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Objectives: Heart failure (HF) remains a significant public health issue, with heart transplantation (HT) being the gold standard treatment for end-stage HF. The increasing use of mechanical circulatory support, particularly left ventricular assist devices (LVADs), as a bridge to transplant (BTT), presents new perspectives for increasingly complex clinical scenarios. This study aimed to compare long-term clinical outcomes in patients in heart failure with reduced ejection fraction (HFrEF) receiving an LVAD as BTT to those undergoing direct-to-transplant (DTT) without mechanical support, focusing on survival and post-transplant complications. Methods: A retrospective, single-center study included 105 patients who underwent HT from 2010. Patients were divided into two groups: BTT (n = 28) and DTT (n = 77). Primary endpoints included overall survival at 1 and 7 years post-HT. Secondary outcomes involved late complications, including organ rejection, renal failure, cardiac allograft vasculopathy (CAV), and cerebrovascular events. Results: At HT, the use of LVADs results in longer cardiopulmonary bypass and cross-clamping times in the BTT group; nevertheless, surgical complexity does not affect 30-day mortality. Survival at 1 year was 89.3% for BTT and 85.7% for DTT (p = 0.745), while at 7 years, it was 80.8% and 77.1%, respectively (p = 0.840). No significant differences were observed in the incidence of major complications, including permanent dialysis, organ rejection, and CAV. However, a higher incidence of cerebrovascular events was noted in the BTT group (10.7% vs. 2.6%). Conclusions: LVAD use as BTT does not negatively impact early post-transplant survival compared to DTT. At long-term follow-up, clinical outcomes remained similar across groups, supporting LVADs as a viable option for bridging patients to transplant. [ABSTRACT FROM AUTHOR]

Background/Objectives: Heart failure is the leading cause of hospital admission and mortality. Racial disparities have been demonstrated in various cardiovascular disorders; however, the data for in-hospital outcomes, complications, and procedural rates are limited. Methods: Utilizing the National Inpatient Sample (NIS) database, this retrospective cohort study included adult patients admitted with a principal diagnosis of heart failure. Coding for race and ethnicity in the NIS combines self-reported race and ethnicity provided by the data source into 1 data element ("RACE"). We compared the outcomes between various racial groups, focusing on mortality, the length of stay (LOS), hospital charges, and complications. Differences in the utilization of advanced therapies, including implantable cardiac defibrillators, cardiac resynchronization therapy (CRT), ventricular assist devices (VADs), and heart transplant, were also analyzed. Results: Out of 1,107,860 patients hospitalized with heart failure, 715,345 (64.57%) patients were White, 244,394 (22.06%) patients were Black, and 97,063 (8.31%) patients were Hispanic. Compared to White people, the odds of in-hospital mortality were lower among Black (aOR 0.74; 95% CI 0.68–0.81; p < 0.001) and Hispanic (aOR 0.78; 95% CI 0.69–0.88; p < 0.001) people. Complication rates including cardiogenic shock were found to be significantly lower in Black people (aOR 0.86; 95% CI 0.77–0.96; p < 0.001) and in Hispanic (aOR 0.72; 95% CI 0.63–0.81; p < 0.001) people. The rates of acute respiratory failure were also lower in Black (aOR 0.72; 95% CI 0.69–0.74; p < 0.001) and Hispanic (aOR 0.77; 95% CI 0.73–0.81; p < 0.001) people as opposed to White people. However, Black people were found to have higher rates of acute kidney injury (aOR 1.11; 95% CI 1.07–1.14; p < 0.001) and cardiac arrest (aOR 1.17; 95% CI 1.03–1.34; p = 0.02) compared to White people. Black people were less likely to receive advanced interventions, including cardiac resynchronization therapy (aOR 0.71; 95% CI 0.60–0.83; p < 0001), a ventricular assist device (aOR 0.45; 95% CI 0.34–0.59; p < 0.001), and heart transplants (aOR 0.57; 95% CI 0.42–0.77; p < 0.001), than White people. Hispanic people were found to have lower rates of ventricular assist device (aOR 0.49; 95% CI 0.33–0.72; p < 0.001) use than White people. Conclusions: These findings highlight significant racial disparities in mortality, secondary outcomes, and advanced therapy utilization in heart failure admissions. Further research is needed to identify the root factors for these disparities in order to guide targeted interventions to reduce this racial gap. [ABSTRACT FROM AUTHOR]

