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Background: Left ventricular assist device (L‐VAD) implantation is increasingly used in patients with heart failure (HF) and most patients also have an implantable cardioverter defibrillator (ICD). Limited data are available on the incidence of ICD therapies and complications in this special setting. The aim of this study was to analyze the real‐world incidence and predictors of ICD therapies, complications and interactions between ICD and L‐VAD. Methods: We conducted a multicenter retrospective observational study in patients with advanced HF implanted with ICD and a continuous‐flow L‐VAD, followed‐up in five advanced HF centers in Northern Italy. Results: A total of 234 patients (89.7% male, median age 59, 48.3% with ischemic etiology) were enrolled. After a median follow‐up of 21 months, 66 patients (28.2%) experienced an appropriate ICD therapy, 22 patients (9.4%) an inappropriate ICD therapy, and 17 patients (7.3%) suffered from an interaction between ICD and L‐VAD. The composite outcome of all ICD‐related complications was reported in 41 patients (17.5%), and 121 (51.7%) experienced an L‐VAD‐related complication. At multivariable analysis, an active ventricular tachycardia (VT) zone and a prior ICD generator replacement were independent predictors of ICD therapies and of total ICD‐related complications, respectively. Conclusions: Real‐world patients with both L‐VAD and ICD experience a high rate of ICD therapies and complications. Our findings suggest the importance of tailoring device programming in order to minimize the incidence of unnecessary ICD therapies, thus sparing the need for ICD generator replacement, a procedure associated to a high risk of complications. [ABSTRACT FROM AUTHOR]

The article discusses the rising prevalence of heart failure, particularly in low- and middle-income countries (LMICs), and the limitations of current treatment options such as heart transplantation and ventricular assist devices (VADs). It introduces the concept of implantable cardiac soft robotic sleeves (ICRS) as a potential solution. The ICRS utilizes soft robotics and biomimicry to replicate the natural motion of the myocardium, offering advantages such as pulsatile flow, reduced need for anticoagulation therapy, potential for miniaturization, and synchronization with the natural heart. The article highlights the implications of this technology for LMICs, including cost-effectiveness, manufacturing efficiency, increased accessibility, and long-term sustainability. However, it acknowledges the challenges that need to be addressed, such as safety and efficacy trials, cost, healthcare infrastructure, and patient selection. Despite these challenges, the ICRS represents a promising technology that could significantly benefit end-stage heart failure patients in LMICs and contribute to global health equity. The authors emphasize the importance of collaboration among stakeholders to accelerate the development and deployment of this technology. Overall, the article presents the ICRS as an innovative solution to address the pressing health challenges of heart failure and bridge healthcare disparities. [Extracted from the article]

Background: As the incidence of heart failure in developed countries is on the rise, mechanical circulatory support (MCS) often remains the only treatment option for patients with end‐stage heart failure and is well established worldwide. Even though VAD coordinators play a key role in VAD programs, their responsibilities and daily duties are not clearly defined and characterized. Recently published data from the first 5‐year multicenter clinical trial assessing experience with the HeartMate 3 left ventricular system (Abbott, Abbott Park, IL) show an overall survival of 61% at 5 years. When it comes to possible improvements to these systems, it is necessary for developers not only to know the status quo but also to determine and consider the visions and wishes of those individuals who take care of patients, provide education and deal with possible complications. This would be helpful a meaningful effort towards implementing a standard of care. Methods: To fill this knowledge gap, we conducted an online survey using the SurveyMonkey tool, addressing representatives of programs implanting VADs worldwide. Representatives answered a standardized block of 14 questions and were asked to provide responses within 3 months. Results: A total of 91 VAD coordinators from centers of various regions of the world completed the survey. The majority came from European countries. The numbers of patients followed up by the centers ranged from <20 to 390 patients. The majority of VAD coordinators had a nursing background (68%). Seventy‐seven percent of the centers operate a 24‐h hotline and 3‐monthly visits to the outpatient department are most common. Fifty‐nine percent of the centers do not use an infection scoring system for driveline wound care. The majority of the centers indicated that an optimized follow‐up concept including wound care, medication, and social care is crucial and the key issue for an improved outcome. Smaller components and intensified psychosocial support ranked highest in questions about how to improve quality of life. Surprisingly, the future prospects of telemetric monitoring were not rated high in significance. Conclusions: There is a wide variability in the composition and tasks of VAD programs worldwide. Implementing a standard of care and improving psychosocial care as well as equipment is regarded most important to improve outcomes and quality of life. From the point of view of those responsible, the significance of telemetric monitoring seemed overrated. [ABSTRACT FROM AUTHOR]

Background: Corheart 6 (Corheart) is a newly developed magnetically levitated continuous‐flow left ventricular assist device currently undergoing multicenter clinical trials in China. Featuring a small size, minimal weight, and low power consumption, the Corheart aims to improve pump hemocompatibility, reduce adverse events, and enhance the quality of life of heart failure patients. Methods: Computational simulations assessed flow field, shear stress, and washout, while in vitro and in vivo experiments were performed to further demonstrate hemocompatibility. Results: Numerical results show that the flow path in the Corheart blood pump is well designed. There is no significantly high shear stress in the majority of the flow domain. Short secondary flow paths and small pump size (small priming volume) provide good washing (0.049 and 0.165 s to remove 55% and 95% old blood, respectively), allowing low hemolysis levels both in computational and in vitro hemolysis tests (in vitro hemolysis index ranges from 0.00092 ± 0.00006 g/100 L to 0.00134 ± 0.00019 g/100 L). Good hemocompatibility was further evidenced by ten 60‐day sheep implants tested with relatively low flow rates of 2.0 ± 0.2 L/min; the results showed no hemolysis or thrombosis. Conclusions: Numerical and experimental results shed light on the fluid dynamics characteristics and hemocompatibility of the Corheart. It is believed that the Corheart will provide more promising possibilities for minimally invasive implantation techniques and for those patients with a small body surface area. [ABSTRACT FROM AUTHOR]

