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Background: Evidence regarding the association between malnutrition risk and the prognosis of geriatric heart failure (HF) patients undergoing left ventricular assist device (LVAD) implantation is lacking. Our study aims to investigate how malnutrition risk, assessed using the geriatric nutritional risk index (GNRI) values, relates to the outcomes of geriatric HF patients undergoing LVAD, using data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry., Methods: A retrospective analysis was conducted using data from INTERMACS registry. Patients aged 65 and above who received LVAD implantation between 2008 and 2017 were included. The GNRI was used to stratify patients into three groups: absence of risk (GNRI > 98), mild risk (GNRI 92-98), and moderate to severe risk (GNRI < 92). The primary outcome was long-term survival for up to four years following LVAD implantation., Results: We included 5429 patients aged 65 and above undergoing LVADs. The malnutrition risk was presented in 75.8% of the patients before implantation, decreasing to 32.4% at 3 months, and 59.5% at 24 months post-implantation. Moderate-to-severe malnutrition risk, both pre-implant and 6 months post-implant, was associated with an increased risk of death (pre-implant: hazard ratio (HR): 1.25 [95% CI: 1.12-1.40], p < 0.001; 6 months: HR: 2.36 [95% CI: 2.01-2.77], p < 0.001). Mortality decreased with increasing pre-implant GNRI up to approximately 100 and 6-month post-implant GNRI up to 104. Patients with malnutrition risk also had an increased risk of infection, poor quality of life (QoL), and reduced functional exercise capacity after the LVAD implantation., Conclusions: Malnutrition risk was highly prevalent in HF patients aged 65 and above undergoing LVADs implantation. The presence of malnutrition risk was associated with an increased risk of death, infection, poor quality of life, and reduced functional exercise capacity., (Copyright © 2024 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

Background and Objectives: The use of temporary left ventricular assist devices (tLVADs) for patients suffering from cardiogenic shock (CS) is becoming more common. This study examines the indications and outcomes of microaxial flow pumps (Impella ® , Abiomed Inc., Danvers, MA, USA) when cannulated through the axillary artery in patients with severe CS, with a particular focus on acute phase reactions and hemolytic responses. Materials and Methods: This single-center, retrospective cohort involved patients who received microaxial Impella implantation via the axillary artery from 2020 to 2022 ( n = 47). Results: Among the patients, 66% (N = 31 cases) were treated with the Impella 5.5, 25.5% (N = 12 cases) with the Impella 5.0, and 8.5% (N = 4 cases) with the Impella CP. Additionally, 28% were managed using the ECMELLA concept. The mean length of time for Impella support was 8 days. The overall 30-day survival rate was 78%, with no significant differences observed between the ECMELLA group and the various Impella types. At 30 days post-therapy, 47% of survivors no longer required mechanical support, while 26% were upgraded to a durable LVAD. Interleukin-6 (IL-6) levels were significantly lower in patients receiving Impella 5.5 ( n = 17 vs. 12) immediately following implantation ( p = 0.03) compared with those with smaller devices. Haptoglobin levels were significantly higher in the Impella 5.5 group ( n = 17 vs. 11, p = 0.02), with overall lower rates of hemolysis (45.1%, p < 0.01). Conclusions: The mortality rate in critical CS appears reduced with axillary artery implantation of Impella devices relative to existing literature. A full-flow microaxial pump (Impella 5.5) seems advantageous regarding systemic inflammatory response syndrome (SIRS) and acute hemolysis, indicated by lower IL-6 and higher haptoglobin levels, compared with smaller Impella devices. A tailored escalation/de-escalation concept using axillary access for different mAFP types appears feasible and safe.

Aims: This EUROMACS study was conducted with the primary aim of investigating the association between a centre's annual caseload and postoperative outcomes among patients undergoing left ventricular assist device (LVAD) implantation., Methods and Results: A total of 4802 patients identified between 2011 and 2020 from 35 participating centres were dichotomized based on the annual caseload of the treating centre at the time of device implant (≤30 vs. >30 LVAD implantations/year). The primary endpoint was 1-year survival. Secondary outcomes included overall survival analysis, device-related adverse events and readmissions. Cumulative follow-up was 10 003 patient-years, with a median follow-up of 1.54 years (interquartile range 0.52-3.15). Patients from higher volume centres more frequently presented in INTERMACS levels 1 and 2, suffered from right heart dysfunction and needed inotropic support. No difference was observed in adjusted 1-year survival. Adjusted overall survival probability was lower in higher volume centres (p = 0.002). In the subgroup analysis of HeartMate 3 devices only, higher volume centres were associated with decreased odds of 1-year survival (adjusted odds ratio 0.43, 95% confidence interval 0.20-0.97, p = 0.041). Similar findings were observed in the cumulative (i.e. learning curve) caseload analyses., Conclusion: In patients undergoing LVAD implantation, centre volume was not associated with 1-year survival, but was related to device-related adverse events. Patient profiles differed with respect to centre size. These findings underscore the necessity for ongoing quality improvement initiatives in all centres, regardless of their annual caseload. Efforts are needed to standardize patient selection and preconditioning to further improve patient outcome., (© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: The number of advanced heart failure patients with left ventricular assist devices (LVAD) is increasing. Despite guideline-recommendations, little is known about specialist palliative care involvement in LVAD-patients, especially in Europe. This study aims to investigate timing and setting of specialist palliative care in LVAD-patients., Methods: We conducted a retrospective multicenter study in 2022. Specialist palliative care services in German LVAD-centers were identified and invited to participate. Forty adult LVAD-patients (mean age 65 years (SD 7.9), 90% male) from seven centers that received a specialist palliative care consultation during hospitalization were included., Results: In 37 (67.3%) of the 55 LVAD-centers, specialist palliative care was available. The median duration between LVAD-implantation and first specialist palliative care contact was 17 months (IQR 6.3-50.3 months). Median duration between consultation and death was seven days (IQR 3-28 days). 65% of consults took place in an intensive/intermediate care unit with half of the patients having a Do-Not-Resuscitate order. Care planning significantly increased during involvement (advance directives before: n = 15, after: n = 19, p < 0.001; DNR before: n = 20, after: n = 28, p < 0.001). Symptom burden as assessed at first specialist palliative care contact was higher compared to the consultation requests (request: median 3 symptoms (IQR 3-6); first contact: median 9 (IQR 6-10); p < 0.001) with a focus on weakness, anxiety, overburdening of next-of-kin and dyspnea. More than 70% of patients died during index hospitalization, one third of these in a palliative care unit., Conclusions: This largest European multicenter investigation of LVAD-patients receiving specialist palliative care shows a late integration and high physical and psychosocial symptom burden. This study highlights the urgent need for earlier integration to identify and address poorly controlled symptoms. Further studies and educational efforts are needed to close the gap between guideline-recommendations and the current status quo., (© 2024. The Author(s).)

