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Background: Left ventricular assist devices (LVADs) are utilized as a therapeutic option for patients with end-stage heart failure. While LVAD implantation can enhance survival rates and quality of life, the procedure has its risks, and postoperative complications are common. This review aims to investigate whether there is an association between living in a rural area and the incidence of postoperative complications or hospital readmissions following LVAD implantation, compared to urban LVAD recipients., Methods: A comprehensive literature review examined studies that compared postoperative outcomes between rural and urban LVAD recipients. Data on adverse events, hospitalizations, and mortality rates were extracted, focusing on the impact of geographic location on these outcomes., Results: The review found that rural LVAD recipients may be at a higher risk for certain complications, including gastrointestinal bleeding, ventricular arrhythmias, LVAD complications, and stroke. Rural patients also exhibited higher instances of emergency department visits and hospital readmissions. Despite these challenges, survival rates and heart transplantation outcomes at 1 year were similar between rural and urban recipients. However, rural patients exhibited a higher driveline infection rate at 1 year., Conclusion: The findings of this review suggest that rural residency may be associated with an increased risk of certain postoperative complications and hospital readmissions following LVAD implantation. These results highlight the need for healthcare strategies to address the challenges faced by rural LVAD recipients. Further research is necessary to understand the relationship between geographic location and LVAD outcomes and to develop interventions that can improve postoperative care for this vulnerable population., (© 2024 The Author(s). Clinical Cardiology published by Wiley Periodicals LLC.)

Background/Aims The continuous flow left ventricular assist device (cf-LVAD) has improved the survival of chronic end-stage heart failure (HF) patients. Here we describe our clinical experience of the initial 50 LVAD patients from a single center. Methods A total of 50 patients underwent LVAD implantation as bridge to transplantation (BTT; n = 28, 56%), bridge to candidacy (BTC; n = 2, 4%), or as destination therapy (DT; n = 20, 40%) from 2012 to 2019. Pre-implant characteristics and clinical outcomes were compared between BTT/BTC and DT. Results The median age of patients was 67 years (range, 59 to 73). Men were more likely to receive LVAD (76% vs. 24%) than women. DT patients were older, had smaller body surface area, and worse laboratory profiles than BTT/BTC patients. There was no in-hospital mortality. During an average of 14 months (range, 8 to 23), the all-cause mortality was 22%. The first-year survival was 86 and 90% in BTT/BTC and DT groups, respectively. Hemorrhagic stroke was the most common cause (27%) of death. In the BTT/BTC group, 22 patients successfully underwent heart transplantation during median duration of 10 months (range, 7 to 14). The most common post-LVAD complication during the first year of LVAD implantation was major bleeding (44%). A significant proportion (76%) of patients experienced rehospitalization with gastrointestinal bleeding as the most common cause. Conclusions We describe short-term clinical outcome of LVAD patients from a single center for the first time in Korea. With the newer generation LVAD and a dedicated team approach, improved clinical outcomes of LVAD for end-stage HF are expected.

Abstract Background Bleedings are frequent and dreaded complications in heart failure patients with ventricular assist devices (VAD). Serotonin reuptake inhibitor (SRI) antidepressants are widely used to treat depression in these patients, though they are attributed an increased risk of bleeding due to their modification of hemostasis. Evidence on bleeding risk of VAD patients under SRI medication is scarce and limited. We therefore aimed to assess if SRI use is associated with an elevated bleeding risk in this particularly vulnerable population. Methods We analyzed the medical records of 92 VAD patients at the University Heart Center Zurich between September 2004 and April 2018 for the occurrence of bleedings and the concomitant use of an SRI. Bleeding was defined as any type of post-implantation bleeding requiring medical treatment. We performed univariate analyses and linear mixed-effects models, adjusting for baseline clinical characteristics as potential predictors to identify differences in bleeding rates in patients with vs. without SRI intake. Results The cohort comprised 60.9% of patients with a continuous-flow VAD and 39.1% with a pulsatile-flow VAD. A total of 77.2% of patients experienced at least one bleeding incident. Overall, 28.6% of bleedings occurred under SRI therapy. A generalized linear mixed model showed a predictive effect of SRI medication on bleeding rate, independent of VAD type (z = 2.091, p = 0.037). Conclusions Bleeding events in heart failure patients occur frequently after VAD implantation. Patients with SRI medication were at increased risk of bleeding. The indication and use of SRI, therefore, should be considered carefully.

