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Background: Reduced arterial pulsatility in continuous-flow left ventricular assist devices (CF-LVAD) patients has been implicated in clinical complications. Consequently, recent improvements in clinical outcomes have been attributed to the "artificial pulse" technology inherent to the HeartMate3 (HM3) LVAD. However, the effect of the "artificial pulse" on arterial flow, transmission of pulsatility into the microcirculation and its association with LVAD pump parameters is not known., Methods: The local flow oscillation (pulsatility index, PI) of common carotid arteries (CCAs), middle cerebral arteries (MCAs) and central retinal arteries (CRAs-representing the microcirculation) were quantified by 2D-aligned, angle-corrected Doppler ultrasound in 148 participants: healthy controls, n = 32; heart failure (HF), n = 43; HeartMate II (HMII), n = 32; HM3, n = 41., Results: In HM3 patients, 2D-Doppler PI in beats with "artificial pulse" and beats with "continuous-flow" was similar to that of HMII patients across the macro- and microcirculation. Additionally, peak systolic velocity did not differ between HM3 and HMII patients. Transmission of PI into the microcirculation was higher in both HM3 (during the beats with "artificial pulse") and in HMII patients compared with HF patients. LVAD pump speed was inversely associated with microvascular PI in HMII and HM3 (HMII, r 2  = 0.51, p < 0.0001; HM3 "continuous-flow," r 2  = 0.32, p = 0.0009; HM3 "artificial pulse," r 2  = 0.23, p = 0.007), while LVAD pump PI was only associated with microcirculatory PI in HMII patients., Conclusions: The "artificial pulse" of the HM3 is detectable in the macro- and microcirculation but without creating a significant alteration in PI compared with HMII patients. Increased transmission of pulsatility and the association between pump speed and PI in the microcirculation indicate that the future clinical care of HM3 patients may involve individualized pump settings according to the microcirculatory PI in specific end-organs., (Copyright © 2023 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: The 2018 U.S. heart allocation system offers an accelerated pathway for heart transplantation to the most urgent patients., Objectives: This study sought to determine whether the new allocation system resulted in lower likelihood of candidate recovery., Methods: Adult patients waitlisted for heart transplantation with temporary mechanical circulatory support at the time of initial listing between 2010 and 2020 in the United Network for Organ Sharing registry were included. Competing events of heart transplantation, waitlist death or delisting for deteriorating condition, and delisting for improved condition (candidate recovery) were analyzed in the new vs old heart allocation system., Results: A total of 688 patients were waitlisted with venoarterial extracorporeal membrane oxygenation or a surgical nondischargeable biventricular assist device (status 1 or old 1A). Overall, 2,237 patients were waitlisted with an intra-aortic balloon pump, a percutaneous left ventricular assist device (LVAD), or a surgical nondischargeable LVAD (status 2 or old 1A). Patients waitlisted with venoarterial extracorporeal membrane oxygenation or a nondischargeable biventricular assist device had significantly shorter median waitlist times (5 vs 31 days), higher incidence for cardiac transplantation (81.5% vs 43.0%), and lower incidence of candidate recovery (1.5% vs 7.9%) in the new vs old heart allocation system (all P < 0.05). Patients waitlisted with an intra-aortic balloon pump or percutaneous or a nondischargeable LVAD also had significantly shorter median waitlist times (8 vs 35 days), higher incidence of transplantation (88.9% vs 64.9%), and lower incidence of candidate recovery (0.2% vs 1.6%) in the new vs old heart allocation system (all P < 0.05)., Conclusions: Current practice of the new allocation system may not offer select temporary mechanical circulatory support patients the opportunity and adequate time to recover to the point of waitlist removal. Further research will determine which patients would benefit from urgent transplantation vs recovery strategy., Competing Interests: Funding Support and Author Disclosures Dr Topkara has been supported by NIH K08 HL146964. Dr Sayer has received consulting fees from Abbott Laboratories. Dr Clerkin has been supported by NIH K23 HL148528. Dr Wever-Pinzon has been supported by NIH K23 HL150322. Dr Burkhoff has received institutional educational grant support from Abiomed; and has received consulting fees from CardioDyme Inc and from Abbott Laboratories unrelated to mechanical circulatory assist. Dr Uriel has received consulting fees from Leviticus and LiveMetric. Dr Drakos is supported by the American Heart Association Heart Failure Strategically Focused Research Network (16SFRN29020000), NIH R01 HL135121, NIH R01 HL132067, Merit Review Award I01 CX0002291 (U.S. Department of Veterans Affairs), and Nora Eccles Treadwell Foundation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There is a paucity of data on depression, anxiety and post-traumatic stress disorder after left ventricular assist device (LVAD) implantation. We designed an observational study to integrate these with functional capacity and health-related quality of life (HR-QOL) in surviving LVAD patients., Methods and Results: Consenting patients between 1 month and 9 years after LVAD implantation (n = 121) were screened for functional capacity (World Health Organization Disability Assessment Schedule 2.0 [WHODAS 2.0)]); HR-QOL (European Quality of Life [EQ-5D] and Visual Assessment Scales [EQ-VAS]), depression (Patient Health Questionnaire [PHQ-9], anxiety (Generalized Anxiety Disorder Scale [GAD-7]) and post-traumatic stress disorder (Impact of Event Scale Revised [IES-R]). Of the 94% of patients who consented, 34.7% reported impaired functional capacity (WHODAS 2.0 score of ≥25%), 23.1%-34.7% HR-QOL problems (domain EQ-5D of ≥3), 10.7% "poor health" (EQ-VAS of ≤40), 14.9% depression (PHQ-9 of >14), 11.7% suicidal ideation and 17.5% anxiety (GAD-7 of >10). Among these patients, 23.5% had a positive screen for post-traumatic stress disorder (IES-R of ≥24). An EQ-VAS of 80 or greater predicted good functional capacity (P < .001)., Conclusions: One-third of discharged LVAD patients reported impaired function, HR-QOL, and psychological issues. A standardized evaluation before and after LVAD implantation could facilitate psychologic prehabilitation, inform decision-making, and identify indications for mental health intervention., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Heart failure predisposes to intracardiac thrombus (ICT) formation. There are limited data on the prevalence and impact of preexisting ICT on postoperative outcomes in left ventricular assist device patients. We examined the risk for stroke and death in this patient population., Methods and Results: We retrospectively studied patients who were implanted with HeartMate (HM) II or HM3 between February 2009 and March 2019. Preoperative transthoracic echocardiograms, intraoperative transesophageal echocardiograms and operative reports were reviewed to identify ICT. There were 525 patients with a left ventricular assist device (median age 60.6 years, 81.8% male, 372 HMII and 151 HM3) included in this analysis. An ICT was identified in 44 patients (8.4%). During the follow-up, 43 patients experienced a stroke and 55 died. After multivariable adjustment, presence of ICT increased the risk for the composite of stroke or death at 6-month (hazard ratio [HR] 1.82, 95% confidence interval [CI] 1.00-3.33, P = .049). Patients with ICT were also at higher risk for stroke (HR 2.45, 95% CI 1.14-5.28, P = .021) and death (HR 2.36, 95% CI 1.17-4.79 P = .016) at 6 months of follow-up., Conclusions: The presence of ICT is an independent predictor of stroke and death at 6 months after left ventricular assist device implantation. Additional studies are needed to help risk stratify and optimize the perioperative management of this patient population., (Copyright © 2021 Elsevier Inc. All rights reserved.)

CRP is an established inflammatory biomarker with prognostic value in patients with chronic heart failure, yet its role in continuous-flow left ventricular assist device (LVAD) patients is largely unknown. 5,183 patients from the INTERMACS registry who underwent durable LVAD between 2008 and 2017 and had preimplant CRP levels were included. The sample was stratified into two groups based on preimplant CRP levels: CRP of 0-10 mg/L (low) and >10 mg/L (high). Kaplan-Meier survival estimates were used to assess outcomes at 2 years after LVAD implantation, with log-rank testing used to compare groups. Cox proportional hazard models were used for multivariable adjustment. Patients with high preimplant CRP were younger, more likely to be INTERMACS class I, and had a higher need for temporary mechanical circulatory support before LVAD implant compared to those with lower CRP levels (all P < 0.001). The high CRP group had higher WBC counts and BNP levels (all P < 0.001). After adjustment, higher CRP (>10 mg/L) was associated with greater risk of mortality, RV failure, and stroke postimplant (P < 0.001). In addition, elevated postimplant CRP level at 3 months was associated with increased mortality and stroke on LVAD support (P < 0.001). CRP is a predictor of death and complications on LVAD support. Future studies are necessary to explore the mechanisms underlying this finding and the potential role of antiinflammatory therapies in this population., Competing Interests: Disclosures: The authors have no conflicts of interest to report., (Copyright © ASAIO 2021.)

