Left ventricular assist devices as destination therapy: a new look at survival.

PubMed

Park, Soon J; Tector, Alfred; Piccioni, William; Raines, Edward; Gelijns, Annetine; Moskowitz, Alan; Rose, Eric; Holman, William; Furukawa, Satoshi; Frazier, O Howard; Dembitsky, Walter

2005-01-01

The REMATCH trial compared the use of left ventricular assist devices with optimal medical management for patients with end-stage heart failure. When the trial met its primary end point criteria in July 2001, left ventricular assist device therapy was shown to significantly improve survival and quality of life. With extended follow-up, 2 critical questions emerge: (1) Did these benefits persist, and (2) did outcomes improve over the course of the trial, given the evolving nature of the technology? We analyzed survival in this randomized trial by using the product-limit method of Kaplan and Meier. Changes in the benefits of therapy were analyzed by examining the effect of the enrollment period. The survival rates for patients receiving left ventricular assist devices (n = 68) versus patients receiving optimal medical management (n = 61) were 52% versus 28% at 1 year and 29% versus 13% at 2 years ( P = .008, log-rank test). As of July 2003, 11 patients were alive on left ventricular assist device support out of a total 16 survivors (including 3 patients receiving optimal medical management who crossed over to left ventricular assist device therapy). There was a significant improvement in survival for left ventricular assist device-supported patients who enrolled during the second half of the trial compared with the first half ( P = .03). The Minnesota Living with Heart Failure scores improved significantly over the course of the trial. The extended follow-up confirms the initial observation that left ventricular assist device therapy renders significant survival and quality-of-life benefits compared with optimal medical management for patients with end-stage heart failure. Furthermore, we observed an improvement in the survival of patients receiving left ventricular assist devices over the course of the trial, suggesting the effect of greater clinical experience.

Cerebrovascular accidents in patients with a ventricular assist device.

PubMed

Tsukui, Hiroyuki; Abla, Adib; Teuteberg, Jeffrey J; McNamara, Dennis M; Mathier, Michael A; Cadaret, Linda M; Kormos, Robert L

2007-07-01

A cerebrovascular accident is a devastating adverse event in a patient with a ventricular assist device. The goal was to clarify the risk factors for cerebrovascular accident. Prospectively collected data, including medical history, ventricular assist device type, white blood cell count, thrombelastogram, and infection, were reviewed retrospectively in 124 patients. Thirty-one patients (25%) had 48 cerebrovascular accidents. The mean ventricular assist device support period was 228 and 89 days in patients with and without cerebrovascular accidents, respectively (P < .0001). Sixty-six percent of cerebrovascular accidents occurred within 4 months after implantation. Actuarial freedom from cerebrovascular accident at 6 months was 75%, 64%, 63%, and 33% with the HeartMate device (Thoratec Corp, Pleasanton, Calif), Thoratec biventricular ventricular assist device (Thoratec Corp), Thoratec left ventricular assist device (Thoratec), and Novacor device (WorldHeart, Oakland, Calif), respectively. Twenty cerebrovascular accidents (42%) occurred in patients with infections. The mean white blood cell count at the cerebrovascular accident was greater than the normal range in patients with infection (12,900/mm3) and without infection (9500/mm3). The mean maximum amplitude of the thrombelastogram in the presence of infection (63.6 mm) was higher than that in the absence of infection (60.7 mm) (P = .0309). The risk of cerebrovascular accident increases with a longer ventricular assist device support period. Infection may activate platelet function and predispose the patient to a cerebrovascular accident. An elevation of the white blood cell count may also exacerbate the risk of cerebrovascular accident even in patients without infection. Selection of device type, prevention of infection, and meticulous control of anticoagulation are key to preventing cerebrovascular accident.

Development and evaluation of a new taxonomy of mobility-related assistive technology devices.

PubMed

Shoemaker, Laura L; Lenker, James A; Fuhrer, Marcus J; Jutai, Jeffrey W; Demers, Louise; DeRuyter, Frank

2010-10-01

This article reports on the development of a new taxonomy for mobility-related assistive technology devices. A prototype taxonomy was created based on the extant literature. Five mobility device experts were engaged in a modified Delphi process to evaluate and refine the taxonomy. Multiple iterations of expert feedback and revision yielded consensual agreement on the structure and terminology of a new mobility device taxonomy. The taxonomy uses a hierarchical framework to classify ambulation aids and wheeled mobility devices, including their key features that impact mobility. Five attributes of the new taxonomy differentiate it from previous mobility-related device classifications: (1) hierarchical structure, (2) primary device categories are grouped based on their intended mobility impact, (3) comprehensive inclusion of technical features, (4) a capacity to assimilate reimbursement codes, and (5) availability of a detailed glossary. The taxonomy is intended to support assistive technology outcomes research. The taxonomy will enable researchers to capture mobility-related assistive technology device interventions with precision and provide a common terminology that will allow comparisons among studies. The prominence of technical features within the new taxonomy will hopefully promote research that helps clinicians predict how devices will perform, thus aiding clinical decision making and supporting funding recommendations.

Outcomes of HeartWare Ventricular Assist System support in 141 patients: a single-centre experience.

PubMed

Wu, Long; Weng, Yu-Guo; Dong, Nian-Guo; Krabatsch, Thomas; Stepanenko, Alexander; Hennig, Ewald; Hetzer, Roland

2013-07-01

A third-generation ventricular assist device, the HeartWare Ventricular Assist System, has demonstrated its reliability and durability in animal models and clinical experience. However, studies of a large series of applications are still lacking. We evaluate the safety and efficacy of the HeartWare pump in 141 patients with end-stage heart failure at a single centre. A total of 141 patients (116 men and 25 women with a mean age of 52 years) in New York Heart Association (NYHA) Class IV received implantation of the HeartWare Ventricular Assist System between August 2009 and April 2011 at the Deutsches Herzzentrum Berlin. The outcomes were measured in terms of laboratory data, adverse events, NYHA functional class and survival during device support. The HeartWare system provided an adequate haemodynamic support for patients both inside and outside the hospital. NYHA class improved to I-II. Organ function and pulmonary vascular resistance improved significantly. In this cohort of patients, 14 patients underwent heart transplantation, one had had the device explanted following myocardial recovery, one had changed to another assist device, 81 were on ongoing support and 44 died. The overall actuarial survival rates at 6 and 12 months were 70 and 67%, respectively, and the 3-, 6- and 12-month survival rates on a left ventricular assist device (LVAD) support for bridge to transplantation patients were 82, 81 and 79%, respectively. Infection and bleeding were the main adverse events. Four patients underwent an LVAD exchange for pump thrombosis. The HeartWare system provides a safe and effective circulatory support in a population with a wide range of body surface areas, with a satisfactory actuarial survival time and an improved quality of life. It can be used for univentricular or biventricular support, being implanted into the pericardial space with simplified surgical techniques.

Development of NASA-DeBakey Ventricular Assist Device Using Numerical Aerospace Simulation Technology

NASA Technical Reports Server (NTRS)

Kwak, Dochan

2000-01-01

Over three million Americans and 20 million people worldwide suffer from some form of heart failure. Mechanical heart assist devices are being used as a temporary support to sick ventricle and valves as a bridge-to-transplant or bridge-to-recovery. This viewgraph presentation gives an overview of the development of NASA-DeBakey Ventricular Assist Device (VAD) using numerical aerospace simulation technology.

Effect of HeartMate left ventricular assist device on cardiac autonomic nervous activity.

PubMed

Kim, S Y; Montoya, A; Zbilut, J P; Mawulawde, K; Sullivan, H J; Lonchyna, V A; Terrell, M R; Pifarré, R

1996-02-01

Clinical performance of a left ventricular assist device is assessed via hemodynamic parameters and end-organ function. This study examined effect of a left ventricular assist device on human neurophysiology. This study evaluated the time course change of cardiac autonomic activity of 3 patients during support with a left ventricular assist device before cardiac transplantation. Cardiac autonomic activity was determined by power spectral analysis of short-term heart rate variability. The heart rate variability before cardiac transplantation was compared with that on the day before left ventricular assist device implantation. The standard deviation of the mean of the R-R intervals of the electrocardiogram, an index of vagal activity, increased to 27 +/- 7 ms from 8 +/- 0.6 ms. The modulus of power spectral components increased. Low frequency (sympathetic activity) and high frequency power (vagal activity) increased by a mean of 9 and 22 times of each baseline value (low frequency power, 5.2 +/- 3.0 ms2; high frequency power, 2.1 +/- 0.7 ms2). The low over high frequency power ratio decreased substantially, indicating an improvement of cardiac sympatho-vagal balance. The study results suggest that left ventricular assist device support before cardiac transplantation may exert a favorable effect on cardiac autonomic control in patients with severe heart failure.

Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: design and rationale of the ROADMAP clinical trial.

PubMed

Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C

2015-02-01

Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

Management of severe ischemic cardiomyopathy: left ventricular assist device as destination therapy versus conventional bypass and mitral valve surgery.

PubMed

Maltais, Simon; Tchantchaleishvili, Vahtang; Schaff, Hartzell V; Daly, Richard C; Suri, Rakesh M; Dearani, Joseph A; Topilsky, Yan; Stulak, John M; Joyce, Lyle D; Park, Soon J

2014-04-01

Patients with severe ischemic cardiomyopathy (left ventricular ejection fraction <25%) and severe ischemic mitral regurgitation have a poor survival with medical therapy alone. Left ventricular assist device as destination therapy is reserved for patients who are too high risk for conventional surgery. We evaluated our outcomes with conventional surgery within this population and the comparative effectiveness of these 2 therapies. We identified patients who underwent conventional surgery or left ventricular assist device as destination therapy for severe ischemic cardiomyopathy (left ventricular ejection fraction <25%) and severe mitral regurgitation. The era for conventional surgery spanned from 1993 to 2009 and from 2007 to 2011 for left ventricular assist device as destination therapy. We compared baseline patient characteristics and outcomes in terms of end-organ function and survival. A total of 88 patients were identified; 55 patients underwent conventional surgery (63%), and 33 patients (37%) received a left ventricular assist device as destination therapy. Patients who received left ventricular assist device as destination therapy had the increased prevalence of renal failure, inotrope dependency, and intra-aortic balloon support. Patients undergoing conventional surgery required longer ventilatory support, and patients receiving a left ventricular assist device required more reoperation for bleeding. Mortality rates were similar between the 2 groups at 30 days (7% in the conventional surgery group vs 3% in the left ventricular assist device as destination therapy group, P = .65) and at 1 year (22% in the conventional surgery group vs 15% in the left ventricular assist device as destination therapy group, P = .58). There was a trend toward improved survival in patients receiving a left ventricular assist device compared with the propensity-matched groups at 1 year (94% vs 71%, P = .171). The operative mortality and early survival after conventional surgery seem to be acceptable. For inoperable or prohibitive-risk patients, left ventricular assist device as destination therapy can be offered with similar outcomes. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Functional impairment in patients with sporadic Inclusion Body Myositis.

PubMed

Dunlap, Heather V; Macneil, Lauren G; Tarnopolsky, Mark A

2014-03-01

We conducted a retrospective chart review of 53 patients diagnosed with sporadic Inclusion Body Myositis (sIBM) who have been followed at the McMaster Neuromuscular Clinic since 1996. We reviewed patient medical histories in order to compare our findings with similar cohorts, and analyzed quantitative strength data to determine functionality in guiding decisions related to gait assistive devices. Patient information was acquired through retrospective clinic chart review. Our study found knee extension strength decreased significantly as patients transitioned to using more supportive gait assistive devices (P < 0.05). A decline to below 30 Nm was particularly indicative of the need for a preliminary device (i.e. cane)(P < 0.05). Falls and fear of falling poses a significant threat to patient physical well-being. The prevalence of dysphagia increased as patients required more supportive gait devices, and finally a significant negative correlation was found between time after onset and creatine kinase (CK) levels (P < 0.01). This study supports that knee extension strength may be a useful tool in advising patients concerning ambulatory assistance. Further investigations concerning gait assistive device use and patient history of falling would be beneficial in preventing future falls and improving long-term patient outcomes.

The use of mobile devices as assistive technology in resource-limited environments: access for learners with visual impairments in Kenya.

PubMed

Foley, Alan R; Masingila, Joanna O

2015-07-01

In this paper, the authors explore the use of mobile devices as assistive technology for students with visual impairments in resource-limited environments. This paper provides initial data and analysis from an ongoing project in Kenya using tablet devices to provide access to education and independence for university students with visual impairments in Kenya. The project is a design-based research project in which we have developed and are refining a theoretically grounded intervention--a model for developing communities of practice to support the use of mobile technology as an assistive technology. We are collecting data to assess the efficacy and improve the model as well as inform the literature that has guided the design of the intervention. In examining the impact of the use of mobile devices for the students with visual impairments, we found that the devices provide the students with (a) access to education, (b) the means to participate in everyday life and (c) the opportunity to create a community of practice. Findings from this project suggest that communities of practice are both a viable and a valuable approach for facilitating the diffusion and support of mobile devices as assistive technology for students with visual impairments in resource-limited environments. Implications for Rehabilitation The use of mobile devices as assistive technology in resource-limited environments provides students with visual impairments access to education and enhanced means to participate in everyday life. Communities of practice are both a viable and a valuable approach for facilitating the diffusion and support of mobile devices as assistive technology for students with visual impairments in resource-limited environments. Providing access to assistive technology early and consistently throughout students' schooling builds both their skill and confidence and also demonstrates the capabilities of people with visual impairments to the larger society.

Bioartificial liver assist devices in support of patients with liver failure.

PubMed

Patzer II, John F; Lopez, Roberto C; Zhu, Yue; Wang, Zi-Fa; Mazariegos, George V; Fung, John J

2002-02-01

Bioartificial liver assist devices (BALs) offer an opportunity for critical care physicians and transplant surgeons to stabilize patients prior to orthotopic liver transplantation. Such devices may also act as a bridge to transplant, providing liver support to patients awaiting transplant, or as support for patients post living-related donor transplant. Four BAL devices that rely on hepatocytes cultured in hollow fiber membrane cartridges (Circe Biomedical HepatAssist(r), Vitagen ELADTM, Gerlach BELS, and Excorp Medical BLSS) are currently in various stages of clinical evaluation. Comparison of the four devices shows that several unique approaches based upon the same overall system architecture are possible. Preliminary results of the Excorp Medical BLSS Phase I safety evaluation at the University of Pittsburgh, after treating four patients (F, 41, acetominophen-induced, two support periods; M, 50, Wilson's disease, one support period; F, 53, acute alcoholic hepatitis, two support periods; F, 24, chemotherapy-induced, one support period, are presented. All patients presented with hypoglycemia and transient hypotension at the start of extracorporeal perfusion. Hypoglycemia was treated by IV dextrose and the transient hypotension responded positively to IV fluid bolus. Heparin anticoagulation was used only in the second patient. No serious or adverse events were noted in the four patients. Moderate Biochemical response to support was noted in all patients. More complete characterization of the safety of the BLSS requires completion of the Phase I safety evaluation.

The future of intelligent assistive technologies for cognition: devices under development to support independent living and aging-with-choice.

PubMed

Boger, Jennifer; Mihailidis, Alex

2011-01-01

A person's ability to be independent is dependent on his or her overall health, mobility, and ability to complete activities of daily living. Intelligent assistive technologies (IATs) are devices that incorporate context into their decision-making process, which enables them to provide customised and dynamic assistance in an appropriate manner. IATs have tremendous potential to support people with cognitive impairments as they can be used to support many facets of well-being; from augmenting memory and decision making tasks to providing autonomous and early detection of possible changes in health. This paper presents IATs that are currently in development in the research community to support tasks that can be impacted by compromised cognition. While they are not yet ready for the general public, these devices showcase the capabilities of technologies one can expect to see in the consumer marketplace in the near future.

US FDA perspective on regulatory issues affecting circulatory assist devices.

PubMed

Sapirstein, Wolf; Chen, Eric; Swain, Julie; Zuckerman, Bram

2006-11-01

There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue.

What the Psychiatrist Needs to Know About Ventricular Assist Devices: A Comprehensive Review.

PubMed

Caro, Mario A; Rosenthal, Julie L; Kendall, Kay; Pozuelo, Leopoldo; Funk, Margo C

2016-01-01

The number of patients with end-stage heart failure using mechanical circulatory support has dramatically increased over the past decade. Left ventricular assist devices, the most common type of mechanical circulatory support, can be used as a bridge to transplant, destination therapy, and as a bridge to recovery. As this patient population continues to grow, consultation-liaison psychiatrists will become increasingly involved in their care. A thorough biopsychosocial assessment is required to ensure adequate recognition and management of medical, psychiatric, social, and ethical challenges posed by this population. We performed a literature review to identify key issues relevant to the practice of consultation-liaison psychiatrists. General functioning of left ventricular assist devices, device types, system components, life with a left ventricular assist device, preoperative evaluation, treatment of psychiatric comorbidities, and end-of-life decision-making are discussed. Consultation-liaison psychiatrists need to be familiar with the high prevalence of psychopathology in patients implanted with left ventricular assist devices. A detailed biopsychosocial formulation is required to adequately identify and, if possible, resolve a myriad of medical, psychiatric, social, and ethical challenges presented by this population. Future efforts should accurately identify and report specific psychiatric disorders and adverse events within this cohort. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Energy transmission and power sources for mechanical circulatory support devices to achieve total implantability.

PubMed

Wang, Jake X; Smith, Joshua R; Bonde, Pramod

2014-04-01

Left ventricular assist device therapy has radically improved congestive heart failure survival with smaller rotary pumps. The driveline used to power today's left ventricular assist devices, however, continues to be a source of infection, traumatic damage, and rehospitalization. Previous attempts to wirelessly power left ventricular assist devices using transcutaneous energy transfer systems have been limited by restrictions on separation distance and alignment between the transmit and receive coils. Resonant electrical energy transfer allows power delivery at larger distances without compromising safety and efficiency. This review covers the efforts to wirelessly power mechanical circulatory assist devices and the progress made in enhancing their energy sources. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Applying a soft-robotic glove as assistive device and training tool with games to support hand function after stroke: Preliminary results on feasibility and potential clinical impact.

PubMed

Prange-Lasonder, Gerdienke B; Radder, Bob; Kottink, Anke I R; Melendez-Calderon, Alejandro; Buurke, Jaap H; Rietman, Johan S

2017-07-01

Recent technological developments regarding wearable soft-robotic devices extend beyond the current application of rehabilitation robotics and enable unobtrusive support of the arms and hands during daily activities. In this light, the HandinMind (HiM) system was developed, comprising a soft-robotic, grip supporting glove with an added computer gaming environment. The present study aims to gain first insight into the feasibility of clinical application of the HiM system and its potential impact. In order to do so, both the direct influence of the HiM system on hand function as assistive device and its therapeutic potential, of either assistive or therapeutic use, were explored. A pilot randomized clinical trial was combined with a cross-sectional measurement (comparing performance with and without glove) at baseline in 5 chronic stroke patients, to investigate both the direct assistive and potential therapeutic effects of the HiM system. Extended use of the soft-robotic glove as assistive device at home or with dedicated gaming exercises in a clinical setting was applicable and feasible. A positive assistive effect of the soft-robotic glove was proposed for pinch strength and functional task performance 'lifting full cans' in most of the five participants. A potential therapeutic impact was suggested with predominantly improved hand strength in both participants with assistive use, and faster functional task performance in both participants with therapeutic application.

Beyond the VAD: Human Factors Engineering for Mechanically Assisted Circulation in the 21st Century.

PubMed

Throckmorton, Amy L; Patel-Raman, Sonna M; Fox, Carson S; Bass, Ellen J

2016-06-01

Thousands of ventricular assist devices (VADs) currently provide circulatory support to patients worldwide, and dozens of heart pump designs for adults and pediatric patients are under various stages of development in preparation for translation to clinical use. The successful bench-to-bedside development of a VAD involves a structured evaluation of possible system states, including human interaction with the device and auxiliary component usage in the hospital or home environment. In this study, we review the literature and present the current landscape of preclinical design and assessment, decision support tools and procedures, and patient-centered therapy. Gaps of knowledge are identified. The study findings support the need for more attention to user-centered design approaches for medical devices, such as mechanical circulatory assist systems, that specifically involve detailed qualitative and quantitative assessments of human-device interaction to mitigate risk and failure. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

[Importance of mechanical assist devices in acute circulatory arrest].

PubMed

Ferrari, Markus Wolfgang

2016-03-01

Mechanical assist devices are indicated for hemodynamic stabilization in acute circulatory arrest if conventional means of cardiopulmonary resuscitation are unable to re-establish adequate organ perfusion. Their temporary use facilitates further diagnostic and therapeutic options in selected patients, e.g. coronary angiography followed by revascularization.External thorax compression devices allow sufficient cardiac massage in case of preclinical or in-hospital circulatory arrest, especially under complex transfer conditions. These devices perform standardized thorax compressions at a rate of 80-100 per minute. Invasive mechanical support devices are used in the catheter laboratory or in the intensive care unit. Axial turbine pumps, e.g. the Impella, continuously pump blood from the left ventricle into the aortic root. The Impella can also provide right ventricle support by pumping blood from the vena cava into the pulmonary artery. So-called emergency systems or ECMO devices consist of a centrifugal pump and a membrane oxygenator allowing complete takeover of cardiac and pulmonary functions. Withdrawing blood from the right atrium and vena cava, oxygenated blood is returned to the abdominal aorta. Isolated centrifugal pumps provide left heart support without an oxygenator after transseptal insertion of a venous cannula into the left atrium.Mechanical assist devices are indicated for acute organ protection and hemodynamic stabilization for diagnostic and therapeutic measures as well as bridge to myocardial recovery. Future technical developments and better insights into the pathophysiology of mechanical circulatory support will broaden the spectrum of indications of such devices in acute circulatory arrest.

Device Management and Flow Optimization on Left Ventricular Assist Device Support.

PubMed

Tchoukina, Inna; Smallfield, Melissa C; Shah, Keyur B

2018-07-01

The authors discuss principles of continuous flow left ventricular assist device (LVAD) operation, basic differences between the axial and centrifugal flow designs and hemodynamic performance, normal LVAD physiology, and device interaction with the heart. Systematic interpretation of LVAD parameters and recognition of abnormal patterns of flow and pulsatility on the device interrogation are necessary for clinical assessment of the patient. Optimization of pump flow using LVAD parameters and echocardiographic and hemodynamics guidance are reviewed. Copyright © 2018 Elsevier Inc. All rights reserved.

Perioperative management of two patients with left ventricular assist devices presenting for noncardiac surgery in the prone position.

PubMed

Chacon, M Megan; Hattrup, Emily A; Shillcutt, Sasha K

2014-03-15

Ventricular assist devices (VADs) provide mechanical circulatory support for patients with advanced heart failure. Patients with VADs are presenting for noncardiac surgery with increasing frequency. Understanding anesthetic management of patients with VADs is timely and necessary for perioperative physicians. We present 2 patients supported by left VADs who required intraoperative prone positioning, and how transesophageal echocardiography and VAD variables can be used to guide management.

Use of a Left Ventricular Assist Device as a Bridge to Transplantation in a Pediatric Patient

PubMed Central

Frazier, O.H.; Bricker, J. Timothy; Macris, Michael P.; Cooley, Denton A.

1989-01-01

Despite many advances in heart transplantation and in mechanical circulatory support, the benefits of staged cardiac transplantation have not been extended to the pediatric transplant recipient, chiefly because implantable circulatory assist devices are still too large. Extracorporeal devices, however, can overcome this impediment. Here we report the 1st case, to our knowledge, in which an extracorporeal left ventricular assist device has been used in a child to support circulation prior to cardiac transplantation. The patient was a 9-year-old boy in New York Heart Association functional class IV, with congestive heart failure as a result of idiopathic biventricular cardiomegaly. In mid-May of 1987, while awaiting a suitable donor, he suffered severe oliguria after an episode of circulatory arrest. Therefore we decided to maintain his circulation—and consequently his peripheral organ function—with an extracorporeal left ventricular assist device. After establishing cardiopulmonary bypass under normothermia and without cardiac arrest, we established flow from the left ventricle through a 36-Fr wire-reinforced straight cannula to a Biomedicus BP-80 centrifugal force pump, with return to the proximal ascending aorta through a 28-Fr wire-reinforced straight cannula. The patient's hemodynamic course under subsequent mechanical circulatory support was remarkably stable, with controllable systemic hypertension and no evidence of hemolysis. Although cardiac activity was minimal and systemic blood flow nonpulsatile, the patient's renal, pulmonary, and hepatic functions improved, and his peripheral circulation was well preserved. After 12 hours of support, a donor heart became available, and a routine orthotopic cardiac transplant was performed. Upon removal, the left ventricular assist device showed a small amount of thrombus formation. The patient's postoperative recovery has been easily manageable, and 20 months after transplant he enjoys unrestricted physical activity. We conclude that an extracorporeal left ventricular assist device can be used as a bridge to cardiac transplantation in children. Moreover, this application of a continuous force centrifugal pump without adverse effect encourages the conclusion that long-term maintenance of terminal heart disease patients might be possible through development of small, implantable pumps with the potential of lower power requirements and reduced thrombogenesis. (Texas Heart Institute Journal 1989;16:46-50) PMID:15227237

Challenges faced in long term ventricular assist device support.

PubMed

Ikegami, Hirohisa; Kurlansky, Paul; Takeda, Koji; Naka, Yoshifumi

2016-08-01

The development of ventricular assist device (VAD) has been one of the revolutionary advancements in end-stage heart failure management. Although the device has developed and improved significantly over the last few decades, we still face multiple challenges. This review will discuss quality of life, survival, and clinically encountered complications in patients with VAD support. The literature was extensively reviewed for studies describing the above topic area. We describe the impact of major challenges faced in VAD support and discuss their future and expectations. Expert commentary: The technological advancement of VADs has contributed to major improvement of overall survival, enhancement of quality of life and decrease of incidence of complications. It is expected that technologies will continue to evolve. At the same time, the indications for and timing of device implantation, and selection of device type are continuously important in clinical practice setting.

