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Purpose Highly sensitized recipients remain a challenge in lung transplantation. There are no standardized protocols among lung transplant centers to guide management of these patients. Some centers choose not to transplant highly sensitized patients due to the risk of graft dysfunction and death. We describe our center's experience and outcomes managing lung transplant recipients with positive flow-cytometric prospective cross matches (FXM). Methods We retrospectively analyzed patients who underwent lung transplantation with positive FXM from August 2015 to November 2019. Outcomes included overall length of stay, 1-year survival, graft function at one year, and incidence of antibody mediated rejection (AMR) and CLAD (BOS). Results There were 11 patients with FXM (6 females, 5 males; 6 with restrictive lung disease, 3 with obstructive lung disease, 1 with cystic fibrosis, and 1 with pulmonary vascular disease). 7 (63%) had concomitant positive virtual cross matches. 10 (91%) were managed with high-dose IVIg alone immediately post-op. 3 patients additionally received intra and/or post-op plasma exchange, rituximab and/or bortezimab. Median length of hospital stay was 50 days. Median length of follow up is 30 months (range 11-63 months). KM estimate of one-year survival was 90%. Clinical episodes of AMR requiring treatment occurred in 1 (9%) patient at 3 years post-transplant. DSA cleared in 8 patients (73%). Infections occurred in 5 patients (45%). None were life threatening. CLAD grade ≥ 1 occurred in only 2 patients (18%), one at 1.5 years and the other 3 years post-transplant. FEV1 at one year was >89% of personal best in all patients. Conclusion Successful lung transplantation of highly sensitized recipients is feasible. Using our center's approach results in longer hospital stay but excellent one-year outcomes. Further study is needed to identify patients at risk for graft dysfunction and death due to AMR who benefit from early aggressive treatment, and to avoid unnecessary treatment in lower risk patients.

Purpose To evaluate the effect of the new heart transplant allocation system on LVAD supported patients listed as bridge to transplantation (BTT). Methods Adult patients, who were listed for heart transplant between October 1,2016 and September 30, 2019, and were supported with an LVAD, enrolled in the UNOS database were enrolled in this study. Patients were classified according in the old or new system if they were listed or transplanted before or after October 18, 2018. Results A total of 2184 LVAD patients were listed for transplant. Of these, 1229 were classified in the old and 955 in the new system. The cumulative incidence of death or removal from the transplant list due to worsening clinical status, 1 year after listing, was lower in the new system (5% vs. 9%, p Conclusion With the implementation of the new HT allocation system, LVAD-BTT patients have a lower frequency of transplantation and similar short-term post-transplant survival. LVAD-BTT patients are more likely to receive Hep C (+) donor hearts.

Purpose To evaluate the effect of the new heart transplant allocation system on patients listed for re-transplantation. Methods Adult patients, who were listed for heart re-transplant between Jan 1, 2017 and September 30, 2019, enrolled in the UNOS database were included in this study. Patients were classified in the old or new system if they were listed or re-transplanted before or after October 18, 2018, respectively. Results A total of 214 patients were listed for re-transplant in the study period. Of these, 127 and 87 patients were classified in the old and new systems, respectively. Patients listed in the new system had a higher frequency of transplantation within 1 year of listing (HR: 1.63 (1.23-2.17), p=0.001) (Figure 1A). Patient listed for re-transplant in the new system had a higher frequency of ECMO (16.1% vs. 6.8%, p=0.037) and IABP (20.7% vs. 4.7%, p=0.001) support. A total of 72 and 93 patients were re-transplanted in the old and new systems, respectively. Clinical characteristics did not differ between re-transplanted patients in old vs. new systems. The 1-year post-transplant survival was 91.5% and 86.4% for the old and new systems, respectively (Figure 1B, p=0.35). Conclusion With the implementation of the new HT allocation system, Patients listed for re-transplantation have an increased access to a second heart transplant with similar 1-year post-re-transplant survival.

Purpose To analyze the clinical characteristics and outcomes of patients who were bridged with ECMO to durable mechanical circulatory support (dMCS). Methods Adult patients who received dMCS between Jan 2008 and Dec 2017, registered in INTERMACS were included. Baseline characteristics, outcomes, risk factors and adverse events were analyzed in patients supported by ECMO (ECMO group) prior to dMCS implantation, and compared with INTERMACS profile 1 patients not supported by ECMO (non-ECMO group). Results Patients bridged to dMCS on ECMO were younger, more likely to have acute heart failure, ischemic etiology, and a bridge to candidacy implantation compared to other INTERMACS profile 1 patients (Table 1). Patients who received dMCS on ECMO had 1, 6, and 12 month survival of 83.8%, 71.2%, and 66.1%, inferior to non-ECMO group patients (91.4% 81.7% and 75.4%, p Conclusion Patients bridged by ECMO to dMCS have lower survival compared with other INTERMACS profile 1 patients. Older age and longer duration of HF are associated with worse outcomes. ECMO implantation was independently associated with poorer outcome.