This narrative review discusses the various challenges associated with the presence of a left ventricular assist device (LVAD) during pregnancy. Given the hemodynamic and coagulation changes associated with pregnancy, the presence of an LVAD adds a layer of complexity with respect to optimal management. This review will discuss the anesthetic considerations when dealing with this subset of patients who may have other comorbidities alongside their advanced heart failure. Additionally, this paper aims to review successful pregnancies with an LVAD placement focusing on the mode of delivery and hemodynamic management risk. [ABSTRACT FROM AUTHOR]

Introduction: Sacubitril/valsartan is an angiotensin receptor–neprilysin inhibitor (ARNI) drug used to treat patients with heart failure and has shown improvement in outcomes. Different studies reported the use of an ARNI in patients using left ventricular assist devices (LVADs). However, there are limited data on the use of ARNIs in this population. We aimed to assess the efficacy of ARNIs in LVAD patients. Methods: A systematic search was performed in PubMed, Scopus, Web of Science, Embase, and Cochrane from inception to November 2024. We used all relevant words for "ARNI" and "LVAD" to search, and we included studies that assessed ARNIs in patients with LVAD. Efficacy and safety outcomes were extracted from the included studies. R software version 4.4.2 was used for a meta-analysis. Results: Seven studies totaling 249 patients were included. The ARNI was found to be effective in improvements from baseline in the New York Heart Association (NYHA), B-type natriuretic peptide (BNP) (mean = −630.07 pg/mL, 95% CI [−1113.13, −147.01]), diuretic dose (furosemide equivalents) (mean= −76.05 mg/day, 95% CI [−145.11, −6.99]), left ventricular end-diastolic diameter (LVEED) (mean = −7.3 mm, 95% CI [−11.4, −3.1]), and left ventricular ejection fraction (LVEF) (mean =5, 95% CI [3.52, 6.48]). No improvement was found in the creatinine (Cr) level. However, a slight increase in the potassium level was noticed (mean= 0.17 mEq/L, 95% CI [0.02, 0.34]). The overall mortality in patients using the ARNI was 5%, 95% CI [0.00, 20], and discontinuation was found in 25%, 95% CI [0, 100]. Conclusions: The ARNI improved several cardiac structural and hemodynamic parameters in patients on LVAD support. [ABSTRACT FROM AUTHOR]

