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Source: ASAIO Journal

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Total 95 results found since Jan 2013.

Virtual Fitting and Hemodynamic Simulation of the EVAHEART 2 Left Ventricular Assist Device and Double-Cuff Tipless Inflow Cannula
Inflow malposition during surgery, postoperative pump migration, inflow obstruction, and right ventricular compression are major contributors to low flow and adverse events in patients with ventricular assist devices (VADs). These position abnormalities can lead to adverse events including ischemic stroke. To address these problems, we conducted a virtual anatomical fitting study and hemodynamic simulation on iterative cannula designs, resulting in the EVAHEART 2 with the novel double-cuff tipless (DCT) inflow cannula and smaller pump design. Anatomical fitting was based on computed tomography scans of six patients with he...
Source: ASAIO Journal - September 1, 2019 Category: Medical Devices Tags: Biomedical Engineering Source Type: research

Increased Stroke Risk in Children and Young Adults on Extracorporeal Life Support with Carotid Cannulation
Patients on extracorporeal life support (ECLS) are at risk for central nervous system (CNS) injury. One potentially modifiable risk factor is site of arterial cannulation in venoarterial (VA) ECLS, as in most cases one can choose the femoral or carotid artery. There is acute alteration in cerebral blood flow with carotid cannulation, potentially increasing the risk of stroke. Children may have lower risk of stroke with carotid cannulation compared with adults because of impaired cerebral circulation with aging. Our objective was to evaluate risk of stroke with carotid versus femoral cannulation and determine whether this d...
Source: ASAIO Journal - September 1, 2019 Category: Medical Devices Tags: Pediatric Circulatory Support Source Type: research

Atrial Fibrillation Is Not Associated With Thromboembolism in Left Ventricular Assist Device Patients: A Systematic Review and Meta-Analysis
Atrial fibrillation (AF) is a well-established risk factor of thromboembolism (TE). Thromboembolism is one of the most common complications in patients supported by continuous-flow left ventricular assisted devices (CF-LVADs). However, the association between AF and TE complications in this population is controversial. We conducted a systematic review and meta-analysis to assess the association between AF and overall TE, stroke, and device thrombosis events in CF-LVAD patients. We performed a comprehensive literature search through September 2017 in the databases of MEDLINE and EMBASE. Included studies were prospective or ...
Source: ASAIO Journal - July 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Salutary Effects of the PULVAD, a Novel Implantable Counterpulsation Assist Device, on Cardiac Mechanoenergetics
In conclusion, the PULVAD unloads the failing LV, optimizes LV mechanoenergetics, and augments coronary blood flow. These salutary effects of short-term PULVAD support provide the foundation for long-term testing.
Source: ASAIO Journal - July 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Shear-Mediated Platelet Activation Enhances Thrombotic Complications in Patients With LVADs and Is Reversed After Heart Transplantation
This study provides further insight into our understanding of the pathogenesis of LVAD thrombosis, addressing SMPA as a relevant key factor associated with thrombotic complications. With the PAS assay, we have identified a reliable biomarker to promote tailored pharmacological therapy for the prevention of thromboembolic events in patients with LVADs.
Source: ASAIO Journal - April 30, 2019 Category: Medical Devices Tags: Case Reports Source Type: research

Outcomes After Infections in Adolescents and Young Adults with Continuous-Flow Left Ventricular Assist Devices
Infections in adult ventricular assist device patients increase subsequent mortality and stroke risk. Less is known about outcomes after infections in younger patients, where diabetes and obesity, risk factors associated with poor outcomes, are less prevalent. The purpose of this study was to examine outcomes after infections in adolescents and young adults with continuous-flow left ventricular assist devices (VAD) bridged to transplant. From Pediatric Interagency Registry for Mechanically Assisted Circulatory Support and Interagency Registry for Mechanical Circulatory Support registries, we identified patients aged 12–2...
Source: ASAIO Journal - April 30, 2019 Category: Medical Devices Tags: Pediatric 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

Modification of a Ventricular Assistance Device for a Hemiplegic Left Ventricular Assist Device Patient
Neurologic events occur in up to 18% of patients with continuous-flow left ventricular assist devices (LVAD) and is associated with significant morbidity and mortality. The current form of the LVAD equipment is not suited to serve patients who are impaired by a stroke. By creating an assistance device for the LVAD equipment, we have been able to greatly improve the quality of life and self-dependence of a hemiplegic LVAD patient.
Source: ASAIO Journal - December 28, 2018 Category: Medical Devices Tags: Case Reports Source Type: research