Ventricular assist devices have become a valuable tool in the treatment of heart failure in children. The use of ventricular assist devices has decreased mortality in children with end-stage heart failure awaiting transplant. It is not uncommon for children with end-stage heart failure associated with cardiomyopathy or congenital heart disease to have significant systemic semilunar and atrioventricular valve regurgitation, which can impact the efficiency and efficacy of hemodynamic support provided by a ventricular assist device. Therefore, implanting clinicians should carefully assess for valve abnormalities that may need repair and impact device selection and cannulation strategy to effectively support this diverse population. The purpose of this review is to provide an overview of this important and relevant topic and to discuss strategies for managing these patients.

Background US regulatory framework for advanced heart failure therapies (AHFT), ventricular assist devices, and heart transplants, delegate eligibility decisions to multidisciplinary groups at the center level. The subjective nature of decision‐making is at risk for racial, ethnic, and gender bias. We sought to determine how group dynamics impact allocation decision‐making by patient gender, racial, and ethnic group. Methods and Results We performed a mixed‐methods study among 4 AHFT centers. For ≈ 1 month, AHFT meetings were audio recorded. Meeting transcripts were evaluated for group function scores using de Groot Critically Reflective Diagnoses protocol (metrics: challenging groupthink, critical opinion sharing, openness to mistakes, asking/giving feedback, and experimentation; scoring: 1 to 4 [high to low quality]). The relationship between summed group function scores and AHFT allocation was assessed via hierarchical logistic regression with patients nested within meetings nested within centers, and interaction effects of group function score with gender and race, adjusting for patient age and comorbidities. Among 87 patients (24% women, 66% White race) evaluated for AHFT, 57% of women, 38% of men, 44% of White race, and 40% of patients of color were allocated to AHFT. The interaction between group function score and allocation by patient gender was statistically significant (P=0.035); as group function scores improved, the probability of AHFT allocation increased for women and decreased for men, a pattern that was similar irrespective of racial and ethnic groups. Conclusions Women evaluated for AHFT were more likely to receive AHFT when group decision‐making processes were of higher quality. Further investigation is needed to promote routine high‐quality group decision‐making and reduce known disparities in AHFT allocation.

ObjectiveSevere biventricular heart failure (BHF) can be remedied using a biventricular assist device (BVAD). Two devices are currently in development: a universal ventricular assist device (UVAD), which will be able to assist either the left, right, or both ventricles, and a continuous-flow total artificial heart (CFTAH), which replaces the entire heart. In this study, the in vitro hemodynamic performances of two UVADs are compared to a CFTAH acting as a BVAD.MethodsFor this experiment, a biventricular mock circulatory loop utilizes two pneumatic pumps (Abiomed AB5000™, Danvers, MA, USA), in conjunction with a dual-output driver, to create heart failure (HF) conditions (left, LHF; right, RHF; biventricular, BHF). Systolic BHF for four different situations were replicated. In each situation, CFTAH and UVAD devices were installed and operated at two distinct speeds, and cannulations for ventricular and atrial connections were evaluated.ResultsBoth CFTAH and UVAD setups achieved our recommended hemodynamic criteria. The dual-UVAD arrangement yielded a better atrial balance to alleviate LHF and RHF. For moderate and severe BHF scenarios, CFTAH and dual UVADs both created excellent atrial pressure balance. Conversely, when CFTAH was atrial cannulated for LHF and RHF, the needed atrial pressure balance was not met.ConclusionComprehensive in vitro testing of two different BVAD setups exhibited self-regulation and exceptional pump performance for both (single- and dual-device) BHF support scenarios. For treating moderate and severe BHF, UVAD and CFTAH both functioned well with respect to atrial pressure regulation and cardiac output. Though, the dual-UVAD setup yielded a better atrial pressure balance in all BHF testing scenarios.