Embedded systems for supporting computer accessibility.

PubMed

Mulfari, Davide; Celesti, Antonio; Fazio, Maria; Villari, Massimo; Puliafito, Antonio

2015-01-01

Nowadays, customized AT software solutions allow their users to interact with various kinds of computer systems. Such tools are generally available on personal devices (e.g., smartphones, laptops and so on) commonly used by a person with a disability. In this paper, we investigate a way of using the aforementioned AT equipments in order to access many different devices without assistive preferences. The solution takes advantage of open source hardware and its core component consists of an affordable Linux embedded system: it grabs data coming from the assistive software, which runs on the user's personal device, then, after processing, it generates native keyboard and mouse HID commands for the target computing device controlled by the end user. This process supports any operating system available on the target machine and it requires no specialized software installation; therefore the user with a disability can rely on a single assistive tool to control a wide range of computing platforms, including conventional computers and many kinds of mobile devices, which receive input commands through the USB HID protocol.

Improving hemodynamics of cardiovascular system under a novel intraventricular assist device support via modeling and simulations.

PubMed

Zhu, Shidong; Luo, Lin; Yang, Bibo; Li, Xinghui; Wang, Xiaohao

2017-12-01

Ventricular assist devices (LVADs) are increasingly recognized for supporting blood circulation in heart failure patients who are non-transplant eligible. Because of its volume, the traditional pulsatile device is not easy to implant intracorporeally. Continuous flow LVADs (CF-LVADs) reduce arterial pulsatility and only offer continuous flow, which is different from physiological flow, and may cause long-term complications in the cardiovascular system. The aim of this study was to design a new pulsatile assist device that overcomes this disadvantage, and to test this device in the cardiovascular system. Firstly, the input and output characteristics of the new device were tested in a simple cardiovascular mock system. A detailed mathematical model was established by fitting the experimental data. Secondly, the model was tested in four pathological cases, and was simulated and coupled with a fifth-order cardiovascular system and a new device model using Matlab software. Using assistance of the new device, we demonstrated that the left ventricle pressure, aortic pressure, and aortic flow of heart failure patients improved to the levels of a healthy individual. Especially, in state IV level heart failure patients, the systolic blood pressure increased from 81.34 mmHg to 132.1 mmHg, whereas the diastolic blood pressure increased from 54.28 mmHg to 78.7 mmHg. Cardiac output increased from 3.21 L/min to 5.16 L/min. The newly-developed assist device not only provided a physiological flow that was similar to healthy individuals, but also effectively improved the ability of the pathological ventricular volume. Finally, the effects of the new device on other hemodynamic parameters are discussed.

Concurrent Left Ventricular Assist Device (LVAD) Implantation and Percutaneous Temporary RVAD Support via CardiacAssist Protek-Duo TandemHeart to Preempt Right Heart Failure.

PubMed

Schmack, Bastian; Weymann, Alexander; Popov, Aron-Frederik; Patil, Nikhil Prakash; Sabashnikov, Anton; Kremer, Jamila; Farag, Mina; Brcic, Andreas; Lichtenstern, Christoph; Karck, Matthias; Ruhparwar, Arjang

2016-05-05

Right ventricular failure (RVF) is an unfortunate complication that continues to limit outcomes following durable left ventricular assist device (LVAD) implantation. Despite several 'RVF risk scores' having been proposed, preoperative prediction of post-LVAD RVF remains a guesstimate at best. Current strategies for institution of temporary RVAD support are invasive, necessitate additional re-thoracotomy, restrict postoperative mobilization, and/or entail prolonged retention of prosthetic material in-situ. The authors propose a novel surgical strategy comprising simultaneous implantation of a permanent LVAD and percutaneous TandemHeart® plus ProtekDuo® to provide temporary RVAD support and preempt RVF in patients with impaired RV function.

Bridge to Removal: A Paradigm Shift for Left Ventricular Assist Device Therapy

PubMed Central

Selzman, Craig H.; Madden, Jesse L.; Healy, Aaron H.; McKellar, Stephen H.; Koliopoulou, Antigone; Stehlik, Josef; Drakos, Stavros G.

2014-01-01

Ventricular assist devices have become standard therapy for patients with advanced heart failure either as a bridge to transplantation or destination therapy. Despite the functional and biologic evidence of reverse cardiac remodeling, few patients actually proceed to myocardial recovery, and even fewer to the point of having their device explanted. An enhanced understanding of the biology and care of the mechanically supported patient has redirected focus on the possibility of using ventricular assist devices as a bridge to myocardial recovery and removal. Herein, we review the current issues and approaches to transforming myocardial recovery to a practical reality. PMID:25442985

Technology and Web-Based Support

ERIC Educational Resources Information Center

Smith, Carol

2008-01-01

Many types of technology support caregiving: (1) Assistive devices include medicine dispensers, feeding and bathing machines, clothing with polypropylene fibers that stimulate muscles, intelligent ambulatory walkers for those with both vision and mobility impairment, medication reminders, and safety alarms; (2) Telecare devices ranging from…

Investigating the Efficacy of a Computerized Prompting Device to Assist Children with Autism Spectrum Disorder with Activities of Daily Living

ERIC Educational Resources Information Center

Bimbrahw, Justin; Boger, Jennifer; Mihailidis, Alex

2012-01-01

Learning to perform self-care skills can pose a major challenge for children with Autism Spectrum Disorder (ASD) as well as the parents and caregivers who support them. The computerized device described in this paper has been used by children with ASD and their carers to autonomously assist with self-care activities. The device uses computer…

Biventricular assist device for scombroid poisoning with refractory myocardial dysfunction: a bridge to recovery.

PubMed

Grinda, Jean-Michel; Bellenfant, Florence; Brivet, François Gilles; Carel, Yvan; Deloche, Alain

2004-09-01

We report the usefulness of biventricular mechanical circulatory support in a 36-yr-old woman with refractory myocardial dysfunction resulting from scombroid poisoning. Case report. Medical and surgical university care units. A previously healthy 36-yr-old woman with severe myocardial dysfunction unresponsive to epinephrine (1.3 microg/kg/min) and dobutamine (18 microg/kg/min) after the ingestion of cooked fresh tuna. Implantation at day 3 of a biventricular assist device consisting of two paracorporeal pneumatic pumps set at 70 beats/min to reach an output of 5.6 L/min during 8 days. The biventricular mechanical circulatory assist device allowed weaning of the inotropic drugs, maintenance of end-organ function, and support of the patient until myocardial recovery. The patient was successfully explanted 11 days after ingestion. Cardiac function had totally recovered, but a stroke was noted. At 3-yrs follow-up, there was no cardiac or neurologic sequela. This report describes severe myocardial dysfunction secondary to scombroid poisoning and demonstrates the usefulness of a mechanical circulatory assist device as a bridge to recovery.

Introduction of assistive devices: home nurses' practices and beliefs.

PubMed

Roelands, Marc; Van Oost, Paulette; Depoorter, Anne Marie; Buysse, Ann; Stevens, Veerle

2006-04-01

This paper reports a study describing home nurses' intention and current practices regarding introducing assistive devices, and investigating whether their practice is related to social cognitive factors (attitudes, subjective norms and self-efficacy). Home nurses not only care for patients in particular medical domains, but also educate and guide them towards more independence. Patients with age-related disabilities in mobility and self-care might benefit from the use of assistive devices. A home nurse might be the first and only person to discuss the disability and use of an assistive device. Therefore, home nurses' beliefs about the introduction of assistive devices could affect their daily practices. A cross-sectional study was conducted with a convenience sample of 64 home nurses chosen from a random sample of home nursing departments. The home nurses completed a self-administered questionnaire. The Theory of Planned Behaviour framework was used to develop the social cognitive measures regarding each of the six steps distinguished in the introduction of assistive devices. Home nurses had positive attitudes and high levels of intention, subjective norm and self-efficacy towards most steps of the decision process to introduce assistive devices. In a multiple linear regression analysis, attitude and self-efficacy predicted intention to introduce assistive devices to older clients with disabilities. Intention was correlated to home nurses' current practices. The findings suggest that conditions are present to involve home nurses more explicitly in the introduction of assistive devices to their patients. Social cognitive factors should be taken into account when developing interventions that aim to support home nurses to do this.

HeartWare HVAD for Biventricular Support in Children and Adolescents: The Stanford Experience.

PubMed

Stein, Mary Lyn; Yeh, Justin; Reinhartz, Olaf; Rosenthal, David N; Kaufman, Beth D; Almond, Chris S; Hollander, Seth A; Maeda, Katsuhide

2016-01-01

Despite increasing use of mechanical circulatory support in children, experience with biventricular device implantation remains limited. We describe our experience using the HeartWare HVAD to provide biventricular support to three patients and compare these patients with five patients supported with HeartWare left ventricular assist device (LVAD). At the end of the study period, all three biventricular assist device (BiVAD) patients had been transplanted and were alive. LVAD patients were out of bed and ambulating a median of 10.5 days postimplantation. The BiVAD patients were out of bed a median of 31 days postimplantation. Pediatric patients with both left ventricular and biventricular heart failure can be successfully bridged to transplantation with the HeartWare HVAD. Rapid improvement in functional status following HVAD implantation for isolated left ventricular support is seen. Patients supported with BiVAD also demonstrate functional recovery, albeit more modestly. In the absence of infection, systemic inflammatory response raises concern for inadequate support.

Revealing a new mode of sensitization induced by mechanical circulatory support devices: Impact of anti-AT1 R antibodies.

PubMed

Zhang, Xiaohai; Mirocha, James; Aintablian, Tamar; Dimbil, Sadia; Moriguchi, Jaime; Arabia, Francisco; Kobashigawa, Jon A; Reinsmoen, Nancy

2018-02-01

Increased levels of angiotensin II type 1 receptor (AT 1 R) antibody have been shown to be associated with allograft rejection. This study aims to determine the rate of development of antibody to AT 1 R after mechanical circulatory support device (MCS) implantation, and if the development of strong binding AT 1 R antibodies is associated with survival. Eighty-eight patients who had one MCS implantation were accessed based on serum availability. Mechanical circulatory support devices in this cohort included pneumatic bilateral paracorporeal ventricular assist device, continuous flow left ventricular assist device, and total artificial heart. Of 88 patients, seven patients had AT 1 R antibodies ≥40 U/mL preimplantation. For 81 patients who had AT 1 R antibodies <40 U/mL, the median value was 8 U/mL. Of these 81 patients, AT 1 R antibody levels in 55 (68%) patients reached the saturated concentration (≥40 U/mL) postimplantation (P < .0001), with the highest percentage of patients with the saturated level of AT 1 R antibody observed in the pneumatic bilateral paracorporeal ventricular assist device group. Compared to patients without the saturated level of AT 1 R antibodies, patients with the saturated AT 1 R antibody level had lower 18-month survival (P = .040). Mechanical circulatory support devices implantation significantly increases AT 1 R antibody levels. The saturated level of AT 1 R antibodies is associated with lower patient survival postimplantation. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Predictors of survival and ability to wean from short-term mechanical circulatory support device following acute myocardial infarction complicated by cardiogenic shock.

PubMed

Garan, A Reshad; Eckhardt, Christina; Takeda, Koji; Topkara, Veli K; Clerkin, Kevin; Fried, Justin; Masoumi, Amirali; Demmer, Ryan T; Trinh, Pauline; Yuzefpolskaya, Melana; Naka, Yoshifumi; Burkhoff, Dan; Kirtane, Ajay; Colombo, Paolo C; Takayama, Hiroo

2017-11-01

Cardiogenic shock following acute myocardial infarction (AMI-CS) portends a poor prognosis. Short-term mechanical circulatory support devices (MCSDs) provide hemodynamic support for patients with cardiogenic shock but predictors of survival and the ability to wean from short-term MCSDs remain largely unknown. All patients > 18 years old treated at our institution with extra-corporeal membrane oxygenation or short-term surgical ventricular assist device for AMI-CS were studied. We collected acute myocardial infarction details with demographic and hemodynamic variables. Primary outcomes were survival to discharge and recovery from MCSD (i.e. survival without heart replacement therapy including durable ventricular assist device or heart transplant). One hundred and twenty-four patients received extra-corporeal membrane oxygenation or short-term surgical ventricular assist device following acute myocardial infarction from 2007 to 2016; 89 received extra-corporeal membrane oxygenation and 35 short-term ventricular assist device. Fifty-five (44.4%) died in the hospital and 69 (55.6%) survived to discharge. Twenty-six (37.7%) required heart replacement therapy (four transplant, 22 durable ventricular assist device) and 43 (62.3%) were discharged without heart replacement therapy. Age and cardiac index at MCSD implantation were predictors of survival to discharge; patients over 60 years with cardiac index <1.5 l/min per m 2 had a low likelihood of survival. The angiographic result after revascularization predicted recovery from MCSD (odds ratio 9.00, 95% confidence interval 2.45-32.99, p=0.001), but 50% of those optimally revascularized still required heart replacement therapy. Cardiac index predicted recovery from MCSD among this group (odds ratio 4.06, 95% confidence interval 1.45-11.55, p=0.009). Among AMI-CS patients requiring short-term MCSDs, age and cardiac index predict survival to discharge. Angiographic result and cardiac index predict ventricular recovery but 50% of those optimally revascularized still required heart replacement therapy.

Ventricular assist device implantation in a young patient with non-compaction cardiomyopathy and hereditary spherocytosis.

PubMed

Huenges, Katharina; Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-04-01

A case of a 15-year-old female patient with acute heart failure due to non-compaction cardiomyopathy and hereditary anaemia (hereditary spherocytic elliptocytosis) requiring ventricular assist device implantation as a bridge to transplantation is presented. The possible effects of mechanical stress on erythrocytes potentially induced by mechanical circulatory support remains unclear, but it may lead to haemolytic crisis in patients suffering from hereditary anaemia. In our case, ventricular assist device therapy was feasible, and haematological complications did not occur within 6 weeks of bridging our patient to heart transplantation.

Chronic outpatient management of patients with a left ventricular assist device

PubMed Central

Franzwa, Jennifer

2015-01-01

The use of mechanical circulatory support (MCS) as treatment for advanced heart failure (HF) has grown exponentially over the past 15 years. The continuous flow left ventricular assist device (CF-LVAD) has become the most used form of MCS in advanced HF, especially since approval of use as destination therapy (DT) and with the lack of organ availability. Long-term survival has improved and diligent outpatient management is thus particularly critical to achieve optimal outcomes. This review will discuss outpatient management strategies for patients with HF and a left ventricular assist device (LVAD). PMID:26793331

Durability of central aortic valve closure in patients with continuous flow left ventricular assist devices.

PubMed

McKellar, Stephen H; Deo, Salil; Daly, Richard C; Durham, Lucian A; Joyce, Lyle D; Stulak, John M; Park, Soon J

2014-01-01

A competent aortic valve is essential to providing effective left ventricular assist device support. We have adopted a practice of central aortic valve closure by placing a simple coaptation stitch at left ventricular assist device implantation in patients with significant aortic insufficiency. We conducted a follow-up study to evaluate the efficacy and durability of this procedure. The study included patients who had undergone continuous flow left ventricular assist device implantation. The patients were divided into 2 groups, those who did not require any aortic procedure because the valve was competent and those who underwent central aortic valve closure for mild or greater aortic regurgitation. The clinical endpoints were mortality, progression or recurrence of aortic insufficiency, and reoperation for aortic valve pathologic features. Aortic insufficiency was measured qualitatively from mild to severe on a scale of 0 to 5. A total of 123 patients received continuous flow left ventricular assist devices from February 2007 to August 2011. Of those, 18 (15%) underwent central aortic valve closure at left ventricular assist device implantation because of significant aortic insufficiency (1.8 ± 1.4) and 105 who did not (competent aortic valve, 0.15 ± 0.43; P < .01). At follow-up (median, 312 days; range, 0-1429 days), the mean aortic insufficiency score remained low for the patients with central aortic valve closure (0.27 ± 0.46) in contrast to those without central aortic valve closure who experienced aortic insufficiency progression (0.78 ± 0.89; P = .02). In addition, the proportion of patients with more than mild aortic insufficiency was significantly less in the central aortic valve closure group (0% vs 18%; P = .05). The patients in the central aortic valve closure group were significantly older and had a greater incidence of renal failure at baseline. The 30-day mortality was greater in the central aortic valve closure group, but the late survival was similar between the 2 groups. No reoperations were required for recurrent aortic insufficiency. The results of our study have shown that repair of aortic insufficiency with a simple central coaptation stitch is effective and durable in left ventricular assist device-supported patients, with follow-up extending into 2 years. Although aortic insufficiency progressed over time in those with minimal native valve regurgitation initially, no such progression was noted in those with central aortic valve closure. Additional investigation is needed to evaluate whether prophylactic central aortic valve closure should be performed at left ventricular assist device implantation to avoid problematic aortic regurgitation developing over time, in particular in patients undergoing left ventricular assist device implantation for life-long (destination therapy) support. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Left ventricular assist device implantation via left thoracotomy: alternative to repeat sternotomy.

PubMed

Pierson, Richard N; Howser, Renee; Donaldson, Terri; Merrill, Walter H; Dignan, Rebecca J; Drinkwater, Davis C; Christian, Karla G; Butler, Javed; Chomsky, Don; Wilson, John R; Clark, Rick; Davis, Stacy F

2002-03-01

Repeat sternotomy for left ventricular assist device insertion may result in injury to the right heart or patent coronary grafts, complicating intraoperative and postoperative management. In 4 critically ill patients, left thoracotomy was used as an alternative to repeat sternotomy. Anastomosis of the outflow conduit to the descending thoracic aorta provided satisfactory hemodynamic support.

Novel nonsurgical left ventricular assist device and system.

PubMed

Misiri, Juna; DeSimone, Christopher V; Park, Soon J; Kushwaha, Sudhir S; Friedman, Paul A; Bruce, Charles J; Asirvatham, Samuel J

2013-01-01

Treatment options for advanced stages of congestive heart failure remain limited. Left ventricular assist devices (LVADs) have emerged as a means to support failing circulation. However, these devices are not without significant risk such as major open chest surgery. We utilized a novel approach for device placement at the aorto-left atria continuity as a site to create a conduit capable of accommodating a percutaneous LVAD system. We designed and developed an expandable nitinol based device for placement at this site to create a shunt between the LA and aorta. Our experiments support this anatomic location as an accessible and feasible site for accommodation of an entirely percutaneous LVAD. The novelty of this approach would bypass the left ventricle, and thereby minimize complications and morbidities associated with current LVAD placement. Copyright © 2013 Elsevier Inc. All rights reserved.

Assistive technology for memory support in dementia.

PubMed

Van der Roest, Henriëtte G; Wenborn, Jennifer; Pastink, Channah; Dröes, Rose-Marie; Orrell, Martin

2017-06-11

The sustained interest in electronic assistive technology in dementia care has been fuelled by the urgent need to develop useful approaches to help support people with dementia at home. Also the low costs and wide availability of electronic devices make it more feasible to use electronic devices for the benefit of disabled persons. Information Communication Technology (ICT) devices designed to support people with dementia are usually referred to as Assistive Technology (AT) or Electronic Assistive Technology (EAT). By using AT in this review we refer to electronic assistive devices. A range of AT devices has been developed to support people with dementia and their carers to manage their daily activities and to enhance safety, for example electronic pill boxes, picture phones, or mobile tracking devices. Many are commercially available. However, the usefulness and user-friendliness of these devices are often poorly evaluated. Although reviews of (electronic) memory aids do exist, a systematic review of studies focusing on the efficacy of AT for memory support in people with dementia is lacking. Such a review would guide people with dementia and their informal and professional carers in selecting appropriate AT devices. Primary objectiveTo assess the efficacy of AT for memory support in people with dementia in terms of daily performance of personal and instrumental activities of daily living (ADL), level of dependency, and admission to long-term care. Secondary objectiveTo assess the impact of AT on: users (autonomy, usefulness and user-friendliness, adoption of AT); cognitive function and neuropsychiatric symptoms; need for informal and formal care; perceived quality of life; informal carer burden, self-esteem and feelings of competence; formal carer work satisfaction, workload and feelings of competence; and adverse events. We searched ALOIS, the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG), on 10 November 2016. ALOIS is maintained by the Information Specialists of the CDCIG and contains studies in the areas of dementia prevention, dementia treatment and cognitive enhancement in healthy people. We also searched the following list of databases, adapting the search strategy as necessary: Centre for Reviews and Dissemination (CRD) Databases, up to May 2016; The Collection of Computer Science Bibliographies; DBLP Computer Science Bibliography; HCI Bibliography: Human-Computer Interaction Resources; and AgeInfo, all to June 2016; PiCarta; Inspec; Springer Link Lecture Notes; Social Care Online; and IEEE Computer Society Digital Library, all to October 2016; J-STAGE: Japan Science and Technology Information Aggregator, Electronic; and Networked Computer Science Technical Reference Library (NCSTRL), both to November 2016; Computing Research Repository (CoRR) up to December 2016; and OT seeker; and ADEAR, both to February 2017. In addition, we searched Google Scholar and OpenSIGLE for grey literature. We intended to review randomised controlled trials (RCTs) and clustered randomised trials with blinded assessment of outcomes that evaluated an electronic assistive device used with the single aim of supporting memory function in people diagnosed with dementia. The control interventions could either be 'care (or treatment) as usual' or non-technological psychosocial interventions (including interventions that use non-electronic assistive devices) also specifically aimed at supporting memory. Outcome measures included activities of daily living, level of dependency, clinical and care-related outcomes (for example admission to long-term care), perceived quality of life and well-being, and adverse events resulting from the use of AT; as well as the effects of AT on carers. Two review authors independently screened all titles and abstracts identified by the search. We identified no studies which met the inclusion criteria. This review highlights the current lack of high-quality evidence to determine whether AT is effective in supporting people with dementia to manage their memory problems.

PERKAT RV: first in vivo data of a novel right heart assist device.

PubMed

Kretzschmar, Daniel; Lauten, Alexander; Schubert, Harald; Bischoff, Sabine; Schulze, Christian; Ferrari, Markus W

2018-04-06

Mechanical right ventricular (RV) support offers a treatment option for critically ill patients with RV failure (RVF). We developed an assist device for rapid percutaneous implantation. The aim of the present study was to investigate the implantation procedure, haemodynamic performance and possible side effects of the novel right ventricular assist device - PERKAT RV - in an animal model. The PERkutane KATheterpumptechnologie RV (PERKAT RV) device consists of a nitinol chamber covered by foil containing inflow valves. An outlet tube is attached to its distal part. The system is designed for 18 Fr percutaneous implantation. The chamber is unfolded in the inferior vena cava while the outlet tube bypasses the right heart with the tip in the pulmonary trunk. An IABP balloon is placed inside. Balloon deflation generates blood flow into the chamber; during inflation, blood is guided into the pulmonary arteries. Acute RVF was induced by venous injection of Sephadex in seven sheep for evaluation of the device. The PERKAT RV was able to improve haemodynamics immediately generating a median increase in cardiac output of 59%. Longer pump support was evaluated in a second study. Four sheep were supported for eight hours without any problems. The percutaneous implantation and explantation of the PERKAT RV device was possible in the designed way. The sheep studies proved beneficial haemodynamic effects in acute RVF. The system offers easy and safe treatment in acute RVF.

[Intelligent operating room suite : From passive medical devices to the self-thinking cognitive surgical assistant].

PubMed

Kenngott, H G; Wagner, M; Preukschas, A A; Müller-Stich, B P

2016-12-01

Modern operating room (OR) suites are mostly digitally connected but until now the primary focus was on the presentation, transfer and distribution of images. Device information and processes within the operating theaters are barely considered. Cognitive assistance systems have triggered a fundamental rethinking in the automotive industry as well as in logistics. In principle, tasks in the OR, some of which are highly repetitive, also have great potential to be supported by automated cognitive assistance via a self-thinking system. This includes the coordination of the entire workflow in the perioperative process in both the operating theater and the whole hospital. With corresponding data from hospital information systems, medical devices and appropriate models of the surgical process, intelligent systems could optimize the workflow in the operating theater in the near future and support the surgeon. Preliminary results on the use of device information and automatically controlled OR suites are already available. Such systems include, for example the guidance of laparoscopic camera systems. Nevertheless, cognitive assistance systems that make use of knowledge about patients, processes and other pieces of information to improve surgical treatment are not yet available in the clinical routine but are urgently needed in order to automatically assist the surgeon in situation-related activities and thus substantially improve patient care.

Left heart bypass support with the Rotaflow Centrifugal Pump® as a bridge to decision and recovery in an adult.

PubMed

Kashiwa, Koichi; Nishimura, Takashi; Saito, Aya; Kubo, Hitoshi; Fukaya, Aoi; Tamai, Hisayoshi; Yambe, Tomoyuki; Kyo, Shunei; Ono, Minoru

2012-06-01

Since left heart bypass or biventricular circulatory assist with an extracorporeal centrifugal pump as a bridge to decision or recovery sometimes requires long-time support, the long-term durability of extracorporeal centrifugal pumps is crucial. The Rotaflow Centrifugal Pump(®) (MAQUET Cardiopulmonary AG, Hirrlingen, Germany) is one of the centrifugal pumps available for long-term use in Japan. However, there have been few reports of left heart bypass or biventricular circulatory support over the mid-term. This is a case report of left heart bypass support with the Rotaflow Centrifugal Pump(®) as a bridge to decision and recovery for an adult patient who could not be weaned from cardiopulmonary bypass and percutaneous cardiopulmonary support after cardiac surgery. We could confirm that the patient's consciousness level was normal; however, the patient could not be weaned from the left heart bypass support lasting 1 month. Therefore, the circulatory assist device was switched to the extracorporeal Nipro ventricular assist device (VAD). This time, left heart bypass support could be maintained for 30 days using a single Rotaflow Centrifugal Pump(®). There were no signs of hemolysis during left heart bypass support. The Rotaflow Centrifugal Pump(®) itself may be used as a device for a bridge to decision or recovery before using a VAD in cardiogenic shock patients.

Reduced size liver transplantation from a donor supported by a Berlin Heart.

