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Lessons Learned from Managing Antithrombotic Therapy in Children Supported with Pediatric Ventricular Assist Devices
Stroke, thromboembolism, and bleeding are the most recognized complications associated with pediatric ventricular assist devices (VADs) and the leading cause of death and disability on VAD support. Recently, newer antithrombotic strategies like bivalirudin have emerged that appear to be associated with a reduction in the neurologic event rates, especially for smaller pediatric-specific VADs like the Berlin Heart and PediMag/CentriMag systems where the risk of stroke is the highest. While contemporary antithrombotic therapies have likely contributed to lowering adverse event rates, we speculate that clotting and bleeding ad...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Review Source Type: research

Analysis of Trends and Outcomes of 90 and 180 Day Readmissions After Left Ventricular Assist Device Implantation
Despite decreasing morbidity and mortality in left ventricular assist device (LVAD) recipients, readmission after implantation remains a major problem. Our aim was to investigate the trends and outcomes of 90 and 180 day readmission in this population. The National Readmission Database from 2012 to 2017 was queried to identify LVAD recipients. A total of 5,907 adults (90 day readmissions) and 3,653 adults (180 day readmissions) who survived LVAD implantation during the index admission were included in our analysis. Readmissions occurred in 45.6% and 65.1% by 90 and 180 days, respectively, with most readmissions occurring w...
Source: ASAIO Journal - February 27, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Axillary or Subclavian Impella 5.0 Support in Cardiogenic Shock: A Systematic Review and Meta-analysis
Summary data around survival and adverse events of cardiogenic shock (CS) patients supported with axillary or subclavian artery 5.0 Impella are presently unavailable. We performed a systematic search of studies reporting the outcomes of axillary or subclavian access 5.0 Impella for refractory CS in PubMed, EMBASE, and the Cochrane Library. The primary outcome was 30-day survival. Secondary outcomes included survival to next therapy and adverse events on support. Proportional meta-analysis was used to pool across studies. Of the 795 potential studies identified, 13 studies were included in the meta-analysis (n = 256 pat...
Source: ASAIO Journal - February 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Alarms and Their Outcomes in Left Ventricular Assist Device Patients
Low flow and suction alarms are provided to alert caregivers of changes in left ventricular assist device pump function but may be reset in clinical practice. We investigated the incidence and underlying causes of these alarms as well as their prognostic significance. HeartWare ventricular assist device patients (n = 113) were divided into quartiles based on their frequency of low flow and suction alarms. Survival and adverse events (thrombus, stroke, bleeding, and right heart failure) were compared between quartiles. Low flow alarms peaked in the first few months of pump support before dropping down to near negligible lev...
Source: ASAIO Journal - December 1, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Impact of COVID-19 on Patients Supported with a Left Ventricular Assist Device
Patients on left ventricular assist device (LVAD) support may be susceptible to severe disease and complications from coronavirus disease-19 (COVID-19). The purpose of this study was to describe the clinical course of COVID-19 in LVAD patients. A retrospective review was performed at our center; 28 LVAD patients who developed COVID-19 between March 2020 and March 2021, and six patients with a prior COVID-19 infection who underwent LVAD implantation, were identified and examined. Of the 28 patients, nine (32%) died during the study period, five (18%) during their index hospitalization for COVID-19. Two patients (7%) present...
Source: ASAIO Journal - November 1, 2021 Category: Medical Devices Tags: Management of COVID-19 Patients Source Type: research

Increased Rate of Pump Thrombosis and Cardioembolic Events Following Ventricular Tachycardia Ablation in Patients Supported With Left Ventricular Assist Devices
Ventricular arrhythmias are common following left ventricular assist device implantation (LVAD), and the effects of ventricular tachycardia (VT) ablation on thrombosis and embolic events are unknown. We aimed to assess LVAD thrombosis, stroke, and embolic event rates after VT ablation. Left ventricular assist device implantation patients from two academic centers who underwent endocardial VT ablation between 2009 and 2016 were compared to a control group with VT who were not ablated and followed for one year. The primary composite outcome was confirmed or suspected LVAD thrombosis, stroke, or other embolic event. Survival ...
Source: ASAIO Journal - November 1, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Ischemic Stroke and Intracranial Hemorrhages During Impella Cardiac Support
Impella is a percutaneously placed, ventricular assist device for short-term cardiac support. We aimed to study acute neurologic complications during short-term cardiac support with Impella. We reviewed prospectively collected data of 79 consecutive persons implanted with Impella at a single tertiary center. Acute neurologic events (ANE) were defined as ischemic strokes or intracranial hemorrhages. Among those with ANE, specific causes of ischemic and hemorrhagic events were collected and discussed. Of 79 persons with Impella with median 8 days of support (range 1–33 days), six (7.5%) developed ANE at a median of 5 days ...
Source: ASAIO Journal - July 30, 2020 Category: Medical Devices Tags: Case Report Source Type: research

