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Background: Evidence on infection risk factors is scarce, and precise localization of the site of infection and its treatment remain clinically challenging., Objectives: This study aimed to map the recommendations for adult patients undergoing left ventricular assist device implantation., Design: This is a scoping review, registered in the Open Science Framework under DOI10.17605/OSF.IO/Q76B3(https://osf.io/q76b3/)., Method: This is a scoping review limited to the period between 2015 and 2022.The results of this scoping review are discussed and presented separately in 3 articles. This second paper synthesizes research evidence on the risk factors, diagnostic methods and treatment of infection in adult patients undergoing left ventricular assist device implantation., Results: The initial searches identified 771 studies. Sixty-nine patients met the eligibility criteria and were included in the scoping review. Forty-three articles addressing the risk factors, diagnosis and treatment of infection were included to answer the questions of this review., Conclusion: Obesity has been shown to be the most common risk factor for the described process of infection by left ventricular assist devices. 18 F-fluorodeoxyglucose positron emission tomography showed high sensitivity in detecting cardiac device infection, and labeled leukocyte or gallium citrate-67 scintigraphy showed high specificity for left ventricular assist device infections; therefore, it can help differentiate infection from inflammation, particularly in patients with equivocal fluorodeoxyglucose positron emission tomography. Also, this review brings and discusses the limitations and strengths of diagnostic tests, the knowledge regarding the risk factors for left ventricular assist device infection, the therapeutic heterogeneity, the methodological issues of the studies, and the vast opportunity for future research on left ventricular assist device., Implications for Clinical Practice: Ventricular assist device professionals should evaluate risk factors prior to device implantation and periodically. 18 F-fluorodeoxyglucose positron emission tomography should be considered as diagnostic tool in detecting superficial and deep driveline infections. Early treatment, including chronic suppressive therapy and serial surgical debridement, combined with driveline exteriorization and delayed driveline relocation may constitute a potential therapeutic strategy for deep driveline infections., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) provides detailed information on pediatric patients supported with ventricular assist devices (VADs)., Methods: From September 19, 2012, to December 31, 2020, 1229 devices in 1011 patients were reported to the registry from 47 North American Hospitals in patients aged younger than 19 years., Results: Cardiomyopathy was the most common underlying etiology (58%), followed by congenital heart disease (CHD; 25%) and myocarditis (10%). The most common devices implanted were implantable continuous (IC; 419 [41%]), followed by paracorporeal pulsatile (PP; 269 [27%]), paracorporeal continuous (PC; 263 [26%]), and percutaneous (53 [5%]). Overall, at 6 months after VAD implantation, 83% had a positive outcome (transplant, explant, or alive on device). The freedom from stroke at 3 months was highest in IC VADs (93%), compared with PP VADs (84%) and with PC VADs (75%). There were differences in survival by device type, with patients on IC VADs having the best overall survival and those on PC having the lowest overall survival, though the patient populations being supported by each VAD type differed significantly from each other., Conclusions: This Fifth Pedimacs Report demonstrates the continued robust growth of VADs in the pediatric community, now with more than 1000 patients reported to the registry. The multiple available device types (PC, PP, IC) serve different populations with different pre-VAD risk profiles, which may account for differences in survival and adverse events between device types., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Paracorporeal continuous-flow ventricular assist devices (PCF VAD) are increasingly used in pediatrics, yet PCF VAD resource utilization has not been reported to date., Methods: Pediatric Interagency Registry for Mechanically Assisted Circulatory Support (PediMACS), a national registry of VADs in children, and Pediatric Health Information System (PHIS), an administrative database of children's hospitals, were merged to assess VAD implants from 19 centers between 2012 and 2016. Resource utilization, including hospital and intensive care unit length of stay (LOS), and costs are analyzed for PCF VAD, durable VAD (DVAD), and combined PCF-DVAD support., Results: Of 177 children (20% PCF VAD, 14% PCF-DVAD, 66% DVAD), those with PCF VAD or PCF-DVAD are younger (median age 4 [IQR 0-10] years and 3 [IQR 0-9] years, respectively) and more often have congenital heart disease (44%; 28%, respectively) compared to DVAD (11 [IQR 3-17] years; 14% CHD); p < 0.01 for both. Median post-VAD LOS is prolonged ranging from 43 (IQR 15-82) days in PCF VAD to 72 (IQR 55-107) days in PCF-DVAD, with significant hospitalization costs (PCF VAD $450,000 [IQR $210,000-$780,000]; PCF-DVAD $770,000 [IQR $510,000-$1,000,000]). After adjusting for patient-level factors, greater post-VAD hospital costs are associated with LOS, ECMO pre-VAD, greater chronic complex conditions, and major adverse events (p < 0.05 for all). VAD strategy and underlying cardiac disease are not associated with LOS or overall costs, although PCF VAD is associated with higher daily-level costs driven by increased pharmacy, laboratory, imaging, and clinical services costs., Conclusion: Pediatric PCF VAD resource utilization is staggeringly high with costs primarily driven by pre-implantation patient illness, hospital LOS, and clinical care costs., Competing Interests: Conflict of interest disclosure The PediMACS database is funded by a contract grant (HHSN268201100025C) from the National Heart, Lung, and Blood Institute. JWR has served as a consultant for Novartis, Abiomed, Bayer, Amgen. DLSM has served as a consultant for Abbott, Syncardia, and Berlin Heart. The other authors have no relevant disclosures to report., (Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Patients suffering an acute myocardial infarction complicated by cardiogenic shock (AMICS) may experience clinical deterioration with concomitant atrial fibrillation (AF). Recent data suggest that percutaneous ventricular assist devices (pVADs) provide superior hemodynamic support over intra-aortic balloon pump (IABP) in AMICS. In patients with AF+AMICS, however, outcomes data comparing these two devices remain limited., Methods: Using the National Inpatient Sample datasets (2008-2014) and a propensity-score matched analysis, we compared the outcomes of AMICS+AF hospitalized patients undergoing PCI with pVAD vs. IABP support., Results: A total of 12,842 AMICS+AF patients were identified (pVAD=468, IABP=12,374). The matched groups (pVAD=443, IABP=443) were comparable in terms of mean age (70.3 ± 12.0 vs. 70.4 ± 11.0yrs, p = 0.92). The utilization of pVAD was higher in whites but lower in Medicare/Medicaid beneficiaries as compared to IABP. The pVAD group demonstrated higher rates of obesity (13.6% vs. 7.8%, p = 0.006) and dyslipidemia (48.4% vs. 41.8%, p = 0.05). There was no difference in the in-hospital mortality (40.5% vs. 36.8%, p = 0.25); however, pVAD group had a lower incidence of post-procedural MI and higher incidences of stroke (7.8% vs. 4.4%, p = 0.03), hemorrhage (5.6% vs. 2.3%, p = 0.01), discharges to home health care (13.5% vs. 10.1%, p<0.001) and to other facilities (29.1% vs. 24.9%, p<0.001) as compared to IABP group. There was no difference between the groups in terms of mean length of stay or hospital charges., Conclusions: All-cause inpatient mortality was similar in AMICS+AF patients undergoing PCI who were treated with either pVAD or IABP. The pVAD group, however, experienced more complications while consuming greater healthcare resources., (Copyright © 2020 Southern Society for Clinical Investigation. All rights reserved.)

