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Source: ASAIO Journal
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Total 95 results found since Jan 2013.
Sex-Specific Outcome Disparities in Patients Receiving Continuous-Flow Left Ventricular Assist Devices: A Systematic Review and Meta-analysis
Continuous-flow left ventricular assist devices (CF-LVADs) decrease mortality and improve quality of life in patients with advanced heart failure (HF). Their widespread utilization has led to concerns regarding increased adverse effects, especially in women. Nevertheless, sex-specific data remain limited. We searched Medline, Embase, Scopus, and the Cochrane Library for publications reporting sex-specific outcomes after CF-LVADs from January 2008 through January 2017. Outcomes were compared under the random-effects model and heterogeneity examined via χ2 test and I2 statistics. A total of 10 studies including 4,493 CF-LVA...
Source: ASAIO Journal - June 29, 2018 Category: Medical Devices Tags: Review Articles Source Type: research
Individualized Biventricular Epicardial Augmentation Technology in a Drug-Induced Porcine Failing Heart Model
This study investigated an individualized biventricular epicardial augmentation technology in a drug-induced porcine failing heart model. A total of 11 pigs were used, for the assessment of hemodynamics and cardiac function under various conditions of support pressures and support durations (n = 4), to assess device positioning and function by in vivo computer tomographic imaging (n = 3) and to investigate a minimally invasive implantation on the beating heart (n = 4). Support pressures of 20–80 mm Hg gradually augmented cardiac function parameters in this animal model as indicated by increased left ventricular stroke ...
Source: ASAIO Journal - June 29, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
The Starling Relationship and Veno-Arterial ECMO: Ventricular Distension Explained
This study examined the impact of VA ECMO on left ventricular (LV) Starling curves to elaborate a framework for anticipating and treating LV distension. A previously developed and validated model of the cardiovascular system was used to generate pressure–volume (PV) loops and Starling curves while holding mean arterial pressure (mABP) constant at a range of values either by adjusting systemic resistance or by adding VA ECMO support. It was found that under all conditions of similar mAPB, the Starling curve was unchanged; therefore, the degree of LV distension is obligated by the mAPB (irrespective of whether controlled p...
Source: ASAIO Journal - June 29, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Left Ventricular Assist Device Infections: A Systematic Review
Left ventricular assist devices (LVADs) are becoming a more frequent life-support intervention. Gaining an understanding of risk factors for infection and management strategies is important for treating these patients. We conducted a systematic review and meta-analysis of studies describing infections in continuous-flow LVADs. We evaluated incidence, risk factors, associated microorganisms, and outcomes by type of device and patient characteristics. Our search identified 90 distinct studies that reported LVAD infections and outcomes. Younger age and higher body mass index were associated with higher rates of LVAD infection...
Source: ASAIO Journal - April 28, 2018 Category: Medical Devices Tags: Review Article Source Type: research
Sildenafil in Left Ventricular Assist Device Is Safe and Well-Tolerated
Right heart failure is a potentially devastating complication of mechanical circulatory support, occurring at a rate of 0.49 events per 100 patient-months.1 Pulmonary vasodilators such as phosphodiesterase-5 inhibitors (PDE5i) have been frequently used to unload the right ventricle in left ventricular assist device (LVAD) patients, but there is scant evidence to support this practice.2,3 The purpose of this analysis is to provide additional data regarding the safety and efficacy of the PDE5i sildenafil in a real world population of patients supported with LVADs at Washington University in St. Louis. Sildenafil use was not ...
Source: ASAIO Journal - February 24, 2018 Category: Medical Devices Tags: Brief Communication Source Type: research
Hydrodynamic and Geometric Behavior of Two Pericardial Prostheses Implanted in Small Aortic Roots
Hydrodynamic performance of stented bioprostheses is far below that of the native valve. One of the reasons is that the internal diameter of the prosthesis is usually smaller than that of the native valve. However, other valve characteristics are also important in generating the pressure drop. We aimed to assess, in an ex vivo pulsatile mock loop, the hydrodynamic behavior of two bioprostheses, Trifecta and Mitroflow, to ascertain which geometric terms are limiting factors in hydrodynamic performance. At stroke volumes between 30 and 60 ml, Trifecta showed lower pressure drop, energy dissipation and valve resistance, and...
Source: ASAIO Journal - January 1, 2018 Category: Medical Devices Tags: Clinical Cardiovascular Source Type: research
Adverse Event Rates Change Favorably Over Time for Patients Bridged With the HeartWare Left Ventricular Assist Device
The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridge-to-transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30,>30–180,>180–365,>365–730,>730–1,095 days) after HVAD implant. The Kaplan–Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively...