Ventricular assist devices (VADs) are designed to provide sufficient blood flow to patients with severe heart failure. Once implanted, the patient becomes dependent on the VAD, making it essential to prevent situations that could harm the patient while receiving circulatory support. VADs are classified as critical systems (CS), and adverse events (AEs) can lead to serious consequences, including hospitalization or even death. At present, patient care is provided through in-person consultations, with incidents reported via medical device reports (MDRs) to the Food and Drug Administration (FDA). However, there is no real-time monitoring of AEs or oversight of these events. In response to this gap, a system for supervising critical adverse processes in patients with implanted VADs (SCVAD) is proposed, based on horizontally and vertically integrated architecture. This system aims to address the complexity of AEs by considering multiple domains of operation: the device, the patient, and the medical team, as well as the interactions between these entities. In this context, the formalism of Petri nets (PN) is used to develop models that represent adverse processes based on the actions recommended by the medical team. These models allow for the mapping of events with the potential to cause harm to the patient. Therefore, the medical team will be able to monitor adverse processes, as the models in interpreted PN can be isomorphically transcribed into computable algorithms that can be processed on compatible devices, enabling the tracking of complications caused by adverse processes. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusion Utilization of ventricular assist device (VAD) support in patients with end‐stage heart failure is well advanced. Recent studies emphasize the need to develop and evaluate evidence‐based psychosocial support interventions for patients following VAD implantation.A national, multi‐center study in four established German heart centers was initiated. An evidence‐based VAD curriculum was developed; a randomized controlled trial evaluated the impact of the interprofessional intervention over time. Primary combined endpoint was the occurrence of adverse events (thromboembolic events, driveline infections, bleeding, rehospitalization, and death); secondary endpoints were psychosocial outcomes (anxiety, depression [HADS], quality of life [QoLVAD], social support [FSoZu], and self‐management [SELMA]). A total of 140 patients were randomized block‐wise to intervention (IG n = 70) or control (CG n = 70). Center‐effects were considered. Instruments were completed at four time points (T0‐T3).At baseline, intervention group (IG) patients were 19% female (control group [CG] 19%; p = 0.982); 58 ± 11 years. (CG 58 ± 11 years.; p = 0.966); 80% were implanted electively (CG 79%; p = 0.968). No significant difference in primary endpoint was found between IG versus CG (p > 0.05). For secondary endpoints, mixed linear regression revealed a significant reduction in depression scores in IG compared to CG (est. 1.18; 95% CI −2.17 to −0.18; p = 0.021). Clinically significant reductions in anxiety were greater in IG patients between T0 and T3 (IG 51.9%; CG 40.7%); increased anxiety was reported in 3.7% IG (11.1% CG). Mixed linear regression analyses favored IG (all >0.05) for QoL, social support, and self‐management.A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support. [ABSTRACT FROM AUTHOR]

Background: Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) have been shown to reduce risks of clinical events in patients with heart failure (HF). However, data on the use of SGLT2-i in patients with left ventricular assist devices (LVADs) are scarce. We thought to assess the efficacy and safety of SGLT2-i in patients with LVADs. Methods: A systematic search was conducted in PubMed, Scopus, Web of Science, Embase, and Cochrane from inception to November 2024. We used all relevant words for "SGLT2-i" and "LVAD" to search in databases, and we included studies and published abstracts in peer-reviewed journals of studies that assessed SGLT2-i in patients with LVAD. Results: Four studies and seven abstracts totaling 228 patients using SGLT2-i were included. Empagliflozin, Dapagliflozin, and Canagliflozin were the used SGLT2-i across the included studies. Pooled analysis showed that SGLT2-i significantly improved ejection fraction (EF) (Mean= 4.2, 95% CI [1.22, 7.19]) and hemoglobin A1c (HbA1c) (Mean = −0.44, 95% CI [−0.79, −0.09]) from baseline. However, no significant changes in B-type natriuretic peptide (BNP), or glomerular filtration rate (GFR) were noticed. Other outcomes of interest not included in the meta-analysis did not show significant changes, such as cardiac index (CI), left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), mean arterial pressure (MAP), or mean pulmonary artery pressure (MPAP). The pooled percentage of people with driveline infection was 9%, 95% CI (3, 19). Conclusions: SGLT2-i effectively improves EF and HbA1c in patients using LVAD. Further adequately powered randomized studies are warranted to ascertain its clinical efficacy and safety in that unique population. [ABSTRACT FROM AUTHOR]

Background: 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. Methods: 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. Results: 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. Conclusion: 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]

Background: 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). Methods: 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. Results: 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). Conclusions: 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]

