Ventricular Assist Device Research Articles

Clinical outcomes of modified left ventricular assist device driveline management.

Left ventricular assist devices (LVADs) are implanted in patients with heart failure to support cardiac circulation. However, no standardized methods have been established for LVAD driveline exit site management for the prevention of infections. Therefore, this study evaluated the efficacy of modified driveline management compared with that of conventional driveline management. We retrospectively assessed the outcomes of 262 patients who underwent continuous-flow LVAD implantation between January 2005 and March 2023 at Osaka University in Japan. In conventional driveline management, an LVAD driveline penetrates the skin along the body surface and is fixed near the penetration site (n = 224). In contrast, in our modified fixation method, the LVAD driveline vertically penetrates the skin to prevent ischemia at the driveline exit site and is fixed at a distant abdominal site to prevent the movement of the driveline exit site due to body movement (n = 38). The rates of freedom from LVAD driveline infection in patients with conventional driveline management were 86, 75, and 63% at 1, 2, and 3years after LVAD implantation, respectively. The rate of freedom from LVAD driveline infection in patients managed by the modified fixation method was 91% at 1, 2, as well as 3years after LVAD implantation. The freedom rates from LVAD driveline infection in the patients with modified fixation method was lower than in the patients with the conventional method (p = 0.04). Our study revealed that the modified fixation method may offer the possibility for preventing LVAD driveline infection.

The burden of left ventricular assist device (LVAD) infections on costs, lengths of stay, antimicrobial consumption and resistance: a prospective case control approach

BackgroundCongestive heart failure has reached pandemic levels, and left-ventricular assist devices (LVAD) are increasingly used to treat refractory heart failure. Infection is a leading complication of LVADs. Despite numerous reports (most being retrospective), several knowledge gaps pertaining to the epidemiology and burden of an LVAD-associated infection (LVADi) remain. We sought to address these gaps using a prospective, case-control design.MethodsAll patients who received an LVAD from November 1, 2018 to August 31, 2023 (n = 110) were included and prospectively monitored until death. Data were extracted from clinical encounters and medical records in real-time or near real-time and imported to Excel and REDcap electronic data capture tools. An LVADi was ascertained using definitions from the mechanical circulatory support academic research consortium in conjunction with and the U.S. National Health Safety Network. All meeting those definitions were included as ‘cases.’ Patients with no LVADi were controls. Excess lengths-of-stays (LOS) and direct costs were calculated from billing records using a commercial cost accounting software platform (Strata®, Chicago, IL).ResultsThe amount of healthcare contact before implantation and discharge to a rehabilitation or skilled nursing facility instead of home were the primary risks for infection, resulting in mean excesses of 25 hospital and 60 antibiotic-days and $43,000 per event. One-third occurred > 1 year after implantation. 35% developed > 1 infection. Gram-negative, fungal, and antimicrobial-resistant organisms predominated deep or repeat infections. 7.2% developed ≥ 3 infections. Organisms became increasingly antimicrobial resistant with subsequent infections, leading to extensive or pan-drug resistance in 4.5% of patients. The burden of an LVADi was 1862 excess hospital days, 3960 excess antibiotic days, and $3.4 million.ConclusionsPatients with LVADis had significant increases in costs, LOS, readmissions, and antibiotic usage. Antimicrobial resistance varied directly with the number of repeat infections and antibiotic exposure. Identification of factors associated with LVADi, and quantification of the burden of LVADi can inform prevention efforts and lead to reduced infection rates. As preventing infections in the first place is also important for limiting the emergence of antimicrobial resistance, we offer strategies to avoid LVADis.Trial registryNot applicable.

System Proposal for Supervision of Critical Adverse Processes in Patients with Implanted Ventricular Assist Devices

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.

Impact of concomitant aortic valve replacement in patients with mild-to-moderate aortic valve regurgitation undergoing left ventricular assist device implantation: EUROMACS analysis.

