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Objective: This study sought to determine the prevalence, predictors, prognostic relevance and evolution of pulmonary hypertension (PH) (mean pulmonary artery pressure ≥25 mm Hg) in adult patients with a subaortic right ventricle (RV) in a biventricular circulation (2V-RV)., Methods: We analysed retrospective data from patients with 2V-RV undergoing cardiac catheterisation in our centre between 2000 and 2018. Echocardiographic assessment of subpulmonary ventricular pressures (left ventricular systolic pressure (LVSP)), age and B-type natriuretic peptide (BNP) were assessed as PH screening tools. Kaplan-Meier curves examined time to a composite outcome of death, transplant or ventricular assist device (VAD). Data from repeat catheterisations were analysed to evaluate PH changes over time, including the effects of therapy., Results: A total of 141 patients (median age 39 (IQR 33-45) years, 68% men) underwent 191 cardiac catheterisations. At baseline, 55% had PH (isolated postcapillary 24%, combined precapillary and postcapillary 26% and precapillary 5%). BNP (area under the curve 0.80; 95% CI 0.72 to 0.88; p<0.0001), but not age at catheterisation or echocardiographic estimates of LVSP were associated with the presence of PH. The absence of PH and BNP <100 pg/mL discriminated a subgroup at very low risk during short-term (2.5 (1.3-3.9) years) follow-up (p<0.0001). Diuretics, milrinone and VAD improved haemodynamics over time., Conclusion: PH is prevalent in patients with 2V-RV even when asymptomatic. It is difficult to identify by echocardiography and most importantly, is strongly associated with adverse outcomes. PH affects prognosis and transplant options for this patient group and yet is often amenable to treatment. Awareness of these results ought to lower the threshold for invasive haemodynamic assessment and may change the management of failing patients with 2V-RV., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: The risk of HeartMate II (HMII) left ventricular assist device (LVAD) thrombosis has been reported, and serum lactate dehydrogenase (LDH), a biomarker of haemolysis, increases secondary to LVAD thrombosis. This study evaluated longitudinal measurements of LDH post-LVAD implantation, hypothesizing that LDH trends could timely predict future LVAD thrombosis., Methods and Results: From October 2004 to October 2014, 350 HMIIs were implanted in 323 patients at Cleveland Clinic. Of these, patients on 339 HMIIs had at least one post-implant LDH value (7996 total measurements). A two-step joint model combining longitudinal biomarker data and pump thrombosis events was generated to assess the effect of changing LDH on thrombosis risk. Device-specific LDH trends were first smoothed using multivariate boosted trees, and then used as a time-varying covariate function in a multiphase hazard model to analyse time to thrombosis. Pre-implant variables associated with time-varying LDH values post-implant using boostmtree were also investigated. Standardized variable importance for each variable was estimated as the difference between model-based prediction error of LDH when the variable was randomly permuted and prediction error without permuting the values. The larger this difference, the more important a variable is for predicting the trajectory of post-implant LDH. Thirty-five HMIIs (10%) had either confirmed (18) or suspected (17) thrombosis, with 15 (43%) occurring within 3 months of implant. LDH was associated with thrombosis occurring both early and late after implant (P < 0.0001 for both hazard phases). The model demonstrated increased probability of HMII thrombosis as LDH trended upward, with steep changes in LDH trajectory paralleling trajectories in probability of pump thrombosis. The most important baseline variables predictive of the longitudinal pattern of LDH were higher bilirubin, higher pre-implant LDH, and older age. The effect of some pre-implant variables such as sodium on the post-implant LDH longitudinal pattern differed across time., Conclusions: Longitudinal trends in surveillance LDH for patients on HMII support are useful for dynamic prediction of pump thrombosis, both early after implant and late. Incorporating upward and downward trends in LDH that dynamically update a model of LVAD thrombosis risk provides a useful tool for clinical management and decisions., (© 2019 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

Background: Women comprise approximately one-third of the advanced heart failure population but may receive fewer advanced heart failure therapies including left ventricular assist devices (LVADs). During the early pulsatile-flow device era, women had higher post-LVAD mortality and increased complications. However, knowledge about these differences in the continuous-flow device era is limited. Therefore, we sought to explore temporal trends in LVAD utilization and post-LVAD mortality by sex., Methods and Results: Patients with LVAD implantation from 2004 to 2016 were identified using the Nationwide Inpatient Sample. Trends in LVAD utilization and post-LVAD inpatient mortality were compared by sex and device era. Although LVADs are being increasingly utilized for patients with advanced systolic heart failure, women continue to represent a smaller proportion of LVAD recipients-25.8% in 2004 to 21.9% in 2016 ( P for trend, 0.91). Women had increased inpatient mortality after LVAD implantation compared with men in the pulsatile-flow era (46.9% versus 31.1%, P <0.0001) but not in the continuous-flow era (13.3% versus 12.1%, P =0.27; P for interaction=0.0002). Inpatient mortality decreased for both sexes over time after LVAD, with a sharp fall in 2008 to 2009. Female sex was independently associated with increased post-LVAD inpatient mortality beyond adjustment for demographics and risk factors during the pulsatile-flow era (odds ratio, 2.13; 95% CI, 1.45-3.10; P <0.0001) but not during the continuous-flow era (1.18; 0.93-1.48; P =0.16)., Conclusions: Although utilization of LVAD therapy increased over time for both sexes, LVAD implantation remains stably lower in women, which may suggest a potential underutilization of this potentially life-saving therapy. Prospective studies are needed to confirm these findings.

Objective: The aim of the study was to examine the functional outcomes and medical complications of patients with left ventricular assist device implantation and subsequent stroke during comprehensive inpatient rehabilitation., Design: Retrospective cohort study of 21 patients admitted to an inpatient rehabilitation facility between 2009 and 2015. Main outcome measurements include admission and discharge Functional Independence Measure, length of stay, and Functional Independence Measure efficiency., Results: The study included 17 male and 4 female patients aged 32-75 yrs. Eleven patients (52%) required transfer to an acute care hospital for evaluation. Fifteen patients completed inpatient rehabilitation with median [interquartile range] length of stay 26 [13.5-34] days (range = 7-59 days), median [interquartile range] Functional Independence Measure gain of 18 [12.5-32], and median [interquartile range] Functional Independence Measure efficiency of 1.0 [0.6-1.44]. Patients who required transfer to acute care during their course but ultimately completed inpatient rehabilitation (n = 5) demonstrated larger median [interquartile range] Functional Independence Measure gain (40 [23-42]) and longer median [interquartile range] length of stay (35 [35-42]) compared with patients who completed inpatient rehabilitation without transfer (Functional Independence Measure gain = 15 [9.25-26.5]; length of stay = 14.5 [11.5-26.25])., Conclusions: Patients with left ventricular assist device implantation and subsequent stroke demonstrate functional gains during acute inpatient rehabilitation programs. A large percent of patients required transfer to acute care.

