BACKGROUND:Multiple advanced preservation technologies are now available and have demonstrated utility in organ assessment and preservation. The Paragonix SherpaPak Cardiac Transport System (SCTS) has become the most common method of static preservation, demonstrating superior outcomes to historic ice storage. To date, no preservation method has reported improved post-transplant survival. METHODS:Data from the GUARDIAN-Heart Registry, the largest real-world registry focused on organ preservation, were analyzed to quantify post-transplant clinical outcomes and survival in transplant cases utilizing ice cooler storage or moderate hypothermic preservation using SCTS. The independent contributions of the organ preservation method on outcomes, including severe primary graft dysfunction (PGD), right ventricular dysfunction (RVD), and mortality, were analyzed using propensity matching and logistic regression. RESULTS:Among 1,261 US adult heart transplants performed between October 2015 and January 2024, SCTS utilization was associated with significant reductions in incidence of severe PGD (Ice 10.8% vs SCTS 6.8%, p = 0.015) and severe RVD (Ice 9.9% vs SCTS 6.1%, p = 0.022). SCTS use was identified as an independent predictor of severe PGD (Odds Ratio = 0.60, p = 0.012) and severe RVD (OR = 0.75, p = 0.047). In the propensity-matched cohort, SCTS utilization was associated with a significant reduction in mortality after 2 years (Ice 10.5% vs. SCTS 5.7%, p = 0.042), and the Kaplan-Meier survival probability over 2 years was significantly higher in the SCTS cohort (p = 0.022). CONCLUSIONS:Moderate, controlled hypothermic preservation using SCTS significantly improves post-transplant outcomes and 2-year survival. This is the first study of any advanced heart preservation modality to demonstrate a significant impact on transplant survival.

Purpose: Following FDA approval of the Organ Care Heart Perfusion System (OCS) for donation after cardiac death (DCD) heart transplants in the US, the OHP registry was initiated in April 2022. We are reporting donor/recipient characteristics and early clinical outcomes of the DCD heart transplant cohort from the OHP Registry.

Purpose: Controlled moderate hypothermia using the Paragonix SherpaPak Cardiac Transport System (STS) has been shown to result in significant improvements in post-transplant outcomes especially those related to severe primary graft dysfunction (PGD) and right ventricular dysfunction (RVD). However, there are limited data available describing the upper and lower bounds around the ideal temperature. We sought to stratify the post-transplant outcomes by temperature as observed in the GUARDIAN Heart Registry.

Purpose: Organs from blood type O donors can go to a recipient with any blood type, but recipients with blood type O are limited to receiving type O donor hearts. Consequently, type O recipients tend to wait longer for a heart, increasing the opportunity to worsen prior to transplant, and studies have shown higher post-transplant mortality in Type O recipients. We evaluated outcomes from recipients in GUARDIAN Heart stratified by blood type to assess impact on post-transplant outcomes.

Purpose: This report evaluates characteristics and clinical outcomes of DCD heart transplants using OCS Heart System to concurrent DCD heart transplants using other methods of reperfusion/preservation at the same US institutions.

Purpose: Stroke remains a devastating complication of durable LVAD therapy. Pre-implant patient factors have traditionally been used to predict the risk of post-implant stroke. The purpose of this study was to evaluate the incidence and risk factors for early stroke within 7 days following LVAD implantation with particular attention to the impact of intraoperative variables.