Left ventricular assist device (LVAD) therapy may lead to an aortic regurgitation, limiting left ventricular unloading and causing adverse events. Whether concomitant aortic valve replacement may improve outcomes in patients with preoperative mild-to-moderate aortic regurgitation remains unclear. A retrospective propensity score-matched analysis of adult patients with preoperative mild-to-moderate aortic regurgitation undergoing durable LVAD implantation between 01/01/2011 and 30/11/2021 was performed. Patients undergoing concomitant valve surgery other than biological aortic valve replacement were excluded, resulting in 77 with concomitant biological aortic valve replacement and 385 without. Following 1:1 propensity score matching, two groups of 55 patients with and without biological aortic valve replacement were obtained, (mean age 59 ± 11 years, 92% male, 59.1% HeartWare). Aortic regurgitation was mild in 72.7% and 76.4% and moderate in 27.3% and 23.6% in non-replacement and replacement cohorts respectively. The 30-day survival was 89.1% vs. 85.5% (p = 0.59), 1-year survival 69.1% vs. 56.4% (p = 0.19), and 2-year survival 61.8% vs. 47.3% (p = 0.10) in the non-replacement and replacement groups, respectively. After a mean follow-up of 1.2 years, non-replacement patients had a higher incidence of pump thrombosis (11 [20%] vs. 3 [5.5%], p = 0.022) and fewer major bleedings (2 [3.6%] vs. 11 [20%], p = 0.008). Compared with those treated conservatively, patients with mild-to-moderate aortic regurgitation undergoing concomitant aortic valve replacement during LVAD implantation have a similar survival up to 2 years on support. Patients with concomitant valve replacement had a higher risk of bleeding complications but fewer pump thromboses.

Long-term outcomes of apixaban as main anticoagulant in patients with HeartMate 3 left ventricular assist devices.

HeartMate 3 (HM3) left ventricular assist devices (LVADs) offer improved haemocompatibility-related outcomes for end-stage heart failure patients, facilitating the exploration of alternative anticoagulation therapies beyond warfarin. This study presents a long-term evaluation of thrombotic and bleeding outcomes in HM3 LVAD patients transitioned from warfarin to apixaban. We retrospectively identified HM3 LVAD patients at our single centre who transitioned from warfarin to apixaban. Baseline characteristics were described at discharge from implant hospitalization and at the last follow-up on each anticoagulation regimen. We reported survival, thrombo-embolic events (including LVAD pump thrombosis, stroke, arterial thrombo-embolic events and pump exchange) and bleeding events on both warfarin and apixaban. Eight patients were identified between May 2018 and June 2022 who transitioned from warfarin to apixaban 5mg twice daily. Patients were followed for a mean of 1233days after LVAD implantation and 789days after transition to apixaban. All patients were transitioned due to difficulty maintaining a therapeutic international normalized ratio (INR), including five patients who experienced bleeding complications on warfarin. No patients encountered LVAD pump thrombosis, stroke events, arterial thrombo-embolic event, pump exchange or death. While on warfarin, five patients had eight bleeding events: one major [requiring 2units of packed red blood cells (pRBCs)] and seven minors (five gastrointestinal bleeds, one episode of haematuria and one episode of haemoptysis). After switching to apixaban, one patient with angioectasia had a major gastrointestinal bleed requiring two pRBCs and endoscopic clipping. Apixaban demonstrated safe and favourable long-term outcomes in a cohort of HM3 LVAD patients over a mean follow-up of more than 2years. To our knowledge, our report provides the longest follow-up duration for this patient population to date. Larger prospective studies are needed before this can be adopted as the standard of care.

MELD score predicts outcomes in patients with advanced heart failure: A longitudinal evaluation.