PubMed

Misra, M V; Smithers, C J; Krawczuk, L E; Jenkins, R L; Linden, B C; Weldon, C B; Kim, H B

2009-11-01

Patients on cardiac assist devices are often considered to be high-risk solid organ donors. We report the first case of a reduced size liver transplant performed using the left lateral segment of a pediatric donor whose cardiac function was supported by a Berlin Heart. The recipient was a 22-day-old boy with neonatal hemochromatosis who developed fulminant liver failure shortly after birth. The transplant was complicated by mild delayed graft function, which required delayed biliary reconstruction and abdominal wall closure, as well as a bile leak. However, the graft function improved quickly over the first week and the patient was discharged home with normal liver function 8 weeks after transplant. The presence of a cardiac assist device should not be considered an absolute contraindication for abdominal organ donation. Normal organ procurement procedures may require alteration due to the unusual technical obstacles that are encountered when the donor has a cardiac assist device.

Assessment of Safety and Effectiveness of the Extracorporeal Continuous-Flow Ventricular Assist Device (BR16010) Use as a Bridge-to-Decision Therapy for Severe Heart Failure or Refractory Cardiogenic Shock: Study Protocol for Single-Arm Non-randomized, Uncontrolled, and Investigator-Initiated Clinical Trial.

PubMed

Fukushima, Norihide; Tatsumi, Eisuke; Seguchi, Osamu; Takewa, Yoshiaki; Hamasaki, Toshimitsu; Onda, Kaori; Yamamoto, Haruko; Hayashi, Teruyuki; Fujita, Tomoyuki; Kobayashi, Junjiro

2018-06-08

The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock. NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device and the day of withdrawal of a trial device), and changes in left ventricular diastolic dimension (7 days after implantation of a trial device and the day of withdrawal of a trial device). We will disseminate the findings through regional, national, and international conferences and through peer-reviewed journals. UMIN Clinical Trials Registry (UMIN-CTR; R000033243) registered on 8 September 2017.

Novel Method for Exchange of Impella Circulatory Assist Catheter: The "Trojan Horse" Technique.

PubMed

Phillips, Colin T; Tamez, Hector; Tu, Thomas M; Yeh, Robert W; Pinto, Duane S

2017-07-01

Patients with an indwelling Impella may require escalation of hemodynamic support or exchange to another circulatory assistance platform. As such, preservation of vascular access is preferable in cases where anticoagulation cannot be discontinued or to facilitate exchange to an alternative catheter or closure device. Challenges exist in avoiding bleeding and loss of wire access in these situations. We describe a single-access "Trojan Horse" technique that minimizes bleeding while maintaining arterial access for rapid exchange of this percutaneous ventricular assist device.

Advances in bioartificial liver assist devices.

PubMed

Patzer, J F

2001-11-01

Rapid advances in development of bioartificial liver assist devices (BLADs) are exciting clinical interest in the application of BLAD technology for support of patients with acute liver failure. Four devices (Circe Biomedical HepatAssist, Vitagen ELAD, Gerlach BELS, and Excorp Medical BLSS) that rely on hepatocytes cultured in hollow-fiber membrane technology are currently in various stages of clinical evaluation. Several alternative approaches for culture and perfusion of hepatocytes have been evaluated in preclinical, large animal models of liver failure, or at a laboratory scale. Engineering design issues with respect to xenotransplantation, BLAD perfusion, hepatocyte functionality and culture maintenance, and ultimate distribution of a BLAD to a clinical site are delineated.

Single-centre experience with the Thoratec paracorporeal ventricular assist device for patients with primary cardiac failure.

PubMed

Kirsch, Matthias; Vermes, Emmanuelle; Damy, Thibaud; Nakashima, Kuniki; Sénéchal, Mélanie; Boval, Bernadette; Drouet, Ludovic; Loisance, Daniel

2009-01-01

Temporary mechanical circulatory support may be indicated in some patients with cardiac failure refractory to conventional therapy, as a bridge to myocardial recovery or transplantation. To evaluate outcomes in cardiogenic shock patients managed by the primary use of a paracorporeal ventricular assist device (p-VAD). We did a retrospective analysis of demographics, clinical characteristics and survival of patients assisted with a Thoratec p-VAD. p-VADs were used in 84 patients with cardiogenic shock secondary to acute myocardial infarction (35%), idiopathic (31%) or ischaemic (12%) cardiomyopathy, myocarditis or other causes (23%). Before implantation, 23% had cardiac arrest, 38% were on a ventilator and 31% were on an intra-aortic balloon pump. Cardiac index was 1.6+/-0.5 L/min/m(2) and total bilirubin levels were 39+/-59 micromol/L. During support, 29 patients (35%) died in the intensive care unit and seven (10%) died after leaving. Forty-seven patients (56%) were weaned or transplanted, with one still under support. Despite significantly more advanced preoperative end-organ dysfunction, survival rates were similar in patients with biventricular devices (74%) and those undergoing isolated left ventricular support (24%) (63% versus 45%, respectively; p=0.2). Actuarial survival estimates after transplantation were 78.7+/-6.3%, 73.4+/-6.9% and 62.6+/-8.3% at 1, 3 and 5 years, respectively. Our experience validates the use of p-VAD as a primary device to support patients with cardiogenic shock. In contrast to short-term devices, p-VADs provide immediate ventricular unloading and pulsatile perfusion in a single procedure. Biventricular support should be used liberally in patients with end-organ dysfunction.

Loose-Lipped Mobile Device Intelligent Personal Assistants: A Discussion of Information Gleaned from Siri on Locked iOS Devices.

PubMed

Horsman, Graeme

2018-04-23

The forensic analysis of mobile handsets is becoming a more prominent factor in many criminal investigations. Despite such devices frequently storing relevant evidential content to support an investigation, accessing this information is becoming an increasingly difficult task due to enhanced effective security features. Where access to a device's resident data is not possible via traditional mobile forensic methods, in some cases it may still be possible to extract user information via queries made to an installed intelligent personal assistant. This article presents an evaluation of the information which is retrievable from Apple's Siri when interacted with on a locked iOS device running iOS 11.2.5 (the latest at the time of testing). The testing of verbal commands designed to elicit a response from Siri demonstrate the ability to recover call log, SMS, Contacts, Apple Maps, Calendar, and device information which may support any further investigation. © 2018 American Academy of Forensic Sciences.

A Human–Robot Interaction Perspective on Assistive and Rehabilitation Robotics

PubMed Central

Beckerle, Philipp; Salvietti, Gionata; Unal, Ramazan; Prattichizzo, Domenico; Rossi, Simone; Castellini, Claudio; Hirche, Sandra; Endo, Satoshi; Amor, Heni Ben; Ciocarlie, Matei; Mastrogiovanni, Fulvio; Argall, Brenna D.; Bianchi, Matteo

2017-01-01

Assistive and rehabilitation devices are a promising and challenging field of recent robotics research. Motivated by societal needs such as aging populations, such devices can support motor functionality and subject training. The design, control, sensing, and assessment of the devices become more sophisticated due to a human in the loop. This paper gives a human–robot interaction perspective on current issues and opportunities in the field. On the topic of control and machine learning, approaches that support but do not distract subjects are reviewed. Options to provide sensory user feedback that are currently missing from robotic devices are outlined. Parallels between device acceptance and affective computing are made. Furthermore, requirements for functional assessment protocols that relate to real-world tasks are discussed. In all topic areas, the design of human-oriented frameworks and methods is dominated by challenges related to the close interaction between the human and robotic device. This paper discusses the aforementioned aspects in order to open up new perspectives for future robotic solutions. PMID:28588473

A Human-Robot Interaction Perspective on Assistive and Rehabilitation Robotics.

PubMed

Beckerle, Philipp; Salvietti, Gionata; Unal, Ramazan; Prattichizzo, Domenico; Rossi, Simone; Castellini, Claudio; Hirche, Sandra; Endo, Satoshi; Amor, Heni Ben; Ciocarlie, Matei; Mastrogiovanni, Fulvio; Argall, Brenna D; Bianchi, Matteo

2017-01-01

Assistive and rehabilitation devices are a promising and challenging field of recent robotics research. Motivated by societal needs such as aging populations, such devices can support motor functionality and subject training. The design, control, sensing, and assessment of the devices become more sophisticated due to a human in the loop. This paper gives a human-robot interaction perspective on current issues and opportunities in the field. On the topic of control and machine learning, approaches that support but do not distract subjects are reviewed. Options to provide sensory user feedback that are currently missing from robotic devices are outlined. Parallels between device acceptance and affective computing are made. Furthermore, requirements for functional assessment protocols that relate to real-world tasks are discussed. In all topic areas, the design of human-oriented frameworks and methods is dominated by challenges related to the close interaction between the human and robotic device. This paper discusses the aforementioned aspects in order to open up new perspectives for future robotic solutions.

Early Right Ventricular Assist Device Use in Patients Undergoing Continuous-Flow Left Ventricular Assist Device Implantation: Incidence and Risk Factors From the Interagency Registry for Mechanically Assisted Circulatory Support.

PubMed

Kiernan, Michael S; Grandin, E Wilson; Brinkley, Marshall; Kapur, Navin K; Pham, Duc Thinh; Ruthazer, Robin; Rame, J Eduardo; Atluri, Pavan; Birati, Edo Y; Oliveira, Guilherme H; Pagani, Francis D; Kirklin, James K; Naftel, David; Kormos, Robert L; Teuteberg, Jeffrey J; DeNofrio, David

2017-10-01

To investigate preimplant risk factors associated with early right ventricular assist device (RVAD) use in patients undergoing continuous-flow left ventricular assist device (LVAD) surgery. Patients in the Interagency Registry for Mechanically Assisted Circulatory Support who underwent primary continuous-flow-LVAD surgery were examined for concurrent or subsequent RVAD implantation within 14 days of LVAD. Risk factors for RVAD implantation and the combined end point of RVAD or death within 14 days of LVAD were assessed with stepwise logistic regression. We compared survival between patients with and without RVAD using Kaplan-Meier method and Cox proportional hazards modeling. Of 9976 patients undergoing continuous-flow-LVAD implantation, 386 patients (3.9%) required an RVAD within 14 days of LVAD surgery. Preimplant characteristics associated with RVAD use included interagency registry for mechanically assisted circulatory support patient profiles 1 and 2, the need for preoperative extracorporeal membrane oxygenation or renal replacement therapy, severe preimplant tricuspid regurgitation, history of cardiac surgery, and concomitant procedures other than tricuspid valve repair at the time of LVAD. Hemodynamic determinants included elevated right atrial pressure, reduced pulmonary artery pulse pressure, and reduced stroke volume. The final model demonstrated good performance for both RVAD implant (area under the curve, 0.78) and the combined end point of RVAD or death within 14 days (area under the curve, 0.73). Compared with patients receiving an isolated LVAD, patients requiring RVAD had decreased 1- and 6-month survival: 78.1% versus 95.8% and 63.6% versus 87.9%, respectively ( P <0.0001 for both). The need for RVAD implantation after LVAD is associated with indices of global illness severity, markers of end-organ dysfunction, and profiles of hemodynamic instability. © 2017 American Heart Association, Inc.

Cross-cultural adaptation of the assistive technology device - Predisposition assessment (ATD PA) for use in Brazil (ATD PA Br).

PubMed

Alves, Ana Cristina de Jesus; Matsukura, Thelma Simões; Scherer, Marcia J

2017-02-01

The purpose of this study is to conduct a cross-cultural adaptation of the Assistive Technology Device Predisposition Assessment (ATD PA) for use in Brazil. The selection of the Assistive Technology Device Predisposition Assessment (ATD PA) was determined by previous literature reviews of articles published in 2014 and 2016 in six databases with the terms "assistive device" or "assistive technology" or "self-help device" combined with "evidence-based practice" or "framework" or "measurement scale" or "model and outcome assessment". This review indicated that the conceptual model of Assistive Technology (AT) most discussed in the literature was the Matching Person and Technology (MPT) model, and this finding determined the selection of ATD PA as an assessment within the MPT portfolio of measures. The procedures for cross-cultural adaptation were as follows: Equivalence of Concept, Semantic and Operational. Five experts were asked to translate 725 items and these translations were evaluated and a high level of agreement was demonstrated. The Portuguese version, Avaliação de Tecnologia Assistiva - Predisposição ao Uso - ATD PA Br, was derived from the original version in English (ATD PA). The ATD PA Br will support professionals and people with disabilities in Brazil to better select AT devices according to the clients' needs. Implications for rehabilitation Provides a systematic way of selecting assistive technology devices for the use of individuals with disabilities according to the Brazilian reality. A systematic way of selecting the assistive technology that can help decrease the abandonment of the assistive technology use. The use of the Matching Person and Technology theorical model and of the assessment ATD PA Br is essential to guide the researches and clinical practice in Brazil.

A robot and control algorithm that can synchronously assist in naturalistic motion during body-weight-supported gait training following neurologic injury.

PubMed

Aoyagi, Daisuke; Ichinose, Wade E; Harkema, Susan J; Reinkensmeyer, David J; Bobrow, James E

2007-09-01

Locomotor training using body weight support on a treadmill and manual assistance is a promising rehabilitation technique following neurological injuries, such as spinal cord injury (SCI) and stroke. Previous robots that automate this technique impose constraints on naturalistic walking due to their kinematic structure, and are typically operated in a stiff mode, limiting the ability of the patient or human trainer to influence the stepping pattern. We developed a pneumatic gait training robot that allows for a full range of natural motion of the legs and pelvis during treadmill walking, and provides compliant assistance. However, we observed an unexpected consequence of the device's compliance: unimpaired and SCI individuals invariably began walking out-of-phase with the device. Thus, the robot perturbed rather than assisted stepping. To address this problem, we developed a novel algorithm that synchronizes the device in real-time to the actual motion of the individual by sensing the state error and adjusting the replay timing to reduce this error. This paper describes data from experiments with individuals with SCI that demonstrate the effectiveness of the synchronization algorithm, and the potential of the device for relieving the trainers of strenuous work while maintaining naturalistic stepping.

Lung assist device technology with physiologic blood flow developed on a tissue engineered scaffold platform.

PubMed

Hoganson, David M; Pryor, Howard I; Bassett, Erik K; Spool, Ira D; Vacanti, Joseph P

2011-02-21

There is no technology available to support failing lung function for patients outside the hospital. An implantable lung assist device would augment lung function as a bridge to transplant or possible destination therapy. Utilizing biomimetic design principles, a microfluidic vascular network was developed for blood inflow from the pulmonary artery and blood return to the left atrium. Computational fluid dynamics analysis was used to optimize blood flow within the vascular network. A micro milled variable depth mold with 3D features was created to achieve both physiologic blood flow and shear stress. Gas exchange occurs across a thin silicone membrane between the vascular network and adjacent alveolar chamber with flowing oxygen. The device had a surface area of 23.1 cm(2) and respiratory membrane thickness of 8.7 ± 1.2 μm. Carbon dioxide transfer within the device was 156 ml min(-1) m(-2) and the oxygen transfer was 34 ml min(-1) m(-2). A lung assist device based on tissue engineering architecture achieves gas exchange comparable to hollow fiber oxygenators yet does so while maintaining physiologic blood flow. This device may be scaled up to create an implantable ambulatory lung assist device.

The Myosuit: Bi-articular Anti-gravity Exosuit That Reduces Hip Extensor Activity in Sitting Transfers.

PubMed

Schmidt, Kai; Duarte, Jaime E; Grimmer, Martin; Sancho-Puchades, Alejandro; Wei, Haiqi; Easthope, Chris S; Riener, Robert

2017-01-01

Muscle weakness-which can result from neurological injuries, genetic disorders, or typical aging-can affect a person's mobility and quality of life. For many people with muscle weakness, assistive devices provide the means to regain mobility and independence. These devices range from well-established technology, such as wheelchairs, to newer technologies, such as exoskeletons and exosuits. For assistive devices to be used in everyday life, they must provide assistance across activities of daily living (ADLs) in an unobtrusive manner. This article introduces the Myosuit, a soft, wearable device designed to provide continuous assistance at the hip and knee joint when working with and against gravity in ADLs. This robotic device combines active and passive elements with a closed-loop force controller designed to behave like an external muscle (exomuscle) and deliver gravity compensation to the user. At 4.1 kg (4.6 kg with batteries), the Myosuit is one of the lightest untethered devices capable of delivering gravity support to the user's knee and hip joints. This article presents the design and control principles of the Myosuit. It describes the textile interface, tendon actuators, and a bi-articular, synergy-based approach for continuous assistance. The assistive controller, based on bi-articular force assistance, was tested with a single subject who performed sitting transfers, one of the most gravity-intensive ADLs. The results show that the control concept can successfully identify changes in the posture and assist hip and knee extension with up to 26% of the natural knee moment and up to 35% of the knee power. We conclude that the Myosuit's novel approach to assistance using a bi-articular architecture, in combination with the posture-based force controller, can effectively assist its users in gravity-intensive ADLs, such as sitting transfers.

The Myosuit: Bi-articular Anti-gravity Exosuit That Reduces Hip Extensor Activity in Sitting Transfers

PubMed Central

Schmidt, Kai; Duarte, Jaime E.; Grimmer, Martin; Sancho-Puchades, Alejandro; Wei, Haiqi; Easthope, Chris S.; Riener, Robert

2017-01-01

Muscle weakness—which can result from neurological injuries, genetic disorders, or typical aging—can affect a person's mobility and quality of life. For many people with muscle weakness, assistive devices provide the means to regain mobility and independence. These devices range from well-established technology, such as wheelchairs, to newer technologies, such as exoskeletons and exosuits. For assistive devices to be used in everyday life, they must provide assistance across activities of daily living (ADLs) in an unobtrusive manner. This article introduces the Myosuit, a soft, wearable device designed to provide continuous assistance at the hip and knee joint when working with and against gravity in ADLs. This robotic device combines active and passive elements with a closed-loop force controller designed to behave like an external muscle (exomuscle) and deliver gravity compensation to the user. At 4.1 kg (4.6 kg with batteries), the Myosuit is one of the lightest untethered devices capable of delivering gravity support to the user's knee and hip joints. This article presents the design and control principles of the Myosuit. It describes the textile interface, tendon actuators, and a bi-articular, synergy-based approach for continuous assistance. The assistive controller, based on bi-articular force assistance, was tested with a single subject who performed sitting transfers, one of the most gravity-intensive ADLs. The results show that the control concept can successfully identify changes in the posture and assist hip and knee extension with up to 26% of the natural knee moment and up to 35% of the knee power. We conclude that the Myosuit's novel approach to assistance using a bi-articular architecture, in combination with the posture-based force controller, can effectively assist its users in gravity-intensive ADLs, such as sitting transfers. PMID:29163120

Options for temporary mechanical circulatory support

PubMed Central

Saffarzadeh, Areo

2015-01-01

Temporary mechanical circulatory support (MCS) refers to a group of devices generally used for less than 30 days to maintain adequate organ perfusion by compensating for a failure of the pumping mechanism of the heart. The increased availability and rapid adoption of new temporary MCS strategies necessitate physicians to become familiar with devices placed both percutaneously and via median sternotomy. This review will examine the different options for commonly used temporary MCS devices including intra-aortic balloon pumps (IABPs), veno-arterial-extracorporeal membrane oxygenation (VA-ECMO), TandemHeart® (CardiacAssist, Pittsburg, PA, USA) Impella® and BVS 5000® (both Abiomed Inc., Danvers, MA, USA), CentriMag® and Thoratec percutaneous ventricular assist device (pVAD)® (both Thoratec Corporation, Pleasanton, CA, USA). A specific emphasis will be made to describe relevant mechanisms of action, standard placement strategies, hemodynamic effects, relevant contraindications and complications, and important daily management considerations. PMID:26793330

Could a Mobile-Assisted Learning System Support Flipped Classrooms for Classical Chinese Learning?

ERIC Educational Resources Information Center

Wang, Y.-H.

2016-01-01

In this study, the researcher aimed to develop a mobile-assisted learning system and to investigate whether it could promote teenage learners' classical Chinese learning through the flipped classroom approach. The researcher first proposed the structure of the Cross-device Mobile-Assisted Classical Chinese (CMACC) system according to the pilot…

Students with Special Educational Needs and Assistive Technologies: A Literature Review

ERIC Educational Resources Information Center

Erdem, Raziye

2017-01-01

The term "assistive technologies" refers to the equipment, devices and apparatus, and the services, systems, processes and adaptations made to the environment that support and facilitate their functions, used by persons with special education needs. This study is a literature review of the use of assistive technologies in the education…

Development of Device to Evoke Stretch Reflexes by Use of Electromagnetic Force for the Rehabilitation of the Hemiplegic Upper Limb after Stroke

NASA Astrophysics Data System (ADS)

Hayashi, Ryota; Ishimine, Tomoyasu; Kawahira, Kazumi; Yu, Yong; Tsujio, Showzow

In this research, we focus on the method of rehabilitation with stretch reflexes for the hemiplegic upper limb in stroke patients. We propose a new device which utilizes electromagnetic force to evoke stretch reflexes. The device can exert an assisting force safely, because the electromagnetic force is non contact force. In this paper, we develop a support system applying the proposed device for the functional recovery training of the hemiplegic upper limb. The results obtained from several clinical tests with and without our support system are compared. Then we discuss the validity of our support system.

A description of assistive technology sources, services and outcomes of use in a number of African settings.

PubMed

Visagie, Surona; Eide, Arne H; Mannan, Hasheem; Schneider, Marguerite; Swartz, Leslie; Mji, Gubela; Munthali, Alister; Khogali, Mustafa; van Rooy, Gert; Hem, Karl-Gerhard; MacLachlan, Malcolm

2017-10-01

Purpose statement: The article explores assistive technology sources, services and outcomes in South Africa, Namibia, Malawi and Sudan. A survey was done in purposively selected sites of the study countries. Cluster sampling followed by random sampling served to identify 400-500 households (HHs) with members with disabilities per country. A HH questionnaire and individual questionnaire was completed. Country level analysis was limited to descriptive statistics. Walking mobility aids was most commonly bought/provided (46.3%), followed by visual aids (42.6%). The most common sources for assistive technology were government health services (37.8%), "other" (29.8%), and private health services (22.9%). Out of the participants, 59.3% received full information in how to use the device. Maintenance was mostly done by users and their families (37.3%). Devices helped a lot in 73.3% of cases and improved quality of life for 67.9% of participants, while 39.1% experienced functional difficulties despite the devices. Although there is variation between the study settings, the main impression is that of fragmented or absent systems of provision of assistive technology. Implications for rehabilitation Provision of assistive technology and services varied between countries, but the overall impression was of poor provision and fragmented services. The limited provision of assistive technology for personal care and handling products is of concern as many of these devices requires little training and ongoing support while they can make big functional differences. Rural respondents experienced more difficulties when using the device and received less information on use and maintenance of the device than their urban counterparts. A lack of government responsibility for assistive device services correlated with a lack of information and/or training of participants and maintenance of devices.

Improvement of Wearable Power Assist Wear for Low Back Support using Pneumatic Actuator

NASA Astrophysics Data System (ADS)

Cho, Feifei; Sugimoto, Riku; Noritsugu, Toshiro; Li, Xiangpan

2017-10-01

This study focuses on developing a safe, lightweight, power assist device that can be worn by people who like caregivers during lifting or static holding tasks to prevent low back pain (LBP). Therefore in consideration of their flexibility, light weight, and large force to weight ratio we have developed a Wearable Power Assist Wear for caregivers, two types of pneumatic actuators are employed in assisting low back movement for their safety and comfort. The device can be worn directly on the body like normal clothing. Because there is no rigid exoskeleton frame structure, it is lightweight and user friendly. In this paper, we proposed the new type of the wearable power assist wear and improved the controller of control system.

Left ventricular assist device malfunction: a systematic approach to diagnosis.

PubMed

Horton, Steven C; Khodaverdian, Reza; Powers, Amanda; Revenaugh, James; Renlund, Dale G; Moore, Stephanie A; Rasmusson, Brad; Nelson, Karl E; Long, James W

2004-05-05

A protocol was designed to diagnose the common malfunctions of a left ventricular assist device (LVAD). Mechanical circulatory support, primarily with an LVAD, is increasingly used for treatment of advanced heart failure (HF). Left ventricular assist device dysfunction is a recognized complication; but heretofore, a systematic method to accurately diagnose LVAD dysfunction has not been thoroughly described. We developed a catheter-based protocol designed to characterize a normally functioning LVAD and diagnose multiple types of dysfunction. A total of 15 studies of 10 patients supported with an LVAD were reviewed. All patients had been evaluated due to concerns regarding LVAD dysfunction. Of 15 examinations performed, 11 documented severe LVAD inflow valve regurgitation. One of these cases proved to have coexistent severe mitral valve regurgitation. One case was diagnosed with distortion of the LVAD outflow graft. One case of suspected embolization from the pumping chamber excluded the outflow graft as the source of emboli. One study had aortic insufficiency. As LVAD use for treatment of end-stage HF becomes widespread and durations of support are extended, dysfunction will be increasingly prevalent. This catheter-based protocol provided a practical method to diagnose multiple causes of LVAD dysfunction.

Sensor-Based Assistive Devices for Visually-Impaired People: Current Status, Challenges, and Future Directions

PubMed Central

Elmannai, Wafa; Elleithy, Khaled

2017-01-01

The World Health Organization (WHO) reported that there are 285 million visually-impaired people worldwide. Among these individuals, there are 39 million who are totally blind. There have been several systems designed to support visually-impaired people and to improve the quality of their lives. Unfortunately, most of these systems are limited in their capabilities. In this paper, we present a comparative survey of the wearable and portable assistive devices for visually-impaired people in order to show the progress in assistive technology for this group of people. Thus, the contribution of this literature survey is to discuss in detail the most significant devices that are presented in the literature to assist this population and highlight the improvements, advantages, disadvantages, and accuracy. Our aim is to address and present most of the issues of these systems to pave the way for other researchers to design devices that ensure safety and independent mobility to visually-impaired people. PMID:28287451

Involving children in the development of assistive technology devices.

