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Objectives: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy., Methods: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol., Results: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts., Conclusions: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device., Competing Interests: Conflict of Interest Statement Dr Gosev reports consulting for Abbott. Dr Pham reports consulting for Abbott, Abiomed, and Medtronic. Dr Itoh reports speaker honoraria from Abbott and Abiomed. Dr Kotkar is a speaker (nonfinancial) for Abiomed and 3M. Dr Naka reports consulting for Abbott, Biomet-Zimmer, Cryolife, and receiving speaker’s fees for Nipro Co. Dr Peltz reports research support from Bridge to Life Ltd and Paragonix Inc. Dr Silvestry reports consulting for Abbott, Abiomed, Medtronic, and data and safety monitoring board participation for Carmat. Dr Leacche reports consulting for Abbott and advisory board participation for Abiomed. Dr Rao reports consulting for Abbott, Medtronic, and Gore. Dr Sun reports consulting for Abbott. Dr Tedford reports consulting for Abbott, Medtronic, Aria CV Inc, Alleviant, Acorai, Acceleron, Cytokinetics, Itamar, Edwards LifeSciences, Eidos Therapeutics, Lexicon Pharmaceuticals, Gradient, and United Therapeutics. He is the national co-principal investigator for the RIGHT-FLOW clinical trial (Edwards), serves on steering committees for Merck, and a research advisory board for Abiomed. He also does hemodynamic core lab work for Merck. Dr Mokadam reports consulting for Abbott, Medtronic, SynCardia, Carmat, and Xylocor. Drs McNutt and Crandall are employees of Abbott. Dr Mehra reports payment made to institution from Abbott for consulting; consulting fees from Mesoblast, Janssen, Moderna, and Paragonix, and Baim Institute for clinical research; he is an advisory board member for Transmedics, NuPulseCV, Leviticus, and FineHeart. Dr Salerno reports consulting for Abbott. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article reported no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Severe primary graft dysfunction (PGD) is a major cause of early mortality after heart transplant, but the impact of donor organ preservation conditions on severity of PGD and survival has not been well characterized., Methods: Data from US adult heart-transplant recipients in the Global Utilization and Registry Database for Improved Heart Preservation-Heart Registry (NCT04141605) were analyzed to quantify PGD severity, mortality, and associated risk factors. The independent contributions of organ preservation method (traditional ice storage vs controlled hypothermic preservation) and ischemic time were analyzed using propensity matching and logistic regression., Results: Among 1,061 US adult heart transplants performed between October 2015 and December 2022, controlled hypothermic preservation was associated with a significant reduction in the incidence of severe PGD compared to ice (6.6% [37/559] vs 10.4% [47/452], p = 0.039). Following propensity matching, severe PGD was reduced by 50% (6.0% [17/281] vs 12.1% [34/281], respectively; p = 0.018). The Kaplan-Meier terminal probability of 1-year mortality was 4.2% for recipients without PGD, 7.2% for mild or moderate PGD, and 32.1%, for severe PGD (p < 0.001). The probability of severe PGD increased for both cohorts with longer ischemic time, but donor hearts stored on ice were more likely to develop severe PGD at all ischemic times compared to controlled hypothermic preservation., Conclusions: Severe PGD is the deadliest complication of heart transplantation and is associated with a 7.8-fold increase in probability of 1-year mortality. Controlled hypothermic preservation significantly attenuates the risk of severe PGD and is a simple yet highly effective tool for mitigating post-transplant morbidity., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

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.

To evaluate outcomes of patients undergoing heart transplants (HTs) using an intra-aortic balloon pump (IABP) under exception status. Adult patients supported by an IABP who underwent HT between November 18, 2018, and December 31, 2020, as documented in the United Network for Organ Sharing, were included. Patients were stratified according to requests for exception status. Kaplan-Meier methodology was used to look for differences in survival between groups. A total of 1284 patients were included; 492 (38.3%) were transplanted with an IABP under exception status. Exception status patients had higher body mass index, were more likely to be Black, and had longer waitlist times. Exception status patients received organs from younger donors, had a shorter ischemic time, and had a higher frequency of sex mismatch. The 1-year posttransplant survival was 93% for the nonexception and 88% for the exception IABP patients (hazard ratio: 1.85 [95% confidence interval: 1.12-2.86, P = .006]). The most common reason for requesting an exception status was inability to meet blood pressure criteria for extension (37% of patients). The most common reason for an extension request for an exception status was right ventricular dysfunction (24%). IABP patients transplanted under exception status have an increased 1-year mortality rate posttransplant compared with those without exception status., (Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

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.)