Over the past 2 years advancements in the techniques and technology of pediatric heart transplantation have exponentially increased. However, even as the number of pediatric donor hearts has grown, demand for this limited resource continues to far outpace supply. Thus, lifesaving support in the form of ventricular assist devices (VAD) has become increasingly utilized in bridging pediatric patients to cardiac transplant. In the current pediatric heart transplant listing criteria, adopted by the United Network for Organ Sharing (UNOS) in 2016, all pediatric patients with a VAD are granted 1A status and assigned top transplant priority regardless of their underlying pathology. However, should this be the case? We suggest that the presence of a VAD alone may not be sufficient for status 1A listing. In doing so, we specifically highlight the heightened acuity, resource utilization, risk profile, and diminished outcomes in patients with single ventricle physiology supported with VAD as compared to patients with structurally normal hearts who would both be listed under 1A status. Given this, from a distributive justice perspective, we further suggest that the lack of granularity in current pediatric cardiac transplant listing categories may inadvertently lead to an inequitable distribution of donor organs and hospital resources especially as it pertains to those with single ventricle anatomy on VAD support. We propose revisiting the current listing priorities in light of improved techniques, technology, and recent data to mitigate this phenomenon. By doing this, pediatric patients with single ventricle disease might be more equitably stratified while awaiting heart transplant.

Background Advanced kidney disease is often a relative contraindication to left ventricular assist device (LVAD) implantation because of concerns for poor outcomes including worsening kidney disease. Data are lacking on long‐term changes and sex‐based differences in estimated glomerular filtration rate (eGFR), with published data limited by potential bias introduced by the competing risks of death and heart transplantation. Methods and Results We conducted a longitudinal analysis of 288 adults receiving durable continuous‐flow LVADs from January 2010 to December 2017 at a single center. A joint model was constructed to evaluate change in eGFR over 2 years, the prespecified primary outcome, adjusted for the competing risks of death and heart transplantation. Median baseline eGFR was 60 mL/min per 1.73 m2 (interquartile range 42–78). At 2 years, 74 patients died and 104 received a heart transplant. In unadjusted analysis, LVAD recipients had a modest initial increase in eGFR of ≈2 mL/min per 1.73 m2 within the first 6 months after implantation, followed by a decrease in eGFR below baseline values at 1 and 2 years. Men experienced an eGFR decline of 5 to 10 mL/min per 1.73 m2 over the first year which then stabilized, while women had an ≈5 mL/min per 1.73 m2 increase in eGFR within the first 6 months followed by decline towards baseline eGFR levels (interaction P=0.005). Conclusions Estimated GFR remains relatively stable in most patients following LVAD implantation. Larger studies are needed to investigate sex‐based differences in eGFR and to evaluate eGFR trajectory and mortality in LVAD recipients with lower eGFR.

Heart failure remains a major global burden regarding patients’ morbidity and mortality and health system organization, logistics, and costs. Despite continual advances in pharmacological and resynchronization device therapy, it is currently well accepted that heart transplantation and mechanical circulatory support represent a cornerstone in the management of advanced forms of this disease, with the latter becoming an increasingly accepted treatment modality due to the ongoing shortage of available donor hearts in an ever-increasing pool of patients. Mechanical circulatory support strategies have seen tremendous advances in recent years, especially in terms of pump technology improvements, indication for use, surgical techniques for device implantation, exchange and explantation, and postoperative patient management, but not in the field of treatment of critically ill patients and those undergoing cardiac arrest. This contemporary review aims to summarize the collected knowledge of this topic with an emphasis on complications in patients with left ventricular assist devices, their treatment, and establishing a clear-cut algorithm and the latest recommendations regarding out-of-hospital or emergency department management of cardiac arrest in this patient population.