PubMed

Allsop, M; Gallagher, J; Holt, R; Bhakta, B; Wilkie, R M

2011-01-01

To investigate the implementation of a web-based survey for involving children in the design of assistive technology devices within the primary school environment. Children were recruited within their normal school environment. They completed tasks within the survey that sought to gather their personal preferences about assistive technology devices. From six primary schools, 257 children (mean age = 9 years and 8 months, SD = 1.51; 123 males, 134 females) including children with cerebral palsy (N = 11), varying levels of deafness (N = 7), global developmental delay (N = 2) and Down's syndrome (N = 1) participated. Observations were taken whilst the children completed the survey tasks. All children were able to complete the tasks from the survey, although children with disabilities had higher completion times and most required a form of assistance from support assistants and/or sign language interpreters. The use of the web-based survey provided a novel means with which to involve children with and without disabilities in the design of assistive technology devices within a primary school environment. In order for the survey to be utilised more widely, issues that arose when involving children with disabilities need to be addressed.

Central-Approach Surgical Repair of Coarctation of the Aorta with a Back-up Left Ventricular Assist Device for an Infant Presenting with Severe Left Ventricular Dysfunction.

PubMed

Kim, Tae Hoon; Shin, Yu Rim; Kim, Young Sam; Kim, Do Jung; Kim, Hyohyun; Shin, Hong Ju; Htut, Aung Thein; Park, Han Ki

2015-12-01

A two-month-old infant presented with coarctation of the aorta, severe left ventricular dysfunction, and moderate to severe mitral regurgitation. Through median sternotomy, the aortic arch was repaired under cardiopulmonary bypass and regional cerebral perfusion. The patient was postoperatively supported with a left ventricular assist device for five days. Left ventricular function gradually improved, eventually recovering with the concomitant regression of mitral regurgitation. Prompt surgical repair of coarctation of the aorta is indicated for patients with severe left ventricular dysfunction. A central approach for surgical repair with a back-up left ventricular assist device is a safe and effective treatment strategy for these patients.

Extracorporeal Life Support Bridge to Ventricular Assist Device: The Double Bridge Strategy.

PubMed

Marasco, Silvana F; Lo, Casey; Murphy, Deirdre; Summerhayes, Robyn; Quayle, Margaret; Zimmet, Adam; Bailey, Michael

2016-01-01

In patients requiring left ventricular assist device (LVAD) support, it can be difficult to ascertain suitability for long-term mechanical support with LVAD and eventual transplantation. LVAD implantation in a shocked patient is associated with increased morbidity and mortality. Interest is growing in the utilization of extracorporeal life support (ECLS) as a bridge-to-bridge support for these critically unwell patients. Here, we reviewed our experience with ECLS double bridging. We hypothesized that ECLS double bridging would stabilize end-organ dysfunction and reduce ventricular assist device (VAD) implant perioperative mortality. We conducted a retrospective review of prospectively collected data for 58 consecutive patients implanted with a continuous-flow LVAD between January 2010 and December 2013 at The Alfred Hospital, Melbourne, Victoria, Australia. Twenty-three patients required ECLS support pre-LVAD while 35 patients underwent LVAD implantation without an ECLS bridge. Preoperative morbidity in the ECLS bridge group was reflected by increased postoperative intensive care duration, blood loss, blood product use, and postoperative renal failure, but without negative impact upon survival when compared with the no ECLS group. ECLS stabilization improved end-organ function pre-VAD implant with significant improvements in hepatic and renal dysfunction. This series demonstrates that the use of ECLS bridge to VAD stabilizes end-organ dysfunction and reduces VAD implant perioperative mortality from that traditionally reported in these "crash and burn" patients. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

First pediatric transatlantic air ambulance transportation on a Berlin Heart EXCOR left ventricular assist device as a bridge to transplantation.

PubMed

Tissot, Cecile; Buchholz, Holger; Mitchell, Max B; da Cruz, Eduardo; Miyamoto, Shelley D; Pietra, Bill A; Charpentier, Arnaud; Ghez, Olivier

2010-03-01

Mechanical circulatory devices are indicated in patients with refractory cardiac failure as a bridge to recovery or to transplantation. Whenever required, transportation while on mechanical support is a challenge and still limited by technical restrictions or distance. We report the first pediatric case of transatlantic air transportation on a Berlin Heart EXCOR ventricular assist device (Berlin Heart, Berlin, Germany) of a 13-yr-old American female who presented in cardiogenic shock with severe systolic dysfunction while vacationing in France. Rapid hemodynamic deterioration occurred despite maximal medical treatment, and she was supported initially with extracorporeal membrane oxygenation converted to a Berlin Heart EXCOR left ventricular assist device. Long-distance air transportation of the patient was accomplished 3 wks after implantation from Marseille, France, to Denver, Colorado. No adverse hemodynamic effects were encountered during the 13.5-hr flight (8770 km). The patient did not recover sufficient cardiac function and underwent successful orthotopic heart transplantation 3 months after the initial event. Our experience suggests that long-distance air transportation of pediatric patients using the Berlin Heart EXCOR mobile unit as a bridge to recovery or transplantation is feasible and appears safe.

Miracle Workers: When Appropriately Prescribed and Supported by Solid Instruction, Alternative and Augmentative Communication Devices Can Give Voices to Students Otherwise "Trapped" by Their Disabilities

ERIC Educational Resources Information Center

Bainbridge, Marc

2005-01-01

The Individuals with Disabilities Education Act (IDEA-PL 101-478) of 1990 assures the right to assistive technology for individuals with disabilities. Later versions of the law increased spending, support, and consumer decision making and encouraged research and development for a range of assistive instructional technologies. As a result, the…

Focused review on transthoracic echocardiographic assessment of patients with continuous axial left ventricular assist devices.

PubMed

Topilsky, Yan; Maltais, Simon; Oh, Jae K; Atchison, Fawn W; Perrault, Louis P; Carrier, Michel; Park, Soon J

2011-02-08

Left ventricular assist devices (LVADs) are systems for mechanical support for patients with end-stage heart failure. Preoperative, postoperative and comprehensive followup with transthoracic echocardiography has a major role in LVAD patient management. In this paper, we will present briefly the hemodynamics of axial-flow LVAD, the rationale, and available data for a complete and organized echocardiographic assessment in these patients including preoperative assessment, postoperative and long-term evaluation.

Noninvasive estimation of assist pressure for direct mechanical ventricular actuation

NASA Astrophysics Data System (ADS)

An, Dawei; Yang, Ming; Gu, Xiaotong; Meng, Fan; Yang, Tianyue; Lin, Shujing

2018-02-01

Direct mechanical ventricular actuation is effective to reestablish the ventricular function with non-blood contact. Due to the energy loss within the driveline of the direct cardiac compression device, it is necessary to acquire the accurate value of assist pressure acting on the heart surface. To avoid myocardial trauma induced by invasive sensors, the noninvasive estimation method is developed and the experimental device is designed to measure the sample data for fitting the estimation models. By examining the goodness of fit numerically and graphically, the polynomial model presents the best behavior among the four alternative models. Meanwhile, to verify the effect of the noninvasive estimation, the simplified lumped parameter model is utilized to calculate the pre-support and the post-support left ventricular pressure. Furthermore, by adjusting the driving pressure beyond the range of the sample data, the assist pressure is estimated with the similar waveform and the post-support left ventricular pressure approaches the value of the adult healthy heart, indicating the good generalization ability of the noninvasive estimation method.

Left Ventricular Assist Devices: The Adolescence of a Disruptive Technology.

PubMed

Pinney, Sean P

2015-10-01

Clinical outcomes for patients with advanced heart failure receiving left ventricular assist devices are driven by appropriate patient selection, refined surgical technique, and coordinated medical care. Perhaps even more important is innovative pump design. The introduction and widespread adoption of continuous-flow ventricular assist devices has led to a paradigm shift within the field of mechanical circulatory support, making the promise of lifetime device therapy closer to reality. The disruption caused by this new technology, on the one hand, produced meaningful improvements in patient survival and quality of life, but also introduced new clinical challenges, such as bleeding, pump thrombosis, and acquired valvular heart disease. Further evolution within this field will require financial investment to sustain innovation leading to a fully implantable, durable, and cost-effective pump for a larger segment of patients with advanced heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

Enterprise digital assistants: the progression of wireless clinical computing.

PubMed

Bergeron, Bryan P

2002-01-01

By virtue of increasingly pervasive wireless connectivity, the proliferation of wireless handheld devices in clinical care is rapidly transforming the concept of the personal digital assistant (PDA) to the enterprise digital assistant (EDA). Wireless handheld devices are becoming extensions of the central hospital information system, in which it's understood that the health care enterprise, not the clinician carrying the information-dispensing device, owns the data. The practical implication for clinicians is that, despite the potential long-term benefits of seamless, just-in-time clinical data access, this paradigm shift portends decreased efficiency in the short term, as clinicians duplicate clinical data collection on private devices. Assuming eventual clinician acceptance, EDAs can form the basis of a national real-time clinical data acquisition system that ensures uniform prescribing, decision support, and diagnosis, and the means for tracking unusual disease presentation patterns that could be indicative of bioterrorism or natural disease outbreaks.

Experimental and numeric investigation of Impella pumps as cavopulmonary assistance for a failing Fontan.

PubMed

Haggerty, Christopher M; Fynn-Thompson, Francis; McElhinney, Doff B; Valente, Anne Marie; Saikrishnan, Neelakantan; Del Nido, Pedro J; Yoganathan, Ajit P

2012-09-01

This study sought to evaluate the performance of microaxial ventricular assist devices for the purposes of supporting failing Fontan physiology by decreasing central venous pressure. Three Abiomed Impella pumps (Abiomed, Inc, Danvers, Mass) were evaluated in a mock circulatory system of the Fontan circuit. The local response of pressures and flows to pump function was assessed as a function of pump speed and pulmonary vascular resistance at a high baseline central venous pressure. For one device, subsequent modeling studies were conducted using a lumped parameter model of the single ventricle circuit. The left ventricular devices (Impella 2.5, 5.0) were shown to be suboptimal as single device solutions for cavopulmonary support. The small area of these devices relative to vessel diameter led to significant flow recirculation without an obstructive separator in place. Furthermore, downstream pressure augmentation adversely affected the pressure in the superior vena cava. The use of 2 devices would be mandatory for successful support. The right-sided device (Impella RP), whose outflow was positioned in the left pulmonary artery, demonstrated decreased flow recirculation and did not impede superior caval venous flow. Although static pressure is still required to drive flow through the opposite lung, numeric modeling demonstrated the potential for modest but significant improvements in lowering the central venous pressure (2-8 mm Hg). Left-sided microaxial pumps are not well suited for cavopulmonary support because of severe flow recirculation and the need for multiple devices. The right-ventricular Impella device provides improved performance by directing flow into the pulmonary artery, resulting in modest decreases in central venous pressure. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Assistive technologies after stroke: self-management or fending for yourself? A focus group study

PubMed Central

2013-01-01

Background Assistive Technologies, defined as “electrical or mechanical devices designed to help people recover movement” have demonstrated clinical benefits in upper-limb stroke rehabilitation. Stroke services are becoming community-based and more reliant on self-management approaches. Assistive technologies could become important tools within self-management, however, in practice, few people currently use assistive technologies. This study investigated patients’, family caregivers and health professionals’ experiences and perceptions of stroke upper-limb rehabilitation and assistive technology use and identified the barriers and facilitators to their use in supporting stroke self-management. Methods A three-day exhibition of assistive technologies was attended by 204 patients, family caregivers/friends and health professionals. Four focus groups were conducted with people purposively sampled from exhibition attendees. They included i) people with stroke who had used assistive technologies (n = 5), ii) people with stroke who had not used assistive technologies (n = 6), iii) family caregivers (n = 5) and iv) health professionals (n = 6). The audio-taped focus groups were facilitated by a moderator and observer. All participants were asked to discuss experiences, strengths, weaknesses, barriers and facilitators to using assistive technologies. Following transcription, data were analysed using thematic analysis. Results All respondents thought assistive technologies had the potential to support self-management but that this opportunity was currently unrealised. All respondents considered assistive technologies could provide a home-based solution to the need for high intensity upper-limb rehabilitation. All stakeholders also reported significant barriers to assistive technology use, related to i) device design ii) access to assistive technology information and iii) access to assistive technology provision. The lack of and need for a coordinated system for assistive technology provision was apparent. A circular limitation of lack of evidence in clinical settings, lack of funded provision, lack of health professional knowledge about assistive technologies and confidence in prescribing them leading to lack of assistive technology service provision meant that often patients either received no assistive technologies or they and/or their family caregivers liaised directly with manufacturers without any independent expert advice. Conclusions Considerable systemic barriers to realising the potential of assistive technologies in upper-limb stroke rehabilitation were reported. Attention needs to be paid to increasing evidence of assistive technology effectiveness and develop clinical service provision. Device manufacturers, researchers, health professionals, service funders and people with stroke and family caregivers need to work creatively and collaboratively to develop new funding models, improve device design and increase knowledge and training in assistive technology use. PMID:23968362

Measuring the Impact of Cognitive Prosthetics on the Daily Life of People with Dementia and Their Carers

NASA Astrophysics Data System (ADS)

Meiland, Franka; Dröes, Rose-Marie; Sävenstedt, Stefan

Assistive technologies to support persons with dementia and their carers are used increasingly often. However, little is known about the effectiveness of most assistive devices. Much technology is put on the market without having been properly tested with potential end-users. To increase the chance that an assistive device is well accepted and useful for the target group, it is important, especially in the case of disabled persons, to involve potential users in the development process and to evaluate the impact of using the device on them before implementing it in the daily care and support. When evaluating the impact, decisions have to be made regarding the selection of measuring instruments. Important considerations in the selection process are the underlying domains to be addressed by the assistive technology, the target group and the availability of standardized instruments with good psychometric properties. In this chapter the COGKNOW project is used as a case example to explain how the impact of cognitive prosthetics on the daily lives of people with dementia and their carers can be measured. In COGKNOW a cognitive prosthetic device is being developed to improve the quality of life and autonomy of persons with dementia and to help them to remember and remind, to have social contact, to perform daily activities and to enhance feelings of safety. For all these areas, potential measuring instruments are described. Besides (standardized) measuring instruments, other data collection methods are used as well, such as semi-structured interviews and observations, diaries and in situ measurement. Within the COGKNOW project a first uncontrolled small-scale impact measurement takes place during the development process of the assistive device. However, it is recommended to perform a larger randomized controlled study as soon as the final product is ready to evaluate the impact of the device on persons with dementia and carers before it is released on the market.

Technology and active agency of older adults living in service house environment.

PubMed

Sallinen, Merja; Hentonen, Outi; Kärki, Anne

2015-01-01

The purpose of the study was to explore whether or not the assistive and safety technology that is currently used in service house environment supports the active agency of the elderly residents. Twelve purposively chosen elderly residents were interviewed. The data were analyzed by theory-driven content analysis using the modalities of the agency-model as a theoretical frame. The technological devices and systems partially support the active agency of the residents. Deterioration of their functioning seems to limit the use of devices as well as complicate their learning on how to use these systems. The respondents had only few insights of the possibilities that this technology could offer to them in their daily life and they were not expecting their functioning to improve in the future. The homeliness and intimacy of the environment was highly appreciated. Although the attitude towards technology was, in general, reserved, technology was seen as one possibility to support active agency. The current technologies seem to be designed from the needs of the organization and not from the needs of the residents. In the future, more emphasis needs to be put on designing individualized devices in cooperation with the users. Implications for Rehabilitation To support independence, autonomy and active agency of the older adults, the technological solutions must be based on perceived needs of the individual and the design should be adaptable to the functional limitations one has. Nursing staff's knowledge about assistive devices and technologies need to be updated on regular bases in order to be able to recommend appropriate devices for the elderly. Taking into account the fact that many older adults have mild to moderate memory problems as well as difficulties with vision and hearing, more attention needs to be paid to didactics, i.e. how the introduction and guidance of the use of new technologies, assistive devices or safety systems is best done with them.

Prologue: ventricular assist devices and total artificial hearts. A historical perspective.

PubMed

Frazier, O H

2003-02-01

In the 1960s, when LVADs and TAHs were introduced into clinical use, researchers estimated that, with this technology, the problem of heart failure could be solved within 20 years. Unfortunately, the evolution of these devices has taken much longer than anticipated. Nevertheless, significant advances have been achieved in both cardiac assistance and replacement, and today's cardiac surgeons have a wide range of devices from which to choose (Table 4). This progress has largely been due to the support of the NHLBI, especially the Devices and Technology Division headed by John Watson, and of the devoted commitment of the investigators. Because of the long-term commitment required for both basic and clinical research, commercial medical technology companies are unable to assume this burden. Advances in mechanical circulatory support and replacement have benefited numerous patients worldwide who would otherwise have died of heart failure, and devices now exist for use as bridges to recovery, bridges to transplant, and destination therapy. The current challenge is to refine what we have and to apply these technologies to broader patient populations with maximal safety and at a reasonable cost.

AUDIS wear: a smartwatch based assistive device for ubiquitous awareness of environmental sounds.

PubMed

Mielke, Matthias; Bruck, Rainer

2016-08-01

A multitude of assistive devices is available for deaf people (i.e. deaf, deafened, and hard of hearing). Besides hearing and communication aids, devices to access environmental sounds are available commercially. But the devices have two major drawbacks: 1. they are targeted at indoor environments (e.g. home or work), and 2. only specific events are supported (e.g. the doorbell or telephone). Recent research shows that important sounds can occur in all contexts and that the interests in sounds are diverse. These drawbacks can be tackled by using modern information and communication technology that enables the development of new and improved assistive devices. The smartwatch, a new computing platform in the form of a wristwatch, offers new potential for assistive technology. Its design promises a perfect integration into various different social contexts and thus blends perfectly into the user's life. Based on a smartwatch and algorithms from pattern recognition, a prototype for awareness of environmental sounds is presented here. It observes the acoustic environment of the user and detects environmental sounds. A vibration is triggered when a sound is detected and the type of sound is shown on the display. The design of the prototype was discussed with deaf people in semi-structured interviews, leading to a set of implications for the design of such a device.

Performance Improvement to Decrease Readmission Rates for Patients With a Left Ventricular Assist Device.

PubMed

Iseler, Jackeline; Fox, John; Wierenga, Kelly

2018-06-01

The 30-day readmission rate for patients with a left ventricular assist device implantation at a large, urban, Midwest hospital system (from October 2013 to September 2014) was estimated at 32.1%. Readmission rates were a concern at this facility. Review of the readmissions, change in practice, and home expectations of patients and families have identified an opportunity to improve the transitions of care for this left ventricular assist device (LVAD) program. Therefore, the purpose of this project was to evaluate the effectiveness and feasibility of a transitional care model (TCM) for care of patients with left ventricular devices. Ten patients were enrolled in the pilot that was implemented in June 2015. A transitional care nurse trained to support patients with ventricular assist devices was used to facilitate patient flow. The goal was to create an individualized plan for the development or improvement of self-management skills to decrease readmission rates. The transitional care nurse collaborated with the ventricular device team. The 30-day readmission rate during the pilot was 14.3% compared to the previous annual overall rate of 42.6%. Based on these results, further research is recommended into interventions consistent with the TCM to advance care coordination and to facilitate care transition in the this fragile patient population.

Advancements in mechanical circulatory support for patients in acute and chronic heart failure

PubMed Central

Csepe, Thomas A.

2017-01-01

Cardiogenic shock (CS) continues to have high mortality and morbidity despite advances in pharmacological, mechanical, and reperfusion approaches to treatment. When CS is refractory to medical therapy, percutaneous mechanical circulatory support (MCS) should be considered. Acute MCS devices, ranging from intra-aortic balloon pumps (IABPs) to percutaneous temporary ventricular assist devices (VAD) to extracorporeal membrane oxygenation (ECMO), can aid, restore, or maintain appropriate tissue perfusion before the development of irreversible end-organ damage. Technology has improved patient survival to recovery from CS, but in patients whom cardiac recovery does not occur, acute MCS can be effectively utilized as a bridge to long-term MCS devices and/or heart transplantation. Heart transplantation has been limited by donor heart availability, leading to a greater role of left ventricular assist device (LVAD) support. In patients with biventricular failure that are ineligible for LVAD implantation, further advancements in the total artificial heart (TAH) may allow for improved survival compared to medical therapy alone. In this review, we discuss the current state of acute and durable MCS, ongoing advances in LVADs and TAH devices, improved methods of durable MCS implantation and patient selection, and future MCS developments in this dynamic field that may allow for optimization of HF treatment. PMID:29268418

Support and maneuvering apparatus for solar energy receivers

DOEpatents

Murphy, Lawrence M.

1989-01-01

A support and maneuvering apparatus is disclosed for a solar energy receiving device adpated for receiving and concentrating solar energy and having a central axis extending through the center thereof. The apparatus includes a frame for mounting the perimeter of said solar energy receiving device. A support member extends along the central axis of the receiving device and has a base end passing through the center of the receiving device and an outer distal end adapted for carrying a solar energy receiving and conversion mechanism. A variable tension mechanism interconnects the support member with the frame to provide stiffening for the support member and the frame and to assist in the alignment of the frame to optimize the optical efficiency of the solar energy receiving device. A rotatable base is provided, and connecting members extend from the base for pivotable attachment to the frame at spaced positions therealong. Finally, an elevation assembly is connected to the receiving device for selectively pivoting the receiving device about an axis defined between the attachment positions of the connecting members on the frame.

Bioartificial liver: current status.

PubMed

Pless, G; Sauer, I M

2005-11-01

Liver failure remains a life-threatening syndrome. With the growing disparity between the number of suitable donor organs and the number of patients awaiting transplantation, efforts have been made to optimize the allocation of organs, to find alternatives to cadaveric liver transplantation, and to develop extracorporeal methods to support or replace the function of the failing organ. An extracorporeal liver support system has to provide the main functions of the liver: detoxification, synthesis, and regulation. The understanding that the critical issue of the clinical syndrome in liver failure is the accumulation of toxins not cleared by the failing liver led to the development of artificial filtration and adsorption devices (artificial liver support). Based on this hypothesis, the removal of lipophilic, albumin-bound substances, such as bilirubin, bile acids, metabolites of aromatic amino acids, medium-chain fatty acids, and cytokines, should be beneficial to the clinical course of a patient in liver failure. Artificial detoxification devices currently under clinical evaluation include the Molecular Adsorbent Recirculating System (MARS), Single-Pass Albumin Dialysis (SPAD), and the Prometheus system. The complex tasks of regulation and synthesis remain to be addressed by the use of liver cells (bioartificial liver support). The Extracorporeal Liver Assist Device (ELAD), HepatAssist, Modular Extracorporeal Liver Support system (MELS), and the Amsterdam Medical Center Bioartificial Liver (AMC-BAL) are bioartificial systems. This article gives a brief overview on these artificial and bioartificial devices and discusses remaining obstacles.

Devices as destination therapy.

PubMed

Kukuy, Eugene L; Oz, Mehmet C; Rose, Eric A; Naka, Yoshifumi

2003-02-01

The use of circulatory support as destination therapy has been a goal for the treatment of endstage heart failure for several decades. Current investigations are evaluating several circulatory pumps with that particular objective. With continued modification of design, the current and future pumps will become more reliable and provide improved quality of life to patients in need of mechanical circulatory assistance. The new pumps on the horizon specifically address reliability, size, and cost, and are based on the centrifugal system. These devices use the Maglev (Magnetic Levitation) concept that allows for frictionless pumping, low thrombogenicity, minimal noise, and increased durability. Further research with this goal in mind and support from the federal government will be the key to the future use of circulatory assistance as destination therapy for heart failure patients. In addition, the cost-effectiveness of these devices will need to be maintained as the technology improves, as in any new technology that confronts a more intuitive option like the native heart.

Left thoracotomy HeartWare implantation with outflow graft anastomosis to the descending aorta: a simplified bridge for patients with multiple previous sternotomies.

PubMed

Umakanthan, Ramanan; Haglund, Nicholas A; Stulak, John M; Joyce, Lyle D; Ahmad, Rashid; Keebler, Mary E; Maltais, Simon

2013-01-01

Advances in mechanical circulatory support have been critical in bridging patients awaiting heart transplantation. In addition, improvement in device durability has enabled left ventricular assist device therapy to be applied as destination therapy in those not felt to be transplant candidate. Because of the increasing complexity of patients, there continues to be a need for alternative strategies for device implantation to bridge high-risk patients awaiting heart transplantation, wherein the risks of numerous previous sternotomies may be prohibitive. We present a unique technique for placement of the HeartWare ventricular assist device via left anterior thoracotomy to the descending aorta in a patient awaiting heart transplantation with a history of multiple previous sternotomies.

38 CFR 62.33 - Supportive service: Assistance in obtaining and coordinating other public benefits.

Code of Federal Regulations, 2012 CFR

2012-07-01

... pharmaceuticals, supplies, equipment, devices, appliances, and assistive technology. (b) Daily living services...) Child care, which includes the: (1) Referral of a participant, as appropriate, to an eligible child care provider that provides child care with sufficient hours of operation and serves appropriate ages, as needed...

38 CFR 62.33 - Supportive service: Assistance in obtaining and coordinating other public benefits.

Code of Federal Regulations, 2014 CFR

2014-07-01

... pharmaceuticals, supplies, equipment, devices, appliances, and assistive technology. (b) Daily living services...) Child care, which includes the: (1) Referral of a participant, as appropriate, to an eligible child care provider that provides child care with sufficient hours of operation and serves appropriate ages, as needed...

38 CFR 62.33 - Supportive service: Assistance in obtaining and coordinating other public benefits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... pharmaceuticals, supplies, equipment, devices, appliances, and assistive technology. (b) Daily living services...) Child care, which includes the: (1) Referral of a participant, as appropriate, to an eligible child care provider that provides child care with sufficient hours of operation and serves appropriate ages, as needed...