Left Ventricular Assist Device Inflow Cannula Insertion Depth Influences Thrombosis Risk
Left ventricular assist device (LVAD) use has continued to grow. Despite recent advances in technology, LVAD patients continue to suffer from devastating complications, including stroke and device thrombosis. Among several variables affecting thrombogenicity, we hypothesize that insertion depth of the inflow cannula into the left ventricle (LV) influences hemodynamics and thrombosis risk. Blood flow patterns were studied in a patient-derived computational model of the LV, mitral valve (MV), and LVAD inflow cannula using unsteady computational fluid dynamics (CFD). Hundreds of thousands of platelets were tracked individuall...
Source: ASAIO Journal - June 27, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

The WATCHMAN left atrial appendage closure device for patients with atrial fibrillation: current status and future perspectives.
Authors: Wintgens LIS, Maarse M, Swaans MJ, Rensing BJWM, van Dijk VF, Boersma LVA Abstract INTRODUCTION: Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding. AREAS COVERED: This review will focus on LAAC with the Watchman device for stroke prevent...
Source: Expert Review of Medical Devices - June 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Telemedicine Is Here to Stay
COVID-19 has prompted a rapid adoption of telemedicine, a trend that some experts say could have a significant and lasting impact on the medical device industry. Jason Mills, a medtech analyst at Canaccord Genuity, shared conclusions earlier this week from three recent physician surveys that his firm conducted across the structural heart, robotic surgery, and stroke/venous thromboembolism fields. One of the key takeaways is that the overwhelming majority of doctors have "swiftly embraced" telemedicine during the crisis. A look at some of the major telemedicine players' earnings projectio...
Source: MDDI - April 15, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Digital Health Source Type: news

Fibrinogen Albumin Ratio and Ischemic Stroke During Venoarterial Extracorporeal Membrane Oxygenation
Fibrinogen is a clotting factor and a major determinant of platelet aggregation. Albumin, on the other hand, inhibits platelet function and thrombus formation. Taken together, an elevated fibrinogen albumin ratio (FAR) has been described as a marker of disease severity during prothrombotic conditions. We evaluated the association of FAR and ischemic stroke during venoarterial extracorporeal membrane oxygenation (VA ECMO) support. A single center, retrospective study was performed including all adult patients placed on VA ECMO. FAR was calculated from fibrinogen and albumin measurements in the first 24 hours of VA-ECMO init...
Source: ASAIO Journal - February 28, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

What Causes LVAD-Associated Ischemic Stroke? Surgery, Pump Thrombosis, Antithrombotics, and Infection
Acute ischemic stroke (AIS) is a major complication in left ventricular assist device (LVAD) population. A better understanding of clinical risk factors associated with AIS may help mitigate risk of stroke. We reviewed prospectively collected data of 477 LVAD patients from a tertiary center from October 1, 2004 to December 31, 2016. Supplemental data abstraction was performed on patients with AIS. Fifty-seven (12%) developed 61 AIS. Of 61, 17 (28%) AIS occurred perioperatively. The median time from implant to perioperative AIS was 5 days (interquartile range: 3–9). Pump thrombosis accounted for 19 (31%) of 61 AIS, and 7 ...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Bloodstream Infections in Continuous Flow Left Ventricular Assist Device Recipients: Diagnostic and Clinical Implications
Bloodstream infection (BSI) is a common complication of left ventricular assist device (LVAD) support and particularly difficult to treat. The presentation is often variable because of altered physiology and augmentation of cardiac output by the device. We studied LVAD recipients at a single institution. Multivariate logistic and Cox (with time-varying parameters) regression were implemented. Of 212 patients, 58% experienced infections. Driveline infection (DLI) affected 31%, with 60% of them having deep-tissue involvement. Sixty-six patients (31%) suffered from 135 BSIs. Systemic inflammatory response syndrome (SIRS) was ...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Preclinical Evaluation of the EVAHEART 2 Centrifugal Left Ventricular Assist Device in Bovines
The EVAHEART 1 left ventricular assist device was miniaturized to the EVAHEART 2, with a new inflow cannula designed to mitigate the risks of malposition. To evaluate the safety of the new double-cuff tipless inflow cannula, in vivo studies were performed in healthy bovines. Eight consecutive studies were done: five short-term studies of hematological adaptation and three long-term studies of tissue adaptation. Each inflow cannula was purposefully implanted in the worst-case setting with marked malposition. Two studies terminated early: one because of an animal-specific ancillary component and one because of an accidental ...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Surgical Techniques for Implanting the EVAHEART 2 Double Cuff Tipless Inflow Cannula
The EVAHEART 2 (Sun Medical Technology Research Corporation, Nagano, Japan) is an investigational centrifugal ventricular assist device in the United States, introduced a new type inflow, named “double cuff tipless” inflow cannula intended to mitigate the risks of cannula malposition and subsequent ischemic stroke events associated with thrombi around the inflow cannula. To achieve these performance benefits of the “tipless” design, however, it is crucial to adhere to the recommended surgical procedure. We introduced a polymer-based patient model that mimics a dilated cardiomyopathy apex for inflow cannula implanta...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: How to do it Article Source Type: research

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