Critically ill pediatric patients supported on ventricular assist devices (VADs) are increasingly being anticoagulated on bivalirudin, but with difficulty monitoring anticoagulation. Activated partial thromboplastin time (aPTT) has recently been shown to poorly correlate with bivalirudin plasma concentrations, while dTT had excellent correlation. However, aPTT is the more common monitoring test and dTT testing is rarely used. In addition, effects of frequent clinical VAD scenarios (such as inflammation) on the accuracy of aPTT and dTT testing remains uncertain. We reviewed the effects of clinical scenarios (infection/inflammation, chylothorax, and steroids administration) on anticoagulation monitoring in 10 pediatric VAD patients less than 3 years at Cincinnati Children's Hospital Medical Center from 10/27/2020 to 5/6/2022 using bivalirudin for anticoagulation. There were 16 inflammation/infection, 3 chylothorax, and 6 steroids events. Correlation between dTT and aPTT was significantly lower after infection/inflammation, with dTT increasing prior to inflammation/infection while aPTT remained unchanged. In addition, steroids are administered to VAD patients to reduce inflammation and thus additionally stabilize anticoagulation. However, this anticoagulation stabilization effect was reflected more accurately by dTT compared to aPTT. In children requiring VAD support utilizing bivalirudin anticoagulation, inflammation/infection is a common occurrence resulting in anticoagulation changes that may be more accurately reflected by dTT as opposed to aPTT. [ABSTRACT FROM AUTHOR]

Abstract Aims It is unclear whether activated partial thromboplastin time (aPTT) or anti‐Xa is more accurate for monitoring heparin anticoagulation in mechanical circulatory support (MCS) patients. This study investigates the relationship between aPTT and anti‐Xa in MCS patients and identifies predictors of discordance. Methods and results aPTT and anti‐Xa were simultaneously measured in a prospective cohort of MCS patients receiving unfractionated heparin at a tertiary academic medical centre. Therapeutic aPTT and anti‐Xa levels were 60–100 s and 0.3–0.7 IU/mL, respectively, and concordance was defined as both levels being subtherapeutic, therapeutic, or supratherapeutic. To identify predictors of discordance, both a machine learning random forest model and a multivariate regression model were applied to patient demographics, device type, and 14 laboratory variables; 23 001 pairs of simultaneously measured aPTT/anti‐Xa were collected from 699 MCS patients. aPTT and anti‐Xa were concordant in 35.5% of paired observations and discordant in 64.5% (aPTT > antiXa 61.5%; aPTT antiXa) was associated with high INR, eGFR, and total bilirubin, as well as low platelets, haemoglobin, pre‐albumin, white blood cell count, and haptoglobin. Total artificial heart and durable ventricular assist devices were more likely to be associated with aPTT > anti‐Xa than temporary MCS devices. Conclusions aPTT and anti‐Xa were frequently discordant in MCS patients receiving heparin anticoagulation. Clinical conditions common in MCS patients such as concurrent warfarin use, malnutrition, haemolysis, and thrombocytopenia, as well as durable type of MCS devices were associated with a high aPTT relative to anti‐Xa.

Mechanical circulatory support devices have profoundly transformed the management of severe cardiothoracic disorders. While heart transplantation is the gold standard therapy for end-stage heart disease, long-term mechanical support devices are a viable alternative for those ineligible and/or those awaiting organ availability. Major technological advancements were made over first 5 decades of development, resulting in improved durability and survival with reduced adverse events. However, gains have tapered recently for various complications (e.g., internal bleeding, multisystem organ failure), which collectively represent a significant proportion of disability and/or mortality. Further, in light of mature ventricular assist devices failing during clinical trials or even after clinical approval (class I withdrawals), it is timely to consider: Are our preclinical assessment protocols vital in the design and development of mechanical circulatory support devices, providing a realistic and reliable profile of future clinical performance? This commentary explores this question and analyses development pathways through the lens of the various disciplines involved in the preclinical assessment of mechanical circulatory support technologies: Limitations in approaches to benchtop blood testing, computational design and simulation, and animal testing are discussed as likely contributors to some of the common hemocompatibility-related adverse events (HRAEs). While it is acknowledged that some shortcomings are pragmatic in nature, possible solutions are presented that will only be realized through truly transdisciplinary and open approaches that challenge the current nature of medical device development. We suggest that these can and must be overcome to diminish HRAEs and will potentially demarcate the fourth generation of cardiac assist devices. [ABSTRACT FROM AUTHOR]

