scholarly journals Antithrombotic therapy in pediatric ventricular assist devices: Multicenter survey of the European EXCOR Pediatric Investigator Group

2018 ◽  
Vol 41 (7) ◽  
pp. 385-392 ◽  
Author(s):  
Oliver Miera ◽  
Katharina L Schmitt ◽  
Hakan Akintuerk ◽  
Angele Boet ◽  
Robert Cesnjevar ◽  
...  

Objectives: Mechanical circulatory support for pediatric heart failure patients with the Berlin Heart EXCOR ventricular assist system is the only approved and established bridging strategy for recovery or heart transplantation. In recent years, the burden of thromboembolic events has led to modifications of the recommended antithrombotic therapy. Therefore, we aimed to assess modifications of antithrombotic practice among the European EXCOR Pediatric Investigator Group members. Methods: We sent a questionnaire assessing seven aspects of antithrombotic therapy to 18 European hospitals using the EXCOR device for children. Returned questionnaires were analyzed and identified antithrombotic strategies were descriptively compared to “Edmonton protocol” recommendations developed for the US EXCOR pediatric approval study. Results: Analysis of 18 received surveys revealed substantial deviations from the Edmonton protocol, including earlier start of heparin therapy at 6–12 h postoperatively and in 50% of surveyed centers, monitoring of heparin effectiveness with aPTT assay, administering vitamin K antagonists before 12 months of age. About 39% of centers use higher international normalized ratio targets, and platelet inhibition is changed in 56% including the use of clopidogrel instead of dipyridamole. Significant inter-center variability with multiple deviations from the Edmonton protocol was discovered with only one center following the Edmonton protocol completely. Conclusion: Current antithrombotic practice among European EXCOR users representing the treatment of more than 600 pediatric patients has changed over time with a trend toward a more aggressive therapy. There is a need for systematic evidence-based evaluation and harmonization of developmentally adjusted antithrombotic management practices in prospective studies toward revised recommendations.

2021 ◽  
Vol 8 ◽  
Author(s):  
Chiara Giorni ◽  
Alessandra Rizza ◽  
Isabella Favia ◽  
Antonio Amodeo ◽  
Fabrizio Chiusolo ◽  
...  

Pediatric mechanical circulatory support (MCS) is considered a strategy for heart failure management as a bridge to recovery and transplantation or as a destination therapy. The final outcome is significantly impacted by the number of complications that may occur during MCS. Children on ventricular assist devices (VADs) and extracorporeal membrane oxygenation (ECMO) are at high risk for bleeding and thrombotic complications that are managed through anticoagulation. The first detailed guideline in pediatric VADs (Edmonton Anticoagulation and Platelet Inhibition Protocol) was based on conventional antithrombotic drugs, such as unfractionated heparin (UFH) and warfarin. UFH is the first-line anticoagulant in pediatric MCS, although its profile is not considered optimal in pediatric setting. The broad variation in heparin doses among children is associated with frequent occurrence of cerebrovascular accidents, bleeding, and thrombocytopenia. Direct thrombin inhibitors (DTIs) have been utilized as alternative strategies to heparin. Since 2018, bivalirudin has become the chosen anticoagulant in the long-term therapy of patients undergoing MCS implantation, according to the most recent protocols shared in North America. This article provides a review of the non-traditional anticoagulation strategies utilized in pediatric MCS, focusing on pharmacodynamics, indications, doses, and monitoring aspects of bivalirudin. Moreover, it exposes the efforts and the collaborations among different specialized centers, which are committed to an ongoing learning in order to minimize major complications in this special pediatric population. Further prospective trials regarding DTIs in a pediatric MCS setting are necessary and in specific well-designed randomized control trials between UFH and bivalirudin. To conclude, based on the reported literature, the clinical use of the bivalirudin in pediatric MCS seems to be a value added in controlling and maybe reducing thromboembolic complications. Further research is necessary to confirm all the results provided by this literature review.


Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 861
Author(s):  
Gennaro Martucci ◽  
Federico Pappalardo ◽  
Harikesh Subramanian ◽  
Giulia Ingoglia ◽  
Elena Conoscenti ◽  
...  