Aims: Increasing numbers of patients with advanced heart failure and significant comorbidity and social barriers are considered for left ventricular assist devices (LVADs). We sought to examine health care utilization post-LVAD implantation, including the influence of individual-level socio-economic position and multimorbidity., Methods and Results: We conducted a Danish nationwide cohort study linking individual-level data from clinical LVAD databases, the Scandiatransplant Database, and Danish national medical and administrative registries. Socio-economic position included cohabitation status, educational level, and employment status. Multimorbidity was defined as two or more chronic conditions from at least two chronic disease groups. Health care utilization (hospital activity, general practice activity, and redeemed medical prescriptions) within 2 years post-discharge after LVAD implantation was evaluated using descriptive statistics at 0.5 year intervals. We identified 119 patients discharged alive with first-time LVAD implanted between 2006 and 2018. The median age of the patients was 56.1 years, and 88.2% were male. Patients were followed until heart transplantation, LVAD explantation, death, 31 December 2018, or for 2 years. The median follow-up was 0.8 years. The highest median use of health care services was observed 0-0.5 years post-LVAD discharge compared with the subsequent follow-up intervals: 0.5-1, 1-1.5, and 1.5-2 years, respectively. The median (interquartile range) number of hospitalizations was 10 (7-14), bed days 14 (9-28), outpatient visits 8 (5-12), telephone contacts with a general practitioner 4 (2-8), and total redeemed medical prescriptions 26 (19-37) within 0-0.5 years post-LVAD discharge compared with the median utilization within the consecutive follow-up periods [e.g. within 0.5-1 year: hospitalizations 5 (3-8), bed days 8 (4-14), outpatient visits 5 (3-8), telephone contacts 2 (0-5), and redeemed medical prescriptions 24 (18-30)]. The median use of health care services was stable from 0.5 years onwards. The median number of hospitalizations and bed days was slightly higher in patients living alone with a low educational level or low employment status within 0-0.5 years post-LVAD implantation. Finally, the median number of in-hospital days and redeemed prescriptions was higher among patients with pre-existing multimorbidity., Conclusions: Among patients who underwent LVAD implantation, health care utilization was high in the early post-LVAD discharge phase and was influenced by socio-economic position. Multimorbidity influenced the number of in-hospital days and redeemed prescriptions during the 2 year follow-up., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Patients with refractory cardiogenic shock (CS) necessitating peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) often require an intra-aortic balloon pump (IABP) or Impella for unloading; however, comparative effectiveness data are currently lacking., Methods and results: Using Diagnosis Procedure Combination data from approximately 1,200 Japanese acute care hospitals (April 2018-March 2022), we identified 940 patients aged ≥18 years with CS necessitating peripheral VA-ECMO along with IABP (ECMO-IABP; n=801) or Impella (ECPella; n=139) within 48 h of admission. Propensity score matching (126 pairs) indicated comparable in-hospital mortality between the ECPella and ECMO-IABP groups (50.8% vs. 50.0%, respectively; P=1.000). However, the ECPella cohort was on mechanical ventilator support for longer (median [interquartile range] 11.5 [5.0-20.8] vs. 9.0 [4.0-16.8] days; P=0.008) and had a longer hospital stay (median [interquartile range] 32.5 [12.0-59.0] vs. 23.0 [6.3-43.0] days; P=0.017) than the ECMO-IABP cohort. In addition, medical costs were higher for the ECPella than ECMO-IABP group (median [interquartile range] 9.09 [7.20-12.20] vs. 5.23 [3.41-7.00] million Japanese yen; P<0.001)., Conclusions: Our nationwide study could not demonstrate compelling evidence to support the superior efficacy of Impella over IABP in reducing in-hospital mortality among patients with CS necessitating VA-ECMO. Further investigations are imperative to determine the clinical situations in which the potential effect of Impella can be maximized.

Background/aim: Effective management of heart failure involves evidence-based use of multiple medications and their combinations. Furthermore, dosage escalation of the recommended medications is advised. In cases of advanced heart failure, long-term mechanical assistance devices or heart transplantation surgery may be necessary. Socio-economic disparities create unequal opportunities for people to access these treatments.The study aimed to analyze and compare medical and advanced heart failure treatments recommended by guidelines across various regions in Türkiye., Materials and Methods: About 85 million citizens medical treatment records were utilized between January 1, 2016, and December 31, 2022. Medical and heart replacement treatment opportunities for heart failure in Türkiye were evaluated in the general population and across different geographical regions., Results: According to this study, beta-blockers were the most commonly prescribed medication for heart failure in Türkiye. This was followed by angiotensin-converting enzyme inhibitors at 44% and mineralocorticoid receptor antagonists at 38.9%. However, only 0.6% of patients used angiotensin receptor blocker-neprilysin inhibitors. Despite the high incidence of diabetes mellitus among heart failure patients, only 11% used sodium-glucose cotransporter two inhibitors. The study also found that using an implantable cardioverter defibrillator (ICD) was 0.8%, and cardiac resynchronization therapy (CRT) was 0.3% among all intracardiac device treatments. Heart replacement therapies, cardiac transplantation surgery, and long-term left ventricle-assisted device (LVAD) surgery had very low rates., Conclusion: The use of guideline-directed medical therapy is not optimal in Türkiye and varies across different geographical regions. It is a fact that heart transplant or LVAD surgery, CRT, and ICD implantation rates in Türkiye are significantly lower than those in developed countries, regardless of geographical region., Competing Interests: Conflict of interest: The authors declare that there are no conflicts of interest regarding the publication of this manuscript., (© TÜBİTAK.)