Background: Invasive hemodynamic variables obtained from right heart catheterization have been used for risk‐stratifying patients with advanced heart failure (HF). However, there is a paucity of data on the prognostic value of invasive hemodynamic variables in patients with left ventricular assist devices (LVAD). We hypothesized that cardiac power output (CPO), cardiac power efficiency (CPE), and left ventricular stroke work index (LVSWI) can serve as prognostic markers in patients with LVADs. Methods: Baseline hemodynamic data from patients who had LVAD ramp studies at our institution from 4/2014 to 7/2018 were prospectively collected, from which advanced hemodynamic variables (CPO, CPE, and LVSWI) were retrospectively analyzed. Univariate and multivariable analyses were performed for hemocompatibility‐related adverse events (HRAE), HF admissions, and mortality. Results: Ninety‐one participants (age 61 ± 11 years, 34% women, 40% Black or African American, and 38% ischemic cardiomyopathy) were analyzed. Low CPE was significantly associated with mortality (HR 2.42, 95% CI 1.02–5.74, p = 0.045) in univariate analysis and Kaplan–Meier analysis (p = 0.04). Low LVSWI was significantly associated with mortality (HR 2.13, 95% CI 1.09–4.17, p = 0.03) in univariate analysis and Kaplan–Meier analysis (p = 0.02). CPO was not associated with mortality. CPO, CPE, and LVSWI were not associated with HRAE or HF admissions. Conclusions: Advanced hemodynamic variables can serve as prognostic indicators for patients with LVADs. Low CPE and LVSWI are prognostic for higher mortality, but no variables were associated with HF admissions or HRAEs. [ABSTRACT FROM AUTHOR]

Background: Exercise oscillatory ventilation (EOV), indicating pathological fluctuations on pulmonary arterial pressure, is associated with mortality in patients with heart failure (HF). Whether left ventricular assist device (LVAD)‐induced ventricular unloading can reverse EOV and may prevent short‐term rehospitalization has not been investigated. Methods: We performed a retrospective single‐center in‐ and outpatient analysis of patients with (n = 20, LVAD) and without (n = 27, HF) circulatory support and reduced ejection fraction (EF, 22.8 ± 7.9%). The association of cardiopulmonary exercise testing (CPET) variables and 3 months‐rehospitalization (3MR) as a primary outcome was analyzed. Furthermore, CPET variables were compared regarding the presence of EOV (+/−). Results: Lower VO2peak (11.6 ± 4.9 ml/kg/min vs. 14.4 ± 4.3 ml/kg/min, p = 0.039), lower increase of PETCO2 (CI = 0.049–1.127; p = 0.068), and higher VE/VCO2 (43.8 ± 9.5 vs. 38.3 ± 10.6; p = 0.069) were associated with 3MR. Flattening of O2 pulse (CI = 0.139–2.379; p = 0.487) had no impact on 3MR. EOV was present in 59.5% (n = 28/47) of patients, without a significant difference between LVAD and HF patients (p = 0.959). Patients with HF/EOV+ demonstrated significantly lower VO2peak compared with HF/EOV− (p = 0.039). LVAD/EOV+ displayed significantly lower EF (p = 0.004) and fewer aortic valve opening than LVAD/EOV− (p = 0.027). Conclusions: Lower VO2peak, but not EOV, was associated with 3MR. EOV occurred at a similar rate in LVAD and HF patients, which may illustrate insufficient unloading during exercise in chronic LVAD therapy and may contribute to the limited exercise capacity following LVAD implantation. Simultaneous CPET and right heart catheterization studies are needed to elucidate whether EOV may serve as a non‐invasive predictor of insufficient LV unloading necessitating LVAD reprograming. [ABSTRACT FROM AUTHOR]

Background: We investigated the synergistic effect of the new cone‐bearing design of Jarvik 2000 (Jarvik Heart Inc., NY) together with a minimally‐invasive approach to outcomes of LVAD patients. Methods: We retrospectively reviewed all patients from 5 institutions involved in the Jarvik 2000 Italian Registry, from October 2008 to October 2016. Patients were divided into three groups according to pump design and implantation technique: pin‐bearing design and conventional approach (Group 1); cone‐bearing and conventional approach (Group 2); cone‐bearing and minimally‐invasive implantation (Group 3). Results: A total of 150 adult patients with end‐stage heart failure were enrolled: 26 subjects in Group 1, 74 in Group 2, and 50 in Group 3. Nineteen patients (73%) in Group 1, 51 (69%) in Group 2, and 36 (72%) in Group 3 were discharged. During follow‐up, 22 patients underwent transplantation, while in 3 patients the LVAD was explanted. The overall 1‐year survival was 58 ± 10%, 64 ± 6%, and 74% ± 7% in Groups 1, 2, and 3, respectively (p = 0.034). The competing‐risks‐adjusted cumulative incidence rate for adverse events was 42.1 [27–62.7] per 100 patient‐years in Group 1, 35.4 [25.3–48.2] in Group 2, and 22.1 [12.4–36.4] in Group 3 (p = 0.046 for Group 1 vs. 3). Conclusions: The association of the modern cone‐bearing configuration of Jarvik 2000 and minimally invasive surgery improved survival and minimized the risk for cardiovascular events, as a result of combining technology and technique. [ABSTRACT FROM AUTHOR]

