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Donor hearts are allocated to recipients according to pre-specified criteria. HTPO are defined as those that were transplanted after more than 50 centers declined the offer. Transplant centers may decline organs due to multiple characteristics (i.e. size, quality of the allograft). The objective of this study was to evaluate the clinical and epidemiological characteristics and post-transplant outcomes of patients who received HTPO. Adult patients listed for heart transplant (HT) between October 18, 2018 and December 7, 2021 and underwent transplantation in the new allocation system were included in the study. Clinical and epidemiological characteristics of the donor and recipient at time of transplant were compared between groups. Post-transplant survival was compared between organs accepted within 50 offers and HTPO. A total of 2084 patients received HT. Of these, 1891 (90.7%) patients received hearts that were accepted within 50 offers and 193 (9.3%) patients received HTPO. Recipients of HTPO were more likely to be female (45% vs 24% p<0.001), less likely to require life support (ECMO/IABP), less likely to be on IV inotropes, had better hemodynamics, were listed at a lower status, and had longer times on the waitlist (354 vs 242 days p<0.001). There was more distance between the donor center and the transplant center and longer ischemic times (3.2 vs 3.6 hrs p<0.001) in HTPO. Donors of HTPO were older (38 vs 32 yrs p<0.001) and more often female (58% vs 27% p<0.001). The one year post-transplant survival was similar between the group of patients that received a heart within 50 offers and the group that received a HTPO (93% vs 96%, p = 0.092). In the new heart transplant allocation system, patients who received hard to place organs (HTPO) had similar post-transplant survival compared to those who received hearts in <50 offers. This preserved survival occurred in spite of older donors and longer ischemic times. [ABSTRACT FROM AUTHOR]

Cardiogenic shock patients who are supported by ECMO have high mortality and morbidity. We evaluated the 1-year outcomes in ECMO supported patients with decompensated heart failure (DHF) or acute myocardial infarction (AMI), including death, heart transplantation (HT), left ventricular assist device (LVAD) implantation as well as dependency on hemodialysis or ventilation. Patients supported by ECMO due to DHF or AMI registered in the Spectrum Health ECMO registry were included in this study. Clinical, echocardiographic, laboratory and hemodynamic characteristics were obtained in all patients. Survival analysis using Kaplan-Meier curves for the combined outcome of death, heart transplantation (HT) and LVAD implantation were developed. These outcomes were compared between DHF and AMI patients. The frequency of renal replacement therapy or ventilator dependency on 1-year survivors was calculated. A total of 283 patients received ECMO, 228 due to DHF and 55 due to AMI. Of these, 22 patients received LVAD, and 1patient received HT. A total of 174 patients died (including 6 LVAD patients and 1 HT patient) within 1 year of ECMO. Patients with AMI had higher troponin (2.5 ng/dL (0.49 - 7.85) vs. 1.4 ng/dL (0.15 - 4.6), p=0.013), lower total bilirubin 0.65 mg/dL (0.4 - 1.12) vs. 0.8 mg/dL (0.5 - 1.6), p=0.025), higher ALT (117 IU (61- 225) vs. 48 IU (29 - 171), p = 0.003), lower creatinine (1.35 mg/dL ± 0.75 vs. 1.6 mg/dL ± 1.17, p=0.006), lower inotropic score (7 (1 - 18) vs. 9 (4 - 20), p=0.022). The combined endpoint survival free of HT or LVAD implantation at 1-month was 45.5% vs. 38.6% for AMI and DHF, respectively. There was a small but continued decrease in the survival of combined outcome at 1 year (36.4% vs. 32%, p=0.607, Figure 1). The 1-year survival probability free of the combined outcome for those patients who survived 30 days was 81.4% vs. 81.7% for AMI and DHF, respectively. Of the 92 patients who were alive at one year, 5 (5.4%) had end stage renal disease and were receiving hemodialysis and 3 (3.2%) were dependent on a ventilator. The 1-year survival free of HT or LVAD in AMI or DHF patients requiring ECMO is low. This is predominantly driven by the outcome on the first 30 days after ECMO implantation. A small proportion of 1-year survivors have end stage renal disease or are dependent on mechanical ventilation. [ABSTRACT FROM AUTHOR]