Central MessagePatients implanted with an LVAD late in the week may be more likely to have renal adverse events, longer lengths of stay, and lower event-free survival than those implanted earlier in the week. Patients implanted with an LVAD late in the week may be more likely to have renal adverse events, longer lengths of stay, and lower event-free survival than those implanted earlier in the week. Previous studies reported worse outcomes when procedures occur during “off hours” (holidays, weekends, and nights).1Bell C.M. Redelmeier D.A. Mortality among patients admitted to hospitals on weekends as compared with weekdays.N Engl J Med. 2001; 345: 663-668Crossref PubMed Scopus (897) Google Scholar This “off-hours effect” is likely more significant in the treatment of acute, deadly diseases such as cardiogenic shock (CS), when small deviations in timing could have a large impact on patient morbidity and mortality. Left-ventricular assist device (LVAD) implantations are usually scheduled as weekday procedures, but little is known about differences in preoperative status and outcomes in those implanted on early compared with late weekdays. In a retrospective review of LVAD recipients in our prospectively maintained single-institutional Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) database, we compared differences in patient characteristics and outcomes between those implanted during early (Monday-Wednesday) and late (Thursday-Friday) weekdays. Patients implanted between January 2017 and March 2022 were included. This study was approved by the institutional review board of Baylor Scott & White Research Institute under an umbrella protocol for retrospective research with consent form waiver (IRB File No. 011-274, November 30, 2022). The primary outcome was a composite of survival to recovery or transplant free of debilitating stroke, similar to landmark LVAD trials (eg, Mehra and colleagues2Mehra M.R. Uriel N. Naka Y. Cleveland Jr., J.C. Yuzefpolskaya M. Salerno C.T. et al.A fully magnetically levitated left ventricular assist device—final report.N Engl J Med. 2019; 380: 1618-1627Crossref PubMed Scopus (743) Google Scholar), debilitating stroke with modified Rankin scale >3 included for moderately severe-to-severe disability. Length of stay (LOS) post-LVAD was calculated from implant to discharge dates. Complications up to 1-year postimplant were collected from adverse events defined according to Society of Thoracic Surgeons Intermacs, version 6.1, definitions.2Mehra M.R. Uriel N. Naka Y. Cleveland Jr., J.C. Yuzefpolskaya M. Salerno C.T. et al.A fully magnetically levitated left ventricular assist device—final report.N Engl J Med. 2019; 380: 1618-1627Crossref PubMed Scopus (743) Google Scholar Patient characteristics, described using proportions or median and quartiles, were compared between early to late weekday cohorts using Wilcoxon rank sum, χ2, or Fisher exact tests. Time to mortality or debilitating stroke was censored if the LVAD was explanted for recovery, exchange or transplant, and compared up to 1-year postimplant using Kaplan–Meier analysis with log-rank tests. The hazard ratio (HR) was estimated with Cox proportional hazards models. Analyses were performed in R (Version 4.2; R Foundation for Statistical Computing) and significance assessed 2-sided at a threshold <.05. Of 117 patients included, 66 and 51 patients were implanted on early and late weekdays, respectively. Patient characteristics were comparable (Table 1). Four additional patients implanted on Saturday were excluded.Table 1Patient characteristics and outcomes comparing LVAD implants on early (Monday-Wednesday) versus late weekdays (Thursday-Friday)VariableOverall (n = 117)Early (n = 66)Late (n = 51)P valueAge, y59 [50-68]59 [51-66]59 [51-69].53Sex, male96 (82%)56 (85%)40 (78%).51Race African American37 (32%)18 (27%)19 (37%).34 White78 (67%)46 (70%)32 (63%).55BMI, kg/m228 [24-32]28 [24-32]27 [25-31].69Bridge to transplant22 (19%)13 (20%)9 (18%).97Severe diabetes3 (3%)2 (3%)1 (2%)1.00Chronic renal disease25 (21%)12 (18%)13 (25%).47Ischemic cardiomyopathy65 (58%)37 (60%)28 (56%)1.00Intermacs profile.59 119 (16%)12 (18%)7 (14%) 250 (43%)29 (43%)21 (41%) 340 (34%)19 (29%)21 (41%) 4+8 (7%)6 (9%)2 (4%)Reason for admission, planned VAD placement41 (35%)25 (38%)16 (31%).59Temporary mechanical support32 (27%)18 (27%)17 (33%).36Device brand.66 HeartMate 389 (76%)51 (77%)38 (75%) HeartMate II11 (9%)7 (11%)4 (8%) Medtronic HVAD17 (15%)8 (12%)9 (18%)In-hospital outcomes LOS post-LVAD, d15 [11-20]14 [11-17]18 [12-23].04 In-hospital mortality7 (6%)3 (5%)4 (8%).70 Major bleeding5 (4%)2 (3%)3 (6%).65 Major infection6 (5%)5 (8%)1 (2%).23 Device-related infection0 (0%)0 (0%)0 (0%)1.00 Renal dysfunction3 (3%)1 (2%)2 (4%).58 Right heart failure9 (8%)3 (5%)6 (12%).17 Stroke5 (4%)3 (5%)2 (4%)1.00 Debilitating stroke (mRS >3)2 (2%)1 (2%)1 (2%)1.001-y outcomes Death17 (15%)6 (9%)11 (22%).10 Readmitted64 (55%)35 (53%)29 (57%).82 Number of readmissions per patient1 [0-1]1 [0-1]1 [0-3].21 Total number of days readmitted10.5 [2-26.2]7 [1.5-22.5]17 [3-37].09 Major bleeding23 (20%)11 (17%)12 (24%).49 Major infection33 (28%)18 (27%)15 (29%).96 Device-related infection4 (3%)2 (3%)2 (4%)1.00 Renal dysfunction11 (9%)1 (2%)10 (20%).001 Right heart failure19 (16%)8 (12%)11 (22%).26 Stroke11 (9%)4 (6%)7 (14%).21 Debilitating stroke (mRS >3)4 (3%)1 (2%)3 (6%).32 Death or debilitating stroke18 (15%)6 (9%)12 (24%).04Categorical data is summarized as the frequency (%) and continuous data as the median [quartile 1-quartile 3]. P values less than .05 is significant indicated in bold. BMI, Body mass index; Intermacs, Interagency Registry for Mechanically Assisted Circulatory Support; VAD, ventricular assist device; HVAD, HeartWare Ventricular Assist Device; LOS, length of stay; mRS, modified Rankin