SynCardia Temporary Total Artificial Heart: Single-Center Experience at a Children’s Hospital
We describe our experience at a children’s hospital with the TAH-t. Seven patients implanted with a TAH-t at Cincinnati Children’s Hospital Medical Center from November 2012 to March 2021 were included. Duration of support ranged from 10 to 414 days with a median of 27 days. There was a trend toward decreased time to extubation and intensive care unit (ICU) length of stay, with the three most recent patients being extubated on postoperative day 1. Seventy-one percent of the patients were successfully transplanted following their TAH-t placement. Children and young adults with transplant graft failure requiring durable,...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Pediatric Circulatory Support Source Type: research

In Vivo Suction Pressures of Venous Cannulas During Veno-venous Extracorporeal Membrane Oxygenation
Extracorporeal lung support includes the risk of hemolysis due to suction pressures. Manufacturers measure the negative suction pressure across drainage cannulas for their products in vitro using water. Clinical experience suggests that hemolysis occurs in vivo already at much lower flow rates. The aim of this study was to analyze the in vivo suction pressure for veno-venous extracorporeal membrane oxygenation (VV-ECMO) cannulas. Prospective, observational study at a tertiary-care intensive care unit: 15 patients on VV-ECMO for severe ARDS were prospectively included. In vitro, the 25 Fr drainage cannula pressure drops bel...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Clinical Critical Care Source Type: research

Clinical and Prognostic Role of Noninvasive Hemodynamic Assessment in Left Ventricular Assist Device Carriers
Persistence of heart failure symptoms or suboptimal hemodynamic is a frequent condition in LVAD carriers, associated with adverse outcome. Invasive hemodynamic optimization was associated with a better outcome. Our group recently validated an echocardiographic protocol to noninvasively assess hemodynamics of LVAD patients. Aim of this prospective study was to investigate its utility in clinical practice and its prognostic role. (Source: ASAIO Journal)
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Clinical Cardiovascular Source Type: research

Patient-Specific Computational Modeling of Different Cannulation Strategies for Extracorporeal Membrane Oxygenation
Institution of extracorporeal membrane oxygenation (ECMO) results in unique blood flow characteristics to the end-organ vascular beds. We studied the interplay between cardiac-driven and extracorporeal membrane oxygenation (ECMO)-driven flow to vascular beds in different ECMO configurations using a patient-specific computational fluid dynamics (CFD) analysis. A computational ECMO model (femoral artery cannulation [FAC]) was constructed using patient-specific imaging and hemodynamic data. Following model calibration, we augmented the 3D geometrical model to represent alternative ECMO configurations (ascending aorta cannulat...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Biomedical Engineering Source Type: research

Improved Flow Dynamics of Extracorporeal Membrane Oxygenation via Design Modification of Dual-Lumen Cannulas
This study numerically investigated the effects of DLC side holes on blood flow dynamics since the maximum wall shear stress (WSS) occurs around the side holes. A DLC based on the Avalon Elite 27Fr model was implanted into an idealized 3D model of the vena cava and right atrium (RA). Eight DLCs were developed by changing the number, diameter, and spacing of side holes through an iterative design process. Physiologic flow at the inferior vena cava (IVC) and superior vena cava (SVC) were applied along with a partial ECMO support of 2 L/min. The SST k-ω turbulent model was solved for 6.4 seconds. WSS, washout, stagnation v...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Biomedical Engineering Source Type: research

Bioprosthetic Total Artificial Heart Implantation Does Not Induce Chronic Inflammation
In conclusion, using a cytokine multiplex assay combined with a flow cytometry approach, we demonstrated the absence of inflammatory signals in peripheral blood over a period of 12 months following A-TAH implantation. (Source: ASAIO Journal)
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Evaluation of a Disposable Vascular Pressure Device for Pre- and Postmembrane Pressure Monitoring During Venovenous Extracorporeal Membrane Oxygenation
Membrane pressure monitoring during extracorporeal membrane oxygenation (ECMO) is integral to monitoring circuit health. We compared a disposable vascular pressure device (DVPD) to the transducer pressure bag arterial line (TPBAL) monitoring system to determine whether the DVPD can reliably and accurately monitor membrane pressures during venovenous extracorporeal membrane oxygenation (VV ECMO). We analyzed existing quality assurance data collected at a single center as part of routine circuit performance monitoring and process improvement on a convenience sample of four VV ECMO circuits. We placed and zeroed a DVPD in lin...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Ventricular Assist Device Self-care Education at Tertiary Care Medical Centers
Ventricular assist device (VAD) implantation requires patients and caregivers to attain self-care knowledge and skills before discharge from implant hospitalization. Inability to perform these skills can have devastating outcomes (i.e., death from pump malfunction, driveline site infections, and stroke). No standard-of-care guiding VAD self-care education exists. We sought to describe how select tertiary care VAD implant centers across the United States currently educate VAD patients and their caregivers. Using a multiple case studies design with a purposive sampling strategy, we conducted semistructured interviews of VAD ...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