Heart failure (HF) remains a leading cause of morbidity, hospitalization, and mortality worldwide. Advancement of mechanical circulatory support technology has led to the use of continuous-flow left ventricular assist devices (LVADs), reducing hospitalizations, and improving quality of life and outcomes in advanced HF. Recent studies have highlighted how metabolic and endocrine dysfunction may be a consequence of, or associated with, HF, and may represent a novel (still neglected) therapeutic target in the treatment of HF. On the other hand, it is not clear whether LVAD support, may impact the outcome by also improving organ perfusion as well as improving the neuro-hormonal state of the patients, reducing the endocrine dysfunction. Moreover, endocrine function is likely a major determinant of human homeostasis, and is a key issue in the recovery from critical illness. Care of the endocrine function may contribute to improving cardiac contractility, immune function, as well as infection control, and rehabilitation during and after a LVAD placement. In this review, data on endocrine challenges in patients carrying an LVAD are gathered to highlight pathophysiological states relevant to this setting of patients, and to summarize the current therapeutic suggestions in the treatment of thyroid dysfunction, and vitamin D, erythropoietin and testosterone administration.


2021 ◽  
Author(s):  
Aaron M. Gusdon ◽  
Salia Farrokh ◽  
James C. Grotta

AbstractPrevention of ischemic stroke relies on the use of antithrombotic medications comprising antiplatelet agents and anticoagulation. Stroke risk is particularly high in patients with cardiovascular disease. This review will focus on the role of antithrombotic therapies in the context of different types of cardiovascular disease. We will discuss oral antiplatelet medications and both IV and parental anticoagulants. Different kinds of cardiovascular disease contribute to stroke via distinct pathophysiological mechanisms, and the optimal treatment for each varies accordingly. We will explore the mechanism of stroke and evidence for antithrombotic therapy in the following conditions: atrial fibrillation, prosthetic heart values (mechanical and bioprosthetic), aortic arch atherosclerosis, congestive heart failure (CHF), endocarditis (infective and nonbacterial thrombotic endocarditis), patent foramen ovale (PFO), left ventricular assist devices (LVAD), and extracorporeal membrane oxygenation (ECMO). While robust data exist for antithrombotic use in conditions such as atrial fibrillation, optimal treatment in many situations remains under active investigation.


2014 ◽  
Vol 8s1 ◽  
pp. CMC.S15718 ◽  
Author(s):  
Nisha A. Gilotra ◽  
Gerin R. Stevens

Cardiogenic shock remains a challenging disease entity and is associated with significant morbidity and mortality. Temporary mechanical circulatory support (MCS) can be implemented in an acute setting to stabilize acutely ill patients with cardiomyopathy in a variety of clinical situations. Currently, several options exist for temporary MCS. We review the indications, contraindications, clinical applications, and evidences for a variety of temporary circulatory support options, including the intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), CentriMag blood pump, and percutaneous ventricular assist devices (pVADs), specifically the TandemHeart and Impella.


2021 ◽  
Vol 32 (4) ◽  
pp. 424-433
Author(s):  
Emalie Petersen

Heart failure is a leading cause of morbidity and mortality in the United States. Treatment of this condition increasingly involves mechanical circulatory support devices. Even with optimal medical therapy and use of simple cardiac devices, heart failure often leads to reduced quality of life and a shortened life span, prompting exploration of more advanced treatment approaches. Left ventricular assist devices constitute an effective alternative to cardiac transplantation. These devices are not without complications, however, and their use requires careful cooperative management by the patient’s cardiology team and primary care provider. Left ventricular assist devices have undergone many technological advancements since they were first introduced, and they will continue to evolve. This article reviews the history of different types of left ventricular assist devices, appropriate patient selection, and common complications in order to increase health professionals’ familiarity with these treatment options.


Author(s):  
Sung-Min Cho ◽  
J. Hunter Mehaffey ◽  
Susan L. Myers ◽  
Ryan S. Cantor ◽  
Randall C. Starling ◽  
...  

