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Background Methods Results Conclusion Cold atmospheric plasma (CAP) therapy has been recognized as effective treatment option for reducing bacterial load in chronic wounds, such as adult ventricular assist device (VAD) driveline exit‐site infections. Currently, there have been no reports on the safety and efficacy of CAP therapy for pediatric cannula infections and inflammations in paracorporeal pulsatile VADs.The mechanical strength of Berlin Heart EXCOR cannulas were tested both before and after CAP treatment (SteriPlas, Adtec Healthcare Limited, UK) to prove material safety. A ring tensile test of 20 untreated and 20 CAP‐treated (5 min) EXCOR cannulas (Ø12mm), assessed the force at the breaking point of the cannulas (Fmax), at 25% (F25%) and 50% (F50%) of the maximum displacement. Additionally, the scanning electron microscope (SEM) micrographs for both groups examined any surface changes. Finally, the case of a 13‐year‐old male EXCOR patient with cannula infections, treated with CAP over 100 days, is presented.The in vitro measurements revealed no statistically significant differences in mechanical strength between the control and CAP group for F25% (8.18 ± 0.36 N, vs. 8.02 ± 0.43 N, p = 0.21), F50% (16.87 ± 1.07 N vs. 16.38 ± 1.32 N, p = 0.21), and FMAX (44.55 ± 3.24 N vs. 42.83 ± 4.32 N, p = 0.16). No surface structure alterations were identified in the SEM micrographs. The patient's cannula exit‐sites showed a visible improvement in DESTINE wound staging, reduction in bacterial load and inflammatory parameters after CAP treatment without any side effects.Overall, CAP therapy proved to be a safe and effective for treating EXCOR cannula exit‐site wound healing disorders in one pediatric patient, but further studies should investigate this therapy in more detail. [ABSTRACT FROM AUTHOR]

This study aimed to explore the therapeutic potential of human induced pluripotent stem cell (hiPSC)-derived cardiac tissues (HiCTs) in the emerging approach of bridge to recovery for severe heart failure with ventricular assist devices. We used a rat model of heterotopic heart transplantation (HTx) to mimic ventricular assist device support and heart unloading. HiCTs were created by inserting gelatin hydrogel microspheres between cell sheets made from hiPSC-derived cardiovascular cells. Male athymic nude rats underwent myocardial infarction (MI) and were divided into the following groups: MI (loaded, untreated control), MI + HTx (unloaded, untreated control), MI + HTx + HiCT (unloaded, treated), and MI + HiCT (loaded, treated). HiCTs were placed on the epicardium of the heart in treated groups. We evaluated HiCT engraftment, fibrosis, and neovascularization using histologic analysis. After 4 weeks, HiCTs successfully engrafted in 5 of 6 rats in the MI + HTx + HiCT group (83.3%). The engrafted HiCT area was greater under unloaded conditions (MI + HTx + HiCT) than loaded conditions (MI + HiCT) (P <.05). MI + HTx + HiCT had a significantly smaller infarct area compared with MI and MI + HTx. The MI + HTx + MiCT group exhibited greater vascular density in the border zone than MI and MI + HTx. HiCT treatment suppressed cardiomyocyte atrophy due to left ventricular unloading (P =.001). The protein level of muscle-specific RING finger 1, an atrophy-related ubiquitin ligase, was lower in the MI + HTx + HiCT group than in MI + HTx (P =.036). Transplanting HiCTs into ischemic hearts under unloaded conditions promoted engraftment, neovascularization, attenuated infarct remodeling, and suppressed myocyte atrophy. These results suggest that HiCT treatment could contribute to future advancements in bridge to recovery. [ABSTRACT FROM AUTHOR]

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

Implantable ventricular assist device (VAD) has enabled patients with severe heart failure to be discharged from the hospital and to continue their care at home. The presence of caregivers is essential to maintain home care of patients with VAD. The caregivers are mainly the family members who live with the patient with VAD. The caregivers need to be trained (1) VAD device management, (2) disinfection of driveline skin punctures, (3) medication management, and (4) responding to sudden changes. The caregivers' lifestyle is also forced to change. In this article, we discuss the role of caregivers in the VAD era, where long-term support beyond 5 years is now possible. This review was created based on a translation of the Japanese review written in the Japanese Journal of Artificial Organs in 2023 (Vol. 52, No. 1, pp. 81–84), with some modifications. [ABSTRACT FROM AUTHOR]

Since 2011, implantable ventricular assist devices have been a standard treatment for severe heart failure alongside heart transplantation in Japan. However, the limited availability of donors has led to a prolonged wait for transplants, now averaging 1719 days, intensifying the issue of aortic insufficiency in patients with continuous flow ventricular assist devices. These devices limit the opening of the aortic valve, leading to sustained closure and increased shear stress, which accelerates valve degradation. Risk factors for aortic insufficiency include having a smaller body surface area, being of advanced age, and the presence of mild aortic insufficiency prior to device implantation. In patients presenting with mild or moderate aortic regurgitation at the time of ventricular assist device implantation, interventions such as aortic valve repair or bioprosthetic valve replacement are performed with the aim of halting its progression. The choice of surgical procedure should be tailored to each patient's individual condition. The management of de novo aortic insufficiency in patients with continuous flow ventricular assist devices remains challenging, with no clear consensus on when to intervene. Interventions for significant aortic insufficiency typically consider the patient's symptoms and aortic insufficiency severity. De novo aortic insufficiency progression in continuous flow ventricular assist devices patients necessitates careful monitoring and intervention based on individual patient assessments and valve condition. This review was created based on a translation of the Japanese review written in the Japanese Journal of Artificial Organs in 2023 (Vol. 52, No. 1, pp. 77–80), with some modifications. [ABSTRACT FROM AUTHOR]

