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Malnutrition is common among paediatric heart failure patients, with nutritional rehabilitation critical for survival and optimal health outcomes. Ventricular assist devices have been associated with improved growth, though additional nutritional support may be needed. Here, we report the use of human milk-based fortifiers to avoid severe malnutrition in a neonate supported on a ventricular assist device until transplantation.

Objective: In patients with advanced heart failure, heart transplantation is currently the most effective treatment. However, in a low-organ donation environment, it is usually necessary to proceed in long-term mechanical circulatory support through left ventricular assist device (LVAD) implantation as bridge-to-transplantation., Methods: The study included all patients with advanced heart failure who underwent continuous flow LVAD implantation as a bridge to transplant strategy in our center (n = 68). Following LVAD implantation and for the period that patients were on LVAD support, pump thrombosis, strokes, gastrointestinal bleeding, and right heart failure occurrence rates were recorded. Outcomes were compared between patients implanted with HeartMate 3 (HM3) and HeartWare LVADs, as well as between patients who did reach heart transplantation (HTx group) and those who did not (noHTx group)., Results: A total of 35 out of 68 patients underwent heart transplantation at a mean time of 691 ± 457 days; 41 received a HeartWare and 27 a HM3 device. HM3 patients had significantly better survival (p = 0.010) and lower complication rates (p = 0.025). In addition, the noHTx group had significantly higher complication rates compared with the HTx group (p = 0.00041). The 5-year estimated Kaplan-Meier survival rate following heart transplantation was 77%., Conclusion: Patients with advanced heart failure gain substantial benefit from LVADs awaiting heart transplantation. In a low organ donation environment, the need for reliable LVADs can further improve the outcomes through the reduction of complications provided by current devices., (Copyright © 2024 Hellenic Society of Cardiology. Publishing services by Elsevier Inc. All rights reserved.)

Background: Patients with continuous flow left ventricular assist devices (CF-LVADs) are at increased risk of gastrointestinal bleeding (GIB). Statins are commonly prescribed in LVAD patients for cardiovascular disease prevention. However, their impact on GIB events is controversial. Importantly, literature regarding statins impact on GIB in CF-LVAD patients is lacking., Methods: A single-center, retrospective review of adult patients who underwent CF-LVAD implantation between May 2016 and January 2020 was performed. Patients were categorized based on statin use throughout the study period. The primary outcome was the composite of arteriovenous malformation confirmed GIB and major GIB events for up to 1-year post-LVAD implantation., Results: Of 123 patients included in the final analysis, 66 (54%) received statin therapy during the study period. No difference was observed in the primary outcome between the statin and control groups (RR: 1.73; 95% CI: 0.75-3.98; p =0.20). Multivariable Cox regression revealed that older age and higher baseline creatinine were associated with an increased risk of GIB within 1-year of CF-LVAD implantation., Conclusion: Among patients with CF-LVADs, there was no significant difference in the incidence of major GIB events associated with the use of statin therapy. Further studies are needed to assess whether a true association exists., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Heart failure is the leading cause of morbidity and mortality in adults with congenital heart disease. However, for many in this population, heart transplantation is not possible or requires longer wait times, necessitating prolonged circulatory support. The medium to long-term durable ventricular assist device therapy provides a possible solution. We analyzed outcomes of 9 patients with congenital heart disease and at least 3 years of durable mechanical support, all age 18 or older at the time of ventricular assist device implantation at our affiliated pediatric and adult hospitals. Palliated congenital anatomies varied and included biventricular physiologies as well as single ventricles with Fontan circulation. The median duration of support was 4.2 years, including 3 patients successfully bridged to transplant, averaging 2.1 years on the waitlist. Device-related complications were infrequent with HeartMate 3, a feasible and sustainable option for either bridge to transplant or destination strategies in adults with congenital heart disease., Competing Interests: Disclosure statement C.R.B. reports a financial relationship with Abbott; H.T. reports a relationship with Abbott; I.A. serves as a consultant and proctor for Berlin Heart, Inc., Medtronic Inc., Jarvik Inc., BiVACOR Inc., and Sony-Olympus Medical Solutions Inc.; A.C. reports financial relationships with Medtronic Inc. and Abbott. The remaining authors have no conflicts of interest to report., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Failing Fontan poses a significant clinical challenge. This study aims to improve patients' outcomes by comprehensively understanding the incidence, pathophysiology, risk factors, and treatment of failing Fontan after total cavopulmonary connection., Methods: We performed a retrospective analysis of patients who underwent total cavopulmonary connection at the German Heart Center Munich between 1994 and 2022. The onset of failing Fontan was defined as: protein-losing enteropathy, plastic bronchitis, NYHA class IV, NYHA class III for > one year, unscheduled hospital admissions for heart failure symptoms, and evaluation for heart transplantation., Results: Among 634 patients, 76 patients presented with failing Fontan, and the incidence was 1.48 per 100 patient-years. Manifestations included protein-losing enteropathy (n = 34), hospital readmission (n = 28), NYHA III (n = 18), plastic bronchitis (n = 16), evaluation for heart transplantation (n = 14), and NYHA IV (n = 4). Risk factors for the onset of failing Fontan were dominant right ventricle (p = 0.010) and higher pulmonary artery pressure before total cavopulmonary connection (p = 0.004). A total of 72 interventions were performed in 59 patients, including balloon dilatation/stent implantation in the total cavopulmonary connection pathway (n = 49) and embolization of collaterals (n = 24). Heart transplantation was performed in four patients. The survival after the onset of Fontan failure was 77% at 10 years. Patients with failing Fontan revealed significantly higher zlog-NT-proBNP levels after onset compared to those without (p = 0.021)., Conclusions: The incidence of Fontan failure was 1.5 per 100 patient years. Dominant right ventricle and higher pulmonary artery pressure before total cavopulmonary connection were significant risks for the onset of failing Fontan. Zlog-NT-proBNP is only a late marker of Fontan failure.