scale; LVAD, left ventricular assist device. Open table in a new tab Categorical data is summarized as the frequency (%) and continuous data as the median [quartile 1-quartile 3]. P values less than .05 is significant indicated in bold. BMI, Body mass index; Intermacs, Interagency Registry for Mechanically Assisted Circulatory Support; VAD, ventricular assist device; HVAD, HeartWare Ventricular Assist Device; LOS, length of stay; mRS, modified Rankin scale; LVAD, left ventricular assist device. Table 1 shows outcomes and complications during the index hospitalization. Patients in the late week cohort had longer post-LVAD LOS (median 18 vs 14 days, P = .04). Other complications analyzed including in-hospital mortality, major bleeding, major infection, right heart failure, renal dysfunction, and stroke did not differ significantly. At 1-year postimplantation, more patients in the late weekday cohort experienced renal dysfunction (20% vs 2%, P = .001), whereas other complications did not differ significantly. (Table 1). Eighteen patients died and/or experienced a debilitating stroke, of whom 6 (9%) and 12 (24%) were in the early and late weekday cohorts, respectively. Survival free from debilitating stroke was lower in the late weekday relative to early weekday cohorts (P = .029, stratified by device type P = .037; Figure 1) with a 2.85 increase in the risk of the composite outcome (HR; 95% confidence interval [CI], 1.07-7.59). The majority (11/18) of the composite outcome events occurred within the first 3 months post-VAD. Complications occurring within the first 3 months that were associated with the composite outcome were major infections (HR, 4.5; 95% CI, 1.7-11.6, P = .002) and renal dysfunction (HR, 4.1; 95% CI, 1.2-14.3, P = .03). Our study is the first to report differences in outcomes in late-week LVAD implants. Patients implanted in on late weekdays had (1) longer LOS post-LVAD, (2) more renal adverse events at 1 year, and (3) lower rates of survival or debilitating stroke than those implanted earlier in the week. For those implanted later in the week, postoperative care within the first 48 hours of implant may be impacted by a “weekend” effect. Optimal level of care may be harder to achieve on the weekend due to lack of staffing and resource limitations during off hours with “on-call” and “more-experienced” staff available only for emergency situations.3Chen Y.F. Armoiry X. Higenbottam C. Cowley N. Basra R. Watson S.I. et al.Magnitude and modifiers of the weekend effect in hospital admissions: a systematic review and meta-analysis.BMJ Open. 2019; 9e025764Google Scholar Thus, our late weekday patients’ experience and outcomes may show similarities with those admitted over the weekend. A weekend effect on renal outcomes was also reported previously in patients with CS.4Harhash A.A. Kennedy K.F. Fendler T.J. Khumri T.M. Nassif M.E. Magalski A. et al.Comparison of outcomes among patients with cardiogenic shock admitted on weekends versus weekdays.Am J Cardiol. 2021; 144: 20-25Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Renal dysfunction occurred early on at 3 months and persisted at 1 year following implantation. Worsening peri- and postoperative renal function is perhaps a surrogate of sicker patients not detected by our study and warrants further exploration. Currently, one of the leading methods to improve outcomes associated with CS is improvement of treatment protocols.5Basir M.B. Kapur N.K. Patel K. Salam M.A. Schreiber T. Kaki A. et al.Improved outcomes associated with the use of shock protocols: updates from the National Cardiogenic Shock Initiative.Catheter Cardiovasc Interv. 2019; 93: 1173-1183Crossref PubMed Scopus (276) Google Scholar At our center (Baylor University Medical Center, Dallas, Tex), we have recently added 24/7 in-house heart failure attending coverage (in addition to 24/7 in house critical care attending coverage), daily multidisciplinary team rounding, and having system-wide protocols to guide timely transfers into the cardiac intensive care unit when warranted. In the setting of LVAD placement, the availability of expert care may eliminate deficits in patient care, allow for definitive planning regardless of implantation time and further provide immediate intervention for acute complications. Although we realize that dual in-house 24/7 attending coverage is not possible in all institutions, we propose that each institution periodically review their outcomes and modify protocols based on resources available to deliver optimal patient care regardless of the day of the week.5Basir M.B. Kapur N.K. Patel K. Salam M.A. Schreiber T. Kaki A. et al.Improved outcomes associated with the use of shock protocols: updates from the National Cardiogenic Shock Initiative.Catheter Cardiovasc Interv. 2019; 93: 1173-1183Crossref PubMed Scopus (276) Google Scholar There are several limitations to the study, including a retrospective single-center investigation with a modest sample size, so our results may not be generalizable to other centers. The sample size was sufficient to detect a difference in the primary outcome but may have limited power to detect smaller rate differences (eg, complication rate differences smaller than 25% when one group has a rate of 50%) between groups. In addition, some factors including team experience, on-call schedule, and staff fatigue may influence patient outcomes but are not captured in our medical record and thus were not included in this analysis. Patients implanted with LVADs late in the week may be more likely to have renal adverse events at 1 year and longer length of stay following LVAD implantation with lower event-free survival than those who received an LVAD earlier in the week. Analysis of the full Intermacs database to ascertain if these results are generalizable is warranted.