38 CFR 62.33 - Supportive service: Assistance in obtaining and coordinating other public benefits.

Code of Federal Regulations, 2011 CFR

2011-07-01

... pharmaceuticals, supplies, equipment, devices, appliances, and assistive technology. (b) Daily living services...) Child care, which includes the: (1) Referral of a participant, as appropriate, to an eligible child care provider that provides child care with sufficient hours of operation and serves appropriate ages, as needed...

EXPERIMENTAL AND MODELING SUPPORT TO OPPT AND ORIA UNDER THE "BUY CLEAN" INITIATIVE

EPA Science Inventory

Under the Buy Clean program, EPA is responsible for developing and disseminating guidance that will assist users procure lower-emitting products and devices that aim to reduce the exposure of indoor occupants' exposure. The initial focus has been to assist school personnel minimi...

Rehabilitation Engineering & Assistive Technology Society (RESNA) position on the application of wheelchair standing devices: 2013 current state of the literature.

PubMed

Dicianno, Brad E; Morgan, Amy; Lieberman, Jenny; Rosen, Lauren

2016-01-01

This article, approved by the Rehabilitation Engineering & Assistive Technology Society of North America Board of Directors on December 23, 2013, shares typical clinical applications and provides evidence from the literature supporting the use of wheelchair standers.

Exercise physiology, testing, and training in patients supported by a left ventricular assist device.

PubMed

Loyaga-Rendon, Renzo Y; Plaisance, Eric P; Arena, Ross; Shah, Keyur

2015-08-01

The left ventricular assist device (LVAD) is an accepted treatment alternative for the management of end-stage heart failure. As we move toward implantation of LVADs in less severe cases of HF, scrutiny of functional capacity and quality of life becomes more important. Patients demonstrate improvements in exercise capacity after LVAD implantation, but the effect is less than predicted. Exercise training produces multiple beneficial effects in heart failure patients, which would be expected to improve quality of life. In this review, we describe factors that are thought to participate in the persistent exercise impairment in LVAD-supported patients, summarize current knowledge about the effect of exercise training in LVAD-supported patients, and suggest areas for future research. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Ethical analysis of withdrawing ventricular assist device support.

PubMed

Mueller, Paul S; Swetz, Keith M; Freeman, Monica R; Carter, Kari A; Crowley, Mary Eliot; Severson, Cathy J Anderson; Park, Soon J; Sulmasy, Daniel P

2010-09-01

To describe a series of patients with heart failure supported with a ventricular assist device (VAD) who requested (or whose surrogates requested) withdrawal of VAD support and the legal and ethical aspects pertaining to these requests. We retrospectively reviewed the medical records of patients at Mayo Clinic, Rochester, MN, from March 1, 2003, through January 31, 2009, who requested (or whose surrogates requested) withdrawal of VAD support and for whom the requests were fulfilled. We then explored the legal and ethical permissibility of carrying out such requests. The median age of the 14 patients identified (13 men, 1 woman) was 57 years. Requests were made by 2 patients and 12 surrogates. None of the patients' available advance directives mentioned the VAD. For 11 patients, multidisciplinary care conferences were held before withdrawal of VAD support. Only 1 patient had an ethics consultation. All 14 patients died within 1 day of withdrawal of VAD support. Patients have the right to refuse or request the withdrawal of any unwanted treatment, and we argue that this right extends to VAD support. We also argue that the cause of death in these cases is the underlying heart disease, not assisted suicide or euthanasia. Therefore, patients with heart failure supported with VADs or their surrogates may request withdrawal of this treatment. In our view, carrying out such requests is permissible in accordance with the principles that apply to withdrawing other life-sustaining treatments.

The Achilles' heel of left ventricular assist device therapy: right ventricle.

PubMed

Ranganath, Neel K; Smith, Deane E; Moazami, Nader

2018-06-01

Many patients suffer from either persistent right ventricular failure (RVF) at the time of left ventricular assist device (LVAD) or have ongoing symptoms consistent with RVF during chronic mechanical circulatory support. The lack of long-term right ventricular assist devices (RVADs) has limited the impact that mechanical circulatory support can provide to patients with biventricular failure. We aim to review the entire spectrum of RVF in patients receiving LVADs and reflect on why this entity remains the Achilles' heel of LVAD therapy. In the early postoperative period, LVAD implantation reduces right ventricle (RV) afterload, but RV dysfunction may be exacerbated secondary to increased venous return. With prolonged therapy, the decreased RV afterload leads to improved RV contractile function. Bayesian statistical models outperform previously published preoperative risk scores by considering inter-relationships and conditional probabilities amongst independent variables. Various echocardiographic parameters and the pulmonary artery pulsatility index have shown promise in predicting post-LVAD RVF. Recent publications have delineated the emergence of 'delayed' RVF. Several devices are currently being investigated for use as RVADs. Post-LVAD RVF depends on the RV's ability to adapt to acute hemodynamic changes imposed by the LVAD. Management options are limited due to the lack of an easily implantable, chronic-use RVAD.

RESNA Position on the Application of Seat-Elevating Devices for Wheelchair Users

ERIC Educational Resources Information Center

Arva, Julianna; Schmeler, Mark R.; Lange, Michelle L.; Lipka, Daniel D.; Rosen, Lauren E.

2009-01-01

This document, approved by the Rehabilitation Engineering & Assistive Technology Society of North America (RESNA) Board of Directors in September 2005, shares typical clinical applications and provides evidence from the literature supporting the use of seat-elevating devices for wheelchair users. Wheelchair mobility is often only considered from…

Assessing Patient and Caregiver Intent to Use Mobile Device Videoconferencing for Remote Mechanically-Ventilated Patient Management

ERIC Educational Resources Information Center

Smith, Brian R.

2017-01-01

The Michigan Medicine adult Assisted Ventilation Clinic (AVC) supports patients with neuromuscular disorders and spinal cord injuries and their caregivers at home, helping them avoid expensive emergency department visits, hospitalization, and unnecessary or excessive treatments. Mobile device videoconferencing provides an effective capability for…

Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

PubMed

Starling, Randall C; Naka, Yoshifumi; Boyle, Andrew J; Gonzalez-Stawinski, Gonzalo; John, Ranjit; Jorde, Ulrich; Russell, Stuart D; Conte, John V; Aaronson, Keith D; McGee, Edwin C; Cotts, William G; DeNofrio, David; Pham, Duc Thinh; Farrar, David J; Pagani, Francis D

2011-05-10

The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Outcomes of pediatric patients supported with continuous-flow ventricular assist devices: A report from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS).

PubMed

Rossano, Joseph W; Lorts, Angela; VanderPluym, Christina J; Jeewa, Aamir; Guleserian, Kristine J; Bleiweis, Mark S; Reinhartz, Olaf; Blume, Elizabeth D; Rosenthal, David N; Naftel, David C; Cantor, Ryan S; Kirklin, James K

2016-05-01

Continuous-flow (CF) ventricular assist devices (VADs) have largely replaced pulsatile-flow VADs in adult patients. However, there are few data on CF VADs among pediatric patients. In this study we aimed to describe the overall use, patients' characteristics and outcomes of CF VADs in this population. The Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS) is a national registry for U.S. Food and Drug Adminstration (FDA)-approved VADs in patients <19 years of age. Patients undergoing placement of durable CF VADs between September 2012 and June 2015 were included and outcomes were compared with those of adults from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). CF VADs were implanted in 109 patients at 35 hospitals. The median age at implantation was 15 years (2.8 to 18.9 years) and median weight was 62 kg (range 16 to 141 kg). The underlying disease was cardiomyopathy in 89 (82%) patients. The INTERMACS level at time of implant was Level 1 in 20 (19%), Level 2 in 64 (61%) and Levels 3 to 7 in 21 (20%) patients. Most were implanted as LVADs (n = 102, 94%). Median duration of support was 2.3 months (range <1 day to 28 months). Serious adverse event rates were low, including neurologic dysfunction (early event rate 4.1 per 100 patient-months with 2 late events). Competing outcomes analysis at 6 months post-implant indicated 61% transplanted, 31% alive with device in place and 8% death before transplant. These outcomes compared favorably with the 3,894 adults supported with CF VADs as a bridge to transplant. CF VADs are commonly utilized in older children and adolescents, with excellent survival rates. Further study is needed to understand impact of patient and device characteristics on outcomes in pediatric patients. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Gateway-Assisted Retransmission for Lightweight and Reliable IoT Communications.

PubMed

Chang, Hui-Ling; Wang, Cheng-Gang; Wu, Mong-Ting; Tsai, Meng-Hsun; Lin, Chia-Ying

2016-09-22

Message Queuing Telemetry Transport for Sensor Networks (MQTT-SN) and Constrained Application Protocol (CoAP) are two protocols supporting publish/subscribe models for IoT devices to publish messages to interested subscribers. Retransmission mechanisms are introduced to compensate for the lack of data reliability. If the device does not receive the acknowledgement (ACK) before retransmission timeout (RTO) expires, the device will retransmit data. Setting an appropriate RTO is important because the delay may be large or retransmission may be too frequent when the RTO is inappropriate. We propose a Gateway-assisted CoAP (GaCoAP) to dynamically compute RTO for devices. Simulation models are proposed to investigate the performance of GaCoAP compared with four other methods. The experiment results show that GaCoAP is more suitable for IoT devices.

Gateway-Assisted Retransmission for Lightweight and Reliable IoT Communications

PubMed Central

Chang, Hui-Ling; Wang, Cheng-Gang; Wu, Mong-Ting; Tsai, Meng-Hsun; Lin, Chia-Ying

2016-01-01

Message Queuing Telemetry Transport for Sensor Networks (MQTT-SN) and Constrained Application Protocol (CoAP) are two protocols supporting publish/subscribe models for IoT devices to publish messages to interested subscribers. Retransmission mechanisms are introduced to compensate for the lack of data reliability. If the device does not receive the acknowledgement (ACK) before retransmission timeout (RTO) expires, the device will retransmit data. Setting an appropriate RTO is important because the delay may be large or retransmission may be too frequent when the RTO is inappropriate. We propose a Gateway-assisted CoAP (GaCoAP) to dynamically compute RTO for devices. Simulation models are proposed to investigate the performance of GaCoAP compared with four other methods. The experiment results show that GaCoAP is more suitable for IoT devices. PMID:27669243

Y stenting assisted coiling using a new low profile visible intraluminal support device for wide necked basilar tip aneurysms: a technical report.

PubMed

Conrad, Marcelo D; Brasiliense, Leonardo B C; Richie, Alexa N; Hanel, Ricardo A

2014-05-01

Many endovascular techniques have been described in recent years for the management of wide necked aneurysms. The Y stent assisted technique has been generally used for coil embolization of wide necked bifurcation aneurysms. This technique was first described for the treatment of basilar tip aneurysms in combination with several different devices, demonstrating encouraging results. We report the results of the first two cases of wide necked basilar tip aneurysms treated with Y stent assisted coil embolization using a new low profile visible intraluminal stent (LVIS Jr; MicroVention, Tustin, California, USA) delivered through a 0.017 inch microcatheter. We also reviewed the literature comparing other endovascular techniques (coiling alone, stent assisted coiling, and Y stent assisted coiling) for wide necked aneurysms. The LVIS Jr device offers a new option for the treatment of these challenging lesions, with clear advantages over currently available intracranial stents. Larger series and long term results are needed to confirm the applicability and durability of this technique/technology.

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

PubMed

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

Assistive technology for postsecondary students with learning disabilities.

PubMed

Day, S L; Edwards, B J

1996-09-01

An increasing number of students with learning disabilities are attending postsecondary institutions. To meet the educational demands of these students, support service providers will likely rely on assistive technology. This article lists types of assistive technology appropriate for use with persons with learning disabilities at the postsecondary level and discusses ways in which assistive technology enhances learning. Additionally, an overview of legislation that has had an impact on assistive technology at the postsecondary level is presented. Issues involving assistive technology programs at the postsecondary level are discussed. Postsecondary assistive technology program components, device selection, and training guidelines also are outlined.

In vivo quantification of intraventricular flow during left ventricular assist device support

NASA Astrophysics Data System (ADS)

Vu, Vi; Wong, Kin; Del Alamo, Juan; Aguilo, Pablo M. L.; May-Newman, Karen; Department of Bioengineering, San Diego State University Collaboration; Department of Mechanical; Aerospace Engineering, University of California San Diego Collaboration; Mechanical Assist Device Program, Sharp Memorial Hospital Collaboration

2014-11-01

Left ventricular assist devices (LVADs) are mechanical pumps that are surgically connected to the left ventricle (LV) and aorta to increase aortic flow and end-organ perfusion. Clinical studies have demonstrated that LVADs improve patient health and quality of life and significantly reduce the mortality of cardiac failure. However, In the presence of left ventricular assisted devices (LVAD), abnormal flow patterns and stagnation regions are often linked to thrombosis. The aim of our study is to evaluate the flow patterns in the left ventricle of the LVAD-assisted heart, with a focus on alterations in vortex development and blood stasis. To this aim, we applied color Doppler echocardiography to measure 2D, time resolved velocity fields in patients before and after implantation of LVADs. In agreement with our previous in vitro studies (Wong et al., Journal of Biomechanics 47, 2014), LVAD implantation resulted in decreased flow velocities and increased blood residence time near the outflow tract. The variation of residence time changes with LVAD operational speed was characterized for each patient.

Low cost assistive technology to support educational activities for adolescents with cerebral palsy.

PubMed

da Silva, Alan Patricio; Bulle Oliveira, Acary Souza; Pinheiro Bezerra, Italla Maria; Pedrozo Campos Antunes, Thaiany; Guerrero Daboin, Blanca Elena; Raimundo, Rodrigo Daminello; Dos Santos, Vagner Rogério; de Abreu, Luiz Carlos

2017-08-30

The concept of assistive technology covers several areas of action; one of them is communication with the elaboration of accessible solutions to overcome daily difficulties. It contributes to the resumption of functional abilities, expanding and facilitating inclusion and independent living. To analyze the usability of a low cost prototype device to support educational activities of adolescents with cerebral palsy. A descriptive observational study. The evaluation of a prototype device was made through a validated questionnaire, Quest Version 2.0, on the level of the user's satisfaction with an assistive technology, composed of 12 evaluation items. The questionnaire was filled out by the educator based on the observation of four wheelchair-bound participants diagnosed with cerebral palsy according to the international classification of diseases and health-related problems, ICD-10, who attend a coexistence and teaching institution in the state of São Paulo, Brazil. The device developed was considered an assistive technology, which provided an experience with a positive level of satisfaction for the participants. The tested prototype contributes to communication and interaction allowing adolescents with cerebral palsy to participate in educational activities. Implications for Rehabilitation The device assists the individual in the educational activities and can positively influence their development, observe the individual number 5, who has an important limitation in coordination and fine movements, placing the role of the task in the vertical position offers a new perspective to perform the task, this stimulates him to try to perform the work, so the challenge was adjusted to the demands of each individual which can contribute to its neuromotor development, the amplitude of the distal movements and the manual ability, since it must look for alternatives to complete the task requested.

Resource Utilization in Pediatric Patients Supported With Ventricular Assist Devices in the United States: A Multicenter Study From the Pediatric Interagency Registry for Mechanically Assisted Circulatory Support and the Pediatric Health Information System.

PubMed

Rossano, Joseph W; Cantor, Ryan S; Dai, Dingwei; Shamszad, Pirouz; Huang, Yuan-Shung; Hall, Matthew; Lin, Kimberly Y; Edens, R Erik; Parrino, P Eugene; Kirklin, James K

2018-06-01

Few data exist on resource utilization with pediatric ventricular assist devices (VADs). We tested the hypothesis that device type and adverse events are associated with increased resource utilization in pediatric patients supported with VADs. The Pediatric Interagency Registry for Mechanically Assisted Circulatory Support, a national registry of VADs in patients <19 years old, and the Pediatric Health Information System, an administrative database, were merged. Univariate analysis was performed assessing the association of all factors with the total cost and length of stay first. Significant variables ( P <0.05) were subjected to multivariable analysis. The study included 142 patients from 19 centers with VAD implants from October 2012 to June 2016. The median age was 9 years (interquartile range [IQR] 2-15), 84 (59%) supported with a continuous-flow VAD. Overall median hospital costs were $750 000 (IQR $539 000 to $1 100 000) with a median hospital length of stay of 81 days (IQR 54-128). On multivariable analysis, device type and postoperative complications were not associated with resource utilization. Factors associated with increased costs included patient age, lower-volume VAD center, being intubated, being on extracorporeal membrane oxygenation, number of complex chronic medical conditions, and length of stay. Among continuous-flow VAD patients, discharge to home before transplant versus remaining hospitalized was associated with lower hospital costs (median $600 000 [IQR $400 000 to $820 000] versus median $680 000 [IQR $500 000 to $970 000], P =0.03). VADs in pediatric patients are associated with high resource utilization. Increased resource utilization was associated with lower-volume VAD centers, disease severity at VAD implantation, and the presence of complex chronic medical conditions. Further study is needed to develop cost-effective strategies in this complex population. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Integrating medical, assistive, and universally designed products and technologies: assistive technology device classification (ATDC).

PubMed

Bauer, Stephen; Elsaesser, Linda-Jeanne

2012-09-01

ISO26000:2010 International Guidance Standard on Organizational Social Responsibility requires that effective organizational performance recognize social responsibility, including the rights of persons with disabilities (PWD), engage stakeholders and contribute to sustainable development. Millennium Development Goals 2010 notes that the most vulnerable people require special attention, while the World Report on Disability 2011 identifies improved data collection and removal of barriers to rehabilitation as the means to empower PWD. The Assistive Technology Device Classification (ATDC), Assistive Technology Service Method (ATSM) and Matching Person and Technology models provide an evidence-based, standardized, internationally comparable framework to improve data collection and rehabilitation interventions. The ATDC and ATSM encompass and support universal design (UD) principles, and use the language and concepts of the International Classification of Functioning, Disability and Health (ICF). Use ATDC and ICF concepts to differentiate medical, assistive and UD products and technology; relate technology "types" to markets and costs; and support provision of UD products and technologies as sustainable and socially responsible behavior. Supply-side and demand-side incentives are suggested to foster private sector development and commercialization of UD products and technologies. Health and health-related professionals should be knowledgeable of UD principles and interventions.

Analysis of baroreflex sensitivity during undulation pump ventricular assist device support.

PubMed

Liu, Hongjian; Shiraishi, Yasuyuki; Zhang, Xiumin; Song, Hojin; Saijo, Yoshifumi; Baba, Atsushi; Yambe, Tomoyuki; Abe, Yusuke; Imachi, Kou

2009-07-01

The aim of this study was to examine the baroreflex sensitivity (BRS), which involves the autonomic nervous system, in a goat with a chronically implanted undulation pump ventricular assist device (UPVAD). The UPVAD involved transforming the rotation of a brushless DC motor into an undulating motion by a disc attached via a special linking mechanism, and a jellyfish valve in the outflow cannula to prevent diastolic backflow. The pump was implanted into the thoracic cavity of a goat by a left thoracotomy, and the inflow and outflow cannulae were sutured to the apex of the left ventricle and to the descending aorta, respectively. The driving cable was wired percutaneously to an external controller. Electrocardiogram and hemodynamic waveforms were recorded at a sampling frequency of 1 kHz. BRS was determined when awake by the slope of the linear regression of R-R interval against mean arterial pressure changes, which were induced by the administration of methoxamine hydrochloride, both with continuous driving of the UPVAD as well as without assistance. BRS values during the UPVAD support and without assistance were 1.60 +/- 0.30 msec/mm Hg and 0.98 +/- 0.22 msec/mm Hg (n = 5, P < 0.05), respectively. BRS was significantly improved during left ventricular assistance. Therefore, UPVAD support might decrease sympathetic nerve activity and increase parasympathetic nerve activity to improve both microcirculation and organ function.

Support and maneuvering apparatus for solar energy receivers

DOEpatents

Murphy, L.M.

1988-07-28

A support and maneuvering apparatus is disclosed for a solar energy receiving device adapted for receiving and concentrating solar energy and having a central axis extending through the center thereof. The apparatus includes a frame for mounting the perimeter of said solar energy receiving device. A support member extends along the central axis of the receiving device and has a base end passing through the center of the receiving device and an outer distal end adapted for carrying a solar energy receiving and conversion mechanism. A variable tension mechanism interconnects the support member with the frame to provide stiffening for the support member and the frame and to assist in the alignment of the frame to optimize the optical efficiency of the solar energy receiving device. A rotatable base is provided, and connecting members extend from the base for pivotable attachment to the frame at spaced positions therealong. Finally, an elevation assembly is connected to the receiving device for selectively pivoting the receiving about an axis defined between the attachment positions of the connecting members on the frame. 4 figs.

Left ventricular assist device as destination therapy: application of the payment-by-results approach for the device reimbursement.

PubMed

Messori, Andrea; Trippoli, Sabrina; Bonacchi, Massimo; Sani, Guido

2009-08-01

Value-based methods are increasingly used to reimburse therapeutic innovation, and the payment-by-results approach has been proposed for handling interventions with limited therapeutic evidence. Because most left ventricular assist devices are supported by preliminary efficacy data, we examined the effectiveness data of the HeartMate (Thoratec Corp, Pleasanton, CA) device to explore the application of the payment-by-results approach to these devices and to develop a model for handling reimbursements. According to our model, after establishing the societal economic countervalue for each month of life saved, each patient treated with one such device is associated to the payment of this countervalue for every month of survival lived beyond the final date of estimated life expectancy without left ventricular assist devices. Our base-case analysis, which used the published data of 68 patients who received the HeartMate device, was run with a monthly countervalue of euro 5000, no adjustment for quality of life, and a baseline life expectancy of 150 days without left ventricular assist devices. Sensitivity analysis was aimed at testing the effect of quality of life adjustments and changes in life expectancy without device. In our base-case analysis, the mean total reimbursement per patient was euro 82,426 (range, euro 0 to euro 250,000; N = 68) generated as the sum of monthly payments. This average value was close to the current price of the HeartMate device (euro 75,000). Sensitivity testing showed that the base-case reimbursement of euro 82,426 was little influenced by variations in life expectancy, whereas variations in utility had a more pronounced impact. Our report delineates an innovative procedure for appropriately allocating economic resources in this area of invasive cardiology.

GP-support by means of AGnES-practice assistants and the use of telecare devices in a sparsely populated region in Northern Germany – proof of concept

PubMed Central

Berg, Neeltje van den; Fiß, Thomas; Meinke, Claudia; Heymann, Romy; Scriba, Sibylle; Hoffmann, Wolfgang

2009-01-01

Background In many rural regions in Germany, the proportion of the elderly population increases rapidly. Simultaneously, about one-third of the presently active GPs will retire until 2010. Often it is difficult to find successors for vacant GP-practices. These regions require innovative concepts to avoid the imminent shortage in primary health care. The AGnES-concept comprises the delegation of GP-home visits to qualified AGnES-practice assistants (AGnES: GP-supporting, community-based, e-health-assisted, systemic intervention). Main objectives were the assessment of the acceptance of the AGnES-concept by the participating GPs, patients, and AGnES-practice assistants, the kind of delegated tasks, and the feasibility of home telecare in a GP-practice. Methods In this paper, we report first results of the implementation of this concept in regular GP-practices, conducted November 2005 – March 2007 on the Island of Rügen, Mecklenburg-Western Pomerania, Germany. This study was meant as a proof of concept. The GP delegated routine home-visits to qualified practice employees (here: registered nurses). Eligible patients were provided with telecare-devices to monitor disease-related physiological values. All delegated tasks, modules conducted and questionnaire responses were documented. The participating patients were asked for their acceptance based on standardized questionnaires. The GPs and AGnES-practice assistants were asked for their judgement about different project components, the quality of health care provision and the competences of the AGnES-practice assistants. Results 550 home visits were conducted. 105 patients, two GPs and three AGnES-practice assistants (all registered nurses) participated in the project. 48 patients used telecare-devices to monitor health parameters. 87.4% of the patients accepted AGnES-care as comparable to common GP-care. In the course of the project, the GPs delegated an increasing number of both monitoring and interventional tasks to the AGnES-practice assistants. The GPs agreed that delegating tasks to a qualified practice assistant relieves them in their daily work. Conclusion A part of the GPs home visits can be delegated to AGnES-practice assistants to support GPs in regions with an imminent or already existing undersupply in primary care. The project triggered discussions among the institutions involved in the German healthcare system and supported a reconciliation of the respective competences of physicians and other medical professions. PMID:19545376

Left Thoracotomy HeartWare Implantation With Outflow Graft Anastomosis to the Descending Aorta: A Simplified Bridge for Patients With Multiple Previous Sternotomies

PubMed Central

Umakanthan, Ramanan; Haglund, Nicholas A.; Stulak, John M.; Joyce, Lyle D.; Ahmad, Rashid; Keebler, Mary E.; Maltais, Simon

2014-01-01

Advances in mechanical circulatory support have been critical in bridging patients awaiting heart transplantation. In addition, improvement in device durability has enabled left ventricular assist device therapy to be applied as destination therapy in those not felt to be transplant candidate. Because of the increasing complexity of patients, there continues to be a need for alternative strategies for device implantation to bridge high-risk patients awaiting heart transplantation, wherein the risks of numerous previous sternotomies may be prohibitive. We present a unique technique for placement of the HeartWare ventricular assist device via left anterior thoracotomy to the descending aorta in a patient awaiting heart transplantation with a history of multiple previous sternotomies. PMID:24172273

Prognostic Value of Serum Lactate Levels in Patients Undergoing Urgent Heart Transplant: A Subanalysis of the ASIS-TC Spanish Multicenter Study.