Background: Long-term support with a HeartMate 3 (HM3) left ventricular assist device (LVAD) has improved outcomes of patients with end-stage heart failure. However, there is a paucity of data on the outcomes of patients who underwent concomitant cardiac surgical procedure (CCSP) during HM3-LVAD implantation., Objectives: To assess our single-center experience with patients who underwent CCSP during the implantation of an HM3-LVAD., Methods: From December 2016 until April 2022, 131 adult patients underwent HM3-LVAD implantation. A total of 23 patients underwent CCSP during the HM3-LVAD implantation+CCSP, and 108 underwent only HM3-LVAD implantation (HM3-only)., Results: The median age was 59 ± 11 years (range 54-67), 82% (n=108) were male, and 76% (n=100) were implanted as a bridge-to-transplant. The concomitant procedures performed during the implantation included 8 aortic valve repairs/replacements, 14 tricuspid valve repairs, 4 patent foramen ovales or atrial septal defect closures, and 3 other cardiac procedures. The mean cardiopulmonary bypass time was 113 ± 58 minutes for the HM3-only group and 155 ± 47 minutes for the HM3+CCSP group (P = 0.007). The mortality rates at 30 days, 6 months, and 12 months post-implantation were 2 (9%), 5 (22%), and 6 (26%) respectively for the HM3+CCSP group, and 7 (6%), 18 (17%), and 30 (28%) for the HM3-only group (P = 0.658, 0.554, and 1.000)., Conclusions: Our experience demonstrated no significant difference in the 30-day, 6-month, and 12-month mortality rates for patients who underwent a CCSP during HM3-LVAD implantation compared to patients who did not undergo CCSP during HM3-LVAD implantation.

Objective: Venoarterial extracorporeal membrane oxygenation is a rescue therapy for patients in cardiogenic shock. We hypothesize that patients bridged to heart transplant with extracorporeal membrane oxygenation have decreased survival., Methods: The United Network of Organ Sharing database was retrospectively reviewed from January 1, 1999, to March 31, 2018, for heart transplant recipients. Recipients bridged with any form of mechanical support and those without support were compared with recipients bridged with extracorporeal membrane oxygenation. The primary end point was restricted mean survival time through 16.7 years., Results: Of 26,918 recipients, 15,076 required no pretransplant mechanical support (56.0%). Support patients included 9321 with left ventricular assist devices (34.6%), 53 with right ventricular assist devices (0.2%), 258 with total artificial hearts (1.0%), 686 with biventricular assist devices (2.6%), 1378 with intra-aortic balloon pumps (5.1%), and 146 who required extracorporeal membrane oxygenation (0.5%). In the first 16.7 years post-transplant, compared with recipients bridged with extracorporeal membrane oxygenation, estimated adjusted restricted mean survival time was higher in patients who required no mechanical support (16.6 months [14.0-19.4]) and patients with a left ventricular assist device (16.5 months [99% confidence interval, 13.9-19.2]), an intra-aortic balloon pump (11.2 months [8.3-14.7]), or a biventricular assist device (6.6 months [3.6-10.3]). Restricted mean survival time in patients with a right ventricular assist device or a total artificial heart was similar to patients with extracorporeal membrane oxygenation., Conclusions: Recipients bridged with extracorporeal membrane oxygenation were estimated to survive 16.6 months less than nonmechanical circulatory support recipients. Bridge to heart transplant with extracorporeal membrane oxygenation is a viable option, and these patients should be considered transplant candidates., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Left ventricular assist device (LVAD) implantation has been shown to increase allosensitization before orthotopic heart transplantation, but the influence of LVAD support on posttransplant rejection is controversial. This study examines the postoperative incidence of acute cellular rejection (ACR) in patients bridged with continuous flow LVAD (CF-LVAD) relative to primary transplant (Primary Tx)., Methods: All patients who underwent orthotopic heart transplantation at our institution between July 2006 and March 2019 were retrospectively reviewed (n = 395). Patients were classified into Primary Tx (n = 145) and CF-LVAD (n = 207) groups. Propensity score matching on 13 covariates implemented a 0.1 caliper logistic model with nearest neighbor 1:1 matching. Development of moderate to severe (ie, 2R/3R) rejection was evaluated using a competing risks model. Potential predictors of 2R/3R ACR were evaluated using Fine-Gray regression on the marginal subdistribution hazard., Results: Propensity score matching yielded 122 patients in each group (n = 244). At 12 and 24 months, the cumulative incidence of 2R/3R ACR was 17% and 23% for the CF-LVAD group and 26% and 31%, respectively, for the Primary Tx group (P = .170). CF-LVAD was not predictive of 2R/3R rejection on multivariable Fine-Gray regression (subdistribution hazard ratio, 0.73; 95% confidence interval, 0.40-1.33; P = .301). There was no difference in the 5-year incidence of antibody mediated rejection (10% [n = 12] vs 9% [n = 11]; P = .827)., Conclusions: After adjusting for covariates, CF-LVAD was not associated with an increased risk of moderate to severe ACR during the 24 months after cardiac transplantation. Further investigation is warranted with larger cohorts, but CF-LVAD may have minimal influence on posttransplant ACR., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Mechanical circulatory support (MCS) with an implantable left ventricular assist device (LVAD) is an established therapeutic option for advanced heart failure. Most of the currently used LVADs generate a continuous stream of blood that decreases arterial pulse pressure. This study investigated whether a change of the pulse pressure during different pump speed settings would affect cerebral autoregulation and thereby affect cerebral blood flow (CBF). The study included 21 haemodynamically stable outpatients with a continuous-flow LVAD (HeartMate II, Abbott, USA) implanted a median of 6 months before the study (interquartile range 3 to 14 months). Arterial blood pressure (measured by finger plethysmography) was recorded simultaneously with CBF (measured by transcranial Doppler ultrasound) during baseline pump speed (8900 rpm [IQR 8800; 9200]) and during minimum and maximum tolerated pump speeds (8000 rpm [IQR 8000; 8200] and 9800 rpm [IQR 9800; 10 000]). An increase in LVAD pump speed by 800 rpm [IQR 800; 1000] from the baseline lead to a significant decrease in arterial pulse pressure and cerebral blood flow pulsatility (relative change ?24% and ?32%, both p < 0.01), but it did not affect mean arterial pressure and mean CBF velocity (relative change 1% and ?1.7%, p = 0.1 and 0.7). In stable patients with a continuous-flow LVAD, changes of pump speed settings within a clinically used range did not impair static cerebral autoregulation and cerebral blood flow.

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

Trials on intra-aortic balloon pump (IABP) use in cardiogenic shock related to acute myocardial infarction have shown disappointing results. The role of IABP in cardiogenic shock treatment remains unclear, and new (potentially more potent) mechanical circulatory supports with arguably larger device profile are emerging. A reappraisal of the physiological premises of intra-aortic counterpulsation may underpin the rationale to maintain IABP as a valuable therapeutic option for patients with acute decompensated heart failure and tissue hypoperfusion. Several pathophysiological features differ between myocardial infarction- and acute decompensated heart failure-related hypoperfusion, encompassing cardiogenic shock severity, filling status, systemic vascular resistances rise, and adaptation to chronic (if preexisting) left ventricular dysfunction. IABP combines a more substantial effect on left ventricular afterload with a modest increase in cardiac output and would therefore be most suitable in clinical scenarios characterized by a disproportionate increase in afterload without profound hemodynamic compromise. The acute decompensated heart failure syndrome is characterized by exquisite afterload-sensitivity of cardiac output and may be an ideal setting for counterpulsation. Several hemodynamic variables have been shown to predict response to IABP within this scenario, potentially guiding appropriate patient selection. Finally, acute decompensated heart failure with hypoperfusion may frequently represent an end stage in the heart failure history: IABP may provide sufficient hemodynamic support and prompt end-organ function recovery in view of more definitive heart replacement therapies while preserving ambulation when used with a transaxillary approach.