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.

PurposeAs demand for heart transplant (HT) increases, there is growing interest in expanding the donor pool. Donor hearts with multiple risk factors are often avoided, such as long down times in combination with long recovery distances resulting in longer ischemic times. The [SherpaPak] Cardiac Transport System (CTS) is a controlled hypothermic organ preservation technology potentially mitigating this risk when compared to ice. We aim to assess outcomes following HT from donors having both longer down and ischemic times.MethodsFrom October 2015-August 2022, 761 recipients from 9 US centers that received HT utilizing either CTS or ICE were enrolled in the GUARDIAN Heart registry. Subgroup analysis of HTs using donors with cardiac arrest >20 minutes and ischemia time >3 hours were performed, resulting in cohorts of 29 CTS and 10 ICE. Summary statistics were used for comparison.ResultsSignificantly fewer recipients in CTS cohort had durable VAD at baseline, but cohorts were otherwise well-matched. Although small numbers within cohorts limit the statistical rigor, significantly fewer recipients in CTS cohort required new post-transplant mechanical circulatory support (MCS) compared to ICE (6.9% v 40.0%, p = 0.01). Notably, there was a trend towards more than 4 times fewer need of ECMO/VAD (p=0.06) in CTS cohort. The rate of severe primary graft dysfunction (PGD) was meaningfully reduced by 3 times in CTS cohort. Interestingly, PGD rate in the CTS cohort (6.9%) was similar to that observed in the overall registry (7.2%). Survival between the cohorts was similar.ConclusionOur analysis demonstrates that using CTS in prolonged cardiac arrest and longer ischemic times leads to less use of MCS post transplant. Further assessment of outcomes utilizing different preservation methods in this particular cohort will need to be pursued with large number of participants. As demand for heart transplant (HT) increases, there is growing interest in expanding the donor pool. Donor hearts with multiple risk factors are often avoided, such as long down times in combination with long recovery distances resulting in longer ischemic times. The [SherpaPak] Cardiac Transport System (CTS) is a controlled hypothermic organ preservation technology potentially mitigating this risk when compared to ice. We aim to assess outcomes following HT from donors having both longer down and ischemic times. From October 2015-August 2022, 761 recipients from 9 US centers that received HT utilizing either CTS or ICE were enrolled in the GUARDIAN Heart registry. Subgroup analysis of HTs using donors with cardiac arrest >20 minutes and ischemia time >3 hours were performed, resulting in cohorts of 29 CTS and 10 ICE. Summary statistics were used for comparison. Significantly fewer recipients in CTS cohort had durable VAD at baseline, but cohorts were otherwise well-matched. Although small numbers within cohorts limit the statistical rigor, significantly fewer recipients in CTS cohort required new post-transplant mechanical circulatory support (MCS) compared to ICE (6.9% v 40.0%, p = 0.01). Notably, there was a trend towards more than 4 times fewer need of ECMO/VAD (p=0.06) in CTS cohort. The rate of severe primary graft dysfunction (PGD) was meaningfully reduced by 3 times in CTS cohort. Interestingly, PGD rate in the CTS cohort (6.9%) was similar to that observed in the overall registry (7.2%). Survival between the cohorts was similar. Our analysis demonstrates that using CTS in prolonged cardiac arrest and longer ischemic times leads to less use of MCS post transplant. Further assessment of outcomes utilizing different preservation methods in this particular cohort will need to be pursued with large number of participants.

