Ventricular Assist Device Support Research Articles

Association of Renin-Angiotensin-Aldosterone System Inhibitors With Clinical Outcomes, Hemodynamics, and Myocardial Remodeling Among Patients With Advanced Heart Failure on Left Ventricular Assist Device Support.

We evaluated the potential benefits of renin-angiotensin-aldosterone system inhibitors (RAASi) in patients with left ventricular assist device support. A total of 165 consecutive patients undergoing left ventricular assist device implant and alive at 6-month on support were studied. RAASi status after 6-month visit along with clinical reasons for nonprescription/uptitration were retrospectively assessed. The primary outcome was a composite of heart failure hospitalization or cardiovascular death between 6 and 24 months after left ventricular assist device implant. Remodeling and hemodynamic outcomes were explored by studying the association of RAASi new prescription/uptitration versus unmodified therapy at 6-month visit with the change in echocardiographic parameters and hemodynamics between 6 and 18 months. After the 6-month visit, 76% of patients were on RAASi. Patients' characteristics among those receiving and not receiving RAASi were mostly similar. Of 85 (52%) patients without RAASi new prescription/uptitration at 6-month visit, 62% had no apparent clinical reason. RAASi were independently associated with the primary outcome (adjusted hazard ratio, 0.31 [95% CI, 0.16-0.69]). The baseline rates of optimal echocardiographic profile (neutral interventricular septum, mitral regurgitation less than mild, and aortic valve opening) and hemodynamic profile (cardiac index ≥2.2 L/min per m2, wedge pressure <18 mm Hg, and right atrial pressure <12 mm Hg) were similar between groups. At 18 months, patients receiving RAASi new prescription/uptitration at 6 months had higher rates of optimal hemodynamic profile (57.5% versus 37.0%; P=0.032) and trends for higher rates of optimal echocardiographic profile (39.6% versus 22.9%; P=0.055) compared with patients with 6-month unmodified therapy. Optimal 18-month hemodynamic and echocardiographic profiles were associated with the primary outcome (log-rank=0.022 and log-rank=0.035, respectively). RAASi are associated with improved outcomes and improved hemodynamics among mechanically unloaded patients.

Noncardiac Surgery in Patients with Left Ventricular Assist Devices: A 11-Year Institutional Experience.

Limited options in the end-stage treatment of heart failure have led to increased use of left ventricular assist devices. For this reason, the rate of non-cardiac surgeries in patients with left ventricular assist devices is also increasing. Our study aims to analyze surgical rate, anesthesia management, and results by reviewing our 11-year experience with patients who underwent non-cardiac surgery receiving left ventricular assist devices support. We retrospectively evaluated 57 patients who underwent non-cardiac surgery and 67 non-cardiac surgical procedures among 274 patients who applied between January 2011 and December 2022 and underwent left ventricular assist devices implantation with end-stage heart failure. Fifty (74.6%) patients with left ventricular assist devices admitted to the hospital for non-cardiac surgery were emergency interventions. The most common reasons for admission were general surgery (52.2%), driveline wound revision (22.3%), and neurological surgery (14.9%). This patient group has the highest in-hospital mortality rate (12.8%) and the highest rate of neurological surgery (8.7%). While 70% of the patients who underwent neurosurgery were taken to surgery urgently, the International Normalized Ratio values of these patients were between 3.5 and 4.5 at the time of admission to the emergency department. With a perioperative multidisciplinary approach, higher morbidity and mortality risks can be reduced during emergencies and major surgical procedures.

Impact of inflammation and steroids on anti-coagulation in children supported on a ventricular assist device.

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 3years 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.

(874) - Usefulness of Established Risk Scores in Predicting Right Heart Failure Requiring Temporary Right Ventricular Assist Device Support Following Left Ventricular Assist Device Implantation

(874) - Usefulness of Established Risk Scores in Predicting Right Heart Failure Requiring Temporary Right Ventricular Assist Device Support Following Left Ventricular Assist Device Implantation

(873) - Outcomes in HeartMate 3 Left Ventricular Assist Device Patients Requiring Temporary Right Ventricular Assist Device Support

(873) - Outcomes in HeartMate 3 Left Ventricular Assist Device Patients Requiring Temporary Right Ventricular Assist Device Support

(1133) - Cardiac Recovery and Improved Outcomes During Left Ventricular Assist Device Support: The First Heart-Mate 3 in Argentina

(1133) - Cardiac Recovery and Improved Outcomes During Left Ventricular Assist Device Support: The First Heart-Mate 3 in Argentina

