Ventricular Assist Device Patients Research Articles

Bivalirudin Monitoring in Pediatric Ventricular Assist Device and Extracorporeal Membrane Oxygenation: Analysis of Single-Center Retrospective Cohort Data 2018-2022.

The activated partial thromboplastin time (aPTT) is the most frequently used monitoring assay for bivalirudin in children and young adults on mechanical circulatory support including ventricular assist devices (VADs) and extracorporeal membrane oxygenation (ECMO). However, intrinsic variability of the aPTT complicates management and risks bleeding or thrombotic complications. We evaluated the utility and reliability of a bivalirudin-calibrated dilute thrombin time (Bival dTT) assay for bivalirudin monitoring in this population. Retrospective analysis of clinical data (including aPTT, dilute thrombin time [dTT]) and results of residual plasma samples from VAD patients were assessed in two drug-calibrated experimental assays. One assay (Bival dTT) was validated for clinical use in VAD patients, and subsequently used by clinicians in ECMO patients. Pearson correlation and simple linear regression were used to determine R2 correlation coefficients between the different laboratory parameters using Statistical Package for Social Sciences (Armonk, NY). ICUs at Cincinnati Children's Hospital Medical Center. Children on VAD or ECMO support anticoagulated with bivalirudin. None. One hundred fifteen plasma samples from 11 VAD patients were analyzed. Both drug-calibrated experimental assays (anti-IIa and Bival dTT) showed excellent correlation with each other (R2 = 0.94) and with the dTT (R2 = 0.87), but poor correlation with aPTT (R2 = 0.1). Bival dTT was selected for validation in VAD patients. Subsequently, clinically ordered results (105) from 11 ECMO patients demonstrated excellent correlation between the Bival dTT and the standard dTT (R2 = 0.86) but very poor correlation with aPTT (R2 = 0.004). APTT is unreliable and correlates poorly with bivalirudin's anticoagulant effect in ECMO and VAD patients. A drug-calibrated Bival dTT offers superior reliability and opportunity to standardize results across institutions. Additional studies are needed to determine an appropriate therapeutic range and correlation with clinical outcomes.

Alterations in Sarcopenia Index are Associated with Inflammation, Gut and Oral Microbiota among Heart Failure, Left Ventricular Assist Device and Heart Transplant Patients.

BackgroundSarcopenia, characterized by loss of muscle mass and function, is prevalent in heart failure (HF) and predicts poor outcomes. We investigated alterations in sarcopenia index (SI), a surrogate for skeletal muscle mass, in HF, left ventricular assist device (LVAD) and heart transplant (HT), and assessed its relationship with inflammation and digestive tract (gut and oral) microbiota. MethodsWe enrolled 460 HF, LVAD and HT patients. Repeated measures pre/post procedures were obtained prospectively in a subset of LVAD and HT patients. SI (serum Creatinine/Cystatin C) and inflammatory biomarkers (C-reactive protein, interleukin-6, tumor necrosis factor-alpha) were measured in 271 and 622 blood samples, respectively. Gut and saliva microbiota were assessed via 16S rRNA sequencing among 335 stool and 341 saliva samples. Multivariable regression assessed the relationship between SI and i) New York Heart Association class; ii) pre- vs. post-LVAD or HT; iii) biomarkers of inflammation and microbial diversity. ResultsMedian (interquartile range) natural logarithm (ln)-SI was -0.13 (-0.32,0.05). Ln-SI decreased across worsening HF class, further declined at 1-month after LVAD and HT and rebounded over time. Ln-SI was correlated with inflammation (r=-0.28, p<0.01), and gut (r=0.28, p<0.01) and oral microbial diversity (r=0.24, p<0.01), these associations remained significant after multivariable adjustment in the combined cohort but not for all individual cohorts. Presence of the gut taxa Roseburia inulinivorans was associated with increased SI. ConclusionsSI levels decreased in symptomatic HF and remained decreased long-term after LVAD and HT. In the combined cohort, SI levels covaried with inflammation in a similar fashion and significantly related to overall microbial (gut and oral) diversity, including specific taxa compositional changes.

Temporarily Reversing Warfarin With Low-Dose 4-Factor Prothrombin Complex Concentrate in Left Ventricular Assist Device Patients Undergoing an Invasive Procedure.