Purpose The Paragonix SherpaPak Cardiac Transport System (CTS) is a controlled hypothermic organ preservation technology which maintains donor heart temperatures between 4°C - 8°C. Available for clinical use since 2018, CTS has been implemented into centers' procurement regimen to achieve various goals. A subgroup analysis of real-world data collected in the GUARDIAN Heart registry was performed to evaluate outcomes at centers whose primary goal was to reduce post-transplant rates of severe primary graft dysfunction (PGD), or those centers who wished to safely grow a program without sacrificing existing post-transplant outcomes. 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. Centers were further delineated by those with baseline PGD rates >15% (Group A, 6 centers), and those with an already low PGD rate (∼ <10%) but seeking to grow their program by expanding donor access (Group B, 3 centers). Summary statistics were used for comparisons. Results In Group A (n=265 CTS, n=199 ICE), although there were few baseline differences including longer total ischemic time in the CTS cohort, post-transplant rate of PGD compared to ICE was reduced by 26% (p=0.065) and severe PGD was significantly reduced by 40% (p=0.046). In Group B (n=154 CTS, n=143 ICE), recipient age was significantly older in the CTS cohort, total ischemic time increased by 23% (43 minutes, p<0.001) compared to ICE, and total distance traveled to organ retrieval doubled (p<0.001). The rate of post-transplant use of MCS, however, decreased (17.5% v 9.7%, p=0.05) while severe PGD incidence remained stable (5.6% v 4.5%, p=0.68) for ICE and CTS. Conclusion This subgroup analysis of the GUARDIAN Heart Registry demonstrates that the SherpaPak CTS can be used to improve post-transplant outcomes as well as to safely extend acquisition of donor organs to greater distances without sacrificing recipient outcomes.