OBJECTIVES The study's primary outcome was to evaluate if post-transplant survival has improved over the last 2 decades. Secondary outcomes were the infant's waitlist mortality, waitlist time and identifying factors that affected the infant's survival. METHODS United Network for Organ Sharing (UNOS) database was queried for infants (age ≤ 1) who were listed for heart transplantation between 2000 and 2020. The years were divided into 3 eras (Era 1 2000–2006, Era 2 2007–2013 and Era 3 2014–2020). Non-parametric tests, Chi-Squared, Log-Rank test and Cox-Proportional hazard ratio were used for analysis (α  = 0.05). RESULTS 4234 infants were listed for heart transplants between 2000 and 2020. At the time of listing, Infants in era 3 were more likely to be heavier [in kg (P  < 0.001)] and had better renal function (P  < 0.001). Additionally, they were less likely to be on dialysis (P  < 0.001), on a ventilator (P  < 0.001) and on extracorporeal membrane oxygenation (P  < 0.001). There has been a significant increase in left ventricular assist device use (P  < 0.001), though there was no difference in waitlist (0.154) or post-transplant survival (0.51). In all 3 eras, waitlist survival (P  < 0.001) and post-transplant survival (P  < 0.001) have improved significantly. Congenital heart disease and extracorporeal membrane oxygenation were associated with worse waitlist survival in all 3 eras (P  < 0.05). Infants are now waiting longer on the waitlist (in days) (33 Era 1 vs 46 Era 2 vs 67 Era 3, P  < 0.001). CONCLUSIONS Infant heart transplant outcomes have improved, but they are now waiting longer on the waitlist. Further improvement in increasing the donor pool, expert consensus on listing strategies and donor utilization is needed to improve outcomes. [ABSTRACT FROM AUTHOR]

OBJECTIVES To evaluate the correlation between left ventricular assist device flow parameter and invasive cardiac output measurements. METHODS We retrospectively evaluated right heart catheterization examinations performed in left ventricular assist device patients from 2 tertiary medical centres. We evaluated the correlation between cardiac output measurement methods (indirect Fick and thermodilution) and pump flow parameter using linear regression, and the agreement was graphically displayed using Bland–Altman plot technique. Clinical, echocardiographic, pump and haemodynamic parameters were compared between patients with and without discordance, defined as at least a 20% difference between measurements. RESULTS The study population consisted of 102 patients [median age 58 (51–64), 86% males, 17 ± 12 months post left ventricular assist device implantation] with a total of 544 measurements compared. Discordance between measurements was present in 102 of 226 (45%) comparisons between indirect Fick and pump flow and in 72 of 161 (48%) between thermodilution and pump flow. A comparison of indirect Fick and left ventricular assist device exhibited a statistical correlation of R  = 0.751, and that of thermodilution and left ventricular assist device of R  = 0.789. Parameters associated with the presence of discordance between cardiac output measurements included a higher rate of aortic valve opening, lower indirect Fick and higher thermodilution cardiac output. After excluding the lowest tertile of indirect Fick cardiac output values, the correlation between measurements improved (thermodilution: R  = 0.879 and indirect Fick: R  = 0.843, P  < 0.001). CONCLUSIONS The current left ventricular assist device flow parameter provides an estimation of cardiac output that correlates well with indirect Fick and exhibits the strongest correlation with thermodilution. This correlation was stronger after excluding lower cardiac output values. [ABSTRACT FROM AUTHOR]