Background: Left ventricular assist device (LVAD) use remains uncommon in advanced heart failure (HF) patients not dependent on inotropes., Objectives: Before considering a randomized trial comparing a strategy of earlier use of LVAD to continued medical therapy, a better understanding is needed of the clinical trajectory of ambulatory patients with advanced systolic HF on optimal guideline-directed medical therapy (GDMT)., Methods: REVIVAL enrolled 400 patients with advanced ambulatory systolic HF, ≥1 HF mortality risk marker (≥2 HF hospitalizations past year; or HF hospitalization and high natriuretic peptide; or no HF hospitalizations but low peak oxygen consumption, 6-minute walk, serum sodium, HF survival score or Seattle HF model predicted survival), and no LVAD contraindication at 21 LVAD centers from July 2015 to June 2016. Patients were followed for 2 years or until a primary outcome (death, durable ventricular assist device, or urgent transplant). Clinical outcomes and health-related quality of life were evaluated., Results: Mean baseline left ventricular ejection fraction was 21%, median 6-minute walk was 341 m, and 92% were Interagency Registry for Mechanically Assisted Circulatory Support profiles 5 to 7. Adherence to GDMT and electrical device therapies was robust. Composite primary outcome occurred in 22% and 37% at 1 and 2 years, with death alone in 8% and 16%, respectively. Patients surviving for 2 years maintained GDMT intensity and had no decline in health-related quality of life., Conclusions: Structured, serial follow-up at programs with expertise in caring for advanced ambulatory systolic HF patients facilitates triage for advanced therapies. Better strategies are still needed to avoid deaths in a small but significant group of patients who die without advanced therapies. REVIVAL patients not selected for VAD or transplant have robust survival and patient-reported outcomes, which challenges advocacy for earlier VAD implantation. (Registry Evaluation of Vital Information for VADs in Ambulatory Life [REVIVAL]; NCT01369407)., Competing Interests: Funding Support and Author Disclosures Supported by funding from the National Institutes of Health, National Heart, Lung, and Blood Institute (contract number HHSN268201100026C) for REVIVAL and the National Center for Advancing Translational Sciences (grant numbers UL1TR002240 and UM1TR004404) for the Michigan Institute for Clinical and Health Research. The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services. Dr Aaronson has received research support from Medtronic, Abbott, Bioventrix, Amgen; has held ownership interest in Procyrion; and has served as a consultant/on the Advisory Board for Medtronic and Procyrion; at the time of submission of this manuscript, he does not have industry research funding, ownership interests, or ongoing consulting relationships. Dr Stewart has served as a consultant for Abbott and Procyrion. Dr Cascino has received research support from Johnson & Johnson and has served as a consultant for Merck & Co. Dr Stehlik has received honoraria from Medtronic; has served as a consultant for Medtronic, TransMedics, and Natera; and has received research support from Natera and Merck. Dr Lala has received honoraria from Zoll. Dr Pagani has served as a scientific advisor (without compensation) for Abbott, CH Biomedical, FineHeart, and Medtronic; has served as a medical monitor (without compensation) for Abiomed; and has received salary support from Blue Shield of Michigan. Dr Mann has served as a consultant/on the Advisory Board for Novartis and Bristol Myers Squibb. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. All rights reserved.)

Introduction: Implantation of a left ventricular assist device (LVAD) requires extensive aftercare. It is largely unclear how aftercare should be designed from the patients' perspective. Implications can be developed based on an examination of the healthcare context. Its main components are mapped on five tiers in the Human Factors of Home Health Care Model by Henriksen, Joseph, and Zayas-Caban (2009). Using this model, the present study explores the patient perspective on the context of healthcare after an LVAD implantation., Methods: We employed a qualitative cross-sectional study, in which LVAD patients participated in semi-structured interviews. The transcribed interviews were analyzed using content analysis. First, relevant meaning units were identified and deductively categorized into the model. Then, categories of care-related aspects were developed inductively within each of the model tiers., Results: We interviewed 18 patients aged 33 to 78 years who had been living with the LVAD between a few weeks and more than 10 years. Twenty-eight categories related to care aspects were developed within the model tiers: 3 categories on patient characteristics (e.g., self-management skills), 3 on caregiver characteristics (e.g., professionalism), 11 healthcare-related tasks and requirements (e.g., wound management), 8 on factors of the physical environment (e.g., controllability), medical devices and technologies (e.g., carrying systems for external components), and cultural, social and community environment (e.g., interaction with peers), as well as 3 on external environmental factors (e.g., healthcare infrastructure)., Discussion: The present study represents the first investigation focusing on aspects of the healthcare context influencing healthcare quality and safety from the perspective of LVAD patients in Germany. LVAD aftercare covers a broad and complex range of tasks. For this, patients, caregivers and healthcare professionals need specific knowledge, which is lacking in various respects. In the first place, this is compensated by the patients' own initiative and the personal care provided by the VAD outpatient clinics., Conclusion: Three key recommendations to optimize aftercare from the patient perspective are derived: Patients would benefit from a more flexible and decentralized aftercare concept, to which telemedicine could contribute. LVAD-specific expertise among general healthcare providers is perceived as insufficient by patients and could be strengthened through training and counseling services. The broad scope of tasks and the high level of responsibilities in LVAD aftercare pose challenges for patients and their families, which could be addressed through continuous information and training programs., (Copyright © 2024. Published by Elsevier GmbH.)

