Defining Vasoplegia Following Durable, Continuous Flow Left Ventricular Assist Device Implantation
This study aimed to develop a definition of vasoplegia that reliably predicts clinical outcomes. Vasoplegia was evaluated using data from the electronic health record for each 15-minute interval for 72 hours following cardiopulmonary bypass. Standardized definitions considered clinical features (systemic vascular resistance [SVR], mean arterial pressure [MAP], cardiac index [CI], norepinephrine equivalents [NEE]), threshold strategy (criteria occurring in any versus all measurements in an interval), and duration (criteria occurring over multiple consecutive versus separated intervals). Minor vasoplegia was MAP  (Source: ASAIO Journal)
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Survival on Venoarterial Extracorporeal Membrane Oxygenation in Cardiogenic Shock: Which Lactate Is Most Useful?
Prognostic significance of elevated serum lactate in patients on venoarterial extracorporeal membrane oxygenation (ECMO) is widely known. Our objective was to study the utility of lactate measured at different points of time and lactate clearance in predicting the two study endpoints: successful ECMO weaning and hospital survival. Among 238 consecutive patients treated with ECMO, lactic acid was collected before initiating ECMO and then on days 1, 3, 5, and 10 while on ECMO. Out of our cohort, 129 (54.2%) were successfully weaned and 98 (41.2%) were discharged alive. Patients successfully weaned from ECMO had a significant...
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Downsizing of a Pulsatile Total Artificial Heart—The Effect on Hemolysis
A downsized version of the ReinHeart total artificial heart (TAH) was developed. Hemocompatibility needs to be revised since the operating point of the downsized TAH has changed to a higher pump frequency to accomplish the same cardiac output. A mock circulation loop was designed, containing a left side for hemocompatibility testing and a right side to mimic realistic work conditions. A protocol for hemolysis testing was established using pooled porcine blood with an operation point of 5 L/min, a mean outlet pressure of 100 mm Hg and a mean inlet pressure of 12 mm Hg. Six trials were performed testing two downsized T...
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Meet the Authors
No abstract available (Source: ASAIO Journal)
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Meet the Authors Source Type: research

Concept and Design of a Novel Pulsatile Left Heart Assist Device—The PERKAT Left Ventricle System
Cardiogenic shock is associated with high mortality. Patients often require temporary mechanical circulatory support. We aimed to develop a percutaneously implantable, assist device that unloads the left ventricle (LV) in a pulsatile way. The PERkutane KATheter pump technologie (PERKAT LV) device consists of a nitinol pump chamber, which is covered by foils carrying outflow valves. A flexible tube with a pigtail-shaped tip and inflow holes represents the distal part of the pump. The system is designed for 16F percutaneous implantation. The nitinol chamber is placed in the descending aorta while the flexible tube bypasses a...
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Does Size Matter for Female Continuous-flow LVAD Recipients? A Translational Approach to a Decade Long Question
Females have increased risk of right-ventricular failure (RVF) and 3 month mortality after left-ventricular assist device (LVAD) implantation. In this translational study, we tested the hypothesis that sex differences in outcomes are driven by pump-induced LV size-volume mismatch, due to a negative impact on interventricular septal (IVS) interdependence. Adult continuous-flow LVAD recipients from the International Society For Heart And Lung Transplantation Mechanically Assisted Circulatory Support registry (n = 15,498) were studied to determine association of female sex with outcomes of 3 month mortality and RVF. Femal...
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients
The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0–3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials. Evaluable subjects (n = 495) had>1 INR value recorded 1–24 months postimplant and were categorized as: low TTR (10–39%), moderate TTR (40–69%), and high TTR (≥70%). Baseline characteristics, adverse events, and survival were analyzed. Low TTR patients experienced higher rates of major bleeding (1.69 vs. 0.54 events per patient year [EPPY]; p (Source: ASAIO Journal)
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Hemolysis Testing In Vitro: A Review of Challenges and Potential Improvements
Many medical devices such as cardiopulmonary bypass systems, mechanical heart valves, or ventricular assist devices are intended to come into contact with blood flow during use. In vitro hemolysis testing can provide valuable information about the hemocompatibility of prototypes and thus help reduce the number of animal experiments required. Such tests play an important role as research and development tools for objective comparisons of prototypes and devices as well as for the extrapolation of their results to clinical outcomes. Therefore, it is important to explore and provide new ways to improve current practices. In th...
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Review Source Type: research