Background: Ventricular assist device (VAD) implantation has become an alternative treatment for patients with end-stage heart failure. In Germany, valid and reliable instruments to assess health-related quality of life in patients with VAD are lacking. Objective: The aim of this study was to present the psychometric validation of the German version of the Quality of Life with a Ventricular Assist Device questionnaire. Methods: In a multicenter, cross-sectional study, 393 participants (mean age, 58.3 years; 85.8%male, 60.3%bridge to transplant, and 72.8%living with VAD for =2 years) completed the German Quality of Life with a Ventricular Assist Device questionnaire of physical, emotional, social, cognitive, and meaning/spiritual domains. Item and confirmatory factor analyses were conducted to test item difficulty and discrimination and the underlying structure, respectively. To examine internal consistency, Cronbach a was assessed. Convergent construct validity was tested using the Kansas City Cardiomyopathy Questionnaire and the Patient Health Questionnaire-9. Readability was examined using Flesch Reading Ease index and Vienna Factual Text Formula. Results: The Quality of Life with a Ventricular Assist Device showed reasonable itemdifficulty (Ptotal = .67) and mostly moderate to high discriminatory power (rit > 0.30). In confirmatory factor analysis, root-mean-square error of approximation (0.07) was acceptable for model fit, but no other indices. Acceptable internal consistency was found (a = 0.79), with the exception of the cognitive domain (α = 0.58). The overall questionnaire and single domains demonstrated convergent validity (r = 0.45, P < .001). The questionnaire showed adequate readability (Flesch Reading Ease, 64.11; Vienna Factual Text Formula, 6.91). Conclusion: Findings indicate a promising standardized clinical instrument to assess health-related quality of life in patients with VAD. [ABSTRACT FROM AUTHOR]

Increasing evidence suggests that dalbavancin is an effective long-term treatment for ventricular assist device (VAD) infections, with various prolonged dosing regimens currently in use. This retrospective study aimed to assess dalbavancin pharmacokinetics in VAD patients and identify optimal, feasible dosing regimens for long-term suppressive outpatient therapy. Data from Heidelberg University Hospital's VAD register were analyzed using non-linear mixed-effects modeling for pharmacokinetic analysis and dosing simulations (Lixoft®). The probability of target attainment (PTA) and cumulative fraction of response (CFR) were calculated for different protein-binding scenarios considering the minimum inhibitory concentration (MIC) distribution of Staphylococcus aureus. Using data from 13 patients with 38 blood samples, a two-compartment model best described the dalbavancin pharmacokinetics, with a typical value for clearance of 0.050 L/h, central volume of distribution of 6.5 L, and peripheral volume of 15.4 L. No covariates significantly improved the model fit. The observed protein binding varied between 96 and 98%. Dosing simulations demonstrated that 1500 mg every 3 weeks ensured the target attainment for stasis at MIC values of 0.125 mg/L (PTA ≥ 90%) up to a protein binding of 99%. Considering the CRF, longer dosing intervals up to 5 weeks might be possible. Depending on individual MICs and protein binding, a dalbavancin regimen of 1500 mg every 3 to 5 weeks therefore appears to be a valuable option for outpatient therapy of VAD infections. Therapeutic drug monitoring should be considered to manage inter-individual variability and to support clinicians in long-term treatments of subacute and chronic infections. [ABSTRACT FROM AUTHOR]

Mechanical circulatory support is a potential treatment for failing Fontan patients. In this study, we performed a theoretical analysis using a computational model to clarify the effects of systemic ventricular assist device (VAD) in failing Fontan patients. Cardiac chambers and vascular systems were described using the time-varying elastance model and modified Windkessel model, respectively. A VAD was simulated as a nonlinear function. In systolic and diastolic ventricular dysfunction and atrioventricular valve regurgitation models, systemic VAD increased the cardiac index and decreased the central venous pressure (CVP). However, in the high pulmonary vascular resistance model, CVP became extremely high above 15 mmHg to maintain the cardiac index when the pulmonary vascular resistance index (PVRI) was above 5 Wood units m2. In Fontan patients with ventricular dysfunction or atrioventricular valve regurgitation, systemic VAD efficiently improves the hemodynamics. In Fontan patients with PVRI of > 5 Wood units m2, systemic VAD seems ineffective. [ABSTRACT FROM AUTHOR]