Background: Percutaneous mechanical circulatory support devices (pMCSDs) are increasingly used on the assumption (but without solid proof) that their use will improve prognosis. A meta-analysis was undertaken according to the PRISMA guidelines to evaluate the benefits of pMCSDs in patients undergoing high-risk percutaneous coronary intervention (hr-PCI)., Methods: We searched PubMed, EMbase, Cochrane Library, Clinical Trial.gov, and other databases to identify eligible studies. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated for 30-day and 6-month all-cause mortality rates, reinfarction, and other adverse events using a random effect model., Results: Sixteen randomized controlled trials (RCTs) were included in this study. In the pooled analysis, intra-aortic balloon pump (IABP) was not associated with a decrease in 30-day and 6-month all-cause mortality (RR 1.01 95% CI 0.61-1.66; RR 0.88 95% CI 0.66-1.17), reinfarction (RR 0.89 95% CI 0.69-1.14), stroke/transient ischemic attack (TIA) (RR 1.75 95% CI 0.47-6.42), heart failure (HF) (RR 0.54 95% CI 0.11-2.66), repeat revascularization (RR 0.73 95% CI 0.25-2.10), embolization (RR 3.00 95% CI 0.13-71.61), or arrhythmia (RR 2.81 95% CI 0.30-26.11). Compared with IABP, left ventricular assist devices (LVADs) were not associated with a decrease in 30-day and 6-month all-cause mortality (RR 0.96 95% CI 0.71-1.29; RR 1.23 95% CI 0.88-1.72), reinfarction (RR 0.98 95% CI 0.68-1.42), stroke/TIA (RR 0.45 95% CI 0.1-1.95), acute kidney injury (AKI) (RR 0.83 95% CI 0.38-1.80), or arrhythmia (RR 1.52 95% CI 0.71-3.27), but LVADs were associated with a decrease in repeat revascularization (RR 0.26 95% CI 0.08-0.83). However, LVADs significantly increased the risk of bleeding compared with IABP (RR 2.85 95% CI 1.72-4.73)., Conclusions: Neither LVADs nor IABP improves short or long-term survival in hr-PCI patients. LVADs are more likely to reduce repeat revascularization after PCI, but to increase the risk of bleeding events than IABP.

Cardiogenic shock (CS) is associated with high morbidity and mortality despite recent advances in the temporary mechanical circulatory support (MCS) devices. The current utilization and outcomes of these MCS devices with or without vasopressors compared with conventional medical therapy (no-MCS) in CS remain poorly described. The study population was extracted from the 2014 Nationwide Readmissions Database using International Classification of Diseases, Ninth Revision, Clinical Modification codes for CS, temporary MCS devices, and vasopressor infusion. Study end points included in-hospital all-cause mortality, length of index hospital stay (LOS), the likelihood of receiving invasive treatment, postprocedural bleeding, vascular complications, total hospitalization charges, and discharge disposition. A total of 59,148 discharges with a diagnosis of CS were identified (age 67 years; 38.5% female). Temporary MCS devices were utilized in 22.7%. The use of these devices was associated with lower in-hospital all-cause mortality (33.0% vs 39.7%, p <0.01), increased likelihood of invasive therapy (75.7% vs 26.3%, p <0.01), and increased likelihood of being discharged home (24.8% vs 20.6%, p <0.01). However, the MCS group had longer LOS (16.9 vs 12.1 days, p <0.01), higher vascular complications (2.6% vs 1.4%, p <0.01), bleeding (31.2% vs 16.8%, p <0.01), and total hospitalization charges ($374,574 vs $182,045, p <0.01). In conclusion, the use of the temporary MCS devices for the treatment of CS was associated with lower mortality, increased the likelihood of receiving invasive treatment and the likelihood of being discharged home. However, it was associated with higher in-hospital complications, LOS, and hospitalization charges., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: The use of ventricular assist devices for pediatric patients with heart failure is increasing, but is associated with significant morbidity and mortality. Our objectives were to describe the admission outcomes and resource utilization of pediatric patients supported with ventricular assist devices, utilizing a multicenter database., Data Sources: Pediatric Health Information System database (comprising 49 nonprofit children's hospitals)., Study Selection: Retrospective cohort analysis of the database from January 2006 to September 2015 for all admissions less than or equal to 21 years old with ventricular assist device implantation., Data Extraction: The primary outcome was hospital mortality. The secondary outcomes were hospital length of stay and adjusted cost., Data Synthesis: We analyzed 744 ventricular assist device implantations (740 patients), 422 (57%) males, and 363 (49%) non-Hispanic white. Median age at admission was 5.9 years (interquartile range, 0.9-13.5 yr), and median length of stay was 69 days (interquartile range, 36-122 d). The overall hospital mortality was 188 (25%), whereas 395 (53%) were transplanted and 141 (19%) were discharged on ventricular assist device. Extracorporeal membrane oxygenation was used, in addition to ventricular assist device, in 340 (46%). The majority of ventricular assist device implantations (453, 61%) were from 2011 to 2015 (compared to 2006-2010). More patients discharged on ventricular assist device from 2011 to 2015 (23% vs 13% in 2006-2010; p = 0.001). There was no difference in median age, mortality, length of stay, or adjusted costs between these time periods. On multivariable analysis, underlying congenital heart disease, renal failure, liver congestion, sepsis, cerebrovascular accident, and extracorporeal membrane oxygenation were associated with hospital mortality. Sepsis and ventricular assist device replacement/repair were associated with higher adjusted cost and longer length of stay., Conclusions: The pediatric ventricular assist device experience continues to grow, with a significant increase in the number of patients undergoing ventricular assist device implantation and a higher proportion being discharged from hospital on ventricular assist device support in recent years. Underlying congenital heart disease, renal failure, sepsis, cerebrovascular accident, and extracorporeal membrane oxygenation are significantly associated with hospital mortality.

