Early Outcomes in Patients With LVAD Undergoing Heart Transplant via Use of the SherpaPak Cardiac Transport System.

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.

Impact of controlled hypothermic preservation on outcomes following heart transplantation.

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.

Outcomes in Heart Transplant Recipients by Bridge to Transplant Strategy When Using the SherpaPak Cardiac Transport System.

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.

Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT).

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.

Conservative Management of LVAD-Associated Ventricular Pseudoaneurysm.

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.

Increased disparities in waitlist and post-heart transplantation outcomes according to socioeconomic status with the new heart transplant allocation system.

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.

Predicting Survival of End-Stage Heart Failure Patients Receiving HeartMate-3: Comparing Machine Learning Methods.

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.

Status 2 upgrade indication impacts posttransplant mortality in patients bridged with intraaortic balloon pump in the new heart allocation system.

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.

Durable Mechanical Circulatory Support: JACC Scientific Statement.

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.

A Paradigm Shift in Heart Preservation: Improved Post-transplant Outcomes in Recipients of Donor Hearts Preserved With the SherpaPak System.

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.

Interleukin-10: A Potential Pre-Cannulation Marker for Development of Acute Kidney Injury in Patients Receiving Veno-Arterial Extracorporeal Membrane Oxygenation.

INTRODUCTION: Acute kidney injury (AKI) in patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is associated with high mortality. The objective of this study was to investigate whether cytokine levels before the initiation of ECMO treatment could predict AKI. We also aimed to investigate the impact of AKI on 30-day and 1-year mortality. METHODS: Serum cytokine levels were analyzed in 100 consecutive VA-ECMO-treated patients at pre-cannulation, at 48 h post-cannulation, and at 8 days. Clinical data to establish the incidence and outcome of AKI after the start of ECMO was retrieved from the local ECMO registry. SETTING: The study was conducted at tertiary care, university hospital. Participants included 100 patients treated with VA-ECMO. INTERVENTIONS: The blood samples for cytokine analysis were collected before VA-ECMO treatment, at 48 h after VA-ECMO treatment was started, and at 8 days. RESULTS: Pre-cannulation serum IL-10 levels were significantly higher in patients who developed AKI (212 [38.9, 620.7]) versus those who did not (49.0 [11.9, 102.2]; p = 0.007), and the development of AKI can be predicted by pre-cannulation IL-10 levels (p = 0.025, OR = 1.2 [1.02-1.32]). The development of AKI during ECMO treatment is associated with increased 30-day mortality (p = 0.049) compared to patients who did not develop AKI and had a pre-cannulation estimated glomerular filtration rate ≥ 45 mL/min. The 1-year survival rate for patients with AKI who survived the first 30 days of ECMO treatment is comparable to that of patients without AKI. CONCLUSION: Increased pre-cannulation IL-10 levels are associated with the development of AKI during VA-ECMO support. AKI is associated with increased 30-day mortality compared to patients with no AKI and better renal function. However, patients with AKI who survive the first 30 days have a 1-year survival rate similar to those without AKI.

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Extracorporeal membrane oxygenation as a bridge to advanced heart failure therapies.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a key support modality for cardiogenic shock. The 2018 United Network for Organ Sharing (UNOS) heart transplant allocation algorithm prioritizes VA-ECMO patients. OBJECTIVE: To evaluate the role of VA-ECMO in bridging to advanced heart failure therapies. METHODS: We analyzed adult patients from the multicenter Extracorporeal Life Support Organization registry receiving VA-ECMO for cardiac support or resuscitation between 2016 and 2021 in the United States, comparing bridge-to-transplant (BTT) and non-BTT intent patients, as well as pre- vs post-2018 patients, on a wide range of demographic and clinical outcome predictors. RESULTS: Of 17,087 patients, 797 received left ventricular assist device (LVAD)/heart transplant, 7,931 died or had poor prognosis, and 8,359 had expected recovery at ECMO discontinuation. Patients supported with BTT intent had lower clinical acuity than non-BTT candidates and were more likely to receive LVAD/transplant. The proportion of patients who received VA-ECMO as BTT and received LVAD/transplant increased after 2018. Post-2018 BTT patients had significantly lower clinical acuity and higher likelihood of transplant than both post-2018 non-BTT patients and pre-2018 BTT patients. ECMO complications were associated with lower likelihood of transplant but were significantly less common post-2018 than pre-2018. CONCLUSIONS: After implementation of the 2018 UNOS allocation system, ECMO utilization as BTT or LVAD has increased, and the acuity of BTT intent patients cannulated for ECMO has decreased. There has not yet been an increase in more acute ECMO patients getting transplanted. This may partially explain the post-transplant outcomes of ECMO patients in the current era reported in UNOS.