Future Perspectives of Mechanical Circulatory Support with Left Ventricular Assist Devices: Lessons Learned from the HeartWare Ventricular Assist Device
No abstract available (Source: ASAIO Journal)
Source: ASAIO Journal - December 30, 2021 Category: Medical Devices Tags: Editorial Source Type: research

Novel Innovations for Ventricular Assist Device Infection
We report a case of a third-time LVAD exchange (4th device implant) for device infection within eight years of the index implant, and we briefly discuss the role of the greater omentum in the surgical treatment of this complication. (Source: ASAIO Journal)
Source: ASAIO Journal - December 1, 2021 Category: Medical Devices Tags: Case Reports Source Type: research

Chronic Ventricular Assist Device Support in Adult Congenital Heart Disease Patients: A Children’s Hospital Perspective
We describe our center’s experience with chronic VAD therapy in ACHD patients receiving care exclusively within our children’s hospital. (Source: ASAIO Journal)
Source: ASAIO Journal - December 1, 2021 Category: Medical Devices Tags: Case Reports Source Type: research

3D Holographic Virtual Surgical Planning for a Single Right Ventricle Fontan Patient Needing Heartmate III Placement
A 15 year old female with hypoplastic left heart syndrome status post Norwood with Sano modification, bidirectional Glenn and extracardiac conduit Fontan developed severe right ventricular (RV) systolic dysfunction. Due to symptomatic heart failure, she underwent assessment for ventricular assist device (VAD) placement as a bridge-to-cardiac transplantation strategy. To evaluate her atypical anatomy, a chest computed tomography (CT) was uploaded into an EchoPixel True3D (Santa Clara, CA) view portal along with an accurately scaled 3D surface model of the HeartMate III (HM3) device. The surgeon then manipulated the position...
Source: ASAIO Journal - December 1, 2021 Category: Medical Devices Tags: Case Reports Source Type: research

Angiotensin Receptor-Neprilysin Inhibition Improves Blood Pressure and Heart Failure Control in Left Ventricular Assist Device Patients
Angiotensin receptor-neprilysin inhibitors (ARNIs) greatly benefit functional capacity and longevity in heart failure with reduced ejection fraction (HFrEF). Angiotensin receptor-neprilysin inhibitors remain underutilized and unstudied, however, in left ventricular assist device (LVAD) recipients, in spite of their underlying HFrEF. In this case series, we studied the feasibility and short-term efficacy of ARNI utilization in 21 LVAD patients. Angiotensin receptor-neprilysin inhibitor initiation was successful in most, resulting in significant consolidation of blood pressure (BP) medical management and marked improvements ...
Source: ASAIO Journal - December 1, 2021 Category: Medical Devices Tags: Brief Communications Source Type: research

Effect of Extracorporeal Membrane Oxygenation Support on the Plasma Levels of Commonly Utilized Catecholamines
No abstract available (Source: ASAIO Journal)
Source: ASAIO Journal - December 1, 2021 Category: Medical Devices Tags: Brief Communications Source Type: research

Neurological Outcome According to the Site of Cannulation in Septic Children Supported by Venoarterial Extracorporeal Membrane Oxygenation
The impact of cervical cannulation on neurologic outcome has not been yet studied among children receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) in the context of severe sepsis or septic shock. A retrospective cohort study was performed using the extracorporeal life support organization (ELSO) registry. A total of 559 children weighing less than 20 kg with a primary or secondary diagnosis of severe sepsis, septic shock or toxic shock syndrome were included between January 1, 2010, and December 31, 2019. Cervical cannulation was performed in 485 children (87%) and central cannulation in 74 children (1...
Source: ASAIO Journal - December 1, 2021 Category: Medical Devices Tags: Pediatric Circulatory Support Source Type: research