Background: While rates of stroke have declined with the HeartMate3 (HM3) continuous- flow (CF) left ventricular assist device (LVAD), the impact of non-pulsatile flow and artificial pulse physiology on cerebrovascular function is not known. We hypothesized that improved hemodynamics and artificial pulse physiology of HM3 patients would augment cerebrovascular metabolic reactivity (CVR) compared with HeartMate II (HMII) CF-LVAD and heart failure (HF) patients., Methods: Mean, peak systolic and diastolic flow velocities (MFV, PSV, MinFV, respectively) and cerebral pulsatility index were determined in the middle cerebral artery (MCA) before and after a 30 sec breath-hold challenge in 90 participants: 24 healthy controls; 30 HF, 15 HMII, and 21 HM3 patients., Results: In HM3 patients, breath-holding increased MFV (Δ8 ± 10 cm/sec, p < .0001 vs baseline) to levels similar to HF patients (Δ9 ± 8 cm/sec, p > .05), higher than HMII patients (Δ2 ± 8 cm/sec, p < .01) but lower than healthy controls (Δ13 ± 7 cm/sec, p < .05). CF-LVAD altered the proportion of systolic and diastolic flow responses as reflected by a differential cerebral pulsatility index (p = .03). Baseline MFV was not related to CVR (r 2  = 0.0008, p = .81). However, CF-LVAD pump speed was strongly inversely associated with CVR in HM II (r 2  = 0.51, p = .003) but not HM3 patients (r 2  = 0.01, p = .65)., Conclusions: Compared with HMII, HM3 patients have a significantly improved CVR. However, CVR remains lower in HM3 and HF patients than in healthy controls, therefore suggesting that changes in cerebral hemodynamics are not reversed by CF-LVAD therapy. Further research on the mechanisms and the long-term impact of altered cerebral hemodynamics in this unique patient population are warranted., (Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: In the general population, increased aortic stiffness is associated with an increased risk of cardiovascular events. Previous studies have demonstrated an increase in aortic stiffness in patients with a continuous flow left ventricular assist device (CF-LVAD). However, the association between aortic stiffness and common adverse events is unknown., Methods and Results: Forty patients with a HeartMate II (HMII) (51 $ 11 years; 20% female; 25% ischemic) implanted between January 2011 and September 2017 were included. Two-dimensional transthoracic echocardiograms of the ascending aorta, obtained before HMII placement and early after heart transplant, were analyzed to calculate the aortic stiffness index (AO-SI). The study cohort was divided into patients who had an increased vs decreased AO-SI after LVAD support. A composite outcome of gastrointestinal bleeding, stroke, and pump thrombosis was defined as the primary end point and compared between the groups. While median AO-SI increased significantly after HMII support (AO-SI 4.4-6.5, P = .012), 16 patients had a lower AO-SI. Patients with increased (n = 24) AO-SI had a significantly higher rate of the composite end point (58% vs 12%, odds ratio 9.8, P < .01). Similarly, those with increased AO-SI tended to be on LVAD support for a longer duration, had higher LVAD speed and reduced use of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers., Conclusions: Increased aortic stiffness in patients with a HMII is associated with a significantly higher rates of adverse events. Further studies are warranted to determine the causality between aortic stiffness and adverse events, as well as the effect of neurohormonal modulation on the conduit vasculature in patients with a CF-LVAD., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to compare outcomes between patients on extracorporeal membrane oxygenation (ECMO) bridged to left ventricular assist device (LVAD) versus heart transplantation (HT) using registry data., Background: Patients with heart failure supported with ECMO represent the highest priority in the new HT allocation system. For patients on ECMO, bridging to LVAD may be non-inferior compared with bridging to HT., Methods: Adult patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) from 2006 to 2017 and United Network for Organ Sharing (UNOS) database from 2006 to June 2019 requiring ECMO were included. Cause-specific hazard models were created and cumulative incidence functions were calculated with mortality, transplantation, and re-transplantation as competing events., Results: A total of 906 patients received ECMO as bridge to VAD (n = 587, 64.8%) or as bridge to HT (n = 319, 35.2%). Patients bridged directly to HT were younger (age 46.3 ± 15.4 years vs. 52.1 ± 13.2 years; p < 0.001) and more likely to be female (93 [29.2%] vs. 139 [23.7%]; p = 0.022). Patients bridged directly to HT were more likely to have a nonischemic cardiomyopathy, restrictive physiologies, and allograft failure; (p < 0.05 for all). ECMO use increased over time in both UNOS and INTERMACS. There was no significant difference in mortality between groups (Gray's p = 0.581). This remained true even when the analysis was restricted to transplant-listed or eligible patients as well as patients with dilated phenotypes (excluding patients with congenital heart disease, restrictive phenotypes, and allograft failure)., Conclusions: There was no difference in mortality on pump support compared with posttransplant mortality among those bridged from ECMO to LVAD or HT., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Only a subset of patients with hypertrophic cardiomyopathy (HCM) develop adverse cardiac events - e.g., end-stage heart failure, cardiovascular death. Current risk stratification methods are imperfect, limiting identification of high-risk patients with HCM. Our aim was to improve the prediction of adverse cardiac events in patients with HCM using machine learning methods., Methods: We applied modern machine learning methods to a prospective cohort of adults with HCM. The outcome was a composite of death due to heart failure, heart transplant, and sudden death. As the reference model, we constructed logistic regression model using known predictors. We determined 20 predictive characteristics based on random forest classification and a priori knowledge, and developed 4 machine learning models. Results Of 183 patients in the cohort, the mean age was 53 (SD = 17) years and 45% were female. During the median follow-up of 2.2 years (interquartile range, 0.6-3.8), 33 subjects (18%) developed an outcome event, the majority of which (85%) was heart transplant. The predictive accuracy of the reference model was 73% (sensitivity 76%, specificity 72%) while that of the machine learning model was 85% (e.g., sensitivity 88%, specificity 84% with elastic net regression). All 4 machine learning models significantly outperformed the reference model - e.g., area under the receiver-operating-characteristic curve 0.79 with the reference model vs. 0.93 with elastic net regression (p < 0.001)., Conclusions: Compared with conventional risk stratification, the machine learning models demonstrated a superior ability to predict adverse cardiac events. These modern machine learning methods may enhance identification of high-risk HCM subpopulations., Competing Interests: Declaration of competing interest No author has a relationship with industry to disclose., (Copyright © 2020. Published by Elsevier B.V.)

Background: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used as a life-saving therapy for patients with cardiovascular collapse, but identifying patients unlikely to benefit remains a challenge., Methods and Results: We created the RESCUE registry, a retrospective, observational registry of adult patients treated with VA-ECMO between January 2007 and June 2017 at 3 high-volume centers (Columbia University, Duke University, and Washington University) to describe short-term patient outcomes. In 723 patients treated with VA-ECMO, the most common indications for deployment were postcardiotomy shock (31%), cardiomyopathy (including acute heart failure) (26%), and myocardial infarction (17%). Patients frequently suffered in-hospital complications, including acute renal dysfunction (45%), major bleeding (41%), and infection (33%). Only 40% of patients (n = 290) survived to discharge, with a minority receiving durable cardiac support (left ventricular assist device [n = 48] or heart transplantation [n = 7]). Multivariable regression analysis identified risk factors for mortality on ECMO as older age (odds ratio [OR], 1.26; 95% confidence interval [CI], 1.12-1.42) and female sex (OR, 1.44; 95% CI, 1.02-2.02) and risk factors for mortality after decannulation as higher body mass index (OR 1.17; 95% CI, 1.01-1.35) and major bleeding while on ECMO support (OR, 1.92; 95% CI, 1.23-2.99)., Conclusions: Despite contemporary care at high-volume centers, patients treated with VA-ECMO continue to have significant in-hospital morbidity and mortality. The optimization of outcomes will require refinements in patient selection and improvement of care delivery., Competing Interests: Declaration of competing interest Dr Loungani receives research support from Pfizer and Boston Scientific. Dr Fudim serves as a consultant for AxonTherapies and Daxor. Dr Samsky is supported by a National Institutes of Health T32 training grant (grant HL069749), and receives research support from Boston Scientific. Dr DeVore receives research funding from the American Heart Association, Amgen, Bayer, Intra-Cellular Therapies, Luitpold Pharmaceuticals, the NHLBI, Novartis, and PCORI. He also provides consulting services for Amgen, AstraZeneca, Bayer, InnaMed, LivaNova, Mardil Medical, Novartis, Procyrion, scPharmaceuticals, and Zoll. He has also received personal fees from Abbott. All other authors report no relevant disclosures., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Vasoplegia is a frequent complication of left ventricular assist device (LVAD) implantation. We investigated the effectiveness of methylene blue (MB) for vasoplegia in LVAD recipients., Methods: Twenty-seven patients received MB for vasoplegia after LVAD implantation and met study criteria between March 2015 and May 2018. Propensity score inverse probability weighting identified 41 controls who did not receive MB for post-LVAD vasoplegia. Clinical outcomes were compared between control and MB groups and between patients who received doses during (n = 15) and after surgery (n = 12). Hemodynamics and vasopressor requirements were analyzed using analysis of covariance., Results: Median total MB dose was 1.9 mg/kg (interquartile range, 1.2-2.2 mg/kg). Methylene blue recipients experienced a transient initial decline in norepinephrine requirement from 141 ng/kg per min (95% confidence interval [CI], 81-201 ng/kg per min) to 117 ng/kg per min (95% CI, 58-176 ng/kg per min; P = .022) and a delayed decline in vasopressin from 4.8 U/h (95% CI, 3.8-5.8 U/h) to 4.0 U/h (95% CI, 2.8-5.1 U/h) (P = .004). In-hospital mortality, postoperative complications, and end-organ dysfunction did not differ from those of controls. There were no observed differences in mean arterial pressure, vasopressor requirements, or outcomes between patients who received doses during or after surgery. Weighted overall mortality in the entire study cohort was 8.8%., Conclusions: Although MB may affect vasopressor requirements, clinical outcomes in vasoplegia after LVAD implantation did not improve and were not affected by the timing of administration., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background Functional tricuspid regurgitation (TR) can occur secondary to atrial fibrillation (AF). The impact of AF on functional TR and cardiovascular events is uncertain in patients with left ventricular assist devices. This study aimed to investigate the effect of AF on functional TR and cardiovascular events in patients with a HeartMate 3 left ventricular assist device. Methods and Results We retrospectively reviewed 133 patients who underwent HeartMate 3 implantation at our center between November 2014 and November 2018. We excluded patients who had undergone previous or concomitant tricuspid valve procedures and those whose echocardiographic images were of insufficient quality. The primary end point was death and the presence of a cardiovascular event at 1 year. We defined cardiovascular event as a composite of death, stroke, and hospital readmission due to recurrent heart failure and significant residual TR as vena contracta width ≥3 mm. In total, 110 patients were included in this analysis. Patients were divided into 3 groups: no AF (n=51), paroxysmal AF (n=40), and persistent AF (PeAF) (n=19). Kaplan-Meier analysis showed that patients with PeAF had the worst survival (no AF 98%, paroxysmal AF 98%, PeAF 84%, log-rank P =0.038) and event-free rate (no AF 93%, paroxysmal AF 89%, PeAF 72%, log-rank P =0.048) at 1 year. Thirty-one (28%) patients had residual TR 1 month after left ventricular assist device implantation. Patients with residual TR had a significantly poor prognosis compared with those without residual TR (log-rank P =0.014). Conclusions PeAF was associated with increased mortality, cardiovascular events, and residual TR compared with no AF and paroxysmal AF.