The assessment of frailty remains an integral part in selecting patients for durable left ventricular assist device (LVAD). A standard objective multi-disciplinary approach is needed. From March 2019-July 2021, a novel frailty score was applied to 54 patients with the following components: hand grip strength (0=strong/ normal; 2=weak, normalized to age/gender), nutritional status by registered dietician (0= standard risk; 1= intermediate risk; 2=high risk); Timed Up and Go (TUG) test (0 pts < 10 seconds; 1 pt - 11-20 seconds; 2 pts - > 20 seconds or patient unwilling, unable or required assistance), cognitive function (draw clock hands to indicate a time of 'ten after eleven' (0= no errors, 1= minor spacing errors, 2=more errors), mood (sad or depressed; 0=no, 1= sometimes, 2=often), anemia (Hgb < 13 for men and < 12 for women (but greater than values below): 1 pt; Hgb < 10 for men and < 9 for women: 2 pts.) Cumulative scores are grouped as not or mildly frail (0-3, Group 1), moderate-severely frail (4-12, Group 2) or no score obtainable (Group 3). Group 3 had the worst one year post-implant survival (Figure 1), the longest median post-implant length of stay (Figure 2), the highest rolling 12-month rates of unplanned RVAD use (25% compared to 0%) and highest rates of CVA within 6 months of implant (20% compared to 0%). Patients too sick and unable to complete a frailty score had the worst outcomes post LVAD implant. These data underscore the importance of a standard objective assessment of frailty in the selection of LVAD candidates. [ABSTRACT FROM AUTHOR]

To evaluate the effect of the new heart transplant allocation system on LVAD supported patients listed as bridge to transplantation (BTT). 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. 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<0.001). Patients listed in the new system had a lower frequency of transplantation within 1 year of listing (52% vs. 60%, p=0.004) (Figure 1). A total of 1086 and 853 patients were transplanted in the old and new systems, respectively. Patients who were transplanted in the new system were more likely to receive a Hep C (+) donor heart and had a longer ischemic time. The 6 months post-transplant survival was 93.2% and 91.5% for the old and new systems, respectively (p=0.18). 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. [ABSTRACT FROM AUTHOR]

To evaluate the effect of the new heart transplant allocation system on patients listed for re-transplantation. 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. 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). 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. [ABSTRACT FROM AUTHOR]

In the new heart transplant (HT) allocation system patients, (pts) with durable left ventricular assist device (LVAD) have worse outcomes. Donor hearts are allocated to recipients according to pre-specified criteria (urgency, blood type, size, HLA profile, etc). If an organ is not accepted by the selected center it will be offered to the next center. Unsuitable organs may be rejected by multiple centers. We studied the post-transplant outcomes on LVAD-BTT patients according to the order of acceptance of a donor organ. Adult pts with an LVAD listed for HT between 10/18/2018 and 12/7/2021 & underwent HT in the new system were included in the study. Clinical characteristics of the donor and recipient at time of transplant were compared between groups. Post-transplant survival was compared between organs accepted in <20 offers to those accepted in ≥20 offers. 859 pts with LVAD received HT. 592 (68.9%) pts received organs accepted in <20 offers and 267 (31.1%) pts received hearts in ≥20 offers. Notable differences between the two groups were (<20 vs ≥20, respectively): organ donors were more often female (19% vs 39% p <0.001), & had worse kidney function (Creatinine 1.7 vs 2.1 p=0.035). There was more gender mismatch [15% (<20) vs 26% (≥20) p<0.001] and longer ischemic time [3.2 (<20) vs 3.5 hrs (≥20) p<0.001]. LVAD pts who received HT in <20 attempts were more likely to be listed at status 1, 2 or 3 at time of transplant compared to those who received HT in ≥20 offers were often listed status 3 or 4 (P<0.001). Pts with LVADs who received a heart in ≥20 offers had increased survival 365 days post-transplant compared to those who received HT in <20 offers (94% vs 90% p=0.047). In the new system, LVAD-HT pts who received organs that had ≥20 allocation attempts have better post-transplant survival than patients who had <20 allocation attempts. This improved survival was observed despite longer ischemic time, increased donor age and gender mismatch, and is likely due to pts being more stable at the time of HT. [ABSTRACT FROM AUTHOR]

