Ventricular Assist Device Research Articles

The Society of Thoracic Surgeons National Intermacs Database Risk Model for Durable Left Ventricular Assist Device Implantation.

Statistical risk models for durable left ventricular assist device (LVAD) implantation inform candidate selection, quality improvement, and evaluation of provider performance. We developed a 90-day mortality risk model utilizing The Society of Thoracic Surgeons National Intermacs Database (STS Intermacs). STS Intermacs was queried for primary durable LVAD implants from 1/ 2019 - 9/2023. Multivariable logistic regression was used to derive a model based upon pre-implant risk factors using derivation (2019-2021 implants) and validation (2022-2023 implants) cohorts. Model performance (derivation and validation cohorts) was assessed using C-statistics, Brier Scores, and calibration plots. A refined model (all patients) was generated to calculate observed/expected [O/E, 95% confidence intervals (CI)] ratios for each center. The study population consisted of 11,342 patients from 2019-2023 sequentially divided in time into derivation (n=6,775) and validation (n=4,567). Ninety-day mortality was 8.0% (9.2% in derivation cohort vs. 7.4% in validation cohort; p=0.001). Logistic regression applied to derivation and validation cohorts produced similar discrimination (area under the curve (AUC) 0.714, CI: 0.69-0.74 and AUC 0.707, CI: 0.67-0.72, respectively) and calibration (Brier score .08 vs .07), with overestimation of risk among patients with predicted risk > 0.4. The O/E analysis identified 22 (12.5%) centers with worse-than-expected mortality with a CI > 1.0 and 14 centers (8.0%) with better-than-expected mortality with a CI < 1.0 (all p < 0.05). The STS Intermacs Risk Model demonstrated satisfactory discrimination and calibration. This tool may be used to inform candidate selection, facilitate quality improvement, and assess provider performance.

Regional Variation In Engagement Of Remote Patient Monitoring (RPM) Data Among Left Ventricular Assist Device Patients.

Regional Variation In Engagement Of Remote Patient Monitoring (RPM) Data Among Left Ventricular Assist Device Patients.

Prediction Of Adverse Events After Left Ventricular Assist Device Implantation Based On Pre-implantation Comorbidities

Prediction Of Adverse Events After Left Ventricular Assist Device Implantation Based On Pre-implantation Comorbidities

Left Atrial Reverse Remodeling In Patients Supported With Durable Left Ventricular Assist Devices And Clinical Implications

Left Atrial Reverse Remodeling In Patients Supported With Durable Left Ventricular Assist Devices And Clinical Implications

Epidemiology and Impact of Device-Specific Infections on Patients Receiving Left Ventricular Assist Devices

Epidemiology and Impact of Device-Specific Infections on Patients Receiving Left Ventricular Assist Devices

Efficacy Of Left Ventricular Assist Device In Advanced Heart Failure Among Patients With Chronic Kidney Disease And End Stage Renal Disease

Efficacy Of Left Ventricular Assist Device In Advanced Heart Failure Among Patients With Chronic Kidney Disease And End Stage Renal Disease

Numerical Optimization of the Hydraulic and Hemolytic Performance of a Centrifugal Ventricular Assist Device Based on Impeller Flow Passage and Outlet Geometry

As technology continues to advance and modern lifestyles become increasingly mechanized, the prevalence of heart disease is steadily growing. On the other hand, donor hearts ready for transplantation are limited worldwide. Therefore, blood pumps are a suitable alternative to help the patient during the waiting period and even until the end of life. Blood pumps must meet biological requirements, including adequate output pressure and flow rate, within an acceptable margin of safety in the event of blood damage. Reduction of pump size, blood exposure time, and blood damage such as hemolysis have been mentioned as important challenges in the design of blood pumps. Statistics show that 30% of the patients who use a left ventricular blood pump need a right ventricular blood pump due to right ventricular failure. The purpose of this research is to determine the effect of the geometrical shape of the impellers (flow passage) and the thrust tube geometry of the volute chamber on the pump’s hydraulic performance, the amount of axial and radial forces, and the amount of blood damage. So, for this study, six blades and two types of geometry for the volute chamber thrust tube were designed. This pump has been simulated using computational fluid dynamics used the Ansys CFX 17. Finally, the appropriate pump has been selected for low hemolysis index (HI). The HI calculated using the Lagrangian method is 0.00279 in the pump with a flow rate of 5 L per minute and 1100 rpm.

Impact of Left Ventricular Size on Outcomes Following HeartMate 3 Left Ventricular Assist Device Implantation: Analysis of the European Registry for Patients With Mechanical Circulatory Support (EUROMACS).