Background: Functional mitral regurgitation (MR) (FMR) and atrial fibrillation (AF) are common in patients undergoing left ventricular assist device (LVAD) implantation. However, the impact of FMR and AF on clinical outcomes is uncertain. This study aimed to investigate the characteristics and prognostic significance of FMR and AF in patients with LVADs., Methods: We retrospectively reviewed all patients who underwent LVAD implantation at our center between January 2010 and December 2017. We defined significant FMR as the ratio of MR color jet area to left atrial area of >20% and persistent or permanent AF (PeAF) as persistent or permanent AF at LVAD implantation., Results: A total of 380 patients were included in this analysis. Patients were divided into 6 groups: patients with no PeAF and no significant FMR (Group 1), patients with no PeAF but with significant FMR (Group 2), patients with PeAF but no significant FMR (Group 3), patients with PeAF and significant FMR (Group 4), patients with concomitant mitral valve surgery (MVS) at LVAD implantation and without PeAF (Group 5), and patients with concomitant MVS and with PeAF (Group 6). A total of 56 patients (15%) died within 2 years. Kaplan-Meier curve analysis demonstrated a 2-year survival of 81% in Group 1, 89% in Group 2, 87% in Group 3, 47% in Group 4, 87% in Group 5, and 79 % in Group 6 (log-rank test, p < 0.001). The multivariable Cox proportional-hazards model showed that classification in Group 4 was an independent predictor of mortality (hazard ratio, 4.31; 95% CI: 2.19-8.46; p < 0.001)., Conclusions: The coexistence of significant FMR and PeAF may represent a poor prognostic marker in patients undergoing LVAD implantation., (Copyright © 2020 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Context: Palliative care consultation before left ventricular assist device (LVAD) surgery (PreVAD) has been recommended, but its impact on goal-concordant care is unknown., Objectives: To describe the association between patients' unique unacceptable condition articulated during PreVAD with the actual care provided at the end of life., Methods: Among 308 patients who had PreVAD between 2014 and 2019, 72 patients died before December 31, 2019. Based on the answers to the question, "Is there any condition you would find unacceptable?" patients were divided into ARTICULATE (those who could articulate their unacceptable condition clearly, n = 58) and non-ARTICULATE (those who could not, n = 14). Circumstances at death and end-of-life care were compared between groups., Results: Mean age at death was 63.2 years (SD ±13.1), 56 patients (77.8%) were males, and median duration of LVAD was 167.5 days (interquartile range 682). ARTICULATE patients died less frequently in the intensive care unit than non-ARTICULATE patients (33 patients, 57.9% vs. 13 patients, 92.9%; P = 0.014) and had ethics consultation less frequently (four patients, 6.9% vs. five patients, 35.7%; P = 0.011). Frequency of LVAD withdrawal was similar in both groups. Among ARTICULATE cohort, the unacceptable condition articulated in PreVAD did not seem to influence decisions at the end of life., Conclusion: Patients who articulated their unacceptable condition clearly before LVAD surgery had less frequent ethics consultations and received less intensive care at the end of life, but it did not seem to affect the decision of LVAD withdrawal. It may be more important to engage in discussions around their unacceptable conditions, rather than the specific condition articulated. The question of an unacceptable condition should be part of any routine palliative care consultation before LVAD surgery., (Copyright © 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Gut microbial imbalance may contribute to endotoxemia, inflammation, and oxidative stress in heart failure (HF). Changes occurring in the intestinal microbiota and inflammatory/oxidative milieu during HF progression and following left ventricular assist device (LVAD) or heart transplantation (HT) are unknown. We aimed to investigate variation in gut microbiota and circulating biomarkers of endotoxemia, inflammation, and oxidative stress in patients with HF (New York Heart Association, Class I-IV), LVAD, and HT., Methods: We enrolled 452 patients. Biomarkers of endotoxemia (lipopolysaccharide and soluble [sCD14]), inflammation (C-reactive protein, interleukin-6, tumor necrosis factor-α, and endothelin-1 adiponectin), and oxidative stress (isoprostane) were measured in 644 blood samples. A total of 304 stool samples were analyzed using 16S rRNA sequencing., Results: Gut microbial community measures of alpha diversity were progressively lower across worsening HF class and were similarly reduced in patients with LVAD and HT (p < 0.05). Inflammation and oxidative stress were elevated in patients with Class IV HF vs all other groups (all p < 0.05). Lipopolysaccharide was elevated in patients with Class IV HF (vs Class I-III) as well as in patients with LVAD and HT (p < 0.05). sCD14 was elevated in patients with Class IV HF and LVAD (vs Class I-III, p < 0.05) but not in patients with HT., Conclusions: Reduced gut microbial diversity and increased endotoxemia, inflammation, and oxidative stress are present in patients with Class IV HF. Inflammation and oxidative stress are lower among patients with LVAD and HT relative to patients with Class IV HF, whereas reduced gut diversity and endotoxemia persist in LVAD and HT., (Copyright © 2020 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Although extremely high pulmonary vascular resistance (PVR) is a relative contraindication for heart transplantation (HTx), recent data with continuous-flow left ventricular assist devices (LVADs) indicate HTx outcomes may be different when high PVR is managed with an LVAD. This study clarifies the contemporary association between PVR at HTx and posttransplant survival in LVAD vs non-LVAD cohorts., Methods: We reviewed the United Network for Organ Sharing registry for adults who received a transplant from 2008 to 2015. In those with continuous-flow LVADs and those with no VADs at HTx, (non-VAD), we grouped patients by low PVR (PVR <3), intermediate PVR (PVR 3 to <6), and high PVR (PVR ≥6) groups. Adjusted hazard ratios (aHRs) for death after HTx were calculated by Cox regression., Results: The non-LVAD cohort included 6270 patients (4385 in low, 1643 in intermediate, and 242 in high PVR), and the LVAD cohort included 4111 patients (3227 in low, 798 in intermediate, and 86 in high PVR). The high PVR LVAD group had the worst survival, which was not significant, likely to low power (P = .300). The aHR for death in non-LVAD was 1.047 (95% confidence interval, 1.010-1.088) and in LVAD was 1.063 (95% confidence interval, 1.010-1.119). Cubic spline analysis demonstrated nonlinear associations between PVR and the aHR, especially in the LVAD cohort., Conclusions: There was no significant evidence to conclude the effect of pretransplant PVR on posttransplant survival is higher in LVAD vs non-LVAD patients, based on analysis of the United Network for Organ Sharing database. However, further investigations are indicated to clarify HTx candidacy in those with extremely high PVR even after LVAD., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: In heart transplantation (HT), although blood type O organs can go to any blood type, non-O organs may not be allocated to adult O recipients. Therefore, O candidates wait longer than non-O candidates and frequently require bridging with left ventricular assist devices (LVADs). The effects of this discrepancy are rarely investigated in a large registry. The purpose of this study was to assess the association between candidates' blood type and their outcomes after HT listing., Methods: This is a retrospective cohort study using the United Network for Organ Sharing Registry, including 34,352 candidates listed for a single-organ, primary HT from January 2000 through December 2015. Main outcome measures were waitlist mortality and post-HT mortality, using blood type A as reference. We conducted inverse-probability weighting to adjust for baseline profiles., Results: Among 34,352 candidates (median age 55, interquartile range 46-62; female 24.8%; blood type A: 13,258, AB: 1,572, B: 4,599, O:14,923), 22,714 candidates (A: 71.5%, AB: 82.1%, B: 73.0%, O: 57.5%; p < 0.001) underwent HT during the study period. Among recipients, bridging LVAD rate was highest in O recipients (A: 23.0%, AB: 15.3%, B: 23.4%, O: 32.1%; p < 0.001). After inverse-probability weighting, O patients demonstrated a significantly higher hazard of death after listing (adjusted hazard ratio 1.11, 95% confidence interval [CI] 1.07-1.16) and after HT (adjusted hazard ratio 1.07, 95% CI 1.01-1.13) as compared with A., Conclusions: There is a survival discrepancy among blood types. Our findings should facilitate more prospective studies to revisit current policies regarding equity in allocation, where possible., (Copyright © 2020 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular assist device (LVAD) therapy has revolutionized the treatment options for patients with advanced heart failure. Patient selection is essential for obtaining successful results. However, few data exist concerning the outcomes of patients evaluated for LVAD therapy but subsequently rejected or deferred., Methods and Results: This is a retrospective review of all patients referred for LVAD therapy at our institution between January 2009 and December 2016. Baseline demographics and Interagency Registry for Mechanically Assisted Circulatory Support profiles were collected, and reasons for rejection or deferral for LVAD placement were investigated. A total of 669 patients were referred for LVAD therapy, and 228 patients (34%) were turned down. The yearly acceptance rate ranged between 57% and 75%. The average age of the turned-down cohort was 60.8 ± 12.5 years; 83% were men. Reasons for rejection included: patient being too sick (34%); psychosocial concerns (25%); patient declined (16%); decision was deferred for medical optimization (15%); or patient being too well (10%). The percentage of patients who were rejected due to psychosocial concerns has increased over time (P = 0.02), whereas the rate of deferral for medical optimization has remained stable (P = 0.10). One-year survival after initial LVAD consultation was 42% in those who were too sick, 64% in those with psychosocial concerns, 68% in patients who declined, 86% in those deferred for medical optimization; and 100% in those too well (P < 0.01)., Conclusions: One-year survival is reduced among patients who were initially turned down for LVAD therapy, except for those in whom this decision was deferred for medical optimization or because the patient was too well. Psychosocial concerns have become a significant barrier to LVAD therapy., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: Right heart failure after left ventricular assist device (LVAD) implantation is associated with significant morbidity and mortality. A new generation of percutaneous right ventricular assist devices (RVADs) may mitigate the need for invasive surgical RVAD implantation. The purpose of this study was to evaluate the safety and efficacy of the Protek Duo (TandemLife, Pittsburgh, PA, USA) RVAD in patients who developed severe acute right heart failure in the intensive care unit after LVAD implantation., Methods: This was a retrospective cohort study of 27 patients who received a Protek Duo after LVAD implantation from January 2016 to March 2019 at our centre. The primary outcome of interest was survival to hospital discharge. Secondary outcomes included procedural success, device-related complications and conversion to a surgical RVAD., Results: The median age of patients was 63 years (interquartile range 58-71), 78% were men and 78% were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2. Patients were on a median of 2 inotropes and 2 pressors prior to Protek Duo insertion. The device successfully implanted on the first attempt in all patients a median of 1 day (interquartile range 1-2) after LVAD implantation and the median duration of support was 11 days (interquartile range 7-16). Device weaning occurred in 86% of patients, with 15% in-hospital mortality. Major complications related to the device included new moderate-to-severe tricuspid regurgitation (36%), haemolysis (14%) and cannula migration (7%). Three patients (11%) required conversion to surgical RVAD. Overall survival to 1 year was 81%., Conclusions: The use of the Protek Duo as a percutaneous RVAD is a safe and feasible treatment for patients who develop acute right heart failure after LVAD implantation., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Continuous-flow left ventricular assist devices (CF-LVADs) are increasingly used in advanced heart failure patients. Recent studies suggest that low socioeconomic status (SES) predicts worst survival after heart transplantation. Both individual-level and neighborhood-level SES (nSES) have been linked to cardiovascular health; however, the impact of SES in CF-LVAD patients remains unknown. We hypothesized that SES is a major determinant of CF-LVAD candidacy and postimplantation outcomes. A retrospective chart review was conducted on 362 patients between February 2009 and May 2016. Neighborhood-level SES was measured using the American Community Survey data and the Agency for Healthcare Research and Quality SES index score. Individual-level SES was self reported. Kaplan-Meier survival analysis and multivariable Cox proportional hazards regression determined survival statistics. Patients in the highest SES tertile were older (58 ± 13 vs. 53 ± 14; p < 0.001), less likely to be black or Hispanic (26% vs. 70%; p < 0.001), more likely to be married (87% vs. 65%; p < 0.001), more likely to have private insurance (50% vs. 39%; p < 0.001), and more likely to have employment (29% vs. 15%; p < 0.001) compared with patients in the lowest tertile. Low nSES was associated with a decreased risk of death (hazard ratio [HR], 0.580; 95% confidence interval [CI], 0.347-0.970; p = 0.038) in comparison to the high nSES. However, after adjusting for baseline clinical morbidities, the relationship was no longer present. When selecting patients for a LVAD, SES should not be thought of as an immutable risk factor. Carefully selected low-SES patients could be safely implanted with CF-LVAD with outcomes comparable to high-SES patients.

