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Source: ASAIO Journal
Condition: Bleeding
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Total 28 results found since Jan 2013.
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
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
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
Management of Antiplatelet Therapy During Continuous-Flow Left Ventricular Assist Device Support After Thrombotic Hemorrhagic Events
Hemorrhagic or thrombotic events are common complications in heart failure patients with continuous-flow left ventricular assist device (CF-LVAD) support. Aim of this study is to investigate the effect of change in antiplatelet therapy after thrombotic or hemorrhagic events in patients with CF-LVAD support. A total of 231 CF-LVAD patients were included in this study. Patients with CF-LVAD were categorized into three groups: (1) high antiplatelet regimen as control group (aspirin [ASA] 325 mg; n = 115), (2) low antiplatelet regimen (ASA 81 mg; n = 82), started after hemorrhagic complications, and (3) double antiplatelet...
Source: ASAIO Journal - September 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Impact of 30 Day Readmission After Left Ventricular Assist Device Implantation
Early readmission (within 30 days) after left ventricular assist device (LVAD) implantation might be a marker for increased mortality. We retrospectively reviewed the records of 277 adults who underwent continuous-flow LVAD implantation from 2005 through 2015 at our institution. The baseline characteristics of patients who were (versus were not) readmitted within 30 days after LVAD implantation were compared. To assess the impact of 30 day readmission on long-term survival, we used multivariate Cox regression. We also compared the cardiac transplant rate between the two groups. Of the 277 patients, 217 (78.3%) underwent LV...
Source: ASAIO Journal - February 28, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Low-Dose Prothrombin Complex Concentrate in Patients with Left Ventricular Assist Devices
We describe two cases of warfarin reversal with low-dose 4-factor PCC (4F-PCC) in two different LVAD patient scenarios. Low-dose 4F-PCC was administered to one patient with a Heart Mate II (HM II) LVAD, international normalized ratio (INR) of 4.7 on admission and in need of an urgent procedure. He received approximately 16 units/kg of 4F-PCC with reversal of his INR to 2.3 within 45 minutes. The second patient also had a HM II LVAD and presented with a right occipital intraparenchymal hemorrhage and subdural hematoma with an INR of 3.7. He received approximately 11 units/kg of 4F-PCC with INR reversal to 1.6 within 1 hour....
Source: ASAIO Journal - January 30, 2019 Category: Medical Devices Tags: Case Reports Source Type: research