PubMed

Couto-Mallón, David; González-Vílchez, Francisco; Almenar-Bonet, Luis; Díaz-Molina, Beatriz; Segovia-Cubero, Javier; González-Costello, José; Delgado-Jiménez, Juan; Castel-Lavilla, María A; Crespo-Leiro, María G; Rangel-Sousa, Diego; Martínez-Sellés, Manuel; Rábago-Juan-Aracil, Gregorio; De-la-Fuente-Galán, Luis; Blasco-Peiró, Teresa; Hervás-Sotomayor, Daniela; Garrido-Bravo, Iris P; Mirabet-Pérez, Sonia; Muñiz, Javier; Barge-Caballero, Eduardo

2018-05-30

To study the prognostic value of serum lactate in patients under temporary preoperative mechanical circulatory support who underwent urgent heart transplant. We conducted a subanalysis of a Spanish multicenter registry recording data on patients under temporary mechanical circulatory support listed for highly urgent heart transplant from 2010 to 2015. Participants selected for the present study were those who received a transplant and who had known preoperative serum lactate levels. The main study outcome was 1-year survival after transplant. A total of 177 heart transplant recipients were studied; preoperatively, 90 were supported on venoarterial extracorporeal membrane oxygenation, 51 on temporary left ventricular assist devices, and 36 on temporary biventricular assist devices. Preoperative hyperlactatemia (≥ 2 mmol/L) was present in 44 (25%) patients. On multivariable analysis, pretransplant serum lactate was identified as an independent predictor of 1-year posttransplant survival (adjusted HR per 0.1 mmol/L, 1.02; 95%CI, 1.01-1.03; P = .007). One-year posttransplant survival was 53.1% (95%CI, 45.3-60.9) in patients with preoperative hyperlactatemia and 75.6% (95%CI, 71.8-79.4) in those without preoperative hyperlactatemia (adjusted HR, 1.94; 95%CI, 1.04-3.63; P = .039). Preoperative hyperlactatemia correlated with adverse outcomes in patients supported with extracorporeal membrane oxygenation, but not in patients supported on ventricular assist devices. Preoperative serum lactate is a strong independent predictor of worse outcomes in patients undergoing urgent heart transplant on short-term mechanical circulatory support. Copyright © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Elevated Body Mass Index Is Not a Risk Factor for Adverse Outcomes Following Ventricular Assist Device Implantation.

PubMed

Hullmann, Jonathan E; Mather, Paul J

2018-06-01

Despite ventricular assist devices (VADs) becoming more common in heart failure (HF) treatment, it is still uncertain which patients are more prone to complications. One potential risk factor is increased body mass index (BMI), which is known to increase both all-cause mortality and mortality from ischemic heart disease; however, the role of the BMI in predicting morbidity and mortality following device implantation is unclear. The study population for this single-institution retrospective chart review consisted of 136 patients with HF, who underwent VAD implantation between 2004 and 2015. Patients were divided into 2 groups based on their BMI: a nonobese group (18.5 < BMI < 30.0; n = 82) or an obese group (BMI >30.0; n = 54). These groups were compared at baseline and after implantation for survival, hospital readmission, and adverse events. No significant difference was found in initial hospital length of stay, number or length of readmissions, or readmission diagnosis. At 1 year, rates of ongoing device support, orthotopic heart transplant (OHT), and death were not significantly different between groups ( P = .89, P = .90, and P = .70, respectively). Multivariate analysis did not identify obesity as an independent predictor of mortality ( P = .90); only biventricular assist device implantation was associated with decreased survival (hazard ratio [HR] = 5.90, P = .002). Obesity in itself should not preclude the use of VAD support in patients with HF, as carefully selected obese patients were shown to have similar rates of hospital readmission, 1-year outcomes, and survival following device implantation compared to nonobese patients.

Person factors and work environments of workers who use mobility devices.

PubMed

Gray, David B; Morgan, Kerri A; Gottlieb, Meghan; Hollingsworth, Holly H

2014-01-01

Nearly 25% of people with mobility impairments and limitations who are of working age are employed, yet few studies have examined their perspectives on their jobs or work environments required to complete job tasks. The purpose of this study was to describe the factors that contribute to successful employment for those who use mobility devices. A convenience sample of 132 workers who use power wheelchairs, manual wheelchairs, canes, crutches or walkers. Participants completed an online version of the Mobility Device User Work Survey (MWS). A multivariate analysis and a two-step multiple linear regression analysis were used. Study participants had few secondary health conditions that influenced their work. Employee satisfactoriness to their employers was high. Accessibility of worksites was high. Assistive technologies were inexpensive, and personal assistance was used infrequently and usually was unpaid. Co-worker communications were very positive. Flexible work rules and supportive managers were highly valued. Job satisfaction positively correlated with accessibility, work tasks, co-worker communication and work support. The description of work environments of successfully employed mobility device users can provide some useful guidance to employers, vocational rehabilitation (VR) counselors and unemployed mobility device users to balance employee abilities and preferences with the needs of employers.

Octreotide for left ventricular assist device-related gastrointestinal hemorrhage: can we stop the bleeding?

PubMed

Rennyson, Stephen L; Shah, Keyur B; Tang, Daniel G; Kasirajan, Vigneshwar; Pedram, Sammy; Cahoon, William; Malhotra, Rajiv

2013-01-01

Left ventricular support devices (LVADs) are associated with a propensity toward gastrointestinal bleeding. A postulated mechanism is related to gastrointestinal arteriovenous malformations secondary to nonpulsatile flow. We describe a case of LVAD-related, gastrointestinal bleeding successfully treated with a combination of subcutaneous and intramuscular depot formulations of octreotide.

Presentation on assistive technologies for the seating and mobility needs of persons with osteogenesis imperfecta.

PubMed

Axelson, P; Zollars, J A

1995-01-01

Persons with Osteogenesis Imperfecta (OI) are often protected and sheltered because of the fragile nature of their bones. Regardless of the degree of OI. over protecting a person with OI can be just as devastating as fractured bones. It is important that persons with OI are given the opportunity to participate in a wide variety of activities to develop the experiential, physical, and sociological dimensions of their lives. Assistive technology can help to make this participation a reality. Assistive technology should help protect the person from fractures, provide support to assist with postural alignment, and stability so that function and comfort can be enhanced. Technologies such as contoured foam mattresses, seating supports, temperature regulation technologies, orthotic supports, walking and wheelchair mobility devices can enhance the quality of live of people with OI.

Incidence and predictors of myocardial recovery on long-term left ventricular assist device support: Results from the United Network for Organ Sharing database.

PubMed

Pan, Stephen; Aksut, Baran; Wever-Pinzon, Omar E; Rao, Shaline D; Levin, Allison P; Garan, Arthur R; Fried, Justin A; Takeda, Koji; Hiroo, Takayama; Yuzefpolskaya, Melana; Uriel, Nir; Jorde, Ulrich P; Mancini, Donna M; Naka, Yoshifumi; Colombo, Paolo C; Topkara, Veli K

2015-12-01

Mechanical circulatory support (MCS) leads to favorable changes in the failing heart at the molecular, cellular, and structural levels. However, myocardial recovery leading to device explantation is rare. We reasoned that the multicenter United Network for Organ Sharing (UNOS) registry might provide insights into clinical predictors and outcomes of the recovery process. The MCS device data set of the UNOS registry was queried for patients with long-term continuous-flow left ventricular assist devices (CF-LVADs) that were explanted for heart transplantation or indication of recovery. Analysis was restricted to adult patients (≥18 years old) who were listed for an initial heart transplantation. Patients with CF-LVADs that were explanted because of recovery were compared with patients with CF-LVADs who underwent transplantation. We identified 594 patients with HeartMate II devices and 92 patients with HeartWare devices. Duration of support was on average 500.4 ± 325.3 days. In 34 (5.0%) patients, devices were explanted secondary to myocardial recovery. Univariate predictors of recovery in patients with long-term LVADs included younger age (40 years vs 53 years), female sex, lower body mass index (25.7 kg/m(2) vs 27.9 kg/m(2)), non-ischemic etiology (91% vs 59%), lack of implantable cardioverter defibrillator at the time of listing (44% vs 79%), and lower serum creatinine (0.97 mg/dl vs 1.28 mg/dl) (all p < 0.05). In the post-explantation period, freedom from death or transplantation was 66% at 1 year. The incidence of recovery on device support is low in the current MCS era and limited to a select cohort of predominantly young patients with non-ischemic myopathy. Given the high incidence of disease recurrence, patients should be closely followed after device explantation. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Early Feasibility Testing and Engineering Development of the Transapical Approach for the HeartWare MVAD Ventricular Assist System

PubMed Central

Tamez, Daniel; LaRose, Jeffrey A.; Shambaugh, Charles; Chorpenning, Katherine; Soucy, Kevin G; Sobieski, Michael A; Sherwood, Leslie; Giridharan, Guruprasad A; Monreal, Gretel; Koenig, Steven C; Slaughter, Mark S

2014-01-01

Implantation of ventricular assist devices (VADs) for treatment of end-stage heart failure (HF) falls decidedly short of clinical demand, which exceeds 100,000 HF patients per year. VAD implantation often requires major surgical intervention with associated risk of adverse events and long recovery periods. To address these limitations, HeartWare, Inc. (Miami Lakes, FL) has developed a platform of miniature ventricular devices with progressively reduced surgical invasiveness and innovative patient peripherals. One surgical implant concept is a transapical version of the miniaturized left ventricular assist device (MVAD). The HeartWare MVAD Pump® is a small, continuous flow, full-support device that has a displacement volume of 22mL. A new cannula configuration has been developed for transapical implantation, where the outflow cannula is positioned across the aortic valve. The two primary objectives for this feasibility study were to evaluate anatomic fit and surgical approach and efficacy of the transapical MVAD configuration. Anatomic fit and surgical approach were demonstrated using human cadavers (n=4). Efficacy was demonstrated in acute (n =2) and chronic (n = 1) bovine model experiments and assessed by improvements in hemodynamics, biocompatibility, flow dynamics, and histopathology. Potential advantages of the MVAD Pump include flow support in the same direction as the native ventricle, elimination of cardiopulmonary bypass, and minimally-invasive implantation. PMID:24399057

Left ventricular diastolic filling with an implantable ventricular assist device: beat to beat variability with overall improvement

NASA Technical Reports Server (NTRS)

Nakatani, S.; Thomas, J. D.; Vandervoort, P. M.; Zhou, J.; Greenberg, N. L.; Savage, R. M.; McCarthy, P. M.

1997-01-01

OBJECTIVES: We studied the effects of left ventricular (LV) unloading by an implantable ventricular assist device on LV diastolic filling. BACKGROUND: Although many investigators have reported reliable systemic and peripheral circulatory support with implantable LV assist devices, little is known about their effect on cardiac performance. METHODS: Peak velocities of early diastolic filling, late diastolic filling, late to early filling ratio, deceleration time of early filling, diastolic filling period and atrial filling fraction were measured by intraoperative transesophageal Doppler echocardiography before and after insertion of an LV assist device in eight patients. A numerical model was developed to simulate this situation. RESULTS: Before device insertion, all patients showed either a restrictive or a monophasic transmitral flow pattern. After device insertion, transmitral flow showed rapid beat to beat variation in each patient, from abnormal relaxation to restrictive patterns. However, when the average values obtained from 10 consecutive beats were considered, overall filling was significantly normalized from baseline, with early filling velocity falling from 87 +/- 31 to 64 +/- 26 cm/s (p < 0.01) and late filling velocity rising from 8 +/- 11 to 32 +/- 23 cm/s (p < 0.05), resulting in an increase in the late to early filling ratio from 0.13 +/- 0.18 to 0.59 +/- 0.38 (p < 0.01) and a rise in the atrial filling fraction from 8 +/- 10% to 26 +/- 17% (p < 0.01). The deceleration time (from 112 +/- 40 to 160 +/- 44 ms, p < 0.05) and the filling period corrected by the RR interval (from 39 +/- 8% to 54 +/- 10%, p < 0.005) were also significantly prolonged. In the computer model, asynchronous LV assistance produced significant beat to beat variation in filling indexes, but overall a normalization of deceleration time as well as other variables. CONCLUSIONS: With LV assistance, transmitral flow showed rapidly varying patterns beat by beat in each patient, but overall diastolic filling tended to normalize with an increase of atrial contribution to the filling. Because of the variable nature of the transmitral flow pattern with the assist device, the timing of the device cycle must be considered when inferring diastolic function from transmitral flow pattern.

The application of computer assisted technologies (CAT) in the rehabilitation of cognitive functions in psychiatric disorders of childhood and adolescence.

PubMed

Srebnicki, Tomasz; Bryńska, Anita

2016-01-01

First applications of computer-assisted technologies (CAT) in the rehabilitation of cognitive deficits, including child and adolescent psychiatric disorders date back to the 80's last century. Recent developments in computer technologies, wide access to the Internet and vast expansion of electronic devices resulted in dynamic increase in therapeutic software as well as supporting devices. The aim of computer assisted technologies is the improvement in the comfort and quality of life as well as the rehabilitation of impaired functions. The goal of the article is the presentation of most common computer-assisted technologies used in the therapy of children and adolescents with cognitive deficits as well as the literature review of their effectiveness including the challenges and limitations in regard to the implementation of such interventions.

Don't Mess with the NEST

DOE Office of Scientific and Technical Information (OSTI.GOV)

Larson, M

NEST stands for Nuclear Emergency Support Team. The NEST Mission Statement as first established: (1) Conduct, direct, coordinate search and recovery operations for nuclear material, weapons or devices; and (2) Assist in identification and deactivation of Improvised Nuclear Devices (INDs) and Radiological Dispersal Devices (RDDs). Then in 1980 a very sophisticated improvised explosive device was found at Harvey's Casino at Lake Tahoe, Nevada. The FBI and Bomb Squads were unprepared and it detonated. As a result the additional phrase 'and Sophisticated Improvised Explosive Devices (SIEDs)' was added to the Mission Statement.

Short-term mechanical circulatory support as a bridge to durable left ventricular assist device implantation in refractory cardiogenic shock: a systematic review and meta-analysis.

PubMed

den Uil, Corstiaan A; Akin, Sakir; Jewbali, Lucia S; Dos Reis Miranda, Dinis; Brugts, Jasper J; Constantinescu, Alina A; Kappetein, Arie Pieter; Caliskan, Kadir

2017-07-01

Short-term mechanical circulatory support (MCS) is increasingly used as a bridge to decision in patients with refractory cardiogenic shock. Subsequently, these patients might be bridged to durable MCS either as a bridge to candidacy/transplantation, or as destination therapy. The aim of this study was to review support duration and clinical outcome of short-term MCS in cardiogenic shock, and to analyse application of this technology as a bridge to long-term cardiac support (left ventricular assist device, LVAD) from 2006 till June 2016. Using Cochrane Register of Trials, Embase and Medline, a systematic review was performed on patients with cardiogenic shock from acute myocardial infarction, end-stage cardiomyopathy, or acute myocarditis, receiving short-term MCS. Studies on periprocedural, post-cardiotomy and cardiopulmonary resuscitation support were excluded. Thirty-nine studies, mainly registries of heterogeneous patient populations (n = 4151 patients), were identified. Depending on the device used (intra-aortic balloon pump, TandemHeart, Impella 2.5, Impella 5.0, CentriMag and peripheral veno-arterial extracorporeal membrane oxygenation), mean support duration was (range) 1.6-25 days and the mean proportion of short-term MCS patients discharged was (range) 45-66%. The mean proportion of bridge to durable LVAD was (range) 3-30%. Bridge to durable LVAD was most frequently performed in patients with end-stage cardiomyopathy (22 [12-35]%). We conclude that temporary MCS can be used to bridge patients with cardiogenic shock towards durable LVAD. Clinicians are encouraged to share their results in a large multicentre registry in order to investigate optimal device selection and best duration of support. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Results of the post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE).

PubMed

Strueber, Martin; Larbalestier, Robert; Jansz, Paul; Zimpfer, Daniel; Fiane, Arnt E; Tsui, Steven; Simon, André; Schmitto, Jan D; Khaghani, Asghar; Wieselthaler, George M; Najarian, Kevin; Schueler, Stephan

2014-05-01

The post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated registry established to collect post-CE Mark Trial clinical data on patients receiving a HeartWare ventricular assist device (HVAD) in the European Union and Australia. The ReVOLVE is a multi-center, prospective, single-arm registry performed at seven centers in Europe and two in Australia. Herein we describe a total of 254 commercial HVAD implants according to labeled indications between February 2009 and November 2012. Summary statistics included patients' demographics, adverse events, length of support and outcomes. Compared with the clinical trial supporting the CE Mark of the HeartWare system, patient selection differed in that patients were older, and there were higher proportions of females and patients with idiopathic cardiomyopathies in the ReVOLVE cohort. Duration of support ranged from 1 to 1,057 days, with a mean of 363 ± 280 days (median 299.5 days). Transplantation was done in 56 patients (22%), explant for recovery was performed in 3 patients (1%), 43 died while on support (17%), and 152 (60%) remain on the device. Success in patients with the HeartWare system was 87% at 6 months, 85% at 1 year, 79% at 2 years and 73% at 3 years. Adverse event rates were low, comparable or improved when compared to the CE Mark Trial. Real-world use of the HeartWare system continues to demonstrate excellent clinical outcomes in patients supported with the device. Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Modeling and control of a brushless DC axial flow ventricular assist device.

PubMed

Giridharan, Guruprasad A; Skliar, Mikhail; Olsen, Donald B; Pantalos, George M

2002-01-01

This article presents an integrated model of the human circulatory system that incorporates circulatory support by a brushless DC axial flow ventricular assist device (VAD), and a feedback VAD controller designed to maintain physiologically sufficient perfusion. The developed integrated model combines a network type model of the circulatory system with a nonlinear dynamic model of the brushless DC pump We show that maintaining a reference differential pressure between the left ventricle and aorta leads to adequate perfusion for different pathologic cases, ranging from normal heart to left heart asystole, and widely varying physical activity scenarios from rest to exercise.

Patient adaptive control of end-effector based gait rehabilitation devices using a haptic control framework.

PubMed

Hussein, Sami; Kruger, Jörg

2011-01-01

Robot assisted training has proven beneficial as an extension of conventional therapy to improve rehabilitation outcome. Further facilitation of this positive impact is expected from the application of cooperative control algorithms to increase the patient's contribution to the training effort according to his level of ability. This paper presents an approach for cooperative training for end-effector based gait rehabilitation devices. Thereby it provides the basis to firstly establish sophisticated cooperative control methods in this class of devices. It uses a haptic control framework to synthesize and render complex, task specific training environments, which are composed of polygonal primitives. Training assistance is integrated as part of the environment into the haptic control framework. A compliant window is moved along a nominal training trajectory compliantly guiding and supporting the foot motion. The level of assistance is adjusted via the stiffness of the moving window. Further an iterative learning algorithm is used to automatically adjust this assistance level. Stable haptic rendering of the dynamic training environments and adaptive movement assistance have been evaluated in two example training scenarios: treadmill walking and stair climbing. Data from preliminary trials with one healthy subject is provided in this paper. © 2011 IEEE

Social Support Moderates the Relationship Between Perceived Stress and Quality of Life in Patients With a Left Ventricular Assist Device.

PubMed

Abshire, Martha; Russell, Stuart D; Davidson, Patricia M; Budhathoki, Chakra; Han, Hae-Ra; Grady, Kathleen L; Desai, Shashank; Dennison Himmelfarb, Cheryl

2018-04-20

Living with a left ventricular assist device has significant psychosocial sequelae that affect health-related quality of life (HRQOL). The purpose of this study was to (1) describe psychosocial indicators of stress including perceived stress, depression, fatigue, and coping; (2) examine relationships among stress indicators by level of perceived stress; (3) examine relationships among indicators of stress and clinical outcomes; and (4) test the moderation of social support on the relationship between stress and clinical outcomes. Participants were recruited from 2 outpatient clinics in a cross-sectional study design. Standardized measures were self-administered via survey. Descriptive statistics, correlation, and multiple linear regression analysis were conducted. The sample (N = 62) was mostly male (78%), black (47%), and married (66%), with a mean age of 56.5 ± 13 years. The overall sample had a moderate stress profile: moderate perceived stress (mean, 11.7 ± 7), few depressive symptoms (mean, 3.2 ± 3.9), and moderate fatigue (mean, 14.3 ± 9.1). Increased perceived stress was associated with fatigue, depressive symptoms, and maladaptive coping (P < .001). Regression analysis demonstrated that perceived stress and fatigue were significant correlates of overall HRQOL (adj. R = 0.41, P < .0001). Social support moderated the relationship between perceived stress and HRQOL, controlling for fatigue (R = 0.49, P < .001). Individuals living with left ventricular assist device with high perceived stress have worse depressive symptoms, fatigue, and coping. The influence of high social support to improve the relationship between stress and HRQOL underscores the importance of a comprehensive plan to address psychosocial factors.

Perioperative management of left ventricular assist devices.

PubMed

Sanjay, O P

2016-10-01

The use of mechanical circulatory support for patients with severe heart failure is on the rist. The poeoperative, intraoperative and postoperative challenges the anaesthesiologists skills. These are discussed in this review.

Performance of the High Sensitivity Open Source Multi-GNSS Assisted GNSS Reference Server.

NASA Astrophysics Data System (ADS)

Sarwar, Ali; Rizos, Chris; Glennon, Eamonn

2015-06-01

The Open Source GNSS Reference Server (OSGRS) exploits the GNSS Reference Interface Protocol (GRIP) to provide assistance data to GPS receivers. Assistance can be in terms of signal acquisition and in the processing of the measurement data. The data transfer protocol is based on Extensible Mark-up Language (XML) schema. The first version of the OSGRS required a direct hardware connection to a GPS device to acquire the data necessary to generate the appropriate assistance. Scenarios of interest for the OSGRS users are weak signal strength indoors, obstructed outdoors or heavy multipath environments. This paper describes an improved version of OSGRS that provides alternative assistance support from a number of Global Navigation Satellite Systems (GNSS). The underlying protocol to transfer GNSS assistance data from global casters is the Networked Transport of RTCM (Radio Technical Commission for Maritime Services) over Internet Protocol (NTRIP), and/or the RINEX (Receiver Independent Exchange) format. This expands the assistance and support model of the OSGRS to globally available GNSS data servers connected via internet casters. A variety of formats and versions of RINEX and RTCM streams become available, which strengthens the assistance provisioning capability of the OSGRS platform. The prime motivation for this work was to enhance the system architecture of the OSGRS to take advantage of globally available GNSS data sources. Open source software architectures and assistance models provide acquisition and data processing assistance for GNSS receivers operating in weak signal environments. This paper describes test scenarios to benchmark the OSGRSv2 performance against other Assisted-GNSS solutions. Benchmarking devices include the SPOT satellite messenger, MS-Based & MS-Assisted GNSS, HSGNSS (SiRFstar-III) and Wireless Sensor Networks Assisted-GNSS. Benchmarked parameters include the number of tracked satellites, the Time to Fix First (TTFF), navigation availability and accuracy. Three different configurations of Multi-GNSS assistance servers were used, namely Cloud-Client-Server, the Demilitarized Zone (DMZ) Client-Server and PC-Client-Server; with respect to the connectivity location of client and server. The impact on the performance based on server and/or client initiation, hardware capability, network latency, processing delay and computation times with their storage, scalability, processing and load sharing capabilities, were analysed. The performance of the OSGRS is compared against commercial GNSS, Assisted-GNSS and WSN-enabled GNSS devices. The OSGRS system demonstrated lower TTFF and higher availability.

The Impact of Exemplary Technology-Support Programs on Students with Disabilities.

ERIC Educational Resources Information Center

National Council on Disability, Washington, DC.

This report examines effects of technology-supported programs on students with disabilities at the postsecondary level, including issues of access to technology and alternatives for acquiring assistive technology devices and services. After an introduction, the first chapter presents the report's recommendations, which deal with full technological…

A computer model of the pediatric circulatory system for testing pediatric assist devices.

PubMed

Giridharan, Guruprasad A; Koenig, Steven C; Mitchell, Michael; Gartner, Mark; Pantalos, George M

2007-01-01

Lumped parameter computer models of the pediatric circulatory systems for 1- and 4-year-olds were developed to predict hemodynamic responses to mechanical circulatory support devices. Model parameters, including resistance, compliance and volume, were adjusted to match hemodynamic pressure and flow waveforms, pressure-volume loops, percent systole, and heart rate of pediatric patients (n = 6) with normal ventricles. Left ventricular failure was modeled by adjusting the time-varying compliance curve of the left heart to produce aortic pressures and cardiac outputs consistent with those observed clinically. Models of pediatric continuous flow (CF) and pulsatile flow (PF) ventricular assist devices (VAD) and intraaortic balloon pump (IABP) were developed and integrated into the heart failure pediatric circulatory system models. Computer simulations were conducted to predict acute hemodynamic responses to PF and CF VAD operating at 50%, 75% and 100% support and 2.5 and 5 ml IABP operating at 1:1 and 1:2 support modes. The computer model of the pediatric circulation matched the human pediatric hemodynamic waveform morphology to within 90% and cardiac function parameters with 95% accuracy. The computer model predicted PF VAD and IABP restore aortic pressure pulsatility and variation in end-systolic and end-diastolic volume, but diminish with increasing CF VAD support.

Experience With a Long-term Pulsatile Ventricular Assist Device as a Bridge to Heart Transplant in Adults.

PubMed

Gómez Bueno, Manuel; Segovia Cubero, Javier; Serrano Fiz, Santiago; Ugarte Basterrechea, Juan; Hernández Pérez, Francisco José; Goirigolzarri Artaza, Josebe; Castedo Mejuto, Evaristo; Burgos Lázaro, Raúl; García Montero, Carlos; Moñivas Palomero, Vanessa; Mingo Santos, Susana; González Román, Ana Isabel; Álvarez Avelló, José Manuel; Vidal Fernández, Mercedes; Forteza Gil, Alberto; Alonso-Pulpón, Luis

2017-09-01

Most long-term ventricular assist devices (VADs) that are currently implanted are intracorporeal continuous-flow devices. Their main limitations include their high cost and inability to provide biventricular support. The aim of this study was to describe the results of using paracorporeal pulsatile-flow VADs as a bridge to transplant (BTT) in adult patients. Retrospective analysis of the characteristics, complications, and outcomes of a single-center case series of consecutive patients treated with the EXCOR VAD as BTT between 2009 and 2015. During the study period, 25 VADs were implanted, 6 of them biventricular. Ventricular assist devices were indicated directly as a BTT in 12 patients and as a bridge to decision in 13 due to the presence of potentially reversible contraindications or chance of heart function recovery. Twenty patients (80%) were successfully bridged to heart transplant after a median of 112 days (range, 8-239). The main complications included infectious (52% of patients), neurological events (32%, half of them fatal), bleeding (28%), and VAD malfunction requiring component replacement (28%). Eighty percent of patients with the EXCOR VAD as BTT achieved the goal after an average of almost 4 months of support. The most frequent complications were infectious, and the most severe were neurological. In our enivonment, the use of these pulsatile-flow VAD as BTT is a feasible strategy that obtains similar outcomes to those of intracorporeal continuous-flow devices. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Situation-Dependent Medical Device Risk Estimation: Design and Evaluation of an Equipment Management Center For Vendor-Independent Integrated Operating Rooms.