Background: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), originally a National Institutes of Health-sponsored U.S. database, provides a platform to understand the population of children supported with ventricular assist devices (VADs) during this time of increasing numbers, new devices, expanding indications, and improved outcomes., Methods: Between September 19, 2012, and December 31, 2019, 44 hospitals implanted 1031 devices in 856 patients under 19 years of age., Results: Overall, diagnosis was cardiomyopathy in 497 (58%) patients, congenital heart disease (CHD) in 216 (25%), myocarditis in 85 (10%), and other in 58 (7%). Positive outcome (alive on device or bridge to transplantation and recovery) occurred in 82% at 6 months. The patient cohort for implantable continuous (IC) pumps (n = 365) (age 13.2 ± 3.9 years, 18% Interagency Registry for Mechanically Assisted Circulatory Support [Intermacs] profile 1, 23% intubated at implantation, 16% with CHD) was significantly different from the paracorporeal continuous (PC) pump cohort (n = 212) (age 3.6 ± 4.9 years, 46% Intermacs profile 1, 81% intubated, 42% CHD) and the paracorporeal pulsatile (PP) pump cohort (n = 230) (age 2.7 ± 3.5 years, 31% Intermacs profile 1, 76% intubated, 26% CHD). Consistent with their cohort composition, positive outcomes at 6 months based on device type were the following: IC, 92%; PC, 68%; and PP, 81%. The incidence of cerebrovascular accidents in the IC, PC, and PP cohorts was 7%, 14%, and 15%, respectively., Conclusions: IC VADs, the most common VAD type placed in children, are associated with improved outcomes compared with PP and PC devices, though PP and PC devices are limited to supporting our most challenging patients. Noteworthy, the incidence of cerebrovascular accidents for pediatric VADs has significantly decreased and is now 11% overall. This report demonstrates again that although often attributed to age, size, or device type, much of the burden in mortality and adverse events is correlated to the patient's overall state at VAD implantation., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The objective of this study was to characterize practical use trends and outcomes for intraaortic balloon pump (IABP) and percutaneous left ventricular assist device (pVAD) use in cardiogenic shock at a national level., Methods: An analysis of all adult patients admitted nonelectively for cardiogenic shock from January 2008 through December 2017 was performed using the National Inpatient Sample. Trends of inpatient IABP and pVAD use were analyzed using survey-weighted estimates and the modified Cochran-Armitage test for significance. Multivariable regression models and inverse probability of treatment weights were used to perform risk-adjusted analyses of pVAD mortality, a composite of adverse events (AE), and resource use, with IABP as reference., Results: Of an estimated 774,310 patients admitted with cardiogenic shock, 143,051 received a device: IABP, 127,792 (16.5%); or pVAD, 15,259 (2.0%). IABP use decreased (23.8% to 12.7%; P for trend <.001), whereas pVAD implantation increased significantly during the study period (0.2% to 4.5%; P for trend <.001). Inverse probability of treatment weights demonstrated significantly higher odds of mortality with pVAD (odds ratio, 1.9; 95% confidence interval, 1.7 to 2.2), but not AE (odds ratio, 1.1; 95% confidence interval, 0.96 to 1.27), compared with IABP. After risk adjustment, pVAD use was associated with an additional $15,202 (P < .001) in cost for survivors and $29,643 for nonsurvivors (P < .001)., Conclusions: Over the study period, the rate of pVAD use for cardiogenic shock significantly increased. Compared with IABP, pVAD use was associated with increased mortality, higher costs, and several AEs. Multi-institutional clinical trials with rigorous inclusion criteria are warranted to evaluate the clinical utility of pVADs in the modern era., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system., Methods: Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices., Results: Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P < .001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P < .001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P < .001)., Conclusions: Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Human immunodeficiency virus-positive (HIV+) patients are not routinely offered heart transplantation (HT) due to lack of adequate outcomes data. Between January 2004 and March 2017, we identified 41 adult (≥18 years) HT recipients with known HIV+ serostatus at the time of transplant in UNOS and evaluated post-HT outcomes. Overall, Kaplan-Meier (KM) estimates of survival at 1 and 5 years were 85.9% and 77.3%, respectively, with no significant difference in bridge-to-transplant ventricular-assist device (BTT-VAD, n = 22) and no-BTT-VAD (n = 19). KM estimates of cardiac allograft vasculopathy (CAV) and malignancy at 5 years were 32% and 19%, respectively. Using propensity scores, 41 HIV+ HT recipients were matched to 41 HIV- HT recipients for idiopathic dilated-cardiomyopathy; and there was no significant difference in post-HT survival up to 5 years. Furthermore, only 24 centers in the United States had performed HIV+ HT during the study period, indicating that >80% of HT centers in the United States had not performed any HIV+ HT. In a cohort representative of the current status of HIV+ HTs in the United States, we found that the posttransplant survival was excellent and rates of CAV and malignancy were comparable to the overall HT population. These results should encourage greater number of centers to offer HT to suitable HIV+ candidates and help reduce unequal access to HT for HIV+ patients., (© 2019 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: Growth differentiation factor-15 (GDF-15) is a stress-inducible cytokine and member of the transforming growth factor-β cytokine superfamily that refines prognostic assessment in subgroups of patients with heart failure (HF). We evaluated its role in HF patients with chronic kidney disease (CKD, estimated glomerular filtration rate <60 mL/min/1.73 m 2 )., Methods: A total of 358 patients with stable systolic HF were followed for a median of 1121 (interquartile range, 379-2600) days. Comprehensive evaluation including B-type natriuretic peptide (BNP) and GDF-15 testing was performed at study entry; the analysis was stratified according to kidney function., Results: Patients with CKD (33.8%) were older, had more often diabetes, and were less often treated with angiotensin converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARB). GDF-15 was associated with estimated glomerular filtration rate, whereas BNP was associated with left ventricular-end diastolic diameter and ejection fraction (P < 0.01). During follow-up, 244 patients (68.2%) experienced an adverse outcome (death, urgent transplantation, implantation of mechanical circulatory support). In patients with HF and CKD, the Cox proportional hazard model identified BNP, GDF-15, sex, systolic blood pressure, sodium, total cholesterol, and ACEi/ARB treatment as significant variables associated with an adverse outcome (P < 0.05). In multivariable analysis, BNP was replaced by GDF-15. Net reclassification improvement confirmed prognostic superiority of the model encompassing GDF-15 (GDF-15, sodium, total cholesterol, ACEi/ARB treatment) compared with the model without GDF-15 (BNP, sex, sodium, ACEi/ARB treatment), net reclassification improvement 0.62, P = 0.005. In contrast, in patients with HF and normal kidney function, BNP remained superior to GDF-15 in a multivariable model., Conclusions: In patients with systolic HF and CKD, GDF-15 is more strongly associated with adverse outcomes than the conventionally used BNP., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: The influence of ventricular assist device (VAD) use in the care of children with end-stage heart failure is growing rapidly through increasing numbers, new devices, expanding indications, and improving outcomes. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Institutes of Health-sponsored United States database, provides a platform to understand this emerging population., Methods: Between September 19, 2012, and December 31, 2017, 30 hospitals implanted 508 devices in 423 patients aged younger than 19 years. This past year was one of evolution for the database as its management was transitioned to The Society of Thoracic Surgery; therefore, this report does not include data from institutions not under contract by August 1, 2018., Results: Of the 423 patients, the diagnosis was cardiomyopathy in 261 (62%), myocarditis in 48 (11%), other in 28 (7%), and congenital heart disease (CHD) in 86 (20%), with 52 of these patients having single-ventricle physiology. The two most common support strategies included left VAD in 342 (81%) and biventricular assist device in 64 (15%). Positive outcome (alive on device or bridge to transplantation/recovery) was 80% at 6 months (overall mortality of 20%). The patient cohort for implantable continuous-flow (IC) pumps (n = 197; age at implant, 13.4 ± 3.8 years; 19% Interagency Registry for Mechanically Assisted Circulatory Support [Intermacs] profile 1, 21% intubated at implant, and 12% with CHD) was significantly different from the paracorporeal continuous-flow (PC) pump cohort (n = 79; age, 3.9 ± 5.2 years; 49% Intermacs profile 1, 86% intubated at implant, and 38% with CHD) and the paracorporeal pulsatile (PP) pump cohort (n = 121; age, 3.3 ± 3.9 years; 41% Intermacs profile 1, 77% intubated at implant, and 21% with CHD). Consistent with their cohort composition, device type positive outcomes at 6 months were PC, 63%; PP, 77%; and IC, 92%. Parametric hazard modeling showed an early hazard for death was associated with Intermacs profile 1, biventricular assist device, percutaneous devices, PC devices, small-volume institutions, low age, and low weight, whereas a constant hazard was associated with intubation and liver dysfunction at time of implant., Conclusions: IC VADs are the most common VAD type placed in children. The positive outcomes for the IC VADs exceed 90% at 6 months, which may represent our field's maturation in both patient selection and timing of implantation. The PP/PC devices are currently limited to supporting our most challenging patients, those weighing less than 20 kg and those with CHD. The introduction of new devices and our communities' commitment to shared learning and improvement will lead to more pediatric lives saved by VAD support and will also focus on improving the quality of life of children supported with VADs., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study examined sex-related differences in use and outcomes of continuous-flow left ventricular assist devices (CF-LVADs) among individuals awaiting heart transplantation using the United Network for Organ Sharing registry., Background: Advanced therapies for heart failure including CF-LVADs remain underused in women. There have been contradictory results regarding sex-specific outcomes. Many studies have been limited by small sample sizes or included pulsatile-flow devices., Methods: De-identified patient-level data were obtained from the United Network for Organ Sharing database. The database was queried to identify adult patients (≥18 years of age) who required mechanical circulatory support with HeartWare HVAD (Medtronic, Minneapolis, Minnesota), HeartMate II (Abbott, Lake Bluff, Illinois), or HeartMate 3 (Abbott) as bridge to heart transplantation between 2008 and 2018. Each patient was assigned a propensity score. The primary outcomes of interest were rates of transplantation and death., Results: A total of 13,305 patients (2,771 women, 20.8%) received support with CF-LVAD in the study period. There were significant sex disparities in CF-LVAD use in listed patients (29.9% men vs. 18.9% women in 2017). Female patients receiving CF-LVAD support had lower chances of heart transplantation (55.1% vs. 67.5%), increased risk of waitlist mortality (7.0% vs. 4.2%), and delisting for worsening clinical status (8.5% vs. 4.7%) at 2 years post-implantation (all p < 0.001). After adjusting for device type, sex was still a significant predictor of waitlist mortality (hazard ratio: 1.51; p < 0.001)., Conclusions: Durable mechanical circulatory support with CF-LVADs remains underused in women. When matched with similar male control subjects, women experienced higher mortality and lower rates of heart transplantation., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Aortic root thrombosis (ART) is a recently recognized complication of continuous-flow left ventricular assist device (CF-LVAD) therapy. However, little is known about the prevalence or clinical significance of this complication. The aim of our study was to systematically evaluate the incidence and significance of ART on CF-LVAD support., Methods: We retrospectively reviewed all patients who underwent HeartMate II or HeartWare HVAD CF-LVAD implantation from April 2004 through June 2016 at the Columbia University Medical Center. Echocardiography studies were systematically reviewed to identify patients who developed ART. Study outcomes included post-ART survival on CF-LVAD support, stroke, pump thrombosis, and clinically significant myocardial infarction (MI)., Results: The study cohort consisted of 436 CF-LVAD patients with 21 patients (4.8%) diagnosed with confirmed ART at a median time of 22 days (interquartile range [IQR] 3 to 56 days) after CF-LVAD implantation. Involvement of the non-coronary cusp was the most common location of the ART (n = 15, 71.4%) and concomitant RV failure occurred in 14 patients (66.7%). Actuarial survival at 1 and 2 years after diagnosis of ART was 73.8% and 44.3%, respectively. ART was associated with a high rate of complications, including stroke (28.6%, 0.337 episode per patient-year [EPPY]) and clinically significant MI (28.6%, 0.337 EPPY)., Conclusions: ART is not uncommon after CF-LVAD implantation and is associated with significant morbidity and mortality in CF-LVAD patients. Given the early occurrence and high incidence of stroke and MI in patients who develop ART, surveillance and treatment strategies should be implemented to address this potentially devastating complication., (Copyright © 2018 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objective: The Kaplan-Meier method may overestimate absolute mortality risk (AMR) in the presence of competing risks. Urgent heart transplantation (UHT) and ventricular assist device implantation (VADi) are important competing events in heart failure. We sought to quantify the extent of bias of the Kaplan-Meier method in estimating AMR in the presence of competing events and to analyze the effect of covariates on the hazard for death and competing events in the clinical model of decompensated chronic heart failure with reduced ejection fraction (DCHFrEF)., Study Design and Setting: We studied 683 patients. We used the cumulative incidence function (CIF) to estimate the AMR at 1 year. CIF estimate was compared with the Kaplan-Meier estimate. The Fine-Gray subdistribution hazard analysis was used to assess the effect of covariates on the hazard for death and UHT/VADi., Results: The Kaplan-Meier estimate of the AMR was 0.272, whereas the CIF estimate was 0.246. The difference was more pronounced in the patient subgroup with advanced DCHF (0.424 vs. 0.338). The Fine-Gray subdistribution hazard analysis revealed that established risk markers have qualitatively different effects on the incidence of death or UHT/VADi., Conclusion: Competing risks analysis allows more accurately estimating AMR and better understanding the association between covariates and major outcomes in DCHFrEF., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Proposed changes to the United Network for Organ Sharing heart transplant allocation protocol will prioritize patients receiving temporary mechanical circulatory support (tMCS), including extracorporeal membrane oxygenation (ECMO), percutaneous ventricular assist devices (PVADs), and intra-aortic balloon pumps (IABPs). We sought to evaluate contemporary trends in the incidence and outcomes of patients who required tMCS during the hospitalization before heart transplantation., Methods: Using the National Inpatient Sample from 1998 to 2014, we identified 6,892 patients who received an orthotopic heart transplant and classified them by pre-transplant ECMO, PVAD, or IABP placement or no pre-transplant tMCS. We compared baseline characteristics and in-hospital outcomes between patients who underwent pre-transplant ECMO, PVAD, or IABP and patients who did not receive tMCS before heart transplantation., Results: Of patients who underwent heart transplantation, 456 (6.6%) received tMCS before transplant. During the study period, the use of tMCS more than doubled, from 17 cases per year from 1998 to 2002 to 40 cases per year from 2012 to 2014 (p < 0.001 for trend). Of patients with tMCS, 341 (74.8%) were supported by IABP, 130 (28.5%) were supported by ECMO, and 21 (4.6%) were supported by PVAD. Before 2007, patients who required tMCS had higher in-hospital mortality than patients who did not require tMCS before transplant (14.3% vs 7.5%, p = 0.05). In the subsequent era (2007 to 2014), mortality was not significantly different (4.7% vs 5.1%, p = 0.9). Hospital mortality improved over time for all patients but most significantly in patients who required tMCS (9.6% absolute risk reduction). However, patients who received tMCS had increased lengths of stays and rates of acute renal, hepatic, and respiratory failure, sepsis, bleeding complications, and surgical reoperations., Conclusions: The use of tMCS before cardiac transplantation is increasing, with no difference in in-patient post-transplant mortality in the recent era between patients who did and did not receive tMCS but with increased complication