Background: In view of the role of mechanical circulatory support in patients with severe cardiac insufficiency during perioperative period, we searched the relevant articles on mechanical circulatory support at Fuwai Hospital, and analyzed the indications and complications of different mechanical circulatory support methods. Methods: Relevant studies were identified by computerized searches of PubMed, Ovid, Embase, Cochrane Library, Wanfang Data, VIP Data, Chinese BioMedical Literature & Retrieval System (SinoMed), and China National Knowledge Infrastructure (CNKI), using search words (“intra-aortic balloon counter pulsation” OR “IABP” OR “extracorporeal membrane oxygenation” OR “ECMO” OR “ventricular assist device” OR “VAD”) AND (“Fuwai” OR “fuwai”). All studies concerning the application of IABP, ECMO, and VAD at Fuwai Hospital were included, exclusion criteria included: (1) studies published as review, case report or abstract; (2) animal or cell studies; (3) duplicate publications; (4) studies lacking information about outcomes of interest. Results: A total of 36 literatures were selected for analysis. The specific mechanical circulatory support methods of ECMO and VAD retrieved from the studies were VA-ECMO and LVAD. The number of cases using IABP, ECMO, LVAD was 1968, 972, 67; and the survival rate was 80.4%, 54.9%, 56.7%, respectively. The major complications of IABP, ECMO and LVAD were hemorrhage (1.2%, 35.9% and 14.5%), infection (3.7%, 12.7% and 9.7%), acute kidney injury (9.1%, 29.6% and 6.5%), the secondary complications were limb ischemia, neurological events, cardiovascular events and thrombosis. Conclusions: The present study suggested that, IABP, ECMO and VAD, either alone or in combination, were effective and safe mechanical circulation support when managing cardiovascular surgical patients with severe hemodynamic instability at Fuwai Hospital. [ABSTRACT FROM AUTHOR]

A 57‐year‐old man suffered chest pain during the COVID‐19 pandemic, but he delayed medical treatment due to fear of infection. After 4 months, symptoms of chest tightness and shortness of breath appeared. Electrocardiogram (ECG) revealed old myocardial infarction; color sonography and myocardial computed tomography revealed apical myocardial defect. He refused surgery and percutaneous transcatheter closure, and follow‐up observation. After 22 months, the symptoms of chest tightness and shortness of breath aggravated. He recovered after percutaneous transcatheter closure, and was discharged. This case shows delayed closure is one of the possible options for patients without severe organ dysfunction or hemodynamic disturbance. [ABSTRACT FROM AUTHOR]

Introduction: Many institutions suspended surveillance and contact precautions for multidrug‐resistant organisms (MDROs) at the outset of the coronavirus disease 2019 (COVID‐19) pandemic due to a lack of resources. Once our institution reinstated surveillance in September 2020, a vancomycin‐resistant Enterococcus (VRE) faecium outbreak was detected in the cardiothoracic transplant units, a population in which we had not previously detected outbreaks. Methods: An outbreak investigation was conducted using pulsed‐field gel electrophoresis for strain typing and electronic medical record review to determine the clinical characteristics of involved patients. The infection prevention (IP) team convened a multidisciplinary process improvement team comprised of IP, cardiothoracic transplant nursing and medical leadership, environmental services, and the microbiology laboratory. Results: Between December 2020 and March 2021, the outbreak involved thirteen patients in the cardiothoracic transplant units, four index cases, and nine transmissions. Of the 13, seven (54%) were on the transplant service, including heart and lung transplant recipients, patients with ventricular assist devices, and a patient on extracorporeal membrane oxygenation as a bridge to lung transplantation. Four of 13 (31%) developed a clinical infection. Discussion: Cardiothoracic surgery/transplant patients may have a similar risk for VRE‐associated morbidity as abdominal solid organ transplant and stem cell transplant patients, highlighting the need for aggressive outbreak management when VRE transmission is detected. Our experience demonstrates an unintended consequence of discontinuing MDRO surveillance in this population and highlights a need for education, monitoring, and reinforcement of foundational infection prevention measures to ensure optimal outcomes. [ABSTRACT FROM AUTHOR]