Background: Patients receiving left ventricular assist device (LVAD) support require long-term anticoagulation to reduce the risk of thromboembolic complications. Apixaban is a direct oral anticoagulant that has become first-line therapy; however, its safety in LVAD recipients has not been well described., Objectives: This study sought to investigate whether, in patients with a fully magnetically levitated LVAD, treatment with apixaban would be feasible and comparable with respect to safety and freedom from the primary composite outcome of death or major hemocompatibility-related adverse events (HRAEs) (stroke, device thrombosis, major bleeding, aortic root thrombus, and arterial non-central nervous system thromboembolism) as compared with treatment with warfarin., Methods: The DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) trial was a phase 2, open label trial of LVAD recipients randomized 1:1 to either apixaban 5 mg twice daily or warfarin therapy. All patients were required to take low-dose aspirin. Patients were followed up for 24 weeks to evaluate the primary composite outcome., Results: A total of 30 patients were randomized: 14 patients to warfarin and 16 patients to apixaban. The median patient age was 60 years (Q1-Q3: 52-71 years), and 47% were Black patients. The median time from LVAD implantation to randomization was 115 days (Q1-Q3: 56-859 days). At 24 weeks, the primary composite outcome occurred in no patients receiving apixaban and in 2 patients (14%) receiving warfarin (P = 0.12); these 2 patients experienced major bleeding from gastrointestinal sources., Conclusions: Anticoagulation with apixaban was feasible in patients with an LVAD without an excess of HRAEs or deaths. This study informs future pivotal clinical trials evaluating the safety and efficacy of apixaban in LVAD recipients. (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices [DOAC LVAD]; NCT04865978)., Competing Interests: Funding Support and Author Disclosures This study was sponsored by Inova Health System and funded by Abbott. Dr P. Shah has received grant support unrelated to this work and paid to Inova from Merck, Bayer, and Roche; and has served as a consultant for Natera, Merck, Ortho Clinical Diagnostics, and Procyrion. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

In April 2021, destination therapy (DT) was finally approved in Japan. Since DT does not aim at heart transplantation (HT), our goal is to have a patient safely remain on an implantable ventricular assist device (VAD) for the rest of his/her life. To achieve this goal, similarly to bridge-to-transplant (BTT) patients, the authors believe the following six aspects are even more crucial in DT patients: (1) to appropriately assess risks before implantation, (2) to carefully determine the ability to manage the device by multidisciplinary discussions, (3) to prevent complications by improving the quality of care, (4) to expand the number of facilities that can take care of DT patients by improving collaboration among the facilities, (5) to reduce the burden of caregivers by utilizing social resources, and (6) to establish a home palliative care system based on advance care planning. In addition, for elderly DT patients to live happy and long lives, it is essential to help them to find a purpose of life and to keep activities of daily living, such as employment, schooling, and participation in social activities, just like the general elderly population. Our goals are not only to do our best for the patients just in front of us, but also to establish a system to follow up our DT cohort, same as BTT one, by all-Japan manner. In the present review, we discuss the current state of DT in Japan and what we need to focus on to maintain or improve its long-term performance., (© 2024. The Author(s).)

With improvement in survival after Fontan surgery resulting in an increasing number of older survivors, there are more patients with a Fontan circulation experiencing circulatory failure each year. Fontan circulatory failure may have a number of underlying etiologies. Once Fontan failure manifests, prognosis is poor, with patient freedom from death or transplant at 10 years of only about 40%. Medical treatments used include traditional heart failure medications such as renin-angiotensin-aldosterone system blockers and beta-blockers, diuretics for symptomatic management, antiarrhythmics for rhythm control, and phosphodiesterase-5 inhibitors to decrease PVR and improve preload. These oral medical therapies are typically not very effective and have little data demonstrating benefit; if there are no surgical or catheter-based interventions to improve the Fontan circulation, patients with severe symptoms often require inotropic medications or mechanical circulatory support. Mechanical circulatory support benefits patients with ventricular dysfunction but may not be as useful in patients with other forms of Fontan failure. Transplant remains the definitive treatment for circulatory failure after Fontan, but patients with a Fontan circulation face many challenges both before and after transplant. There remains significant room and urgent need for improvement in the management and outcomes of patients with circulatory failure after Fontan surgery.

Simulators are expected to assume a prominent role in the process of design—development and testing of cardiovascular medical devices. For this purpose, simulators should capture the complexity of human cardiorespiratory physiology in a realistic way. High fidelity simulations of pathophysiology do not only allow to test the medical device itself, but also to advance practically relevant monitoring and control features while the device acts under realistic conditions. We propose a physiologically controlled cardiorespiratory simulator developed in a mixed in silico-in vitro simulation environment. As inherent to this approach, most of the physiological model complexity is implemented in silico while the in vitro system acts as an interface to connect a medical device. As case scenarios, severe heart failure was modeled, at rest and at exercise and as medical device a left ventricular assist device (LVAD) was connected to the simulator. As initial validation, the simulator output was compared against clinical data from chronic heart failure patients supported by an LVAD, that underwent different levels of exercise tests with concomitant increase in LVAD speed. Simulations were conducted reproducing the same protocol as applied in patients, in terms of exercise intensity and related LVAD speed titration. Results show that the simulator allows to capture the principal parameters of the main adaptative cardiovascular and respiratory processes within the human body occurring from rest to exercise. The simulated functional interaction with the LVAD is comparable to the one clinically observed concerning ventricular unloading, cardiac output, and pump flow. Overall, the proposed simulation system offers a high fidelity in silico-in vitro representation of the human cardiorespiratory pathophysiology. It can be used as a test bench to comprehensively analyze the performance of physically connected medical devices simulating clinically realistic, critical scenarios, thus aiding in the future the development of physiologically responding, patient-adjustable medical devices. Further validation studies will be conducted to assess the performance of the simulator in other pathophysiological conditions.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited cardiomyocyte disease characterized by intractable ventricular arrhythmia in the majority of affected patients. Some of these patients also manifest right ventricular dysfunction and heart failure symptoms. Fatal ventricular arrhythmia has been the primary cause of death in ARVC patients. However, increased early recognition of ARVC and improvement in arrhythmic risk stratification and treatment have dramatically improved survival. A small proportion of the patients are further complicated by left ventricular impairment at the late phase in addition to right heart failure, for whom only heart transplantation is the last resort. Because of the relative rarity of ARVC with biventricular failure, no consensus or guideline has been reported on how to effectively support these patients with a mechanical circulatory device. Herein, four ARVC patients with biventricular failure were presented who were successfully bridged to heart transplantation after long-term support by isolated continuous-flow LVAD.