Background: 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. Methods: 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. Results: 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. Conclusions: 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 Left ventricular assist device (LVAD) therapy has evolved from a short-term bridge-to-transplant strategy into a long-term and often chronic therapy due to long waiting times for heart transplantation and application as destination therapy. Consequently, patients are at risk of developing complications necessitating LVAD exchange. The aim of this study is to assess patient outcomes after LVAD exchange. METHODS Patients who underwent LVAD exchange between January 2010 and December 2022 were included. Logistic and cox regression analyses were used to identify potential risk factors for short and long-term adverse events, respectively. Survival after exchange was assessed using Kaplan–Meier estimates. RESULTS Sixty-one patients underwent a total of 80 LVAD exchanges. Most frequently observed short-term complications were pulmonary infections (16.3%) and right heart failure (16.3%). Exit-site infections (34.7%) and device malfunctions (25.3%) were the most often observed long-term complications. HeartWare ventricular assist device as index device was associated with a higher risk of right heart failure [hazard ratio 6.42, 95% confidence interval (CI) 1.80–22.90] and respiratory failure (hazard ratio 7.81, 95% CI 1.95–31.23) compared to HeartMate II and HeartMate 3. Survival was 83% (95% CI 75.5–95.3%) at 1 year and 67% (95% CI 53.9–84.7%) at 6 years after exchange. After 5 years, 25.0% was transplanted, 23.8% had undergone a re-exchange and 32.5% was alive without new intervention. CONCLUSIONS Although LVAD exchange can be performed with a relatively low mortality, other post-operative adverse events are common. Patients with the HeartWare ventricular assist device as index device may be at higher risk of developing right heart failure and respiratory failure after exchange. [ABSTRACT FROM AUTHOR]

Aims: It is unclear whether activated partial thromboplastin time (aPTT) or anti‐Xa is more accurate for monitoring heparin anticoagulation in mechanical circulatory support (MCS) patients. This study investigates the relationship between aPTT and anti‐Xa in MCS patients and identifies predictors of discordance. Methods and results: aPTT and anti‐Xa were simultaneously measured in a prospective cohort of MCS patients receiving unfractionated heparin at a tertiary academic medical centre. Therapeutic aPTT and anti‐Xa levels were 60–100 s and 0.3–0.7 IU/mL, respectively, and concordance was defined as both levels being subtherapeutic, therapeutic, or supratherapeutic. To identify predictors of discordance, both a machine learning random forest model and a multivariate regression model were applied to patient demographics, device type, and 14 laboratory variables; 23 001 pairs of simultaneously measured aPTT/anti‐Xa were collected from 699 MCS patients. aPTT and anti‐Xa were concordant in 35.5% of paired observations and discordant in 64.5% (aPTT > antiXa 61.5%; aPTT < antiXa 3.0%). Discordance with a high aPTT relative to anti‐Xa (aPTT > antiXa) was associated with high INR, eGFR, and total bilirubin, as well as low platelets, haemoglobin, pre‐albumin, white blood cell count, and haptoglobin. Total artificial heart and durable ventricular assist devices were more likely to be associated with aPTT > anti‐Xa than temporary MCS devices. Conclusions: aPTT and anti‐Xa were frequently discordant in MCS patients receiving heparin anticoagulation. Clinical conditions common in MCS patients such as concurrent warfarin use, malnutrition, haemolysis, and thrombocytopenia, as well as durable type of MCS devices were associated with a high aPTT relative to anti‐Xa. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate thrombosis and bleeding events in the children implanted with two types of ventricular assist devices (VAD). A total of 26 paediatric end-stage heart failure patients with the mean age of 11.32 ± 4.17 years, 15 were boys, implanted with a VAD, either the Berlin Heart EXCOR (BHE group; n = 9) or the HeartWare (HW group, n = 17), were included in this retrospective study. Follow up data on bleeding events, thrombosis events, bridge-to-transplantation rates and survival outcome were recorded. Overall, 16(33.3%) bleeding events and 32(66.7%) thrombosis events occurred, while 14(53.8%) patients had at least one thrombotic event and 8(30.8%) patients had at least one bleeding event. BHE and HW groups were similar in terms of number of patients with at least one thrombotic (33.3% vs. 64.7%, p =.218) or bleeding (22.2% vs.35.3%, p =.399) event. Mortality occurred in 9(34.6%) patients and 13(50.0%) patients achieved bridge-to-transplantation, similarly in BHE and HW groups (mortality: 44.4% vs. 29.4%, p =.667 and transplantation: 77.8% vs. 35.3%, p =.097). In conclusion, our findings revealed that VAD application in children with heart failure enables successful heart transplantation achievement with an acceptable risk of bleeding/thromboembolic events in most of cases. More advanced VAD technologies and more successful management for haematologic complications are necessary to improve the transplantation rates in children. [ABSTRACT FROM AUTHOR]