Background: Gastrointestinal bleeding (GIB) is a common complication of left ventricular assist device (LVAD) therapy accounting for frequent hospitalizations and high resource utilization., Methods: We previously developed an endoscopic algorithm emphasizing upfront evaluation of the small bowel and minimizing low-yield procedures in LVAD recipients with GIB. We compared the diagnostic and therapeutic yield of endoscopy, health-care costs, and re-bleeding rates between conventional GIB management and our algorithm using chi-square, Fisher's exact test, Wilcoxon-Mann-Whitney, and Kaplan-Meier analysis., Results: We identified 33 LVAD patients with GIB. Presentation was consistent with upper GIB in 20 (61%), lower GIB in 5 (15%), and occult GIB in 8 (24%) patients. Forty-one endoscopies localized a source in 23 (56%), resulting in 14 (34%) interventions. Algorithm implementation compared with our conventional cohort was associated with a 68% increase in endoscopic diagnostic yield (P< .01), a 113% increase in therapeutic yield (P= .01), a 27% reduction in the number of procedures per patient (P < .01), a 33% decrease in length of stay (P < .01), and an 18% reduction in estimated costs (P < .01). The same median number of red blood cell transfusions were used in the 2 cohorts, with no increase in re-bleeding events in the algorithm cohort (33.3%) compared with our conventional cohort (43.7%)., Conclusions: Our endoscopic management algorithm for GIB in LVAD patients proved effective in reducing low-yield procedures, improving the diagnostic and therapeutic yield of endoscopy, and decreasing health-care resource utilization and costs, while not increasing the risk of a re-bleeding event., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: When left ventricular assist device (LVAD) therapy no longer is able to achieve patients' desired quality of life, withdrawal of LVAD therapy (WLVAD) may be requested. Objectives: To evaluate factors associated with WLVAD, including the time taken before WLVAD. Setting/Subjects: Sixty-two patients who newly underwent initial LVAD therapy during January 1, 2010 and October 30, 2018 and subsequently underwent WLVAD by December 31, 2018 were divided into those who participated in the decision of WLVAD (defined as PT+, n  = 14), and those who could not participate in the decision because of the medical reasons (defined as PT-, n  = 48). Measurements: Time to WLVAD in PT+ and PT- was defined as WD&#95;PT+ (days between patients' request and WLVAD) and WD&#95;PT- (days between when patients became unable to express themselves and WLVAD), respectively. Circumstances around WLVAD, including location of death and use of palliative care (PC), were reviewed. Results: Mean age at WLVAD was 65.4 ± 10.1 years and 52 (83.9%) were men. Median days on LVAD support was 166.5 days (interquartile range = 838). The majority of WLVAD occurred in the intensive care unit (ICU) (83.6%) but less frequent in PT+ than in PT- (64.3% vs. 89.4%, p  = 0.041). The median number of PC visits in the last month was higher in PT+ than in PT- (4.5 vs. 0.5, p  = 0.005). The median WD&#95;PT+ was 5.5 days and was significantly shorter in the ICU (1 day vs. 46 days, p  = 0.013). The median WD&#95;PT- was 5.5 days and tended to be shorter in the ICU (4 days vs. 13 days, p  = 0.072). A multivariate analysis showed that male gender and ICU setting were both negatively associated with WD&#95;PT- ( p  = 0.025 for men, p  = 0.005 for ICU setting). Conclusions: The majority of WLVAD occurred in the ICU and required PC involvement. Time to WLVAD was shorter in the ICU. Requests for WLVAD directly made by patients, especially in a non-ICU setting, seemed to have posed more difficulty.

For patients bridged to transplant (BTT) with left ventricular assist devices (LVAD), data regarding the use of induction immunosuppressive therapy remain limited. The objectives of the current study were to describe the current trends and clinical consequences of IT in patients BTT with LVAD. The United Network of Organ Sharing database was queried to identify adult, single-organ heart transplant recipients who were BTT with LVAD between 2008 and 2018. Propensity score matching was then used to balance clinical covariates between those patient who did and did not receive IT. The primary outcomes of interest were graft survival, hospitalization for rejection and infection, and freedom from transplant coronary artery disease (TCAD). In the overall cohort, 49.1% (n = 3,978) received IT, with basiliximab being the most commonly used agent followed by antithymocyte globulin. After propensity score matching, 4,388 patients (2,194 without induction and 2,194 with induction) were identified. Between those who did and did not receive IT, there was no significant difference in graft survival, freedom from hospitalization for rejection, and freedom from hospitalization for infection. Patients who received IT experienced increased freedom from TCAD (p = 0.004) with unadjusted hazard ratio of 0.81 (95% Cardiac Index: 0.70-0.93). For freedom from TCAD, antithymocyte globulin was associated with better outcomes than basiliximab (80.2% vs. 73.1% at 5 years, log rank p value = 0.004). In a sensitivity analysis, there was no significant increase in hospitalization for infection in those patients with an infected LVAD before transplant. Use of induction therapy in patients BTT with LVAD appears to be safe and feasible, without a significant increase in the risk of infection or rejection, even in those patients with pretransplant device-related infections. IT, particularly antithymocyte globulin, was associated with increased time to development of TCAD. Routine use of IT in patients BTT with LVAD may be considered, and further randomized control trials are warranted to further support these data.