Objectives: The choice of ventricular mechanical support for end-stage patients presenting with Inter-Institutional Registry for Mechanical Assisted Circulatory Support (INTERMACS) profiles I and II is still controversial. In this study, we aimed to analyze the INTERMACS I and II patients who underwent extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) as a bridge to decision. Methods: Twenty-four patients were retrospectively analyzed as Group 1: ECMO and Group 2: LVAD implanted due to critical clinical status at INTERMACS profile I and II during 2014 and 2022. Results: Mechanical support was ECMO in 9 patients and LVAD in 15 patients. The baseline characteristics of patients receiving ECMO and LVAD were not different in terms of comorbidities or cardiac parameters. Total mortality was 17 (70.8%) in INTERMACS I and II patients. Mortality did not differ between patients with ECMO and directly implanted LVAD. (p=0.669). Conclusion: As both types of mechanical support will be highly mortal, in multiorgan failure with severe metabolic disorder, ECMO shall be the first choice. On the other hand, LVAD can be the therapy of choice when there is no organ failure or metabolic disorder. Additionally, the availability of organ transplantation should be considered in final decision making on a patient basis. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES Extracorporeal membrane oxygenation (ECMO) support prior to ventricular assist device (VAD) therapy is frequently used for stabilizing INTERMACS 1 and 2 paediatric patients. Data regarding outcomes with this strategy is limited. METHODS Patient characteristics and outcomes post-VAD therapy with and without preop ECMO support were compared. Survival and risk factor analysis was performed for all patients and INTERMACS profile 1 subgroup. RESULTS Of 541 INTERMACS 1 and 2 patients enrolled in Paediatric Interagency Registry for Mechanical Circulatory Support registry, 391 received primary VAD implantation and ECMO prior to VAD therapy was utilized in 150 patients. Younger age (P  < 0.0001) and shock (P  < 0.0001) were more common in group 2, with lower survival at 1, 6 and 12 months compared to group 1 (P  < 0.0001). Freedom from infection (P  = 0.03) was higher in group 1. Freedom from stroke (P  = 0.7) was similar. Paracorporeal continuous flow devices led to poor survival in both groups 1 and 2 (P  = 0.4). Implantable continuous flow (P  < 0.0001) and paracorporeal pulsatile devices (P  = 0.007) had better survival in primary VAD group. INTERMACS profile 1, lower weight, hepatic dysfunction, renal failure, paracorporeal continuous and percutaneous devices were associated with higher mortality. Preop ECMO therapy was not associated with higher mortality (P  = 0.12). Survival of INTERMACS profile 1 patient was similar at 1, 6 and 12 months in both groups (P  = 0.1). CONCLUSIONS INTERMACS profile 1, lower weight, hepatic dysfunction, renal failure and use of paracorporeal continuous flow or percutaneous assist devices are associated with a higher postoperative mortality. Preop ECMO therapy however is not independently associated with higher postop mortality. [ABSTRACT FROM AUTHOR]

The use of mechanical circulatory support (MCS) for pediatric patients who have undergone heart transplant has grown rapidly in the past decade. This includes support in the immediate post‐transplant period and "rescue" therapy for patient later in their transplant course. Extracorporeal membrane oxygenation (ECMO) remains a standard modality of support for intraoperative concerns and for acute decompensation in the immediate post‐transplant period. However, both pulsatile and continuous flow ventricular assist devices (VADs) have been used with increasing success in transplant patients for longer durations of support. Centers participating in the Pediatric Heart Transplant Society (PHTS) were queried to provide their internal protocols and rationale for mechanical circulatory support following heart transplant. These protocols coupled with evidence‐based literature were used to provide the following description of clinical approaches to MCS in the transplant patient highlighting areas of both broad consensus and significant practice variation. [ABSTRACT FROM AUTHOR]

Background: VAD support for early graft failure after HTx is a rare event in pediatrics. Methods: We retrospectively describe our single‐center experience with post‐HTx VAD support in a cohort of patients transplanted between 01/05 and 12/20. Results: Nine patients underwent VAD insertion in the early post‐HTx period [median age 6.1 years (Range 0.3–20.3), median weight 17.6 kg (Range 3.5–65.0), and congenital heart disease (67%)]. Of the nine patients with early graft failure, almost half (44%) were implanted after 2015 and all of these patients had a pre‐HTx plan for possible post‐transplant VAD insertion. Time to VAD implant was a median of 0 day (Range 0–11). Total time on VAD support was a median of 12 days (Range 3.0–478.0). Two‐thirds (n = 6; 67%) of the patients were weaned from support, retransplanted (11%) and two patients died (22%). In all of the patients where post‐HTx VAD was anticipated there was 100% survival. Conclusions: In this small patient series, post‐HTx VAD was a useful measure in selected patients especially with pre‐HTx planning. However, more shared experiences to verify these findings are needed. [ABSTRACT FROM AUTHOR]