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]

Left ventricular assist devices (LVADs) are increasingly implanted in patients with advanced heart failure. Currently, LVAD care is predominantly concentrated at specialized tertiary care hospitals. However, the increasing workload and logistical burden for implanting centres pose significant challenges to accessing care for individual patients in remote areas. An emerging approach to LVAD patient management is the use of a shared care model (SCM), which facilitates collaboration between implanting centres and local non-implanting hospitals. This scoping review explores and synthesizes the current scientific evidence on the use of SCMs in LVAD care management. Eligible studies were identified in EMBASE, PubMed MEDLINE, Web of Science, Cochrane and Google Scholar. Findings were synthesized in accordance with PRISMA-ScR guidelines. Of the 950 records screened, five articles met the inclusion criteria. Four review articles focused on the proposed benefits and challenges of using SCMs. Main benefits included improved patient satisfaction and continuity of care. Important challenges were initial education of non-implanting centre staff and maintaining competency. One prospective study showed that absence of LVAD-specific care was associated with impaired survival and higher rates of pump thrombosis and LVAD-related infections. The use of SCMs is a promising approach in the long-term management of LVAD patients. However, sufficient evidence about the impact of SCMs on patients and the healthcare system is not currently available. Standardized protocols based on prospective studies are needed to develop safe and effective shared care for LVAD patients. [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]

Organ transplantation practices have witnessed tremendous advances all over the world and in Türkiye in recent years, and the pre-transplantation preparation, operation and postoperative follow-up procedures are being meticulously handled. However, there is very limited information about follow-up processes of pediatric patients with autism spectrum disorder (ASD) undergoing organ transplantation. Furthermore, it is difficult to manage the arduous and long-term care and follow-up processes in ASD cases undergoing organ transplantation. In this case report, an 11-year-old male patient with a diagnosis of ASD and attention deficit-hyperactivity disorder (ADHD) was reviewed psychiatrically for the suitability of ventricular assist device (VAD) implantation and heart transplantation, and the multidisciplinary council process was evaluated. The council decided that the case was suitable for heart transplantation but not suitable for long-term intracorporeal device implantation due to behaviors such as plucking wounds, playing with vascular access, and being nervous about vascular access. The council stated that due to sensory hypersensitivity of the case, implantation of such a device may further increase anxiety, and involuntary damage to the device may result in personal harm. We hope that this case report will guide future endeavors to develop devices suitable for cases with ASD or other behavioral problems. [ABSTRACT FROM AUTHOR]

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.

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.

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]

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]

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]

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 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]

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]

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]