Advanced heart failure (AHF) is characterized by recurrent episodes of haemodynamic instability and frequent hospitalizations, leading to a progressive decline in quality of life and high mortality rates. The objectives of this study were to evaluate the effect of the model for end-stage liver disease (MELD) score and its variations in predicting adverse outcomes [death, urgent heart transplant, and left ventricular assist device (LVAD) implant] among patients with AHF to assess the clinical associations of the MELD score in this population and to compare the efficacy of this tool with other prognostic scores in AHF. In this longitudinal prospective study, 162 patients with advanced heart failure (AHF) were enrolled; all patients included in the study were receiving the maximum tolerated medical therapy according to guidelines. The MELD score was measured at baseline and every 6months during follow-up. All patients underwent echocardiographic assessment and cardiopulmonary testing, which included the evaluation of maximal oxygen uptake (VO2max) and the minute ventilation/carbon dioxide production (VE/VCO2) slope. The mean age of the study group was 57.7±11.6years. There were 26 deaths, 5 urgent transplants, and 1 LVAD implantation during a follow-up period of 31.4±15.6months. The mean New York Heart Association (NYHA) class was 2.8±0.5, ejection fraction (EF) was 26.3±6.5%, the mean VO2max was 11.7±3.5mL/kg/min. Multiple regression analysis revealed a positive correlation between the MELD score and NT-proBNP (β=0.215; P=0.041) and furosemide dosage (β=0.187; P=0.040). Conversely, a negative correlation was observed between the MELD score and TAPSE (β=-0.204; P=0.047). Multivariate Cox regression on combined outcome shows a HR of 1.094 (95% CI 1.003-1.196) for unit increase in MELD considered as a continuous variable. The predictive role is independent by the effect of covariates considered in the analysis such as age, sex, NYHA class, EF, TAPSE, PASP, VO2max, NT-proBNP, MELD score worsening, and NT-proBNP increase. Changes in MELD score percentage, considered as a dichotomous variable (≤100% and >100%), were found to be predictors of mortality, urgent heart transplant and LVAD implant. Receiver operating characteristic (ROC) curves showed an area under the curve (AUC) of 0.887 for MELD score and composite outcome of death, urgent transplant, and need for LVAD. The predictive performance of MELD was even superior compared with MELD-Na, MELD-XI, MAGGIC risk score, and MECKI. The MELD score and its longitudinal changes are effective predictors of adverse outcomes in AHF.

The Introduction of a New Mobile Driving Unit for a Ventricular Assist Device in a Pediatric Patient (EXCOR Active)

Pediatric patients supported by extracorporeal ventricular assist devices traditionally require long-term stationary inpatient settings. Limited mobility and permanent hospitalization significantly reduce their quality of life. Berlin Heart address this with their novel mobile driving unit, EXCOR® Active. This case report presents its first application outside of Germany, where it was developed, focusing on staff education and safety measures leading to a successful switch of driving units.

Curricular Self-management for patients on ventricular assist device support decreases depression: A multicenter randomized controlled trial.

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.

Intraoperative Epoprostenol in Type II Heparin-Induced Thrombocytopenia During Left-Ventricular Assist Device Implantation: A Case Series and Review of Literature.

Type II heparin-induced thrombocytopenia and thrombosis (type II HITT) is a rare but serious complication in patients receiving heparin for anticoagulation. In type II HITT, an immune-mediated reaction against platelet factor four-heparin complexes results in thrombocytopenia and an elevated risk of thrombosis. This poses significant challenges for patients with advanced heart failure requiring urgent left-ventricular assist device (LVAD) implantation. The use of direct thrombin inhibitors, the typical alternative to heparin, is associated with increased bleeding risk and lacks a reversal agent, limiting their use in cardiac surgery. We present two cases of intraoperative epoprostenol to facilitate implantation of a durable LVAD in type II HITT, of which one case underwent preoperative plasmapheresis and intravenous immunoglobulin (IVIG) therapy. Epoprostenol, a prostacyclin analog, was used intraoperatively during LVAD implantation to inhibit platelet activation and allowed for the safe administration of heparin during cardiopulmonary bypass. Both patients underwent successful LVAD implantation without thrombotic or major bleeding complications. These cases highlight the potential of using intraoperative epoprostenol in conjunction with preoperative plasma exchange (PLEX) and IVIG to mitigate the risks associated with heparin use in patients with type II HITT, offering an alternative approach for this high-risk group requiring urgent cardiac surgery.

In Vitro Analysis of Left Ventricular Assist Device Outflow Graft Orientations and Their Effect on Aortic Hemodynamics.