PubMed

Maktabi, Marianne; Neumuth, Thomas

2017-12-22

The complexity of surgical interventions and the number of technologies involved are constantly rising. Hospital staff has to learn how to handle new medical devices efficiently. However, if medical device-related incidents occur, the patient treatment is delayed. Patient safety could therefore be supported by an optimized assistance system that helps improve the management of technical equipment by nonmedical hospital staff. We developed a system for the optimal monitoring of networked medical device activity and maintenance requirements, which works in conjunction with a vendor-independent integrated operating room and an accurate surgical intervention Time And Resource Management System. An integrated situation-dependent risk assessment system gives the medical engineers optimal awareness of the medical devices in the operating room. A qualitative and quantitative survey among ten medical engineers from three different hospitals was performed to evaluate the approach. A series of 25 questions was used to evaluate various aspects of our system as well as the system currently used. Moreover, the respondents were asked to perform five tasks related to system supervision and incident handling. Our system received a very positive feedback. The evaluation studies showed that the integration of information, the structured presentation of information, and the assistance modules provide valuable support to medical engineers. An automated operating room monitoring system with an integrated risk assessment and Time And Resource Management System module is a new way to assist the staff being outside of a vendor-independent integrated operating room, who are nevertheless involved in processes in the operating room.

A novel method for percutaneous insertion of a right ventricular assist device.

PubMed

Avgerinos, Dimitrios V; DeBois, William; Mongero, Linda; Krieger, Karl; Salemi, Arash

2013-06-01

Right heart failure is a rare but often fatal complication both in the pre- and postoperative setting. Right heart support with a ventricular assist device inserted in the operating room through median sternotomy can be a time-consuming procedure that requires a reoperation for removal. In cases of urgent need of right heart support, a percutaneous technique option may be of benefit. We present our initial experience with a percutaneously inserted right ventricular assist device (RVAD) in an elderly patient with severe right heart failure. An 81-year-old female patient underwent combined aortic and mitral valve replacement at our institution. During the first postoperative evening, the patient sustained sudden cardiovascular collapse and a bedside transesophageal echocardiogram revealed severe right heart failure. A coronary angiogram showed thrombosis of the right coronary artery, which was cleared with a suction device. As a result of the patient's critical condition, it was decided that an RVAD was needed as a bridge to recovery. The patient's condition improved significantly almost immediately. Her right heart function recovered over the next few days and the RVAD was removed at the bedside. She made a complete recovery and was discharged home. This patient is a prime example that a totally RVAD can be inserted in urgent situations easily and safely under fluoroscopic and echocardiographic guidance. More clinical experience with percutaneous RVADs is required to establish this technique as an alternative equivalent to the traditional open method. Right heart failure complicates many heart diseases both in the pre- and the postoperative setting. In cases of urgent need of right heart support, a percutaneous technique of a RVAD is needed for a successful outcome. We present our initial experience with a percutaneously inserted RVAD in an elderly patient with severe postoperative right heart failure.

Perioperative management of left ventricular assist devices

PubMed Central

Sanjay, O. P.

2016-01-01

The use of mechanical circulatory support for patients with severe heart failure is on the rist. The poeoperative, intraoperative and postoperative challenges the anaesthesiologists skills. These are discussed in this review. PMID:27762244

Enhancement of Arterial Pressure Pulsatility by Controlling Continuous-Flow Left Ventricular Assist Device Flow Rate in Mock Circulatory System.

PubMed

Bozkurt, Selim; van de Vosse, Frans N; Rutten, Marcel C M

Continuous-flow left ventricular assist devices (CF-LVADs) generally operate at a constant speed, which reduces pulsatility in the arteries and may lead to complications such as functional changes in the vascular system, gastrointestinal bleeding, or both. The purpose of this study is to increase the arterial pulse pressure and pulsatility by controlling the CF-LVAD flow rate. A MicroMed DeBakey pump was used as the CF-LVAD. A model simulating the flow rate through the aortic valve was used as a reference model to drive the pump. A mock circulation containing two synchronized servomotor-operated piston pumps acting as left and right ventricles was used as a circulatory system. Proportional-integral control was used as the control method. First, the CF-LVAD was operated at a constant speed. With pulsatile-speed CF-LVAD assistance, the pump was driven such that the same mean pump output was generated. Continuous and pulsatile-speed CF-LVAD assistance provided the same mean arterial pressure and flow rate, while the index of pulsatility increased significantly for both arterial pressure and pump flow rate signals under pulsatile speed pump support. This study shows the possibility of improving the pulsatility of CF-LVAD support by regulating pump speed over a cardiac cycle without reducing the overall level of support.

Support with intra-aortic balloon pump vs. Impella2.5® and blood flow to the heart, brain and kidneys - an experimental porcine model of ischaemic heart failure.

PubMed

Møller-Helgestad, Ole K; Poulsen, Christian B; Christiansen, Evald H; Lassen, Jens F; Ravn, Hanne B

2015-01-15

Cardiogenic shock as a complication to an acute myocardial infarction has an unacceptably high death rate that has not changed for the last 15years. Mortality is partly related to organ hypoperfusion and mechanical assist devices are used for the most severe cases but we do not know which assist device is the best option. Therefore, we have investigated how an IABP and an Impella®-pump influenced blood flow to the brain, heart and kidneys, in a closed-chest porcine model of severe left ventricular failure. 13 pigs were anesthetised and left ventricular failure was induced by occluding the proximal LAD for 45min followed by 30min of reperfusion. Blood flow was measured in the carotid artery, the LAD, and the renal artery. The Impella® and IABP were inserted via the femoral arteries, and the two devices were tested individually and combined after induction of heart failure. Carotid- (p=0.01) and renal blood flow (p=0.045) were higher on Impella®-support, compared to no support. None of the devices altered the blood flow in the LAD. Cardiac power output (p<0.005) and left ventricular work (p<0.00) were also higher on Impella®-support compared to no support. Haemodynamics and blood flow to the brain and kidneys were significantly better on Impella®-support, suggesting that the Impella® is superior to the IABP in a state of ischaemia induced left ventricular failure. These data, however, needs to be confirmed in a proper clinical trial with patients in cardiogenic shock. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Assessment of hydraulic performance and biocompatibility of a MagLev centrifugal pump system designed for pediatric cardiac or cardiopulmonary support.

PubMed

Dasse, Kurt A; Gellman, Barry; Kameneva, Marina V; Woolley, Joshua R; Johnson, Carl A; Gempp, Thomas; Marks, John D; Kent, Stella; Koert, Andrew; Richardson, J Scott; Franklin, Steve; Snyder, Trevor A; Wearden, Peter; Wagner, William R; Gilbert, Richard J; Borovetz, Harvey S

2007-01-01

The treatment of children with life-threatening cardiac and cardiopulmonary failure is a large and underappreciated public health concern. We have previously shown that the CentriMag is a magnetically levitated centrifugal pump system, having the utility for treating adults and large children (1,500 utilized worldwide). We present here the PediVAS, a pump system whose design was modified from the CentriMag to meet the physiological requirements of young pediatric and neonatal patients. The PediVAS is comprised of a single-use centrifugal blood pump, reusable motor, and console, and is suitable for right ventricular assist device (RVAD), left ventricular assist device (LVAD), biventricular assist device (BVAD), or extracorporeal membrane oxygenator (ECMO) applications. It is designed to operate without bearings, seals and valves, and without regions of blood stasis, friction, or wear. The PediVAS pump is compatible with the CentriMag hardware, although the priming volume was reduced from 31 to 14 ml, and the port size reduced from 3/8 to (1/4) in. For the expected range of pediatric flow (0.3-3.0 L/min), the PediVAS exhibited superior hydraulic efficiency compared with the CentriMag. The PediVAS was evaluated in 14 pediatric animals for up to 30 days, demonstrating acceptable hydraulic function and hemocompatibility. The current results substantiate the performance and biocompatibility of the PediVAS cardiac assist system and are likely to support initiation of a US clinical trial in the future.

Ambient Assisted Living spaces validation by services and devices simulation.

PubMed

Fernández-Llatas, Carlos; Mocholí, Juan Bautista; Sala, Pilar; Naranjo, Juan Carlos; Pileggi, Salvatore F; Guillén, Sergio; Traver, Vicente

2011-01-01

The design of Ambient Assisted Living (AAL) products is a very demanding challenge. AAL products creation is a complex iterative process which must accomplish exhaustive prerequisites about accessibility and usability. In this process the early detection of errors is crucial to create cost-effective systems. Computer-assisted tools can suppose a vital help to usability designers in order to avoid design errors. Specifically computer simulation of products in AAL environments can be used in all the design phases to support the validation. In this paper, a computer simulation tool for supporting usability designers in the creation of innovative AAL products is presented. This application will benefit their work saving time and improving the final system functionality.

Optimal Timing of Heart Transplant After HeartMate II Left Ventricular Assist Device Implantation.

PubMed

Steffen, Robert J; Blackstone, Eugene H; Smedira, Nicholas G; Soltesz, Edward G; Hoercher, Katherine J; Thuita, Lucy; Starling, Randall C; Mountis, Maria; Moazami, Nader

2017-11-01

Optimal timing of heart transplantation in patients supported with second-generation left ventricular assist devices (LVADs) is unknown. Despite this, patients with LVADs continue to receive priority on the heart transplant waiting list. Our objective was to determine the optimal timing of transplantation for patients bridged with continuous-flow LVADs. A total of 301 HeartMate II LVADs (Thoratec Corp, Pleasanton, CA) were implanted in 285 patients from October 2004 to June 2013, and 86 patients underwent transplantation through the end of follow-up. Optimal transplantation timing was the product of surviving on LVAD support and surviving transplant. Three-year survival after both HeartMate II implantation and heart transplantation was unchanged when transplantation occurred within 9 months of implantation. Survival decreased as the duration of support exceeded this. Preoperative risk factors for death on HeartMate II support were prior valve operation, prior coronary artery bypass grafting, low albumin, low glomerular filtration rate, higher mean arterial pressure, hypertension, and earlier date of implant. Survival for patients without these risk factors was lowest when transplant was performed within 3 months but was relatively constant with increased duration of support. Longer duration of support was associated with poorer survival for patients with many of these risk factors. Device reimplantation, intracranial hemorrhage, and postimplant dialysis during HeartMate II support were associated with decreased survival. Survival of patients supported by the HeartMate II is affected by preoperative comorbidities and postoperative complications. Transplantation before complications is imperative in optimizing survival. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Study of space shuttle EVA/IVA support requirements. Volume 4: Requirements study for space shuttle mobility aids

NASA Technical Reports Server (NTRS)

Wood, P. W., Jr.

1973-01-01

The requirements for mobility aids and restraint devices for use by personnel of the space shuttle were investigated. The devices considered were as follows: (1) translational devices to assist crewmen in moving from place to place and in moving equipment, (2) restraint devices for crewman at the worksite to prevent undesired induced motion between the crewman and the worksite, and (3) other necessary worksite provisions. Existing devices in each category are reviewed and new concepts are generated as required. Diagrams and line drawings of items of equipment are provided.

Closing the gap in paediatric ventricular assist device therapy with the Berlin Heart EXCOR® 15-ml pump.

PubMed

De Rita, Fabrizio; Griselli, Massimo; Sandica, Eugen; Miera, Oliver; Karimova, Ann; d'Udekem, Yves; Goldwasser, Ranny; Januszewska, Katarzyna; Amodeo, Antonio; Jurrmann, Nadine; Ersel, Simon; Menon, Ares K

2017-05-01

The Berlin Heart EXCOR ® (EXCOR) paediatric ventricular assist device is used worldwide for mechanical support of infants and small children with end-stage heart failure. A clinically important gap between the smallest EXCOR blood pump (10 ml) and the next larger size (25 ml) limited the choice of pump size in patients with a body surface area (BSA) between 0.33 and 0.5 m 2 . We present the first clinical experience from the early product surveillance (EPS) of the new EXCOR 15-ml blood pump. After CE and U.S. Food and Drug Administration approval in January 2013, 20 patients with a mean age of 1.6 years (range 0.5-3.5 years) and a mean BSA of 0.45 m 2 (range 0.33-0.59 m 2 ) were enrolled in the EPS. The main diagnosis was idiopathic cardiomyopathy in 13 patients; the majority ( n =  16) of children were in INTERMACS level 1 or 2. Data from high-volume paediatric transplant centres were collected prospectively for a defined follow-up period of 60 days after device implantation. Mean time on the EXCOR 15-ml blood pump was 43 days; the survival rate was 100% at the end of the EPS period. Seven patients underwent a heart transplant from the device; 2 children were weaned; and 11 patients remained on support. Infection of cannula exit sites occurred in 3 patients. Two patients had minor thromboembolic strokes but made a complete neurological recovery. The new EXCOR 15-ml blood pump demonstrated optimal ventricular assist device support of children with a BSA of 0.33-0.5 m 2 . © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

First use of an untethered, vented electric left ventricular assist device for long-term support.

PubMed

Frazier, O H

1994-06-01

This report describes the first long-term (505-day) application of the vented electric (VE) HeartMate left ventricular assist device (LVAD) (Thermo Cardiosystems, Inc). The device consists of an abdominally placed, battery-powered titanium blood pump that, in contrast to earlier pneumatically powered systems, allows patients untethered freedom of movement. The batteries last 5 to 8 hours and can be changed on a rotating basis indefinitely. The patient, a 33-year-old man (90 kg, blood type O) with idiopathic cardiomyopathy, experienced end-organ heart failure (New York Heart Association [NYHA] class IV) while he was awaiting heart transplantation. When his hemodynamic criteria met those outlined in the protocol, we implanted the VE-LVAD as a bridge to transplantation. The patient was supported by the device for more than 16 months. His cardiac status returned to NYHA class I, and he was eventually allowed to take day trips outside the hospital as he awaited transplantation. The VE-LVAD enabled the patient to participate in activities such as eating in restaurants, going to movies, and practicing basketball shots. Unfortunately, the patient died suddenly due to a neurological thromboembolic event that occurred on day 503 of VE-LVAD support. The VE-LVAD improved native left ventricular function by chronic unloading, and ventricular remodeling resulted in a more normal configuration anatomically, physiologically, and ultimately, histologically and pathologically.

B-type natriuretic peptide levels and continuous-flow left ventricular assist devices.

PubMed

Sareyyupoglu, Basar; Boilson, Barry A; Durham, Lucian A; McGregor, Christopher G A; Daly, Richard C; Redfield, Margaret M; Edwards, Brooks S; Frantz, Robert P; Pereira, Naveen L; Park, Soon J

2010-01-01

We postulated that postoperative B-type natriuretic peptide (BNP) levels would be reflective of the degree of hemodynamic support rendered by various pump speeds settings (RPM) of continuous-flow left ventricular assist devices (LVADs). Twenty LVAD patients were evaluated prospectively (Jarvik 2000: n = 9, HeartMate II: n = 11). The mean age was 57.7 ± 14.9 years, and 14 were male. B-type natriuretic peptide levels were drawn while the patients were supported on LVADs at variable RPM settings. The RPM settings were correlated with the changes in BNP levels. Eleven patients underwent LVAD implantation for a lifelong support while the rest were as a bridge therapy to transplantation. Four patients required LVAD change out for various causes of pump failure. Postoperative BNP levels decreased dramatically with the initiation of LVAD support. The levels correlated inversely with the degree of hemodynamic support rendered at various RPM settings of the HeartMate II (p < 0.001). Overall, BNP levels decreased significantly in 2 days after RPM increase. We observed a significant inverse correlation between the postoperative BNP levels and the degree of LVAD support. The effective LVAD support seems to result in a marked reduction in BNP levels, and monitoring serial BNP levels may be helpful in managing patients supported on continuous LVAD.

Bridge to transplantation using paracorporeal biventricular assist devices or the syncardia temporary total artificial heart: is there a difference?

PubMed

Nguyen, A; Pozzi, M; Mastroianni, C; Léger, P; Loisance, D; Pavie, A; Leprince, P; Kirsch, M

2015-06-01

Biventricular support can be achieved using paracorporeal ventricular assist devices (p-BiVAD) or the Syncardia temporary total artificial heart (t-TAH). The purpose of the present study was to compare survival and morbidity between these devices. Data from 2 French neighboring hospitals were reviewed. Between 1996 and 2009, 148 patients (67 p-BiVADs and 81 t-TAH) underwent primary, planned biventricular support. There were 128 (86%) males aged 44±13 years. Preoperatively, p-BiVAD recipients had significantly lower systolic and diastolic blood pressures, more severe hepatic cytolysis and higher white blood cell counts than t-TAH recipients. In contrast, t-TAH patients had significantly higher rates of pre-implant ECLS and hemofiltration. Mean support duration was 79±100 days for the p-BiVAD group and 71±92 for t-TAH group (P=0.6). Forty two (63%) p-BiVAD recipients were bridged to transplantation (39, 58%) or recovery (3, 5%), whereas 51 (63%) patients underwent transplantation in the t-TAH group. Death on support was similar between groups (p-BiVAD, 26 (39%); t-TAH, 30 (37%); P=0.87). Survival while on device was not significantly different between patient groups and multivariate analysis showed that only preimplant diastolic blood pressure and alanine amino-transferase levels were significant predictors of death. Post-transplant survival in the p-BiVAD group was 76±7%, 70±8%, and 58±9% at 1, 3, and 5 years after transplantation, respectively, and was similar to that of the t-TAH group (77±6%, 72±6%, and 70±7%, P=0.60). Survival while on support and up to 5 years after heart transplantation was not significantly different in patients supported by p-BiVADs or t-TAH. Multivariate analysis revealed that survival while on transplantation was not affected by the type of device implanted.

Low-cost assistive device for hand gesture recognition using sEMG

NASA Astrophysics Data System (ADS)

Kainz, Ondrej; Cymbalák, Dávid; Kardoš, Slavomír.; Fecil'ak, Peter; Jakab, František

2016-07-01

In this paper a low-cost solution for surface EMG (sEMG) signal retrieval is presented. The principal goal is to enable reading the temporal parameters of muscles activity by a computer device, with its further processing. Paper integrates design and deployment of surface electrodes and amplifier following the prior researches. Bearing in mind the goal of creating low-cost solution, the Arduino micro-controller was utilized for analog-to-digital conversion and communication. The software part of the system employs support vector machine (SVM) to classify the EMG signal, as acquired from sensors. Accuracy of the proposed solution achieves over 90 percent for six hand movements. Proposed solution is to be tested as an assistive device for several cases, involving people with motor disabilities and amputees.

Machines versus medication for biventricular heart failure: focus on the total artificial heart.

PubMed

Arabia, Francisco A; Moriguchi, Jaime D

2014-09-01

The medical/surgical management of advanced heart failure has evolved rapidly over the last few decades. With better understanding of heart failure pathophysiology, new pharmacological agents have been introduced that have resulted in improvements in survival. For those patients that fail to improve, mechanical circulatory support with left ventricular assist devices and total artificial hearts (TAHs) have served as a beneficial bridge to transplantation. The TAH has continued to play a significant role as a bridge to transplantation in patients with biventricular failure and more selected indications that could not be completely helped with left ventricular assist devices. Improved survival with the TAH has resulted in more patients benefiting from this technology. Improvements will eventually lead to a totally implantable device that will permanently replace the failing human heart.

iPhone in the Management of the Berlin Heart EXCOR Ventricular Assist Device.

PubMed

Badheka, Aditya; Allareddy, Veerajalandhar

Berlin Heart Inc. EXCOR is an extracorporeal pneumatically pulsatile ventricular assist device approved for use in pediatric age group since 2011 in the United States. It is a well-established life-saving therapy for the bridge to heart transplant or to provide circulatory support in a transplanted patient. The most commonly reported problem was "membrane defect" in a postmarketing major device reporting. In general, the filling and emptying of the pump can be easily visualized, but the interobserver variability exist. In this first novel report, we used the iPhone slow motion video to quantify and compare the differences in filling and emptying that positively impacted the management of the Berlin Heart. This is an initial exploratory concept that will need further studies to validate this bedside tool.

Hybridization between multi-objective genetic algorithm and support vector machine for feature selection in walker-assisted gait.

PubMed

Martins, Maria; Costa, Lino; Frizera, Anselmo; Ceres, Ramón; Santos, Cristina

2014-03-01

Walker devices are often prescribed incorrectly to patients, leading to the increase of dissatisfaction and occurrence of several problems, such as, discomfort and pain. Thus, it is necessary to objectively evaluate the effects that assisted gait can have on the gait patterns of walker users, comparatively to a non-assisted gait. A gait analysis, focusing on spatiotemporal and kinematics parameters, will be issued for this purpose. However, gait analysis yields redundant information that often is difficult to interpret. This study addresses the problem of selecting the most relevant gait features required to differentiate between assisted and non-assisted gait. For that purpose, it is presented an efficient approach that combines evolutionary techniques, based on genetic algorithms, and support vector machine algorithms, to discriminate differences between assisted and non-assisted gait with a walker with forearm supports. For comparison purposes, other classification algorithms are verified. Results with healthy subjects show that the main differences are characterized by balance and joints excursion in the sagittal plane. These results, confirmed by clinical evidence, allow concluding that this technique is an efficient feature selection approach. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Mechanical circulatory support in pediatrics.

PubMed

Steffen, Robert J; Miletic, Kyle G; Schraufnagel, Dean P; Vargo, Patrick R; Fukamachi, Kiyotaka; Stewart, Robert D; Moazami, Nader

2016-05-01

End-stage heart failure affects thousands of children yearly and mechanical circulatory support is used at many points in their care. Extracorporeal membrane oxygenation supports both the failing heart and lungs, which has led to its use as an adjunct to cardiopulmonary resuscitation as well as in post-operative cardiogenic shock. Continuous-flow ventricular assist devices (VAD) have replaced pulsatile-flow devices in adults and early studies have shown promising results in children. The Berlin paracorporeal pulsatile VAD recently gained U.S. Food and Drug Administration approval and remains the only VAD approved in pediatrics. Failing univentricular hearts and other congenitally corrected lesions are new areas for mechanical support. Finding novel uses, improving durability, and minimizing complications are areas of growth in pediatric mechanical circulatory support.

Massive Atenolol, Lisinopril, and Chlorthalidone Overdose Treated with Endoscopic Decontamination, Hemodialysis, Impella Percutaneous Left Ventricular Assist Device, and ECMO.

PubMed

Heise, C William; Beutler, David; Bosak, Adam; Orme, Geoffrey; Loli, Akil; Graeme, Kimberlie

2015-03-01

Overdose of cardiovascular medications is increasingly associated with morbidity and mortality. We present a case of substantial atenolol, chlorthalidone, and lisinopril overdose treated by multiple modalities with an excellent outcome. Aggressive medical intervention did not provide sufficient hemodynamic stability in this patient with refractory cardiogenic and distributive shock. Impella® percutaneous left ventricular assist device and extracorporeal membrane oxygenation provided support while the effects of the overdose subsided. We present concentrations demonstrating removal of atenolol with continuous venovenous hemodiafiltration. This is the first report of esophagogastroduo denoscopy decontamination of this overdose with a large pill fragment burden.

Outcomes of ventricular assist device implantation in children and young adults: the Melbourne experience.

PubMed

Shi, William Y; Marasco, Silvana F; Saxena, Pankaj; d'Udekem, Yves; Yong, Matthew S; Mitnovetski, Sergei; Brizard, Christian P; McGiffin, David C; Weintraub, Robert G; Konstantinov, Igor E

2016-12-01

We evaluated our experience with ventricular assist device (VAD) implantation in children and young adults. A total of 64 patients underwent VAD implantation in two centres. The mean age was 15 ± 7.2 years. Thirty-five (55%) patients were under 18 years of age. Devices implanted included the Thoratec Paracorporeal in 30 (47%) patients, Berlin Heart EXCOR in 11 (17%) and VentrAssist in 14 (22%). The diagnosis was cardiomyopathy in 53, congenital heart disease in 11, and graft failure in four patients. There were 10 (16%) in-hospital deaths. Mortality was higher in patients <18 years of age (26% compared with 3.4% for those ≥18 years, P = 0.02). The use of extracorporeal membrane oxygenation prior to VAD implantation was associated with higher mortality (P = 0.006). Seventeen (27%) patients experienced stroke. Nine patients (14%) required change of VAD because of thrombosis. Transplantation was performed in 44 patients after a mean of 131 ± 141 days on VAD, 11 patients died without transplantation and three patients currently await transplantation. The VAD was explanted in six patients because of recovery. Overall survival from VAD implantation was 69% and 61% at 5 and 10 years, respectively. The 5-year post-transplant survival for those bridged with VAD support was 91% and was comparable with a cohort of patients who did not receive a pre-transplant VAD. Children requiring pre-transplant VAD support have a higher mortality and morbidity compared with young adults. Survival after heart transplantation those supported with VADs was similar to patients of similar age who did not require pre-transplant support. © 2015 Royal Australasian College of Surgeons.

Risk stratification in patients with advanced heart failure requiring biventricular assist device support as a bridge to cardiac transplantation.