rates among those who received tMCS. These data support the use of tMCS before cardiac transplantation in appropriately selected patients. Clinicians should balance the above outcomes when making decisions to implant tMCS, given the impending changes to the United Network for Organ Sharing heart allocation protocol., (Copyright © 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Ventricular assist device (VAD) use as a bridge to transplant (BTT) for children with end-stage heart failure and congenital heart disease (CHD), although challenging, has increased, but its effect on posttransplant outcome is unknown. This study describes posttransplant outcomes of CHD patients BTT with a VAD., Methods: All heart transplant recipients identified in United Network of Organ Sharing database from 2006 to 2015 (n = 21,865) were divided into four groups by those with (+) and without (-) a diagnosis of CHD and with (+) and without (-) VAD support at transplant: +CHD/+VAD, +CHD/-VAD, +VAD/-CHD, and -VAD/-CHD. Posttransplant survival of +CHD/+VAD was compared with +CHD/-VAD, -CHD/+VAD, and -CHD/-VAD in addition to pretransplant characteristics comparison between +CHD/+VAD and +CHD/-VAD., Results: Of 1,871 patients (8.6%) with CHD, 1,348 (72%) were younger than 18 years old, and 143 (7.6%) were BTT with a VAD (+CHD/+VAD). At transplant, +CHD/+VAD compared with +CHD/-VAD were more likely to have worse functional status (<50%: 60% vs 46%, p = 0.004), infections (29% vs 14%, p < 0.001), to be sensitized (47% vs 30%, p < 0.001) and on ventilator support (20% vs 13%, p = 0.029) and dialysis (13% vs 2.5%, p < 0.001). Overall, 1-year (84% vs 87%) and 5-year (72% vs 75%) survival was similar for +CHD/+VAD and +CHD/-VAD (p = 0.694). Survival was also similar when +CHD/+VAD were compared with -CHD/+VAD (n = 7,363; p = 0.529) and -CHD/-VAD (n = 12,613; p = 0.097)., Conclusions: Although more ill pretransplant, CHD patients BTT with a VAD have similar posttransplant survival compared with CHD patients without a VAD and with other non-CHD heart transplant patients. VAD support may mitigate certain risk factors for poor posttransplant outcomes in the challenging CHD cohort., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Hemodynamic support with Impella (Abiomed Inc., Danvers, MA) devices is becoming a more prevalent treatment option for patients with cardiogenic shock (CS) undergoing percutaneous coronary intervention (PCI). There exists only limited published data regarding outcome differences between male and female patients. Therefore, the objective of this paper is to analyze these gender differences between short-term survival and in-hospital outcomes in those undergoing PCI with CS., Methods: Between January 2011 and July 2016, patients undergoing PCI with simultaneous use of Impella were identified. Only patients presenting with CS were included in the analysis. All-cause in-hospital mortality was the primary outcome. Using SAS 9.4 for propensity score matching, additional secondary outcomes were also compared., Results: The primary outcome was comparable between males and females (39.5% vs. 26.3%, p=0.33) in CS patients. Secondary outcomes were also comparable and included: myocardial infarction, stroke, CS, heart failure, dialysis requirement, bleeding within 72h, blood transfusion, dysrhythmia, composite of all complications, major adverse cardiac events. Survival at 30days was equal in both groups. A reduced mortality in males was noted for pre-PCI initiation of Impella. Additionally, both genders who received pre-PCI Impella support, experienced a significant reduction in inotrope use., Conclusions: Despite the small number of cohorts, this study did not reveal any significant differences among gender with the use of percutaneous left ventricular assist devices for PCI in patients with acute myocardial infarction complicated by CS. However, initiation of Impella prior to PCI may be associated with improved mortality and morbidity in both genders., (Copyright © 2018. Published by Elsevier B.V.)

Background: The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a United States registry for adults receiving durable United States Food and Drug Administration-approved mechanical circulatory support devices (MCSDs). We merged INTERMACS records with Medicare claims to investigate the uncertainty of penetrance of Medicare beneficiaries within INTERMACS., Methods: INTERMACS records and Medicare claims (January 1, 2008, through December 31, 2013) from the Centers for Medicare and Medicaid (CMS) were linked using a deterministic matching methodology., Results: There was annual growth of CMS and INTERMACS centers performing durable MCSD implants among adults from 2008 through 2013 (54% and 87% increase, respectively). The number of CMS centers outnumbered INTERMACS centers throughout all years, with the 68% to 88% of CMS centers being represented in INTERMACS. Although annual patient volume was greatest for INTERMACS, the absolute number of patients significantly increased annually across both data sets from 2008 through 2013 (149% increase in CMS; 268% increase in INTERMACS). As a proportion of all INTERMACS registrants, Medicare beneficiary representation grew from 30% in 2008 to a high of 48% in 2010 and remained stable thereafter. Representation within INTERMACS of MCSDs implanted in Medicare beneficiaries more than doubled, from 36% in 2008 to 77% in 2013., Conclusions: Using a merged data set of MCSDs implanted between 2008 and 2013, we report that the vast majority of CMS centers and Medicare beneficiaries receiving MCSDs are increasingly captured in INTERMACS. Accordingly, contemporary studies in INTERMACS are relevant and generalizable to the Medicare population., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Management of mechanical circulatory support in children with congenital heart disease (CHD) is challenging due to physiologic variations and anatomic limitations to device placement. In this study we examine the use of Berlin Heart EXCOR in CHD patients., Methods: CHD patients were identified from the EXCOR Pediatric Study data set (2007 to 2010). Mortality and serious adverse events were compared between CHD and non-CHD cohorts, and predictors of poor outcomes in the CHD cohort were identified., Results: CHD was present in 29% (n = 59, 18 with 1-ventricle physiology) of all EXCOR patients (N = 204). Successful bridge (transplant or wean) was less likely in CHD patients compared with non-CHD patients (48% vs 80%; p < 0.01). Among CHD patients, no neonates, 25% of infants (30 days to 1 year) and 65% of children (>1 year) were successfully bridged. Pre-implant congenital heart surgery (CHS) and extracorporeal membrane oxygenation (ECMO) on the same admission occurred in 60% of children ≤1 year of age (83% of neonates, 50% of infants), with 8% survival. Regardless of age, patients who did not have CHS and ECMO had 61% survival. Smaller pump, pre-implant bilirubin >1.2 mg/dl and renal dysfunction were independently associated with mortality., Conclusions: End-organ function at implant reliably predicts adverse outcomes and should be considered when making implant decisions. EXCOR use in neonates and infants with CHD should be approached cautiously. If patients have undergone pre-implant CHS and ECMO, EXCOR support may not provide any survival benefit. EXCOR support in non-infants with CHD is challenging but can be consistently successful with appropriate patient selection., (Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Heart failure is the leading cause of morbidity and mortality for adults with congenital heart disease (ACHD). Many patients are ineligible for transplantation, and those who are eligible often face long wait times with high wait-list morbidity. Durable mechanical circulatory support (MCS) may be an option for many patients. This systematic review evaluates the published literature on the use of durable MCS in teenagers and adults with congenital heart disease., Methods: A comprehensive search of MEDLINE (PubMed), EMBASE, and the Cochrane Library was performed electronically in July 2015 and updated in March 2016, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines., Results: Individual case reports and several case series identified 66 patients with ACHD treated with durable MCS. More than half were INTERMACS 1 or 2 at the time of implantation. Patients with Fontan repairs were more frequently classified as INTERMACS 1 or 2 (89% compared to 59% or less among other groups). Cases published after 2010 showed a trend toward less severe INTERMACS status, and patients were less likely to have received transplants by the time of reporting (31% compared to 61% prior). Durable MCS was implanted as bridge-to-transplant in 77%. Patients with Fontan repair accounted for 14% of cases., Conclusion: Reports of durable MCS utilization in patients with ACHD are becoming more frequent and devices are being implanted in more stable patients. Reports