In-Hospital Left Ventricular Assist Devices Deactivation and Death Experience: A Single-Institution Retrospective Analysis
Best practices for left ventricular assist devices (LVADs) deactivation at end-of-life (EOL) have yet to be elucidated. We conducted a single-institution retrospective review of patients who died following LVAD deactivation between January 2017 and March 2020. Data were obtained from institutional databases and electronic health record and were analyzed using descriptive statistics. Fifty-eight patients (70% male, 70% African American, median age 62 years) were categorized by implant strategy: bridge therapy (BT, N = 22, 38%) or destination therapy (DT, N = 36, 62%). Clinical events leading to deactivation were categorized...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Interventional Procedures for Left Ventricular Assist Device-Associated Complications
As patients on long-term left ventricular assist device (LVAD) face a substantial risk for open cardiac reoperation, interventional treatment approaches are becoming increasingly important in this population. We evaluated data of 871 patients who were on LVAD support between January 1, 2016 and December 1, 2020. Interventional treatments for LVAD-associated complications were performed in 76 patients. Seventeen patients underwent transcatheter aortic valve replacements (TAVR) and 61 patients underwent outflow graft interventions (OGI). TAVR improved symptoms in patients with severe symptomatic aortic regurgitation. Postint...
Source: ASAIO Journal - November 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

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

Pulmonary Transplant After More Than 1 Year of Continuous Ambulatory Extracorporeal Support
While extracorporeal support of patients awaiting pulmonary transplantation is now well-established, extracorporeal membrane oxygenation (ECMO) remains a nondurable technology deployed for short-term support or recovery in patients with progressive disease. Here, we describe an anecdotal experience with pulmonary transplant after more than 1 year of continuous veno-venous ECMO support. The case highlights several issues relevant to the increasing use of bridging technologies: (1) the potential impact of extracorporeal circulation on immune sensitization, (2) the safety and questionable need for anticoagulation in long-term...
Source: ASAIO Journal - October 1, 2022 Category: Medical Devices Tags: Case Reports Source Type: research

Potential of the EVAHEART 2 Double-Cuff Tipless Inflow Cannula for Prevention of Thromboembolic Events
A 32-year-old man, who had developed fulminant myocarditis leading to asystole, underwent implantation of an EVAHEART 2 left ventricular assist system with a double-cuff tipless inflow cannula and a concurrent Fontan operation. Approximately 2 years after the simultaneous EVAHEART 2 implantation and the Fontan operation, the patient underwent heart transplantation. There was no device-related thromboembolism or pump malfunction under adequate antithrombotic management during the postoperative support period. Computed tomography showed no malposition of the inflow cannula irrespective of the left ventricular chamber size. M...
Source: ASAIO Journal - October 1, 2022 Category: Medical Devices Tags: Case Reports Source Type: research

Antithrombin Replacement and Extracorporeal Membrane Oxygenation: The time is ripe for a Simpler Solution
No abstract available (Source: ASAIO Journal)
Source: ASAIO Journal - October 1, 2022 Category: Medical Devices Tags: Brief Communication Source Type: research

Thoracoabdominal Normothermic Regional Perfusion for Cardiac Procurement
In donation after circulatory death donors, warm ischemia time is a significant threat to successful cardiac transplantation. The ability to perfuse these organs during the minutes after death, until cardiac evaluation is completed to satisfaction, is crucial in limiting total warm ischemic time. Thoracoabdominal normothermic regional perfusion (TANRP) has emerged as a promising strategy for recovering and monitoring these hearts. We propose a series of clinical practice pearls that we follow for all donation after circulatory death procurements to streamline the process of setting up a TANRP circuit and ensuring all team ...
Source: ASAIO Journal - October 1, 2022 Category: Medical Devices Tags: How to do it Article Source Type: research