Objective: Equivalent myocardial protection and clinical outcomes have been shown with the use of del Nido cardioplegia (DC) compared with blood cardioplegia (BC) in adult isolated coronary artery bypass grafting and valve patients. However, its safety and efficacy in cardiac procedures with aortic crossclamp times >90 minutes is still unknown., Methods: From May 2014 to September 2019, 2506 adult patients at our center underwent cardiac surgery requiring prolonged aortic crossclamp time defined as 90 minutes or longer. Myocardial protection was achieved with BC in 1955 patients and DC in 551 patients. Two surgeons used DC exclusively and 5 used blood exclusively over the study period. BC was delivered anterograde and retrograde whereas DC was delivered anterograde only. Propensity score matching of several preoperative characteristics, including primary cardiac pathology, yielded 526 well matched pairs. Emergency and reoperative cases were included. Troponin T levels were drawn at 12 hours postoperative in all patients. Clinical data were extracted from our local Society of Thoracic Surgeons database. Subgroup analyses were performed on the basis of crossclamp time stratification., Results: For the propensity score-matched cohort, the median crossclamp time was longer in the BC compared with the DC group (114 [interquartile range (IQR), 100-145] minutes for DC vs 153 [IQR, 122-200] minutes for BC; P < .0001) whereas intraoperative peak glucose was higher with BC (173 [IQR, 147-200] g/dL for DC vs 197 [IQR, 171-228] g/dL for BC; P < .001). In addition, perioperative mortality (3.4% vs 3.0%; P = .7273), stroke (3.2% vs 2.1%; P = .2504), renal failure (6.5% vs 4.6%; P = .1767), atrial fibrillation (34% vs 31.4%, P = .3575), intra-aortic balloon pump use (5.3% vs 4.6%, P = .5694), and extracorporeal membrane oxygenation use (3.0% vs 2.9%, P = .8596) did not differ between DC and BC. Postoperative troponin T levels were 0.53 (IQR, 0.30-0.96) ng/mL and 0.62 (IQR, 0.38-1.07) ng/mL for DC and BC, respectively (P = .0024). Subgroup analysis revealed higher troponin T levels with DC for crossclamp times between 150 and 180 minutes. Survival rates at 1, 2, and 5 years were 93.3%, 91.1%, and 78.7% for DC and 94.5%, 91.8%, and 81.5% for BC, respectively (P = .5140)., Conclusions: In adult cardiac surgical procedures with aortic crossclamp times >90 minutes, comparable myocardial protection, perioperative mortality and morbidity, and distant survival were observed with the use of DC compared with BC. Higher troponin levels were seen in DC patients with crossclamp times between 150 and 180 minutes, but this was not associated with increased mortality., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Left ventricular assist devices (LVAD) are surgically implanted mechanical support devices utilized with increasing frequency as a bridge to myocardial recovery, destination therapy, and heart transplantation. While the use of such devices in patients with advanced heart failure has shown significant survival benefits and improved quality of life, they bear their own risks and complications. 1 Bleeding, infection, pump thrombosis, and stroke are just some of the serious complications associated with LVADs. 2 LVAD-associated pseudoaneurysms are rare, with prior reports of occurrence at the left ventricular apex and at the anastomosis site of the outflow graft to the ascending aorta. 3,4 Typically, this device-related complication requires surgical repair and, if at all feasible, heart transplantation. However, in cases of difficult anatomy, unfavorable position, and significant comorbidities, surgery may be contraindicated due to high surgical risk. This case portrays a patient suffering from a left ventricular pseudoaneurysm after HeartMate-III implantation that was not amenable to surgical repair due to heightened surgical risk. We document the first pseudoaneurysm associated with the HeartMate-III in available literature and describe a novel management strategy of documented nonoperative course of LVAD-associated pseudoaneurysm, with the patient surviving 56+ months with medical optimization and management., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2024 The Author(s).)

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.)