We report a case of temporary Berlin Heart EXCOR® explantation in a pediatric patient with idiopathic dilated cardiomyopathy who suffered an uncontrollable inflow cannulation site infection while on bridge-to-transplantation. Despite failure to thrive and catheter-related infections, once free of the device, the patient was cured of infection using systemic antibiotics and surgical debridement. The patient underwent EXCOR® reimplantation after four months, and is awaiting heart transplantation in stable condition. A life-threatening ventricular assist device-related infection may require device explantation under conditions that may not fulfill conventional explantation criteria despite risks. Temporary explantation can be an effective strategy if isolated systolic dysfunction is managed carefully. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusion Von Willebrand factor (VWF) is a critical glycoprotein in hemostasis and is an important factor in diagnosing bleeding disorders. Albeit the analysis of VWF is often compromised by inconsistent methodologies and challenges quantifying multimeric size. Current VWF multimer analysis methods are costly, time‐consuming, and often inconsistent; thus, demanding skilled professionals. This study aimed to streamline and optimize the VWF multimer analysis technique, making it more efficient and reproducible, particularly for identifying or predicting mechanical circulatory support (MCS) induced bleeding disorders.Blood samples from healthy volunteers were exposed to high shear forces via a Medtronic HeartWare ventricular assist device. VWF multimers were analyzed using vertical‐gel agarose electrophoresis and Western blotting. Differences in VWF distribution were determined using densitometry, and two methods of densitometric analysis were compared: proprietary software against open‐source software.Using the developed method: (i) protocol duration was accelerated from three days (in classical methods) to ~ eight hours; (ii) the resolution of the high molecular weight (HMW) VWF multimers were substantially improved; and (iii) densitometric analysis tools were validated. Additionally, the densitometry analysis using two software types showed a strong correlation between results, with the proprietary software reporting slightly higher HMW VWF percentages.This methodology is recommended for affordable, accurate, and reproducible VWF multimer evaluations during MCS use and testing. Further research comparing this method with semi‐automated methods would provide additional insight and improve inter‐laboratory comparisons. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America [294 (39.4%)], Europe [264 (35.4%)] or Asia [141 (18.9%)]. Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3 and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because of lack of funding. Left ventricular assist device trials [odds ratio (OR) 3.65, 95% confidence interval (CI) (1.65–8.00) P  = 0.001], valve surgery trials [OR 4.30, 95% CI (2.33–8.00) P  < 0.001], aortic surgery trials [OR 2.86 95% CI (1.22–6.43) P  = 0.012], phase 2 [OR 3.02, 95% CI (1.31–7.93) P  = 0.015] and phase 4 trials [OR 3.62, 95% CI (1.43–10.23) P  = 0.010] were at higher risk of premature termination while trials performed in Asia [OR 0.18, 95% CI (0.07–0.39) P  ≤ 0.001] and Europe [OR 0.49, 95% CI (0.30–0.80) P  = 0.004] were less likely to be terminated prematurely. CONCLUSIONS Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on left ventricular assist device, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely. [ABSTRACT FROM AUTHOR]

OBJECTIVES Restrictive cardiomyopathy is rare and is generally associated with worse clinical outcomes compared to other cardiomyopathies. Ventricular assist device (VAD) support for these children is seldom applied and often hampered by the surgical difficulties. METHODS All paediatric (<19 years) patients with a restricted cardiomyopathy supported by a VAD from the EUROMACS database were included and compared to patients with a dilated cardiomyopathy (retrospective database analyses). Participating centres were retrospectively contacted to provide additional detailed echo and Swan Ganz measurements to analyse the effect of VAD support on pulmonary artery pressure and right ventricular function. RESULTS Forty-four paediatric VAD-supported patients diagnosed with restricted cardiomyopathy were included, with a median age at implantation of 5.0 years. Twenty-six of the 44 patient with a restricted cardiomyopathy survived to transplantation (59.1%), 16 died (36.4%) and 2 are still on ongoing VAD support (4.5%) after a median duration of support of 95.5 days (interquartile range 33.3–217.8). Transplantation probability after 1 and 2 years of VAD support in patients with a restricted cardiomyopathy were comparable to patients with a dilated cardiomyopathy (52.3% vs 51.4% and 59.5% vs 60.1%, P  = 0.868). However, mortality probability was higher in the restricted cardiomyopathy cohort (35.8% vs 17.0% and 35.8% vs 19.0%, P  = 0.005). Adverse event rates were high (cerebrovascular accident in 31.8%, pump thrombosis in 29.5%, major bleeding 25.0%, eventual biventricular support in 59.1%). In the atrially cannulated group, cerebrovascular accident and pump thrombosis occurred in twice as much patients (21.1% vs 40.0%, P  = 0.595 and 15.8% vs 40.0%, P  = 0.464; probably non-significant due to the small numbers). Pulmonary arterial pressures improved after implantation of a VAD, and 6 patients who were initially labelled as ineligible due to pulmonary hypertension could eventually be transplanted. CONCLUSIONS VAD support in children with a restricted cardiomyopathy is rarely performed. Mortality and adverse event rates are high. On the other hand, survival to cardiac transplantation was 59.1% with all patients surviving the 1st 30 days after cardiac transplantation. Pulmonary arterial pressures improved while on support, potentially making cardiac transplantation a viable option for previously ineligible children. [ABSTRACT FROM AUTHOR]

OBJECTIVES The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs. Our goal was to present the results from the fourth Paedi-EUROMACS report. METHODS All paediatric (<19 years) patients from the EUROMACS database supported by a VAD were included. Patients were stratified into a congenital heart disease (CHD) group and a group with a non-congenital aetiology. End points included mortality, a transplant and recovery. Cox proportional hazard models were used to explore associated factors for mortality, cerebrovascular accident and pump thrombosis. RESULTS A total of 590 primary implants were included. The congenital group was significantly younger (2.5 vs 8.0 years, respectively, P  < 0.001) and was more commonly supported by a pulsatile flow device (73.5% vs 59.9%, P  < 0.001). Mortality was significantly higher in the congenital group (30.8% vs 20.4%, P  = 0.009) than in the non-congenital group. However, in multivariable analyses, CHD was not significantly associated with mortality [hazard ratio (HR) 1.285; confidence interval (CI) 0.8111–2.036, P  = 0.740]. Pump thrombosis was the most frequently reported adverse event (377 events in 132 patients; 0.925 events per patient-year) and was significantly associated with body surface area (HR 0.524, CI 0.333–0.823, P  = 0.005), CHD (HR 1.641, CI 1.054–2.555, P  = 0.028) and pulsatile flow support (HR 2.345, CI 1.406–3.910, P  = 0.001) in multivariable analyses. CONCLUSIONS This fourth Paedi-EUROMACS report highlights the increasing use of paediatric VADs. The patient populations with congenital and non-congenital aetiologies exhibit distinct characteristics and clinical outcomes. [ABSTRACT FROM AUTHOR]

Disturbance in bodily experience (BE) is a potential adverse consequence of ventricular assist device (VAD) implantation. The concept BE encompasses all cognitive and affective processes related to the subjective experience of one's own body. A cross-sectional, multicenter study was performed, involving 365 VAD patients (85% male; time postimplant: 3-36 months). Patients completed a BE questionnaire (BE-S, 5-point Likert scale), and the disturbance in BE was analyzed based on sex, time since implantation (in the first, second, or third years postimplant), and patient acuity (elective vs emergent implantation). Subsidiary, patients' gratitude was surveyed. Disturbance in BE was not particularly pronounced (mean = 2.69, standard deviation = 1.17). Eighty-five percent of patients expressed high levels of gratitude. Disturbance in BE decreased (p = 0.04), while gratitude increased (p = 0.02) with time since implantation. Female patients showed more disturbance in BE (p = 0.01) and less gratitude (p = 0.01) compared to male patients. Among patients who underwent emergency implantation, the decrease in disturbance occurred predominantly in the third year, exceeding the level observed in elective implanted patients (p = 0.03). Disturbance in BE following VAD implantation does generally not reach excessive levels and tends to decrease over time. Our data indicate more disturbance and less gratitude in female patients. In emergently implanted patients, disturbance in BE is prolonged. Screening for disturbance in BE is recommended during follow-up, especially for these at-risk groups, to ensure early and focused psychological support. [ABSTRACT FROM AUTHOR]