Objectives: This study aimed to evaluate incidence, clinical significance, and predictors of early ventricular arrhythmias (VAs) in left ventricular assist device (LVAD) recipients., Background: LVAD implantation is increasingly used in patients with end-stage heart failure. Early VAs may occur during the 30-day post-operative period, but many questions remain unanswered regarding their incidence and clinical impact., Methods: This observational study was conducted in 19 centers between 2006 and 2016. Early VAs were defined as sustained ventricular tachycardia and/or ventricular fibrillation occurring <30 days post-LVAD implantation and requiring appropriate implantable cardioverter-defibrillator therapy, external electrical shock, or medical therapy., Results: A total of 652 patients (median age: 59.8 years; left ventricular ejection fraction: 20.7 ± 7.4%; HeartMate 2: 72.8%; HeartWare: 19.5%; Jarvik 2000: 7.7%) were included in the analysis. Early VAs occurred in 162 patients (24.8%), most frequently during the first week after LVAD implantation. Multivariable analysis identified history of VAs prior to LVAD and any combined surgery with LVAD as 2 predictors of early VAs. The occurrence of early VAs with electrical storm was the strongest predictor of 30-day post-operative mortality, associated with a 7-fold increase of 30-day mortality. However, in patients discharged alive from hospital, occurrence of early VAs did not influence long-term survival., Conclusions: Early VAs are common after LVAD implantation and increase 30-day post-operative mortality, without affecting long-term survival. Further studies will be needed to analyze whether pre- or pre-operative ablation of VAs may improve post-operative outcomes. (Determination of Risk Factors of Ventricular Arrhythmias After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device [ASSIST-ICD]; NCT02873169)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular assist device (LVAD)-associated infections may be life-threatening and impact patients' outcome. We aimed to identify the characteristics, risk factors, and prognosis of LVAD-associated infections., Methods: Patients included in the ASSIST-ICD study (19 centers) were enrolled. The main outcome was the occurrence of LVAD-associated infection (driveline infection, pocket infection, or pump/cannula infection) during follow-up., Results: Of the 652 patients enrolled, 201 (30.1%) presented a total of 248 LVAD infections diagnosed 6.5 months after implantation, including 171 (26.2%), 51 (7.8%), and 26 (4.0%) percutaneous driveline infection, pocket infection, or pump/cannula infection, respectively. Patients with infections were aged 58.7 years, and most received HeartMate II (82.1%) or HeartWare (13.4%). Most patients (62%) had implantable cardioverter-defibrillators (ICDs) before LVAD, and 104 (16.0%) had ICD implantation, extraction, or replacement after the LVAD surgery. Main pathogens found among the 248 infections were Staphylococcus aureus (n = 113' 45.4%), Enterobacteriaceae (n = 61; 24.6%), Pseudomonas aeruginosa (n = 34; 13.7%), coagulase-negative staphylococci (n = 13; 5.2%), and Candida species (n = 13; 5.2%). In multivariable analysis, HeartMate II (subhazard ratio, 1.56; 95% CI, 1.03 to 2.36; P = .031) and ICD-related procedures post-LVAD (subhazard ratio, 1.43; 95% CI, 1.03-1.98; P = .031) were significantly associated with LVAD infections. Infections had no detrimental impact on survival., Conclusions: Left ventricular assist device-associated infections affect one-third of LVAD recipients, mostly related to skin pathogens and gram-negative bacilli, with increased risk with HeartMate II as compared with HeartWare, and in patients who required ICD-related procedures post-LVAD. This is a plea to better select patients needing ICD implantation/replacement after LVAD implantation., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background The effect of implantable cardioverter defibrillators ( ICD ) in patients with continuous flow left ventricular assist devices ( LVAD s) on outcomes has not been evaluated in a randomized clinical trial. Methods and Results This is a retrospective single-center study that included patients who underwent continuous flow LVAD implantation at the Cleveland Clinic between October 2004 and March 2017. Patients were evaluated according to the presence or absence of ICD at the time of LVAD insertion. Among 486 patients in the study cohort, 387 (79.6%) had an ICD before LVAD insertion. Patients with ICD before LVAD were older and had lower use of pre- LVAD inotropes, extracorporeal membrane oxygenation, and mechanical ventilation. There were 81 patients (21.4% of patients with ICD ) who required 93 procedures after LVAD : 74 generator exchanges, 12 lead revisions, and 7 complete system removals because of infection. Of the 99 patients without ICD , 52 (53%) underwent ICD implantation: 29 for primary prevention and 23 for secondary prevention. Patients were followed for a median of 401 (interquartile range 150-966) days. The presence of a pre- LVAD ICD was not associated with mortality in a multivariable model (hazard ratio 1.19, 95% CI 0.73-1.93, P=0.492), nor was the presence of an ICD at any point when analyzed as a time-varying covariate (hazard ratio 1.05, 95% CI 0.50-2.20, P=0.907). Conclusions There is no apparent mortality benefit associated with an ICD in a contemporary cohort of patients with continuous flow LVAD s to balance considerable morbidity involving ICD -related procedures and complications.

The objectives were to study the overall and age-, sex-, and race-stratified incidence of cardiogenic shock (CS) during heart failure hospitalizations (HFHs) not complicated by acute coronary syndromes (ACS), utilization of short-term mechanical circulatory support (MCS) and in-hospital mortality with non-ACS-related CS, and respective temporal trends. Data are lacking regarding the epidemiology of non-ACS-related CS during HFHs., Methods: Retrospective observational analysis of the National Inpatient Sample 2005-2014 to identify all HFHs in adult patients without concomitant ACS., Results: Of 8,333,752 HFHs, incidence rate of non-ACS-related CS was 8.7 per thousand HFHs (N = 72,668), a 4-fold increase from 4.1 to 15.6 per thousand HFHs between 2005 and 2014 (P trend < .001). Among those with non-ACS-related CS, utilization rates of intra-aortic balloon pump, extracorporeal membrane oxygenation, and temporary ventricular assist devices were 12.8%, 1.4%, and 2.5%, respectively. Respective 2005 to 2014 trends were 14.2% to 10.7%, 0.6% to 1.8%, and 0.8% to 2.7% (P trend for all, <.001). In-hospital mortality rate was 27.1%, with a substantial decrease from 42.4% in 2005 to 23.3% in 2014 (P trend < .001). These temporal trends were largely consistent across age, sex, and race subgroups., Conclusion: During HFHs in the United States, non-ACS-related CS occurred infrequently but was associated with substantial mortality. Non-ACS-related CS incidence and certain MCS utilization rates increased, and in-hospital mortality rate decreased between 2005 and 2014. These trends were generally homogenous across the age, sex, and race groups. The observed trends in incidence and mortality may be a reflection of increased identification of CS during HFHs, although further study is needed to assess whether temporal changes in care may have influenced outcomes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Left ventricular assist devices (LVADs) have revolutionized the treatment of advanced heart failure, but proliferation of device therapy has unmasked potential complications. Reports have emerged of outflow graft narrowing due to extrinsic compression., Methods and Results: The records of patients with LVADs that had been implanted at our institution were reviewed. Those who had postimplantation computed tomography angiographies sufficient to analyze the outflow graft lumen were identified, and the studies were analyzed to characterize the outflow graft lumen. We identified 241 patients; 110 (46%) had suitable computed tomography angiographies. Of those, 15 (14%) had evidence of outflow graft lumen narrowing, all in HeartMate devices and all within the portion covered by the bend relief. Of the 15, 3 underwent invasive examination, all without intraluminal thrombus but, rather, with biodebris between the bend relief and the outflow graft. Patients with HeartWare devices had a wide range of biodebris accumulation surrounding the outflow graft but no cases of lumen narrowing. On multivariable analysis, 1) time from device implant to scan, 2) nonischemic cardiomyopathy and 3) age at implant were significantly associated with higher risk of graft narrowing., Conclusion: Outflow graft narrowing can be seen in a number of patients with HeartMate LVADs within the portion covered by the bend relief. In the limited number of patients who underwent invasive evaluation, the narrowing was found to arise from extrinsic compression rather than intraluminal thrombus. The clinical significance of this requires further investigation., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Despite the growing acceptance of left ventricular assist device (LVAD) therapy to improve survival and quality of life in heart failure (HF) patients, uncertainties persist regarding the definition of a successful implant. We sought to define an innovative approach to assess success and subsequently compare preoperative variables affecting outcomes. From January 2007 to 2015, 278 patients underwent LVAD implantation. Median age at implant was 62 years and 81% patients were males. Indication for support was bridge-to-transplantation in 36% patients and the etiology of HF was ischemic in 49% patients. Based on clinically relevant and accepted standards, we defined successful LVAD implant as someone who was alive or transplanted at 2 years, had two or less readmissions in the first year, had no major adverse events in the first year, and had a New York Heart Association class of ≤ II at 6 months. Follow-up was obtained for a median of 1.7 years for a total of 605 patient-years-of-support. Based on our criteria, 81/278 (29%) patients were defined as having a successful implant. Univariate predictors of LVAD failure included destination therapy indication (hazard ratio [HR] = 2.11 [1.24, 3.58]), ischemic cardiomyopathy (HR = 1.73 [1.02, 2.94]), and a higher left ventricular ejection fraction (HR = 1.54 [1.07, 2.22]). After multivariable analysis, only destination therapy indication (HR = 2.2 [1.28, 3.78]) was found to be independently predictive of success failure. Despite an overall trend toward improved outcomes on device therapy, our criteria classified only one-third of patients as successful. Continued improvements in adverse event profiles, appropriate patient selection, and optimal time of implantation, together hold the key to improve outcomes after LVAD therapy.

