Resilience-Oriented Approach to the Control of Ventricular Assist Devices

Context: Advanced heart failure (AHF) poses a global challenge, where heart transplantation is a treatment option but limited by donor scarcity. Proposal: This study aims to enhance the performance of ventricular assist devices (VADs) in the face of adverse events (AEs) using a resilience-based approach. The objective is to develop a method for integrating resilience attributes into VAD control systems, employing dynamic risk analysis and control strategies. Results: The outcomes include a resilient control architecture enabling anticipatory, regenerative, and degenerative actions in response to AEs. A method of applied resilience (MAR) based on dynamic risk management and resilience attribute analysis was proposed. Conclusion: Dynamic integration between medical and technical teams allows continuous adaptation of control systems to meet patient needs over time, improving reliability, safety, and effectiveness of VADs, with potential positive impact on the health of heart failure patients.

Effects of left ventricular assist device on pulmonary functions and pulmonary hemodynamics:A meta-analysis

BACKGROUND Given current evidence,the effect of left ventricular assist device(LVAD)implantation on pulmonary function tests remains controversial.AIM To better understand the factors contributing to the changes seen on pulmonary function testing and the correlation with pulmonary hemodynamics after LVAD implantation.METHODS Electronic databases were queried to identify relevant articles.The summary effect size was estimated as a difference of overall means and standard deviation on a random-effects model.RESULTS A total of four studies comprising 219 patients were included.The overall mean forced expiratory volume in one second(FEV1),forced vital capacity(FVC)and diffusion lung capacity of carbon monoxide(DLCO)after LVAD implantation were significantly lower by 0.23 L(95%CI:0.11-0.34,P=00002),0.18 L(95%CI:0.03-0.34,P=0.02),and 3.16 mmol/min(95%CI:2.17-4.14,P<0.00001),respectively.The net post-LVAD mean value of the cardiac index was significantly higher by 0.49 L/min/m2(95%CI:0.31-0.66,P<0.00001)compared to pre-LVAD value.The pulmonary capillary wedge pressure and pulmonary vascular resistance were significantly reduced after LVAD implantation by 8.56 mmHg(95%CI:3.78-13.35,P=0.0004),and 0.83 Woods U(95%CI:0.11-1.55,P=0.02),respectively.There was no significant difference observed in the right atrial pressure after LVAD implantation(0.61 mmHg,95%CI:-2.00 to 3.32,P=0.65).Overall findings appear to be driven by studies using HeartMateII devices.CONCLUSION LVAD implantation might be associated with a significant reduction of the spirometric measures,including FEV1,FVC,and DLCO,and an overall improvement of pulmonary hemodynamics.

Right Ventricular Failure Following Left Ventricular Assist Device Implantation

Left ventricular assist device (LVAD) is being used increasingly in recent years for end stage heart failure as a bridge to transplant (BTT) and also as a destination therapy (DT). Patients with end stage heart failure have some degree of elevated pulmonary capillary wedge pressure, causing right ventricular hypertrophy which in due course leads to decreased dilatation of the RV and fall in cardiac output & severe tricuspid regurgitation (TR) presenting with features of RV failure (RVF). Implantation of LVAD improves left heart function at the cost of right ventricular output with an incidence of 25%-30%. RVF may lead to impaired LVAD flow, difficulty in weaning from cardio-pulmonary bypass (CPB), decreased tissue perfusion and multi-organ failure. In this article we comprehended the pathophysiology leading to RVF post LVAD implantation and its preoperative predictors and the various treatment modalities for managing RVF post LVAD implantation.

Treatment of gastrointestinal bleeding in left ventricular assist devices:A comprehensive review

Left ventricular assist devices(LVAD)are increasingly become common as life prolonging therapy in patients with advanced heart failure.Current devices are now used as definitive treatment in some patients given the improved durability of continuous flow pumps.Unfortunately,continuous flow LVADs are fraught with complications such as gastrointestinal(GI)bleeding that are primarily attributed to the formation of arteriovenous malformations.With frequent GI bleeding,antiplatelet and anticoagulation therapies are usually discontinued increasing the risk of life-threatening events.Small bowel bleeds account for 15%as the source and patients often undergo multiple endoscopic procedures.Treatment strategies include resuscitative measures and endoscopic therapies.Medical treatment is with octreotide.Novel treatment options include thalidomide,angiotensin converting enzyme inhibitors/angiotensinⅡreceptor blockers,estrogen-based hormonal therapies,doxycycline,desmopressin and bevacizumab.Current research has explored the mechanism of frequent GI bleeds in this population,including destruction of von Willebrand factor,upregulation of tissue factor,vascular endothelial growth factor,tumor necrosis factor-α,tumor growth factor-β,and angiopoetin-2,and downregulation of angiopoetin-1.In addition,healthcare resource utilization is only increasing in this patient population with higher admissions,readmissions,blood product utilization,and endoscopy.While some of the novel endoscopic and medical therapies for LVAD bleeds are still in their development stages,these tools will yet be crucial as the number of LVAD placements will likely only increase in the coming years.