Background: Limited research exists on the influence of social determinants of health (SDOH) on outcomes in pediatric patients with advanced heart failure receiving mechanical circulatory support. Methods: Linkage of the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) and Society of Thoracic Surgeon's Congenital Heart Surgery Database (STS‐CHSD) identified pediatric patients who underwent ventricular assist device (VAD) implantation from 2012 to 2022 with available residential zip codes. Utilizing the available zip codes, each patient was assigned a Childhood Opportunity Index (COI) score. Level of childhood opportunity, race, and insurance type were used as proxies for SDOH. Major outcomes included death, transplant, alive with device, and recovery. Secondary outcomes were adverse events. Statistical analyses were performed using the Kaplan–Meier survival, competing risk analyses, and multivariable Cox proportional hazards model. Results: Three hundred seventeen patients were included in the study. Childhood opportunity level and insurance status did not significantly impact morbidity or mortality after VAD implantation. White race was associated with reduced 1‐year survival (71% in White vs. 87% in non‐White patients, p = 0.05) and increased risk of pump thrombosis (p = 0.02). Conclusion: Childhood opportunity level and insurance status were not linked to morbidity and mortality in pediatric patients after VAD implantation. Notably, White race was associated with higher mortality rates. The study underscores the importance of considering SDOH in evaluating advanced therapies for pediatric heart failure and emphasizes the need for accurate socioeconomic data collection in future studies and national registries. [ABSTRACT FROM AUTHOR]

Patients with heterotaxy syndrome and congenital heart disease (CHD) experience inferior cardiac surgical outcomes. Heart transplantation outcomes are understudied, however, particularly compared to non-CHD patients. Data from UNOS and PHIS were used to identify 4803 children (< 18 years) undergoing first-time heart transplant between 2003 and 2022 with diagnoses of heterotaxy (n = 278), other-CHD (n = 2236), and non-CHD cardiomyopathy (n = 2289). Heterotaxy patients were older (median 5 yr) and heavier (median 17 kg) at transplant than other-CHD (median 2 yr and 12 kg), and younger and lighter than cardiomyopathy (median 7 yr and 24 kg) (all p < 0.001). UNOS status 1A/1 at listing was not different between groups (65–67%; p = 0.683). At transplant, heterotaxy and other-CHD patients had similar rates of renal dysfunction (12 and 17%), inotropes (10% and 11%), and ventilator-dependence (19 and 18%). Compared to cardiomyopathy, heterotaxy patients had comparable renal dysfunction (9%, p = 0.058) and inotropes (46%, p = 0.097) but more hepatic dysfunction (17%, p < 0.001) and ventilator-dependence (12%, p = 0.003). Rates of ventricular assist device (VAD) were: heterotaxy-10%, other-CHD-11% (p = 0.839 vs. heterotaxy), cardiomyopathy-37% (p < 0.001 vs. heterotaxy). The 1-year incidence of acute rejection post-transplant was comparable between heterotaxy and others (p > 0.05). While overall post-transplant survival was significantly worse for heterotaxy than others (p < 0.05 vs. both), conditional 1-year survival was comparable (p > 0.3 vs. both). Children with heterotaxy syndrome experience inferior post-heart transplant survival, although early mortality appears to influence this trend, with 1-year survivors having equivalent outcomes. Given similar pre-transplant clinical status to others, heterotaxy patients are potentially under risk-stratified. Increased VAD utilization and pre-transplant end-organ function optimization may portend improved outcomes. [ABSTRACT FROM AUTHOR]

This article reviews the highlights of pertinent literature of interest to the congenital cardiac anesthesiologist published in 2023. After a search of the US National Library of Medicine PubMed database, several topics emerged where significant contributions were made in 2023. The authors of this article considered the following topics noteworthy to be included in this review: (1) advancements in percutaneous mechanical support in children with congenital heart disease, (2) children with pulmonary hypertension undergoing surgery for congenital heart disease, (3) dexmedetomidine in pediatric cardiac surgery, and (4) recommendations for pediatric heart surgery in the United States: Implications for pediatric cardiac anesthesia. [ABSTRACT FROM AUTHOR]

Introduction Coronavirus disease 2019 (COVID-19) had been declared a global pandemic, affecting millions and impacting St Vincent's Hospital Sydney as of March 2021. The outbreak caused significant disruption to the healthcare system and management of Ventricular Assist Device (VAD) patients. In response, the Mechanical Circulatory Support (MCS) Ventricular Assist Device (VAD) Team developed innovative care and management strategies. Aim We aimed to minimize the risk of VAD patients acquiring COVID-19 as inpatients and outpatients. We also sought to maintain optimal, patient-centred care through self-management monitoring systems and Telehealth, while ensuring ease of use for VAD recipients and caregivers. Method During March 2021 to March 2022 as MCS/VAD Coordinators ensured inpatients and their careers were educated via one-on-one training sessions on the use of monitoring equipment. Then they were transitioned to the use of a Personal VAD Folder for daily observations recording, for ongoing clinician monitoring. Conclusion Despite challenges, no VAD patients in our hospital contracted COVID-19 during March 2021 to March 2022. Self-monitoring systems, enhanced patient education and Telehealth appointments helped our patients avoid critical illness due during the initial pandemic. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions Due to its high impact on quality of life and mental health, close monitoring and often psychotherapy is recommended for patients with a ventricular assist device (VAD). This study investigates the psychological comorbidity and the corresponding psychotherapeutic treatment situation of VAD patients. Special attention is also given to the professional perspective VAD team (assistant and senior cardiologists and specialized nurses).We conducted a cross‐sectional observational study. Data from 50 VAD patients (mean age = 53.52, standard deviation = 13.82 years, 84.0% male) and their VAD team were analyzed. The presence of a psychological disorder was evaluated by structured clinical interviews for DSM‐IV (SCID‐I‐Interviews). Patients answered a questionnaire regarding their current psychotherapeutic treatment status and their attitude towards psychotherapy. The VAD team answered a questionnaire about the patients' needs for psychotherapy and indicated whether they addressed this topic with the patient. Data were analyzed descriptively, by analysis of variance and t‐test.A total of 58% of VAD patients suffered from at least one significant psychological disorder, 79.3% of those were not in psychotherapy. The VAD team could not identify the patients who suffered from a psychological disorder (F = 1.90; p = 0.18). They perceived more need for psychotherapy than they addressed with their patients (T = 3.39; p < 0.001).While there is a high psychological morbidity among VAD patients, only few receive psychotherapy. Psychological comorbidity is not easily detected by the VAD team. Standardized psychosocial care could be implemented by regular psychological assessments and further information of patients and their VAD teams. [ABSTRACT FROM AUTHOR]

Background: Despite significant family caregiver (FCG) burnout, there are currently no tested interventions to support the FCG role after left ventricular assist device (LVAD) implantation or formalized training for clinicians to support FCGs. Objective: We adapted the existing ENABLE (Educate, Nurture, Advise Before Life Ends) intervention to LVAD clinicians and FCGs and assessed clinical implementation and dissemination. Methods: ENABLE-LVAD is an interactive, self-paced clinician training coupled with FCG-facing guidebooks and resources. Implementation and dissemination were evaluated by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Results: As of May 2023, 187 clinicians registered for the training, and 41 completed all modules (22.0% completion rate). Of those who completed the training and responded to a 6-month survey, one-third (n = 10, 33.3%) used ENABLE-LVAD with FCGs, and 100% of those planned to continue using it. The primary barrier to completing the training was time. Conclusions: The ENABLE-LVAD clinician training was successfully disseminated and implemented as a useful resource to support LVAD FCGs. [ABSTRACT FROM AUTHOR]