Background: Ischemic and hemorrhagic cerebrovascular accidents (ICVA and HCVA, respectively) remain common among patients with centrifugal-flow left ventricular assist devices (CF-LVADs), despite improvements in survival and device longevity. Therefore, the incidence of neurological adverse events (NAEs) associated with two contemporary CF-LVADs, the Abbott HeartMate3 ® (HM3) and the Medtronic HeartWare ™ HVAD ® (HVAD), were compared. Methods: Using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), we collected data on adult patients who received a CF-LVAD as a primary isolated implant between 1/1/2017 and 9/30/2019. Major NAEs were defined as transient ischemic attack (TIA), ICVA, and HCVA. The association of HVAD with risk of NAE in the first year post implant was evaluated using propensity score matching to balance for pre-implant risk factors. After matching, freedom from first major NAE in the HM3 and HVAD cohorts was compared with Kaplan-Meier curves. A secondary analysis using multivariable multiphase hazard models was used to identify predictors of NAE, which uses a data driven parametric fit of the early declining and constant phase hazards and the associations of risk factor with either phase. Results: Of 6,205 included patients, 3,076 (49.6%) received the HM3 and 3,129 (50.4%) received the HVAD. Median follow-up was 9 and 12 months (HM3 and HVAD). HVAD patients had more major NAEs (16.4% vs. 6.4%, p <0.001), as well as each subtype (TIA: 3.3% vs. 1.0%, p <0.001; ICVA: 7.7% vs. 3.4%, p <0.001; and HCVA: 7.2% vs. 2.0%, p <0.001), than did HM3 patients. A propensity-matched cohort balanced for pre-implant risk factors showed that HVAD was associated with higher probabilities of major NAEs (% freedom from NAE: 82% vs. 92%, p <0.001). Device type was not significantly associated with NAEs in the early hazard phase, but HVAD was associated with higher incidence of major NAEs during the constant hazard phase (hazard ratio: 5.71, confidence interval: 3.90-8.36). Conclusions: HM3 is associated with lower hazard of major NAEs than is HVAD beyond the early post-implantation period and during the constant hazard phase. Defining the explanation for this observation will inform device selection for individual patients.


2014 ◽  
Vol 53 (02) ◽  
pp. 121-136 ◽  
Author(s):  
E. C. Karvounis ◽  
M. G. Tsipouras ◽  
A. T. Tzallas ◽  
N. S. Katertsidis ◽  
K. Stefanou ◽  
...  

SummaryBackground: Heart failure (HF) is affecting millions of people every year and it is characterized by impaired ventricular performance, exercise intolerance and shortened life expectancy. Despite significant advancements in drug therapy, mortality of the disease remains excessively high, as heart transplant remains the gold standard treatment for end-stage HF when no contraindications subsist. Traditionally, implanted Ventricular Assist Devices (VADs) have been employed in order to provide circulatory support to patients who cannot survive the waiting time to transplantation, reducing the workload imposed on the heart. In many cases that process could recover its contractility performance.Objectives: The SensorART platform focuses on the management and remote treatment of patients suffering from HF. It provides an inter-operable, extendable and VAD-independent solution, which incorporates various hardware and software components in a holistic approach, in order to improve the quality of the patients’ treatment and the workflow of the specialists. This paper focuses on the description and analysis of Specialist’s Decision Support System (SDSS), an innovative component of the SensorART platform.Methods: The SDSS is a Web-based tool that assists specialists on designing the therapy plan for their patients before and after VAD implantation, analyzing patients’ data, extracting new knowledge, and making informative decisions.Results: SDSS offers support to medical and VAD experts through the different phases of VAD therapy, incorporating several tools covering all related fields; Statistics, Association Rules, Monitoring, Treatment, Weaning, Speed and Suction Detection.Conclusions: SDSS and its modules have been tested in a number of patients and the results are encouraging.


Author(s):  
Gaurav Girdhar ◽  
Yared Alemu ◽  
Michalis Xenos ◽  
Jawaad Sheriff ◽  
Jolyon Jesty ◽  
...  

Flow past mechanical heart valves (MHV) in mechanical circulatory support devices including total artificial hearts and ventricular assist devices, is primarily implicated in thromboembolism due to non-physiological flow conditions where the elevated stresses and exposure times are sufficiently high to cause platelet activation and thrombus formation. Mitigation of this risk requires lifelong anticoagulation therapy and less thrombogenic MHV designs should therefore be developed by device manufacturers [1].


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