Evolvement of left ventricular assist device： the implications on heart failure management

Heart failure （HF） is a potentially fatal disease that affects increasing number of people worldwide. Although heart transplant is the ＂gold standard＂ therapy for HF, due to the limited availability of organs, many patients died when waiting for the transplant. Left ventricular assist device （LVAD）, as a mechanical circulatory support, has become a new light for patients with HF. With the technical advancements, LVADs work not only as a bridge to transplant, but also assist heart recovery and even as a destination therapy in long-term treatment. This observation paper reviewed the development of LVAD and its clinical roles. The challenges and possible solutions in nursing care for pa- tients with LVAD at different stage of implantation were discussed. The healthcare professionals could obtain a better understanding about the LVAD treatment for HF patients.

Optimal timing of same-admission orthotopic heart transplantation after left ventricular assist device implantation

AIM To investigate the impact of timing of same-admission orthotopic heart transplant(OHT) after left ventricular assist device(LVAD) implantation on in-hospital mortality and post-transplant length of stay.METHODS Using data from the Nationwide Inpatient Sample from 1998 to 2011, we identified patients 18 years of age or older who underwent implantation of a LVAD and for whom the procedure date was available. We calculated in-hospital mortality for those patients who underwent OHT during the same admission as a function of time from LVAD to OHT, adjusting for age, sex, race, household income, and number of comorbid diagnoses. Finally, we analyzed the effect of time to OHT after LVAD implantation on the length of hospital stay post-transplant.RESULTS Two thousand and two hundred patients underwent implantation of a LVAD in this cohort. One hundred and sixty-four(7.5%) patients also underwent OHT duringthe same admission, which occurred on average 32 d(IQR 7.75-66 d) after LVAD implantation. Of patients who underwent OHT, patients who underwent transplantation within 7 d of LVAD implantation("early") experienced increased in-hospital mortality(26.8% vs 12.2%, P = 0.0483) compared to patients who underwent transplant after 8 d("late"). There was no statistically significant difference in age, sex, race, household income, or number of comorbid diagnoses between the early and late groups. Post-transplant length of stay after LVAD implantation was also not significantly different between patients who underwent early vs late OHT. CONCLUSION In this cohort of patients who received LVADs, the rate of in-hospital mortality after OHT was lower for patients who underwent late OHT(at least 8 d after LVAD implantation) compared to patients who underwent early OHT. Delayed timing of OHT after LVAD implantation did not correlate with longer hospital stays post-transplant.

Comprehensive review of hemolysis in ventricular assist devices

Ventricular assist devices(VADs)have played an important role in altering the natural history of end-stage heart failure.Low-grade hemolysis has been traditionally described in patients with VADs,indicating effective device functionality.However,clinically significant hemolysis could be crucial in terms of prognosis,calling for prompt therapeutic actions.The absence of solid and widely approved diagnostic criteria for clinically significant hemolysis,render the utilization of hemolysis laboratory markers challenging.Hemolysis incidence varies(5%-18%)depending on definition and among different VAD generations,being slightly higher in continuous-flow devices than in pulsatile devices.Increased shear stress of red blood cells and underlying device thrombosis appear to be the main pathogenetic pathways.No certain algorithm is available for the management of hemolysis in patients with VADs,while close clinical and laboratory monitoring remains the cornerstone of management.Imaging examinations such as echocardiography ramp test or computed tomography scan could play a role in revealing the underlying cause.Treatment should be strictly personalized,including either pharmacological(antithrombotic treatment)or surgical interventions.

Utility and correlation of known anticoagulation parameters in the management of pediatric ventricular assist devices

AIM To assess utility and correlation of known anticoagulation parameters in the management of pediatric ventricular assist device(VAD). METHODS Retrospective study of pediatric patients supported with a Berlin EXCOR VAD at a single pediatric tertiary care center during a single year.RESULTS We demonstrated associations between activated thro-mboplastin time(a PTT) and R-thromboelastography(R-TEG) values(rs = 0.65, P < 0.001) and between anti-Xa assay and R-TEG values(rs = 0.54, P < 0.001). The strongest correlation was seen between a PTT and anti-Xa assays(rs = 0.71, P < 0.001). There was also a statistically significant correlation between platelet counts and the maximum amplitude of TEG(rs = 0.71, P < 0.001). Importantly, there was no association between dose of unfractionated heparin and either measure of anticoagulation(a PTT, anti-Xa or R-TEG value). CONCLUSION This study suggests that while there is strong correlation between a PTT, anti-Xa assay and R-TEG values for patients requiring VAD support, there is a lack of relevant correlation between heparin dose and degree of effect. This raises concern as various guidelines continue to recommend using these parameters to titrate heparin therapy.