Purpose Over the last several years, the number of deaths from drug overdose has increased. Heart transplantation (HT) utilizing donor hearts from patients dying from drug overdose has expanded the donor pool. The current standard method of organ procurement includes the use of an ice cooler (ICE), which adds the risk of tissue freezing injury. The SherpaPak Cardiac Transport System (CTS) is a controlled hypothermic organ preservation technology that maintains donor heart temperatures between 4°C - 8°C, potentially mitigating this risk. Methods The GUARDIAN Heart registry (October 2015-August 2022) includes 761 HT patients from 9 US centers in which donor hearts were procured using either CTS or ICE. Subgroup analysis of HTs using donors who died due to drug overdose, and whose total ischemic time was > 4 hours was performed. The outcomes were compared between HTs performed using CTS vs ICE. Summary statistics were used for comparison. Results Our cohort included 26 HTs in CTS and 12 in ICE group. The cohorts were well-matched aside from a few areas. Significantly fewer recipients in the CTS cohort had durable VAD at baseline. Additionally, while the ICE cohort had zero gender mismatches, the CTS cohort included 8 (30.8%) mismatches, with 5 (19.2%) female-to-male mismatches. The ICE cohort showed a trend of requiring new post-transplant mechanical circulatory support (MCS) at a rate more than double that of the CTS cohort (50.0% v 23.1%, p=0.10). The primary graft dysfunction (PGD) and survival between the cohorts were similar (details in Table 1). Conclusion The 30-day survival was similar between the two groups. The use of CTS trends towards a lower need of post-transplant MCS in donors who died of drug overdose and had ischemic times > 4 hours. Utilizing donor hearts from drug overdose individuals and prolonged ischemic time appears to have trended toward favorable outcomes when utilizing CTS over ICE.

Purpose The decades long gold standard for preservation of donor hearts in ice appears to be rapidly shifting to advanced hypothermic preservation. At the time of this abstract, over 25% of donor hearts in the US in 2022 have been transported in a Paragonix SherpaPak Cardiac Transport System (CTS). This controlled hypothermic technology in clinical use since 2018 preserving organ temperatures between 4 - 8°C. Real-world evidence on the clinical benefits of using CTS compared to conventional ice storage (ICE) is evaluated in the GUARDIAN Heart Registry to assess whether improved outcomes are achieved with this technology. Methods Data from 877 adults at 16 US centers receiving donor hearts preserved and transported in either CTS (n=487) or ICE (n=390) between October 2015-August 2022 were analyzed in the GUARDIAN-Heart registry. Propensity matching was performed to balance baseline differences to further evaluate outcomes between cohorts (see Table). Summary statistics were used for comparisons. Results The CTS cohort demonstrated reduced severe primary graft dysfunction (PGD) compared to ICE in the unmatched cohort (p=0.08) (Table). When propensity matched, CTS had significantly lowered severe PGD by 60% (10.0% vs 4.0%, p=0.01). Survival was similar (Figure). Further analysis with ongoing enrollment through December 2022 will be available for presentation. Conclusion Utilization of the Paragonix CTS for organ preservation is associated with lower rates of severe PGD. This finding continues to fundamentally challenge the decades-long status quo of using ice for transporting donor hearts.

Purpose Little is known about the impact of various procurement methods on dd-cfDNA. We aimed to determine if differences exist in dd-cfDNA values when using SherpaPak (SP) compared to historical ice transportation methods. Methods A retrospective review of 50 single organ heart transplant (HT) recipients with heart care measurements within 90 days post-transplant were included. Transportation type and long total ischemic time above the upper tertile of 223 minutes with log-transformed dd-cfDNA levels using repeated measures analysis was performed. Results 29 recipient hearts were transported on ice and 21 with SP. Recipient and donor characteristics were similar with expected shorter mean and maximum total ischemic times on ICE (197 ± 48 minutes, max. 285 minutes) compared to SP (214 ± 50 minutes, max. 325 minutes). The median dd-cfDNA level was the highest within the first 27 days in both groups (median 0.18 v. 0.20) and were comparable up to 90 days (p=0.10). Fig1A. There were 17 patients with long ischemic times with a mean of 256 minutes. In SP patients, long ischemic times had higher dd-cfDNA compared to short ischemic times (p=0.01). This relationship was not observed in ice patients (p=0.41). In long ischemic time patients, higher dd-cfDNA levels approached near significance when comparing SP v. ice patients (p=0.053). In patients with short ischemic times, dd-cfDNA levels were similar between SP v. ice (p=0.80). Fig1B. The overall cohort with long ischemic times, regardless of transport method, had higher levels of dd-cfDNA within the first 90 days (p=0.012). Conclusion Patients with long ischemic times are more likely to have higher dd-cfDNA vs short ischemic times. These results were predominantly driven by the patients in the SP group. Further studies including cost analysis of SP vs ICE modalities are needed to validate these preliminary findings.

