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Background: Heart transplant (HT) in recipients with left ventricular assist devices (LVADs) is associated with poor early post-HT outcomes, including primary graft dysfunction (PGD). As complicated heart explants in recipients with LVADs may produce longer ischemic times, innovations in donor heart preservation may yield improved post-HT outcomes. The SherpaPak Cardiac Transport System is an organ preservation technology that maintains donor heart temperatures between 4 °C and 8 °C, which may minimize ischemic and cold-induced graft injuries. This analysis sought to identify whether the use of SherpaPak versus traditional cold storage was associated with differential outcomes among patients with durable LVAD undergoing HT., Methods: Global Utilization and Registry Database for Improved Heart Preservation-Heart (NCT04141605) is a multicenter registry assessing post-HT outcomes comparing 2 methods of donor heart preservation: SherpaPak versus traditional cold storage. A retrospective review of all patients with durable LVAD who underwent HT was performed. Outcomes assessed included rates of PGD, post-HT mechanical circulatory support use, and 30-day and 1-year survival., Results: SherpaPak (n=149) and traditional cold storage (n=178) patients had similar baseline characteristics. SherpaPak use was associated with reduced PGD (adjusted odds ratio, 0.56 [95% CI, 0.32-0.99]; P =0.045) and severe PGD (adjusted odds ratio, 0.31 [95% CI, 0.13-0.75]; P =0.009), despite an increased total ischemic time in the SherpaPak group. Propensity matched analysis also noted a trend toward reduced intensive care unit (SherpaPak 7.5±6.4 days versus traditional cold storage 11.3±18.8 days; P =0.09) and hospital (SherpaPak 20.5±11.9 days versus traditional cold storage 28.7±37.0 days; P =0.06) lengths of stay. The 30-day and 1-year survival was similar between groups., Conclusions: SherpaPak use was associated with improved early post-HT outcomes among patients with LVAD undergoing HT. This innovation in preservation technology may be an option for HT candidates at increased risk for PGD., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04141605., Competing Interests: Disclosures Dr Lerman received salary support from the National Institutes of Health grant 5T32HL069749-20. Dr Leacche is a consultant for the Abiomed Advisory Board. Dr Silvestry received consulting fees from Abbott and Abiomed. Dr Zuckermann is on the Speakers Bureau of Mallinckrodt Pharmaceuticals. Dr D’Alessandro received honoraria from Abiomed and Paragonix. Dr Milano received research funding from TransMedics. Dr Schroder received research funding from TransMedics. Dr DeVore received grants/contracts from Amgen, the American Heart Association, Biofourmis, Bodyport, Cytokinetics, National Heart, Lung, and Blood Institute, Novartis, Story Health, and Vifor Pharma; consulting fees from Abiomed, AstraZeneca, and CareDx; honoraria from Abiomed and Zoll; and travel/meeting support from Abbott; has participated on Data and Safety Monitoring Board or the Advisory Board of Cardionomic and LivaNova; and has leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid, of Natera. The other authors report no conflicts.

The last several years have seen a rise in use of mechanical circulatory support (MCS) to bridge heart transplant recipients. A controlled hypothermic organ preservation system, the SherpaPak Cardiac Transport System (SCTS), was introduced in 2018 and has grown in utilization with reports of improved posttransplant outcomes. The Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN)-Heart registry is an international, multicenter registry assessing outcomes after transplant using the SCTS. This analysis examines outcomes in recipients bridged with various MCS devices in the GUARDIAN-Heart Registry. A total of 422 recipients with donor hearts transported using SCTS were included and identified. Durable ventricular assist devices (VADs) were used exclusively in 179 recipients, temporary VADs or intra-aortic balloon pump (IABP) in 197, and extracorporeal membrane oxygenation (ECMO) in 14 recipients. Average ischemic times were over 3.5 hours in all cohorts. Severe primary graft dysfunction (PGD) posttransplant increased across groups (4.5% VAD, 5.1% temporary support, 21.4% ECMO), whereas intensive care unit (ICU) length of stay (18.2 days) and total hospital stay (39.4 days) was longer in the ECMO cohort than the VAD and IABP groups. A comparison of outcomes of MCS bridging in SCTS versus traditional ice revealed significantly lower rates of both moderate/severe right ventricular (RV) dysfunction and severe PGD in the SCTS cohort; however, upon propensity matching only the reductions in moderate/severe RV dysfunction were statistically significant. Use of SCTS in transplant recipients with various bridging strategies results in excellent outcomes., Competing Interests: Disclosure: As it relates to this article and technology, all authors (S.S., M.L., Y.S., M.K., B.M., A.Z., D.D., and J.S.) are part of the GUARDIAN-Heart registry that has and is collecting data on transport systems, donor and heart recipient baseline characteristics, and outcomes. Besides this, D.M.M. has no conflicts of interest to report., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