Computational fluid dynamics of left ventricular assist device under unsteady flow

Left ventricular assist device( LVAD) in this study is a mechanical tool that is used to support blood flow in the patient with heart disease. It supports left ventricle by building up the pressure to the pump outlet connected to the aorta. This pump was designed based on the magnetic driven centrifugal pump with a unique small washout hole constructed inside the impeller to generate the washout flow passage to prevent the stagnation at the region underneath and around the rotor. Computational fluid dynamics( CFD) was adopted in this study to assess the performance and optimize the design to avoid recirculation and high shear stress which is the main cause of stagnation and blood damage. Transient simulation was used for this study due to the asymmetric design of the washout hole and the complication of the bottom support of the impeller that has a risk of thrombosis,also,it was used to predict the variation of hydraulic performance caused by the rotation of the impeller and pulsed flow at the pump inlet. The simulation results show no excessive stress and no recirculation observed within the computational domain; in addition,the research result also provides information for further optimization and development to the pump.

To ventricular assist devices or not:When is implantation of a ventricular assist device appropriate in advanced ambulatory heart failure?

Advanced heart failure has been traditionally treated via either heart transplantation,continuous inotropes,consideration for hospice and more recently via left ventricular assist devices(LVAD).Heart transplantation has been limited by organ availability and the futility of other options has thrust LVAD therapy into the mainstream of therapy for end stage heart failure.Improvements in technology and survival combined with improvements in the quality of life have made LVADs a viable option for many patients suffering from heart failure.The question of when to implant these devices in those patients with advanced,yet still ambulatory heart failure remains a controversial topic.We discuss the current state of LVAD therapy and the risk vs benefit of these devices in the treatment of heart failure.

Subacute gastric perforation caused by a left ventricular assist device

This case report describes a rare complication of a left ventricular assist device (LVAD). A patient with ischemic cardiomyopathy had an LVAD placed due to intractable congestive heart failure following a large anterior myocardial infarction. The patient developed chronic bacteremia and multiple septic episodes. A gastric endoscopy revealed perforation of the anterior wall of the stomach by the LVAD. Gastric acid related erosions were present on the metallic surface suggesting prolonged exposure. This is the second case report of this rare complication and the first case report of a subacute course.

Simultaneous ramp right heart catheterization and echocardiography in a Reliant Heart left ventricular assist device

Many clinicians caring for patients with continuous flow left ventricular assist devices(CF-LVAD) use ramp right heart catheterization(RHC) studies to optimize pump speed and also to troubleshoot CF-LVAD malfunction. An investigational device,the Reliant Heart Heart Assist 5(Houston,TX),provides the added benefit of an ultrasonic flow probe on the outflow graft that directly measures flow through the CF-LVAD. We performed a simultaneous ramp RHC and echocardiogram on a patient who received the above CF-LVAD to optimize pump parameters and investigate elevated flow through the CF-LVAD as measured by the flow probe. We found that the patient's hemodynamics were optimized at their baseline pump speed,and that the measured cardiac output via the Fick principle was lower than that measured by the flow probe. Right heart catheterization may be useful to investigate discrepancies between flow measured by a CF-LVAD and a patient's clinical presentation,particularly in investigational devices where little clinical experience exists. More data is needed to elucidate the correlation between the flow measured by an ultrasonic probe and cardiac output as measured by RHC.

Cardiac rehabilitation in a heart failure patient after left ventricular assist device insertion and subsequent heart transplantation:A case report

BACKGROUND Insertion of a left ventricular assist device(LVAD)and heart transplantation(HT)improve the survival of patients with heart failure.In addition,cardiac rehabilitation(CR)further increases the functional capacity.This case report describes a successful case of CR after LVAD insertion and subsequent HT.CASE SUMMARY In the present case,during the LVAD insertion period,peak oxygen consumption(VO2)increased by 12.16%after CR.HT was performed 7 mo after the LVAD insertion,and the patient participated in phases I and II CR.The peak VO2 increased from 17.24 to 22.29 m L/kg/min.This improvement was more significant than that reported in previous studies on CR after LVAD insertion or HT.The patient’s quality of life also improved.The total average score of the short form-36 questionnaire increased from 29.5 points at admission to 53.3 points 9 mo after HT.CONCLUSION A tailored CR program after LVAD insertion or HT may improve the patients’quality of life and increase survival.