An emerging therapeutic modality, ECPELLA, which combines a transvalvular microaxial left ventricular (LV) assist device, Impella, and venoarterial membrane oxygenation (VA-ECMO), has been applied for patients with refractory cardiogenic shock. During ECPELLA support, VA-ECMO increases the LV load, whereas the Impella reduces the LV load. Studies reported that coronary perfusion is influenced by LV unloading conditions, and the effective degree of LV unloading to increase the coronary perfusion on ECPELLA support remains to be determined. Here, we reported a cardiogenic shock case whose coronary arterial flow was assessed by transesophageal echocardiography during ECPELLA support. The left anterior descending coronary artery (LAD) peak blood flow velocity and the velocity time integral (VTI) were not significantly increased when blood was ejected from the LV (partial LV unloading). When the LV blood ejection was completely bypassed by Impella confirmed by non-pulsatile aortic pressure with significantly reduced LV pressure with no aortic valve opening (LV uncoupling: no blood ejection from the LV), both peak velocity and VTI of the LAD were markedly increased and the blood flow became continuous throughout the cardiac cycle. Our case suggests that the coronary arterial flow in the injured myocardium is sensitive to degrees of LV unloading on ECPELLA support., (© 2021 The Authors. Physiological Reports published by Wiley Periodicals LLC on behalf of The Physiological Society and the American Physiological Society.)

The association between ventricular arrhythmias (VAs) and mortality in patients supported by continuous flow left ventricular assist devices (LVAD) remains controversial. To evaluate the association between pre-implantation, early (≤ 30 day) post-implantation VAs and mortality in bridge to transplant (BTT) and destination therapy (DT) LVAD patients, separately. The risk factors for post LVAD VAs were also investigated. In this observational cohort study, we included 341 patients who received a first time, continuous flow LVAD between January 1st 2010 and July 30th 2018. We used Kaplan-Meier curves and multivariable cox regression analyses to study the association between VAs and mortality in the BTT and DT populations. The mean age of the cohort was 58 ± 14 years, with 82% males, 53% had ischemic cardiomyopathy, and 45% were DT. The mean follow-up was 2.2 ± 2.1 years. In both BTT and DT cohorts, pre LVAD VAs were not associated with mortality after LVAD implantation (log-rank p = 0.95 and p = 0.089, respectively). In the BTT population, early post-LVAD VAs were not statistically associated with increased mortality (log rank p = 0.072). In the DT patients, early post LVAD VAs were associated with a 67% increase in the hazards rate of mortality on LVAD support (HR 1.67 [1.05-2.65], p = 0.029). The final model was adjusted for type of cardiomyopathy, INTERMACS profile, glomerular filtration rate, post LVAD atrial fibrillation, age and cerebrovascular events. Early post-LVAD VA is common after LVAD implantation and is an independent predictor of mortality in the DT LVAD population., (© 2021. The Author(s).)

Background: Survival, functional outcomes, and quality of life after left ventricular assist device (LVAD) are ill-defined in elderly patients, and with new-generation devices., Objectives: This study sought to evaluate survival, functional outcomes, and quality of life after LVAD in contemporary practice., Methods: Adults receiving durable LVADs between January 1, 2010, and March 1, 2020, were identified from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database. The primary outcome was adjusted survival; secondary outcomes included quality of life rated using a visual analogue scale (where 0 represents "worst health" and 100 "best health"); 6-minute walk distance; stroke; device malfunction; and rehospitalization, stratified by patient age. Median follow-up was 15 months (IQR: 6-32 months)., Results: The cohort comprised 68.9% (n = 16,808) patients aged <65 years, 26.3% (n = 6,418) patients aged 65-75 years, and 4.8% (n = 1,182) patients aged >75 years, who were predominantly male (n = 19,119, 78%) and on destination therapy (n = 12,425, 51%). Competing outcomes analysis demonstrated mortality (70% CIs) of 34% (33%-34%), 54% (54%-55%), and 66% (64%-68%) for patients aged <65, 65-75, and >75 years, respectively, which improved during the study in patients aged >75 years. Newer-generation devices were associated with reduced late mortality (HR: 0.35; 95% CI: 0.25-0.49). Stroke, device malfunction or thrombosis, and rehospitalizations decreased with increasing age (all P < 0.01). Median 6-minute walk distance increased from 0 feet (IQR: 0-665 feet) to 1,065 feet (IQR: 642-1,313 feet) (P < 0.001), and quality of life improved from 40 (IQR: 15-60) to 75 (IQR: 60-90) (P < 0.001) after LVAD in all age groups., Conclusions: In elderly patients, LVADs are associated with increased functional capacity, similar improvements in quality of life, and fewer complications compared with younger patients., Competing Interests: Funding Support and Author Disclosures The Society of Thoracic Surgeons funded and designed the data analysis which was performed at the University of Alabama at Birmingham Data Coordinating Center, which had primary responsibility for collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. Dr Kirklin has received partial salary support, paid to his institution, from the Society of Thoracic Surgeons. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: Adoption of implantable left ventricular assist devices has dramatically improved survival and quality of life in suitable patients with end-stage heart failure. In the era of value-based healthcare delivery, assessment of clinical outcomes and resource use associated with left ventricular assist devices is warranted., Methods: Adult patients undergoing left ventricular assist device implantation from 2008 to 2016 were identified using the National Inpatient Sample. Hospitals were designated as low-volume, medium-volume, or high-volume institutions based on annual institutional left ventricular assist device case volume. Multivariable logistic regression was used to evaluate adjusted odds of mortality across left ventricular assist device volume tertiles., Results: Over the study period, an estimated 23,972 patients underwent left ventricular assist device implantation with an approximately 3-fold increase in the number of annual left ventricular assist device implantations performed (P for trend <.001). In-hospital mortality in patients with left ventricular assist devices decreased from 19.6% in 2008 to 8.1% in 2016 (P for trend <.001) and was higher at low-volume institutions compared with high-volume institutions (12.0% vs 9.2%, P < .001). Although the overall adjusted mortality was higher at low-volume compared with high-volume institutions (adjusted odds ratio, 1.66; 95% confidence interval, 1.28-2.15), this discrepancy was only significant for 2008 and 2009 (low-volume 2008 adjusted odds ratio, 5.5; 95% confidence interval, 1.9-15.8; low-volume 2009 adjusted odds ratio, 2.3; 95% confidence interval, 1.4-3.8)., Conclusions: Left ventricular assist device use has rapidly increased in the United States with a concomitant reduction in mortality and morbidity. With maturation of left ventricular assist device technology and increasing experience, volume-related variation in mortality and resource use has diminished. Whether the apparent uniformity in outcomes is related to patient selection or hospital quality deserves further investigation., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The coronavirus disease 2019 (COVID-19) pandemic continues to afflict millions of people worldwide. Patients with end-stage heart failure and left ventricular assist devices (LVADs) may be at risk for severe COVID-19 given a high prevalence of complex comorbidities and functional impaired immunity. The objective of this study is to describe the clinical characteristics and outcomes of COVID-19 in patients with end-stage heart failure and durable LVADs., Methods: The Trans-CoV-VAD registry is a multi-center registry of LVAD and cardiac transplant patients in the United States with confirmed COVID-19. Patient characteristics, exposure history, presentation, laboratory data, course, and clinical outcomes were collected by participating institutions and reviewed by a central data repository. This report represents the participation of the first 9 centers to report LVAD data into the registry., Results: A total of 40 patients were included in this cohort. The median age was 56 years (interquartile range, 46-68), 14 (35%) were women, and 21 (52%) were Black. Among the most common presenting symptoms were cough (41%), fever, and fatigue (both 38%). A total of 18% were asymptomatic at diagnosis. Only 43% of the patients reported either subjective or measured fever during the entire course of illness. Over half (60%) required hospitalization, and 8 patients (20%) died, often after lengthy hospitalizations., Conclusions: We present the largest case series of LVAD patients with COVID-19 to date. Understanding these characteristics is essential in an effort to improve the outcome of this complex patient population.