HeartMate 3 is the only durable left ventricular assist devices (LVAD) currently implanted in the United States. The purpose of this study was to develop a predictive model for 1 year mortality of HeartMate 3 implanted patients, comparing standard statistical techniques and machine learning algorithms. Adult patients registered in the Society of Thoracic Surgeons, Interagency Registry for Mechanically Assisted Circulatory Support (STS-INTERMACS) database, who received primary implant with a HeartMate 3 between January 1, 2017, and December 31, 2019, were included. Epidemiological, clinical, hemodynamic, and echocardiographic characteristics were analyzed. Standard logistic regression and machine learning (elastic net and neural network) were used to predict 1 year survival. A total of 3,853 patients were included. Of these, 493 (12.8%) died within 1 year after implantation. Standard logistic regression identified age, Model End Stage Liver Disease (MELD)-XI score, right arterial (RA) pressure, INTERMACS profile, heart rate, and etiology of heart failure (HF), as important predictor factors for 1 year mortality with an area under the curve (AUC): 0.72 (0.66-0.77). This predictive model was noninferior to the ones developed using the elastic net or neural network. Standard statistical techniques were noninferior to neural networks and elastic net in predicting 1 year survival after HeartMate 3 implantation. The benefit of using machine-learning algorithms in the prediction of outcomes may depend on the type of dataset used for analysis., Competing Interests: M.L. discloses grants and consulting fees for Abbott and Abiomed. S.L. discloses support from Abbott to attend the Heart Failure User’s meetings in May 2022 and October 2019. R.Y.L.-R. discloses support from Abbott to attend an educational meeting in August 2023. The other authors have no conflicts of interest to report., (Copyright © ASAIO 2023.)

Traditional ice storage has been the historic standard for preserving donor's hearts. However, this approach provides variability in cooling, increasing risks of freezing injury. To date, no preservation technology has been reported to improve survival after transplantation. The Paragonix SherpaPak Cardiac Transport System (SCTS) is a controlled hypothermic technology clinically used since 2018. Real-world evidence on clinical benefits of SCTS compared to conventional ice cold storage (ICS) was evaluated. Between October 2015 and January 2022, 569 US adults receiving donor hearts preserved and transported either in SCTS (n = 255) or ICS (n = 314) were analyzed from the Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN-Heart) registry. Propensity matching and a subgroup analysis of >240 minutes ischemic time were performed to evaluate comparative outcomes. Overall, the SCTS cohort had significantly lower rates of severe primary graft dysfunction (PGD) ( p = 0.03). When propensity matched, SCTS had improving 1-year survival ( p = 0.10), significantly lower rates of severe PGD ( p = 0.011), and lower overall post-transplant MCS utilization ( p = 0.098). For patients with ischemic times >4 hours, the SCTS cohort had reduced post-transplant MCS utilization ( p = 0.01), reduced incidence of severe PGD ( p = 0.005), and improved 30-day survival ( p = 0.02). A multivariate analysis of independent risk factors revealed that compared to SCTS, use of ice results in a 3.4-fold greater chance of severe PGD ( p = 0.014). Utilization of SCTS is associated with a trend toward increased post-transplant survival and significantly lower severe PGD and MCS utilization. These findings fundamentally challenge the decades-long status quo of transporting donor hearts using ice., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