(819) - Evaluation of Platelet Activation by Flow Cytometry in Contemporary Continuous Flow Left Ventricular Assist Device Support

(819) - Evaluation of Platelet Activation by Flow Cytometry in Contemporary Continuous Flow Left Ventricular Assist Device Support

(62) - Sildenafil Modifies Platelet Activation and Reduces Mediators of Vascular Remodeling During Durable Left Ventricular Assist Device Support: A Double-Blind, Placebo-Controlled, Randomized Study

(62) - Sildenafil Modifies Platelet Activation and Reduces Mediators of Vascular Remodeling During Durable Left Ventricular Assist Device Support: A Double-Blind, Placebo-Controlled, Randomized Study

(1075) - Medium to Long-Term Ventricular Assist Device Support in Adults with Congenital Heart Disease: The Baylor St. Luke’s Medical Center / Texas Children’s Hospital Experience

(1075) - Medium to Long-Term Ventricular Assist Device Support in Adults with Congenital Heart Disease: The Baylor St. Luke’s Medical Center / Texas Children’s Hospital Experience

(1289) - Acclimation of Right Ventricular Function After Durable Left Ventricular Assist Device Support

(1289) - Acclimation of Right Ventricular Function After Durable Left Ventricular Assist Device Support

Professional Employment With Left Ventricular Assist Device Support: Does Working With an LVAD Allow It to Work Too?

Professional Employment With Left Ventricular Assist Device Support: Does Working With an LVAD Allow It to Work Too?

Quality Improvement in Anesthetic Management of Patients with Left Ventricular Assist Device Support Presenting for Non-Cardiac Surgery: A Single Center Experience.

With the growing number of left ventricular assist device (LVAD) recipients requiring non-cardiac surgery and the limited availability of cardiac anesthesiologists, our study reviewed non-cardiac surgeries in HeartMate III patients with LVAD at our institution. We focused on anesthesiologist roles, detailing patient characteristics, anesthetic management, and outcomes and identifying improvement opportunities in this specialized care setting. A retrospective chart review was conducted of all patients with LVAD who underwent non-cardiac surgery at our institution between 2017 and 2022. Patient demographics, surgical characteristics, anesthetic management, and 30-day mortality rates were also assessed. A total of 23 patients were identified, with 17 (73.9%) males and a median age of 61 [53.5, 67.5] years. Cardiac anesthesiologists were present in nine (39.1%) cases. Elective surgeries were more common (73.9%), with intermediate-risk surgeries accounting for 52.2% of all surgeries. General anesthesia was administered to 18 patients (78.3%), with a median duration of 40 [24, 63.5] min. A single patient required reoperation because of bleeding, and two patients (8.7%) experienced 30-day mortality. Despite guidelines lacking detail, involving non-cardiac anesthesiologists in certain cases is essential. Sharing our experience aims to enhance the evolving discourse on non-cardiac surgeries for patients with LVAD, improving their outcomes and safety.

Professional Employment in Patients on Ventricular Assist Device Support-A National Multicenter Survey Study.

This study aimed to assess patients of working age returning to professional employment as a surrogate marker for functional recovery and psychosocial reintegration after ventricular assist device (VAD) implantation. A national, multicenter study considered professional employment and its relationship to sociodemographic, psychosocial, and clinical adverse outcomes in outpatients on VAD support. Patient-reported outcome measures were administered. The survey had a 72.7% response rate. Mean age of 375 subjects was 58 ± 11 years, 53 (14%) were female. Thirty-five patients (15.15%; 95% confidence interval [CI] = 10.9-20.6) were employed, and the majority of them (n = 29, 82.9%) were bridged to transplantation. A regression model after variable selection revealed younger age (odds ratio [OR] = 0.95; 95% CI = 0.91-0.98; p < 0.005), and higher education (OR = 3.05; 95% CI = 1.72-5.41; p < 0.001) associated with professional employment. Employed patients reported higher health-related quality of life (HRQoL) (Kansas City Cardiomyopathy Questionnaire [KCCQ] overall sum-score, OR = 1.04; 95% CI = 0.92-1.07; p < 0.007), the OR for those employed was 2.18 (95% CI = 0.89-5.41; p < 0.08) indicating no significant relation for employment and a history of adverse events. In this sample, professional employment was rather small; the likelihood of adverse events was not significantly different between groups. Those employed perceived better overall HRQoL, which may encourage clinicians to support professional employment for selected patients on VAD support.

Increased phagocytosis capacity of circulating neutrophils in patients on continuous flow ventricular assist device support.