In the United States the Heartmate3 (HM3) has become the only durable LVAD for implantation in end stage heart failure (HF) patients. Prior predictive scores included older generation devices and thus may not applicable. The purpose of this study was to develop a one-year survival predictive score for HM3 candidates. Adult patients registered in the STS-INTERMACS database, who received primary implant with a HM3 device between 1/1/2014 and 6/1/2020 were included in this study. Epidemiological, clinical, hemodynamic, and echocardiographic characteristics were analyzed. Machine learning, elastic-net method, was used to build a one-year mortality predictive model on the derivation cohort; and its performance was tested on the validation cohort. A total of 3642 patients met inclusion criteria. Of these, 429 died within 1 year after HM3 implantation. Non-survivors were older (61.7 vs. 56.8 years, p<0.001), less frequently male (15.2% vs. 20.6%, p=0.01), had higher frequency of chronic HF (82.8% vs. 79% p=0.004), had a higher frequency of ECMO (10.3 %vs. 4.26%, p<0.001), higher rates of dialysis (6.29% vs. 1.93%, p<0.001), higher frequency of previous cardiac surgery (35% vs. 24.2%, p<0.001), and higher frequency of concomitant cardiac surgery (50.4% vs. 44.3%, p =0.02). Machine learning identified 9 variables associated with one-year mortality in the training data set (Age, right atrial pressure, MELD-XI score, INTERMACS profile 1, Chronic HF, White blood cell count, hemoglobin, heart rate < 90, and ECMO prior to implant), with an AUC 0.68 (figure 1A). The importance of each variable in the predicting model is shown in figure 1B. Our score predicted one year survival in the testing cohort with a good accuracy (AUC:0.72, Figure 1C). Using the machine learning algorithm, we developed a model for predicting one-year survival for patients receiving HM3 LVAD. Age, right atrial pressure and MELD-XI score were the most important predictive factors. [ABSTRACT FROM AUTHOR]

The objective of this study is to assess the disparities in heart transplantation (HT) waitlist outcomes according to socioeconomic status (SES) in the old and new HT allocation systems in the US. Adult patients registered for HT in the UNOS database from January 2014 to March 2022 were included. Patients were classified in the old or new system according to listing before or after Oct 18, 2018. SES was calculated according to zip code at time of listing and median household income (MHI) via the US Census Bureau. Competing outcomes in the waitlist were calculated, cumulative frequency of HT and death/delisting due to worsening clinical status were compared among SES and across allocation systems. The interpretation of the data are the responsibility of the authors and in no way should be seen as officially interpretation by OPTN. A total of 26,848 patients met inclusion criteria. At listing, patients (combined old and new systems) in the low SES were more frequently younger, female, African American, had higher BMI and diabetes. The cumulative incidence of HT in the old system was 53.5%, 55.7%, and 57.9% for low, middle and high SES groups (65.3%, 67.6%, 70.2% in the new system); both systems showed increased HT frequency in the high SES group compared to mid and low (Fig. 1A). The cumulative incidence of death/delisting in the old system was similar across SES (low 10.7%, middle 10.3%, high 9.8%). In the new system, the low SES group had a higher cumulative incidence of death/delisting (7.4%) compared to middle (6%) and high (5.4%) SES (Fig. 1B). In the new HT allocation system, SES, determined by MHI, is associated with waitlist outcomes. Patients with low SES had a lower cumulative incidence of HT and increased frequency of death/delisting due to worsening clinical status. [ABSTRACT FROM AUTHOR]