Background: The "gray zone" of myocardial fibrosis (GZF) on cardiovascular magnetic resonance may be a substrate for ventricular arrhythmias (VAs)., Objectives: The purpose of this study was to determine whether GZF predicts sudden cardiac death (SCD) and VAs (ventricular fibrillation or sustained ventricular tachycardia) in patients with coronary artery disease (CAD) and a wide range of left ventricular ejection fractions (LVEFs)., Methods: In this retrospective study of CAD patients, the presence of myocardial fibrosis on visual assessment (MF VA ) and GZF mass in patients with MF VA were assessed in relation to SCD and the composite, arrhythmic endpoint of SCD or VAs., Results: Among 979 patients (mean age [± SD]: 65.8 ± 12.3 years), 29 (2.96%) experienced SCD and 80 (8.17%) met the arrhythmic endpoint over median 5.82 years (interquartile range: 4.1 to 7.3 years). In the whole cohort, MF VA was strongly associated with SCD (hazard ratio: 10.1; 95% confidence interval [CI]: 1.42 to 1,278.9) and the arrhythmic endpoint (hazard ratio: 28.0; 95% CI: 4.07 to 3,525.4). In competing risks analyses, associations between LVEF <35% and SCD (subdistribution hazard ratio [sHR]: 2.99; 95% CI: 1.42 to 6.31) and the arrhythmic endpoint (sHR: 4.71; 95% CI: 2.97 to 7.47) were weaker. In competing risk analyses of the MF VA subcohort (n = 832), GZF using the 3SD method (GZF 3SD ) >5.0 g was strongly associated with SCD (sHR: 10.8; 95% CI: 3.74 to 30.9) and the arrhythmic endpoint (sHR: 7.40; 95% CI: 4.29 to 12.8). Associations between LVEF <35% and SCD (sHR: 2.62; 95% CI: 1.24 to 5.52) and the arrhythmic endpoint (sHR: 4.14; 95% CI: 2.61 to 6.57) were weaker., Conclusions: In CAD patients, MF VA plus quantified GZF 3SD mass was more strongly associated with SCD and VAs than LVEF. In selecting patients for implantable cardioverter-defibrillators, assessment of MF VA followed by quantification of GZF 3SD mass may be preferable to LVEF., Competing Interests: Author Disclosures Medtronic provided support for this study in the form of an unrestricted educational grant. Medtronic provided funding for Dr. Zegard’s salary as a research fellow and had no participation in the study. Dr. Leyva has served as a consultant for and has received research funding from Medtronic Inc., Boston Scientific, Abbott, Microport, and Biotronik. All other 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: The decision to implant durable mechanical circulatory systems (MCSs) in patients on extracorporeal life support (ECLS) is challenging due to expected poor outcomes in these patients., Objectives: The aim of this study was to identify outcome predictors that may facilitate future patient selection and decision making., Methods: The Durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent MCS implantation after ECLS between January 2010 and August 2018 in 11 high-volume European centers. Several perioperative parameters were collected. The primary endpoint was survival at 1 year after durable MCS implantation., Results: A total of 531 durable MCSs after ECLS were implanted during this period. The average patient age was 53 ± 12 years old. ECLS cannulation was peripheral in 87% of patients and 33% of the patients had history of cardiopulmonary resuscitation before ECLS implantation. The 30-day, 1-year, and 3-year actuarial survival rates were 77%, 53%, and 43%, respectively. The following predictors for 1-year outcome have been observed: age, female sex, lactate value, Model of End-Stage Liver Disease XI score, history of atrial fibrillation, redo surgery, and body mass index >30 kg/m 2 . On the basis of this data, a risk score and an app to estimate 1-year mortality was created., Conclusions: The outcome in patients receiving durable MCS after ECLS remains limited, yet preoperative factors may allow differentiating futile patients from those with significant survival benefit., Competing Interests: Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