Multicenter Registry Using Propensity Score Analysis to Compare a Novel Transport/Preservation System to Traditional Means on Postoperative Hospital Outcomes and Costs for Heart Transplant Patients.

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.

Del Nido Cardioplegia in Ascending Aortic Surgery.

Del Nido cardioplegia offers equivalent myocardial protection and clinical outcomes to blood cardioplegia in adult isolated CABG and valve patients, but the safety and efficacy of del Nido in complex cases with prolonged aortic cross-clamp times is still unknown. 443 patients at our center underwent replacement of the ascending aorta using either del Nido (n = 182) or blood (n = 261) cardioplegia. Two surgeons used del Nido exclusively and 6 used blood exclusively over the study period. Propensity matching of preoperative characteristics yielded 172 well matched pairs. Emergency and reoperative cases were included. Clinical data were extracted from our local database. Troponin levels were drawn at 12 hours postop in all patients. Rates of perioperative mortality (4.7% vs 5.2%), stroke (5.8% vs 7.0%), renal failure (11.6% vs 12.2%), atrial fibrillation (36.0% vs 31.4%), intra-aortic balloon pump insertion (2.3% vs1.2%), and extra corporeal membrane oxygenation use (4.7% vs 4.1%) did not differ between blood and del Nido groups. Postop Troponin T levels were 0.50[0.35, 0.86] ng/mL and 0.40[0.20, 0.70] ng/mL for blood and del Nido, respectively (P < 0.0001). Postop echocardiography was available in 333 of 344 (96.8%) patients, and there was no difference in change in EF from pre- to postop between blood 0.0[-6.0, 5.0]% and del Nido 0.0 [-6.0, 3.5]% (P = 0.201). Subgroup analysis of patients with aortic cross-clamp time greater than 180 minutes (blood = 77, del Nido = 27) revealed no difference in troponins, ejection fraction, or clinical outcomes. Five-year survival was 85.9[76.8, 91.7]% and 79.8[71.2, 86.1]% for blood and del Nido, respectively (P = 0.151). In ascending aortic surgery with prolonged operative times, no differences were observed in myocardial protection or clinical outcomes with the use of del Nido cardioplegia compared to blood cardioplegia.

Efficacy of del Nido cardioplegia in adult cardiac procedures with prolonged aortic crossclamp time.

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.

Decreased frequency of transplantation and lower post-transplant survival free of re-transplantation in LVAD patients with the new heart transplant allocation system.

PURPOSE: To evaluate the effect of the new heart transplant (HT) allocation system in left ventricular assist device (LVAD) supported patients listed as bridge to transplantation (BTT). METHODS: Adult patients who were listed for HT between October 18, 2016 and October 17, 2019, and were supported with an LVAD, enrolled in the UNOS database were included in this study. Patients were classified in the old or new system if they were listed or transplanted before or after October 18, 2018, respectively. RESULTS: A total of 3261 LVAD patients were listed for transplant. Of these, 2257 were classified in the old and 1004 in the new system. The cumulative incidence of death or removal from the transplant list due to worsening clinical status at 360-days after listing was lower in the new system (4% vs. 7%, P = .011). LVAD Patients listed in the new system had a lower frequency of transplantation within 360-days of listing (52% vs. 61%, P < .001). A total of 1843 LVAD patients were transplanted, 1004 patients in the old system and 839 patients in the new system. The post-transplant survival at 360 days was similar between old and new systems (92.3% vs. 90%, P = .08). However, LVAD patients transplanted in the new system had lower frequency of the combined endpoint, freedom of death or re-transplantation at 360 days (92.2% vs. 89.6%, P = .046). CONCLUSION: The new HT allocation system has affected the LVAD-BTT population significantly. On the waitlist, LVAD patients have a decreased cumulative frequency of transplantation and a concomitant decrease in death or delisting due to worsening status. In the new system, LVAD patients have a decreased survival free of re-transplantation at 360 days post-transplant.