American Association for Thoracic Surgery and The International Society for Heart and Lung Transplantation (AATS/ISHLT) guidelines recommend warfarin in patients with continuous-flow left ventricular assist devices (LVADs) to reduce the risk of device thrombosis and systemic embolization. Left ventricular assist device patients often undergo elective and emergent procedures that require interrupted anticoagulation. Data and experience vary on the optimal strategy to rapidly reverse warfarin in LVAD patients when an emergent procedure is planned. The purpose of this study was to describe the use of 4-factor prothrombin complex concentrate (PCC4) for warfarin reversal in patients with LVADs undergoing elective and emergent procedures. This retrospective, single-center, cohort review describes the use of PCC4 in patients with LVADs who require warfarin reversal for elective or emergent procedures. The primary outcome was a composite incidence of pump thrombosis, venous thromboembolism, and ischemic stroke within 30 days of PCC4 administration. In total, 14 patients received 17 administrations of PCC4. One patient received 3 administrations, and 1 other patient received 2 administrations during separate encounters. The median dose was 500 units or 6.6 units/kg (range = 4.2-14.1 units/kg). Of the PCC4 administrations, 82% (14/17) were for low bleed risk procedures and 76% (13/17) were for elective procedures. There were no cases of pump thrombosis, venous thromboembolism, or stroke within 30 days of the procedure. Low-dose PCC4 appears to be a safe and effective temporary reversal strategy for patients with LVADs undergoing low-bleed risk elective procedures.

Advance care planning in the treatment of implantable left ventricular assist device: a republication of the review published in Japanese Journal of Artificial Organs.

Advance care planning (ACP) is essential in managing serious and chronic illnesses to ensure that patients receive care aligned with their personal values, goals, and preferences. This review focuses on integrating ACP in the treatment of patients receiving implantable left ventricular assist devices (VADs). The heart failure palliative care team developed a unique advance directive form and pamphlet to facilitate ACP discussions, emphasizing not only medical treatment preferences but also patients' values and life goals.The study highlights the distinction between bridge to transplantation (BTT) and destination therapy (DT) in VAD patients, with different goals and considerations for ACP. The use of decision aids developed especially for DT candidates as a communication tool helps in sharing patients' wishes and facilitates shared decision-making, particularly in the complex decisions surrounding DT therapy.Challenges in implementing ACP, such as time constraints due to urgent medical conditions, difficulties in patient communication, and the recent COVID-19 pandemic, are addressed. The need for a comprehensive healthcare system capable of supporting patients' ACP wishes, especially in the community setting, is also pointed out.Future directions include not only developing materials to ease ACP discussions and ensuring that ACP content is shared among healthcare providers to foster collaborative and detailed planning, but also a call for widespread adoption of ACP in Japan.This is a translation of a paper written in Japanese Journal of Artificial Organs (Vol. 52, No. 1, pp. 89-92) with additions and corrections.

Management of aortic valve insufficiency in patients with continuous-flow left ventricular assist device: a republication of the review published in Japanese Journal of Artificial Organs.

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 1719days, 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.

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.

Epistaxis Rates and Health Care Utilization in Patients With a Ventricular Assist Device.

Identify baseline epistaxis rates and epistaxis-related health care utilization trends in the ventricular assist device (VAD) population. Single center, retrospective cohort study consisting of chart review of adult VAD patients. Analysis of descriptive statistics was assessed using χ 2 tests, independent sample t tests, or Fisher's exact when expected counts were low. Logistic regression was used to assess associations between epistaxis and variables of interest. Two hundred ninety patients were included in the analysis. Ninety-eight (33.8%) patients developed epistaxis and 84 (29.0%) received medical attention. Patients with gastrointestinal (GI) bleeding had increased rates of epistaxis (42.4% vs 29.0%). Logistic regression analysis found GI bleeding to have an adjusted odds of developing epistaxis of 1.94 (95% confidence interval [CI]: 1.12-3.37) and kidney disease to have an adjusted odds of 1.83 (95% CI: 1.06, 3.13). VAD implantation improves survival and quality of life but also carries significant bleeding risks. At our institution, 29% of VAD patients received medical attention for epistaxis. GI bleeding and kidney disease were found to have increased adjusted odds of developing epistaxis. Fifty-nine percent of epistaxis events occurred while inpatient and 32.8% of events were seen in the emergency department. VAD patients are an at-risk group that could potentially benefit from preventative nasal hydration regimen.