Purpose We aim to evaluate the clinical outcomes at 1-year follow-up of heart transplant recipients to assess the Paragonix SherpaPak Cardiac Transport System (SHRP) as compared to conventional methods (ICE). Methods The Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN) study is a retrospective, multi-institutional registry including 11 US heart transplant centers at the time of this analysis. Each center enrolled both SHRP and historic ICE patients to serve as their own control. Results Between 10/2015-08/2021, 383 patients, 227 (59%) SHRP, 156 (41%) ICE were identified to meet analysis inclusion. Baseline characteristics of the two cohorts were largely similar with the exception in the SHRP cohort of more patients transplanted after the 2018 allocation change (96.5% v 55.8%, p<0.001), lower rates of implantable LVADs (35.2% v 55.1%, p<0.001), higher rates of pre -transplant temporary IABP (29.6% v 13.0%, p<0.001) and pre-transplant ECMO (17.2% v 7.8%, p=0.01), longer distance to donor organ (463 v 274 miles, p<0.001), longer ischemic time (217 v 195 min, p<0.001) compared to ICE respectively. The SHRP cohort showed a significant reduction in the incidence of severe PGD (5.3% v 13.0%, p=0.01) and a trend in reduction of newly placed ECMO post-transplant (8.8% v 14.7%, p=0.07). 30-day survival was 97.8% in SHRP v 95.5% in ICE (p=0.22). Follow-up at 1-year found a survival of 91.1% (112 of 123 subjects available for follow-up) in SHRP v 86.0% (111 of 129 subjects available for follow-up) in ICE (p=0.21) (Figure 1). Conclusion Despite a cohort with known risk factors including longer ischemic times and more acute support, the PGNX cohort shows significant reductions in severe PGD. 1-year survival was higher although it did not achieve statistical significance. The Paragonix SherpaPak Cardiac Transport System appears to have a positive effect on patient outcomes across multiple US centers in this analysis. We aim to evaluate the clinical outcomes at 1-year follow-up of heart transplant recipients to assess the Paragonix SherpaPak Cardiac Transport System (SHRP) as compared to conventional methods (ICE). The Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN) study is a retrospective, multi-institutional registry including 11 US heart transplant centers at the time of this analysis. Each center enrolled both SHRP and historic ICE patients to serve as their own control. Between 10/2015-08/2021, 383 patients, 227 (59%) SHRP, 156 (41%) ICE were identified to meet analysis inclusion. Baseline characteristics of the two cohorts were largely similar with the exception in the SHRP cohort of more patients transplanted after the 2018 allocation change (96.5% v 55.8%, p<0.001), lower rates of implantable LVADs (35.2% v 55.1%, p<0.001), higher rates of pre -transplant temporary IABP (29.6% v 13.0%, p<0.001) and pre-transplant ECMO (17.2% v 7.8%, p=0.01), longer distance to donor organ (463 v 274 miles, p<0.001), longer ischemic time (217 v 195 min, p<0.001) compared to ICE respectively. The SHRP cohort showed a significant reduction in the incidence of severe PGD (5.3% v 13.0%, p=0.01) and a trend in reduction of newly placed ECMO post-transplant (8.8% v 14.7%, p=0.07). 30-day survival was 97.8% in SHRP v 95.5% in ICE (p=0.22). Follow-up at 1-year found a survival of 91.1% (112 of 123 subjects available for follow-up) in SHRP v 86.0% (111 of 129 subjects available for follow-up) in ICE (p=0.21) (Figure 1). Despite a cohort with known risk factors including longer ischemic times and more acute support, the PGNX cohort shows significant reductions in severe PGD. 1-year survival was higher although it did not achieve statistical significance. The Paragonix SherpaPak Cardiac Transport System appears to have a positive effect on patient outcomes across multiple US centers in this analysis.