A ventricular assist device (VAD) is a form of mechanical circulatory support that uses a mechanical pump to partially or fully take over the function of a failed heart. In recent decades, the VAD has become a crucial option in the treatment of end-stage heart failure in adult patients. However, due to the lack of suitable devices and more complicated patient profiles, this therapeutic approach is still not widely used for pediatric populations. This article reviews the clinically available devices, adverse events, and future directions of design and implementation in pediatric VADs. [ABSTRACT FROM AUTHOR]

Background Coronavirus disease 2019 (COVID-19) is predominantly known to cause respiratory injury; however, the present case series highlights four instances in which the infection resulted in significant cardiac complications. Among such cases, some represent severe cardiogenic shock, which necessitates the immediate introduction of mechanical circulatory support (MCS) for salvage. Case summary This case series involved patients with COVID-19-associated myocardial injury leading to fulminant cardiogenic shock. These patients required immediate implementation of peripheral MCS, followed by an instant upgrade to a central MCS system due to anatomical limitations and severe biventricular dysfunction. Central MCS provided effective ventricular unloading, resulting in a significant and prompt improvement in ventricular function. The treatment timeline showed rapid deterioration followed by remarkable recovery within 2 weeks of MCS initiation, demonstrating the effectiveness of aggressive and tailored MCS strategies in managing severe COVID-19-related cardiac complications. Discussion This study provides significant insights into the cardiovascular implications of COVID-19, particularly in the context of severe myocardial injury that leads to cardiogenic shock. The report underscores the importance of early recognition and intervention in such cases, focusing on the use of MCS as a life-saving modality. The findings also revealed unique pathological features of COVID-19-associated myocardial injury, including macrophage-predominant infiltration and microthrombosis, which are distinct from the features of conventional myocarditis. These findings highlight the need for further research on the pathophysiology of COVID-19-related cardiac injuries and the development of targeted therapeutic strategies. [ABSTRACT FROM AUTHOR]

Abstract A blood turbine-pump system (iATVA), resembling a turbocharger was proposed as a mechanical right-heart assist device without external drive power. In this study, the iATVA system is investigated with particular emphasis on the blood turbine flow dynamics. A time-resolved 2D particle image velocimetry (PIV) set-up equipped with a beam splitter and two high speed cameras, allowed simultaneous recordings from both the turbine and pump impellers at 7 different phased-locked instances. The iATVA prototype is 3D printed using an optically clear resin following our earlier PIV protocols. Results showed that magnetically coupled impellers operated synchronously. As the turbine flow rate increased from 1.6 to 2.4 LPM, the rotational speed and relative inlet flow angle increase from 630 to 900 rpm, and 38 to 55% respectively. At the trailing edges, backflow region spanned 3/5 of the total passage outlet flow, and an extra leakage flow was observed at the leading edge. For this early turbine design, approximately, 75% of the turbine blade passage was not contributing to the impulse operation mode. The maximum non-wall shear rate was ~ 2288 s−1 near to the inlet exit, which is significantly lower than the commercial blood pumps, encouraging further research and blood experiments of this novel concept. Experimental results will improve the hydrodynamic design of the turbine impeller and volute regions and will be useful in computational fluid dynamics validation studies of similar passive devices.

Objective: Pediatric patients on ventricular assist devices (VAD) are at risk of thromboembolic (TE) complications. Our objective was to identify factors associated with TE events, including the role of initial anticoagulation strategy and device type in the pediatric VAD population. Methods: This was a retrospective, single-center review (2005-2022) of children who were implanted with paracorporeal pulsatile (PP), paracorporeal continuous (PC), or a combination of devices. Patient- and device-related factors were collected. Kaplan-Meier survival analysis was performed to determine freedom from TE. Cox proportional hazard analysis was conducted to look for factors associated with TE events. Results: Ninety-five patients included with a median age of 0.9 years (interquartile range, 0.3, 5.4); median weight of 8.4 kg (interquartile range, 4.5, 17.8), and 63.2% with noncongenital heart disease. Device breakdown included 47.4% PC, 24.2% PP, and 23.2% combination of devices. Initial anticoagulation was either heparin (61.5%) or bivalirudin (38.5%). In Kaplan-Meier analysis, unadjusted freedom from a TE event was significantly greater in those who received bivalirudin as their initial anticoagulation strategy (P = .02) and PP VADs (P = .02). In multivariate analysis, initial anticoagulation strategy with bivalirudin (hazard ratio, 0.30; 95% confidence interval, 0.12-0.75, P = .01) was associated with a reduced hazard of TE events, whereas PC device strategy was found to be associated with an increased hazard (hazard ratio, 2.78; 95% confidence interval, 1.12-6.88, P = .03). Conclusions: This study suggests that PC device strategy and heparin as an initial anticoagulation strategy are associated with increased hazard of TE events. Further research is required to understand the interaction between device type and initial anticoagulation strategy.

Background Methods Results Conclusions Ventricular assist devices (VADs) are used to bridge pediatric patients to heart transplantation. Paracorporeal VADs require the placement of cannulas, which can create an environment for infections. We examined cannula infections in pediatric VAD patients and the role of nutritional status.This retrospective study (2005–2021) included patients <20 years old on VAD support using Berlin Heart EXCOR® cannulas. Cannula infections were defined by a positive culture and need for antibiotic therapy. Malnutrition was defined using the American Society of Parenteral and Enteral Nutrition guidelines as well as the Michigan MTool.There were 76 patients with a median age at implant of 0.9 years (IQR 0.4, 3.6), 50% male, with 73.7% having non‐congenital heart disease. More than one‐quarter (26.3%) of patients developed a cannula infection. Higher pre‐implant weight (OR = 1.93, p = 0.05), creatinine (OR = 1.02, p = 0.044), and pre‐albumin (OR = 15.79, p = 0.025), as well as duration of VAD support (OR = 1.01; p = 0.003) were associated with increased odds of developing a cannula infection. There was no difference in the malnutrition parameters between those with and without an infection.Further exploration in a larger cohort is needed to see whether these associations remain and if the incorporation of objective measures of nutritional status at the time of infection are predictive. [ABSTRACT FROM AUTHOR]