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

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

Objective: Patients with biventricular assist devices (BiVADs) have worse outcomes than those with left ventricular assist devices (LVADs). It is unclear whether these outcomes are due to device selection or patient factors. We used propensity score matching to reduce patient heterogeneity and compare outcomes in pediatric patients supported with BiVADs with a similar LVAD cohort., Methods: The Pedimacs registry was queried for patients who were supported with BiVAD or LVAD. Patients were analyzed by BiVAD or LVAD at primary implant and the 2 groups were compared before and after using propensity score matching., Results: Of 363 patients who met inclusion criteria, 63 (17%) underwent primary BiVAD support. After propensity score matching, differences between cohorts were reduced. Six months after implant, in the BiVAD cohort (LVAD cohort) 52.5% (42.5%) had been transplanted; 32.5% (40%) were alive with device, and 15% (10%) had died. Survival was similar between cohorts (P = .31, log-rank), but patients with BiVADs were more likely to experience a major adverse event in the form of bleeding (P = .04, log-rank). At 1 week and 1 and 3 months' postimplant, the percentage of patients on mechanical ventilation, on dialysis, or with elevated bilirubin was similar between the 2 groups., Conclusions: When propensity scores were used to reduce differences in patient characteristics, there were no differences in survival but more major adverse events in the patients with BiVADs, particularly bleeding. Differences in unmatched patient outcomes between LVAD and BiVAD cohorts likely represent differences in severity of illness rather than mode of support., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background Left ventricular assist devices (LVADs) improve outcomes in patients with end-stage heart failure and are increasingly implanted for destination therapy. We describe dynamic estimates of event-free survival with conditional survival probabilities in a destination therapy LVAD population. Methods and Results We studied 8245 adult patients in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) implanted with a continuous-flow destination therapy LVAD. The composite primary end point was death, device exchange or removal, or heart transplantation. Conditional survival probabilities were calculated and stratified by implantation characteristics and nonfatal adverse events experienced within the first year after implant. Probabilities of surviving an additional 1 to 3 years were numerically higher after longer prior event-free survival. INTERMACS profile 1, extracorporeal membrane oxygenation support, prior or concomitant surgery, and dialysis within 48 hours of implantation were associated with significantly lower event-free survival in the first year but did not impact event-free survival beyond then. For patients who experienced a nonfatal adverse event within the first year, subsequent 1-year conditional survival was lower than in the absence of that event for stroke (65% [95% CI, 57%-73%] versus 75% [95% CI, 73%-77%]; P <0.001), device-related infection (64% [95% CI 57%-71%] versus 76% [95% CI, 74%-78%]; P <0.001), and pump thrombosis or malfunction (64% [95% CI, 57%-70%] versus 76% [95% CI, 74%-78%]; P <0.001). Conclusions Conditional survival in patients with destination therapy LVADs improves over time, even for patients with unfavorable implantation characteristics. However, LVAD-related complications including stroke, device-related infection, and pump thrombosis or malfunction have an enduring negative influence on dynamic estimates of long-term prognosis.

Background: The HeartMate 3 (HM3) left ventricular assist device (LVAD) (Abbott, Inc, Chicago, Ill) is a fully magnetically levitated centrifugal implantable pump used to treat patients with chronic heart failure. The MOMENTUM (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial demonstrated that patients treated with the HM3 experienced reduced need for reoperation for LVAD replacement compared with a control group receiving an axial flow design, Heartmate II (Abbott, Inc). However, there are few reports of using HM3 as the replacement pump in patients who already are supported by a durable LVAD and experience a device-related complication necessitating replacement., Methods: An institutional LVAD database was used to identify 19 consecutive patients who underwent pump replacement to HM3 (group 1) versus 85 consecutive control patients who underwent pump replacement to either Heartmate II or HeartWare Ventricular Assist Device (Medtronic Inc, Minneapolis, Minn) (group 2), at a single institution from January 2010 to August 2018. Patient baseline characteristic and outcomes were obtained from a prospectively maintained database. The primary endpoint was a composite of freedom from death or need for another replacement surgery., Results: There was no difference between the groups in heart failure etiology, indication for replacement, as well as the average days on the previous pump or the type of previous pump. The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P < .001), and a greater number of previous sternotomies (31.6% vs 7.1%, had 3 previous sternotomies, P = .001). No difference was found between the groups in terms of postoperative adverse event rates. With regards to the primary endpoint, the patients with HM3 replacements (group 1) versus group 2 experienced significantly greater freedom from either death or need for another replacement during the follow-up period (P = .039). During follow-up, there were no thrombosis events for the patients who received replacement with HM3., Conclusions: LVAD replacement with HM3 can be performed safely and may be considered as the pump of choice in patients requiring LVAD replacement., (Copyright © 2019 The American Association for Thoracic Surgery. All rights reserved.)

Background: The United Network of Organ Sharing (UNOS) heart allocation policy designates patients on ECMO or with nondischargeable, surgically implanted, nonendovascular support devices (TCS-VAD) to higher listing statuses., Objectives: This study aimed to explore whether temporary circulatory support-ventricular assist devices (TCS-VAD) have a survival advantage over extracorporeal membrane oxygenation (ECMO) as a bridge to transplant., Methods: The UNOS database was used to conduct a retrospective analysis of adult heart transplants performed in the United States between 2005 and 2017. Survival analysis was performed to compare patients bridged to transplant with different modalities., Results: Of the 24,905 adult transplants performed, 7,904 (32%) were bridged with durable left ventricular assist devices (LVADs), 177 (0.7%) with ECMO, 203 (0.8%) with TCS-VAD, 44 (0.2%) with percutaneous endovascular devices, and 8 (0.03%) with TandemHeart (LivaNova, London, United Kingdom). Unadjusted survival at 1 and 5 years post-transplant was 90 ± 0.4% and 77 ± 0.7% for durable LVAD, 84 ± 3% and 71 ± 4% for all TCS-VAD types, 79 ± 9% and 73 ± 14% for biventricular TCS-VAD, and 68 ± 3% and 61 ± 8% for ECMO. After propensity-matched pairwise comparisons were made, survival after all TCS-VAD types continued to be superior to ECMO (p = 0.019) and similar to LVAD (p = 0.380). ECMO was a predictor of post-transplant mortality in the Cox analysis compared with TCS-VAD (hazard ratio 2.40; 95% confidence interval: 1.44 to 4.01; p = 0.001)., Conclusions: Post-transplant survival with TCS-VAD is superior to ECMO and similar to LVAD in a national database., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Impella® pumps are increasingly utilized in patients in cardiogenic shock. We report on a case series where Impella support was insufficient, and a switch to venoarterial extracorporeal membrane oxygenation (VA ECMO) became necessary. ECMO patients with previous Impella devices were identified utilizing our institutional ECMO database. Since 2014, 10 patients with a mean age of 62 ± 3 years were identified. Despite correct placement of all Impella pumps, cardiogenic shock persisted with progressive multi-organ failure (Impella type 2.5/CP n = 6/4 patients). Femoro-femoral VA ECMO was implanted percutaneously on the contralateral side with the Impella initially left on standby but retracted into the descending aorta for transport reasons after a mean support time of 20 ± 8 h. All patients were able to unload their heart by left ventricular ejection with a blood pressure amplitude of 15 ± 3 mmHg on VA ECMO support. After VA ECMO implantation haemodynamic parameters improved significantly within 24 h of support (mean serum lactate levels decreased from 92 ± 17 to 44 ± 10 mg/dl, P = 0.031). Survival to hospital discharge was 70%. These data indicate that the Impella 2.5® and CP® might not be sufficient in profound cardiogenic shock. Comparative studies are necessary to specify which patient population benefits from which type of circulatory support., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Left ventricular assist devices (LVADs) are an established treatment for end stage heart failure patients. As LVADs do not currently respond to exercise demands, attention is also directed towards improvements in exercise capacity and resulting quality of life. The aim of this study was to explore hemodynamic responses observed during maximal exercise tests to infer underlying patient status and therefore investigate possible diagnostics from LVAD derived data and advance the development of physiologically adaptive LVAD controllers., Methods: High resolution continuous LVAD flow waveforms were recorded from 14 LVAD patients and evaluated at rest and during maximum bicycle exercise tests (n = 24). Responses to exercise were analyzed in terms of an increase (↑) or decrease (↓) in minimum (QMIN), mean (QMEAN), maximum flow (QMAX) and flow pulsatility (QP2P). To interpret clinical data, a cardiorespiratory numerical simulator was used that reproduced patients' hemodynamics at rest and exercise. Different cardiovascular scenarios including chronotropic and inotropic responses, peripheral vasodilation, and aortic valve pathologies were simulated systematically and compared to the patients' responses., Results: Different patients' responses to exercise were observed. The most common response was a positive change of ΔQMIN↑ and ΔQP2P↑ from rest to exercise (70% of exercise tests). Two responses, which were never reported in patients so far, were distinguished by QMIN↑ and QP2P↓ (observed in 17%) and by QMIN↓ and QP2P↑ (observed in 13%). The simulations indicated that the QP2P↓ can result from a reduced left ventricular contractility and that the QMIN↓ can occur with a better left ventricular contractility and/or aortic insufficiency., Conclusion: LVAD flow waveforms determine a patients' hemodynamic "fingerprint" from rest to exercise. Different waveform responses to exercise, including previously unobserved ones, were reported. The simulations indicated the left ventricular contractility as a major determinant for the different responses, thus improving patient stratification to identify how patient groups would benefit from exercise-responsive LVAD control., Competing Interests: The authors have declared that no competing interests exist.