Background: Patients considering destination therapy left ventricular assist devices (DT LVAD) often have high comorbid burden but the association between these comorbidities and post-decision outcomes is unknown., Methods: We included subjects in DECIDE-LVAD (NCT02344576), a stepped-wedge multicenter trial of patients considering LVADs, recording comorbidities per INTERMACS protocol. We compared decisional conflict, regret, perceived stress, quality of life (EQ-VAS), depression (PHQ-2), struggle with- and acceptance of illness by comorbid burden and amongst the most common comorbidities., Results: Of 239 patients, LVAD recipients (n = 164) and non-recipients (n = 75) had a similar proportion with ≥1 comorbidity (70% v. 80%, P = .09). Patients with comorbidities were younger regardless of LVAD implantation status. After adjusting for age, overall and amongst LVAD recipients, patients with ≥1 comorbidity had higher mean decision conflict at baseline (23.2 ± 1.5 vs. 17.4 ± 2.2), and at 6 months, higher stress (13.0 ± 0.6 vs. 10.4 ± 1.0) and struggle with illness (13.3 ± 0.4 vs. 11.1 ± 0.6) than those without comorbidities (P < .05). No difference was noted in decision regret, PHQ-2, EQ-VAS, acceptance of illness and survival overall and amongst LVAD recipients. Of the three most common comorbidities, while patients with pulmonary hypertension had worse decision regret, depression, stress and acceptance of illness at 6-month follow-up than those who did not have pulmonary hypertension, no difference was noted in patients with chronic renal disease or high body mass index., Conclusion: Patients considering LVAD implantation with comorbidities experience increased decision conflict, stress and struggle with illness. These findings provide insights in the role comorbidities play in patient decision-making and decisional outcomes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: Publications on the paediatric Berlin Heart EXCOR ventricular assist device have revealed that low body weight <10 kg is a significant risk factor for mortality with children weighing <5 kg being at the highest risk. However, these studies are limited to implantation periods prior to 2011. Since then, progress has been made in the optimization of patient selection and management. This study investigated whether the survival of children weighing <10 kg supported with the EXCOR assist device has improved in recent years and sought to determine the risk factors for mortality., Methods: The Berlin Heart EXCOR prospective registry (n = 1832) was retrospectively reviewed between 2000 and 2017 to compare the outcomes of different weight cohorts: A (<5 kg; n = 204), B (5-10 kg; n = 633) and C (>10 kg; n = 995) in different eras [era 1: January 2000-December 2012 (n = 1089) and era 2: January 2013-June 2017 (n = 743)]., Results: Overall survival in groups A and B significantly increased from era 1 to era 2 (group A 51% vs 65%, P < 0.001; group B 74% vs 78%, P = 0.001), whereas it remained stable in group C (78% vs 73%). In era 2, the survival of group B was not significantly different from group C. On the multivariable analysis of children weighing <5 kg, congenital heart disease, preoperative extracorporeal life support and biventricular support were independently associated with increased mortality in era 1 [hazard ratio 2.04 (95% confidence interval 1.18-3.53); 2.44 (1.36-4.37) and 1.93 (1.11-3.34), respectively] but not in era 2., Conclusions: Paediatric EXCOR ventricular assist device therapy has significantly improved for patients weighing <10 kg. Withholding a ventricular assist device is not justified on the basis of the body weight alone., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

The left ventricular assist device (LVAD) is becoming the standard of care in treating patients with advanced heart failure. This article describes available LVADs, their clinical indications, and important caveats when caring for this complex patient population.

Background: The pulmonary artery catheter (PAC) has been used in a wide range of critically ill patients. It is not indicated for routine care of heart failure (HF), but its role in cardiogenic shock (CS) has not been clarified., Methods and Results: We conducted a retrospective cohort study with the use of the National Inpatient Sample and identified a total of 9,431,944 adult patients admitted from 2004 to 2014 with the primary diagnosis of HF (n = 8,516,528) or who developed CS (n = 915,416) during the index hospitalization. Overall, patients with PAC had increased hospital costs, length of stay, and mechanical circulatory support use. In patients with HF, PAC use was associated with higher mortality (9.9% vs 3.3%, OR 3.96; P < .001) but the excess of mortality declined over time. In those with CS, PAC was associated with lower mortality (35.1% vs 39.2%, OR 0.91; P < .001) and in-hospital cardiac arrest (14.9% vs 18.3%, OR 0.77; P < .001); this paradox persisted after propensity score matching., Conclusions: The use of PAC in CS has decreased from 2004 to 2014, although its use is now associated with improved outcomes, which may reflect better selection of patients or better use of the information to guide therapies. Our data provide reassurance that PAC use in this population is an appropriate strategy., (Copyright © 2019 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: Angiotensin II receptor activation may result in angiogenesis, and ultimately arteriovenous malformations (AVM), through transforming growth factor (TGF)-β and angiopoietin-2 pathway activation., Objectives: The goal of this study was to determine whether angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) were associated with lower risk of major gastrointestinal bleeds (GIB) and AVM-related GIBs in continuous-flow left ventricular assist device (CF-LVAD) patients., Methods: The authors reviewed HeartMate II CF-LVAD recipients between January 2009 and July 2016. Major GIBs were endoscopically confirmed requiring ≥2 U of packed red blood cells or resulting in death. ACE inhibitor/ARB dose was abstracted from medical records. ACE inhibitor/ARB exposure status was landmarked at 30 days post-operatively to avoid immortal time bias. Fine and Gray hazard models assessed the impact of ACE inhibitor/ARB therapy on major GIB and AVM-related GIB, whereas standard Cox regression assessed the impact on mortality, adjusting for baseline variables., Results: One-hundred and eleven patients were included with a mean 2.1 ± 1.4 years follow-up. Patients who received an ACE inhibitor/ARB within 30 days post-operatively had a 57% reduction in the risk of major GIB (adjusted hazard ratio [aHR]: 0.43; 95% confidence interval [CI]: 0.19 to 0.97; p = 0.042) and a 63% reduction in the risk of AVM-related GIB (aHR: 0.37; 95% CI: 0.16 to 0.84; p = 0.017). When the mean daily post-operative lisinopril-equivalent ACE inhibitor/ARB dose was >5 mg, the risk of major GIB decreased in a dose-threshold manner (aHR: 0.28; 95% CI: 0.09 to 0.85; p = 0.025)., Conclusions: ACE inhibitor/ARB therapy is associated with a protective effect of developing GIBs in CF-LVAD patients, with a dose threshold of >5 mg of daily lisinopril equivalence, possibly due to prevention of AVM formation., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to describe the burden of atrial fibrillation (AF)/atrial flutter (AFL) in patients with left ventricular assist devices (LVAD) and to evaluate the impact of rhythm control strategies., Background: AF and AFL among patients with LVADs are poorly characterized., Methods: Retrospective multivariable survival analysis of all LVAD recipients at the Cleveland Clinic from January 1, 2004 to June 30, 2016 examining the association of death, thromboembolism, and major bleeding with AF/AFL and exposure to rhythm control measures., Results: Among 418 patients (median age: 58 [interquartile range: 50 to 67] years, 80% male) with median follow-up of 445 (interquartile range: 165 to 936) days, AF (n = 287 of 418, 69%) and AFL (n = 61 of 418, 15%) were highly prevalent. Patients with AF/AFL (n = 302 of 418, 72%) and without AF/AFL (n = 116 of 418, 28%) had similar mortality (39% vs. 38%; p = 0.88) and major bleeding (46% vs. 49%; p = 0.53); AF/AFL patients had fewer thromboembolic events (13% vs. 23%; p < 0.01). Paroxysmal or persistent AF/AFL was present in 238 patients (57%), and rhythm control exposure (n = 166, 70%) was not associated with decreased mortality (39% vs. 43%; p = 0.57), thromboembolism (13% vs. 17%; p = 0.41), or bleeding (49% vs. 39%; p = 0.16). In the multivariable survival analysis only prior valve surgery (hazard ratio: 2.0; 95% confidence interval: 1.3 to 3.0; p = 0.002) was associated with increased hazard; AF/AFL had no association with risk of death, thromboembolism, or bleeding., Conclusions: Though highly prevalent among LVAD patients, AF/AFL was not associated with increased mortality, thromboembolism, or bleeding, and among paroxysmal/persistent AF patients, rhythm control measures were not associated with improved outcomes., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.)