Objectives: Right ventricular failure following implantation of a durable left ventricular assist device (LVAD) is a major driver of mortality. Reported survival following biventricular (BiVAD) or total artificial heart (TAH) implantation remains substantially inferior to LVAD alone. We report our outcomes with LVAD and BiVAD HeartMate 3 (HM3). Methods: Consecutive patients undergoing implantation of an HM3 LVAD between November 2014 and December 2021, at The Alfred, Australia were included in the study. Comparison was made between the BiVAD and LVAD alone groups. Results: A total of 86 patients, 65 patients with LVAD alone and 21 in a BiVAD configuration underwent implantation. The median age of the LVAD and BiVAD groups was 56 years (Interquartile range 46–62) and 49 years (Interquartile range 37–55), respectively. By 4 years after implantation, 54% of LVAD patients and 43% of BiVAD patients had undergone cardiac transplantation. The incidence of stroke in the entire experience was 3.5% and pump thrombosis 5% (all in the RVAD). There were 14 deaths in the LVAD group and 1 in the BiVAD group. The actuarial survival for LVAD patients at 1 year was 85% and BiVAD patients at 1 year was 95%. Conclusions: The application of HM 3 BiVAD support in selected patients appears to offer a satisfactory solution to patients requiring biventricular support. [ABSTRACT FROM AUTHOR]

Background: Children awaiting heart transplant (Tx) have a high risk of death due to donor organ scarcity. Historically, ventricular assist devices (VADs) reduced waitlist mortality, prompting increased VAD use. We sought to determine whether the VAD survival benefit persists in the current era. Methods: Using the Scientific Registry of Transplant Recipients, we identified patients listed for Tx between 3/22/2016 and 9/1/2020. We compared characteristics of VAD and non‐VAD groups at Tx listing. Cox proportional hazards models were used to identify risk factors for 1‐year waitlist mortality. Results: Among 5054 patients, 764 (15%) had a VAD at Tx listing. The VAD group was older with more mechanical ventilation and renal impairment. Unadjusted waitlist mortality was similar between groups; the curves crossed ~90 days after listing (p =.55). In multivariable analysis, infant age (HR 2.77, 95%CI 2.13–3.60), Black race (HR 1.57, 95%CI 1.31–1.88), congenital heart disease (HR 1.23, 95%CI 1.04–1.46), renal impairment (HR 2.67, 95%CI 2.19–3.26), inotropes (HR 1.28, 95%CI 1.09–1.52), and mechanical ventilation (HR 2.23, 95%CI 1.84–2.70) were associated with 1‐year waitlist mortality. VADs were not associated with mortality in the first 90 waitlist days but were protective for those waiting ≥90 days (HR 0.43, 95%CI 0.26–0.71). Conclusions: In the current era, VADs reduce waitlist mortality, but only for those waitlisted ≥90 days. The differential effect by race, size, and VAD type is less clear. These findings suggest that Tx listing without VAD may be reasonable if a short waitlist time is anticipated, but VADs may benefit those expected to wait >90 days. [ABSTRACT FROM AUTHOR]

OBJECTIVES This study aims to explore characteristics and clinical outcomes of patients with congenital heart disease (CHD) in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). METHODS This is a retrospective study of EUROMACS participants receiving MCS as bridge-to-transplant, possible bridge-to-transplant, or rescue therapy/bridge-to-recovery from 2011 to 2023 (n  = 5340). Adult and paediatric cohorts were analysed separately. The primary outcome was mortality on MCS; secondary outcomes included recovery, transplant and complications including bleeding, cerebrovascular events, and sepsis. RESULTS Among adult patients, mortality at 1-year was 33.3% among the CHD cohort vs 22.1% in the non-CHD cohort. Adult CHD patients had higher hazards of mortality within the first year after MCS implantation [hazard ratios 1.98, 95% confidence interval (CI) 1.35–2.91, P  < 0.001] and bleeding events (subdistribution hazard ratios 2.10, 95% CI 1.40–3.16, P  < 0.001) compared with non-CHD patients. Both associations remained significant after accounting for multiple mediators. Among paediatric patients, mortality at 1 year was 22.1% in the CHD cohort vs 17.3% in the non-CHD cohort (hazard ratios 1.39, 95% CI 0.83–2.32, P  = 0.213). CONCLUSIONS Adult and paediatric patients with CHD on MCS have higher adverse event risk compared with non-CHD MCS patients, though children did not have greater risk of mortality. As the number of CHD patients requiring advanced heart failure management continues to grow, these findings can enhance informed decision-making. Clinical trial registration number Registry name: EUROMACS. [ABSTRACT FROM AUTHOR]

Ventricular assist devices (VADs) and inotropes are feasible modalities to bridge children to heart transplant (HT) in outpatient settings. However, it is unclear which modality yields superior clinical status at HT and posttransplant survival. The United Network for Organ Sharing was used to identify patients aged 18 years or younger, weighing >25 kg, from 2012 to 2022 who were outpatients at HT (n = 835). Patients were grouped by bridging modality at HT: VAD (n = 235 [28%]), inotropes (n = 176 [21%]), or neither (no support) (n = 424 [50%]). VAD patients were of similar age (P =.260) but heavier (P =.007) and more likely to have dilated cardiomyopathy (P <.001) than their inotrope counterparts. VAD patients had similar clinical status at HT but superior functional status (performance scale >70%) (59% vs 31%) (P <.001). Overall posttransplant survival in VAD patients (1-year and 5-year survival, 97% and 88%, respectively) was comparable to patients with no support (93% and 87%, respectively) (P =.090) and those on inotropes (98% and 83%, respectively) (P =.089). One-year conditional survival was superior for VAD vs inotrope (2-year and 6-year survival, 96% and 91%, respectively vs 97% and 79%, respectively) (P =.030) and 5-year conditional survival for VAD patients was superior to inotrope (7-year and 10-year survival, 100% and 100%, respectively vs 100% and 88%, respectively) (P =.022) and no support (100% and 83%, respectively) (P =.011). Consistent with prior studies, short-term outcomes for pediatric patients bridged to HT in the outpatient setting with VAD or inotropes is excellent. However, compared with outpatients bridged to HT on inotropes, outpatient VAD support allowed for better functional status at HT and superior late posttransplant survival. [Display omitted] [ABSTRACT FROM AUTHOR]

• Our review operationalized SDOH within VAD-related literature using the health people 2030 framework. • Studies addressing SDOH with VAD therapy comprised quantitative methodologies with retrospective designs and secondary data analyses. • There are substantial knowledge gaps on how SDOH influence patient decision-making processes and patient selection. Social determinants of health (SDOH) may influence the clinical management of patients with heart failure. Further research is warranted on the relationship between SDOH and Ventricular Assist Device (VAD) therapy for heart failure. The purpose of this integrative review was to synthesize the state of knowledge on the intersection of SDOH with VAD therapy. Guided by Whittemore and Knafl's methodology, this literature search captured three concepts of interest including VAD therapy, SDOH, and their domains of intersection with patient selection, decision-making, treatment outcome, and resource allocation. CINAHL, Embase, PsycINFO, PubMed, and Web of Science were searched in March 2023. Articles were included if they were peer-reviewed publications in English, published between 2006 and 2023, conducted in the United States, and examined VAD therapy in the context of adult patients (age ≥ 18 years). 22 quantitative studies meeting the inclusion criteria informed the conceptualization of SDOH using the Healthy People 2030 framework. Four themes captured how the identified SDOH intersected with different processes relating to VAD therapy: patient decision-making, healthcare access and resource allocation, patient selection, and treatment outcomes. Most studies addressed the intersection of SDOH with healthcare access and treatment outcomes. This review highlights substantial gaps in understanding how SDOH intersect with patient and patient selection for VAD. More research using mixed methods designs is warranted. On an institutional level, addressing bias and discrimination may have mitigated health disparities with treatment outcomes, but further research is needed for implementing system-wide change. Standardized assessment of SDOH is recommended throughout clinical practice from patient selection to outpatient VAD care. [ABSTRACT FROM AUTHOR]