Introduction: Restrictive cardiomyopathy (RCM) and hypertrophic cardiomyopathy (HCM) are two disease processes that are known to progress to heart failure with preserved ejection fraction (HFpEF). Pharmacologic therapies for HFpEF have not improved patient outcomes or reduced mortality in this patient cohort; thus, there continues to be substantial interest in other treatment strategies, including surgical interventions and devices. In this article, we explore and report the current utility of percutaneous therapies and surgically implanted mechanical support in the treatment of patients with HFpEF. Results: Treatment strategies include percutaneous interventions with interatrial shunts, left atrial assist devices (LAADs), and ventricular assist devices (VADs) in various configurations. Although VADs have been employed to treat patients with heart failure with reduced ejection fraction, their efficacy is limited in those with RCM and HCM. A left atrial‐to‐aortic VAD has been proposed to directly unload the left atrium, but data is limited. Alternatively, a LAAD could be placed in the mitral position and simultaneously unload the left atrium, while filling the left ventricle. Conclusion: A left atrial assist device in the mitral position is a promising solution to address the hemodynamic abnormalities in RCM and HCM; these pumps, however, are still under development. [ABSTRACT FROM AUTHOR]

Objectives: To highlight the role of percutaneous left ventricular assist device (LVAD) decommissioning as a safe procedure after myocardial recovery in patients with advanced heart failure. Background: The HeartMate3 LVAD (Abbott, Chicago, IL, USA) is designed to provide circulatory support with enhanced hemocompatibility for patients with advanced heart failure. Most VADs are used as a bridge to heart transplantation; however, in certain cases, myocardial function recovers, and VADs can be explanted after the patient is weaned. Although surgical explantation remains the gold standard, minimally invasive percutaneous decommissioning has been described as a successful alternative. In this study, we present our experience, one‐year outcomes, and adverse events associated with percutaneous LVAD decommissioning. Methods: We conducted a retrospective review of data from six consecutive patients who underwent percutaneous LVAD decommissioning. Results: Six patients were enrolled in the study. For all six patients, HM3 decommissioning was completed at least 6 months ago. No technical complications were documented. No strokes were observed within the study period, and the ejection fraction improved. The mean follow‐up duration was 18 ± 8.5 months, and the survival rate was 100%. Conclusion: Percutaneous HeartMate3 decommissioning appears to be safe. In particular, the survival after the procedure was 100%, and no events, especially thromboembolic ones, occurred. [ABSTRACT FROM AUTHOR]

Objectives: Development in device technology and the scarcity of donor's hearts have increased the number of patients with advanced heart failure receiving durable left ventricular assist devices (LVADs) as a bridge to transplantation and destination therapy, with improved prognosis compared with guideline‐directed medical therapy. We sought to examine the impact of modern durable LVADs on the quality of life (QoL) of the recipients. Methods: We carried out a systematic review of articles on QoL following the implantation of third‐generation LVADs published between January 2010 and February 2021. Included studies were critically analyzed and evidence synthesis was carried out into a meta‐analysis. Results: The systematic search yielded 269 articles, 11 of which met the search predefined criteria. Three of them reported results of randomized trials and eight were retrospective and registry studies. Statistically significant QoL improvement from baseline was observed in all published reports. When using the EuroQol 5L questionnaire (scale 0–100) as a QoL tool 6 months post‐LVAD implantation, a meta‐analysis of four included studies demonstrated a mean difference increase of 28.9 points (95% confidence interval: 26.71–31.14). Conclusions: Third‐generation LVADs confer a significant improvement in QoL and their use can be supported not only for prognosis but also for symptom control. Although methodological limitations should be considered, the available QoL outcomes can be a useful tool in patient selection and the decision‐making process. [ABSTRACT FROM AUTHOR]

Background: The use of left ventricular assist devices (LVAD) in patients with advance heart failure is still associated with an important risk of immune dysregulation and infections. The aim of this study was to determine whether extracorporeal blood purification using the CytoSorb device benefits patients after LVAD implantation in terms of complications and overall survival. Materials and Methods: Between August 2010 and January 2020, 207 consecutive patients underwent LVAD implantation, of whom 72 underwent CytoSorb therapy and 135 did not. Overall survival, major adverse events, and laboratory parameters were compared between 112 propensity score‐matched patients (CytoSorb: 72 patients; non‐CytoSorb: 40 patients). Results: WBC (p =.033), CRP (p =.001), and IL‐6 (p <.001), significantly increased with LVAD implantation, while CytoSorb did not influence this response. In‐hospital mortality and overall survival during follow‐up were similar with CytoSorb. However, patients treated with CytoSorb were more likely to develop respiratory failure (54.2% vs. 30.0%, p =.024), need mechanical ventilation for longer than 6 days post‐implant (50.0% vs. 27.5%, p =.035), and require tracheostomy during hospitalization (31.9% vs. 12.5%, p =.040). No other significant differences were observed with regard to major adverse events during follow‐up. Conclusions: Overall, our results showed that CytoSorb might not convey a significant morbidity or mortality benefit for patients undergoing LVAD implantation. [ABSTRACT FROM AUTHOR]