The impact of cardiac resynchronization therapy (CRT) on clinical outcome in patients with a continuous-flow left ventricular assist device (LVAD) is currently not well understood. We conducted a systematic literature review and meta-analysis with an intention to summarize all published clinical evidence. We searched MEDLINE and EMBASE databases through March 2018 for studies that compared the outcomes in patients with LVAD and CRT. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated using a random-effects model, inverse variance method. The between-study heterogeneity was assessed using the Q statistic and I 2 . A total of seven studies that included 1157 (575 CRT; 582 non-CRT) patients were identified. Our meta-analysis did not demonstrate a significant difference in the risk of mortality (pooled OR = 1.21, 95% CI 0.90-1.63, P = 0.21), ventricular arrhythmia incidence (pooled OR = 1.36, 95% CI 0.99-1.86, P = 0.06), hospitalization (pooled OR = 1.36, 95% CI 0.59-3.14, P = 0.48), or implantable cardioverter defibrillator therapies (pooled OR = 1.08, 95% CI 0.51-2.30, P = 0.84) among the CRT group compared with the non-CRT group. There was high heterogeneity with an I 2 of 75% for ICD therapies. Among LVAD patients, CRT combined did not significantly affect mortality, re-hospitalization, ventricular arrhythmia incidence, and ICD therapies.

Heart failure is a widespread condition in the United States that is predicted to significantly increase in prevalence in the next decade. Many heart failure patients are given a left ventricular assist device (LVAD) while they wait for a heart transplant, while those that are not able to undergo a heart transplant may be given an LVAD permanently. However, past studies have observed a small subset of heart failure patients that recovered cardiac function of their native heart after being placed on an LVAD. As a result, some patients have been able to have their LVAD explanted and no longer needed a heart transplant. In this review, we analyzed the data of 15 studies that observed recovery of cardiac function in LVAD patients in order to investigate the effects that duration of LVAD support has on patient outcomes. From our review, we identified that there may be negative consequences of prolonged duration of mechanical support such as myocardial atrophy and abnormal calcium cycling as well as circumstances that may allow for a longer duration of LVAD support such as in patients using a continuous-flow LVAD, non-ischemic cardiomyopathy patients, and the specific pharmacological therapy.

Objective: To study the survival and patient outcome in a population of UK patients supported by an implantable left ventricular assist device (LVAD) as a bridge to heart transplantation., Methods: Data on all adult patients (n=342) who received a HeartMate II or HVAD as a first long-term LVAD between January 2007 and 31 December 2013 were extracted from the UK Ventricular Assist Device (VAD) Database in November 2015. Outcomes analysed include survival on a LVAD, time to urgent listing, heart transplantation and complications including those needing a pump exchange., Results: 112 patients were supported with the Thoratec HeartMate II and 230 were supported with the HeartWare HVAD. Median duration of support was 534 days. During the study period, 81 patients required moving to the UK urgent waiting list for heart transplantation. Of the 342 patients, 85 (24.8%) received a heart transplant, this included 63 on the urgent list. Thirty-day survival was 88.9%, while overall patient survival at 3 years from LVAD implant was 49.6%. 156 patients (46%) died during LVAD support; the most common cause of death on a VAD was a cerebrovascular accident. There was no significant difference between the two devices used in any outcome., Conclusions: In a population of patients with advanced heart failure, who have a very poor prognosis, support with an implantable LVAD allowed a quarter to receive a heart transplant in a 3-year period. Overall survival of the cohort was about 50%. With improvement in technology and in post-LVAD management, it is likely that outcomes will improve further., Competing Interests: Competing interests: ST: Proctor and Investigator for Medtronic (HeartWare); RV: Proctor and Consultant for Abbott (Thoratec), SSh: Proctor and Consultant for Medtronic (HeartWare), AS: Consultant for Medtronic (HeartWare), SSc: Consultant for Abbott (Thoratec)., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

The number of patients with end-stage heart failure (HF) continues to increase over time, but there has been little change in the availability of organs for cardiac transplantation, intensifying the demand for left ventricular assist devices (LVADs) as a bridge to transplantation. There is also a growing number of patients with end-stage HF who are not transplant candidates but may be eligible for long-term support with an LVAD, known as destination therapy. Due to this increasing demand, LVAD technology has evolved, resulting in transformative improvements in outcomes. Additionally, with growing clinical experience patient management continues to be refined, leading to iterative improvements in outcomes. With outcomes continuing to improve, the potential benefit from LVAD therapy is being considered for patients earlier in their course of advanced HF. We review recent changes in technology, patient management, and implant decision making in LVAD therapy.