Implantable left ventricular assist device (LVAD) therapy is used to improve quality of life, alleviate symptoms and extend survival rates in patients with advanced heart failure. Patients with LVADs require chronic anticoagulation to reduce the risk of thromboembolic complications, and they commonly experience bleeding events. Apixaban is a direct oral anticoagulant that has become first-line therapy for patients with nonvalvular atrial fibrillation and venous thromboembolism; however, its safety in patients with LVADs has not been well characterized. The evaluation of the hemocompatibility in the DOAC LVAD (Direct Oral Anti-Coagulant apixaban in Left Ventricular Assist Devices) trial is a phase 2, open-label trial of patients with LVADs who were randomized to either apixaban or warfarin therapy. Patients randomized to apixaban will be started on a dosage of 5 mg twice daily, whereas those randomized to warfarin will be managed at an International Normalized Ratio goal of 2.0–2.5. All patients will be treated with aspirin at 81 mg daily. We plan to randomize and follow as many as 40 patients for 24 weeks to evaluate the primary outcomes of freedom from death or hemocompatibility-related adverse events (stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism). The DOAC LVAD trial will establish the feasibility of apixaban anticoagulant therapy in patients with LVADs. Clinicaltrials.gov: NCT04865978 Visual graphic: DOAC LVAD study design schematic. As many as 40 patients implanted with an LVAD will be enrolled and randomized in a 1:1 ratio to anticoagulation with either 5 mg apixaban or warfarin titrated to an INR goal of 2.0–2.5. Enrollment will be stratified by either < 3 months or ≥ 3 months from LVAD implant, and enrollment of patients ≥ 3 months from implant will be capped at 20 participants. [Display omitted] [ABSTRACT FROM AUTHOR]

To date, no pediatric studies have highlighted the impact of center's ventricular assist device (VAD) volumes on post implant outcomes. Children (age <19) enrolled in Pedimacs undergoing initial left ventricular assist device implantation from 2012 to 2020 were included. Center volume was analyzed as a continuous and categorical variable. For categorical analysis, center volumes were divided as: low volume (1-15 implants), medium volume (15-30 implants), and high volume (>30 implants) during our study period. Patient characteristics and outcomes were compared by center's VAD volumes. Of 44 centers, 16 (36.4%) were low, 11 (25%) were medium, and 17 (38.6%) were high-volume centers. Children at high-volume centers were least likely intubated, sedated, or paralyzed, and most likely ambulating preimplant (p < 0.05 for all). Center's VAD volumes were not a significant risk factor for mortality post implant when treated as a continuous or a categorical variable (p > 0.05). Compared to low volume, children at high-volume centers had fewer early neurological events. Compared to medium volume, those at high-volume centers had fewer late bleeding events (p < 0.05 for all). There were no significant differences in survival after an adverse event by hospital volumes (p > 0.05). Although hospital volume does not affect post-VAD implant mortality, pediatric centers with higher VAD volumes have fewer patients intubated, sedated, paralyzed pre implant, and have lower adverse events. Failure to rescue was not significantly different between low, medium, and high-volume VAD centers. [ABSTRACT FROM AUTHOR]

Patients with a single ventricle circulation continue to be a challenge for a heart transplant. The patients in this cohort, often in poor clinical condition with frequent hepatic and renal impairment having undergone previous multiple surgical procedures, are often allosensitive and consequently have an increased risk of post-transplant complications. Although the most recently published series results are improved, this group of patients, with preserved ventricular function, continues to have a higher mortality rate. Moreover, the operation can be complicated by anatomical differences among the pulmonary arteries. This case report presents a child with tricuspid atresia and pulmonary vascular resistance contraindicating Fontan surgery, unfavourable anatomy of the central pulmonary arteries and in poor clinical condition. An EXCOR ventricular assist device (Berlin Heart) was used for sub- pulmonary mechanical circulatory support and pulmonary bifurcation reconstruction, as a bridge to a transplant. [ABSTRACT FROM AUTHOR]

The worldwide experience with mechanical circulatory support in adult patients with single ventricle and Fontan palliation is limited. We aimed to see the outcomes in such patients on durable left ventricular assist device. We systematically reviewed the English language literature found on PubMed and Google Scholar, searching the terms "Fontan," "single ventricle," "ventricular assist device," "LVAD," and "mechanical circulatory support," and selected all individual cases with reported outcomes. We identified 4 patients on pulsatile left ventricular assist device, all of whom were successfully bridged to transplant, and 15 patients on continuous flow LVAD, age 25.9 ± 5.8, predominantly males. Mean time on LVAD support was 718.6 ± 616.5 days, and only 2 patients (13.3%) died. Durable left ventricular assist device support in adult patients with Fontan provides excellent results and should be used more frequently. [ABSTRACT FROM AUTHOR]

Background: Continuous-flow ventricular assist devices (CF-VADs) are used increasingly in pediatric end-stage heart failure (ESHF) patients. Alongside common risk factors like oxidant injury from hemolysis, non-pulsatile flow constitutes a unique circulatory stress on kidneys. Post-implantation recovery after acute kidney injury (AKI) is commonly reported, but long-term kidney outcomes or factors implicated in the evolution of chronic kidney disease (CKD) with prolonged CF-VAD support are unknown. Methods: We studied ESHF patients supported > 90 days on CF-VAD from 2008 to 2018. The primary outcome was CKD (per Kidney Disease Improving Global Outcomes (KDIGO) criteria). Secondary outcomes included AKI incidence post-implantation and CKD evolution in the 6–12 months of CF-VAD support. Results: We enrolled 134 patients; 84/134 (63%) were male, median age was 13 [IQR 9.9, 15.9] years, 72/134 (54%) had preexisting CKD at implantation, and 85/134 (63%) had AKI. At 3 months, of the 91/134 (68%) still on a CF-VAD, 34/91 (37%) never had CKD, 13/91 (14%) developed de novo CKD, while CKD persisted or worsened in 49% (44/91). Etiology of heart failure, extracorporeal membrane oxygenation use, duration of CF-VAD, AKI history, and kidney replacement therapy were not associated with different CKD outcomes. Mortality was higher in those with AKI or preexisting CKD. Conclusions: In the first multicenter study to focus on kidney outcomes for pediatric long-term CF-VAD patients, preimplantation CKD and peri-implantation AKI were common. Both de novo CKD and worsening CKD can happen on prolonged CF-VAD support. Proactive kidney function monitoring and targeted follow-up are important to optimize outcomes. A higher resolution version of the Graphical abstract is available as Supplementary information [ABSTRACT FROM AUTHOR]