Implantable cardioverter‐defibrillators (ICDs) have been shown to have survival advantage in advanced heart failure patients. Few studies have evaluated the role of ICDs in patients supported with continuous‐flow left ventricular assist devices (CFVADs). We aimed to evaluate the impact of ICD and CFVAD on heart transplant (HTx) waiting list survival. We queried the United Network for Organ Sharing (UNOS) thoracic transplant database between years 2007 and 2016 for patients aged ≥ 18 years listed for HTx. Patients receiving devices other than CFVAD were excluded. Patients were divided into groups—with and without CFVAD and further subdivided into groups—with and without ICD use. Kaplan‐Meier curves were used to evaluate the survival outcomes. There were 34 860 patients listed for HTx during study period of which 11 481 (32%) had a CFVAD and 26 139 (75%) had an ICD. Within CFVAD group, patients with ICD were older, more likely male, with higher creatinine and listed as UNOS status 1A. In the No‐CFVAD group, 1‐year waitlist survival was significantly better with ICD use (81% vs. 73%, P <.0001); however, in CFVAD patients, 1‐year survival with ICD use was comparable to No‐ICD use (95% vs. 94%, P =.1). Use of ICD is associated with significantly better heart transplant waitlist survival in patients not supported by CFVAD. In patients supported with CFVAD, the ICD does not offer additional survival benefit. [ABSTRACT FROM AUTHOR]

Continuous‐flow left ventricular assist devices (LVADs) have gained tremendous acceptance for the treatment of end‐stage heart failure patients. Among different versions, axial flow and centrifugal flow LVADs have shown remarkable potential for clinical implants. It is also very crucial to know which device serves its purpose better to treat heart failure patients. A thorough comparison of axial and centrifugal LVADs, which may guide doctors in deciding before the implant, still lacks in the literature. In this work, an assessment of axial and centrifugal LVADs has been made to suggest a better device by comparing their engineering, clinical, and technological development of design aspects. Hydrodynamic and hemodynamic aspects for both types of pumps are discussed along with their biocompatibility, bearing types, and sizes. It has been observed numerically that centrifugal LVADs perform better over axial LVADs in every engineering aspect like higher hydraulic efficiency, better characteristics curve, lesser power intake, and also lesser blood damage. However, the clinical outcomes suggest that centrifugal LVADs experience higher events of infections, renal, and respiratory dysfunction. In contrast, axial LVADs encountered higher bleeding and cardiac arrhythmia. Moreover, recent technological developments suggested that magnetic type bearings along with biocompatible coating improve the life of LVADs. [ABSTRACT FROM AUTHOR]

Worsening systemic congestion is often the central trigger of hospitalization in patients with heart failure. However, accurate assessment of congestion is challenging. The prognostic impact of systemic congestion following durable continuous‐flow left ventricular assist device (LVAD) implantation remains unknown. Consecutive patients who received durable continuous‐flow LVAD implantation between January 2014 and June 2017 and were followed for 1 year were included. The association of preoperative plasma volume status, which was calculated using patients' body weight and hematocrit and expressed as a deviation from ideal plasma volume, with 1‐year mortality following LVAD implantation was investigated. In total, 186 patients (median 57 years and 138 males) were included. Baseline plasma volume status was −30.1% (−37.1%, −19.4%) on median. Eighty‐eight patients (47%) had higher plasma volume status (>−29.8%), and their 1‐year survival was significantly lower than those without (67% vs. 87%, P =.001). High plasma volume status was an independent predictor of 1‐year death with an adjusted hazard ratio of 4.52 (95% confidence interval 1.52‐13.5). Baseline systemic congestion, as defined by the high plasma volume status, was associated with higher mortality following durable continuous‐flow LVAD implantation. The implication of improving preoperative plasma volume remains an area of needed investigation. [ABSTRACT FROM AUTHOR]

Continuous flow left ventricular assist devices (LVADs) have become a valuable therapy for end‐stage heart failure. In vitro research highlighted a role of outflow cannula position on the pattern of blood flow in the aorta. However, the clinical effects of the alterations of flow remain unclear. We investigate short‐ and long‐term outcomes of patients implanted with Jarvik 2000 LVAD, according to the ascending (Group 1) versus descending (Group 2) outflow graft connection to the aorta in a multicenter study. From May 2008 to October 2014, 140 consecutive end‐stage heart failure patients underwent Jarvik 2000 LVAD implantation in 17 Italian centers. According with a preliminary multivariate analysis, we selected the 90 patients implanted in the four high‐volume centers to avoid bias (Group 1 n = 39, Group 2 n = 51). Among the groups, no differences were recorded in the hospital mortality and the main complications occurring after LVAD implantation were similar. In multivariable analysis, the ascending aorta outflow cannula position and higher creatinine at discharge were significant predictors for long‐term survival. Postimplant hemolysis was more pronounced in descending aorta outflow graft anastomosis. Outflow graft anastomosis to the ascending aorta is associated with better long‐term survival, independent of age and perfusion techniques, reflecting the previous in vitro results. [ABSTRACT FROM AUTHOR]