Source: ASAIO Journal - October 31, 2017 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Brain Magnetic Resonance Imaging Findings in Pediatric Patients Post Extracorporeal Membrane Oxygenation
Neurologic complications can occur with extracorporeal membrane oxygenation (ECMO) due to several factors. Prior studies identified neonates as having unique risk factors and neuroimaging findings post ECMO. The aim of this study is to describe brain magnetic resonance imaging findings of pediatric patients treated with ECMO. We conducted a retrospective study of nonneonatal pediatric patients who underwent a comprehensive brain magnetic resonance imaging after ECMO between January 2000 and July 2015. We identified 47 pediatric patients in the study cohort with a median age of 8 months (interquartile range 3–170 months) ...
Source: ASAIO Journal - October 31, 2017 Category: Medical Devices Tags: Pediatric Circulatory Support Source Type: research
Osmotic and Hemodynamic Effects of Hypertonic Glucose During Hemodialysis
It was the purpose to quantify the hemodynamic effects of a bolus of hypertonic glucose injected into the extracorporeal system in a group of stable and nondiabetic patients during hemodialysis (HD). Glucose and electrolytes were measured in frequent intervals. Arterial blood pressures and heart rates were continuously recorded by noninvasive vascular unloading technique. Beat-to-beat stroke volume, cardiac output, and total peripheral resistance were determined by Modelflow method. Relative blood volumes were continuously measured by ultrasonic and optical means. Eight patients were studied in two treatments. Although art...
Source: ASAIO Journal - October 31, 2017 Category: Medical Devices Tags: Renal/Extracorporeal Blood Treatment Source Type: research
Permanent Atrial Fibrillation and 2 Year Clinical Outcomes in Patients with a Left Ventricular Assist Device Implant
Atrial fibrillation (AF) may increase the risk of thromboembolic (TE) complications in patients with left ventricular assist devices (LVADs). In a single-center study, we investigated 205 patients with sinus rhythm (SR group) and 117 patients with AF (AF group). Our main read outs were 2 year overall survival (primary end point), perioperative right heart failure (RHF), and 2 year freedom from stroke, pump thrombosis, and gastrointestinal bleeding (secondary end points). Oral anticoagulation was performed with phenprocoumon (international normalized ratio target range: 2.3–2.8) and aspirin (100 mg/day). Propensity scor...
Source: ASAIO Journal - June 29, 2017 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Experience with Extracorporeal Life Support for Cardiogenic Shock in the Older Population more than 70 Years of Age
The two main objectives of this single-center, retrospective study were to analyze the outcomes and to identify the independent predictors of 30 day and long-term mortality in case of cardiopulmonary resuscitation requiring extracorporeal life support (ECLS) in the elderly patients. From October 2004 to May 2014, 163 patients with a mean age of 75.5 years (range 70–91) required veno-arterial ECLS. The main indication was postcardiotomy cardiogenic shock (79.6%). Extracorporeal life support duration averaged 5.6 ± 4.3 days. Thirty-day mortality was 72% (n = 117) and follow-up survival rate was 14.1% with a median fol...
Source: ASAIO Journal - May 1, 2017 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research
Effect of Outflow Graft Size on Flow in the Aortic Arch and Cerebral Blood Flow in Continuous Flow Pumps: Possible Relevance to Strokes
One of the most devastating complications of continuous flow left ventricular devices (CFLVADS) is stroke, with a higher incidence in HeartWare Ventricular Assist Device (HVAD) as compared with HEARTMATE II. The reason for the observed difference in stroke rates is unclear. Because outflow graft diameters are different, we hypothesized that this could contribute to the difference in stroke rates. A computational fluid–structure interaction model was created from the computed tomography (CT) scan of a patient. Pressures were used as the boundary condition and the flow through the cerebral vessels was derived as outputs. F...
Source: ASAIO Journal - February 25, 2017 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research
Postapproval Outcomes: The Berlin Heart EXCOR Pediatric in North America
The Berlin Heart EXCOR Pediatric Ventricular Assist Device (BH) was approved for use in the United States in December 2011, based on a prospective investigational device exemption (IDE) trial. Strict exclusion criteria for the trial selected a low-risk “ideal” cohort. We sought to determine whether postapproval usage of the BH in a “real world” cohort of recipients would result in similar outcomes. Preimplant diagnostic information was collected for all patients. Efficacy was evaluated by comparison of all children (efficacy group, n = 247) implanted between FDA approval and April 2015 to those in the IDE trial (ID...
Source: ASAIO Journal - February 25, 2017 Category: Medical Equipment Tags: Pediatric Circulatory Support Source Type: research
Scaling the Low-Shear Pulsatile TORVAD for Pediatric Heart Failure
This article provides an overview of the design challenges associated with scaling the low-shear pulsatile TORVAD ventricular assist device (VAD) for treating pediatric heart failure. A cardiovascular system model was used to determine that a 15 ml stroke volume device with a maximum flow rate of 4 L/min can provide full support to pediatric patients with body surface areas between 0.6 and 1.5 m2. Low-shear stress in the blood is preserved as the device is scaled down and remains at least two orders of magnitude less than continuous flow VADs. A new magnetic linkage coupling the rotor and piston has been optimized usin...
Source: ASAIO Journal - February 25, 2017 Category: Medical Equipment Tags: Pediatric Circulatory Support Source Type: research