Objectives: Fixed pulmonary hypertension (fPH) is a contraindication for heart transplantation (HTX). Left ventricular assist device (LVAD) implantation as a bridge to candidacy can reverse fPH in patients with terminal heart failure by chronic left ventricular unloading. We report our institutional experience with terminal heart failure patients and fPH that were successfully bridged to candidacy and underwent subsequent HTX., Methods: We retrospectively reviewed the data of 79 patients with terminal heart failure and fPH who were successfully bridged to candidacy for HTX with 6 different LVAD devices at our centre from October 1998 to September 2016 (Novacor n = 4, MicroMed DeBakey n = 29, DuraHeart n = 2, HeartMate II n = 14, HVAD n = 29 and MVAD n = 1). Median duration of LVAD support was 288 days (range 45-2279 days). Within the same timeframe, a control group of 48 patients underwent HTX after bridge-to-transplant LVAD therapy for reasons other than PH. Study end points were (i) development of fPH after LVAD implantation, (ii) post-transplant outcomes and (iii) incidence of severe adverse events., Results: Pulmonary vascular resistance, assessed by vasodynamic catheterization, was 4.3 ± 1.8 WU before LVAD implantation. After a median support period of 89 days (interquartile range 4-156 days), pulmonary vascular resistance decreased to 2.0 ± 0.9 WU (P ≤ 0.001), and patients were listed for HTX. Median duration of LVAD support in the study group was 288 days (45-2279 days). We observed 2 patients (2.5%) with acute right heart failure who required extracorporeal mechanical support after HTX in the study group. Long-term post-transplant survival between the study group (3 years: 83.5%, 5 years: 81.0%) and the control group (3 years: 87.5%, 5 years: 85.4%) was comparable (log-rank: P = 0.585)., Conclusions: LVAD implantation as a bridge to candidacy reverses fPH in patients with terminal heart failure. Post-HTX survival is excellent and comparable to results obtained in patients without fPH at the time of HTX listing.

Objectives: Aim of the study was to assess in-hospital survival rate and the degree of myocardial recovery after MCS treatment (IABP or IMPELLA) at discharge and at 6 months in patients with AMI-CS and planned early percutaneous revascularization., Background: All studies on MCS for acute myocardial infarction related cardiogenic shock (AMI-CS) focused on its impact on in-hospital mortality; however, few data about its role on myocardial recovery are available., Methods: Retrospective study on 64 patients: 36 patients (56%) received IABP and 28 (44%) Impella 2.5/CP., Results: Patients treated with Impella were sicker compared to those treated with IABP as shown by a higher need of catecholamines (93% Impella vs 57% IABP, P = 0.002) and higher inotropic score before procedure: 8 (5-15) versus 4.5 (0-9), P = 0.02. In-hospital survival and MCS-related complications were comparable; hemolysis was more frequent in the Impella group (32% vs 0%, P < 0.0001). Myocardial damage was lower in those patients who were implanted with IMPELLA before PCI: lower troponin peak [3831 ng/dL (1441-8436) vs 16 581 (7802-23 675), P = 0.004] and lower CPK peak [893 UI/L (584-4082) vs 5797 (2483-9292) P = 0.04]. Impella patients had higher LVEF at 6 months [45 (38-52) vs 40 (33-45)%, P = 0.04]. LVEF increase at 6 months was statistically significant in both groups (P < 0.0001), with higher myocardial recovery in patients supported with Impella (absolute delta-LVEF increase 20% vs 10% P = 0.005)., Conclusions: Cardiac unloading with IMPELLA in ACS-CS, especially if implanted before PCI, might provide lower myocardial damage and improved myocardial recovery which translates into significantly higher LVEF at 6 months., (© 2018 Wiley Periodicals, Inc.)

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.)

Objectives: EUROMACS is a registry of the European Association for Cardio-Thoracic Surgery (EACTS) whose purpose is to gather clinical data related to durable mechanical circulatory support for scientific purposes and to publish annual reports. Because the treatment of children with end-stage heart failure has several significantly different characteristics than the treatment of adults, data and outcomes of interventions are analysed in this dedicated paediatric report., Methods: Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (≤19 years of age) performed from 1 January 2000 to 31 December 2017 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events., Results: Twenty-five hospitals contributed 237 registered implants in 210 patients (81 ♀, 129 ♂) to the registry. The most frequent diagnosis was any form of cardiomyopathy (71.4%) followed by congenital heart disease (18.6%). Overall mean support time on a device was 11.6 months (±16.5 standard deviation). A total of 173 children (82.4%) survived to transplant, recovery or are ongoing; 37 patients (17.6%) died while on support within the observed follow-up time. At 12 months 38% of patients received transplants, 7% were weaned from their device and 15% died. At 24 months, 51% of patients received transplants, 17% died while on support, 22% were on a device and 9% were explanted due to myocardial recovery. The adverse events rate per 100 patient-months was 11.97 for device malfunction, 2.83 for major bleeding, 2.83 for major infection and 1.52 for neurological events within the first 3 months after implantation., Conclusions: The first paediatric EUROMACS report reveals a low transplant rate in European countries within the first 2 years of implantation compared to US data. The 1-year survival rate seems to be satisfactory. Device malfunction including pump chamber changes due to thrombosis was the most frequent adverse event.

Introduction: Left ventricular assist device (LVAD) insertion is an increasingly common intervention for patients with advanced heart failure; however, published literature on the emergency department (ED) presentation of this population is limited. The objective of this study was to characterize ED presentations of patients with LVADs with a focus on device-specific complications to inform provider education and preparation initiatives., Methods: This was a retrospective chart review of all patients with LVADs followed at an urban academic medical center presenting to the ED over a five-year period (July 1, 2009, to June 30, 2014). Two abstractors reviewed 45 randomly selected charts to standardize the abstraction process and establish a priori categories for reason for presentation to the ED. Remaining charts were then divided evenly for review by one of the two abstractors. Primary outcomes for this study were (1) frequency of and (2) reason for presentation to the ED by patients with LVADs., Results: Of 349 patients with LVADs identified, 143 (41.0%) had ED encounters during the study period. There were 620 total ED encounters, (range 1 to 32 encounters per patient, median=3, standard deviation=5.3). Among the encounters, 431 (69.5%) resulted in admission. The most common reasons for presentation were bleeding (e.g., gastrointestinal, epistaxis) (182, 29.4%); infection (127, 20.5%); heart failure exacerbation (68, 11.0%); pain (56, 9.0%); other (45, 7.3%); and arrhythmias (40, 6.5%). Fifty-two encounters (8.4%) were device-specific; these patients frequently presented with abnormal device readings (37, 6.0%). Interventions for device-specific presentations included anticoagulation regimen adjustment (16/52, 30.8%), pump exchange (9, 17.3%), and hardware repair (6, 11.5%). Pump thrombosis occurred in 23 cases (3.7% of all encounters). No patients required cardiopulmonary resuscitation or died in the ED., Conclusion: This is the largest study known to the investigators to report the rate of ED presentations of patients with LVADs and provide analysis of device-specific presentations. In patients who do have device-specific ED presentations, pump thrombosis is a common diagnosis and can present without device alarms. Specialized LVAD education and preparation initiatives for ED providers should emphasize the recognition and management of the most common and critical conditions for this patient population, which have been identified in this study as bleeding, infection, heart failure, and pump thrombosis., Competing Interests: Conflicts of Interest: By the WestJEM article submission agreement, all authors are required to disclose all affiliations, funding sources and financial or management relationships that could be perceived as potential sources of bias. No author has professional or financial relationships with any companies that are relevant to this study. There are no conflicts of interest or sources of funding to declare.