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

Cerebral blood flow during exercise is impaired in patients with heart failure implanted with left ventricular assist devices (LVADs). Our aim was to determine whether a 3-mo exercise training program could mitigate cerebrovascular dysfunction. Internal carotid artery (ICA) blood flow and intracranial middle (MCA v ) and posterior cerebral (PCA v ) artery velocities were measured continuously using Doppler ultrasound, alongside cardiorespiratory measures at rest and in response to an incremental cycle ergometer exercise protocol in 12 LVAD participants (5 female, 53.6 ± 11.8 yr; 84.2 ± 15.7 kg; 1.73 ± 0.08) pre- (PreTR) and post- (PostTR) completion of a 3-mo supervised exercise rehabilitation program. At rest, only PCAv was different PostTR (38.1 ± 10.4 cm/s) compared with PreTR (43.0 ± 10.8 cm/s; P < 0.05). PreTR, the reduction in PCAv observed from rest to exercise (5.2 ± 1.8%) was mitigated PostTR ( P < 0.001). Similarly, exercise training enhanced ICA flow during submaximal exercise (~8.6 ± 13.7%), resulting in increased ICA flow PostTR compared with a reduced flow PreTR ( P < 0.001). Although both end-tidal partial pressure of carbon dioxide and mean arterial pressure responses during incremental exercise were greater PostTR than PreTR, only the improved P E T C O 2 was related to the improved ICA flow ( R 2  = 0.14; P < 0.05). Our findings suggest that short-term exercise training improves cerebrovascular function during exercise in patients with LVADs. This finding should encourage future studies investigating long-term exercise training and cerebral and peripheral vascular adaptation. NEW & NOTEWORTHY Left ventricular assist devices, now used as destination therapy in end-stage heart failure, enable patients to undertake rehabilitative exercise training. We show, for the first time in humans, that training improves cerebrovascular function during exercise in patients with left ventricular assist devices. This finding may have implications for cerebrovascular health in patients with heart failure.