are mostly case reports or small case series so reporting bias is likely and prospective protocoled reporting is needed., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes >20,000 patients from >180 hospitals., Methods: The eighth annual report of INTERMACS updates the first decade of patient enrollment., Results: In the current era, >95% of implants are continuous flow devices. Overall survival continues to remain >80% at 1 year and 70% at 2 years. Review of major adverse events shows minimal advantage for patients with ambulatory heart failure pre-implant. Stroke, major infection, and continued inotrope requirement during the first 3 months have a major effect on subsequent survival., Conclusions: Greater application of durable devices to patients with ambulatory heart failure will mandate more effective neutralization or prevention of major adverse events., (Copyright © 2017 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: In Japan, ventricular assist devices (VADs) have been used for patients with severe heart failure as a bridge to transplantation (BTT) since 1992. However, it was not until 1997, when the Organ Transplant Law was enacted, that medical devices received approval by the national health insurance system for that use. To encourage research and development of innovative medical devices, the Pharmaceuticals and Medical Devices Agency has established a public-private partnership in collaboration with academic societies, hospitals and manufacturers., Methods: The Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) is a prospective registry designed to be harmonized with the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS). Participation in J-MACS is mandatory for device manufacturers to meet the conditions of approval as well as for hospitals to obtain authorization for reimbursement from the national health insurance system., Results: From June 2010 to April 2015, 476 patients were registered at 31 hospitals. Of these, analysis of primary VAD patients (n = 332) revealed that their overall 360-day survival was 91% (implantable 93%, extracorporeal 84%)., Conclusions: This initial report from J-MACS focuses on patients' demographics, device types, survival, competing outcomes, adverse events and successful examples of system failure detection., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

aVAD (ReliantHeart Inc, Houston, TX) is a new, compact, axial flow left ventricular assist device with novel features including real flow measurement, remote device monitoring, and a miniaturized pump housing. The aVAD received Conformité Européenne marking in August 2016. The use of this device was performed in a 61-year-old woman with severe heart failure. Following uneventful surgery, the patient recovered and was successfully discharged from the hospital., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial at 2 years., Background: The ROADMAP trial was a prospective nonrandomized observational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients., Methods: The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance ≥75 m., Results: Patients receiving LVAD versus OMM had lower baseline health-related quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. 84%; p = 0.012), and were predominantly INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 4 (65% vs. 34%; p < 0.001) versus profiles 5 to 7. More LVAD patients met the primary endpoint at 2 years: 30% LVAD versus 12% OMM (odds ratio: 3.2 [95% confidence interval: 1.3 to 7.7]; p = 0.012). Survival as treated on original therapy at 2 years was greater for LVAD versus OMM (70 ± 5% vs. 41 ± 5%; p < 0.001), but there was no difference in intent-to-treat survival (70 ± 5% vs. 63 ± 5%; p = 0.307). In the OMM arm, 23 of 103 (22%) received delayed LVADs (18 within 12 months; 5 from 12 to 24 months). LVAD adverse events declined after year 1 for bleeding (primarily gastrointestinal) and arrhythmias., Conclusions: Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ROADMAP]; NCT01452802)., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: This systematic review aimed to evaluate the clinical outcomes and cost-effectiveness of left ventricular assist devices (LVADs) used as bridge to transplantation (BTT), compared to orthotopic heart transplantation (OHT) without a bridge., Method: Systematic searches were performed in electronic databases with available data extracted from text and digitized figures. Meta-analysis of short and long-term term post-transplantation outcomes was performed with summation of cost-effectiveness analyses., Results: Twenty studies reported clinical outcomes of 4575 patients (1083 LVAD BTT and 3492 OHT). Five studies reported cost-effectiveness data on 837 patients (339 VAD BTT and 498 OHT). There was no difference in long-term post-transplantation survival (HR 1.24, 95% CI 1.00-1.54), acute rejection (HR 1.10, 95% CI 0.93-1.30), or chronic rejection and cardiac allograft vasculopathy (HR 0.99, 95% CI 0.73-1.36). No differences were found in 30-day post-operative mortality (OR 0.91, 95% CI 0.42-2.00), stroke (OR 1.64, 95% CI 0.43-6.27), renal failure (OR 1.43, 95% CI 0.58-3.54), bleeding (OR 1.56, 95% CI 0.78-3.13), or infection (OR 2.44, 95% CI 0.81-7.38). Three of the five studies demonstrated incremental cost-effectiveness ratios below the acceptable maximum threshold. The total cost of VAD BTT ranged from $316,078 to $1,025,500, and OHT ranged from $179,051 to $802,200., Conclusion: LVADs used as BTT did not significantly alter post-transplantation long-term survival, rejection, and post-operative morbidity. LVAD BTT may be cost-effective, particularly in medium and high-risk patients with expected prolonged waiting times, renal dysfunction, and young patients., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Background: Several studies have suggested circulating microRNAs (miRs) are associated with heart failure, but these studies were small, and limited to single miR measurements. We examined 7 miRs which were previously linked to heart failure, and tested whether their temporal expression level predicts prognosis in a prospective cohort of chronic heart failure (CHF) patients., Methods and Results: In 2011-2013, 263 CHF patients were included. At inclusion and subsequently every 3months, we measured 7miRs. The primary endpoint (PE) comprised heart failure hospitalization, cardiovascular mortality, cardiac transplantation and LVAD implantation. Associations between temporal miR patterns and the PE were investigated by joint modelling, which combines mixed models with Cox regression. Mean age was 67±13years, 72% were men and 27% NYHA classes III-IV. We obtained 873 blood samples (median 3 [IQR 2-5] per patient). The PE was reached in 41 patients (16%) during a median follow-up of 0.9 [0.6-1.4] years. The temporal pattern of miR-22-3p was independently associated with the PE (HR [95% CI] per doubling of level: 0.64 [0.47-0.77]). The instantaneous change in level (slope of the temporal miR pattern) of miR-22-3p was also independently associated with the PE (HR [95% CI] per doubling of slope: 0.33 [0.20-0.51]). These associations remained statistically significant after adjustment for temporal patterns of NT-proBNP, Troponin T and CRP., Conclusions: The temporal pattern of circulating miR-22-3p contains important prognostic and independent information in CHF patients. This concept warrants further investigation in larger series with extended follow-up., (Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Numerous cohort analyses suggest rapidly increasing use of mechanical circulatory support (MCS) as a bridge to heart transplantation (HTx), but the role of age in selection for MCS remains unknown., Methods: We assessed adult HTx in the International Society for Heart And Lung Transplantation Registry between 2005 and 2013 and we determined MCS use by recipient age group and transplant year. Multivariable logistic regression models were constructed to identify variables associated with continuous flow (CF) left ventricular assist device (LVAD) use within each age group., Results: Among 16,480 HTx recipients the percentage of overall MCS use increased from 23% to 38%, 21% to 41%, and 17% to 42% in age groups 18-39 years, 40-59 years and over 60 years, respectively. This effect was mainly due to an increase in CF LVAD use and primarily in HTx recipients aged over 60. In multivariable analyses, male gender and blood group O were significantly associated with CF LVAD use in all age groups., Conclusions: Bridge to transplant MCS use increased dramatically between 2005 and 2013 primarily due to increased use of CF LVAD and primarily in higher ages. Pre-HTx CF LVAD use was more frequent in men and blood group O., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: This study investigates the impact of left ventricular assist device (LVAD) inflow cannula angulation, pump positional change over time, and the incidence of thrombotic pump