Atrial fibrillation (AF) is a common comorbidity in left ventricular assist device (LVAD) patients and has been identified as a risk factor for thromboembolic stroke. Blood stagnation within the left atrial appendage (LAA) is considered a possible major source of thrombosis and clinical studies have shown reduced thromboembolic risk after LAA occlusion (LAAO). Therefore, this study aims to investigate the effect of LAAO on thrombosis-related parameters using patient-specific simulations. Left ventricular and left atrial geometries of an LVAD patient were obtained from computed tomography and combined with hemodynamic data with either sinus rhythm (SR) or AF generated by a lumped parameter model. In four simulations applying contractile walls, stagnation volume and blood residence times were evaluated with or without AF and with or without LAAO. Reduced atrial contraction in AF resulted in unfavorable flow dynamics within the left atrium. The average atrial velocity was lower for the AF simulation when compared to SR, resulting in a 55% increase in the atrial stagnation volume (from 4.2 to 6.5 cm3). Moreover, blood remained in the LAA for more than 8 cardiac cycles. After LAAO the atrial stagnation decreased from 4.2 to 1.4 cm3 for SR and from 6.5 to 2.3 cm3 for the AF simulation. A significant stagnation volume was found in the LAA for both SR and AF, with larger values occurring with AF. These regions are known as potential sources for thrombus formation and can be diminished by LAAO. This significantly improved the thrombus-related flow parameters and may also lower the risk of thromboembolic events from the appendage.

This article discusses the use of transcatheter aortic valve implantation (TAVI) for the treatment of left ventricular assist device (LVAD)-related aortic regurgitation (AR). LVADs are commonly used in patients with end-stage heart failure, but AR can be a complication. The article explores different strategies for addressing LVAD-related AR, including modifying LVAD settings, surgical interventions, and TAVI. The study presented in the article examines the outcomes of TAVI in patients with LVAD-related AR and proposes an algorithm for treatment. The authors emphasize the importance of a comprehensive approach to optimize intervention timing and improve patient outcomes. [Extracted from the article]

Background: Intracranial hemorrhage (ICH) is a frequent complication in patients with an implanted left ventricular assist device (LVAD) for advanced heart failure. Bloodstream infection is known to be associated with ICH in patients with LVAD, but its effects on ICH-associated mortality are unknown. We compared characteristics and mortality of infection-associated, traumatic, and spontaneous hemorrhages. Methods: Patients in an LVAD registry at a tertiary care center were reviewed for this cohort study. ICH included intraparenchymal hemorrhage, subarachnoid hemorrhage, and subdural hemorrhage. Hemorrhages were categorized into infectious, traumatic, and spontaneous by the presence or absence of concurrent device-associated infection or antecedent trauma. Results: Of 683 patients with an LVAD, 73 experienced ICH (10.7%). Intraparenchymal hemorrhage was the most prevalent (72%), followed by subarachnoid hemorrhage (27%) and subdural hemorrhage (23%), with multiple concurrent hemorrhage subtypes in 16 patients (22%). Median time from implantation to ICH was shorter in spontaneous ICH than in infection-associated ICH (100 days vs. 252 days, p = 0.048). The prevalence of the different subtypes of ICH were similar between spontaneous and infection-associated ICH, and no differences were seen in mortality between the different causes of ICH. Conclusions: Although spontaneous ICH occurred earlier after LVAD implantation than infection-associated ICH, no difference in mortality was seen between the different causes of ICH. [ABSTRACT FROM AUTHOR]

Background: Implantable cardioverter‐defibrillator (ICD) surgery in patients with implanted left ventricular assist devices (LVAD) is associated with an increased risk of bleeding complications because of the need to ensure that these patients are adequately anticoagulated. Our study aimed to evaluate the safety of our new strategy of uninterrupted oral anticoagulation compared to heparin‐bridging during the surgical interval. Methods: Between January 2009 and January 2020, 116 patients with LVAD underwent ICD surgery. Since January 2015, 60 patients were operated under continued sufficient oral anticoagulation with a vitamin k antagonist (VKA group). Fifty‐six patients underwent a heparin‐bridging regimen (heparin group). Demographics, perioperative data, complications, and mortality were analyzed. Results: Bleeding complications attributable to the surgical intervention occurred more often (19.6% vs. 10.0%, p = 0.142) and at a higher rate of re‐exploratory surgery (14.3% vs. 5.0%, p = 0.088) in the heparin group without reaching statistical significance. Moreover, the heparin group patients' postoperative total length of stay was 10 days longer (17.8 ± 23.8 days vs. 8.3 ± 9.5 days, p = 0.007). There were no procedure‐related deaths, no thromboembolic events, and no LVAD‐related thrombosis. Conclusion: Our strategy of uninterrupted oral anticoagulation is safe and results in a reduction by more than half the number of days in hospital without an increase in adverse events. [ABSTRACT FROM AUTHOR]