We investigated the association of preimplant left ventricular end-diastolic diameter (LVEDD) with outcomes after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation. Patients from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) registry who underwent HM3 implantation from August 2014 to February 2023 (n = 834) were analyzed according to preoperative LVEDD: less than or equal to 65 (n = 251), 65-80 (n = 441), and greater than or equal to 80 mm (n = 142). The mean age was 54.4 ± 12.4 years, body surface area (BSA) 2.0 ± 0.23 m2, body mass index (BMI) 27.3 ± 5.0 kg/m2; 87.9% were male and 40% had ischemic cardiomyopathy. Patients with LVEDD less than or equal to 65 mm were older (56.1 ± 11.0 vs. 53.8 ± 13.0 vs. 53.0 ± 12.3 years; p = 0.015), more female (17.9% vs. 11.6% vs. 4.9%; p < 0.001), smaller BSA (1.95 ± 2.03 vs. 2.01 ± 0.22 vs. 2.08 ± 0.22 m2; p < 0.01) and lower BMI (26.6 ± 4.8 vs. 27.4 ± 5.1 vs. 28.2 ± 5.0; p = 0.01) compared to LVEDD 65-80 and greater than or equal to 80 mm, respectively. One year survival was associated with increasing LVEDD (75.7% vs. 84.6% vs. 89.5%; p = 0.003). Patients with LVEDD less than or equal to 65 mm had a higher risk of postoperative right heart failure (14.7% vs.10.4% vs. 6.8%; p = 0.03), the risk for postoperative stroke was similar (10% vs. 12.8% vs. 9.5%; p = 0.4). A small left ventricular (LV) size (LVEDD ≤ 65 mm) was associated with an increase in postoperative right heart failure and unadjusted 1 year mortality in adults who underwent HM3 LVAD implantation.

Exercise and cardiac rehabilitation after LVAD implantation.

Left ventricular assist devices (LVAD) have improved mortality and quality of life for patients with end-stage heart failure by providing an alternative to cardiac transplant or as a bridge to transplantation. The improvement in functional capacity however is minimal to modest depending on the right ventricular function, optimal hemodynamics on LVAD therapy, and comorbidities. There is improvement in submaximal exercise capacity but improvement in peak aerobic capacity is limited. Exercise capacity can be improved by referral to cardiac rehabilitation after LVAD implantation. Cardiac rehabilitation is safe and effective with improvement in functional capacity, and decrease in mortality and heart failure hospitalizations. Cardiopulmonary exercise testing (CPET) is a specialized exercise stress test that measures gas exchange during exercise to determine a variety of variables that have been shown to be predictive of mortality in patients undergoing cardiac transplant. CPET is valuable for prognostication and is a predictor of adverse outcomes, including right heart failure in the immediate post-LVAD implantation period, long-term mortality. CPET is an additional testing that can aid in the decision making for LVAD explantation or decommissioning.

Over 100 Fontan Patients on Systemic Ventricular Assist Device Support: An ACTION Update.

As the Fontan population grows, understanding successful strategies for ventricular assist device (VAD) support of the failing Fontan circulation is needed. We performed a retrospective analysis of patients with Fontan circulation and systemic VAD support in the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry. Competing outcomes and Kaplan-Meier estimated survival methods were used. Between January 2012 and December 2022, 106 Fontan patients underwent VAD implant (median age 10 years, 20% age ≥18 years). At time of implant, 58% were on greater than or equal to 2 inotropes, 26% on extracorporeal membrane oxygenation (ECMO), and 41% intubated. Since 2018, there have been more patients implanted at INTERMACS profile 1 or 2 (88% vs. 71%, p = 0.02) and on inotropic support (95% vs. 76%, p = 0.01). Median duration of VAD support was 113 (interquartile range (IQR): 43-266) days. At 12 months post-VAD implant, 53% were transplanted, 27% were alive on device, 2% had successful recovery, and 18% had died. Overall, 75% experienced greater than or equal to 1 adverse event, with bleeding, infection, and neurologic dysfunction most common. Despite high acuity at the time of VAD implant and high rate of adverse events, the majority of Fontan patients were transplanted or still alive on device at 12 months post-VAD implant.

Comparing mental health and substance use disorders in patients receiving durable VADs versus transplants: A TriNetX database analysis.