(78) - Impact of Vitamin K Antagonist Therapy on Outcomes in a Randomized Controlled Trial of Aspirin Removal in Left Ventricular Assist Device Patients - A Pre-Specified Analysis from The ARIES Trial

(78) - Impact of Vitamin K Antagonist Therapy on Outcomes in a Randomized Controlled Trial of Aspirin Removal in Left Ventricular Assist Device Patients - A Pre-Specified Analysis from The ARIES Trial

(111) - Impact of Concomitant Surgical Procedures in a Randomized Controlled Trial of Aspirin Removal in Left Ventricular Assist Device Patients - An Analysis from The ARIES Trial

(111) - Impact of Concomitant Surgical Procedures in a Randomized Controlled Trial of Aspirin Removal in Left Ventricular Assist Device Patients - An Analysis from The ARIES Trial

(844) - Characterization and Treatment of Iron Deficiency in Left Ventricular Assist Device Patients

(844) - Characterization and Treatment of Iron Deficiency in Left Ventricular Assist Device Patients

(60) - Dynamic and Structural Ophthalmic Evaluation of Continuous-Flow Left Ventricular Assist Device Patients

(60) - Dynamic and Structural Ophthalmic Evaluation of Continuous-Flow Left Ventricular Assist Device Patients

(1308) - A Multidisciplinary Protocol for Anticoagulation Reversal in Left Ventricular Assist Device Patients Presenting with Intracranial Hemorrhage

(1308) - A Multidisciplinary Protocol for Anticoagulation Reversal in Left Ventricular Assist Device Patients Presenting with Intracranial Hemorrhage

(512) - Are the Bleeding and Thrombosis Complications in Left Ventricular Assist Device Patients as Impactful as Infection and Rejection in Heart Transplant Recipients?

(512) - Are the Bleeding and Thrombosis Complications in Left Ventricular Assist Device Patients as Impactful as Infection and Rejection in Heart Transplant Recipients?

(845) - The R-Wave Amplitude Negatively Correlates with Preload in Stable Ventricular Assist Device Patients During Acute Postural Changes

(845) - The R-Wave Amplitude Negatively Correlates with Preload in Stable Ventricular Assist Device Patients During Acute Postural Changes

(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

(1079) - Clinician Assessed Versus Objective Measures of Frailty in Left Ventricular Assist Device Patients

(1079) - Clinician Assessed Versus Objective Measures of Frailty in Left Ventricular Assist Device Patients

Socio-economic position, multimorbidity, and health care utilization among Danish left ventricular assist device patients.

Increasing numbers of patients with advanced heart failure and significant comorbidity and social barriers are considered for left ventricular assist devices (LVADs). We sought to examine health care utilization post-LVAD implantation, including the influence of individual-level socio-economic position and multimorbidity. We conducted a Danish nationwide cohort study linking individual-level data from clinical LVAD databases, the Scandiatransplant Database, and Danish national medical and administrative registries. Socio-economic position included cohabitation status, educational level, and employment status. Multimorbidity was defined as two or more chronic conditions from at least two chronic disease groups. Health care utilization (hospital activity, general practice activity, and redeemed medical prescriptions) within 2years post-discharge after LVAD implantation was evaluated using descriptive statistics at 0.5year intervals. We identified 119 patients discharged alive with first-time LVAD implanted between 2006 and 2018. The median age of the patients was 56.1years, and 88.2% were male. Patients were followed until heart transplantation, LVAD explantation, death, 31 December 2018, or for 2years. The median follow-up was 0.8years. The highest median use of health care services was observed 0-0.5years post-LVAD discharge compared with the subsequent follow-up intervals: 0.5-1, 1-1.5, and 1.5-2years, respectively. The median (interquartile range) number of hospitalizations was 10 (7-14), bed days 14 (9-28), outpatient visits 8 (5-12), telephone contacts with a general practitioner 4 (2-8), and total redeemed medical prescriptions 26 (19-37) within 0-0.5years post-LVAD discharge compared with the median utilization within the consecutive follow-up periods [e.g. within 0.5-1year: hospitalizations 5 (3-8), bed days 8 (4-14), outpatient visits 5 (3-8), telephone contacts 2 (0-5), and redeemed medical prescriptions 24 (18-30)]. The median use of health care services was stable from 0.5years onwards. The median number of hospitalizations and bed days was slightly higher in patients living alone with a low educational level or low employment status within 0-0.5years post-LVAD implantation. Finally, the median number of in-hospital days and redeemed prescriptions was higher among patients with pre-existing multimorbidity. Among patients who underwent LVAD implantation, health care utilization was high in the early post-LVAD discharge phase and was influenced by socio-economic position. Multimorbidity influenced the number of in-hospital days and redeemed prescriptions during the 2year follow-up.