The standard method for cardiac allograft preservation for the past 50 years has been static storage using crushed ice. A heart transplant transportation system designed to improve preservation quality with temperature monitoring, the Paragonix SherpaPak Cardiac Transport System (SCTS), was evaluated for its impact on postoperative costs relative to conventional ice storage. Observational US multicenter registry data collected during the August 2015 to November 2021 timeframe from 12 transplant hospitals were analyzed using logistic regression analysis and propensity matching to balance measured baseline covariates and to reduce selection bias. Hospital cost and outcome data post-transplant were then evaluated using various statistical methods. One hundred seventy-four (174) patients were identified resulting in 87 matches. Baseline characteristics were similar between groups. The SCTS group had a significantly lower proportion of ICU days on post-transplant mechanical circulatory support ( p < 0.0001); significantly fewer patients on extracorporeal membrane oxygenation ( p = 0.017); and significantly fewer patients experiencing severe primary graft dysfunction (PGD) ( p = 0.03). Overall hospital plus mechanical circulatory support post-transplant costs were significantly lower by $26.7K in the CTS cohort ( p = 0.03). Use of the SCTS is associated with improved clinical outcomes resulting in significantly lower overall hospital care costs., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

Background: Limited data are available regarding the outcomes of patients supported by extracorporeal membrane oxygenation (ECMO) who undergo durable mechanical circulatory support implantation (dMCS). We analyzed the clinical characteristics, outcomes, and risk factors for mortality in patients who were bridged with ECMO to dMCS., Methods: Adult patients who received dMCS between January 2008 and December 2017 (n=19 824), registered in the Society of Thoracic Surgeons-Interagency Registry for Mechanical Assisted Circulatory Support (STS-INTERMACS) database were included. Baseline characteristics, outcomes, risk factors, and adverse events were compared between ECMO-supported patients (n=933) and INTERMACS profile 1 (IP-1) patients not supported by ECMO (n=2362). A propensity match analysis was performed., Results: ECMO patients had inferior survival at 12 months (66.1%) than non-ECMO patients (75.4%; P <0.0001). The proportion of patients transplanted at 2 years after dMCS was similar between the ECMO (30.8%) and non-ECMO (31.8%) groups ( P =0.49). A multiphase parametric hazard model identified 2 different periods based on risk of death. ECMO patients had a high hazard for death in the first 6 months after implantation (hazard ratio, 2.18 [1.79-2.66]; P <0.001). Multivariable analysis showed that ECMO was an independent risk factor associated with poor outcome during the early phase after dMCS (hazard ratio, 1.69 [1.37-2.09]; P <0.0001) but not during the constant phase. ECMO patients had similar outcomes to non-ECMO patients when a propensity matched cohort was analyzed., Conclusions: ECMO-supported patients before dMCS have lower survival compared with other IP-1 patients. A multivariable analysis showed that ECMO is an independent risk factor of poor outcome after dMCS. However, a propensity matched analysis suggested that when important clinical variables are controlled the outcome of both groups is similar. These data support the implantation of dMCS in carefully selected ECMO patients.

Background: A simplified minimally invasive mitral valve surgery (MIMVS) approach avoiding cross-clamping and cardioplegic myocardial arrest using a small (5 cm) right antero-lateral incision was developed. We hypothesized that, in high-risk patients and in patients with prior sternotomy, this approach would yield superior results compared to those predicted by the Society of Thoracic Surgeons (STS) algorithm for standard median sternotomy mitral valve surgery., Methods: Five hundred and four consecutive patients (249 males/255 females), median age 65 years (range 20-92 years) underwent MIMVS between 1/06 and 8/09. Median preoperative New York Heart Association function class was 3 (range 1-4). Eighty-two (16%) patients had an ejection fraction ≤35%. Forty-seven (9%) had a STS predicted mortality ≥10%. Under cold fibrillatory arrest (median temperature 28°C) without aortic cross-clamp, mitral valve repair (224/504, 44%) or replacement (280/504, 56%) was performed., Results: Thirty-day mortality for the entire cohort was 2.2% (11/504). In patients with a STS predicted mortality ≥ 10% (range 10%-67%), the observed 30-day mortality was 4% (2/47), lower than the mean STS predicted mortality of 20%. Morbidity in this high-risk group was equally low: 1 of 47 (2%) patients underwent reexploration for bleeding, 1 of 47 (2%) patients suffered a permanent neurologic deficit, none had wound infection. The median length of stay was 8 days (range 1-68 days)., Conclusions: This study demonstrates that MIMVS without aortic cross-clamp is reproducible with low mortality and morbidity rates. This approach expands the surgical options for high-risk patients and yields to superior results than the conventional median sternotomy approach.