dysfunction in a large cohort of HeartMate II (HM2) patients., Methods: Patients (n = 326) who received primary HM2 LVAD between January 2008 and December 2013 at a single institution were retrospectively reviewed. Patients who underwent pump exchange (PE) for pump dysfunction, patients who had pump dysfunction (PD) but did not require pump exchange, and patients with normal LVAD pump dysfunction (NL) were compared. Pump positional change and angle of the inflow cannula with respect to the angle between inflow cannula and the LVAD body (IL angle) were measured from routine chest radiograph at postoperation, before discharge, and follow-up. Pump positional change was assessed based on pump positional differences between discharge and follow-up. Patients were also grouped by IL acute angulation (less than 65 degrees) and pump positional change., Results: There were 21, 15, and 290 patients in the PE group, PD group, and NL group, respectively. There were significant differences in IL angle between PE and NL at all timepoints: postoperation (PD 63.6 ± 12.5, NL 70.6 ± 12.3; p = 0.018), before discharge (PD 64.4 ± 12.8, NL 69.5 ± 10.5; p = 0.039), and follow-up (PD 62.6 ± 14.2, NL 67.9 ± 11.2; p = 0.002). However, the IL angle was insignificant between PE and PD groups and between PD and NL groups. Sixty-seven percent of the PE group had pump positional change as opposed to 36% of the NL group (p = 0.019). Eighty-four of 101 patients with pump positional change and 75 of 91 patients with acute angulation at postoperation did not have pump dysfunction., Conclusions: Pump positional change may contribute to LVAD dysfunction or failure, but it does not entirely account for observed pump dysfunction or failure., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Cardiogenic shock remains a clinical challenge with high mortality rate. Mechanical circulatory support (MCS) devices have become an integral component of the therapeutic armamentarium expanding the treatment options for refractory cardiogenic shock (RCS)., Methods: We included all consecutive patients with biventricular unloading with Impella-2.5 and VA-ECMO admitted for RCS between October 2013 and March 2015. Outcome data included survival to discharge, bridging to VAD and 28-day mortality., Results: A total of 17 patients were included. Mean age was 63.3±10.5 and 15 (88%) patients were male. RCS resulted from acute myocardial infarction in 14 (82%), acute myocarditis in 1 (6%) dilated cardiomyopathy in 2 (12%) patients. Mean SAPS II and SOFA score on admission was 74.7±16.86 and 11.16±1.79, respectively. Vasopressor doses and lactate levels were significantly decreased within 72h on biventricular support (p=0.025 for norepinephrine and p=0.005 for lactate). Nine (53%) patients died while on support. Of the remaining 8 patients, 5 (29%) patients were weaned successfully and discharged in cardiac rehabilitation and 3 (18%) patients were successfully bridged to VAD. All 5 patients who were discharged to rehabilitation survived at day 28 after discharge, while 1 of 3 VAD patients died after VAD implantation, corresponding to an overall 28-day survival rate of 41%., Conclusions: Biventricular support with Impella-2.5 and VA-ECMO in patients with RCS is feasible and led to significant hemodynamic improvement and reduction of lactate levels. Despite high severity scores, ICU- and 28-day mortality rates were better than predicted., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Continuous-flow left ventricular assist devices (LVADs) have become the standard of care for patients with advanced heart failure. The goal of this study was to review our 9-year institutional experience., Methods: From March 2006 through May 2015, 231 patients underwent implantation of 240 CF LVADs, HeartMate II LVAD (Thoratec Corp., Pleasanton, CA; n = 205) or HVAD (HeartWare Inc., Framingham, MA; n = 35). Of these, 127 devices (52.9%) were implanted as bridge to transplantation (BTT) and 113 (47.1%) as destination therapy (DT)., Results: Mean age was 51.2 ± 11.9 years for BTT patients and 58.2 ± 11.4 years for DT patients (p < 0.001). There was a higher incidence of preoperative diabetes, renal insufficiency, peripheral vascular disease, and previous cardiac operation in DT patients (p < 0.05). Survival was higher for BTT patients, with 1-, 6-, 12-, and 24-month survivals of 91.0%, 90.0%, 88.5%, and 72.1%, respectively, versus 85.3%, 81.1%, 75.6%, and 59.0%, respectively, for DT patients (p = 0.038). Gastrointestinal bleeding was the most common complication (29.6%), followed by right ventricular failure (22.5%) and stroke (15.0%), with a similar incidence for BTT and DT patients. Preoperative liver biopsy (hazard ratio [HR] 2.27, p = 0.036), mechanical support (HR 1.82, p = 0.025), aspartate transaminase (HR 1.07, p = 0.001), and alanine aminotransferase (HR 0.95, p = 0.024) were severe independent predictors of survival in multivariate analysis., Conclusions: These data indicate excellent survival for BTT and DT patients on long-term LVAD support. However, for LVAD therapy to become a plausible alternative to heart transplantation, we need to further decrease the incidence of postoperative complications., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Pediatric patients awaiting orthotopic heart transplantation frequently require bridge to transplantation (BTT) with mechanical circulatory support. Posttransplant survival outcomes and predictors of mortality have not been thoroughly described in the modern era using a large-scale analysis., Methods: The United Network for Organ Sharing database was reviewed to identify pediatric heart transplant recipients from 2005 through 2012. Patients were stratified into three groups: extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and direct transplantation (DTXP). The primary outcome was posttransplant survival., Results: Two thousand seven hundred seventy-seven pediatric patients underwent orthotopic heart transplantation. There were 617 patients who required BTT with mechanical circulatory support (22.2%), of whom there were 428 VAD BTT (69.4%) and 189 ECMO BTT (30.6%). An increase in VAD use was observed during the study period (p < 0.0001). Compared with DTXP, patients in the ECMO BTT group had a lower median age (<1 versus 5 years; p < 0.0001) and were significantly smaller (8 versus 14 kg; p < 0.001), whereas patients in the VAD BTT group were older (8 versus 5 years; p = 0.0002) and larger (24 versus 14 kg; p < 0.001). Actuarial survival was greater in the DTXP group compared with ECMO BTT, but similar to VAD BTT at 30 days and 1, 3, and 5 years. However, this survival difference was lost after censoring the first 4 months after transplant. In multivariable analysis, when restricted to the first 4 months of survival, independent predictors for mortality were ECMO BTT, age, diagnosis, and functional status, whereas VAD BTT was not., Conclusions: Pediatric patients with DTXP or VAD BTT have equivalent posttransplant survival. However, those requiring ECMO BTT have inferior early posttransplant survival compared with those receiving DTXP., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular assist devices (LVADs) have shown survival benefit in end-stage heart failure patients. LVAD technology has evolved considerably with the development of continuous-flow devices., Methods: The Nationwide Inpatient Sample was queried from 2005 to 2011 using International Classification of Diseases, 9th Edition procedure code 37.66, Insertion of Implantable Heart System, in any procedure field. Patients with primary diagnosis of orthotopic heart transplant or use of temporary mechanical circulatory support devices were excluded. Procedural complications were identified using International Classification of Diseases, 9th Edition codes and patient safety indicators. Cochran-Armitage and Cuzick tests for trend were used to identify time trends for categorical and continuous variables, respectively., Results: There were 2,038 LVAD implantations from 2005 to 2011. LVAD use increased from 127 procedures in 2005 to 506 procedures in 2011, and in-hospital mortality declined from 47.2% to 12.7% (p < 0.001), with sharp inflection points in the year 2008. Average length of stay decreased from 44 days in the pulsatile-flow era (2005 to 2007) to 36 days in the continuous-flow era (2008 to 2011). Cost of hospitalization increased from $194,380 in 2005 to $234,808 in 2011 but remained constant from 2008 to 2011. There was a trend of increased incidence of major bleeding and thromboembolism and decreased incidence of infectious and iatrogenic cardiac complications in the continuous-flow era., Conclusions: LVAD use has increased and in-hospital mortality and LOS after LVAD implantation have declined. These changes coincide with United States Food and Drug Administration (FDA) approval of continuous-flow devices in 2008., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The first annual report of