Neutrophils take part in the innate immune response, phagocytosis, and pro-inflammatory cytokine release. The phagocytic capacity of circulating neutrophils in patients on continuous flow (CF) ventricular assist device (VAD) has not been well studied. Blood samples from 14 patients undergoing CF-VAD implantation were collected and analyzed preoperatively (at baseline) and on postoperative days (POD) 3, 7, 14, and 28. Flow cytometry was used to assess the surface expression levels of CD62L, CD162, and macrophage antigen-1 (MAC-1) and neutrophil phagocytic capacity. Interleukin 1 (IL1), IL6, IL8, TNF-α, neutrophil elastase, and myeloperoxidase in plasma were measured using enzyme-linked immunosorbent assays. Among the 14 patients, seven patients had preoperative bridge device support. Relative to baseline, patients with no bridge device had elevated leukocyte count and neutrophil elastase by POD3 which normalized by POD7. Neutrophil activation level, IL6, IL8, and TNF-α increased by POD3 and sustained elevated levels for 7-14 days postoperatively. Elevated neutrophil phagocytic capacity persisted even until POD28. Similar patterns were observed in patients on a preoperative bridge device. Neutrophil activation and phagocytic capacity increased in response to VAD support, while inflammatory cytokines remain elevated for up to 2 weeks postoperatively. These findings may indicate that VAD implantation elicits circulating neutrophils to an abnormal preemptive phagocytotic phenotype.

Effects of ventricular assist device with a fenestration in the failing Fontan circulation: a theoretical analysis using a lumped parameter model

Abstract Background Fenestration is surgically created at the time of Fontan operation, in which the extracardiac conduit is connected to the atrium through a small communication. Since the fenestration has been reported to increase venous return to the ventricle and improve the hemodynamics, the fenestration is often made when the risk of postoperative Fontan failure is high. In the failing Fontan circulation, the implantation of ventricular assist device (VAD) is sometimes required as a bridge-to-transplantation therapy. However, it has been controversial whether a closure of fenestration is necessary or not. Purpose To evaluate the effects of fenestration on the hemodynamics under VAD in the failing Fontan circulation. Methods A computational model of Fontan circulation was developed using a time-varying elastance cardiac chamber model and a modified 3-element Windkessel vasculature model. Pressure gradient through fenestration was calculated by the simplified Bernoulli’s equation. The relationship between pressure head and rotational frequency of VAD was modeled as a non-linear function. To simulate Fontan failure, ventricular end-systolic elastance was set at 1.0 mmHg/ml and then pulmonary vascular resistance index (PVRI) was varied from 3.0 to 6.8 WU m². Results In the Fontan failure model with PVRI of 3.0 WU m², mean blood pressure (MBP), cardiac index (CI) and central venous pressure (CVP) were 58.4 mmHg, 1.7 l/min/m² and 19.2 mmHg, respectively. When MBP was maintained at the same value, the 4-mm fenestration rarely affected CI (1.7 l/min/m²) and CVP (18.1 mmHg), but significantly decreased oxygen saturation (SpO2, 84.0 %). The introduction of VAD at 4000 rpm significantly increased MBP and CI in both models with/without fenestration (Fenestration (+): 93.7 mmHg, 3.2 l/min/m², Fenestration (-): 94.5 mmHg, 3.2 l/min/m²). In the model with fenestration, SpO2 recovered to 91.6 % after the VAD initiation. However, CVP slightly changed after the VAD initiation in both models with/without fenestration (18.5 and 18.9 mmHg, respectively). When stressed blood volume (SBV) was decreased until end-systolic ventricular volume became around 0 ml, CVP was decreased to the normal range (Fenestration (+): 8.3 mmHg, Fenestration (-): 10.0 mmHg). Then SBV was significantly lower in the model with fenestration than that without fenestration (-150 ml). The effects of fenestration on CVP and SBV were larger in the model with high PVRI of 6.8 WU m² (CVP: -5.5 mmHg, SBV: -460 ml) than those with PVRI of 3.0 WU m² (CVP: -1.7 mmHg, SBV: -150 ml). Conclusions Although fenestration decreases SpO2 at the onset of Fontan failure, fenestration can significantly decrease CVP and SBV under VAD support. These effects are more significant in the patients with higher PVRI. This study demonstrates that fenestration did not impair the hemodynamics under VAD support, indicating the closure of fenestration may not be necessary.