Tailoring left ventricular assist device cannula implantation using coupled multi-scale multi-objective optimization

BackgroundThe frequent occurrence of thromboembolic cerebral events continues to limit the widespread implementation of Ventricular Assist Devices (VAD) despite continued advancements in VAD design and anti-coagulation treatments. Recent studies point to the optimal positioning of the outflow graft (OG) as a potential mitigator of post implantation thromboembolism. ObjectiveThis study aims to examine the tailoring of the OG implantation orientation with the goal of minimizing the number of thrombi reaching the cerebral vessels by means of a formal shape optimization scheme incorporated into a multi-scale hemodynamics analysis. MethodsA 3-D patient-specific computational fluid dynamics model is loosely coupled in a two-way manner to a 0-D lumped parameter model of the peripheral circulation. A Lagrangian particle-tracking scheme models and tracks thrombi as non-interacting solid spheres. The loose coupling between CFD and LPM is integrated into a geometric shape optimization scheme which aims to optimize an objective function that targets a drop in cerebral embolization, and an overall reduction in particle residence times. ResultsThe results elucidate the importance of OG anastomosis orientation and placement particularly in the case that studied particle release from the OG, as a fivefold decrease in cerebral embolization was observed between the optimal and non-optimal implantations. Another case considered particle release from the ventricle and aortic root walls, in which optimal implantation was achieved with a shallow insertion angle. Particle release from all three origins was investigated in the third case, demonstrating that the optimal configurations were generally characterized by VAD flow directed along the central lumen of the aortic arch. Because optimal configurations depended on the anatomic origin of the thrombus, it is important to determine, in clinical studies, the most likely sites of thrombus formation in VAD patients.

Ventricular Arrhythmias in Left Ventricular Assist Device Patients-Current Diagnostic and Therapeutic Considerations.

Left ventricular assist devices (LVAD) are used in the treatment of advanced left ventricular heart failure. LVAD can serve as a bridge to orthotopic heart transplantation or as a destination therapy in cases where orthotopic heart transplantation is contraindicated. Ventricular arrhythmias are frequently observed in patients with LVAD. This problem is further compounded as a result of diagnostic difficulties arising from presently available electrocardiographic methods. Due to artifacts from LVAD-generated electromagnetic fields, it can be challenging to assess the origin of arrhythmias in standard ECG tracings. In this article, we will review and discuss common mechanisms, diagnostics methods, and therapeutic strategies for ventricular arrhythmia treatment, as well as numerous problems we face in LVAD implant patients.

Mechanical Characterization of Anchoring Devices for the Prevention of Driveline Infection in Left Ventricular Assist Device Patients.

Driveline infection (DLI) is associated with increased mortality and morbidity in left ventricular assist device (LVAD) patients. Because trauma to the driveline exit-site (DLES) is a risk factor for DLI, adhesive anchoring devices are used to immobilize the DL. In this study, commonly used products (identified through literature review and contact with nine international VAD implantation centers) were mechanically characterized to evaluate their effectiveness in preventing DLES trauma. Eight devices were tested in an in vitro abdominal model of the DLES, where a tensile force (10 N) was applied to a HeartMate 3 DL, whereas the resulting force ( FTotal ) on the DLES was recorded using a three-axis load cell. Four devices (CathGrip: FTotal = 2.1 ± 0.4 N, Secutape: FTotal = 2.6 ± 0.3 N, Hollister: FTotal = 2.7 ± 0.5 N, Tubimed: FTotal = 2.9 ± 0.2 N) were significantly ( p < 0.05) better at preventing tensile forces at the DLES compared to the other four devices (Main-Lock: FTotal = 3.7 [0.7] N, Secutape sensitive: FTotal = 3.9 ± 0.4 N, Foley Anchor: FTotal = 4.3 ± 0.5 N, Grip-Lok: FTotal = 5.4 ± 0.8 N). Immobilization of the DL with each anchoring device resulted in lower tensile force on the DLES than without an anchor ( FTotal = 8.2 ± 0.3 N). In conclusion, the appropriate selection of anchoring devices plays a critical role in reducing the risk of DLI, whereas the CathGrip, Secutape, Hollister, or Tubimed were superior in preventing trauma to the DLES in this study.