Purpose Primary Graft Dysfunction (PGD) is the most prevalent cause of one-month mortality following heart transplant(1). With the increase need to use marginal donor, because of the limited pool of donor available, an algorithm to predict PGD following heart transplantation could help identify marginal donors that are still suitable for transplantation. Methods 64 patients who underwent heart transplantation procedure without the use of organ care system were analyzed. PGD was defined as described before (2) and was present in 21. Donor, procedural and Recipient factors were run in an machine learning algorithm with lasso regression based on the coordinate descent technique provided by the glmnet algorithm. The predictive algorithm was generated for the outcome Primary Graft Dysfunction by continuous cross-referencing and re-sampling. Depending on the importance and distribution of each predictor in the model was assigned a score. The sum score was tested in a ROC-analysis with optimal cut-off calculated Results The following variables were found to be high risk to develop PGD (in descendant order): Cardiopulmonary bypass time, units of red blood cells given, cold ischemia time, cardioplegia amount, Time from brain death to recovery, Troponin T level in donor, diabetes in recipient and post-op creatinine level were left for the final algorithm. Scores were assigned in proportion to the weight given to them in the algorithm.). A ROC- analyze for the prediction of PGD showed a AUC (95% conf interval) 0.93(0.86-0.99). The optimal cut off was determined at 10 (0-29) Conclusion GREAT score can intra -operatively be used to prepare the transplantation team for who needs post-procedural support.

Purpose We compared those who got a VAD exchange primarily vs those who got eptifibatide treatment to establish which strategy was most beneficial in avoiding the primary endpoint of death or re-thrombosis Methods In a retrospective cohort study of patients with primary pump thrombosis (n=52), split into those that received an initial pump exchange (n=16) vs those who were treated with eptafibatide (n=36) a survival analysis was performed with the primary combined endpoint of death or new pump thrombosis at six months. The Kaplan-Meier curves created were tested for significant differences with a log-rank test. Univariate analysis of background parameters was performed between cohorts and relevant factors were built in a multiple logistic regression analysis to identify important predictors of the primary endpoint Results Although the Eptafibatide treatment was successful in 40% of the cases in avoiding death or the need for re-addressing pump-thrombosis a primary change of the pump was successful in about 80 % (p= 0.021) of the cases at six months. The frequency of major bleeds was also higher in the eptifibatide group (37.5% vs 52.8%; p=0.009) Conclusion Patients with a significant VAD thrombosis are better served with a primary pump exchange than eptifibatide treatment.

Introduction Continuous-Flow Left Ventricular Assist Devices (CFLVADs) improve mortality and quality of life in end-stage cardiomyopathy patients. Adverse events however remain high. Hypothesis We hypothesize time in therapeutic range (TTR) correlates with adverse events compared to most recent INR. Methods The study group comprised of patients who suffered suspected/confirmed pump thrombosis, stroke or major bleeding event as defined by INTERMACS after ≥ 1 month at home with ≥ 1 month of INR values. Controls (CON) had at least 3 months of INR values after being home for 1 month from LVAD implant and who did not experience any adverse events (AE). Standard statistical methods were employed as indicated: Chi-square, Fishers Exact test, two-sample t-test, Wilcoxon Rank sum test, One way ANOVA and Kruskal Wallis Analysis. Patients with multiple adverse events were excluded. Results From June 2010 - December 2016, 132 patients underwent CFLVAD implantation at our institution who met entry criteria. Mean age was 57±13 yrs and 106 (80%) were male. Seventy-seven (58%) were implanted as bridge to transplant (BTT). There was no statistically significant difference in TTR (p=0.39, Table 1 ) or most recent INR (p=0.33, Table 2 ) prior to AE. Patients who suffered AEs were older than those who did not (59.3± 12 vs. 54.4±14.3 yrs, p=0.04). There was no association of AEs when stratified by gender, LVAD indication, LVAD device type, race, BMI or hospital length of stay (p=ns). Conclusions Neither time in therapeutic range nor most recent INR correlated with major bleeding, neurological dysfunction or pump thrombosis in CFLVAD patients in this analysis. Further investigation beyond strict INR control and anticoagulation is needed to reduce adverse events in this patient population.