Continuous-flow left ventricular assist devices have become an important treatment option for patients with advanced heart failure. However, adverse hemodynamic effects as consequence of an altered blood flow within the aorta and the aortic root remain a topic of concern. In this work, we investigated the influence of the outflow graft orientation on the hemodynamic profile and flow parameters within the thoracic aorta. Aortic models with different outflow graft orientations were designed and three-dimensional (3D) printed to mimic common implantation configurations and were integrated into a pulsatile mock circulatory flow loop. Assist device function was achieved using a rotary pump, replicating nonpulsatile, continuous support flows of 1-5 L/min. Flow velocity, wall shear stress, and pressure gradients were investigated for each configuration using sonography and four-dimensional (4D) flow magnetic resonance imaging. Mean wall shear stresses measured in 4D flow software were lowest for a graft inclination angle of 45°. Streamline visualization revealed areas of nonuniform, retrograde, and vortex flow in all models but most prominent for the aortic model with an outflow graft inclination of 60°. The insights gained from this research may aid in understanding clinical outcomes following assist device implantation and long-term mechanical circulatory support.

CMR and adverse clinical outcomes in peripartum cardiomyopathy

BackgroundPeripartum cardiomyopathy (PPCM) is associated with significant morbidity and mortality. Recent studies show recovery of left ventricular ejection fraction (LVEF) can still be associated with longitudinal adverse clinical outcomes. Cardiac MRI (CMR) may yield additional prognostic parameters of serious adverse outcomes (SAE) beyond LVEF. MethodsIndividuals with PPCM and CMR within 3 months of diagnosis were analyzed from the Investigations in Pregnancy Associated Cardiomyopathy (IPAC) trial and our institution from 2010-present. Indexed left ventricular (LV) mass, ventricular volumes, cardiac output, global longitudinal strain (GLS), extracellular cellular volume (ECV) as well as epicardial fat volume (EFV) were analyzed. SAEs included left ventricular assist device (LVAD), heart transplant and death. CMR parameters were compared between SAE and no SAEs groups by non-parametric techniques. ResultsAmong 51 individuals with mean age of 31 years at diagnosis, 6/51 (12 %) experienced 11 adverse outcomes. EF at time of CMR (15.0 vs 37.3 %, p < 0.001), peak GLS (−4.1 % vs −10.0, p = 0.002) and ECV (43.6 vs 28.2, p = 0.02) differed significantly among groups. In univariate regression analysis, worse LVEF, lower peak GLS and higher mean ECV along with greater LVESVi were predictive of adverse outcomes. ConclusionPrior studies found baseline LVEF by echo is a predictor of serious adverse outcomes. CMR identified LVESVi, peak GLS and ECV as additional predictors of adverse outcomes. If confirmed in larger studies, diffuse myocardial fibrosis may represent a therapeutic target in PPCM.

Pump Exchange for Major Device Related Infection in Patients Receiving a Durable Left Ventricular Assist Device

BackgroundDevice-related infection (DRI) remains a cause of morbidity and mortality following durable left ventricular assist device (dLVAD) implantation. We evaluated outcomes following pump exchange (PE) for DRI following dLVAD implantation. MethodsForty-nine patients underwent PE between 1/2007 and 12/2022 for major DRI. Outcomes included survival, incidence of subsequent DRI, and proportion of patients achieving success (freedom from DRI at 1-year following PE). ResultsMedian age was 49 years. Median time from primary implant to DRI diagnosis and from diagnosis to PE was 26 and 4.1 months, respectively. Median time to DRI recurrence was 5.8 months with 76% of patients achieving success. Success was obtained in 23/24 (96%) of patients whose time to PE from DRI diagnosis was ≤ 4 months and 14/25 (56%) if time > 4 months. ConclusionMost patients achieve success following PE for DRI. The risk of subsequent DRI and mortality remains high. Early (≤ 4 months) PE following DRI diagnosis increases the likelihood of success, while reducing the rate of subsequent DRI.

Entropy Analysis in Magnetized Blood-Based Hybrid Nanofluid Flow via Parallel Disks