Objectives: In this study, we aimed to determine the comparative outcomes of patients supported with continuous-flow left ventricular assist devices (LVADs): HeartMate 2 (HM2), HeartWare (HW) and HeartMate 3 (HM3) in a real-world setting., Methods: The study was an investigator-initiated comparative retrospective analysis of patients who underwent continuous-flow LVAD implantation at our institution between 2008 and 2017. The follow-up duration was 18 months after implantation., Results: The study included 105 continuous-flow LVAD-supported patients of whom 51% (n = 54), 24% (25) and 25% (26) underwent implantation of HM2, HW and HM3, respectively. During follow-up, patients who were supported with HM3 versus either HM2 or HW LVADs demonstrated a lower risk of stroke (0% vs 26%, P < 0.001 and 0% vs 40%, P < 0.001, respectively) and lower rates of thrombosis (0% vs 31%, P < 0.001 and 0% vs 12%, P < 0.001, respectively), findings that were consistent with their calculated haemocompatibility scores (cumulative score 5, 89 and 56 for HM3, HM2 and HW, respectively, P < 0.001). Moreover, patients supported with HM3 versus HW had fewer unplanned hospitalizations [median 1 (25th-75th interquartile range 0-2) vs 3 (interquartile range 2-4), P = 0.012]. Importantly, survival free from stroke or device exchange was higher in patients supported with HM3 compared with either the HM2 or the HW LVADs [hazard ratio (HR) 2.77, confidence interval (CI) 1.13-6.78; P = 0.026 and HR 2.70, CI 1.01-7.20; P = 0.047, respectively]., Conclusions: HM3 device currently presents better prognostic and adverse events profiles when compared with the HM2 or the HW LVADs. A larger-scale head-to-head comparison between the devices is warranted in order to confirm our findings., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Peripheral venoarterial extracorporeal life support (ECLS) for the treatment of cardiogenic shock has shown to improve survival but is associated with complications. However, if the patient cannot be weaned from ECLS, their therapy options are limited. Although durable left ventricular assist device implantation might be an option in such cases, an unclear neurological outcome is often a contraindication. We hypothesize that Impella 5.0 therapy provides sufficient circulatory support while avoiding ECLS-related complications, thereby allowing for an adequate evaluation of a patient's neurological state and facilitating further treatment options., Methods: We retrospectively reviewed data from 22 ECLS patients (mean age 56.5 ± 10.7 years) with an unclear neurological status who underwent Impella 5.0 implantation between January 2016 and July 2018 in our institution. Neurological status was evaluated on a daily basis using the cerebral performance category score and the modified Rankin scale., Results: Sixteen patients (72.7%) were resuscitated before ECLS implantation and 13 patients (59.1%) had acute myocardial infarction. The mean duration on ECLS before Impella 5.0 implantation was 9.3 ± 1.7 days. All patients were successfully weaned from ECLS by Impella 5.0 implantation via the axillary artery. The mean duration on Impella 5.0 was 16.3 ± 4.7 days. In surviving patients, both quantitative measurements of cerebral performance improved after 30 days compared to the baseline (P < 0.01). Six patients (27.3%) were bridged to a durable left ventricular assist device. In 9 patients (40.9%), myocardial function recovered during Impella 5.0 support and the device was successfully explanted. The 30-day survival rate was 68.2%., Conclusions: Impella 5.0 support provides a bridge-to-decision option for patients following ECLS implantation and leads to left ventricular unloading. It allows further evaluation of a patient's neurological situation and facilitates further therapy. About two-thirds of patients survived with acceptable neurological outcomes., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The purpose of this study was to describe pre- and postoperative data from the EUROMACS registry with regard to indications, for and survival and complication rates of patients with primary continuous flow and pulsatile biventricular long-term assist devices (BiVADs) versus total artificial hearts (TAHs) or left ventricular assist devices (LVADs) + short-term right ventricular assist device (RVAD) implants., Methods: We investigated patients who received implants between 1 January 2011 and 21 October 2017. Clinical baseline information about comorbidities, laboratory results, medical and device therapies and echocardiographic, haemodynamic and right ventricle (RV) parameters were evaluated along with the rates of deaths and complications., Results: A total of 413 of 3282 patients (12.5%) needed a biventricular pump. We investigated 37 long-term BiVADs, 342 LVAD + short-term RVAD implants and 34 TAHs. Minor differences were found in the baseline characteristics of our population, which had an overall high morbidity profile. The 1-year survival rate was 55% for patients with a continuous flow BiVAD; 52% for patients with an LVAD + short-term RVAD; 37% for patients with pulsatile BiVADs; and 36% for patients with a TAH. No statistical difference was observed among the groups. Over 50% of patients with BiVAD support were classified as INTERMACS profiles 1 and 2. The percent of patients with ambulatory heart failure (INTERMACS 4‒7) undergoing BiVAD implants was modest at <15%. No patients with a pulsatile BiVAD (n = 15) or a TAH (n = 34) were implanted as destination therapy, but 27% of the patients with continuous flow BiVADs (n = 6) and 23% of the patients with LVAD + short-term RVAD (n = 342) were implanted as 'destination'. The adverse events profile remained high, with no significant difference among pump types. The right ventricular stroke work index and right heart failure scores indicated poor RV function in all groups. After 3 months of LVAD + short-term RVAD support, 46.7% still required ongoing support, and only 18.5% were weaned from RVAD support; 33.1% died., Conclusions: The mortality rate after BiVAD support was high. Survival rates and adverse events were statistically not different among the investigated groups. In the future, composite study end points examining quality of life and adverse events beyond survival may help in shared decision-making prior to general mechanical circulatory support, particularly in patients with BiVAD implants., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Tricuspid regurgitation (TR) is common in patients receiving a left ventricular assist device (LVAD). Controversy exists as to whether concomitant tricuspid valve surgery (TVS) is beneficial in currently treated patients. Therefore, our goal was to investigate the effect of TVS concomitant with a LVAD implant., Methods: The European Registry for Patients with Mechanical Circulatory Support was used to identify adult patients. Matched patients with and without concomitant TVS were compared using a propensity score matching strategy., Results: In total, 3323 patients underwent LVAD implantation of which 299 (9%) had TVS. After matching, 258 patients without TVS were matched to 258 patients with TVS. In the matched population, hospital deaths, days on inotropic support, temporary right ventricular assist device implants and hospital stay were comparable, whereas stay in the intensive care unit was higher in the TVS cohort (11 vs 15 days; P = 0.026). Late deaths (P = 0.17), cumulative incidence of unexpected hospital readmission (P = 0.15) and right heart failure (P = 0.55) were comparable between patients with and without concomitant TVS. In the matched population, probability of moderate-to-severe TR immediately after surgery was lower in patients with concomitant TVS compared to patients without TVS (33% vs 70%; P = 0.001). Nevertheless, the probability of moderate-to-severe TR decreased more quickly in patients without TVS (P = 0.030), resulting in comparable probabilities of moderate-to-severe TR within 1.5 years of follow-up., Conclusions: In matched patients, TVS concomitant with LVAD implant does not seem to be associated with better clinical outcomes. Concomitant TVS reduced TR significantly early after LVAD implant; however, differences in probability of TR disappeared during the follow-up period., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Ventricular assist devices (VADs) are widely accepted as therapy to bridge children to heart transplantation. We provide a systematic review of the current state of clinical outcomes in children after paediatric VAD support by the Berlin Heart EXCOR (BH EXCOR) device. A systematic literature search was performed in April 2018. Studies reporting clinical outcomes in at least 15 children supported by a BH EXCOR VAD were included. Additionally, we focused on outcomes in small children and compared outcomes of children supported by a left ventricular assist device (LVAD) versus children supported by a biventricular assist device (BiVAD). Eighteen publications fulfilled the inclusion criteria and were included in this systematic review. Mortality rates ranged from 6.3% [confidence interval (CI) 0.0-18.1%] to 38.9% (2.8-75.0%) while transplantation rates ranged from 37.0% (CI 18.8-55.2%) to 72.5% (CI 63.9-81.2%) and successful weaning rates from 0.0% to 20.7% (CI 6.0-35.5%). In children under 1 year of age, mortality rates ranged from 20.0% to 55.5% and transplantation rates ranged from 0.0% to 62.5%. BiVAD support seemed to result in worse clinical outcomes than LVAD support. Incidence of stroke ranged from 5.0% to 47.0% in all children supported with the BH EXCOR. Although a high incidence of adverse events such as stroke and pump thrombosis is reported, VAD support should be considered in children with end-stage heart failure awaiting heart transplantation. Further research is warranted, especially on optimal timing of device implantation and anticoagulation regimens., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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: 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.

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.

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 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.

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.)

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.)

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.)

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 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.)

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.)