Changes in heart transplant waitlist and posttransplant outcomes in patients with restrictive and hypertrophic cardiomyopathy with the new heart transplant allocation system.

Historically, patients with restrictive (RCM) and hypertrophic cardiomyopathy (HCM) experienced longer wait-times for heart transplant (HT) and increased waitlist mortality. Recently, a new HT allocation system was implemented in the United States. We sought to determine the impact of the new HT system on RCM/HCM patients. Adult patients with RCM/HCM listed for HT between November 2015 and September 2019 were identified from the UNOS database. Patients were stratified into two groups: old system and new system. We identified 872 patients who met inclusion criteria. Of these, 608 and 264 were classified in the old and new system groups, respectively. The time in the waitlist was shorter (25 vs. 54 days, P < .001), with an increased frequency of HT in the new system (74% vs. 68%, P = .024). Patients who were transplanted in the new system had a longer ischemic time, increased use of temporary mechanical circulatory support and mechanical ventilation. There was no difference in posttransplant survival at 9 months (91.1% vs. 88.9%) (p = .4). We conclude that patients with RCM/HCM have benefited from the new HT allocation system, with increased access to HT without affecting short-term posttransplant survival.

Improved survival after heart transplantation in patients bridged with extracorporeal membrane oxygenation in the new allocation system.

BACKGROUND: Historically, patients bridged on extracorporeal membrane oxygenation (ECMO) to heart transplantation (HT) have very high post-transplant mortality. In the new heart transplant allocation system, ECMO-supported patients have the highest priority for HT. However, data are lacking on the outcomes of these critically ill patients. We compared the waitlist and post-transplant outcomes of ECMO-supported patients in the new and old allocation systems. METHODS: Adult patients supported by ECMO at the time of listing or transplantation who were registered in the United Network for Organ Sharing database between November 1, 2015 and September 30, 2019 were included. Clinical characteristics, outcomes in the waitlist, and post-transplant survival were compared between the old and new systems. Cox Proportional and subdistribution hazard regression models were used to evaluate the variables contributing to the post-transplant and waitlist outcomes RESULTS: A total of 296 ECMO-supported patients were listed for HT. Of these, 191 were distributed to the old system, and 105 were distributed to the new system. Patients listed in the new system had a higher cumulative incidence of HT (p < 0.001) and lower incidence of death or removal (p = 0.001) from the transplant list than patients listed in the old system. The 6-month survival after transplantation was 74.6% and 90.6% for the old- and new-era patients, respectively (p = 0.002). Among ECMO-supported patients, being listed or transplanted on the new system was independently associated with improved outcomes in the waitlist and after transplantation. CONCLUSIONS: With the implementation of the new heart transplant allocation system, ECMO-supported patients have a shorter waitlist time, improved frequency of HT, and improved short-term post-transplant survival.

Increased frequency of heart transplantation, shortened waitlist time and preserved post-transplant survival in adults with congenital heart disease, on the new heart transplant allocation system.

Historically, adult congenital patients have longer waitlist time and worse outcomes on the heart transplant waitlist as well as poorer early post-transplant survival. A new heart transplantation allocation system was implemented in the United States on October 18, 2018. The effect of the new allocation system on adult congenital patients is unknown. Adult congenital patients listed for transplantation between November 1, 2015 and September 30, 2019 registered in the United Network for Organ Sharing were included in the study. October 18, 2018 was used as the limit to distribute listed and transplanted patients into old and new groups. A total of 399 patients were listed for heart transplant only, 284 in the old system and 115 in the new system. Clinical characteristics were similar between both groups. The cumulative incidence of poor outcome on the transplant list was similar in both groups (P = .23), but the cumulative incidence of transplant was higher in the new system group (P < .009) and was associated with a shorter waitlist time. The one-year post-transplant outcome was similar between old and new groups (P = .37). The new allocation system has benefited adult congenital patients with increased cumulative frequency of transplantation without worsening short-term survival after transplantation.