the International Society for Heart and Lung Transplantation (ISHLT) Mechanically Assisted Circulatory Support (IMACS) registry provides global data on 5,942 patients from 31 countries. This initial report focuses on patient demographics, survival, device types, adverse events, competing outcomes, and a risk factor analysis., (Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Peak oxygen uptake (V˙O2peak) is a well-established prognostic marker in chronic heart failure (CHF). Cardiopulmonary exercise testing (CPET) provides physiological parameters other than V˙O2peak that might have prognostic value. We aimed at determining whether exercise recovery data kinetics have prognostic implications over V˙O2peak and Heart Failure Survival Score., Methods: Exercise data from 200 consecutive CHF patients evaluated for possible heart transplantation and received CPET at our institution between 2004 and 2011 were analyzed. The rate of recovery of oxygen uptake (V˙O2) at 2 minutes after exercise (V˙O2-REC2) was calculated using the difference between V˙O2peak and V˙O2 at minute 2 of recovery and expressed as a percentage of V˙O2peak. The composite primary end point was the time from CPET to the first event including death, heart transplant, or mechanical heart implantation., Results: Mean follow-up period was 1271 ± 61 days during which there were 108 first events including 35 deaths, 66 heart transplants, and 7 mechanical heart implantations. The strongest prognostic factors in the univariate analysis were V˙O2-REC2, V˙O2peak, V˙O2 efficiency slope, and ventilation to carbon dioxide excretion ratio slope (all P < 0.0001). Multivariate analysis showed that V˙O2-REC2 (P < 0.0001), ventilation to carbon dioxide excretion ratio slope (P = 0.0022), use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (P = 0.0042), presence of a defibrillator (P = 0.0127), and mean arterial pressure (P = 0.0151) were independent predictors of event-free survival time., Conclusions: V˙O2-REC2 was the strongest prognostic marker of death, heart transplantation, and mechanical heart implantation in severe CHF. This finding should be confirmed prospectively., (Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: We examined whether characteristics, implant strategy, and outcomes in patients who receive continuous-flow left ventricular assist devices (CF-LVAD) differ across geographic regions in the United States., Methods: A total of 7,404 CF-LVAD patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) from 134 participating institutions were analyzed from 4 distinct regions: Northeast, 2,605 (35%); Midwest, 2,210 (30%); West, 973 (13%); and South, 1,616 (22%)., Results: At baseline, patients in the Northeast and South were more likely to have INTERMACS risk profiles 1 and 2. A bridge-to-transplant (BTT) strategy was more common in the Northeast (31.7%; West, 18.5%; South, 26.9%; Midwest, 25.5%; p < 0.0001). In contrast, destination therapy (DT) was more likely in the South (40.6%; Northeast, 32.3%; Midwest, 27.3%; West, 27.3%; p < 0.0001). Although all regions showed a high 1-year survival rate, some regional differences in long-term mortality were observed. Notably, survival beyond 1 year after LVAD implant was significantly lower in the South. However, when stratified by device strategy, no significant differences in survival for BTT or DT patients were found among the regions. Finally, with the exception of right ventricular failure, which was more common in the South, no other significant differences in causes of death were observed among the regions., Conclusions: Regional differences in clinical profile and LVAD strategy exist in the United States. Despite an overall high survival rate at 1 year, differences in mortality among the regions were noted. The lower survival rate in the South may be attributed to patient characteristics and higher use of LVAD as DT., (Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation., Methods: We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712., Findings: Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events., Interpretation: Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study., Funding: TransMedics., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Biventricular assist device (BiVAD) support was a strong predictor of early mortality in the Berlin Heart EXCOR Pediatric investigational device exemption (IDE) study (Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device [VAD]). In adults, it has been identified that 5% to 10% of the VAD population is benefited by BiVAD support over left ventricular assist device (LVAD) support. An analysis of the Berlin Heart study cohort was performed to characterize patients supported with BiVAD, examine risk factors of mortality in this group, and identify subsets of patients in whom BiVAD is associated with survival., Methods: All EXCOR Pediatric devices (Berlin Heart, Inc, The Woodlands, TX) placed in North America between May 2007 and December 2010 comprised the study cohort of 204 patients (128 [63%] LVADs and 76 [37%] BiVADs). The following patient cohorts were analyzed to determine the effect of BiVAD use on survival: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 patients, patients with abnormal bilirubin levels, patients who received previous extracorporeal membrane oxygenation (ECMO), and patients with a 10-mL pump size., Results: There were more patients with BiVADs in INTERMACS profile 1 (63% compared with 46%; p = 0.018). The incidence of major bleeding, neurologic and renal dysfunction, and infection was similar between BiVAD and LVAD groups. White race, abnormal glomerular filtration rate (GFR), sites with experience of less than 5 implantations, and use of 10-mL pumps were predictors of mortality in patients who received BiVADs. BiVADs were not associated with improved survival in any patient cohort; however, they were associated with increased mortality in patients who had undergone ECMO before receiving a VAD., Conclusions: BiVAD support was not associated with improved survival in any identified subset of patients. Although not randomized, these results (which were corrected for multiple possible risk factors) suggest that some children supported with BiVADs might have done better with LVADs alone. Further prospective studies will be needed to identify patient cohorts that will be better served with BIVAD support., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: We sought to evaluate the impact of the evolution of a pediatric mechanical circulatory support (MCS) program on outcomes of children listed for heart transplantation at our institution., Methods: All patients listed for isolated heart transplantation from 1995 to 2013 were included. The use of MCS while on the wait-list was recorded. Wait-list and posttransplant outcomes were compared before and after 2005, which was when we became capable of providing long-term MCS without size limitation., Results: In total, 259 patients were listed for transplant and 201 (78%) reached transplant. The use of MCS was significantly increased between the eras (13% and 37%, p = 0.0001). Wait-list mortality was significantly decreased (25% and 11%, p = 0.0006). Among transplant recipients, the proportion of patients who underwent MCS was significantly increased (13% and 37%, p = 0.0002). Of these MCS patients, the use of long-term devices was significantly increased (50% and 98%, p = 0.0004). Median duration of MCS was significantly increased (12 and 78 days, p = 0.004). Kaplan-Meier estimates showed a trend (p = 0.08) toward improved survival after bridge-to-transplant both at 1 year (70% in the early era and 88% in the late era) and at 5 years (60% and 78%, respectively)., Conclusions: Outcomes of pediatric heart transplantation have significantly improved over the last 2 decades. We believe such improvement is, at least in part, attributable to maturation of MCS strategy, characterized by avoiding the use of temporary devices such as extracorporeal membrane oxygenation as a bridge-to-transplant and a more aggressive use of long-term devices., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Human immunodeficiency virus (HIV) infection has evolved from a highly stigmatized disease with certain progression to acquired immunodeficiency syndrome (AIDS) to a chronic disease affecting over 1 million Americans. With the success of current anti-retroviral therapies, cardiovascular disease, including advanced heart failure (HF), will be a major cause of morbidity and mortality in this population., Methods: A survey concerning heart transplantation (HT) and left ventricular assist device (LVAD) implantation attitudes and outcomes in HIV-infected patients was distributed to 103 American and 9 Canadian HT centers via fax, e-mail or telephone., Results: Eighty-nine centers (79%) responded. Eighteen HTs were performed in HIV(+) patients with 1-, 2- and 5-year survival of 100%, 100% and 63%, respectively. Eighty-two