Simultaneous Venoarterial Extracorporeal Membrane Oxygenation and Percutaneous Left Ventricular Decompression Therapy with Impella Is Associated with Improved Outcomes in Refractory Cardiogenic Shock
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for refractory cardiogenic shock; however, it is associated with increased left ventricular afterload. Outcomes associated with the combination of a percutaneous left ventricular assist device (Impella) and VA-ECMO remains largely unknown. We retrospectively reviewed patients treated for refractory cardiogenic shock with VA-ECMO (2014–2016). The primary outcome was all-cause mortality within 30 days of VA-ECMO implantation. Secondary outcomes included duration of support, stroke, major bleeding, hemolysis, inotropic score, and cardiac recovery. Outc...
Source: ASAIO Journal - December 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Individualized Antithrombotic Therapy in Heartware HVAD Recipients
There are no evidence-based guidelines for antithrombotic therapy in left ventricular assist device patients. We evaluated the efficacy of a multi-agent, test-guided protocol, which remained consistent throughout our use of the Heartware HVAD. Thrombelastography and platelet function analyzer (PFA)-100 guide antiplatelet titration. Goals are normal kaolin thrombelastography maximum amplitude and prolonged PFA-100. We analyzed incidence and rates of nonprocedural bleeding, stroke, and pump thrombosis for all 81 primary Heartware left ventricular assist devices implanted since 2011. For each event, we examined whether each t...
Source: ASAIO Journal - December 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Calculation of the ALMA Risk of Right Ventricular Failure After Left Ventricular Assist Device Implantation
Right ventricular failure after continuous-flow left ventricular assist device (LVAD) implantation is still an unsolved issue and remains a life-threatening event for patients. We undertook this study to determine predictors of the patients who are candidates for isolated LVAD therapy as opposed to biventricular support (BVAD). We reviewed demographic, echocardiographic, hemodynamic, and laboratory variables for 258 patients who underwent both isolated LVAD implantation and unplanned BVAD because of early right ventricular failure after LVAD insertion, between 2006 and 2017 (LVAD = 170 and BVAD = 88). The final study patie...
Source: ASAIO Journal - November 1, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Incidence and Outcomes of Postoperative Atrial Fibrillation After Left Ventricular Assist Device
This study sought to determine the incidence, predictors, and outcomes of postoperative atrial fibrillation (POAF) in patients undergoing implantation of left ventricular assist devices (LVADs). A retrospective analysis of all patients who underwent LVAD implantation from 2013 to 2014 was conducted. Postoperative AF, survival, and thrombotic complications were evaluated after surgery. A total of 47 patients (mean age, 56.4 ± 12.5 years; 33 male) were included and followed for a median of 331 days. Within 30 days of surgery, 13 (28%) patients developed POAF at mean 7.9 ± 8.5 days. Obstructive lung disease was a predictor ...
Source: ASAIO Journal - August 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Effect of Preoperative Atrial Fibrillation on Patients with Chronic Heart Failure Who Undergo Long-Term Continuous-Flow LVAD Implantation
Although preoperative atrial fibrillation (AF) is common in patients undergoing continuous-flow left ventricular assist device (CF-LVAD) implantation, how AF affects outcomes remains unclear. We analyzed our single-center experience with CF-LVAD implantation to determine whether preoperative AF was associated with inferior outcomes. From November 2003 through March 2016, 526 patients with chronic heart failure underwent implantation with the HeartMate II (HMII; n = 403) or HeartWare VAD (HVAD; n = 123). We identified 229 patients (165 HMII, 65 HVAD) who had preoperative AF and compared them with non–preoperative AF patie...
Source: ASAIO Journal - August 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Accelerometer Detects Pump Thrombosis and Thromboembolic Events in an In vitro HVAD Circuit
Pump thrombosis and stroke are serious complications of left ventricular assist device (LVAD) support. The aim of this study was to test the ability of an accelerometer to detect pump thrombosis and thromboembolic events (TEs) using real-time analysis of pump vibrations. An accelerometer sensor was attached to a HeartWare HVAD and tested in three in vitro experiments using different pumps for each experiment. Each experiment included thrombi injections sized 0.2–1.0 mL and control interventions: pump speed change, afterload increase, preload decrease, and saline bolus injections. A spectrogram was calculated from the acc...
Source: ASAIO Journal - August 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research