Abstract 17254: Myocardial Functional Recovery Following Durable Ventricular Assist Device in Children

Introduction: Ventricular Assist Device (VAD) explantation following myocardial functional recovery (MFR) for heart failure (HF) is uncommon and associated with a risk of recurrence of HF. Research Question: What are the patient characteristics and outcomes for VAD explantation in children following MFR? Methods: Retrospective, single centre study of patients who were supported with durable VADs, both intracorporeal continuous flow devices (CFD) and paracorporeal pulsatile flow devices (PFD) between 2004 to 2022. Results: A total of 75 children, of which 43 were female, underwent VAD implantation (PFD = 61 and CFD = 14) at a median (IQR) age of 5.6 (0.8, 13.5) years and with a weight of 16.2 (7.5, 40.7) kg. From this cohort, we identified 8/75 (11%) children who underwent VAD explantation for MFR after a median duration of 56 (22, 115) days. All were supported with durable PFD. Five were listed for transplantation as a part of their HF management strategy following VAD implantation and four patients had dilated cardiomyopathy (DCM). Of those, 7/8 (88%) children with MFR were under 2 years of age and 5/8 (63%) were supported for &gt; 90 days. The pathological findings on the LV core samples were variable in severity and no patient had any evidence of active inflammation (see Table). After explant, 7/8 patients remained in HF remission with no symptoms and stable LV function. One patient had a recurrence of HF following explantation after demonstrating MFR while on VAD support. This patient was 5 years old at implant and was in HF remission for ~9 months following explant before HF recurrence, requiring VAD re-implantation and eventual heart transplantation. Conclusions: MFR resulting in VAD explantation is feasible in children with chronic HF especially for those &lt; 2 years of age. Further work is needed to help better identify the features that promote MFR and maintain it after explant.

Argatroban Use in Pediatric Patients Supported by Paracorporeal Ventricular Assist Devices.

Direct thrombin inhibitor (DTI) use has been associated with decreased stroke and death rates in children on ventricular assist devices (VADs). Most information about DTI use for children on VADs has focused on bivalirudin with limited data on argatroban. We hypothesized that, compared to unfractionated heparin (UFH), argatroban would be associated with decreased bleeding, stroke, and death rates in children on VADs. We retrospectively collected data from patients <18 years old on paracorporeal VADs at Children's Wisconsin between January 1, 2010 and July 1, 2021. We divided patients into cohorts based on anticoagulation strategy with heparin or argatroban. Definitions of bleeding and neurologic events were the same as in other published reports on this population. We compared categorical variables with the χ 2 or Fisher's exact test, and continuous variables with the Mann-Whitney U test. Nineteen children were anticoagulated with argatroban, and 16 with heparin. Demographics between groups were not significantly different. Stroke, bleeding, and death rates did not differ between patients treated with UFH versus argatroban. The study population was complex with a high rate of extracorporeal membrane oxygenation (ECMO) use before VAD support, which likely impacted our findings. Our study does not support argatroban as a superior alternative anticoagulant compared to UFH in children requiring VADs.

Abstract 12339: Erythropoietin Use in Pediatric Ventricular Assist Device Patients

Background: Anemia is common in pediatric ventricular assist device (VAD) patients. Erythropoietin (EPO) has been used to reduce blood transfusions in children after VAD placement. A study in adults showed EPO use after left VAD implantation was associated with higher rates of suspected pump thrombosis. No studies have evaluated the use of EPO in pediatric patients receiving VAD support. Objectives: We aim to assess EPO use in all pediatric patients who underwent placement of a VAD and to assess outcomes for children who received EPO compared to those who did not. Methods: We identified patients from the Pediatric Health Information System who underwent VAD placement from 2010-2020. Use of EPO was described across all sites. Cohorts were compared to assess differences in blood transfusions received post-VAD, incidence of stroke and pump-exchange. Multivariable Cox proportional hazard and logistic regression models were constructed to adjust for confounding factors for outcomes of VAD exchange and stroke, respectively. Results: A total of 1260 patients were included, of which 336 (27%) received EPO. Patients who received EPO were younger (median 3.5y vs. 9y, p&lt;0.001) and more likely to have congenital heart disease (55% vs. 45%, p=0.002). Patients on EPO received fewer blood transfusions compared to those not on EPO [median 0/month (IQR 0-0.9) vs. 0/month (IQR 0-2.3), p&lt;0.001]. VAD exchange and stroke were more common in patients on EPO (10.1% vs. 5.5%, p=0.004 and 37.8% vs. 25%, p&lt;0.001, respectively). After adjusting for confounding factors, the use of EPO was not independently associated with the need for VAD exchange (adjusted hazard ratio 1.2, 95% confidence 0.78 - 1.9, p=0.378). However, EPO remained independently associated with stroke during the hospitalization (adjusted hazard ratio 1.6, 95% confidence 1.2 - 2.1, p=0.002). Conclusion: EPO was used in approximately 1 out of 4 pediatric VAD patients. Those who received EPO were younger and more likely to have congenital heart disease. The use of EPO is associated with fewer post-VAD blood transfusions. EPO was not independently associated with VAD exchange but remained independently associated with stroke during the VAD hospitalization.