centers (92%) have never performed HT in HIV(+) patients and 51 centers (57%) marked HIV(+) status as a contraindication. Rationales for contraindication included: (1) high-risk patients should be avoided given the scarcity of organ supply (59%); (2) immunosuppression required for HT may induce progression to AIDS (51%); and (3) drug interactions may worsen patients' clinical outcomes (49%). Thirty-five left ventricular assist device (LVAD) implantations in HIV(+) patients were reported. Sixty-eight centers (76%) have never implanted an LVAD in an HIV(+) patient and 21 centers (20%) marked HIV(+) status as a contraindication, of which 61% indicated concern for device-related infection., Conclusions: Most centers either explicitly consider HIV(+) status as a contraindication for or have never treated HIV(+) patients with advanced HF therapy. Our findings suggest unequal access to care and underscore the need to educate cardiovascular health-care providers on progress made with HIV therapies., (Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Due to the availability of new devices, the use of ventricular assist devices (VADs) in children has been increasing; however, patient selection and optimal timing of device implantation in this population remains uncertain., Methods: A retrospective review of the United Network for Organ Sharing dataset identified 5,200 listings without mechanical circulatory support (MCS) for isolated pediatric heart transplant, 1995 to 2012. Patients were randomly divided into a derivation and validation cohort. A multivariable logistic regression model predicting the likelihood of death or need for MCS within 60 days was built using the derivation cohort and tested in the validation cohort. A simplified score (PedsMCS score) was developed and evaluated for accuracy., Results: The predictive model consisted of variables present at listing (age, albumin level, creatinine clearance, serum bilirubin, mechanical ventilation, and inotropic support). It had good predictive ability (C statistic 0.7304) within the validation cohort. The simplified PedsMCS score was also predictive (C statistic 0.7217) and there was a strong correlation between predicted and expected outcomes (r=0.91, p<0.0001). Patients with PedsMCS score 16 or greater had a significantly higher risk of death or MCS within 2 months (36.6%) than those with low scores (<6) (1.5%, p<0.0001). A single point increase in PedsMCS score was associated with a 16.7% increase in the risk of death or MCS with 2 months (p<0.0001)., Conclusions: We have developed and validated a simplified score to predict the need for MCS based on risk factors present at listing. This will provide more accurate prognostication in children awaiting heart transplant, and may improve patient selection., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The aim of this study was to evaluate the prevalence of early pump power elevation events in patients with the HeartMate II (HMII) and its impact on subsequent development of stroke and pump thrombosis., Methods: We analyzed >45,000 measurements of pump power and pump speed measured during the initial hospitalization period and >12,000 follow-up measurements obtained from 138 consecutive patients implanted with a HMII between January 2009 and December 2012. An early power elevation (PEL) event was defined as power ≥10 W within the first 14 post-operative days. Patients were divided into two groups: those with an early PEL event and those without (NP)., Results: Median follow-up duration was 316 (range 2 to 1,264) days. Twenty-seven (20%) patients had early PEL events that lasted for a total duration of 4 (range 1 to 77) hours per patient. Pump speed averaged 9,400 rpm in both groups. Although patients in the PEL group had higher median power (7.1 [6.0 to 9.9] W vs 6.7 [5.7 to 7.8] W, p < 0.001) in the immediate post-operative period, there was no difference between the two groups noted at first follow-up (6.6 [5.9 to 8.7] W vs 6.7 [5.5 to 7.7] W, p = 0.940). No differences in the prevalence of hemorrhagic stroke (4% vs 3%, p = 0.56), ischemic stroke (0% vs 4%, p = 0.41), hemolysis (7% vs 5%, p = 0.32), pump thrombosis (7% vs 4%, p = 0.21) or survival (76% at 1 year in both groups) were found between the two groups., Conclusions: In this single-center experience, PEL events that occurred early all resolved by discharge. No relationship was found between early PEL events and subsequent development of pump thrombosis, hemorrhagic stroke or ischemic stroke., (Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study examined the prognostic significance of pre- and post-capillary components of pulmonary hypertension (PH) in patients receiving cardiac resynchronization therapy (CRT)., Background: PH is common in patients with left ventricular systolic dysfunction (LVSD) receiving CRT. The impact of PH subtype on clinical outcome in CRT is unknown., Methods: The study population consisted of 101 patients (average age 66 ± 13 years, left ventricular ejection fraction 0.23 ± 0.07, and New York Heart Association functional class 3.2 ± 0.4) who underwent right heart catheterization in the 6 months before CRT. PH was defined as a mean pulmonary artery pressure ≥25 mm Hg; a significant pre-capillary contribution to elevated mean pulmonary artery pressure was defined as a transpulmonary gradient (TPG) ≥12 mm Hg. Clinical endpoints were assessed at 2 years and included all-cause mortality and a composite of death, left ventricular assist device, or cardiac transplantation., Results: Patients with TPG ≥12 mm Hg were more likely to experience all-cause mortality (hazard ratio [HR]: 3.2; 95% confidence interval [CI]: 1.3 to 7.4; p = 0.009) and the composite outcome (HR: 3.0; 95% CI: 1.4 to 6.3; p = 0.004) compared with patients with TPG <12 mm Hg. After multivariate adjustment for hemodynamic, clinical, and echocardiographic variables, only TPG ≥12 mm Hg and baseline right ventricular (RV) dilation (RV end-diastolic dimension >42 mm) were associated with the composite clinical outcome (p = 0.05 and p = 0.04, respectively)., Conclusions: High TPG PH and RV dilation are independent predictors of adverse outcomes in patients with LVSD who are receiving CRT. RV pulmonary vascular dysfunction may be a therapeutic target in select patients receiving CRT., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The EVAHEART left ventricular assist device was approved in 2010 by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for bridge to heart transplantation (BTT). However, its effectiveness has not been evaluated since approval. In this study we evaluated the EVAHEART device in a commercial setting in Japan., Methods: Ninety-six consecutive patients enrolled in the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS), who were listed for transplant or likely to be listed and who received an EVAHEART device, were enrolled from 2011 to 2013 at 14 Japanese centers. Patients' survival rates, adverse events and quality-of-life data were obtained from the J-MACS Registry., Results: Patients' median age was 43 years (85% male). The Interagency Registry for Mechanically Assisted Circulatory Support profiles revealed 12 patients in Level 1, 45 in Level 2, 37 in Level 3 and 1 in Level 4. The mean support duration was 384.7 days, with a cumulative duration of 101.2 years. The Kaplan-Meier survival rate during support was 93.4% at 6 months, 87.4% at 1 year and 87.4% at 2 years. Seventy-seven patients (80.2%) currently remain on support, 7 received a transplant and 10 died during support. Major adverse events included drive-line infection (14.6%) and neurologic events such as ischemic stroke (17.7%), hemorrhage (13.5%), transient ischemic attack (3.1%), pump thrombosis (1%) and hemolysis (1%). There was no gastrointestinal (GI) bleeding or right heart failure requiring right ventricular assist device (RVAD). There was no pump exchange due to mechanical failure., Conclusions: The EVAHEART device provides safe, reliable and long-term circulatory support with improved survival in commercial settings of BTT in Japan, where the transplant waiting period is much longer. Incidences of GI bleeding, hemolysis, right ventricular failure, device thrombosis and mechanical failure were extremely rare in patients on EVAHEART devices., (Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

The sixth annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 8 years of patient enrollment. The analysis is based on data from >10,000 patients and updates demographics, survival, adverse events and risk factors. Among patients with continuous-flow pumps, actuarial survival continues to be 80% at 1 year and 70% at 2 years. The report features a comparison of two eras of continuous-flow durable devices in the USA in terms of device strategy, patient profiles, adverse event burden, survival and quality of life., (Copyright © 2014 International Society for Heart and Lung Transplantation. All rights reserved.)