Background: Estimated glomerular filtration rate (eGFR) based on serum creatinine (sCr) improves early after left ventricular assist device (LVAD) implantation but subsequently declines. Although sCr is a commonly accepted clinical standard, cystatin C (CysC) has shown superiority in assessment of renal function in disease states characterized by muscle wasting. Among patients with an LVAD, we aimed to (1) longitudinally compare CysC-eGFR and sCr-eGFR, (2) assess their predictive value for early postoperative outcomes, and (3) investigate mechanisms which might explain potential discrepancies., Methods: A prospective cohort (n=116) with CysC and sCr concurrently measured at serial time points, and a retrospective cohort (n=91) with chest computed tomography performed within 40 days post-LVAD were studied. In the prospective cohort, the primary end point was a composite of in-hospital mortality, renal replacement therapy, or severe right ventricular failure. In the retrospective cohort, muscle mass was estimated using pectoralis muscle area indexed to body surface area (pectoralis muscle index)., Results: In the prospective cohort, sCr-eGFR significantly improved early post-LVAD and subsequently declined, whereas CysC-eGFR remained stable. CysC-eGFR but not sCr-eGFR predicted the primary end point: odds ratio per 5 mL/(min·1.73 m 2 ) decrease 1.16 (1.02-1.31) versus 0.99 (0.94-1.05). In retrospective cohort, for every 5 days post-LVAD, a 6% decrease in pectoralis muscle index was observed (95% CI, 2%-9%, P =0.003). After adjusting for time on LVAD, for every 1 cm 2 /m 2 decrease in pectoralis muscle index, there was a 4% decrease in 30-day post-LVAD sCr (95% CI, 1%-6%, P =0.004)., Conclusions: Initial improvement in sCr-eGFR is likely due to muscle wasting following LVAD surgery. CysC may improve assessment of renal function and prediction of early postoperative outcomes in patients with an LVAD.

Chronic systolic heart failure (HF) with acute decompensation can result in cardiogenic shock (CS) requiring short-term mechanical circulatory support. We sought to identify predictors of survival for acute decompensated HF (ADHF) patients requiring veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Patients >18 years old treated at our institution with VA-ECMO from 2009 to 2018 for ADHF with CS were studied. Demographic, hemodynamic, and echocardiographic data were collected. The primary outcome was survival to discharge. Fifty-two patients received VA-ECMO for ADHF with CS; 24 (46.2%) survived. Seventeen (32.7%) had suffered cardiac arrest, and 37 (71.2%) were mechanically ventilated. Mean lactate was 4.33 ± 3.45 mmol/L, and patients were receiving 2.7 ± 1.2 vasopressor/inotropic infusions at ECMO initiation; these did not differ significantly between survivors and nonsurvivors. Pre-ECMO cardiac index was 1.84 ± 0.56L/min/m and 1.94 ± 0.63L/min/m in survivors and nonsurvivors, respectively (p = 0.57). In multivariable analysis, only diabetes mellitus (DM; OR, 13.25; CI, 1.42-123.40; p = 0.02) and mineralocorticoid receptor antagonist use (OR, 0.12; CI, 0.02-0.78; p = 0.03) were independent predictors of mortality. Nineteen (79.2%) survivors required durable ventricular assist device. Among ADHF patients receiving VA-ECMO, DM is a powerful predictor of outcomes while markers of clinical acuity including hemodynamics, vasopressor/inotrope use, and lactate are not. The vast majority of survivors required durable left-ventricular assist devices.

Background: The purpose of this study is to evaluate the utility of vasoactive-inotropic score (VIS) in predicting outcomes after left ventricular assist device (LVAD) implantation and explore possible mechanisms of post-operative hemodynamic instability., Methods: Retrospective review was performed in 418 consecutive patients with LVAD implantation. VIS was calculated as dopamine + dobutamine + 10 × milrinone + 100 × epinephrine + 100 × norepinephrine (all μg/kg/min) + 10000 × vasopressin (U/kg/min) after initial stabilization in the operating room and upon arrival at the intensive care unit. The primary outcome was in-hospital mortality. The secondary outcomes were a composite of in-hospital mortality, delayed right ventricular assist device (RVAD) implantation, and continuous renal replacement therapy. The pre-operative biomarkers of inflammation, oxidative stress, endotoxemia and gut-derived metabolite trimethylamine-N-oxide (TMAO) were measured in a subset of 61 patients., Results: Median VIS was 20.0 (interquartile range 13.3-27.9). VIS was an independent predictor of in-hospital mortality (odds ratio [OR] 1.06, 95% confidence interval [CI] 1.03-1.09, p < 0.001) and composite outcome (OR 1.03, 95% CI 1.01-1.06, p = 0.008). In-hospital mortality increased for each VIS quartile (0% vs 3.9% vs 7.6% vs 12.3%, p = 0.002). VIS was superior to other established LVAD risk models as a predictor of in-hospital mortality (area under the curve 0.73, 95% CI 0.64-0.82). The optimal cut-off point for VIS as a predictor of in-hospital mortality was 20. Pre-operative hemoglobin level was the only independent predictor of VIS ≥ 20 (p = 0.003). Patients with a high VIS were more likely to have elevated TMAO pre-operatively (53.6% vs 25.8%, p = 0.03)., Conclusions: A high post-operative VIS is associated with adverse in-hospital outcomes and is a better predictor of in-hospital mortality compared with existing LVAD risk models. Whether early hemodynamic stabilization using RVAD may benefit patients with a high VIS remains to be investigated., (Copyright © 2019 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

The HeartMate II (HMII) left ventricular assist device can be exchanged to HeartMate 3 (HM3) to reduce the risk of device thrombosis and stroke. However, data of this procedure are still limited. We reviewed early and mid-term outcomes of 9 patients who received a HMII to HM3 exchange at our institution. The median age of the cohort was 58 years [interquartile range (IQR) 53-61], and 7 (78%) patients were men. The median duration of HMII support was 608 days (IQR 493-1116). Indications for device exchange include device thrombosis (n = 8.89%) and driveline injury (n = 1.11%). Procedures were performed through a lateral thoracotomy in all patients. The median cardiopulmonary bypass time was 117 min (IQR 97-133). In-hospital mortality was 0%. One patient required repositioning of the HM3 pump through full sternotomy due to inflow malposition. During 486 days (IQR 235-712) of follow-up, 3 patients (33%) developed late HMII pump pocket infection after discharge. Five patients had a successful heart transplant and 1 patient died due to unknown reason. HMII to HM3 exchange can be performed via lateral thoracotomy. However, there is a risk of inflow malposition and previous pump pocket infection., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Bridge to transplantation (BTT) with left ventricular assist devices (LVADs) is a mainstay of therapy for heart failure in patients awaiting heart transplantation (HT). Criteria for HT listing do not differ between patients medically managed and those mechanically bridged to HT. The objectives of the present study were to evaluate the impact of BTT with LVAD on posttransplantation survival, to describe differences in causes of 1-year mortality in medically and mechanically bridged patients, and to evaluate differences in risk factors for 1-year mortality between those with and those without LVAD at the time of HT., Methods: Using the United Network of Organ Sharing database, we identified 5486 adult, single-organ HT recipients transplanted between 2008 and 2015. Patients were propensity matched for likelihood of LVAD at the time of HT. Kaplan-Meier survival estimates were used to assess the impact of BTT on 1- and 5-year mortality. Logistic regression analysis was used to evaluate the odds ratio of 1-year mortality for patients BTT with LVAD compared with those with medical management across clinically significant variables at various thresholds., Results: Early mortality was higher in mechanically bridged patients: 9.5% versus 7.2% mortality at 1 year (P<0.001). BTT patients incurred an increased risk of 1-year mortality with an estimated glomerular filtration rate of 40 to 60 mL·min -1 ·1.73 m -2 (odds ratio, 1.69; P=0.003) and <40 mL·min -1 ·1.73 m -2 (odds ratio, 2.16; P=0.005). A similar trend was seen in patients with a body mass index of 25 to 30 kg/m 2 (odds ratio, 1.88; P=0.024) and >30 kg/m 2 (odds ratio, 2.11; P<0.001). When patients were stratified by BTT status and the presence of risk factors, including age >60 years, estimated glomerular filtration rate <40 mL·min -1 ·1.73 m -2 , and body mass index >30 kg/m 2 , there were significant differences in 1-year mortality between medium- and high-risk medically and mechanically bridged patients, with 1-year mortality in high-risk BTT patients at 17.6% compared with 10.4% in high-risk medically managed patients., Conclusions: Bridge to HT with LVAD, although necessary because of organ scarcity and capable of improving wait list survival, confers a significantly higher risk of early posttransplantation mortality. Patients bridged with mechanical support may require more careful consideration for transplant eligibility after LVAD placement.