Magnetized hybrid nanofluid combined with ferrite and silver in a blood-based liquid presents their vital role in several aspects such as artificial heart pumping system, drug delivery process, the flow of blood in the artery, etc. This is because the high heat transportation rate of the nanofluid is caused by the inclusion of nanoparticles. The current investigation is based on the characteristic of particle concentration comprised of Fe3O4 and Ag in the base liquid blood that passed in between two infinite parallel disks filled with porous matrix. The electrically conducting fluid associated to maximum of 1.5% of volume concentration from each of the solid particles affects the flow phenomena. However, the impact of thermal radiation vis-à-vis the heat dissipation provides efficient heat transport properties with the inclusion of the effective thermal conductivity assumed from the Hamilton-Crosser model. The proposed conductivity model describes the role of particle shapes on the enhanced thermal properties. Further, numerical treatment is obtained for the transformed designed problem following similarity rules that are used for the conversion of the governing equations into their non-dimensional form. The computation of various flow profiles leads to get the entropy generation due to the irreversibility processes. Along with the fluid velocity and temperature distributions, the study is carried out for the entropy as well as the computation of Bejan number and afterwards the simulation of the shear and heat transportation rate are also depicted graphically. The main finding of the proposed study is that solid particle concentrations have a substantial impact to increasing fluid velocity in magnitude, resulting in a narrower wall thickness at both channel walls. Thermal radiation was shown to be more effective at increasing entropy generation and Bejan value.

Association Between Impella Device Type and Short-Term Prognosis in Patients with Acute Myocardial Infarction-Related Cardiogenic Shock Receiving ECPELLA Support.

The prognosis in patients with acute myocardial infarction-related cardiogenic shock (AMI-CS) remains unsatisfactory even in the era of Impella, especially among the patients who receive concomitant veno-arterial extracorporeal membrane oxygenation (ECMO) support (i.e., ECPELLA). The prognostic impact of Impella device type in patients with AMI-CS receiving ECPELLA support remains uncertain.Patients with AMI-CS who had received Impella-incorporated temporary mechanical circulatory support between 2020 and 2022 were prospectively registered in the Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD). The prognostic impact of Impella device type on the 30-day mortality in patients receiving ECPELLA therapy was retrospectively investigated.A total of 996 patients receiving ECPELLA therapy (median 69 years; out-of-hospital cardiac arrest 36.8%; lactate 8.2 mmol/L) were included. The device type of Impella 5.0/5.5 (n = 73) was associated with a lower 30-day mortality with an adjusted hazard ratio of 0.575 (95% confidence interval 0.369-0.895, P = 0.0143) and a lower 30-day cumulative mortality (35.6% versus 56.8%, P = 0.0002) compared with the Impella 2.5/CP (n = 923).Among the patients with AMI-CS receiving ECPELLA support, Impella 5.0/5.5 use was significantly associated with a lower 30-day mortality compared with smaller Impella devices. Implementing an Impella 5.5 or Impella upgrade from CP to 5.5 may improve the short-term prognosis in patients with advanced AMI-CS who are receiving ECPELLA support.

Standardizing Initial Inpatient Palliative Care Consultations for Patients Receiving Left Ventricular Assist Devices at a Large Urban Hospital.

Left ventricular assist devices can improve survival rates and quality of life for individuals with advanced heart failure. However, complications and repeated hospitalizations are common. Palliative care involvement is required before and after left ventricular assist device placement. However, limited guidance on the objectives and structure of palliative care consultation in the left ventricular assist device context has led to variation in how these consultations are conducted and confusion around the consultations' objectives and structure. We piloted and modified an evidence-based, semistructured script to guide pre-left ventricular assist device palliative care consultations. Palliative care clinicians were trained on use of the script. Presurvey and postsurvey were used to examine changes in clinician confidence and assess script acceptability. Script use did not result in changes to clinicians' confidence. Clinicians felt the script provided valuable structure and guidance but suggested improvements to script structure and flow, emphasizing the need for a standardized workflow and closer collaboration between palliative care and heart failure teams.

Assessment of Platelet Response to Aspirin Therapy and Hemocompatibility-Related Adverse Events in HeartMate 3 Left Ventricular Assist Device Recipients.