Heart failure or congestive heart failure remains a major public health concern on the global scale. End-stage heart failure is a severe disease where the heart is unable to pump enough oxygen and nutrients to other tissues and organs of the body. When the lines of treatment of heart failure such as lifestyle adjustments, medical management, and device therapy fail, a patient may be deemed a candidate for heart transplantation. This article reviews the history of heart transplantation, complications post-heart transplantation, and nursing management considerations for the immediate period after heart transplant surgery.

Background: Despite significant changes in the past decade for children undergoing heart transplantation, including the evolution of mechanical circulatory support and increasing patient complexity, costs and resource utilization have not been reassessed. We sought to use a novel linkage of clinical-registry and administrative data to examine changes in hospitalization costs over time in this population., Methods: We identified all pediatric heart transplant recipients in a unique linked Pediatric Health Information System/Scientific Registry of Transplant Recipients data set (2002-2016). Hospital costs were estimated from charges using cost-to-charge ratios, inflated to 2016 dollars. Severity-adjusted costs were calculated using generalized linear mixed-effects models. Costs were compared across 3 eras (era 1, 2002-2006; era 2, 2007-2011; and era 3, 2012-2016)., Results: A total of 2896 pediatric heart transplant recipients were included: era 1, 649 (22.4%); era 2, 1028 (35.5%); and era 3, 1219 (42.1%). Extracorporeal membrane oxygenation support at transplant decreased over time, concurrent with an increase in ventricular assist device-supported patients. Between era 1 and era 2, there was an increase in pretransplant hospitalization costs (US $343 692 vs US $435 554; P < 0.001). However, between era 2 and era 3, there was a decline in total (US $906 454 vs US $767 221; P < 0.001), pretransplant (US $435 554 vs US $353 364; P < 0.001), and posttransplant (US $586 133 vs US $508 719; P = 0.002) hospitalization costs., Conclusions: Concurrent with the increase in utilization of ventricular assist device support, there has been an increase in pretransplant costs associated with pediatric heart transplantation. However, in the most recent era, costs have declined. These findings suggest the evolution of more cost-effective management strategies, which may be related to shifts in the approach to pediatric mechanical circulatory support.

Heart failure is one of the most common diagnoses in patients requiring multiple hospitalizations. The use of mechanical circulatory support (both temporary and durable), especially left ventricular assist devices (LVADs), in this patient population has evolved over the last decade. There are thousands of durable LVADs implanted in the United States annually as bridge to transplantation, destination therapy, or bridge to recovery. LVAD therapy, just like cardiac transplantation, takes a multidisciplinary team approach to achieve success. Appropriate patient selection is the key to good clinical outcomes. As the technology of LVAD therapy continues to evolve, it will be made available to an increasing number of patients in an attempt to improve their morbidity and mortality.

Heart transplantation is a viable option for many patients with end-stage heart failure. An extensive evaluation by specialists and in-depth testing are done to determine the risks of advanced therapies including the left ventricular assist device, since most patients need one to safely make it to transplant. A multidisciplinary approach is the most effective approach to successfully progressing a patient to transplant safely and helping him or her prosper after transplant.

The study objective is to quantify the impact of donor and recipient variables on heart transplant survival in recipients with a significant proportion of implanted continuous-flow left ventricular assist devices (LVADs). This is a prospective cohort study of International Society for Heart and Lung Transplantation (ISHLT) Registry that includes all primary heart-alone transplants in adult recipients (January 2005 and June 2013, N = 15 532, 27% LVADs). Donor and recipient characteristics were assessed for association with death or graft failure within 90 days and between 90 days and 5 years after transplantation. On Cox proportional hazard model donor cause of death other than head trauma (hazard ratio [HR] 1.985, P < 0.0001), recipient congenital (HR 2.7555, P < 0.0001) and ischemic (HR 1.165, P = 0.0383) vs dilated etiology and female donor heart transplanted into male recipient (HR 1.207, P = 0.0354) were predictors of death or graft failure within 90 days. Between 90 days and 5 years, donor cigarette use (HR 1.232, P = 0.0001), recipient cigarette use (HR 1.193, P = 0.0003), diabetes (HR 1.159, P = 0.0050), arterial hypertension (HR 1.129, P = 0.0115), and ischemic vs dilative cardiomyopathy had an increased probability of death or graft failure., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Aims: The ELEVATE registry was planned to study post-approval outcomes with HeartMate 3™ (HM3), a fully magnetically levitated continuous flow left ventricular assist device (LVAD)., Methods and Results: A total of 482 patients provided consent to participate in ELEVATE (enrolled cohort). Data collection included baseline demographics, survival, adverse events, quality of life (QOL) [EuroQoL-5 Dimensions visual analogue scale (VAS), and 6-minute walk distance (6MWD)]. An additional 58 patients were implanted with HM3 during the same period but expired or were explanted prior to consent, and only survival data were collected (anonymized cohort). We report the 6-month outcomes of the patients who received HM3 as their primary implant (n = 463) and the survival of the 540 patients in the full cohort (enrolled + anonymized). Baseline characteristics included a mean age of 55.6 ± 11.7 years, 89% male, 48% ischaemic aetiology, and 70% on inotropes. The majority of patients (66%) were bridge-to-transplantation (BTT) and 32% were INTERMACS profile 1-2. Full cohort survival at 6 months was 82 ± 2%. In the enrolled primary implant patients, there was no incidence of pump thrombosis, major bleeding was 25%, major infection 35%, and any stroke type 5%. Functional capacity improved significantly (Δ6MWD 230 ± 191 m) as did QOL (ΔVAS 31 ± 23). Freedom from unplanned rehospitalizations at 6 months was 68 ± 2%., Conclusion: The 6-month outcomes of the HM3 LVAD demonstrate a highly reliable, thrombosis free, device with low incidence of stroke and improved functional capacity, and QOL., Clinicaltrials. Gov Identifier: NCT02497950.

Background: Cerebrovascular events (CVE) are among the most common and serious complications after implantation of continuous-flow left ventricular assist devices (CF-LVAD). We studied the incidence, subtypes, anatomical distribution, and pre- and post-implantation risk factors of CVEs as well as the effect of CVEs on outcomes after CF-LVAD implantation at our institution., Methods: Retrospective analysis of clinical and neuroimaging data of 372 patients with CF-LVAD between May 2005 and December 2013 using standard statistical methods., Results: CVEs occurred in 71 patients (19%), consisting of 35 ischemic (49%), 26 hemorrhagic (37%), and 10 ischemic+hemorrhagic (14%) events. History of coronary artery disease and female gender was associated with higher odds of ischemic CVE (OR 2.84 and 2.5, respectively), and diabetes mellitus was associated with higher odds of hemorrhagic CVE (OR 3.12). While we found a higher rate of ischemic CVEs in patients not taking any antithrombotic medications, no difference was found between patients with ischemic and hemorrhagic CVEs. Occurrence of CVEs was associated with increased mortality (HR 1.62). Heart transplantation was associated with improved survival (HR 0.02). In patients without heart transplantation, occurrence of CVE was associated with decreased survival., Conclusions: LVADs are associated with high rates of CVE, increased mortality, and lower rates of heart transplantation. Further investigations to identify the optimal primary and secondary stroke prevention measures in post-LVAD patients are warranted.