Background: The use of short-term mechanical circulatory support (ST-MCS) has increased for refractory cardiogenic shock. However, there are scant data about bridge-to-recovery patients., Methods: We retrospectively reviewed 502 patients with cardiogenic shock who received venoarterial extracorporeal membrane oxygenation or a temporary surgical ventricular assist device as ST-MCS between 2010 and 2016. There were 178 patients (35.5%) who survived through device explantation. Of these, 149 patients (29.7%) survived to discharge and were included for analysis. The primary outcome was midterm survival without undergoing heart replacement therapy., Results: In our bridge-to-recovery cohort, 101 patients (67.8%) were men, and the median age was 59 years (interquartile range, 51 to 67 years). Etiology of cardiogenic shock included postcardiotomy shock in 35.6% of patients (n = 53), allograft failure in 26.8% (n = 40), acute myocardial infarction (AMI) in 24.2% (n = 36), and other acute decompensated heart failure in 14.4% (n = 20). There were 24 major events (16.1%) recorded, including 21 patients who died and 3 patients who received heart replacement therapy during median follow-up of 306 days (interquartile range, 58.25 to 916.75 days). Overall freedom from event at 3 years was 74.2%. In subgroup analysis, AMI patients had a significantly worse freedom-from-event rate at 40.4% (p < 0.001). By univariate Cox analysis, AMI etiology (p = 0.003), length of ST-MCS (p = 0.06), blood urea nitrogen (p = 0.012), and left ventricular ejection fraction (p = 0.005) at discharge were predictors for adverse events., Conclusions: The overall midterm outcome of patients explanted from ST-MCS is favorable except for AMI patients., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Elevated blood pressure (BP) has been linked to adverse events during left ventricular assist device support. In this study we investigated the association between outpatient BP and stroke or suspected pump thrombosis among HeartMate II (HMII) recipients., Methods: We retrospectively studied 220 HMII patients. Serial outpatient BP measurements were averaged. Patients were categorized by: (1) mean arterial pressure (MAP), high (>90 mm Hg) vs intermediate (80 mm Hg ≤ MAP ≤ 90 mm Hg) vs low (<80 mm Hg); (2) systolic BP (SBP), high (≥101 mm Hg, median) vs low; and (3) pulse pressure (PP), high (≥22 mm Hg, median) vs low. To assess visit-to-visit BP variability, patients were divided in quartiles of standard deviation of MAP and SBP. The primary end-point was the composite of stroke or suspected pump thrombosis., Results: The risk for the primary end-point was increased in the high MAP group (adjusted hazard ratio [HR] 2.75, 95% confidence interval [CI] 1.49 to 5.05, vs intermediate MAP; and 6.73, 1.9 to 23.9, vs low MAP). MAP had higher predictive value for the primary end-point compared with SBP (p = 0.05). Patients with high SBP had a higher rate of stroke (HR 2.8, 95% CI 1.09 to 7.17, vs low SBP). The combination of high SBP and low PP was associated with the highest risk for stroke. The lowest quartile of visit-to-visit MAP variability was associated with the highest risk for the primary end-point., Conclusions: Elevated outpatient BP is associated with increased risk for stroke or suspected pump thrombosis in HMII recipients. Reduced PP and low visit-to-visit BP variability may confer additional risk., (Copyright © 2018 International Society for Heart and Lung Transplantation. 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.)

Red cell distribution width (RDW) measures the variance in size of circulating red blood cells and is a strong independent predictor of morbidity and mortality in cardiovascular disease and heart failure. Predictive power of RDW on mortality after continuous-flow left ventricular assist device (CF-LVAD) implantation remains largely unknown. Four hundred nine patients who underwent CF-LVAD implantation between April 2004 and December 2015 were retrospectively analyzed. The primary outcome of interest was 90 day mortality after CF-LVAD implantation. Median RDW before CF-LVAD implantation was 15.8%. Patients with elevated RDW (>15.8%) at baseline had significantly lower hemoglobin (10.6 ± 1.8 vs. 11.9 ± 2.1 mg/dl; p < 0.001), lower mean corpuscular volume (84.9 ± 7.7. vs. 88.7 ± 5.9; p < 0.001), higher blood urea nitrogen (BUN; 36.3 ± 21.8 vs. 30.1 ± 17.1; p < 0.001), lower albumin (3.4 ± 0.6 vs. 3.7 ± 0.5; p < 0.001), and higher total bilirubin levels (1.67 ± 2.21 vs. 1.29 ± 0.96). Red cell distribution width was independently predictive of 90 day mortality (odds ratio [OR], 1.16 for 1% increase; CI, 1.04-1.31; p = 0.010). Discriminatory power of RDW alone was comparable to model of end-stage liver disease excluding international normalized ratio (MELD-Xi) and HeartMate II risk scores. Mechanical unloading with CF-LVAD was associated with a reduction in RDW levels. These findings suggest that RDW, a simple and inexpensive test available through routine complete blood count, can be successfully used for mortality risk assessment in CF-LVAD candidates.

Background: Early right ventricular (RV) failure after left ventricular assist device (LVAD) implantation increases morbidity and mortality. Percutaneous right ventricular assist device (pRVAD) support is an alternative to more invasive surgical RVAD (sRVAD)., Methods and Results: We retrospectively reviewed patients receiving isolated pRVAD or sRVAD after durable LVAD at our center in the years 2007-2018. Hemodynamic parameters before and after implantation and survival outcomes were compared among groups. Nineteen patients received pRVAD and 21 sRVAD. Hemodynamic parameters improved immediately with the use of pRVAD; central venous pressure decreased (from 15.9 ± 2.4 to 12.3 ± 3.2 mm Hg; P<.001) and cardiac index increased (from 2.4 ± 0.5 to 3.5 ± 0.8 L·min -1 ·m - 2 ; P<.001). These were sustained after device removal and were similar to those with the use of sRVAD. Patients with pRVAD required fewer blood transfusions and mechanically ventilated days than those with sRVAD. Among survivors, intensive care unit and hospital days were fewer with the use of pRVAD: 21 (16-27) versus 34 (27-46) ICU days (P = .01); 43.5 (30-66) versus 91 (62-111) hospital days (P = .03). There was no significant difference in 30-day mortality with the use of pRVAD compared with sRVAD (21.1% vs 42.9%; P = .14), but there was a trend toward a higher rate of discharge free from hemodialysis (73.7% vs 47.6%; P = .09)., Conclusions: Novel pRVAD systems for RV failure provide hemodynamic benefits similar to sRVAD, are associated with less morbidity, and should be considered as an alternative to sRVAD., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Primary graft dysfunction (PGD) remains a significant cause of post-transplant morbidity and mortality. The exact mechanism and risk factors for this phenomenon remain unknown in the contemporary era., Methods: In this study we reviewed adult patients undergoing heart transplantation (HT) at our institution between 2009 and 2017. Severe PGD was defined as the need for mechanical circulatory support (MCS) within the first 24 hours after HT. Multivariate logistic regression analysis was used to identify risk factors for severe PGD, focusing on those bridged to transplant (BTT) with a continuous-flow left ventricular assist device (CF-LVAD)., Results: Fifty-six of 480 (11.7%) HT patients experienced severe PGD. Eighty percent of the severe PGD patients were BTT with a CF-LVAD (odds ratio [OR] 3.86, 95% confidence interval [CI] 1.94 to 7.68, p < 0.001). Among the BTT patients, significant associations between >1 year of CF-LVAD support (OR 2.48, 95% CI 1.14 to 5.40, p = 0.022), pre-HT creatinine (OR 3.35, 95% CI 1.42 to 7.92, p = 0.006), elevated central venous pressure/pulmonary capillary wedge pressure (CVP/PCWP) ratio (OR 3.32, 95% CI 1.04 to 10.60, p = 0.043), use of amiodarone before HT (OR 2.69, 95% CI 1.20 to 6.20, p = 0.022), and severe PGD were identified. RADIAL score did not accurately predict severe PGD in this contemporary cohort. Those patients who developed severe PGD had decreased 1-year post-transplant survival (78.3% vs 91.8%, p = 0.007)., Conclusions: Use of CF-LVAD as BTT is associated with an increased risk of severe PGD. Increased time on device support, renal dysfunction, right ventricular dysfunction as assessed by CVP/PCWP ratio, and pre-transplant amiodarone may identify those patients at high risk. Further research is warranted focusing on optimal timing of device implantation and transplantation, as well as the underlying mechanisms of PGD., (Copyright © 2018 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Blood type O heart transplant recipients wait longer than non-O recipients and frequently require bridging left ventricular assist devices (LVADs). However, rarely has the effect of this disparity been shown in a large registry. This study used Markov simulation to clarify the outcome difference between O and non-O candidates and how allocation change could affect survival., Methods: We reviewed the United Network for Organ Sharing registry for adults listed for heart transplantation from 2008 to 2015. Cumulative incidences of death or transplant and survival after listing were compared between O and non-O using propensity matching. A four-state Markov model-waiting without LVAD, waiting with LVAD, transplantation, and death-was created to simulate survival after listing. Sensitivity analysis was performed to see how the percentage of O hearts in non-O recipients would affect survivals., Results: A total of 8,187 O and non-O candidates were included after matching. The cumulative incidence of transplantation was lower in O (p < 0.001), and death after listing was significantly higher (p < 0.001). During a median follow-up of 2.1 years, 69.6% of non-O candidates were transplanted, compared with 54.9% of O candidates (p < 0.001). Despite this disparity, 19% of non-O recipients received O hearts. Our simulated survival demonstrated that decreasing the O heart percentage in non-O recipients from the current 19% to 5% would provide similar survival in O and non-O after listing., Conclusions: Under the current strategy, there are death and transplant rate differences between O and non-O candidates. Our simulation-based allocation strategy might aid in mitigating this discrepancy across blood types., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The role of the intra-aortic balloon pump (IABP) in acute decompensated heart failure (HF) with cardiogenic shock (CS) is largely undefined. In this study we sought to assess the hemodynamic and clinical response to IABP in chronic HF patients with CS and identify predictors of response to this device., Methods: We retrospectively reviewed all patients undergoing IABP implantation from 2011 to 2016 at our institution to identify chronic HF patients with acute decompensation and CS (cardiac index <2.2 liters/min/m 2 and systolic blood pressure <90 mm Hg or need for vasoactive medications to maintain this level). Clinical deterioration on IABP was defined as failure to bridge to either discharge on medical therapy or durable heart replacement therapy (HRT; durable left ventricular assist device or heart transplant) with IABP alone., Results: We identified 132 chronic HF patients with IABP placed after decompensation with hemodynamic evidence of CS. Overall 30-day survival was 84.1%, and 78.0% of patients were successfully bridged to HRT or discharge without need for escalation of device support. The complication rate during IABP support was 2.3%. Multivariable analysis identified ischemic cardiomyopathy (odds ratio [OR] 3.24, 95% confidence interval [CI] 1.16 to 9.06; p = 0.03) and pulmonary artery pulsatility index (PAPi) <2.0 (OR 5.04, 95% CI 1.86 to 13.63; p = 0.001) as predictors of clinical deterioration on IABP., Conclusions: Overall outcomes with IABP in acute decompensated chronic HF patients are encouraging, and IABP is a reasonable first-line device for chronic HF patients with CS. Baseline right ventricular function, as measured by PAPi, is a major predictor of outcomes with IABP in this population., (Copyright © 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objectives: Previous studies have shown the usefulness of the subcostal exchange of the HeartMate II left ventricular assist device for device malfunction. However, long-term data are still limited., Methods: Between March 2004 and July 2017, 41 of 568 (7.2%) patients who had received a HeartMate II implant at our institution had a device exchange via a subcostal incision. We summarized early and late outcomes., Results: Forty-one patients had a total of 48 subcostal pump exchanges. Indications for device exchange included device thrombosis (n = 31, 76%), driveline infection (n = 2, 5%) and driveline injury (n = 8, 19%). All of the procedures were successful, and there were no in-hospital deaths. A Kaplan-Meier survival curve showed 30-day and 1-year survival rates after subcostal exchange of 100% and 94.6%, respectively. However, 10 (25%) patients had left ventricular assist device-related infections following subcostal exchange that included 7 pump pocket infections and 3 driveline infections. Freedom from left ventricular assist device-related infection at 1 year after subcostal exchange was 79.3%. Thirteen (32%) patients had device malfunction due to pump thrombosis that required a 2nd device exchange. Seven patients had recurrent thrombosis. Three (7%) patients had a stroke. Freedom from device thrombosis and from a stroke event at 1 year was 74.4%., Conclusions: Subcostal pump exchange can be safely performed. However, there is a substantial risk of infection and recurrent thrombosis. Careful follow-up for late complications is mandatory.