Ventricular assist device (VAD) and cardiac transplant patients experience significant strain on their physical and mental wellbeing postoperatively. Mental health and substance use disorders (MHDs and SUDs) have substantial effects on the quality of life and compliance of transplant and VAD patients. In this study, we compare and characterize MHDs and SUDs between VAD and cardiac allograft patients and transplant list patients with and without VADs. This study compares the incidence of MHDs and SUDs between VAD and cardiac transplant patients. Cohorts were defined using ICD-10 codes in TriNetX, a large public database. Patient characteristics were matched by using propensity score matching. Incidence was analyzed using the log-rank test. Statistical significance was set at p < 0.05. Survival analysis showed a statistically significant impact of adjustment disorder, nicotine dependence, and mood disorder in VAD patients as compared to cardiac allograft recipients. Depression and opioid use disorder had a significantly higher incidence in post-transplant patients compared to their VAD counterparts. Survival analysis showed that PTSD and mood disorder had a statistically significant effect on the patients waiting on transplant wait list without VADs as compared to those with VADs. MHDs and SUDs have profound implications on quality of life, survival, and medication compliance. The incidence of MHDs and SUDs differed between VAD versus cardiac transplant patients as well as the patients on the transplant waitlist with and without VADs. Mental health resources should be tailored to address risk factors that may be unique to each group of patients.

The Impact of Genetic Polymorphism on Complication Development in Heart Failure Patients

Background: Despite the high progress that has been made in the field of cardiology, the left ventricular assist device (LVAD) can still cause complications (thrombosis/bleeding) in heart failure (HF) patients after implantation. Complications develop due to the incorrect dose of antithrombotic therapy, due to the influence of the non-physiological shear stress of the device, and also due to inherited genetic polymorphisms. Therefore, the aim of our study is to identify the influence of the genetic polymorphisms on complication development in HF patients with implanted LVADs with prescribed antiplatelet therapy. Methods: Our study investigated 98 HF patients with/without complications who were genotyped for 21 single-nucleotide polymorphisms (SNPs) associated with cardiovascular events, the coagulation system, and the metabolism of warfarin and aspirin drugs. This study performed a more detailed analysis on genetic polymorphism in the UGT1A6 gene and its influence on aspirin dose. Results: SNP rs2070959 in the UGT1A6 gene showed a significant association with the group of HF patients with complications [(OR (95% CI): 4.40 (1.06–18.20), p = 0.044]. The genetic polymorphism of rs2070959 in the UGT1A6 gene showed a significant association in HF patients who received aspirin treatment on the 12th month after LVAD implantation [OR (95% CI): 5.10 (1.31–19.87), p = 0.018]. Moreover, our genotype distribution analysis showed that the GG genotype of rs2070959 in the UGT1A6 gene was significantly higher in the group with aspirin treatment than without treatment after the 12th month of treatment (50.0% vs. 0%, p = 0.008), especially in the group of patients with complications. A higher frequency of the GG genotype with long-lasting aspirin therapy up to the 12th month showed that 100 mg of aspirin was not an effective dose in the group of patients with complications. Conclusions: Our study identified that genotyping for genetic polymorphism rs2070959 in the UGT1A6 gene could predict the recommended dose of aspirin in HF patients, which could help to prevent and predict complication development after LVAD implantation.

Racial and Ethnic Disparities in the Outcomes and Treatment of Patients Admitted with Heart Failure: A Nationwide Analysis

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 &lt; 0.001) and Hispanic (aOR 0.78; 95% CI 0.69–0.88; p &lt; 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 &lt; 0.001) and in Hispanic (aOR 0.72; 95% CI 0.63–0.81; p &lt; 0.001) people. The rates of acute respiratory failure were also lower in Black (aOR 0.72; 95% CI 0.69–0.74; p &lt; 0.001) and Hispanic (aOR 0.77; 95% CI 0.73–0.81; p &lt; 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 &lt; 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 &lt; 0001), a ventricular assist device (aOR 0.45; 95% CI 0.34–0.59; p &lt; 0.001), and heart transplants (aOR 0.57; 95% CI 0.42–0.77; p &lt; 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 &lt; 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.

LVAD versus CIED Infections: Distinct Entities, Distinct Suppression Strategies

Abstract A distinction between infections of left ventricular assist devices (LVADs) and cardiac implantable electronic devices (CIEDs) is warranted as they differ markedly in incidence, microbiologic profiles, clinical presentations, and extraction feasibility. These differences necessitate tailored suppressive antibiotic therapy (SAT) strategies. This commentary highlights the need for device-specific SAT approaches.

Intravascular Imaging to Guide Percutaneous Treatment for LeftVentricular Assist Device ExtrinsicOutflow Graft Occlusion.

Intravascular Imaging to Guide Percutaneous Treatment for LeftVentricular Assist Device ExtrinsicOutflow Graft Occlusion.