Aims: We present a single‐centre retrospective experience using oral milrinone in patients with a left ventricular assist device (LVAD) and concurrent refractory right ventricular failure. Methods and results: All patients implanted with LVAD between January 2013 and July 2021 from a high‐volume advanced heart failure service were reviewed. Eight patients were initiated on oral milrinone during this period. Oral milrinone was started 1.5 [inter‐quartile range (IQR) 1–2.3] years after LVAD implantation and continued for 1.2 (IQR 0.5–2.8) years. Therapeutic milrinone levels were achieved (232.2 ± 153.4 ng/mL) with 62.4 ± 18% of time within the therapeutic range. Two patients had adverse events (non‐sustained ventricular tachycardia and ventricular fibrillation effectively treated by internal cardioverter defibrillator) but did not require milrinone discontinuation. Four deaths occurred, one after transplant and three from disease progression determined to be unrelated to oral milrinone use. Three patients continue oral milrinone therapy in the community. There was no significant difference found after the initiation of oral milrinone on any of the physiological measures; however, there were trends in reduction of New York Heart Association class from 3.4 ± 0.5 to 3.0 ± 0.8 (P = 0.08), reduction of right atrial/wedge pressure from 0.9 ± 0.3 to 0.5 ± 0.2 (P = 0.08), and improvement of right ventricular stroke work index from 3.8 ± 2 to 5.8 ± 2.7 (P = 0.16). Conclusions: Oral milrinone appears safe for long‐term use in the outpatient setting when combined with therapeutic monitoring in this complex medical cohort with limited management options. Further study is needed to ascertain whether this treatment is effective in reducing heart failure symptoms and admissions. [ABSTRACT FROM AUTHOR]

Background: A 9-year-old boy with Berlin Heart biventricular assist device for diagnosis of dilated cardiomyopathy developed progressive reduction in left ventricular assist device(VAD) emptying and evidence of low cardiac output despite alterations to the device settings. Computed tomography revealed that the Dacron graft attaching the systemic cannula to the ascending aorta was stenosed.Method& Result: A minimally invasive approach with novel circuit modification was used to achieve antegrade stenting of the stenosed graft.Conclusion: This proposed technique provides a large port for minimally invasive access via an adapted VAD circuit allowing stent insertion to the aortic graft with an excellent outcome. [ABSTRACT FROM AUTHOR]

Background: Mechanical circulatory support (MCS) has been widely utilized in critically ill cardiac transplant candidates. Few studies have investigated the impact of duration of MCS before heart transplantation (HTx) on long‐term patient survival. Methods: A retrospective HTx database was reviewed between 2009 and 2019. Patients who did not or did undergo MCS before HTx were categorized into two groups: (1) A (did not) and (2) B (did), respectively. A receiver operating characteristic (ROC) curve was plotted to assess the cutoff level of MCS duration before HTx in evaluating 5‐year survival. Result: A total of 270 HTx patients (group A: 120, group B: 150) were analyzed. Group B patients had a higher percentage of blood type O, a higher incidence of resuscitation, a shorter listing duration, and a higher likelihood of having United Network for Organ Sharing (UNOS) 1A status than group A. The ROC curve revealed 24 days as a good cut‐off level for determining the best MCS before HTx timing. Group B was categorized into two subgroups: (1) B1 (MCS < 24 days, n = 65) and (2) B2 (MCS > 24 days, n = 85). B2 had a higher incidence of cardiopulmonary resuscitation (CPR), hemodialysis, longer waiting time after MCS, and better ventricular assist device implantation than B1. However, the survival curves showed that B1 outcomes were significantly worse than in groups A and B2. Groups A and B2 had similar survival curves without an increased incidence of infection. Conclusion: The preliminary data demonstrated that a longer duration of MCS may be associated with better outcomes than urgent HTx. [ABSTRACT FROM AUTHOR]