Gastrointestinal (GI) bleeding is a common complication following the placement of continuous‐flow left ventricular assist devices (LVADs) in patients with advanced heart failure. Secondary events arising as a result of GI bleeding have not been well‐described. Furthermore, attribution of these events to bleeding is complicated by the interruption or de‐intensification of antithrombotic therapy, while bleeding is controlled. The purpose of this study was to assess the incidence of pump thrombosis and ischemic stroke in patients with LVADs who experience GI bleeding, while on support. This was a single‐center, retrospective, observational cohort study of consecutive patients with LVADs implanted from January 2012 to June 2018. Patients were assigned to comparator groups based on whether they experienced GI bleeding while on LVAD support. The primary endpoint assessed was the composite of pump thrombosis or ischemic stroke. Secondary endpoints assessed included incidence of pump thrombosis or ischemic stroke. A total of 250 patients were included after screening for exclusion criteria, 101 (40.4%) in the GI bleeding group, and 149 (59.6%) in the non‐bleeding group. The incidence of pump thrombosis or ischemic stroke was not significantly greater in patients experiencing GI bleeding [23 (22.8%) vs. 21 (14.1%); P =.09]; however, the incidence of ischemic stroke alone was significantly greater [17 (16.8%) vs. 10 (6.7%); P =.01]. We conclude that GI bleeding in LVAD patients may be associated with a greater risk of ischemic stroke. [ABSTRACT FROM AUTHOR]

The use of left ventricular assist devices (LVADs) as a treatment method for heart failure patients has been steadily increasing; however, pathological studies showed presence of thrombi around the HeartWare ventricular assist device inflow cannula (IC) in more than 95% of patients after device explantation. Flow fields around the IC might trigger thrombus formation and require further investigation. In this study flow dynamics parameters were evaluated for different patient geometries using computational fluid dynamics (CFD) simulations. Left ventricular (LV) models of two LVAD patients were obtained from CT scans. The LV volumes of Patient 1 (P1) and Patient 2 (P2) were 264 and 114 cm3 with an IC angle of 20° and 9° from the mitral‐IC tip axis at the coronal plane. The IC insertion site at the apex was central for P1, whereas it was lateral for P2. Transient CFD simulations were performed over 9 cardiac cycles. The wedge area was defined from the cannula tip to the wall of the LV apex. Mean velocity magnitude and blood stagnation region (volume with mean velocity <5 mm/s) as well as the wall shear stress (WSS) at the IC surface were calculated. Cardiac support resulted in a flow mainly crossing the ventricle from the mitral valve to the LVAD cannula for P2, while the main inflow jet deviated toward the septal wall in P1. Lower WSS at the IC surface and consequently larger stagnation volumes were observed for P2 (P1: 0.17, P2: 0.77 cm3). Flow fields around an LVAD cannula can be influenced by many parameters such as LV size, IC angle, and implantation site. Careful consideration of influencing parameters is essential to get reliable evaluations of the apical flow field and its connection to apical thrombus formation. Higher blood washout and lower stagnation were observed for a central implantation of the IC at the apex. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVAD) provide cardiac support to patients with advanced heart failure. Methods that can directly measure remaining LV function following device implantation do not currently exist. Previous studies have shown that a combination of loading (LV pressure) and deformation (strain) measurements enables quantitation of myocardial work. We investigated the use of ultrasound (US) strain imaging and pressure–strain loop analysis in LVAD‐supported hearts under different hemodynamic and pump unloading conditions, with the aim of determining LV function with and without LVAD support. Ex vivo porcine hearts (n = 4) were implanted with LVADs and attached to a mock circulatory loop. Measurements were performed at hemodynamically defined "heart conditions" as the hearts deteriorated from baseline. Hemodynamic (including LV pressure) and radio‐frequency US data were acquired during a pump‐ramp protocol at speeds from 0 (with no pump outflow) to 10 000 revolutions per minute (rpm). Regional circumferential (εcirc) and radial (εrad) strains were estimated over each heart cycle. Regional ventricular dyssynchrony was quantitated through time‐to‐peak strain. Mean change in LV pulse pressure and εcirc between 0 and 10 krpm were −21.8 mm Hg and −7.24% in the first condition; in the final condition −46.8 mm Hg and −19.2%, respectively. εrad was not indicative of changes in pump speed or heart condition. Pressure–strain loops showed a degradation in the LV function and an increased influence of LV unloading: loop area reduced by 90% between 0 krpm in the first heart condition and 10 krpm in the last condition. High pump speeds and degraded condition led to increased dyssynchrony between the septal and lateral LV walls. Functional measurement of the LV while undergoing LVAD support is possible by using US strain imaging and pressure–strain loops. This can provide important information about remaining pump function. Use of novel LV pressure estimation or measurement techniques would be required for any future use in LVAD patients. [ABSTRACT FROM AUTHOR]

The spleen has been recognized as an important organ that holds a reserve of 20% to 30% of the total blood volume. Spleen contraction and splenic volume reduction occur in patients with hypovolemic shock. However, the change in the spleen volume and the association between spleen size and hemodynamic parameters remain unclear in patients with advanced heart failure (HF) who need left ventricular assist device (LVAD) support. This study was performed to investigate the change in spleen size and the relationship between spleen size and hemodynamic parameters before and after LVAD implantation in patients with advanced HF. We enrolled 20 patients with advanced HF on LVAD support. All patients underwent right heart catheterization and computed tomography before and after LVAD implantation. The spleen size was measured by computed tomography volumetry. We excluded patients with a mean right atrial pressure (RAP) of <5 mm Hg because of the possibility of hypovolemia and those with a cardiac index of >2.2 L/min/m2 before LVAD implantation. The splenic volume significantly increased from 160.6 ± 46.9 mL before LVAD implantation to 224.6 ± 73.5 mL after LVAD implantation (P <.001). Before LVAD implantation, there was a significant negative correlation between spleen volume and systemic vascular resistance (SVR). After LVAD implantation, however, there were significant correlations between spleen volume and the cardiac index, RAP, and pulmonary capillary wedge pressure despite the absence of a significant correlation between spleen volume and SVR. Furthermore, one patient developed reworsening HF because of LVAD failure due to pump thrombosis. In this case, the splenic volume was 212 mL before LVAD implantation and increased to 418 mL after LVAD implantation, although it decreased to 227 mL after LVAD failure. The spleen size may change depending on hemodynamics in patients with advanced HF with LVAD support, reflecting sympathetic nerve activity and the systemic volume status. [ABSTRACT FROM AUTHOR]