Recovery after acute kidney injury requiring kidney replacement therapy in patients with left ventricular assist device: A metaanalysis

BACKGROUND Acute kidney injury(AKI)is a common and severe complication after left ventricular assist device(LVAD)implantation with an incidence of 37%;13%of which require kidney replacement therapy(KRT).Severe AKI requiring KRT(AKI-KRT)in LVAD patients is associated with high short and long-term mortality compared with AKI without KRT.While kidney function recovery is associated with better outcomes,its incidence is unclear among LVAD patients with severe AKI requiring KRT.AIM To identify studies evaluating the recovery rates from severe AKI-KRT after LVAD placement,which is defined by regained kidney function resulting in the discontinuation of KRT.Random-effects and generic inverse variance method of DerSimonian-Laird were used to combine the effect estimates obtained from individual studies.METHODS A total of 268 patients from 14 cohort studies that reported severe AKI-KRT after LVAD were included.Follow-up time ranged anywhere from two weeks of LVAD implantation to 12 mo.Kidney recovery occurred in 78%of enrollees at the time of hospital discharge or within 30 d.Overall,the pooled estimated AKI recovery rate among patients with severe AKI-KRT was 50.5%(95%CI:34.0%-67.0%)at 12 mo follow up.Majority(85%)of patients used continuous-flow LVAD.While the data on pulsatile-flow LVAD was limited,subgroup analysis of continuous-flow LVAD demonstrated that pooled estimated AKI recovery rate among patients with severe AKI-KRT was 52.1%(95%CI:36.8%-67.0%).Metaregression analysis did not show a significant association between study year and AKI recovery rate(P=0.08).There was no publication bias as assessed by the funnel plot and Egger's regression asymmetry test in all analyses.RESULTS A total of 268 patients from 14 cohort studies that reported severe AKI-KRT after LVAD were included.Follow-up time ranged anywhere from two weeks of LVAD implantation to 12 mo.Kidney recovery occurred in 78%of enrollees at the time of hospital discharge or within 30 d.Overall,the pooled estimated AKI recovery rate among patients with severe AKI-KRT was 50.5%(95%CI:34.0%-67.0%)at 12 mo follow up.Majority(85%)of patients used continuous-flow LVAD.While the data on pulsatile-flow LVAD was limited,subgroup analysis of continuous-flow LVAD demonstrated that pooled estimated AKI recovery rate among patients with severe AKI-KRT was 52.1%(95%CI:36.8%-67.0%).Metaregression analysis did not show a significant association between study year and AKI recovery rate(P=0.08).There was no publication bias as assessed by the funnel plot and Egger's regression asymmetry test in all analyses.CONCLUSION Recovery from severe AKI-KRT after LVAD occurs approximately 50.5%,and it has not significantly changed over the years despite advances in medicine.

Clinical application of BVS5000 left ventricular assist device in heart failure patients

Background Mechanical ventricular assistance is an important therapeutic method for severe heart failure patients. A variety of ventricular assist devices have been designed for use, The purpose of this report was to describe the experience of using Abiomed BVS5000 as a means of left ventricular support as a clinical treatment for heart failure patients. Methods From February 2004 to April 2006, 12 male patients were supported with Abiomed BVS5000 left ventricular assist device （LVAD） at Fu Wai Hospital. The average age was （55.2±9.6） years （range 39 to 68 years）. The mean body surface area was （1.76±0.1） m^2 （range 1.6 to 1.9 m^2 ）. Devices were inserted for post-cardiotomy shock after coronary artery bypass graft in 11 patients （92%） and in 1 dilated cardiomyopathy patient for acute cardiogenic shock. Modified cannulation methods by inserting the arterial cannulae in femoral artery and inserting the venous cannula in left atrium through a segment of bovine jugular vein were used in 7 patients. In this way, the device could be taken off without re-sternotomy when support was finished. A comparison was made between the modified method and routine left atrium-to-ascending aorta cannulating method. Results The median duration of support was 5 （3-43） days, with support flow rate of 3.8-4.5 L/min. There were 9 （75%） patients weaned from support and 8 （67%） patients discharged from the hospital. Four （33%） patients were dead. The most common morbidity was adverse neurological events. There is no statistical difference between modified and routine method on average in BVS5000 support duration, in assisted flow rate, in mechanical ventilation duration, in the intensive care unit stay and thoracic drainage. Conclusions The Abiomed BVS5000 is valuable to support patients with acute cardiogenic shock for short-term use. By the modified cannulating method, the weaning procedure can be effectively simplified. Optimization of inserting indication remains challenging and attributes to a successful assist program.

