of organ acceptance and predicts long-term patient mortalitiy. A score ≥ 17 classifies a high-risk donor and is associated with an inferior 3-year survival compared to low-risk donors. We analyzed correlations between the HDS and Ischemic Time regarding the occurrence of Primary Graft Dysfunction (PGD).