With the acceleration of demographic aging, heart failure has become a global public health issue. Left ventricular assist device (LVAD) provides a therapeutic option serving as a bridge to transplantation or destination treatment for end‐stage heart failure. However, neither the molecular mechanism nor the gene expression profile of LVAD pathophysiology is well understood. Microarray dataset (GSE21610) was retrieved from the online database of the gene expression omnibus (GEO). Differentially expressed genes (DEGs) between microarrays obtained before and after LVAD therapy were analyzed using GEO2R. Gene Ontology enrichment and Kyoto Encyclopedia of Genes and Genomes pathway analysis were carried out, followed by protein–protein interaction (PPI) network construction, which was further visualized by the Cytoscape software. Finally, a target gene‐microRNA (miRNA) network was built using the NetworkAnalyst to predict potential miRNA interactions. A total of 36 upregulated DEGs and 14 downregulated DEGs were screened out. Five hub genes with the highest degree of connectivity were identified, including CCL2, CX3CR1, CD163, TLR7, and SERPINE1. CCL2 was identified as the most outstanding hub gene which is specially regulated by miR‐124, miR‐141, and miR‐495. Our study indicates that CCL2 is crucial to the LVAD pathophysiology. The identified hub genes may be involved in cardiac inflammatory responses, remodeling, and the chemokine signaling pathway. These DEGs, pathways, hub genes, miRNAs are valuable for further investigations. This study provides a better understanding of the gene expression profile in LVAD pathophysiology. [ABSTRACT FROM AUTHOR]

Implantable left ventricular assist devices (LVADs) are increasingly used for patients with heart failure. Despite this evidence, the psychological processes affecting implanted patients and their caregivers are only marginally studied. While common emotional reactions, such as anxiety and depression already receive attention, very little is known about the course of caregiver strain, illness denial, and their reciprocal relation. This preliminary study aims at exploring these critical topics in a cardiac rehabilitation setting, besides offering indications for future research. A total of 44 LVAD patients and caregivers were administered specific questionnaires at admission and discharge from cardiac rehabilitation. Overall, questionnaires completed at discharge showed a positive improvement in the emotional measures used. However, they also showed a worsening in the illness denial measure. We suggest that the denial process may prepare patients and caregivers in returning home. Moreover, we conclude that studying only the common emotional reactions may limit the understanding of the psychological process adaptation to severe illness. [ABSTRACT FROM AUTHOR]

Continuous‐flow left ventricular assist devices (LVADs) reduce peak systolic flow, increase diastolic flow, and eliminate pulsatility of circulation. Altered blood flow may lead to a change in end‐organ perfusion. Analysis of the flow dynamics of the arteries of end organs, such as the brain, may indicate whether an organ is perfused sufficiently. The aim of this study is to evaluate and identify the flow pattern changes of carotid (CA) and middle cerebral arteries (MCA) in LVAD patients and to compare with heart failure patients and healthy volunteers. Eighty‐nine individuals were included in this cross‐sectional study. Participants were divided into three groups: LVAD patients (n = 31), heart failure patients (n = 26), and healthy volunteers (n = 27). Carotid and transcranial Doppler ultrasonography were performed for all study groups for peak systolic velocity (PSV), end‐diastolic velocity (EDV), pulsatility (PI), and resistive (RI) indices of CA and MCA. Flow dynamics were compared between the groups. Doppler ultrasonographic data were analyzed at a median 12 (3‐47) months after LVAD implantation. CA‐PSV was lower in LVAD group compared with the other two groups (P <.001), MCA‐PSV of LVAD and heart failure groups were similar and lower than healthy volunteers (P <.05). The highest values for CA‐EDV were found in the LVAD group (P <.05). MCA‐EDV values were found to be lowest in heart failure group (P <.05). For PI and RI, in all CA and MCA, the LVAD group had lower indices compared with the other two groups (P <.001). In addition, MCA flow analysis in patients with LVADs was identified for the first time with this study. [ABSTRACT FROM AUTHOR]