Abstract 17145: Impact of Preoperative Levosimendan in Patients With Severe Heart Failure Undergoing Left Ventricular Assist Device Support: A Meta-Analysis

Introduction: Left ventricular assist devices (LVADs) are frequently employed as a bridge to transplant or destination therapy. The implementation of preventive preoperative measures can have a beneficial impact on the prognosis of patients undergoing LVAD implantation. However, the role of levosimendan in this context remains uncertain. Goals: To evaluate the efficacy of preoperative levosimendan in reducing complications after LVAD implantation. Methods: We systematically searched PubMed, Scopus, and Cochrane Library for studies comparing the use of levosimendan before LVAD implantation vs. standard of care alone in May 2023. Statistical analyses were performed using Review Manager 5.4.1. Heterogeneity was assessed with I2 statistics. Results: Four studies comprising 4032 patients who underwent LVAD implantation were included, of whom 15,2% were on preoperative levosimendan. There was no significant difference between groups in 30-day mortality (OR, 0.95 [95% CI, 0.70-1.28], I2=0%, p=0.73 - Fig. 1A), right ventricular failure (OR, 0.92 [95% CI, 0.47-1.80], I2=69%, p=0.81 - Fig. 1B), or length of intensive care unit (ICU) stay (mean difference, 2.63 [95% CI, -2.07-7.33], I2=92%, p=0.27 - Fig. 1C). Conclusions: In this meta-analysis, the preoperative use of levosimendan was not associated with reduced mortality, right ventricular failure, or length of ICU stay in patients undergoing LVAD implantation.

Abstract 18152: Clinical Impact and Mechanism of De Novo Aortic Insufficiency During Percutaneous Ventricular Assist Device Support for Cardiogenic Shock

Introduction: Recently, percutaneous ventricular assist device (p-LVAD) has been widely applicable for cardiogenic shock. Clinically significant aortic insufficiency (AI) is contraindication for p-LVAD, nevertheless p-LVAD itself can cause de novo AI (dAI) during the support. However the detail of dAI during p-LVAD support was not fully investigated. The aim of this study was to evaluate the clinical impact of AI during p-LVAD support and also investigate the mechanism and risk factor of dAI. Methods: Seventy-seven consecutive patients who underwent p-LVAD support (average age 66.7 years, Impella CP/2.5 in 65 and 5.5/5.0 in 12 cases) from 2018 to 2022 were retrospectively evaluated. The average support periods was 8.0±6.9 days. dAI was defined as development of AI ≥ moderate during p-LVAD support. Aortic valve pathology was examined using autopsy specimens in eight patients. Results: Three patients had AI ≥ moderate before p-LVAD support and underwent surgical intervention (AVR in 2 and AV repair in 1) during p-LVAD support. dAI was observed in 8 patients (10.3%, moderate in 7 and severe in 1). Moderate dAI in four of these patients improved after cardiac recovery and weaning of p-LVAD support. However, in 3 other patients with dAI ≥ moderate developed hemodynamic instability and deceased due to heart failure. In only a patient, moderate dAI remained after p-LVAD weaning with stable hemodynamics. Progression of AI after p-LVAD removal was not observed in all patients. In-hospital mortality was higher in the patient with dAI (75.0 vs. 47.8%, p=0.14). Pathological evaluation revealed hemorrhagic change at LV side of aortic valve with hemosiderin-laden macrophages in 3 autopsy specimens, which suggested contact of p-LVAD catheter. The univariate analysis identified mild AI before p-LVAD support as independent risk factor for dAI (Odd ratio 5.5, 95%CI 0.074-0.45, p&lt;0.001). Conclusions: Our study demonstrated that de novo AI frequently occurred during p-LVAD support and had a negative impact on hemodynamics and prognosis. Interference with aortic valve by the p-LVAD catheter may cause and exacerbate AI, even in the cases with pre-existing mild AI. Surgical intervention is essential to improve hemodynamics for severe and permanent AI during p-LVAD support.