Objectives: In patients at risk of developing right ventricular failure after cardiac surgery, right ventricular support with a ventricular assist device may be a promising strategy to reduce mortality. We present our experience with intraoperative right ventricular assist device implantation as a prevention strategy of right ventricular failure after cardiac surgery. Methods: Between 2016 and 2022, we implanted four right ventricular assist devices prophylactically in a series of patients with surgical indication for valvular heart disease and high risk of postoperative right ventricular failure. Indications for the right ventricular assist device were suprasystemic pulmonary hypertension or severe right ventricular dysfunction. Results: Externalization of the device cannulas through intercostal spaces was performed in three patients, allowing early mobilization and withdrawal without resternotomy. Removal of the device ocurred on the eighth postoperative day. ICU and hospital length of stay was 12 (±1.6) and 23 days (±4.2) respectively. Hospital mortality was null. No patient died during follow-up, mean follow-up was 32.5 months [1–72]. Patients improved their NYHA functional class up to grade II during follow-up. Conclusions: Acute right ventricular failure after cardiac surgery remains a significant cause of morbidity and mortality. Prophylactic strategies to prevent postoperative right ventricular dysfunction may decrease the incidence of refractory postoperative right ventricular failure. We propose a novel approach to prevent right failure after cardiac surgery with prophylactic intraoperative ventricular assist device implantation. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES Myocardial recovery in children supported by a durable left ventricular assist device is a rare, but highly desirable outcome because it could potentially eliminate the need for a cardiac transplant and the lifelong need for immunosuppressant therapy and the risk of complications. However, experience with this specific outcome is extremely limited. METHODS All patients < 19 years old supported by a durable left ventricular assist device from the European Registry for Patients with Mechanical Circulatory Support database were included. Participating centres were approached for additional follow-up data after explantation. Associated factors for explantation due to myocardial recovery were explored using Cox proportional hazard models. RESULTS The incidence of recovery in children supported by a durable left ventricular assist device was 11.7% (52/445; median duration of support, 122.0 days). Multivariable analyses showed body surface area (hazard ratio 0.229; confidence interval 0.093–0.565; P  = 0.001) and a primary diagnosis of myocarditis (hazard ratio 4.597; confidence interval 2.545–8.303; P  < 0.001) to be associated with recovery. Left ventricular end-diastolic diameter in children with myocarditis was not associated with recovery. Follow-up after recovery was obtained for 46 patients (88.5%). Sustained myocardial recovery was reported in 33/46 (71.7%) at the end of the follow-up period (28/33; >2 year). Transplants were performed in 6/46 (11.4%) (in 5 after a ventricular assist device was reimplanted). Death occurred in 7/46 (15.2%). CONCLUSIONS Myocardial recovery occurs in a substantial portion of paediatric patients supported with durable left ventricular assist devices, and sustainable recovery is seen in around three-quarters of them. Even children with severely dilated ventricles due to myocarditis can show recovery. Clinicians should be attentive to (developing) myocardial recovery. These results can be used to develop internationally approved paediatric weaning guidelines. [ABSTRACT FROM AUTHOR]

A 3-year-old boy with Glenn physiology exhibited refractory heart failure with reduced ejection fraction. To improve the patient’s oxygen saturation, he underwent ventricular assist device (VAD) implantation with concomitant Fontan completion. The extracardiac conduit Fontan operation was performed with a 4-mm fenestration. For VAD implantation, Berlin Heart cannulas were positioned at the left ventricular apex and the neo-aorta. Following weaning from cardiopulmonary bypass, a temporary continuous-flow VAD, equipped with an oxygenator, was utilized for support. After a stabilization period of 1 week, the continuous-flow VAD was replaced with a durable pulsatile-flow device. Following 3 months of support, the patient underwent transplantation without complications. The completion of the Fontan procedure at the time of VAD implantation, along with the use of a temporary continuous-flow device with an oxygenator, may aid in stabilizing postoperative hemodynamics. This approach could contribute to a safe transition to a durable pulsatile VAD in patients with Glenn physiology.

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.

Heart failure, a common clinical syndrome caused by functional and structural abnormalities of the heart, affects 64 million people worldwide. Long-term mechanical circulatory support can offer lifesaving treatment for end-stage systolic heart failure patients. However, this treatment is not without complications. This review covers the major complications associated with implantable mechanical circulatory support devices, including strokes, pump thrombosis and gastrointestinal bleeding. These complications were assessed in patients implanted with the following devices: Novacor, HeartMate XVE, CardioWest, Jarvik 2000, HeartMate II, EVAHEART, Incor, VentrAssist, HVAD and HeartMate 3. Complication rates vary among devices and remain despite the introduction of more advanced technology, highlighting the importance of device design and flow patterns. Beyond clinical implications, the cost of complications was explored, highlighting the difference in costs and the need for equitable healthcare, especially with the expected rise in the use of mechanical circulatory support. Future directions include continued improvement through advancements in design and technology to reduce blood stagnation and mitigate high levels of shear stress. Ultimately, these alterations can reduce complications and enhance cost-effectiveness, enhancing both the survival and quality of life for patients receiving mechanical circulatory support.

Background: EXCOR ventricular assist device (VAD) is the gold standard circulatory support for children with end-stage heart failure. Until recently, the only available driving unit was the stationary Ikus. This study (NCT04634708) investigates the impact of the novel mobile EXCOR Active driving unit on patients’ mobility and the quality of life (QoL) of their families. Methods: Children on EXCOR VAD support with the Ikus who were mobilizable outside the hospital room were eligible for the prospective study. Patients remained on Ikus for 7 days, then switched to Excor Active, and were observed for another 45 days. The end-points were the rates of clinically relevant device exchanges (i.e., exchanges that could raise safety concerns for the patient) and successful patient outcomes, respectively. QoL of patients’ families was recorded through 2 validated questionnaires: the Pediatric Quality of Life Inventory Family Impact Module and Depression, Anxiety and Stress Scale 21. Patients’ mobility and activity levels were monitored through diary entries. Results: A total of 24 patients were enrolled of which 23 patients completed the study. No clinically relevant device exchanges occurred and there was a successful outcome in 22/23 (95.7%) patients. Changing from the Ikus to the EXCOR Active improved QoL as seen in family impact total score (from 53.8 ± 19.8-66.5 ± 20.8, p = 0.005) and mental health (depression: moderate to mild, stress moderate to normal, both p