Background: The difference of end-of-life care for left ventricular assist device (LVAD) patients, between destination therapy (DT) and bridge to transplant (BTT), and the effect of palliative care in this population remain unknown., Objective: The primary outcomes of this retrospective cohort study were the place of death, do-not-resuscitate (DNR) order, palliative care consultation in the last month, and hospice enrollment. Secondary outcomes were time on the LVAD, life-sustaining treatment in the last week of life, LVAD deactivation, and clinical trajectory., Setting/subjects: Eighty-nine patients who newly underwent LVAD therapy between 2010 and 2016 and died before May 2017 were divided into DT (59) and BTT (30)., Results: At death, BTT patients (61.1 ± 8.9 years) were significantly younger (p = 0.046) than DT patients (65.8 ± 12.9 years). Median (25th-75th percentile) time on LVAD was significantly shorter (p = 0.042) in BTT (152 days, 41.3-375.8) than in DT (358 days, 64-892), but the Kaplan-Meier curves were not significantly different (p = 0.055). The place of death (p = 0.092), DNR order (DT; 70.2%, BTT; 76.7%, p = 0.52), palliative care consultation in the last month (DT; 57.1% and BTT; 41.6%, p = 0.22), and hospice enrollment (DT; 8.5%, BTT; 10.0%, p = 1.0), as well as any of secondary outcomes, were not significantly different between groups. After January 2014, palliative care consultation in the last month increased significantly from 14.2% to 78.9% (p < 0.001), and death in intensive care unit decreased significantly (from 79.4% to 52.8%, p = 0.024) with less frequent mechanical ventilation (from 71.4% to 50.0%, p = 0.047) and renal replacement therapy (42.9% to 19.2%, p = 0.017)., Conclusions: The clinical course of deceased LVAD patients, circumstances, and treatments at the end of life did not differ significantly between the BTT and DT groups. Palliative care consult seemed associated with less resource utilization. Palliative care team should get involved in the care of LVAD patients, not only for DT but also for BTT.

Although late-onset right-sided heart failure is recognized as a clinical problem in the treatment of patients with left ventricular assist devices (LVADs), the mechanism and predictors are unknown. Tricuspid valve (TV) deformation leads to the restriction of the leaflet motion and decreased coaptation, resulting in a functional tricuspid regurgitation that may act as a surrogate marker of late right-sided heart failure. This study aimed to investigate the association of preoperative TV deformation (annulus dilatation and leaflet tethering) with late right-sided heart failure development after continuous-flow LVAD implantation. The study cohort consisted of 274 patients who underwent 2-dimensional echocardiography before LVAD implantation. TV annulus diameter and tethering distance were measured in an apical 4-chamber view. Late right-sided heart failure was defined as right-sided heart failure requiring readmission and medical and/or surgical treatment after initial LVAD implantation. During a mean follow-up of 25.1 ± 19.0 months after LVAD implantation, late right-sided heart failure occurred in 33 patients (12.0%). Multivariate Cox proportional hazard analysis demonstrated that TV annulus diameter (hazard ratio 1.221 per 1 mm, p <0.001) was significantly associated with late right-sided heart failure development, whereas leaflet tethering distance was not. The best cut-off value of the TV annular diameter was 41 mm (area under the curve 0.787). Kaplan-Meier analysis showed that patients with dilated TV annulus (TV annular diameter ≥41 mm) exhibited a significantly higher late right-sided heart failure occurrence than those without TV annular enlargement (log-rank p <0.001). In conclusion, preoperative TV annulus diameter, but not leaflet tethering distance, predicted the occurrence of late right-sided heart failure after LVAD implantation., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Although implantation of a left ventricular assist device (LVAD) generally improves tricuspid regurgitation (TR) in short-term follow-up, the clinical significance of residual TR in patients with mid- to long-term LVAD support is unknown. This study aimed to identify the prevalence, predictors, and prognostic value of residual TR in LVAD patients in association with tricuspid valve (TV) deformation., Methods and Results: The study cohort consisted of 127 patients who underwent LVAD implantation without TV procedure and were supported with LVAD at least 1 year. All patients underwent echocardiographic examination preoperatively and 1 year after LVAD implantation. TR was quantitatively assessed by ratio of TR color jet area/right atrial area, and significant residual TR was defined as ≥20% of %TR at follow-up echocardiographic examination. Detailed echocardiographic measurements were also performed, including TV annulus diameter, TV leaflet displacement, and left ventricular and right ventricular systolic function. LVAD implantation significantly improved ratio of TR color jet area/right atrial area as well as left ventricular and right ventricular systolic function and tethering distance (all P <0.05), whereas it enlarged TV annulus diameter ( P =0.002). Significant residual TR was observed in 30 (23.6%) patients. Age, preoperative TV annulus diameter, and residual mitral regurgitation were significantly associated with significant residual TR (all P <0.05), whereas TV tethering was not. During a mean follow-up of 21±17 months, patients with residual TR had significantly higher mortality than those without residual TR (log-rank P <0.001)., Conclusions: Significant residual TR was observed in ≈25% patients supported with LVAD over 1 year and was associated with unfavorable outcome., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Extracorporeal membrane oxygenation (ECMO) has been used increasingly for both respiratory and cardiac failure in adult patients. Indications for ECMO use in cardiac failure include severe refractory cardiogenic shock, refractory ventricular arrhythmia, active cardiopulmonary resuscitation for cardiac arrest, and acute or decompensated right heart failure. Evidence is emerging to guide the use of this therapy for some of these indications, but there remains a need for additional evidence to guide best practices. As a result, the use of ECMO may vary widely across centers. The purpose of this document is to highlight key aspects of care delivery, with the goal of codifying the current use of this rapidly growing technology. A major challenge in this field is the need to emergently deploy ECMO for cardiac failure, often with limited time to assess the appropriateness of patients for the intervention. For this reason, we advocate for a multidisciplinary team of experts to guide institutional use of this therapy and the care of patients receiving it. Rigorous patient selection and careful attention to potential complications are key factors in optimizing patient outcomes. Seamless patient transport and clearly defined pathways for transition of care to centers capable of providing heart replacement therapies (e.g., durable ventricular assist device or heart transplantation) are essential to providing the highest level of care for those patients stabilized by ECMO but unable to be weaned from the device. Ultimately, concentration of the most complex care at high-volume centers with advanced cardiac capabilities may be a way to significantly improve the care of this patient population.