Objective: In preclinical examinations, rotodynamic blood pumps (RBPs) are predominantly evaluated at design-point conditions. In clinical practice, however, they run at diversified modes of operation. This study aimed at extending current preclinical evaluation of hemolytic profiles in RBPs toward broader, clinically relevant ranges of operation. Methods: Two implantable RBPs – the HeartMate 3 (HM3) and the HeartWare Ventricular Assist Device (HVAD) – were analyzed at three pump speeds (HM3: 4300, 5600, 7000 rpm; HVAD: 1800, 2760, 3600 rpm) with three flow rates (1-9L/min) per speed setting. Hemolysis measurements were performed in heparinized bovine blood. The delta free hemoglobin (dfHb) and the normalized index of hemolysis (NIH) served as hemolytic measures. Statistical analysis was performed by multiple comparison of the 9 operating conditions. Moreover, computational fluid dynamics (CFD) was applied to provide mechanistic insights into the interrelation between hydraulics and hemolysis by correlating numerically computed hydraulic losses with in-vitro hemolytic measures. Results: In both devices, dfHb increased toward increasing speeds, particularly during low but also during high flow condition. By contrast, in both RBPs magnitudes of NIH were significantly elevated during low flow operation compared to high flow conditions (p<0.0036). Maps of hemolytic metrics revealed morphologically similar trends to in-silico hydraulic losses (r>0.793). Conclusions: While off-design operation is associated with increased hemolytic profiles, the setting of different operating conditions render a preclinical prediction of clinical impact with current hemolysis metrics difficult. Significance: The identified increase in hemolytic measures during episodes of off-design operation is highlighting the need to consider worst-case operation during preclinical examinations. [ABSTRACT FROM AUTHOR]

The field of pediatric ventricular assist device (VAD) support has expanded significantly over the past 20 years, with one third of pediatric heart transplant recipients currently being bridged to transplant with a VAD. Despite increased pediatric VAD utilization, however, there remains little formalized guidance for patient or device selection. The population of children with advanced heart failure is quite heterogeneous, and the available data suggest that VAD outcomes vary significantly based upon patient size, anatomy, level of illness, and type of device implanted. In an effort to better understand current practice patterns and identify populations for whom there does not appear to be a consensus approach to achieving optimal VAD outcomes, the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) has surveyed clinical decision-making among member sites and conducted a review of the available literature regarding patient population-specific VAD outcomes and center-specific practices related to patient and device selection. Rather than aiming to provide clinical guidelines, this document offers an overview of contemporary approaches to patient and device selection, highlighting specific populations for whom there is not a consensus approach to achieving reliably good VAD outcomes, as these populations may benefit most from future research and quality improvement efforts directed toward identifying best practice. [ABSTRACT FROM AUTHOR]

Acute kidney injury (AKI) remains a leading source of morbidity and mortality after cardiothoracic surgery. Insulin-like growth factor-binding protein 7 (IGFBP7), and tissue inhibitor of metalloproteinases-2 (TIMP-2), are novel early-phase renal biomarkers that have been validated as sensitive predictors of AKI. Here the authors studied the efficacy of these biomarkers for predicting AKI after left ventricular assist device (LVAD) implantation and cardiac transplantation. This was a prospective study of 73 patients undergoing LVAD implantation (n = 37) or heart transplant (n = 36) from 2016 to 2017 at the authors' center. TIMP-2 and IGFBP7 were measured with the NephroCheck Test on urine samples before surgery and one-to-six hours after surgery. NephroCheck scores were assessed as predictors of moderate/severe AKI (Kidney Disease International Global Outcomes 2/3 creatinine criteria) within 48 hours of surgery, and the association with survival to one year was investigated. The LVAD and transplant cohorts overall were similar in demographics and baseline creatinine (p > 0.05), with the exception of having more African-American patients in the LVAD arm (p = 0.003). Eleven (30%) LVAD and 16 (44%) transplant patients developed moderate/severe AKI. Overall, AKI was associated with postsurgery NephroCheck (odds ratio [95% confidence interval] for 0.1 mg/dL increase: 1.36 [1.04-1.79]; p = 0.03), but not with baseline NephroCheck (p = 0.92). When analyzed by cohort, this effect remained for LVAD (1.68 [1.05-2.71]; p = 0.03) but not for transplant (p = 0.15). Receiver operating characteristic analysis showed postoperative NephroCheck to be superior to baseline creatinine in LVAD (p = 0.046). Furthermore, an increase of 0.1 mg/dL in postoperative NephroCheck was associated with a 10% increase in the risk of mortality (adjusted hazard ratio: 1.11 [1.01-1.21]; p = 0.04) independent of age and body mass index. Assessment of TIMP-2 and IGFBP7 within six hours after surgery appeared effective at predicting AKI in patients with LVADs. Larger studies are warranted to validate these findings. [ABSTRACT FROM AUTHOR]

• Pediatric heart transplantation under brain death started in 2011. • Implantable continuous flow ventricular assist devices (VAD) are available since 2011. • Intracorporeal VAD Berlin Heart EXCOR is available from 2015. • There are 55 patients transplanted in Japan and 123 patients transplanted outside Japan to date. • Survival after heart transplantation and care in Japan are better than international registry data. It has been about 10 years since the revised Japanese Organ Transplant Law came into action. Organ donation from brain dead donors has increased in the past decade, but the number of recipients waiting for transplant is increasing more rapidly. Implantable continuous flow ventricular assist device, such as Jarvik 2000 and HeartWare, available from 2011, and Berlin heart EXCOR, available from 2015, has changed the scene for children with severe heart failure. About 80% of the patients who received heart transplantation (HTx) were supported by one of these devices, and average waiting time is 688±502 days. Despite small number of patients transplanted in Japan, patient survival at 10 years was 97.5%, which is superior to that of the International Registry of Heart and Lung Transplantation. Immunosuppression regimen included calcineurin inhibitor (mostly tacrolimus), mycophenolate mofetil, and steroid at the time of HTx. Major complications after HTx include rejection, infection, renal failure, cardiac allograft vasculopathy, and post-transplant lymphoproliferative disorders. Reasons for survival of Japanese pediatric HTx includes selections: limited number of patients with congenital heart disease, low donor risks, and good compliance. Further effort is required to achieve self-sufficiency of organ donors and transplantation, and reduce morbidity and mortality after HTx. [Display omitted] [ABSTRACT FROM AUTHOR]