The high cost of ventricular assist devices results in poor cost‐effectiveness when used as a short‐term bridging solution, thus a low‐cost alternative is desirable. The present study aimed to develop an intraventricular balloon pump (IVBP) for short‐term circulatory support, and to evaluate the effect of balloon actuation timing on the degree of cardiac support provided to a simulated in vitro severe heart failure (SHF) patient. A silicone IVBP was designed to avoid contact with internal left ventricular (LV) features (ie, papillary muscles, chordae, aortic, and mitral valves) based on LV computed tomography data of 10 SHF patients with dilated cardiomyopathy. The hemodynamic effects of varying balloon inflation and deflation timing parameters (inflation duty [D] and end‐inflation point [σ]) were evaluated in a purpose‐built systemic mock circulatory loop. Three IVBP actuation timing categories were defined: co‐, transitional, and counterpulsation. Compared to the SHF baseline, co‐pulsation increased aortic flow from 3.5 to 5.2 L/min, mean arterial pressure from 72.1 to 94.8 mmHg and ejection fraction from 14.4% to 21.5%, while mean left atrial pressure decreased from 14.6 to 10 mmHg. Transitional and counterpulsation resulted in a double ventricular pulse and extended the duration of increased ventricular pressure, potentially impeding diastolic filling and coronary perfusion. This in vitro study showed the IVBP could restore the hemodynamic balance of a simulated SHF patient with dilated cardiomyopathy to healthy levels. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVADs) have improved clinical outcomes and quality of life for those with end‐stage heart failure. However, the costs and risks associated with these devices necessitate appropriate patient selection. LVAD candidates are becoming increasingly more obese and there are conflicting reports regarding obesity's effect on outcomes. Hence, we sought to evaluate the impact of extreme obesity on clinical outcomes after LVAD placement. Consecutive LVAD implantation patients at our center from June 2008 to May 2016 were studied retrospectively. We compared patients with a body mass index (BMI) ≥40 kg/m2 (extremely obese) to those with BMI < 40 kg/m2 with respect to patient characteristics and surgical outcomes, including survival. 252 patients were included in this analysis, 30 (11.9%) of whom met the definition of extreme obesity. We found that patients with extreme obesity were significantly younger (47[33, 57] vs. 60[52, 67] years, P < 0.001) with fewer prior sternotomies (16.7% vs. 36.0%, P = 0.04). They had higher rates of pump thrombosis (30% vs. 9.0%, P = 0.003) and stage 2/3 acute kidney injury (46.7% vs. 27.0%, P = 0.003), but there were no differences in 30‐day or 1‐year survival, even after adjusting for age and clinical factors. Extreme obesity does not appear to place LVAD implantation patients at a higher risk for mortality compared to those who are not extremely obese; however, extreme obesity was associated with an increased risk of pump thrombosis, suggesting that these patients may require additional care to reduce the need for urgent device exchange. [ABSTRACT FROM AUTHOR]

In the treatment of patients with severe heart failure, left ventricle assist device plays an important role, especially as a destination therapy. Nevertheless, even in successful cases, patients' progressive weaning is rarely taken into consideration. The recovery of more physiological circulation conditions is not a main goal. This hypothesis is discussed in this article. [ABSTRACT FROM AUTHOR]

Abstract: Continuous‐flow left ventricular assist devices (CF‐LVADs) prolong survival in advanced heart failure patients. Anticoagulation control is critical in CF‐LVAD patients due to increased thromboembolic and bleeding risk. We assessed the quality of INR control in CF‐LVAD patients measured by time in therapeutic range (TTR). We performed a systematic literature search of MEDLINE and SCOPUS through July 2017 to identify studies evaluating TTR in anticoagulated adult CF‐LVAD patients. Data on key characteristics and the TTR end point were then extracted from each study by two investigators using a standardized tool. Using a Hartung‐Knapp random effects model, a weighted mean TTR estimate with accompanying 95% confidence interval (CI) was calculated. Statistical heterogeneity was estimated using the I2 statistic. Five published studies were included. All studies were single‐center, retrospective investigations that calculated TTR using the Rosendaal method. Sample sizes ranged from 11 to 115 patients (total of 270 patients) with durations of follow‐up ranging from 9 to 76 person‐years. On meta‐analysis, CF‐LVAD patients had a weighted mean TTR of 46.6% (95% CI: 36.0–57.3%, I2 = 94%). This suggests that warfarin is difficult to manage in CF‐LVAD patients, which may contribute to high rates of bleeding and thromboembolic complications. [ABSTRACT FROM AUTHOR]

Abstract: Use of continuous flow left ventricle assist device (CF‐LVAD) in advanced heart failure (HF) patients results in clinically relevant improvements in survival, functional capacity, and quality of life. Peripheral artery disease (PAD) can occur in patients with CF‐LVAD due to the high rate of concomitance between risk factors for atherosclerosis and HF. Diagnosis of PAD can be difficult in the specific setting of a patient supported by this kind of device because of the marked alteration in waveform morphology and velocity created by the artificial physiology of an LVAD. We report the case of a 53‐year‐old man with HF secondary to ischemic cardiomyopathy supported by the HeartWare HVAD as bridge to transplant, who after the implant developed symptoms suggestive of PAD. We describe additional computational flow analysis for the study of PAD‐related hemodynamic disturbances induced by a CF‐LVAD. Flow simulations enhance the information of clinical image data, and may have an application in clinical investigations of the risk of hemodynamic disturbances induced by LVAD implantation. [ABSTRACT FROM AUTHOR]

The design of blood pumps for use in ventricular assist devices, which provide life-saving circulatory support in patients with heart failure, require remarkable precision and attention to detail to replicate the functionality of the native heart. The United States Food and Drug Administration (FDA) initiated a Critical Path Initiative to standardize and facilitate the use of computational fluid dynamics in the study and development of these devices. As a part of the study, a simplified centrifugal blood pump model generated by computer-aided design was released to universities and laboratories nationwide. The effects of changes in fluid rheology due to temperature, hematocrit, and turbulent flow on key metrics of the FDA pump were examined in depth using results from a finite volume-based commercial computational fluid dynamics code. Differences in blood damage indices obtained using Eulerian and Lagrangian formulations were considered. These results are presented and discussed awaiting future validation using experimental results, which will be released by the FDA at a future date. [ABSTRACT FROM AUTHOR]