Heart transplantation utilizing Donation after Circulatory Death (DCD) donors are increasing but data remain limited. We sought to evaluate heart transplant survival and outcomes of LVAD patients transplanted with DCD donor hearts in a large national registry. Using the United Network for Organ Sharing (UNOS) database, adult patients ≥ 18 years old listed for heart transplantation from 1/1/2019 - 12/31/2021 and supported with an LVAD were evaluated. Patients were categorized in DBD (donation after brain death) and DCD groups. Recipient and donor characteristics at the time of transplant and post-transplant outcomes were compared between groups. Of 2281 LVAD patients, the majority (96%, N=2179) were transplanted with DBD donors and 102 patients transplanted with DCD donors. In the DCD group, the most common recipient blood type was O (66%). Compared to the no-DCD group, DCD LVAD patients were most commonly transplanted at UNOS status 4 (55.88%) and had shorter days on the wait list (114 vs. 200 days). The one-year heart transplant survival was not statistically different in LVAD patients transplanted with DCD donors compared with no-DCD donors (92% vs. 90%; p=0.5, Figure). There were more episodes of acute rejection (31% vs. 19%; p=0.004) without differences in graft failure (p=0.281) or frequency of re-transplantation between the DCD compared to the no-DCD group (p=0.338). The DCD group had a significant reduction in hospital length of stay following transplant (18.82 days vs. 23.97 days, p=0.034) and shorter travel distance to the transplant center (419.8 vs. 237.1 nautical miles, p<0.001). Propensity analysis demonstrates no significant difference in one year post transplant survival in LVAD patients transplanted with no-DCD or DCD donors (p=0.54). Heart transplant survival and outcomes for LVAD patients utilizing DCD donor hearts are favorable. This data supports continued use of DCD donor hearts for LVAD patients listed for heart transplant. [ABSTRACT FROM AUTHOR]

A new heart transplant allocation system was implemented in the US on October 18, 2018. We intended to understand its impact on volume, patient characteristics and outcomes. National data was collected from the UNOS standard transplant analysis and research (STAR) file from 2018 through March 31, 2019, and centers data until June 2019 was collected from the UNOS website (https://optn.transplant.hrsa.gov ; retrieved 8/30/2019). Donor and recipient data were analyzed in a univariate analysis to compare the 10 months (1/18-10/18) preceding the allocation change vs. 5 months (11/18-03/19) after allocation change. This study was approved by the local Institutional Review Board. A total of 3407 patients underwent heart transplantation in 2018 and 1525 between 1/2019-06/2019 of which 809 were done between 1/19-3/19. Of 127 centers, six (4.7%) centers went from high to low volume and 8 (6.2%) from low to high volume. There were, however, significant changes in the average number of transplants done per region between 2018 and 2019 with regions 1,5,7, 10 experiencing a significant increase in transplants/per month (Figure 1 A,B,C). There was a significant increase in "migration" of donor with 30±11% of donor out of region for 2018 vs. 48±17 % 2019,p=0.01 with corresponding increased ischemic time (3.43 ±1 hours vs. 3.15± 1 hours). After the new allocation system, fewer patients were transplanted from LVAD 10% vs 19% p=0.01, while more patients were transplanted from ECMO 4.6% vs 1.5% p=0.01. Graft failure rate was similar between 2018 (10 months) 6.7% vs. 2019 (5 months) 7.8% p=0.2. Centers volume has not changed significantly. There is "migration" of donors from in-region to out of region with increased ischemic time. Region 1,5, 7and 10 have seen a significant increase of average per month of transplant. Graft survival from preliminary data is unchanged. [ABSTRACT FROM AUTHOR]