Outcomes of ventricular assist device (VAD) support in patients with Fontan circulatory failure (or failing Fontan physiology) are largely unknown. We conducted a retrospective analysis of patients with a Fontan circulation who underwent VAD implant in the Society of Thoracic Surgeons Pedimacs and Intermacs Databases from September 19, 2012, to December 31, 2019. We identified 55 Fontan patients who had undergone VAD implant with a median age at implantation of 10.2 years (interquartile range, 6.4-16.9 years) and weight, 26.8 kg (interquartile range, 17.7-53.8 years). More VADs were implanted in 2018-2019 than in 2012-2017 (28 vs 27; P =.01). The later era had higher pre-VAD glomerular filtration rate (101.1 ± 48.5 vs 71.2 ± 34.9; P =.02); there was no difference in Interagency Registry for Mechanically Assisted Circulatory Support profile (P =.69). Kaplan-Meier survival on device was 76% at 6 months with no difference by era. Competing outcomes demonstrated a positive outcome of 81% (alive on VAD, transplanted, or recovered) at 6 months, with 58% of mortality occurring during month 1. Median length of support was 3.8 months (interquartile range, 0.6-6.9 months). Five patients were supported for >1 year with no added mortality; the longest support time was 4 years, 7 months. Adverse event rates included pump thrombosis incidence of 4% (3.3 out of 100 patient-months), stroke 5.5% (1.4 out of 100 patient-months), gastrointestinal bleeding of 7% (2.6 out of 100 patient-months), and nongastrointestinal bleeding of 9% (2.3 out of 100 patient-months). This is the largest reported analysis of systemic VAD support of Fontan patients. VAD support of the Fontan circulation is becoming more frequent. This analysis demonstrates that VAD use in this growing population can yield promising outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Infections and thrombotic events remain life‐threatening complications in patients with ventricular assist devices (VAD). Methods: We describe the relationship between both events in our cohort of patients (n = 220) supported with the HeartWare VAD (HVAD). This is a retrospective analysis of patients undergoing HVAD implantation between July 2009 and March 2019 at the Freeman Hospital, Newcastle upon Tyne, United Kingdom. Results: Infection was the most common adverse event in HVAD patients, with 125 patients (56.8%) experiencing ≥ one infection (n = 168, 0.33 event per person year (EPPY)), followed by pump thrombosis (PT) in 61 patients (27.7%, 0.16 EPPY). VAD‐specific infections were the largest group of infections. Of the 125 patients who had an infection, 66 (53%) had a thrombotic event. Both thrombotic events and infections were related to the duration of support, though there was only limited evidence that infections predispose to thrombosis. Those with higher than median levels of C‐reactive protein during the infection were more likely to have an ischaemic stroke (IS) (34.5% vs 16.7%, p =.03), though not PT or a combined thrombotic event (CTE: first PT or IS). However, in multivariate analysis, there was no significant effect of infection predisposing to CTE. Conclusions: Infection and thrombotic events are significant adverse events related to the duration of support in patients receiving HVADs. Infections do not clearly predispose to thrombotic events. [ABSTRACT FROM AUTHOR]

Introduction: Although mechanical circulatory support saved many lives during the last decade, clinical observations have shown that the continuous flow pumps are associated with a much higher incidence of gastrointestinal bleeding and kidney problems, among others, compared with the earlier generation pulsatile pumps. However, the presence of several moving mechanical components made pulsatile pumps less durable, bulky, and prone to malfunction, ultimately leading to bias in favor of continuous flow designs. Objective: The aim of the current work is to create a prototype tubular pulsatile pump and to test the timing of the pump in a left heart simulator. Methods: A left heart simulator to mimic pumping from a failing heart was created. This was used to experimentally test the output of a prototype ventricular assist device relative to a failing heart in the form of flow and pressure. The effect of pulsation timing was quantified. Results: A failing heart was simulated with an average flow rate of 1.1 L/min and a systolic pressure of 47 mm Hg. With the pump, the flow rate increases to 4.8 L/min and a systolic pressure of 110 mm Hg, in a copulsation mode, while activating for 300–400 ms. If the activation time is reduced, or increased, the pump becomes less effective. Load on the heart is reduced when the pump operates in a counterpulsation mode. Conclusion: A pulsatile pump, like the one proposed, provides adequate output for mechanical circulatory support, while minimizing the number of moving parts that could otherwise lead to tribological wear. [ABSTRACT FROM AUTHOR]

Objective: Ventricular assist devices (VADs) increase waitlist survival, yet the risk of stroke remains notable. The purpose of this study was to analyze how strokes on VAD support impact post‐transplant (post‐Tx) outcomes in children. Methods: About 520 pediatric (<18 years) heart transplant candidates listed from January 2011 to April 2018 with a VAD implant date were matched between the United Network of Organ Sharing and Pediatric Health Information System databases. Patients were divided into pre‐Tx Stroke and No Stroke cohorts. Results: About 81% of the 520 patients were transplanted; 28% (n = 146) had a pre‐Tx Stroke; and 59% (n = 89) of the Stroke patients were transplanted at a median of 57 (IQR 17–102) days from stroke. Significantly more No Stroke cohort (90%) were transplanted (p < 0.001). There was no difference in post‐Tx survival between the Stroke and No Stroke cohorts (p = 0.440). Time between stroke and transplant for patients who died within 1 year of transplant was 32.0 days (median) compared to 60.5 days for those alive >1 year (p = 0.18). Regarding patients in whom time from stroke to transplant was more than 60 days, one‐year survival of Stroke vs. No Stroke patients was 96% vs. 95% (p = 0.811), respectively. Conclusion: Patients with stroke during VAD support, once transplanted, enjoy similar survival compared to No Stroke patients. We hypothesize that allowing Stroke patients more time to recover could improve post‐Tx outcomes. Unfortunately, the ideal duration of time between stroke and safe transplantation could not be determined and will require more detailed and larger studies in the future. [ABSTRACT FROM AUTHOR]