Background: The study objective was to assess disparities in outcomes in the waitlist and post-heart transplantation (HT) according to socioeconomic status (SES) in the old and new U.S. HT allocation systems., Methods: Adult HT candidates in the United Network for Organ Sharing database from 2014 through 2021 were included. Old or new system classification was according to listing before or after October 18, 2018. SES was stratified by patient ZIP code and median household income via U.S. Census Bureau and classified into terciles. Competing waitlist outcomes and post-transplantation survival were compared between systems., Results: In total, 26,450 patients were included. Waitlisted candidates with low SES were more frequently younger, female, African American, and with higher body mass index. Reduced cumulative incidence (CI) of HT in the old system occurred in low SES (53.5%) compared to middle (55.7%, p = 0.046), and high (57.9%, p < 0.001). In the new system, the CI of HT was 65.3% in the low SES vs middle (67.6%, p = 0.002) and high (70.2%, p < 0.001), and SES remained significant in the adjusted analysis. In the old system, CI of death/delisting was similar across SES. In the new system, low SES had increased CI of death/delisting (7.4%) vs middle (6%, p = 0.012) and high (5.4%, p = 0.002). The old system showed similar 1-year survival across SES. In the new system, recipients with low SES had decreased 1-year survival (p = 0.041)., Conclusions: SES affects waitlist and post-transplant outcomes. In the new system, all SES had increased access to HT; however, low SES had increased death/delisting due to worsening clinical status and decreased post-transplant survival., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

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.)

Despite advances in medical therapy for patients with stage C heart failure (HF), survival for patients with advanced HF is <20% at 5 years. Durable left ventricular assist device (dLVAD) support is an important treatment option for patients with advanced HF. Innovations in dLVAD technology have reduced the risk of several adverse events, including pump thrombosis, stroke, and bleeding. Average patient survival is now similar to that of heart transplantation at 2 years, with 5-year dLVAD survival now approaching 60%. Unfortunately, greater adoption of dLVAD therapy has not been realized due to delayed referral of patients to advanced HF centers, insufficient clinician knowledge of contemporary dLVAD outcomes (including gains in quality of life), and deprioritization of patients with dLVAD support waiting for heart transplantation. Despite these challenges, novel devices are on the horizon of clinical investigation, offering smaller size, permitting less invasive surgical implantation, and eliminating the percutaneous lead for power supply., Competing Interests: Funding Support and Author Disclosures Dr Tedford has consulting relationships with Medtronic, Abbott, Aria CV Inc, Acceleron/Merck, Alleviant, CareDx, Cytokinetics, Itamar, Edwards Lifesciences, Eidos Therapeutics, Lexicon Pharmaceuticals, and Gradient; is a national principal investigator for the RIGHT-FLOW clinical trial (Edwards Lifesciences); has been a steering committee member for Merck, Edwards, and Abbott; is a research advisory board member for Abiomed; and has done hemodynamic core laboratory work for Merck. Dr Leacche has been a consultant for Abbott and Abiomed. Dr Drakos has been a consultant for Pfizer and Abbott; and receives research support from Novartis, the National Institutes of Health, the American Heart Association, Department of Veterans Affairs, and Treadwell Foundation. Dr Cowger is a paid speaker and receives research-related travel funds (2017) from Abbott; is a paid member of the medical advisory board and steering committee for Tendyne and Cephea valves; is a publication committee member for HeartMate 3 clinical trial; and receives institutional support for clinical trials on HeartMate 3 and Tendyne; is a paid speaker for Medtronic, study steering committee member, and national Principal Investigator (2017-present) for DT-PAS and Apogee trials; is on the advisory board, and has received institutional support for clinical trials from Medtronic; is an advisory board member and steering committee member for the Aortix pilot and pivotal trial (2018-present) for Procyrion; has stock options in the Aortix device; is an unpaid steering committee member for the Cordella device used in the Proactive trial (2019-present); has been a speaker for fellow education activities in 2021, 2022, and 2023 for Zoll (etc); has been a steering committee member for ALIVE trial and speaker/educator for BioVentrix; is a steering committee member for Nuwellis for the Restor-HF trial; is a Data Safety Monitoring Board member for BiVACOR; has been a consultant for CorWave; is a Data Safety Monitoring Board Member for Excor Inc; is deputy editor with MCS focus for the Journal of Heart and Lung Transplantation; and is a member of leadership team for STS Intermacs. Dr Pagani has been a noncompensated ad hoc scientific advisor for Abbott, CH Biomedical, FineHeart, and Medtronic; has been a noncompensated medical monitor for Abiomed; is a member of the Data Safety Monitoring Board for Carmat and the National Heart, Lung, and Blood Institute PumpKIN Study; receives grant funding from the NHLBI and the Agency for Healthcare Research and Quality; and receives partial salary support from Blue Cross/Blue Shield of Michigan as Associate Director of the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Dr Lorts is a consultant, paid speaker, and PI of research study for Abbott; has received a research grant from Medtronic; has been a speaker, served on the medical advisory board, and has received a research grant from Abiomed; has received a research grant from SynCardia; has been a consultant for Bayer; has been a principal investigator of the Berlin Excor Active Trial; has received a research grant and has been a consultant for Berlin Heart; and has served on the medical advisory board for Optum., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)