The prognostic value of the right ventricular (RV) systolic to diastolic duration ratio (S/D ratio) in patients with advanced heart failure is not clear.We enrolled 45 patients with DCM (40 ± 13 years, 33 male) who were admitted to our hospital for evaluation or treatment of heart failure. The RV systolic and diastolic durations were measured using continuous Doppler imaging of tricuspid regurgitation, and the RV S/D ratio was calculated. Cardiac events were defined as cardiac death or left ventricular assist device implantation within the first year. Twenty-eight cardiac events occurred. The RV S/D ratio was significantly higher in the event group than in the event-free group (1.8 ± 0.8 versus 1.2 ± 0.5, P = 0.008). Univariate analysis showed that the RV S/D ratio, plasma brain natriuretic peptide concentration, left atrial volume index, and mitral deceleration time were associated with these events. Receiver operating characteristic curve analysis revealed that the optimal RV S/D cutoff value to predict events was 1.2 (sensitivity 79%, specificity 65%, area under the curve 0.745). Kaplan-Meier analysis indicated a significantly higher event rate in patients with an RV S/D ratio > 1.2 (log-rank test, P = 0.003). The addition of an RV S/D ratio > 1.2 improved the prognostic utility of a model that included conventional variables (P = 0.014).In patients with advanced heart failure with DCM, the RV S/D ratio was higher in patients with events than in those without events. The addition of the RV S/D ratio to conventional parameters may provide better prognostic information.

Intraaortic balloon pumping(IABP)has been used in more than 20,000 cases annually in Japan and this old device may be used differently by less invasive approach via axillar artery, which enabled the patients to ambulate for rehabilitation. Impella, a newly developed microaxial blood pump, has been used as a less invasive left ventricular assist device in more than 50 case in the last 6 months since its approval in Japan. Our experiences in 11 patients indicated that it improved not only cardiac output, but also cardiac function, which resulted in cardiac recovery in 5 patients. Technical advances in less invasive mechanical circulatory support may play an important role in thoracic surgery as well as cardiology.

Continuous-flow left ventricular assist devices (LVADs) are increasingly implanted to support patients with end-stage heart failure. These patients are at high risk for complications, many of which necessitate emergency care. While rehospitalization rates have been described, there is little data regarding emergency department (ED) visits. We hypothesize that ED visits are frequent and often require admission after LVAD implantation. We performed a retrospective review of patients in our health-care system followed by the advanced heart failure service for LVAD management after implantation between January 2011 and July 2015. We accounted for all ED visits in our system through February 2016, 7 months after the last implantation included. Clinically relevant demographic variables and ED visit details were recorded and analyzed to describe this population. We identified 81 patients with complete data, among whom there were 283 visits (3.49 visits/patient), occurring at a rate of approximately 7.3 ED visits per patient per year alive with LVAD. The most common reason for an ED visit is a complication related to bleeding (18% of visits), followed by chest pain (14%) and dizziness or syncope (13%). Thirty-six percent of patients were discharged from the ED without hospital admission. A growing populace with implanted LVADs represents an important population within emergency medicine. They are at risk for significant complications and frequently present to the ED. While many of these visits may be managed without hospital admission, this specialized patient group represents a potential area for improvement in provider education.

Heart failure (HF) is extremely prevalent and for those with end-stage (stage D) disease, 1-year survival is only 25-50%. Several studies have captured the mortality impact of kidney disease on patients with HF, and measures of kidney function are a component of many HF risk stratification scores. The management of advanced HF complicated by cardiorenal syndrome (CRS) is challenging, and irreversible kidney failure often limits patient candidacy for advanced HF therapies, such as transplant or left ventricular assist device therapy. Thus, prompt institution of aggressive therapy is warranted in stage D HF patients with CRS to prevent irreversible kidney failure. In this chapter, we discuss the assessment and management of patients with CRS with end-stage HF. In addition to discussing medical therapy aimed at decongestion and increased cardiac inotropy, we provide a summary of temporary circulatory support devices that can be considered for those whom hospice is not desired. In all circumstances, a close collaboration between the advanced HF specialist and nephrologist is needed to achieve the best patient outcomes., (Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Aim: We describe the characteristics and outcomes of cardiogenic shock (CS) admissions to a UK transplant unit, which is previously unreported., Patients & Methods: Fifty-nine unselected, consecutive patients over a 38-month period in CS (INTERMACS ≤2) and potentially eligible for transplant were retrospectively reviewed., Results: Patients were predominantly male (76.3%), young (mean age 42.2 years) and with severe end-organ dysfunction (acute liver/kidney injury 83%, mean lactate 3.5 mmol/l). 57.6% required mechanical support and 28.8% cardiac transplant. 30 days, discharge and 1-year survival were 78, 68 and 63%, respectively. Predictors of death included no transplant, increasing age and increasing creatinine., Conclusion: Patients with CS and potential for transplant require significant resource input but demonstrate favorable outcomes in our experience.

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 Experimental evidence indicates that left ventricular ( LV ) apical pacing is hemodynamically superior to nonapical LV pacing. Some studies have shown that an LV apical lead position is unfavorable in cardiac resynchronization therapy. We sought to determine whether an apical LV lead position influences cardiac mortality after cardiac resynchronization therapy. Methods and Results In this retrospective observational study, the primary end point of cardiac mortality was assessed in relation to longitudinal (basal, midventricular, or apical) and circumferential (anterior, lateral, or posterior) LV lead positions, as well as right ventricular (apical or septal), assigned using fluoroscopy. Lead positions were assessed in 1189 patients undergoing cardiac resynchronization therapy implantation over 15 years. After a median follow-up of 6.0 years (interquartile range: 4.4-7.7 years), an apical LV lead position was associated with lower cardiac mortality than a nonapical position (adjusted hazard ratio: 0.74; 95% confidence interval, 0.56-0.99) after covariate adjustment. There were no differences in total mortality or heart failure hospitalization. Death from pump failure was lower with apical than nonapical positions (adjusted hazard ratio: 0.69; 95% confidence interval, 0.51-0.94). Compared with a basal position, an apical LV position was also associated with lower risk of sudden cardiac death (adjusted hazard ratio: 0.34; 95% confidence interval, 0.13-0.93). No differences emerged between circumferential LV lead positions or right ventricular positions with respect to any end point. Conclusions In recipients of cardiac resynchronization therapy, an apical LV lead position was associated with better long-term cardiac survival than a nonapical position. This effect was due to a lower risk of pump failure and sudden cardiac death.