Background: Patients with a HeartMate 3 (HM3) left ventricular assist device (LVAD) typically receive anticoagulation and antiplatelet therapy. The HM3 has shown a marked reduction in hemocompatibility-related adverse events (HRAEs) like stroke, bleeding, and pump thrombosis. This study evaluated whether aspirin (ASA) response influences HRAE incidence and if ASA sensitivity changes over time in HM3 recipients. Methods: This single-center, cross-sectional study included 32 HM3 patients (age: 59.0 ± 10.0 years, 15.6% female). ASA sensitivity was assessed twice using the VerifyNow assay, with ASA resistance defined by ASA reactivity units (ARU) > 550. The primary endpoint was HRAE incidence in ASA responders vs. non-responders over two consecutive follow-ups; the secondary endpoint was temporal changes in ASA resistance. Results: At the first follow-up, 13 (40.6%) patients were ASA-resistant, and 8 (28.6%) were resistant at the second follow-up, without significant change (p = 0.22). ASA non-responders and responders had similar ASA doses and baseline characteristics. No significant difference in HRAE incidence was found between ASA non-responders and responders (0.0% vs. 15.8%, p = 0.14), and no additional HRAEs occurred during follow-up. Conclusions: ASA resistance varied considerably among HM3 patients without significant temporal changes, and the demonstrated excellent hemocompatibility supports recent evidence that ASA may have a limited role in the antithrombotic regimen for HM3 recipients.

Inflammatory and Hemolytic Responses of Microaxial Flow Pump Temporary Ventricular Assist Devices via Axillary Access in Cardiogenic Shock

Inflammatory and Hemolytic Responses of Microaxial Flow Pump Temporary Ventricular Assist Devices via Axillary Access in Cardiogenic Shock

Optimizing ventricular assist device rotor design parameters through computational fluid dynamics and design of experiments

Optimizing ventricular assist device rotor design parameters through computational fluid dynamics and design of experiments

Successful biventricular assist device Berlin heart implantation leading to heart transplant in a complicated pediatric case: an experience from a single center

The use of the Berlin heart EXCOR ventricular assist device (VAD) as a bridge to heart transplantation in pediatric patients has become increasingly widespread. This case report presents a detailed account of the successful implantation of a biventricular assist device (BIVAD) Berlin heart device in a complex pediatric case at the esteemed King Faisal Specialist Hospital and Research Center. The patient, diagnosed with dilated cardiomyopathy (DCM) and Kawasaki disease, underwent a series of interventions and treatments before requiring extracorporeal membrane oxygenation (ECMO) support and subsequently receiving the Berlin heart device. The post-implantation period was marked by significant challenges, including instances of bleeding and clot formation, necessitating multiple interventions and careful management. Ultimately, a heart transplant was performed; however, the patient encountered humoral rejection, leading to additional targeted treatment. Despite these intricate complications, the patient exhibited substantial improvement in left ventricular ejection fraction (LVEF) following the transplant, indicating a positive outcome. This case underscores the successful use of a BIVAD Berlin heart device as a viable bridge to heart transplantation in a complicated pediatric case, highlighting the crucial role of a multidisciplinary approach and meticulous management of complications throughout the entire treatment process.

Warfarin and Aspirin Versus Warfarin Alone in Patients With HeartMate 3 Left Ventricular Assist Device: A Systematic Review and Meta-Analysis.

HeartMate 3 (HM3), a fully magnetically levitated ventricular assist device (LVAD), has been associated with reduced thromboembolic events compared to HeartMate II. However, bleeding events remained significant. Among patients undergoing HM3 implantation, the standard antithrombotic regimen comprises both warfarin and aspirin (ASA), but there is a lack of evidence on the optimum antithrombotic therapy. We performed a systematic review and meta-analysis assessing the impact of combined ASA and warfarin therapy compared to warfarin alone on the incidence of non-surgical bleeding events in patients with HM3 LVAD. MEDLINE, Embase, and Cochrane databases were searched for randomized controlled trials (RCTs) and observational studies comparing warfarin alone with warfarin combined with ASA in patients with HM3 LVAD. Binary endpoints were analyzed using computed risk ratios (RRs) with 95% confidence intervals (CIs). A random-effect model was applied for all endpoints. Five studies (one RCT and four observational) encompassing 869 patients were included, with 424 (48.8%) prescribed warfarin alone, and 662 (76.2%) being male. Compared with the combined anticoagulation regimen, warfarin alone significantly reduced non-surgical bleeding (RR 0.30; 95% CI 0.09-0.95; p=0.04) and gastrointestinal bleeding (RR 0.26; 95% CI 0.12-0.58; p<0.001). There was no statistically significant difference between the groups for all-cause mortality (RR 1.02; 95% CI 0.45-2.32; p=0.963). Our findings indicate that the use of warfarin alone for anticoagulation in HM3 patients is associated with a reduced risk of bleeding events when compared to the combined therapy with ASA.