Artificial Heart Valve Scaffold Based on Electrospun PCL/PU Three-Layer Composite Fibers

Abnormal heart valve function is a major cause of heart disease and is often associated with high rates of morbidity and mortality from heart disease. Focusing on the field of valve replacement, tissue-engineered heart valves are becoming popular and attracting more attention. In this work, an artificial heart valve scaffold based on polycaprolactone/polyurethane (PCL/PU) three-layer composite fibers was prepared by 3D printing and electrospinning, including an inner PCL layer, a middle PCL/PU layer, and an outer PCL layer. The obtained valve scaffold had strong circumferential mechanical properties when PCL/PU = 1:2, and its elastic modulus was 14.7 MPa, similar to that of natural valve. The heart valve scaffold had good cytocompatibility, and the final cell survival rate was 99.8% after 14 days of cell culture. The layered structure makes the artificial heart valve more similar to the natural structure of the mammalian heart, which is conducive to cell proliferation and differentiation, and provides a reference solution for interventional treatment of heart valves.

A Systematic Review and Meta-Analysis of an Angiotensin Receptor-Neprilysin Inhibitor in Patients Using a Durable Left Ventricular Assist Device.

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.

Citrate-Coated Iron Oxide Nanoparticles Facilitate Endothelialization of Left Ventricular Assist Device Impeller for Improved Antithrombogenicity.

Although left ventricular assist devices (LVADs) are an alternative to heart transplantation, their artificial surfaces often lead to serious thrombotic complications requiring high-risk device replacement. Coating blood-contacting surfaces with antithrombogenic endothelial cells is considered an effective strategy for preventing thrombus formation. However, this concept has not yet been successfully implemented in LVADs, as severe cell loss is to be expected, especially on the impeller surface with high prothrombogenic supraphysiological shear stress. This study presents a strategy that exploits the magnetic attraction of the impeller on ECs loaded with iron oxide nanoparticles (IONPs) to minimize shear stress-induced cell detachment from the rotating magnetic impeller while ensuring antithrombogenic EC adhesion, especially as a bridge until they formed their adhesion-promoting matrix. In contrast to polyvinylpyrrolidone (PVP)-coated IONPs, more efficient and safer cell loading is achieved with sodium citrate (Cit)-stabilized IONPs, where incubation with 6.6 µg iron mL-1 Cit-IONPs for 24 h resulting in an average internalization of 23 pg iron per cell. Internalization of Cit-IONP significantly improved cell attraction to the highly magnetic impeller surface without affecting cell viability or antithrombogenic function. This protocol is key for the development of a biohybrid LVAD impeller that can prevent life-threatening thrombosis and hemorrhage in a future clinical application.

Advancing LVAD Technology: Overcoming Challenges and Shaping the Future of Mechanical Circulatory Support.

Ventricular assist devices (VADs) invigorated the management of patients with advanced heart failure, providing a lifeline for patients awaiting transplantation or requiring long-term circulatory support. This article reviews recent advances in VAD technologies, focusing on key areas of progress to overcome existing challenges and the potential for future applications. The reduction or possible elimination of infection-prone components and the evolution to transcutaneous energy transfer systems are two main research fields to reach a new quality of life category for VADs patients. Miniaturization and enhanced biocompatibility have resulted in smaller, less invasive devices with a significantly reduced risk of complications and mortality. Advances in percutaneous ventricular assist devices have emerged, contributing to the creation of less invasive options with or without intracardiac pumps, and facilitating their use for both left and right ventricles. These devices have gained more and more features, including the use of artificial intelligence. Moreover, the possibility of long-term use of intracardiac pumps offers a potential bridge to transplantation, allowing ambulation and probably also long-term circulatory support. Despite considerable advances, challenges remain, particularly in terms of improving durability, reducing the risk of ischemic events, further refining materials, and more sophisticated control and synchronization between systems that adapt to changing physiological demands.

Two Coupled Continuous-Flow Ventricular Assist Devices as a Novel BIVAD With One Driveline-Acute Animal Study Results.

The study assesses the feasibility of the DuoCor BiVAS, a novel biventricular assist system integrating magnetic levitation technology. In an acute large animal model involving five sheep, each received the DuoCor BiVAS without cardiopulmonary bypass. Hemodynamic and device parameters were monitored continuously for 1-h post-implantation. Intraoperative implantation was uneventful, demonstrating successful biventricular support with mean blood flows of 5.4 LPM (left) and 5.5 LPM (right). Analysis showed proportional flow rates and relationships between pump speed, flow, and power consumption. No adverse events like thrombus formation, bleeding, stroke, or device failure occurred. This research underscores the DuoCor BiVAS's potential for severe biventricular heart failure treatment, providing insights into its feasibility and functionality in acute animal models. The findings suggest promising clinical applications, particularly with the system's single driveline design potentially enhancing patient mobilization and quality of life. Further investigations are needed to advance this technology for broader clinical use.