Introduction: Recently, the efficacy of middle meningeal artery (MMA) embolization for chronic subdural hematoma (cSDH) in the elderly has been reported. However, no previous reports of MMA embolization for cSDH in children with ventricular assist devices (VAD) have been published. Here, we report a case of MMA embolization for cSDH in a child with VAD. Case: A 15-month-old female was diagnosed with dilated cardiomyopathy at 7 months old. Soon, a VAD was inserted, and anticoagulant and antiplatelet therapy was started. Bilateral cSDH was observed at 15 months, and, 2 months later, an acute exacerbation of the right cSDH necessitated intracerebral hemorrhage removal. Afterwards, increased intracranial pressure occurred due to a contralateral subdural hematoma but, 4 months after intracerebral hemorrhage removal, CT showed new hemorrhaging in the left cSDH. MMA embolization was then conducted to prevent rebleeding in the hematoma. Selective angiography of the left MMA demonstrated stains of hematoma capsules from the frontal and parietal branches, which were embolized using liquid embolic material. During the procedure, the material migrated into the intracranial vessels via an undetected transdural anastomosis. Postoperatively, no new neurological abnormalities, including hemiparesis, were observed. Two months later, CT showed a decrease in hematoma size. Conclusion: MMA embolization for cSDH in pediatric patients with VAD may be effective, if vigilance is maintained against transdural anastomoses. [ABSTRACT FROM AUTHOR]

Background: The extracorporeal life support (ECLS) and temporary bilateral ventricular assist device (t-BiVAD) are commonly applied in patients with cardiogenic shock. Prolonged cardiopulmonary resuscitation (CPR) has poor prognosis. Herein, we report our findings on a combined ECLS and t-BiVAD approach to salvage cardiogenic-shock patients with CPR for more than one hour. Methods: Fifty-nine patients with prolonged CPR and rescued by ECLS and subsequent t-BiVAD were retrospectively collected between January 2015 and December 2019. Primary diagnoses included ischemic, dilated cardiomyopathy, acute myocardial infarction, post-cardiotomy syndrome, and fulminant myocarditis. The mean LVEF was 16.9% ± 6.56% before t-BiVAD. The median ECLS-to-VAD interval is 26 h. Results: A total of 26 patients (44%) survived to weaning, including 13 (22%) bridged to recovery, and 13 (22%) bridged to transplantation. Survivors to discharge demonstrated better systemic perfusion and hemodynamics than non-survivors. The CentriMag-related complications included bleeding (n = 22, 37.2%), thromboembolism (n = 5, 8.4%), and infection (n = 4, 6.7%). The risk factors of mortality included Glasgow Coma Scale (Motor + Eye) ≤ 5, and lactate ≥ 8 mmol/L at POD-1, persistent ventricular rhythm or asystole, and total bilirubin ≥ 6 mg/dL at POD-3. Mortality factors included septic shock (n = 11, 18.6%), central failure (n = 10, 16.9%), and multiple organ failure (n = 12, 20.3%). Conclusions: Combined ECLS and t-BiVAD could be a salvage treatment for patients with severe cardiogenic shock, especially for those already having prolonged CPR. This combination can correct organ malperfusion and allow sufficient time to bridge patients to recovery and heart transplantation, especially in Asia, where donation rates are low, as well as intracorporeal VAD or total artificial heart being seldom available. [ABSTRACT FROM AUTHOR]

Background: Implanted cardioverter defibrillators (ICDs) and left ventricular assist devices (LVADs) are established interventions that prolong life in advanced heart failure, but their combination has not been demonstrated as beneficial. Electromagnetic interference (EMI) produced by a LVAD can preclude ICD interrogation with external programmers. We undertook a systematic evaluation of the LVAD–ICD interaction "in‐vitro" to clarify the extent of this interaction. Methods: Using explanted ICDs and VADs in a mock physiological rig, we assessed interrogation and reprogramming of ICD devices in the presence of a running LVAD. When connectivity between the ICD programmer and the ICD failed, we attempted three different techniques to re‐establish connectivity: (1) Electromagnetic shielding of the ICD with a pseudo‐faraday cage; (2) altering the LVAD speed; and (3) increasing the distance between the VAD and the ICD. Results: We tested a total of 24 ICDs from different manufacturers in the presence of the Heartware (HW) and HeartMate 3 (HM3) LVADs. With HW, we only observed interaction with Biotronik ICD devices at very close range (0–6 cm). With HM3, only Medtronic ICD devices showed no interaction. Interactions could be mitigated by increasing the VAD–ICD distance. Conclusions: LVADs, notably the HM3, produce EMI that interferes with the communication between an ICD and its respective programmer. This may need to be considered when choosing the type of VAD to implant in patients with a previously implanted left‐sided ICD. The only safe way to regain connectivity is to increase the distance between the VAD and the ICD, with patients raising their arm above their head. [ABSTRACT FROM AUTHOR]

Background: A relation between the left ventricular assist device inflow cannula (IC) malposition and pump thrombus has been reported. This study aimed to investigate if the pump position, derived from chest X‐rays in HeartMate 3 (HM3) patients, correlates with neurological dysfunction (ND), ischemic stroke (IS), hemorrhagic stroke (HS) and survival. Methods: This analysis was performed on routinely acquired X‐rays of 42 patients implanted with a HM3 between 2014 and 2017. Device position was quantified in patients with and without ND from frontal and lateral X‐rays characterizing the IC and pump in relation to spine, diaphragm or horizontal line. The primary end‐point was freedom from stroke and survival one‐year after HM3 implantation stratified by pump position. Results: The analysis of X‐rays, 33.5 (41.0) days postoperative, revealed a significant smaller IC angle of HM3 patients with ND versus no ND (0.1° ± 14.0° vs. 12.9° ± 10.1°, p = 0.005). Additionally, the IC angle in the frontal view, IS: 4.1 (20.9)° versus no IS: 13.8 (7.5)°, p = 0.004 was significantly smaller for HM3 patients with IS. Using receiver operating characteristics derived cut‐off, IC angle <10° provided 75% sensitivity and 100% specificity (C‐statistic = 0.85) for predicting IS. Stratified by IC angle, freedom from IS at 12 months was 100% (>10°) and 60% (<10°) respectively (p = 0.002). No significant differences were found in any end‐point between patients with and without HS. One‐year survival was significantly higher in patients with IC angle >10° versus <10° (100% vs. 71.8%, p = 0.012). Conclusions: IC malposition derived from standard chest X‐rays serves as a risk factor for ND, IS and worse survival in HM3 patients. [ABSTRACT FROM AUTHOR]