OBJECTIVE: Pediatric heart failure is an important cause of morbidity and mortality in childhood. Left ventricular assist devices (L-VAD) are used for bridging to transplantation in patients with indications for heart transplantation. PATIENTS AND METHODS: The children included in the study were patients who underwent implantation of an L-VAD due to advanced heart failure at Ege University Faculty of Medicine Hospital between January 2009 and January 2023. RESULTS: Of the 33 patients who underwent L-VAD implantation, 16 (48.5%) were female and 17 (51.5%) were male. The median age at surgery was 13 years (IQR, 9.5-15). The median weight was 44 kg (IQR, 25.65-52), the median height was 158 cm (IQR, 134.5-168.5), and the median body surface area was 1.37 m2 (IQR, 0.95-1.51). All patients who underwent L-VAD implantation had an echocardiographic diagnosis of dilated cardiomyopathy. The patients underwent a median of 16 (IQR, 9-21) ECGs, and the median number of 24-hour Holter ECGs obtained was 3 (IQR, 2-5). Arrhythmias that occurred after L-VAD implantation were classified as atrial and ventricular. Ventricular arrhythmia included ventricular tachycardia (VT) lasting for more than 30 seconds (sustained VT), VT lasting for less than 30 seconds (nonsustained VT), and ventricular fibrillation. Atrial arrhythmias included atrial flutter, atrial fibrillation, supraventricular tachycardia, and atrial ectopic tachycardia. During the follow-up, atrial or ventricular arrhythmias were observed in 11 (33%) patients. The most common rhythm disturbances before L-VAD implantation were ventricular arrhythmias, while after the surgery, atrial arrhythmias were found to be the most frequent. A total of 5 patients underwent cardioversion (n=2) or defibrillation (n=3) due to arrhythmia. CONCLUSIONS: In patients undergoing L-VAD implantation, rhythm disorders that could normally lead to hemodynamic instability are frequently encountered. In these rhythm disorders, medical therapy should be attempted before resorting to cardioversion or defibrillation, and subsequently, more aggressive treatment methods should be considered. [ABSTRACT FROM AUTHOR]

Hybrid cardiovascular mock circuits (HMC), designed for dynamic testing of Ventricular Assist Devices (VAD), offer physiologic accuracy by sequestering model complexity in silico and ease of construction by reducing number of model elements in vitro. Despite superior response time and precision, pneumatic actuation is avoided in HMCs due to nonlinear dynamics and noise. We tested the hypothesis that a HMC consisting of a variable elastance‐driven numerical cardiovascular circuit (CVS) coupled to a pneumo‐hydraulic physical circuit can be controlled without linearizing system dynamics. Reference left ventricular and aortic pressures were generated in silico in a seventh‐order electrical analogue of the CVS and transmitted via an electro‐hydraulic interface to the physical circuit. There, they were tracked in in vitro preload and afterload pneumo‐hydraulic reservoirs, respectively. The nonlinear pneumatic dynamics in the reservoirs was controlled using the Lyapunov stability criterion. A centrifugal pump, the speed (i.e., flow) of which was adjusted manually or using PID control, was interposed between the reservoirs and mimicked the VAD under evaluation. The flow of a recirculating gear pump was controlled by an integral backstepping method to equalize reservoir fluid volumes by rejecting pressure and flow disturbances. Sensor noise was reduced with discrete‐time Kalman filtering. Our results showed that normal, failing, and assisted cardiovascular physiologies simulated in silico were commensurate with clinical data obtained from subjects with similar pathologies. The numerical pressure references were tracked with high accuracy at the physical VAD terminals. Reservoir volumes remained stable at various combinations of heart rate, pressure, and VAD flow for prolonged durations with negligible steady‐state error. The HMC described here offers a stable performance testing platform for VAD prototypes. [ABSTRACT FROM AUTHOR]

Heart failure, a common clinical syndrome caused by functional and structural abnormalities of the heart, affects 64 million people worldwide. Long-term mechanical circulatory support can offer lifesaving treatment for end-stage systolic heart failure patients. However, this treatment is not without complications. This review covers the major complications associated with implantable mechanical circulatory support devices, including strokes, pump thrombosis and gastrointestinal bleeding. These complications were assessed in patients implanted with the following devices: Novacor, HeartMate XVE, CardioWest, Jarvik 2000, HeartMate II, EVAHEART, Incor, VentrAssist, HVAD and HeartMate 3. Complication rates vary among devices and remain despite the introduction of more advanced technology, highlighting the importance of device design and flow patterns. Beyond clinical implications, the cost of complications was explored, highlighting the difference in costs and the need for equitable healthcare, especially with the expected rise in the use of mechanical circulatory support. Future directions include continued improvement through advancements in design and technology to reduce blood stagnation and mitigate high levels of shear stress. Ultimately, these alterations can reduce complications and enhance cost-effectiveness, enhancing both the survival and quality of life for patients receiving mechanical circulatory support. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES Aortic valve regurgitation (AR) frequently complicates the clinical course after left ventricular assist device (LVAD) implantation. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) in this cohort with a mostly high surgical risk profile. The unique challenges in LVAD patients, such as presence of non-calcified aortic valves and annular dilatation, raise concerns about device migration and paravalvular leakage (PVL) leading to missing device success. This study evaluates procedural outcomes and survival rates in LVAD patients who underwent TAVI, emphasizing strategies to enhance device success. METHODS Between January 2017 and April 2023, 27 LVAD patients with clinically significant AR underwent elective or urgent TAVI at our centre. Primary end-points were procedural success rates, without the need for a second transcatheter heart valve (THV) and postprocedural AR/PVL. Secondary outcomes included survival rates and adverse events. RESULTS Among the cohort, 14.8% received AR-dedicated TAVI devices, with none requiring a second THV. There was no intraprocedural AR, and 1 patient (25%) had AR > 'trace' at discharge. Additionally, 25.9% underwent device landing zone (DLZ) pre-stenting with a standard TAVI device, all without needing a second THV. There was no intraprocedural AR, and none to trace AR at discharge. Among the 59.3% receiving standard TAVI devices, 37.5% required a second THV. In this subgroup, intraprocedural AR > 'trace' occurred in 12.5%, decreasing to 6.25% at discharge. In-hospital mortality was 3.7%, and median follow-up survival was 388 days (interquartile range 208–1167 days). CONCLUSIONS TAVI yields promising procedural outcomes and early survival rates in LVAD patients with AR. Tailored TAVI devices and pre-stenting techniques enhance procedural success. Continued research into these strategies is essential to optimize outcomes in this complex patient cohort. [ABSTRACT FROM AUTHOR]

Background: Individuals living with mechanical circulatory support (MCS) devices are confronted with risks for catastrophic outcomes such as stroke and systemic infection. Considering these complexities, ongoing advance care planning (ACP) is important for shared decision making. Objective: The purpose of this study was to describe how experiences of the MCS trajectory informed decision making about ACP. Methods: All aspects of the research were guided by constructivist grounded theory. Focused conversations were conducted with a semistructured interview guide. Results: A total of 24 community-dwelling patients living with MCS were interviewed (33%female; mean age, 60.6 years; 50%White). Participants were implanted with MCS (average duration, 29.8 months; bridge to transplant, 58%). Reflected in the narrativeswere tensions between initial expectations of livingwith the device in contrast with the realities that emerged over time. A crucial finding was that ACP decisionmaking pivoted around the growing awareness of uncertainties in the MCS trajectory. Yet, clinicians were perceived to be silent in initiating ACP, and their reticence was understood as a sign of encouragement to hold on to hope for a heart transplant. The complex and dynamic decision-making processes around ACP were organized into the theory of pivoting uncertainties. Conclusions: In this sample, patients were ready to share their concerns about the uncertainties of living with MCS and waited for MCS clinicians to initiate ACP. The theory of pivoting uncertainties is useful for elucidating the ebb and flow of ACP and lending clinicians' guidance for opportunities to initiate these sensitive conversations. [ABSTRACT FROM AUTHOR]