Objective: Cardiogenic shock (CS) often occurs in patients suffering from rapidly progressing end‐stage heart failure or acute myocardial infarction. Mechanical circulatory support may be used for patients who do not respond to medication or revascularization to stabilize hemodynamics. Extracorporeal ventricular assist device (Extra‐VAD) has been reported to be successful for patients with cardiogenic shock. This study aimed to evaluate the 30‐day in‐vivo performance and safety of a newly developed Extra‐VAD with maglev centrifugal pump technology, MoyoAssist®. Method: The study was conducted with 6 healthy ovine models, weighing 43.2 ~ 59.6 kg. Cannulation was performed with a 34 Fr venous cannula surgically connected to the left arterial appendage and a 24 Fr arterial cannula inserted into descending aorta. The pump flow rate was maintained at 2 ~ 3 L/min to provide sufficient cardiac support without suction. Activated clotting time was maintained within the range of 150 ~ 250 s. Results: No device‐related adverse events occurred throughout the study. Plasma‐free hemoglobin results were within the acceptable range of ventricular assist device therapy (<40 mg/dl). MGS01 had an anticoagulation management related bleeding event and was terminated on day 29. All other sheep's biochemical test results were stable. The autopsy showed no embolism or thrombus formation and no end‐organ damage. Conclusion: This study demonstrated that the MoyoAssist® Extra‐VAD is able to provide cardiac support effectively and safely and may provide a new alternative choice for patients with CS in China. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate variations across hospitals in infection rates and associated costs, the latter reflected in 90-day Medicare payments. Despite high rates and expenditures of health care--associated infections associated with durable ventricular assist device implantation, few studies have examined interhospital variation and associated costs. Clinical data on 8688 patients who received primary durable ventricular assist devices from July 2008 to July 2017 from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) hospitals (n = 120) were merged with postimplantation 90-day Medicare claims. Terciles of hospital-specific, risk-adjusted infection rates per 100 patient-months were estimated using Intermacs and associated with Medicare payments (among 5440 Medicare beneficiaries). Primary outcomes included infections within 90 days of implantation and Medicare payments. There were 3982 infections identified among 27.8% (2417/8688) of patients developing an infection. The median (25th, 75th percentile) adjusted incidence of infections (per 100 patient-months) across hospitals was 14.3 (9.3, 19.5) and varied according to hospital (range, 0.0-35.6). Total Medicare payments from implantation to 90 days were 9.0% (absolute difference: $13,652) greater in high versus low infection tercile hospitals (P <.0001). The period between implantation to discharge accounted for 73.1% of the difference in payments during the implantation to 90-day period across terciles. Health care--associated infection rates post durable ventricular assist device implantation varied according to hospital and were associated with increased 90-day Medicare expenditures. Interventions targeting preventing infections could improve the value of durable ventricular assist device support from the societal and hospital perspectives. Adjusted incidence of infections varied according to hospital, and total Medicare payments from date of implantation to 90 days were 9.0% greater in high versus low infection tercile hospitals. Infection prevention could improve the value of durable VADs. VAD , Ventricular assist device; STS Intermacs , The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support. [Display omitted] [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVADs) improve survival and quality of life for patients with advanced heart failure but are associated with high rates of thromboembolic and hemorrhagic complications. Antithrombotic therapy is required following LVAD implantation, though practices vary. Identifying a therapeutic strategy that minimizes the risks of thromboembolic and hemorrhagic complications is critical to optimizing patient outcomes and is an area of active investigation. This paper reviews strategies for initiating and maintaining antithrombotic therapy in durable LVAD recipients, focusing on those with centrifugal-flow devices. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: In complex operations surgeon volume may impact outcomes. We sought to understand if individual surgeon volume affects left ventricular assist device (LVAD) outcomes.Methods: We reviewed primary LVAD implants at an experienced ventricular assist devices (VAD)/transplant center between 2013 and 2019. Cases were dichotomized into a high-volume group (surgeons averaging 11 or more LVAD cases per year), and a low-volume group (10 or less per year). Propensity score matching was performed. Survival to discharge, 1-year survival, and incidence of major adverse events were compared between the low- and high-volume groups. Predictors of survival were identified with multivariate analysis.Results: There were 315 patients who met inclusion criteria-45 in the low-volume group, 270 in the high-volume group. There was no difference in survival to hospital discharge between the low (91.9%) and high (83.3%) volume matched groups (p = .22). Survival at 1-year was also similar (85.4% vs. 80.6%, p = .55). There was no difference in the incidence of major adverse events between the groups. Predictors of mortality in the first year included: age (hazards ratio [HR]: 1.061, p < .001), prior sternotomy (HR: 1.991, p = .01), increasing international normalized ratio (HR: 4.748, p < .001), increasing AST (HR: 1.001, p < .001), increasing bilirubin (HR: 1.081, p = .01), and preoperative mechanical ventilation (HR: 2.662, p = .005). Individual surgeon volume was not an independent predictor of discharge or 1-year survival.Conclusion: There was no difference in survival or adverse events between high and low volume surgeons suggesting that, in an experienced multidisciplinary setting, low-volume VAD surgeons can achieve similar outcomes to their high-volume colleagues. [ABSTRACT FROM AUTHOR]