Development and current clinical application of ventricular assist devices in China

Heart failure has become one of the biggest threats to human health. Transplantation remains the most effective therapy for heart failure, but because of the shortage of donors, it cannot meet the demand. Ventricular assist devices （VADs） were developed to treat heart failure, and have now been clinically applied worldwide. As the country with the largest population, China is also facing the threat of heart failure. However, the development of VADs in China is very slow and is seldom discussed. This paper first talks about the background for VAD development in China. Then several home-developed VADs in China are introduced. The current clinical application status of VADs in China is also presented. Finally the challenge and opportunity for VAD development in China are discussed.

Non-physiological shear stress-induced blood damage in ventricular assist device

Ventricular assist devices(VADs)have been used for treating the end-stage heart failure(HF)patients in the past few decades,which had improved survival rates.In parallel,clinical applications of VADs are accompanied with endangered complications,such as thrombosis,bleeding and infection,which hamper the patient recovery.Nonphysiological shear stress(NPSS)is inevitably created during VAD application.When HF patients implanted with VADs,this high level NPSS can induce damage on blood components including blood cells(red blood cells,platelets,leukocytes et al.)and protein(von Willebrand Factor(VWF)).The damage of these blood cells and proteins may lead to the dysfunction of coagulation and immune systems,contributing to complications in VAD patients.To understand how VADs-created NPSS induces blood damage,and find the link between NPSS-induced blood damage and VAD related complications would potentially help to guide the VAD optimization and to find the effect way for treating VAD associated complications.Here we provide a review to investigate what is currently known about NPSS-induced blood damage within VADs and how the NPSS-induced blood damage links to complications(thrombosis,bleeding and infection)in VAD patients.

A new way to evaluate thrombotic risk in failure heart and ventricular assist devices

Thrombosis is one of the main complications in patients implanted with ventricular assist device(VAD).The complicated structure and disturbed flow field within failure heart and blood pump play an important role in thrombosis formation.In this study,the influence of Left ventricular(LV)volumes on flow field contributing to thrombosis formation within failure heart and VAD was investigated.Computational Fluid Dynamics(CFD)methods were employed to investigate the effect of different LV volumes on the thrombogenic potential of failure heart and VAD.Lagrangian methods were utilized to obtain information on platelet voyage trajectories.The concepts of mean and threshold of stress accumulation and residence time were introduced to accurately assess the likelihood of thrombus.Eulerian methods were used to identify thrombus-prone locations.CFD results showed that residence time(RT)was the main cause of thrombus formation in the failure heart,and the percentage of platelet trajectories above the RT threshold increased significantly with increasing LV volume.The RT in the left atrial appendage and LV increased significantly with LV volume increasing,which indicated that thrombus is prone to form there.Compared with the failure heart,non-physiological shear stress(NPSS)-caused platelet activation is the main reason for thrombus formation within VAD.The narrow zones(top clearance and secondary flow passage)within VAD have a high incidence of thrombus generation.In VAD patients,the LV volume has an important impact on thrombosis probability within failure heart,in which the larger size of the LV volume is,the higher risk of thrombosis will be.The size of LV volume has little effect on the thrombosis formation probability of VAD,where the NPSS plays the leading role in thrombosis formation.The finding of this study can be utilized to guild the clinical treatment and VAD structure optimization design for reducing the thrombosis risk.

A numerical analysis on different-generation prototypes of ventricular assist device

The ventricular assist device(VAD)assists the patients with heart diseases for limited and prolonged periods.This device synchronizes with normal heart activities to help foster its performance.Consequently,its sensitive design requires high accuracy.The pumps are the essential part of every VAD which should operate in wide ranges of flow and pressure.As there are various types of VAD under different designs,it is neither practical nor plausible to experimentally/clinically investigate their performances.Therefore,in the concurrent study,a numerical study was carried out on four different generation prototypes of VAD pumps for reaching an optimum design.Using computational fluid dynamics(CFD)method,the software derived,showed and streamlined the flow field shear stress both inside the VAD and its blades.Furthermore,the vortices and flow rate-pressure curves were observed.The results showed that the curved blade pumps operate better compared to that of the straight blade types,concerning the provision of enough pressure and less damage to the red blood cells.The results have implications not only for comparing different types of VAD designs but also for understanding the resulted shear stresses and pressures as a result of the blade’s structure.