The common complications in heart failure patients with implanted ventricular assist devices (VADs) include hemolysis, thrombosis, and bleeding. These are linked to shear stress-induced trauma to erythrocytes, platelets, and von Willebrand factor (vWF). Novel device designs are being developed to reduce the blood trauma, which will need to undergo in vitro and in vivo preclinical testing in large animal models such as cattle, sheep, and pig. To fully understand the impact of device design and enable translation of preclinical results, it is important to identify any potential species-specific differences in the VAD-associated common complications. Therefore, the purpose of this study was to evaluate the effects of shear stress on cells and proteins in bovine, ovine, and porcine blood compared to human. Blood from different species was subjected to various shear rates (0-8000/s) using a rheometer. It was then analyzed for complete blood counts, hemolysis by the Harboe assay, platelet activation by flow cytometry, vWF structure by immunoblotting, and function by collagen binding activity ELISA (vWF : CBA). Overall, increasing shear rate caused increased total blood trauma in all tested species. This analysis revealed species-specific differences in shear-induced hemolysis, platelet activation, and vWF structure and function. Compared to human blood, porcine blood was the most resilient and showed less hemolysis, similar blood counts, but less platelet activation and less vWF damage in response to shear. Compared to human blood, sheared bovine blood showed less hemolysis, similar blood cell counts, greater platelet activation, and similar degradation of vWF structure, but less impact on its activity in response to shear. The shear-induced effect on ovine blood depended on whether the blood was collected via gravity at the abattoir or by venepuncture from live sheep. Overall, ovine abattoir blood was the least resilient in response to shear and bovine blood was the most similar to human blood. These results lay the foundations for developing blood trauma evaluation standards to enable the extrapolation of in vitro and in vivo animal data to predict safety and biocompatibility of blood-handling medical devices in humans. We advise using ovine venepuncture blood instead of ovine abattoir blood due to the greater overall damage in the latter. We propose using bovine blood for total blood damage in vitro device evaluation but multiple species could be used to create a full understanding of the complication risk profile of new devices. Further, this study highlights that choice of antibody clone for evaluating platelet activation in bovine blood can influence the interpretation of results from different studies. [ABSTRACT FROM AUTHOR]

A case study of a 77-year-old male patient suffering from end-stage heart failure is presented, who underwent HeartMate II implantation through full sternotomy. It mentions patient presented an anterolateral intercostal prolapse of the pump corpus. it also mentions treatment of pump prolapse with an upgrade from HMII to HM3.

In patients with heart failure, sacubitril/valsartan therapy was associated with a decrease in NT-proBNP and improved echocardiographic parameters, which suggests a potential effect on cardiac reverse remodeling.1,2 Despite optimization of medical management, a significant proportion of heart failure patients progress to an advanced stage of the disease and require implantation of a left ventricular assist device (LVAD). CASE SERIES We analyzed clinical, echocardiographic, and laboratory data in six LVAD patients receiving sacubitril/valsartan therapy. Sacubitril/valsartan therapy was introduced instead of ACE inhibitors at 1 year after LVAD implantation; patients were followed for 6 months. [Extracted from the article]

Mechanical circulatory assist devices that provide temporary support in heart failure patients are needed to enable recovery or provide a bridge to decision. Minimizing risk of blood damage (i.e., hemolysis) with these devices is critical, especially if the length of support needs to be extended. Hematologic responses of the RotaFlow (Maquet) and CentriMag (Thoratec) temporary support devices were characterized in an in vitro feasibility study. Paired static mock flow loops primed with fresh bovine blood (700 mL, hematocrit [Hct] = 25 ± 3%, heparin titrated for activated clotting time >300 s) pooled from a single-source donor were used to test hematologic responses to RotaFlow ( n = 2) and CentriMag ( n = 2) simultaneously. Pump differential pressures, temperature, and flow were maintained at 250 ± 10 mm Hg, 25 ± 2°C, and 4.2 ± 0.25 L/min, respectively. Blood samples (3 mL) were collected at 0, 60, 120, 180, 240, 300, and 360 min after starting pumps in accordance with recommended Food and Drug Administration and American Society for Testing and Materials guidelines. The CentriMag operated at a higher average pump speed (3425 rpm) than the RotaFlow (3000 rpm) while maintaining similar constant flow rates (4.2 L/min). Hematologic indicators of blood trauma (hemoglobin, Hct, platelet count, plasma free hemoglobin, and white blood cell) for all measured time points as well as normalized and modified indices of hemolysis were similar (RotaFlow: normalized index of hemolysis [NIH] = 0.021 ± 0.003 g/100 L, modified index of hemolysis [MIH] = 3.28 ± 0.52 mg/mg compared to CentriMag: NIH = 0.041 ± 0.010 g/100 L, MIH = 6.08 ± 1.45 mg/mg). In this feasibility study, the blood trauma performance of the RotaFlow was similar or better than the CentriMag device under clinically equivalent, worst-case test conditions. The RotaFlow device may be a more cost-effective alternative to the CentriMag. [ABSTRACT FROM AUTHOR]

Despite ongoing advances in the design of left ventricular assist devices (LVADs), and associated improvements in intraoperative surgical techniques, index hospitalization mortality continues to account for a disproportionate share of overall LVAD recipient mortality. The study, "Independent Risk Factors for ICU Mortality after Left Ventricular Assist Device Implantation,"[3] directly addresses risk factors specific to the index hospitalization mortality following LVAD implantation. [Extracted from the article]

The article describes several cases of long-term hemodialysis via arteriovenous fistula in heart failure patients with continuous-flow left ventricular assist devices. One patient was a 69-year-old white male with stage IV chronic kidney disease (CKD) who underwent HeartMateII implantation as destination therapy (DT) for ischemic cardiomyopathy. Another patient was a 59-year-old white male with stage III CKD who underwent HeartMateII Long-Term implantation as DT for dilated cardiomyopathy.