Microaxial left ventricular assist devices (LVAD) are increasingly used to support patients with cardiogenic shock; however, outcome results are limited to single-center studies, registry data and select reviews. We conducted a systematic review and meta-analysis, searching three databases for relevant studies reporting on microaxial LVAD use in adults with cardiogenic shock. We conducted a random-effects meta-analysis (DerSimonian and Laird) based on short-term mortality (primary outcome), long-term mortality and device complications (secondary outcomes). We assessed the risk of bias and certainty of evidence using the Joanna Briggs Institute and the GRADE approaches, respectively. A total of 63 observational studies (3896 patients), 6 propensity-score matched (PSM) studies and 2 randomized controlled trials (RCTs) were included (384 patients). The pooled short-term mortality from observational studies was 46.5% (95%-CI: 42.7–50.3%); this was 48.9% (95%-CI: 43.8–54.1%) amongst PSM studies and RCTs. The pooled mortality at 90 days, 6 months and 1 year was 41.8%, 51.1% and 54.3%, respectively. Hemolysis and access-site bleeding were the most common complications, each with a pooled incidence of around 20%. The reported mortality rate of microaxial LVADs was not significantly lower than extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pumps (IABP). Current evidence does not suggest any mortality benefit when compared to ECMO or IABP. [ABSTRACT FROM AUTHOR]

Background: Although extracorporeal life support (ECLS) can provide emergency systemic perfusion for acute fulminant myocarditis (AFM), the mortality rate remains extremely high, especially in those undergoing extracorporeal cardiopulmonary resuscitation (ECPR). Temporary ventricular assist device (VAD) can provide a more physiological blood flow direction and better subsequent organ perfusion than ECLS. We investigated temporary VAD efficacy in ECPR-revived AFM patients.Methods: During January 2012-May 2019, we retrospectively recruited 22 AFM patients with hemodynamic collapse and ECPR; 11 underwent ECLS only and 11 underwent additional VAD support after ECLS. Systemic perfusion was compared via laboratory biochemistry at post-ECPR days 2 (D2) and 4 (D4). Consciousness and cardiac function were assessed through the Glasgow Coma Scale (GCS) and echocardiography, respectively. All major complications and causes of mortality were recorded; 30-day survival was analyzed and risk factors were predicted.Results: The VAD group had significantly better hemodynamic improvement; more inotropes being tapered at D2 and D4; better data representative of systemic perfusion, including albumin, pH, bicarbonate, and lactate levels at D4; and better 30-day survival (72.7% vs. 27.2%, p = 0.033). The causes of mortality included central failure, multiple organ failure, and bacteremia with sepsis. The risk factors included lethal dysrhythmia before ECLS, GCS <5 at D2, and elevated cardiac enzymes at D4.Conclusion: For AFM patients, temporary VAD could provide better systemic perfusion and organ preservation than ECLS. VAD had better survival, including improved recovery and successful transplantation. Hence, temporary VAD should be considered if ECLS cannot revive the sustained cardiogenic shock. [ABSTRACT FROM AUTHOR]

Cardiac amyloidosis is a debilitating disease associated with poor long‐term survival. Medical or palliative treatment is the usual course of therapy, but patients are often intolerant of conventional heart failure treatment. The current standard of care of sequential heart and bone marrow transplant is usually not feasible for ill or frail patients or in countries with limited organ donors or without transplant programmes. Left ventricular assist devices (LVAD) are not usually offered to these patients due to high peri‐operative risks and risks of suction events with the LVAD in a small left ventricle. We report the 2 year outcome and discuss the challenges faced in the management of our patient with end‐stage heart failure due to cardiac amyloidosis, who was successfully supported with an LVAD using a modified left atrium to aorta implantation technique. [ABSTRACT FROM AUTHOR]