Objectives: Venoarterial extracorporeal membrane oxygenation (ECMO) use as a bridge to transplant is extremely infrequent in adults. We investigated patient outcomes of the use of ECMO as bridge to transplant., Methods: United Network of Organ Sharing provided de-identified patient-level data. Between 2003 and 2016, 25,168 adult recipients were identified. Of these, 107 (0.4%) were bridged with ECMO and 6148 (24.4%) were bridged with a continuous-flow left ventricular assist device., Results: Patients in ECMO group were younger, more likely to have severely disabled functional status, shorter waitlist time, and were more frequently mechanically ventilated than were patients in the continuous-flow left ventricular assist device group. Kaplan-Meier analysis demonstrated estimated posttransplant survival of 73.1% versus 93.1% at 90 days (P < .001) and 67.4% versus 82.4% at 3 years (P < .001) in ECMO and continuous-flow left ventricular assist device groups, respectively. Analysis of a propensity-matched cohort still demonstrated a lower survival in ECMO group at 90 days (74.8% vs 88.8%; P = .025) and 3 years (69.3% vs 82.2%; P = .054). Among the ECMO patients, multivariable logistic and Cox regression analyses showed model for end-stage liver disease excluding international normalized ratio (MELD-XI) score to be the sole contributor to both 90-day (odds ratio, 1.94; 95% confidence interval, 1.00-3.76; P = .050) and 3-year mortality (hazard ratio, 1.47; 95% confidence interval, 1.16-1.88; P = .002). ECMO-supported patients with a high MELD-XI score (>17) were associated with poor posttransplant survival compared with those with a low MELD-XI score (<13) (90 day, 54.4% vs 85.0% [P < .001] and 3 year, 49.5% vs 73.5% [P < .001])., Conclusions: Bridge to transplant with ECMO was associated with increased early/mid-term mortality, especially in patients with a high MELD-XI score who demonstrated > 50% 3-year mortality. These findings may help to inform future organ allocation policies., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Hospital readmissions have an adverse effect on the quality of life in patients with end-stage heart failure. We examined the temporal pattern, predictors, and outcomes of readmission in continuous flow left ventricular assist device-supported patients., Methods: We retrospectively reviewed inpatient data of 350 consecutive patients who received a continuous-flow left ventricular assist device at our center between May 2004 and December 2014. A total time-restricted model was used to estimate hazard ratios for readmission, and the Nelson nonparametric method was used to estimate mean cumulative function for each cause of readmission., Results: The mean age was 57 ± 13 years, 82.6% received a HeartMate II (Abbott Laboratories, Chicago, IL), and 26.3% were destination therapy. The 30-day readmission rate was 21.7%, and 264 readmissions (41.1%) occurred within the first 6 months of support. The leading cause of readmission was bleeding (0.74 mean cumulative events per person), followed by infection (0.7), device failure (0.52), arrhythmia (0.3), and right heart failure (0.28) at 3 years. The number of readmissions did not have an adverse effect on survival (hazard ratio, 1.03; 95% confidence interval, 0.92 to 1.17; p = 0.58). Increase in each body mass index unit was associated with 1.029 times the rate of overall readmission (p = 0.041). Patients with a body mass index of 30 kg/m 2 or higher had increased readmissions for device failure (p = 0.008) and right heart failure (p = 0.03)., Conclusions: Readmission burden is highest during the first few months of continuous-flow left ventricular assist device support, but survival is not affected. Patients with an elevated body mass index are at increased risk for readmissions for device failure and right heart failure., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Continuous-flow left ventricular assist devices (CF-LVADs) have become a standard treatment choice in advanced heart failure patients. We hypothesized that practice patterns with regards to CF-LVAD utilization vary significantly among transplant centers and impact waitlist outcomes., Methods and Results: The United Network for Organ Sharing registry was queried to identify adult patients who were waitlisted for heart transplantation (HT) between 2008 and 2015. Each patient was assigned a propensity score based on likelihood of receiving a durable CF-LVAD before or while waitlisted. The primary outcomes of interest were death or delisting for worsening status and HT at 1 year. A total of 22 863 patients from 92 centers were identified. Among these, 9013 (39.4%) were mechanically supported. CF-LVAD utilization varied significantly between and within United Network for Organ Sharing regions. Freedom from waitlist death or delisting was significantly lower in propensity-score-matched patients who were mechanically supported versus medically managed (83.5% versus 79.2%; P <0.001). However, cumulative incidence of HT was also lower in mechanically supported patients (53.3% versus 63.6%; P <0.001). Congruous mechanical and medical bridging strategies based on clinical risk profile were associated with lower risk of death or delisting (hazard ratio, 0.88; P =0.027) and higher likelihood of HT (hazard ratio, 1.14; P <0.001)., Conclusions: CF-LVAD utilization may lower waitlist mortality at the expense of lower likelihood of HT. Decision to use CF-LVAD and timing of transition should be individualized based on patient-, center-, and region-level risk factors to achieve optimal outcomes., (© 2018 American Heart Association, Inc.)

Background: Patients with restrictive cardiomyopathy (RCM) and hypertrophic cardiomyopathy (HCM) generally are considered poor candidates for mechanical circulatory support devices (MCSDs) and often not able to be bridged mechanically to heart transplantation. This study characterized MCSD utilization and transplant waitlist outcomes in patients with RCM/HCM under the current allocation system and discusses changes in the era of the new donor allocation system., Methods and Results: Patients waitlisted from 2006 to 2016 in the United Network for Organ Sharing registry were stratified by RCM/HCM versus other diagnoses. MCSD utilization and waitlist duration were analyzed by propensity score models. Waitlist outcomes were assessed by cumulative incidence functions with competing events. Predictors of waitlist mortality or delisting for worsening status in patients with RCM/HCM were identified by proportional hazards model. Of 30 608 patients on the waitlist, 5.1% had RCM/HCM. Patients with RCM/HCM had 31 fewer waitlist days ( P <0.01) and were ≈26% less likely to receive MCSD ( P <0.01). Cumulative incidence of waitlist mortality was similar between cohorts; however, patients with RCM/HCM had higher incidence of heart transplantation. Predictors of waitlist mortality or delisting for worsening status in patients with RCM/HCM without MCSD support included estimated glomerular filtration rate <60 mL/min per 1.73 m 2 , pulmonary capillary wedge pressure >20 mm Hg, inotrope use, and subjective frailty., Conclusions: Patients with RCM/HCM are less likely to receive MCSD but have similar waitlist mortality and slightly higher incidence of transplantation compared with other patients. The United Network for Organ Sharing RCM/HCM risk model can help identify patients who are at high risk for clinical deterioration and in need of expedited heart transplantation., (© 2018 American Heart Association, Inc.)

Background: There is mixed evidence of racial and socioeconomic disparities in heart transplant outcomes. Their underlying cause-and whether individual- or community-level traits are most influential-remains unclear. The current study aimed to characterize socioeconomic disparities in outcomes and identify time trends and mediators of these disparities., Methods and Results: We used United Network for Organ Sharing registry data and included 33 893 adult heart transplant recipients between 1994 and 2014. Socioeconomic status (SES) indicators included insurance, education, and neighborhood SES measured using a composite index. Black race and multiple indicators of low SES were associated with the primary outcome of death or retransplant, independent of baseline clinical characteristics. Blacks had lower HLA and race matching, but further adjustment for these and other graft characteristics only slightly attenuated the association with black race (HR, 1.25 after adjustment). This and the associations with neighborhood SES (HR, 1.19 for lowest versus highest decile), Medicare (HR, 1.17), Medicaid (HR, 1.29), and college education (HR, 0.90) remained significant after full adjustment. When comparing early (1994-2000) and late (2001-2014) cohorts, the disparities associated with the middle (second and third) quartiles significantly decreased over time, but those associated with lowest SES quartile and black race persisted. Low neighborhood SES was also associated with higher risks of noncompliance (HR, 1.76), rejection (HR, 1.28), hospitalization (HR, 1.13), and infection (HR, 1.10)., Conclusions: Racial and socioeconomic disparities exist in heart transplant outcomes, but the latter may be narrowing over time. These disparities are not explained by differences in clinical or graft characteristics., (© 2018 American Heart Association, Inc.)

Background: Aortic regurgitation is a prevalent, detrimental complication of left ventricular assist devices (LVADs). The altered hemodynamics of LVADs results in aortic valves (AVs) having distinct mechanical stimulation. Our hypothesis was that the altered AV hemodynamics modulates the valve cells and matrix, resulting in changes in valvular mechanical properties that then can lead to regurgitation., Methods: AVs were collected from 16 LVAD and 6 non-LVAD patients at time of heart transplant. Standard demographic and preoperative data were collected and comparisons between the two groups were calculated using standard statistical methods. Samples were analyzed using biaxial mechanical tensile testing, mass spectrometry-based proteomics, and transmission electron microscopy to assess ultrastructure., Results: The maximum circumferential leaflet strain in LVAD patients was less than in non-LVAD patients (0.35 ± 0.10MPa versus 0.52 ± 0.18 MPa, p = 0.03) with a trend of reduced radial strain (p = 0.06) and a tendency for the radial strain to decrease with increasing LVAD duration (p = 0.063). Numerous proteins associated with actin and myosin, immune signaling and oxidative stress, and transforming growth factor β were increased in LVAD patients. Ultrastructural analysis showed a trend of increased fiber diameter in LVAD patients (46.2 ± 7.2 nm versus 45.1 ± 6.9 nm, p = 0.10), but no difference in fiber density., Conclusions: AVs in LVAD patients showed decreased compliance and increased expression of numerous proteins related to valve activation and injury compared to non-LVAD patients. Further knowledge of AV changes leading to regurgitation in LVAD patients and the pathways by which they occur may provide an opportunity for interventions to prevent and/or reverse this detrimental complication., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)