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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

Adverse Events Associated with Cardiac Catheterization in Children Supported with Ventricular Assist Devices
Children on ventricular assist device (VAD) support can present several unique challenges, including small patient size, univentricular or biventricular congenital heart disease (1V- or 2V-CHD) and need for biventricular VAD (BiVAD) support. While cardiac catheterization can provide valuable information, it is an invasive procedure with inherent risks. We sought to evaluate the safety of catheterization in pediatric patients on VAD support. We performed a retrospective review of patients on VAD support who underwent catheterization at Lucile Packard Children’s Hospital between January 1, 2014 and September 1, 2019. Using...
Source: ASAIO Journal - September 1, 2022 Category: Medical Devices Tags: Pediatric Circulatory Support Source Type: research

Early Experience with the HeartMate Percutaneous Heart Pump from the SHIELD II Trial
The HeartMate Percutaneous Heart Pump (PHP) is a novel circulatory support catheter delivering a self-expanding 24 French impeller across the aortic valve. The SHIELD II trial compares outcomes among heart failure patients undergoing high-risk percutaneous coronary intervention (HR-PCI) with the PHP versus Impella systems. The trial was halted in 2017 due to device malfunctions. We aimed to describe procedural, hemodynamic, and clinical outcomes among HR-PCI patients treated with PHP as part of the SHIELD II trial roll-in phase. Procedural, hemodynamic, and 90 day outcomes were assessed among patients undergoing HR-PCI wit...
Source: ASAIO Journal - April 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Apixaban: Alternative Anticoagulation for HeartMate 3 Ventricular Assist Device
Patients with left ventricular assist devices currently require long-term anticoagulation with warfarin. Warfarin requires frequent blood tests and is associated with adverse events when not in the therapeutic range. Apixaban is a possible alternative that is potentially better for compliance and requires no additional testing. The purpose of this study was to compare adverse events in patients with a HeartMate 3 LVAD receiving apixaban versus warfarin. Thirty-five patients underwent HM3 implantation between January 01, 2016 to January 31, 2021. The groups compared were apixaban (n = 15, 43%) and warfarin (n = 20, 57%). Al...
Source: ASAIO Journal - February 27, 2022 Category: Medical Devices Tags: Adult Circulatory Support 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

HVAD Usage and Outcomes in the Current Pediatric Ventricular Assist Device Field: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Analysis
Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is the first pediatric ventricular assist device (VAD) quality improvement network (46 centers). We aimed to describe outcomes with the HeartWare HVAD from ACTION centers. Patients with an HVAD implant in the ACTION registry (April 2018–April 2020) were analyzed. Baseline characteristics, adverse events, and survival were described. There were 50 patients implanted with a HVAD during the study period [36 cardiomyopathy, 8 congenital heart disease (CHD), and 6 other] and 21 (42%) had a prior sternotomy. Median age (range) was 12.9 years (3.4–19.1), body surf...
Source: ASAIO Journal - June 1, 2021 Category: Medical Devices Tags: Pediatric Circulatory Support Source Type: research

In-hospital Outcomes of Left Ventricular Assist Devices (LVAD) Patients Undergoing Noncardiac Surgery
An increasing number of stage D heart failure patients are supported with left ventricular assist devices (LVADs), and the management of LVAD patients who require noncardiac surgery (NCS) presents unique challenges. Using the 2010–2014 National Inpatient Sample, we identified all adult cases of LVAD patients undergoing noncardiac surgeries using ICD-9-CM codes. We estimated inpatient mortality, bleeding complications, stroke, length of stay (LOS), and cost of hospitalization of the admissions related to NCS using mixed effects logistic and linear mixed regressions, respectively. A total of 30,323 patients with LVADs unde...
Source: ASAIO Journal - February 1, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

VAD 911: Process Improvement for First Responders Treating Ventricular Assist Device Patients
This study conducted an assessment of first responders generalized knowledge and self-reported competency regarding VAD use, provided an education course, and tested for improvement immediately after and 1 month postintervention. Two hundred thirty-six first responders participated from communities with known VAD patients. Responses indicated poor knowledge, experience, and competency. Twenty-one percent had seen a manufacturer training video, 26% had attended prior training, and 38% knew who to contact with a VAD emergency. Generalized knowledge of VAD therapy was poor with majority not understanding use of anticoagulatio...
Source: ASAIO Journal - November 1, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Comparative study on the efficacy and safety of alteplase and urokinase in the treatment of acute cerebral infarction.
CONCLUSION: The intravenous thrombolysis with urokinase or alteplase in the ultra-early stage of acute cerebral infarction can reduce the neurological injury symptoms and effectively improve the prognosis of patients with stroke. Urokinase is lower in risk of bleeding, but better in safety, when compared to alteplase. PMID: 32925123 [PubMed - as supplied by publisher]
Source: Technology and Health Care - September 3, 2020 Category: Medical Devices Authors: Bao H, Gao HR, Pan ML, Zhao L, Sun HB Tags: Technol Health Care Source Type: research

Venoarterial Extracorporeal Membrane Oxygenation Support for Ventricular Tachycardia Ablation: A Systematic Review
In conclusion, VA-ECMO is used infrequently for hemodynamic support for VT ablation. Further data on patient selection, procedural optimization, and clinical outcomes are needed to evaluate the efficacy of this strategy.
Source: ASAIO Journal - September 1, 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

Adverse Event Profile Associated with Prolonged Use of CentriMag Ventricular Assist Device for Refractory Cardiogenic Shock
In conclusion, temporary VAD with CentriMag support is an effective treatment for patients in refractory cardiogenic shock. Despite its side effect, profile including a high rate of blood transfusion early in the immediate postoperative period of CentriMag support, aggressive use of the CentriMag support device has acceptable survival to discharge and 1 year survival.
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

A Blood Filter Fights Deadly Inflammatory Response
A new blood filtration technology may prove to be life-saving for patients whose normally healthy inflammatory response to injury or illness has gone into overdrive, resulting in fatally high levels of cytokines in their blood. In an interview with MD+DI, Dr. Phillip Chan, MD, PhD, CEO of CytoSorbents Corp., explained that inflammation, and the production of substances called cytokines that drive inflammation, are the body’s natural response to heal injury or infection. But sometimes, the inflammatory response is so severe in such conditions as sepsis and infection, burn injuries, trauma, pancreatitis, li...
Source: MDDI - October 9, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Cardiovascular Source Type: news

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