Purpose: There are marked gender differences in all etiologies of advanced heart failure. We sought to determine whether there is evidence of gender‐specific decision making for transplant assessments, and how gender effects outcomes. Methods: Retrospective analysis of adult heart transplant assessments at a single UK center between April 2015 and March 2020. Results: Females were 32% of referrals (N = 137 females, 285 males), with marked differences between diagnoses – 11% ischemic and 43% of adult congenital. Females were younger, shorter, weighed less, and had lower pulmonary pressures. Females were much less likely to receive a ventricular assist device (13%). Blood type "O" females were relatively more likely compared to males to receive a transplant (45%). Comparing males and females who received a ventricular assist device, both had similar levels of high pulmonary pressures, indicating consistent decision‐making based on hemodynamics to implant a device. Overall survival was better for females (in noncongenital patients), and this was due to female patients who were not accepted for transplant or a ventricular assist device being more often "too well for transplant," rather than in males when they were more often "unsuitable." Conclusions: Marked gender differences exist at all stages of the heart transplant assessment pathway. Appropriate decision‐making based on clinical grounds is shown with less transplants in male blood type "O"s and hemodynamic criteria for ventricular assist device implantation in both genders. Further studies are needed to determine if there is a wider community bias in advanced heart failure treatments for females. [ABSTRACT FROM AUTHOR]

Children with advanced heart failure may require ventricular assist devices (VAD) while awaiting heart transplantation. Currently, no data exist regarding the safety of exercise rehabilitation (ER) in children on VAD support. The purpose of this study was to determine the safety and feasibility of ER in children on VAD support awaiting heart transplantation. Eligible patients underwent VAD placement between 1998 and 2019; both inpatient and outpatient participants were included. After VAD implantation and when ambulatory, patients were enrolled in ER. Exercise sessions were scheduled three times a week and consisted of aerobic and musculoskeletal conditioning. A total of 29 patients (59% male, mean age 14 ± 3.2 years) were included with a median VAD duration of 120 ± 109 days. Cardiac diagnoses included cardiomyopathy (81%) and congenital heart disease (19%). VAD type included pulsatile (59%) and continuous-flow devices (41%). Eight hundred and sixty-four (85%) ER sessions were successfully completed and began at a mean of 49 days (range 19–108) after VAD implant. No adverse events, including episodes of hypotension, significant complex arrhythmia, or VAD malfunction occurred during exercise testing or ER, and no sessions were discontinued prematurely. Pediatric patients on VAD support can safely participate in ER with relatively high compliance, and sessions can be implemented early after VAD implantation. Given the safety profile, ER in pediatric VAD recipients, which is a modifiable pre-transplant risk factor that may improve functional capacity, warrants further study as a potential modality to improve post-transplant outcomes. [ABSTRACT FROM AUTHOR]

Advances in surgical techniques and outpatient cardiac care have led to a growing population of pediatric patients surviving well into adulthood with previous single-ventricle palliation. Continued improvement in survival has resulted in subsequent increases in the number of patients with single-ventricle physiology listed for heart transplantations. Some of these patients require mechanical circulatory support as a bridge to transplantation, although establishing successful mechanical circulatory support in these complex patients remains challenging. Only limited published data exist describing the perioperative anesthetic management and key considerations dedicated to patients with failing single-ventricle physiology presenting for ventricular assist devices. This clinical review aims to provide a focused evaluation of the vital perioperative considerations encountered in this novel population. [ABSTRACT FROM AUTHOR]

Cardiogenic shock is a state of end-organ hypoperfusion due to primary cardiac dysfunction and portends a poor prognosis. Shock refractory to inotropic and vasopressor support is often an indication for mechanical circulatory support. When mechanical support device complications or malfunction arise, echocardiography offers rapid assessment of device position and function. Repositioning can be done under echocardiographic guidance. Despite the widespread use of percutaneous mechanical circulatory support, there is a dearth of information regarding echocardiography as it pertains to these devices. In this review, we discuss the utility of echocardiography with percutaneous mechanical circulatory support devices. [ABSTRACT FROM AUTHOR]

Recently, the Sherlock 3CG™ Tip Confirmation System, including a magnetic tracking system and an intracavitary electrocardiography guidance system, has been introduced for bedside peripherally inserted central catheter (PICC) insertion. Magnetic field sources interfere with the magnetic tracking system. Electromagnetic interference of the ventricular assist device (VAD) has already been reported with various devices but not on Sherlock 3CG™. We assessed the availability of the magnetic tracking system in patients with and without a VAD during Sherlock 3CG™ insertion and evaluated the rate of optimal PICC tip position. We retrospectively reviewed 99 patients who had undergone PICC insertion using Sherlock 3CG™ on the bedside at our institutional intensive care unit from February 2018 to December 2020. Patients were divided into groups with and without a VAD. The availability of magnetic navigation and the success rate of optimal catheter tip position in each group were assessed. Among 87 cases analyzed, there were 12 and 75 cases with a VAD and without a VAD, respectively. The availability of magnetic navigation during Sherlock 3CG™ insertion was significantly lower in the group with a VAD [4/12 (33%) with VAD vs. 72/75 (96%) without VAD, P < 0.001]. In addition, the rate of optimal PICC tip position was also significantly lower in the group with a VAD [6/12 (50%) vs. 63/75 (84%), P = 0.015] The VAD significantly led to magnetic tracking system failure due to its electromagnetic interference during Sherlock 3CG™ insertion and significantly reduced the success rate of PICC insertions in the optimal position. [ABSTRACT FROM AUTHOR]