PubMed

Cheng, Richard K; Deng, Mario C; Tseng, Chi-hong; Shemin, Richard J; Kubak, Bernard M; MacLellan, W Robb

2012-08-01

Prior studies have identified risk factors for survival in patients with end-stage heart failure (HF) requiring left ventricular assist device (LVAD) support. However, patients with biventricular HF may represent a unique cohort. We retrospectively evaluated a consecutive cohort of 113 adult, end-stage HF patients at University of California Los Angeles Medical Center who required BIVAD support between 2000 and 2009. Survival to transplant was 66.4%, with 1-year actuarial survival of 62.8%. All patients were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Level 1 or 2 and received Thoratec (Pleasanton, CA) paracorporeal BIVAD as a bridge to transplant. Univariate analyses showed dialysis use, ventilator use, extracorporal membrane oxygenation use, low cardiac output, preserved LV ejection fraction (restrictive physiology), normal-to-high sodium, low platelet count, low total cholesterol, low high-density and high-density lipoprotein, low albumin, and elevated aspartate aminotransferase were associated with increased risk of death. We generated a scoring system for survival to transplant. Our final model, with age, sex, dialysis, cholesterol, ventilator, and albumin, gave a C-statistic of 0.870. A simplified system preserved a C-statistic of 0.844. Patients were divided into high-risk or highest-risk groups (median respective survival, 367 and 17 days), with strong discrimination between groups for death. We have generated a scoring system that offers high prognostic ability for patients requiring BIVAD support and hope that it may assist in clinical decision making. Further studies are needed to prospectively validate our scoring system. Copyright © 2012 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Accessibility of Mobile Devices for Visually Impaired Users: An Evaluation of the Screen-Reader VoiceOver.

PubMed

Smaradottir, Berglind; Håland, Jarle; Martinez, Santiago

2017-01-01

A mobile device's touchscreen allows users to use a choreography of hand gestures to interact with the user interface. A screen reader on a mobile device is designed to support the interaction of visually disabled users while using gestures. This paper presents an evaluation of VoiceOver, a screen reader in Apple Inc. products. The evaluation was a part of the research project "Visually impaired users touching the screen - a user evaluation of assistive technology".

De novo aortic insufficiency during long-term support on a left ventricular assist device: a systematic review and meta-analysis.

PubMed

Deo, Salil V; Sharma, Vikas; Cho, Yang Hyun; Shah, Ishan K; Park, Soon J

2014-01-01

Aortic insufficiency (AI) may occur while supported on a left ventricular assist device (LVAD). We conducted a systematic review to determine the incidence, predictors, and consequences of AI during LVAD support. MEDLINE was searched for original studies presenting clinical data regarding patients who developed AI during LVAD implant. Seven observational studies (657 patients) were selected for review; 65% of patients underwent implantation with a continuous-flow device (Cf-LVAD). The incidence of AI was 25% (11-42%) (Support period: 412 ± 281 days). AI increased by 4% (1-6%) per month of support (p < 0.01). AI-positive patients were older at implant (weighted mean difference, 7.7 [4.3; 11.1]; p < 0.01). Female sex (0.002 ± 0.001; p = 0.01) and smaller body surface area (-0.003 ± 0.001 per m; p < 0.01) correlated with progressive AI. Destination therapy patients (odds ratio [OR], 5.3 [1.2, 24]; p = 0.02) and those with Cf-LVAD pumps were likely to develop AI (hazard ratio [HR], 2.2 [1.2, 3.8]; p < 0.01). A closed aortic valve was associated with AI (OR, 4.7 [1.9, 11.8]; p < 0.01). Survival was comparable in both cohorts (HR, 1.5 [0.81, 2.8]; p = 0.2). A significant number of patients develop de novo AI during LVAD support. Advanced age, longer support duration, continuous-flow pumps, and a closed aortic valve are associated with AI. Large cohort studies would improve our understanding of this condition.

3 CFR 8663 - Proclamation 8663 of April 29, 2011. Older Americans Month, 2011

Code of Federal Regulations, 2012 CFR

2012-01-01

... technology, including social media and assistive devices, can help adults remain engaged in their communities... children and stock the shelves at food pantries and libraries. Programs supported by the Corporation for...

34 CFR 303.13 - Early intervention services.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) Assistive technology device and service are defined as follows: (i) Assistive technology device means any... device. (ii) Assistive technology service means any service that directly assists an infant or toddler with a disability in the selection, acquisition, or use of an assistive technology device. The term...

34 CFR 303.13 - Early intervention services.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) Assistive technology device and service are defined as follows: (i) Assistive technology device means any... device. (ii) Assistive technology service means any service that directly assists an infant or toddler with a disability in the selection, acquisition, or use of an assistive technology device. The term...

34 CFR 303.13 - Early intervention services.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) Assistive technology device and service are defined as follows: (i) Assistive technology device means any... device. (ii) Assistive technology service means any service that directly assists an infant or toddler with a disability in the selection, acquisition, or use of an assistive technology device. The term...

Evolution of general surgical problems in patients with left ventricular assist devices.

PubMed

McKellar, Stephen H; Morris, David S; Mauermann, William J; Park, Soon J; Zietlow, Scott P

2012-11-01

Left ventricular assist devices (LVADs) are increasingly used to treat patients with end-stage heart failure. These patients may develop acute noncardiac surgical problems around the time of LVAD implantation or, as survival continues to improve, chronic surgical problems as ambulatory patients remote from the LVAD implant. Previous reports of noncardiac surgical problems in LVAD patients included patients with older, first-generation devices and do not address newer, second-generation devices. We describe the frequency and management of noncardiac surgical problems encountered during LVAD support with these newer-generation devices to assist noncardiac surgeons involved in the care of patients with LVADs. We retrospectively reviewed the medical records of consecutive patients receiving LVADs at our institution. We collected data for any consultation by noncardiac surgeons within the scope of general surgery during LVAD support and subsequent treatment. Ninety-nine patients received implantable LVADs between 2003 and 2009 (first-generation, n = 19; second-generation, n = 80). Excluding intestinal hemorrhage, general surgical opinions were rendered for 34 patients with 49 problems, mostly in the acute recovery phase after LVAD implantation. Of those, 27 patients underwent 28 operations. Respiratory failure and intra-abdominal pathologies were the most common problems addressed, and LVAD rarely precluded operation. Patients with second-generation LVADs were more likely to survive hospitalization (P = .04) and develop chronic, rather than emergent, surgical problems. Patients with LVADs frequently require consultation from noncardiac surgeons within the scope of general surgeons and often require operation. Patients with second-generation LVADs are more likely to become outpatients and develop more elective surgical problems. Noncardiac surgeons will be increasingly involved in caring for patients with LVADs and should anticipate the problems unique to this patient population. Copyright © 2012 Mosby, Inc. All rights reserved.

Interhospital air transport of a blind patient on extracorporeal life support with consecutive and successful left ventricular assist device implantation.

PubMed

Bauer, Adrian; Schaarschmidt, Jan; Grosse, F Oliver; Al Alam, Nidal; Hausmann, Harald; Krämer, Klaus; Strüber, Martin; Mohr, Friedrich W

2014-06-01

The use of extracorporeal life support systems (ECLS) in patients with postcardiotomy low cardiac output syndrome (LCO) as a bridge to recovery and bridge to implantation of ventricular assist device (VAD) is common nowadays. A 59-year-old patient with acute myocardial infarction received a percutaneous transluminal angioplasty and stenting of the circumflex artery. During catheterization of the left coronary artery (LAD), the patient showed ventricular fibrillation and required defibrillation and cardiopulmonary resuscitation. After implantation of an intra-aortic balloon pump, the patient immediately was transmitted to the operating room. He received emergency coronary artery bypass grafting in a beating heart technique using pump-assisted minimal extracorporeal circulation circuit (MECC). Two bypass grafts were performed to the LAD and the right posterior descending artery. Despite initial successful weaning off cardiopulmonary bypass with high-dose inotropic support, the patient presented postcardiotomy LCO and an ECLS was implanted. The primary setup of the heparin-coated MECC system was modified and used postoperatively. As a result of the absence of an in-house VAD program, the patient was switched to a transportable ECLS the next day and was transferred by helicopter to the nearest VAD center where the patient received a successful insertion of a left VAD 3 days later.

Mechanical circulatory support in pediatrics

PubMed Central

De Rita, Fabrizio; Hasan, Asif; Griselli, Massimo

2014-01-01

There is no reliable published data on the overall prevalence or incidence of heart failure (HF) in children. However, the success of mechanical circulatory support (MCS) in management of HF has raised the prospect of a previously unavailable treatment modality. Orthotopic heart transplant (OHTx) remains the gold standard treatment, but the number of patients requiring this treatment far outweighs the donor availability. It is therefore not surprising to see the popularity of various MCS modalities, with different devices ranging from veno-arterial extra corporeal membrane oxygenation (VA-ECMO) to ventricular assist devices (VADs), which are either para-corporeal or intra-corporeal, with pulsatile or continuous flow. Indication, timing and the choice of the type of mechanical support are crucial so in order to avoid potential lethal complications such as hemorrhage, thrombo-embolism and infections. In the pediatric population, MCS is used mainly as bridge to transplantation but can be used as bridge to recovery in patients with acute myocarditis or following open-heart surgery. Active research is currently underway to develop newer and more durable devices that will assist the pediatric population across all age groups. This research will support different pathologies that have lower incidences of major morbidities, particularly as greater durations of MCS are expected due to a paucity of donors for OHTx. The combined experience developed through the usage of different devices in pediatric and adult populations has led to the to the application of MCS in some subgroups of grown–up congenital heart diseases (CHDs) patients, particularly those with systemic right ventricular failure. PMID:25452912

Effectiveness of Podcasts Delivered on Mobile Devices as a Support for Student Learning during General Chemistry Laboratories

ERIC Educational Resources Information Center

Powell, Cynthia B.; Mason, Diana S.

2013-01-01

Chemistry instructors in teaching laboratories provide expert modeling of techniques and cognitive processes and provide assistance to enrolled students that may be described as scaffolding interaction. Such student support is particularly essential in laboratories taught with an inquiry-based curriculum. In a teaching laboratory with a high…

Choroidal microcirculation in patients with rotary cardiac assist device.

PubMed

Polska, Elzbieta; Schima, Heinrich; Wieselthaler, Georg; Schmetterer, Leopold

2007-06-01

In recent years, fully implanted rotary blood pumps have been used for long-term cardiac assist in patients with end-stage heart failure. With these pumps, the pulsatility of arterial blood flow and arterial pressure pulse is considerably reduced. Effects on end-organ perfusion, particularly microcirculation, have been assessed. The ocular choroid offers a unique opportunity to study the pulsatile component of blood flow by measurement of fundus pulsation amplitude (FPA) as well as the microcirculation by laser Doppler flowmetry. Both techniques were applied in three male patients with rotary pumps (MicroMed DeBakey VAD), in whom pump velocity was adjusted to four levels of flow between individual minimal need and maximal support. In addition, blood flow velocities in the ophthalmic artery (peak, end-diastolic and mean flow velocity--PSV, EDV and MFV, respectively) were measured using color Doppler imaging. Systolic blood pressure increased by 6 to 22 mm Hg with increasing support. At maximal support FPA was reduced by -60% to -52% as compared with minimal pump support. Blood flow in the choroidal microvasculature, however, did not show relevant changes. A reduction in PSV (-31%, range -47% to -21%) and a pronounced rise in EDV (+93%, range +28% to +147%) was observed, whereas MFV was independent of pump flow. Our data indicate that mean choroidal blood flow is maintained when pump support is varied within therapeutic values, whereas the ratio of pulsatile to non-pulsatile choroidal flow changes. This study shows that, in patients with ventricular assist devices, a normal perfusion rate in the ocular microcirculation is maintained over a wide range of support conditions.

Restoration of Pulsatile Flow Reduces Sympathetic Nerve Activity Among Individuals With Continuous-Flow Left Ventricular Assist Devices.

PubMed

Cornwell, William K; Tarumi, Takashi; Stickford, Abigail; Lawley, Justin; Roberts, Monique; Parker, Rosemary; Fitzsimmons, Catherine; Kibe, Julius; Ayers, Colby; Markham, David; Drazner, Mark H; Fu, Qi; Levine, Benjamin D

2015-12-15

Current-generation left ventricular assist devices provide circulatory support that is minimally or entirely nonpulsatile and are associated with marked increases in muscle sympathetic nerve activity (MSNA), likely through a baroreceptor-mediated pathway. We sought to determine whether the restoration of pulsatile flow through modulations in pump speed would reduce MSNA through the arterial baroreceptor reflex. Ten men and 3 women (54 ± 14 years) with Heartmate II continuous-flow left ventricular assist devices underwent hemodynamic and sympathetic neural assessment. Beat-to-beat blood pressure, carotid ultrasonography at the level of the arterial baroreceptors, and MSNA via microneurography were continuously recorded to determine steady-state responses to step changes (200-400 revolutions per minute) in continuous-flow left ventricular assist device pump speed from a maximum of 10,480 ± 315 revolutions per minute to a minimum of 8500 ± 380 revolutions per minute. Reductions in pump speed led to increases in pulse pressure (high versus low speed: 17 ± 7 versus 26 ± 12 mm Hg; P<0.01), distension of the carotid artery, and carotid arterial wall tension (P<0.05 for all measures). In addition, MSNA was reduced (high versus low speed: 41 ± 15 versus 33 ± 16 bursts per minute; P<0.01) despite a reduction in mean arterial pressure and was inversely related to pulse pressure (P=0.037). Among subjects with continuous-flow left ventricular assist devices, the restoration of pulsatile flow through modulations in pump speed leads to increased distortion of the arterial baroreceptors with a subsequent decline in MSNA. Additional study is needed to determine whether reduction of MSNA in this setting leads to improved outcomes. © 2015 American Heart Association, Inc.

Cardio-supportive devices (VRD & DCC device) and patches for advanced heart failure: A review, summary of state of the art and future directions.

PubMed

Naveed, Muhammad; Han, Lei; Khan, Ghulam Jilany; Yasmeen, Sufia; Mikrani, Reyaj; Abbas, Muhammad; Cunyu, Li; Xiaohui, Zhou

2018-06-01

Congestive heart failure (CHF) is a complicated pathophysiological syndrome, leading cause of hospitalization as well as mortalities in developed countries wherein an irregular function of the heart leads to the insufficient blood supply to the body organs. It is an accumulative slackening of various complications including myocardial infarction (MI), coronary heart disease (CAD), hypertension, valvular heart disease (VHD) and cardiomyopathy; its hallmarks include hypertrophy, increased interstitial fibrosis and loss of myocytes. The etiology of CHF is very complex and despite the rapid advancement in pharmacological and device-based interventional therapies still, a single therapy may not be sufficient to meet the demand for coping with the diseases. Total artificial hearts (TAH) and ventricular assist devices (VADs) have been widely used clinically to assist patients with severe HF. Unfortunately, direct contact between the patient's blood and device leads to thromboembolic events, and then coagulatory factors, as well as, infection contribute significantly to complicate the situation. There is no effective treatment of HF except cardiac transplantation, however, genetic variations, tissue mismatch; differences in certain immune response and socioeconomic crisis are an important concern with cardiac transplantation suggesting an alternate bridge to transplant (BTT) or destination therapies (DT). For these reasons, researchers have turned to mechanically driven compression devices, ventricular restraint devices (VRD) and heart patches. The ASD is a combination of all operational patches and cardiac support devices (CSD) by delivering biological agents and can restrain or compress the heart. Present study summarizes the accessible peer-reviewed literature focusing on the mechanism of Direct Cardiac Compression (DCC) devices, VRD and patches and their acquaintance to optimize the therapeutic efficacy in a synergistic way. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Assessment of Hydraulic Performance and Biocompatibility of a MagLev Centrifugal Pump System Designed for Pediatric Cardiac or Cardiopulmonary Support

PubMed Central

Dasse, Kurt A.; Gellman, Barry; Kameneva, Marina V.; Woolley, Joshua R.; Johnson, Carl A.; Gempp, Thomas; Marks, John D.; Kent, Stella; Koert, Andrew; Richardson, J. Scott; Franklin, Steve; Snyder, Trevor A.; Wearden, Peter; Wagner, William R.; Gilbert, Richard J.; Borovetz, Harvey S.

2011-01-01

The treatment of children with life-threatening cardiac and cardiopulmonary failure is a large and underappreciated public health concern. We have previously shown that the CentriMag is a magnetically levitated centrifugal pump system, having the utility for treating adults and large children (1,500 utilized worldwide). We present here the Pedi-VAS, a pump system whose design was modified from the CentriMag to meet the physiological requirements of young pediatric and neonatal patients. The PediVAS is comprised of a single-use centrifugal blood pump, reusable motor, and console, and is suitable for right ventricular assist device (RVAD), left ventricular assist device (LVAD), biventricular assist device (BVAD), or extracorporeal membrane oxygenator (ECMO) applications. It is designed to operate without bearings, seals and valves, and without regions of blood stasis, friction, or wear. The PediVAS pump is compatible with the CentriMag hardware, although the priming volume was reduced from 31 to 14 ml, and the port size reduced from 3/8 to ¼ in. For the expected range of pediatric flow (0.3–3.0 L/min), the PediVAS exhibited superior hydraulic efficiency compared with the CentriMag. The PediVAS was evaluated in 14 pediatric animals for up to 30 days, demonstrating acceptable hydraulic function and hemocompatibility. The current results substantiate the performance and biocompatibility of the PediVAS cardiac assist system and are likely to support initiation of a US clinical trial in the future. PMID:18043164

Challenges of user-centred assistive technology provision in Australia: shopping without a prescription.

PubMed

Steel, Emily J; Layton, Natasha Ann; Foster, Michele M; Bennett, Sally

2016-01-01

People with disability have a right to assistive technology devices and services, to support their inclusion and participation in society. User-centred approaches aim to address consumer dissatisfaction and sub-optimal outcomes from assistive technology (AT) provision, but make assumptions of consumer literacy and empowerment. Policy discourses about consumer choice prompt careful reflection, and this paper aims to provide a critical perspective on user involvement in assistive technology provision. User-centred approaches are considered, using literature to critically reflect on what user involvement means in AT provision. Challenges at the level of interactions between practitioners and consumers, and also the level of markets and policies are discussed, using examples from Australia. There is no unanimous conceptual framework for user-centred practice. Power imbalances and differing perspectives between practitioners and consumers make it difficult for consumers to feel empowered. Online access to information and international suppliers has not surmounted information asymmetries for consumers or lifted the regulation of publicly funded AT devices. Ensuring access and equity in the public provision of AT is challenging in an expanding market with diverse stakeholders. Consumers require personalised information and support to facilitate their involvement and choice in AT provision. Implications for Rehabilitation Variations in approaches informing AT provision practices have a profound impact on equity of access and outcomes for consumers. An internationalised and online market for AT devices is increasing the need for effective information provision strategies and services. Power imbalances between practitioners and consumers present barriers to the realisation of user-centred practice.

[Management of hearing impairment in adults].

PubMed

Frachet, Bruno; Poncet-Wallet, Christine; Ernst, Imilie; Quéruel, Françoise; Eshraghi, Adrien

2009-10-20

Hearing impairment, mainly the deafness with possible distortions, assorted with tinnitus concerns about 4 million of the French population. It can be of variable severity. Deafness is an invisible disability until we must answer a question. The permanent improvement of the computer and microelectronics sciences benefit to the prosthetic devices: cochlear implants compensate for complete hearing loss, hearing aids are hidden by being miniaturized, being partially or totally implantable. The management of disability is not limited to this material part: human assistance and assistive devices are part of the armory. Rest to continue and to increase the financial support. This claim is obviously not specific to disability hearing although the hearing aid is only refunded 138 Euro per device for a unit cost from 1300 Euro to 2500 Euro with an observed lifetime of 4 or 5 years.

Design and evaluation of a single-pivot supported centrifugal blood pump.

PubMed

Yoshino, M; Uemura, M; Takahashi, K; Watanabe, N; Hoshi, H; Ohuchi, K; Nakamura, M; Fujita, H; Sakamoto, T; Takatani, S

2001-09-01

In order to develop a centrifugal blood pump that meets the requirements of a long-term, implantable circulatory support device, in this study a single-pivot bearing supported centrifugal blood pump was designed to evaluate its basic performance. The single-pivot structure consisted of a ceramic ball male pivot mounted on the bottom surface of the impeller and a polyethylene female pivot incorporated in the bottom pump casing. The follower magnet mounted inside the impeller was magnetically coupled to the driver magnet mounted on the shaft of the direct current brushless motor. As the motor rotated, the impeller rotated supported entirely by a single-pivot bearing system. The static pump performance obtained in the mock circulatory loop revealed an acceptable performance as a left ventricular assist device in terms of flow and head pressure. The pump flow of 5 L/min against the head pressure of 100 mm Hg was obtained at rotational speeds of 2,000 to 2,200 rpm. The maximum pump flow was 9 L/min with 2,200 rpm. The maximum electrical-to-hydraulic power conversion efficiency was around 14% at pump flows of 4 to 5 L/min. The stability of the impeller was demonstrated at the pump rpm higher than 1,400 with a single-pivot bearing without an additional support at its top. The single-pivot supported centrifugal pump can provide adequate flow and pressure as a ventricular assist device, but its mechanical stability and hemolytic as well as thrombotic performances must be tested prior to clinical use.

Can use of walkers or canes impede lateral compensatory stepping movements?

PubMed

Bateni, Hamid; Heung, Evelyn; Zettel, John; McLlroy, William E; Maki, Brian E

2004-08-01

Although assistive devices, such as walkers and canes are often prescribed to aid in balance control, recent studies have suggested that such devices may actually increase risk of falling. In this study, we investigated one possible mechanism: the potential for walkers or canes to interfere with, or constrain, lateral movement of the feet and thereby impede execution of compensatory stepping reactions during lateral loss of balance. Lateral stepping reactions were evoked, in 10 healthy young adults (ages 22-27 years), by means of sudden unpredictable medio-lateral support surface translation. Subjects were tested while holding and loading a standard pickup walker or single-tip cane or while using no assistive device (hands free or holding an object). Results supported the hypothesis that using a walker or cane can interfere with compensatory stepping. Collisions between the swing-foot and mobility aid were remarkably frequent when using the walker (60% of stepping reactions) and also occurred in cane trials (11% of stepping reactions). Furthermore, such collisions were associated with a significant reduction (26-37%) in lateral step length. It appeared that subjects were sometimes able to avoid collision by increasing the forward or backward displacement of the swing-foot or by moving the cane; however, attempts to lift the walker out of the way occurred rarely and were usually impeded due to collision between the contralateral walker post and stance foot. The fact that compensatory stepping behavior was altered significantly in such a healthy cohort clearly demonstrates some of the safety limitations inherent to these assistive devices, as currently designed. Copyright 2003 Elsevier B.V.

Characteristics of a virtual community for individuals who are d/deaf and hard of hearing.

PubMed

Shoham, Snunith; Heber, Meital

2012-01-01

The content of 2,050 messages on a virtual forum for d/Deaf and hard of hearing people in Israel was analyzed. Interactions and behavior were monitored to determine if behavior on the forum expressed social support, and whether the community was an entirely virtual community or a real community whose members also met in other venues. Subjects discussed in messages included technical difficulties, coping with difficulties presented by hearing loss, adjusting to assistive devices, difficulties at school and work, accessibility issues, difficulties communicating with the hearing world, and rights. Messages were also used to initiate a range of social activities. Classification of behaviors per the Social Support Behavior Code (Cutrona & Suhr, 1992) showed that most were in the category of informational support. Other types of support in the model, tangible assistance, emotional support, social network support, and esteem support, were evident in fewer messages.

Design of a minimally constraining, passively supported gait training exoskeleton: ALEX II.

PubMed

Winfree, Kyle N; Stegall, Paul; Agrawal, Sunil K

2011-01-01

This paper discusses the design of a new, minimally constraining, passively supported gait training exoskeleton known as ALEX II. This device builds on the success and extends the features of the ALEX I device developed at the University of Delaware. Both ALEX (Active Leg EXoskeleton) devices have been designed to supply a controllable torque to a subject's hip and knee joint. The current control strategy makes use of an assist-as-needed algorithm. Following a brief review of previous work motivating this redesign, we discuss the key mechanical features of the new ALEX device. A short investigation was conducted to evaluate the effectiveness of the control strategy and impact of the exoskeleton on the gait of six healthy subjects. This paper concludes with a comparison between the subjects' gait both in and out of the exoskeleton. © 2011 IEEE

Pulsatile mechanical cardiac assistance in pediatric patients with the Berlin heart ventricular assist device.

PubMed

Merkle, Frank; Boettcher, Wolfgang; Stiller, Brigitte; Hetzer, Roland

2003-06-01

Mechanical cardiac assistance for neonates, infants, children and adolescents may be accomplished with pulsatile ventricular assist devices (VAD) instead of extracorporeal membrane oxygenation or centrifugal pumps. The Berlin Heart VAD consists of extracorporeal, pneumatically driven blood pumps for pulsatile univentricular or biventricular assistance for patients of all age groups. The blood pumps are heparin-coated. The stationary driving unit (IKUS) has the required enhanced compressor performance for pediatric pump sizes. The Berlin Heart VAD was used in a total number of 424 patients from 1987 to November 2001 at our institution. In 45 pediatric patients aged 2 days-17 years the Berlin Heart VAD was applied for long-term support (1-111 days, mean 20 days). There were three patient groups: Group I: "Bridge to transplantation" with various forms of cardiomyopathy (N = 21) or chronic stages of congenital heart disease (N = 9); Group II: "Rescue" in intractable heart failure after corrective surgery for congenital disease (N = 7) or in early graft failure after heart transplantation (N = 1); and Group III: "Acute myocarditis" (N = 7) as either bridge to transplantation or bridge to recovery. Seventeen patients were transplanted after support periods of between 4 and 111 days with 12 long-term survivors, having now survived for up to 10 years. Five patients (Groups I and III) were weaned from the system with four long-term survivors. In Group II only one patient survived after successful transplantation. Prolonged circulatory support with the Berlin Heart VAD is an effective method for bridging until cardiac recovery or transplantation in the pediatric age group. Extubation, mobilization, and enteral nutrition are possible. For long-term use, the Berlin Heart VAD offers advantages over centrifugal pumps and ECMO in respect to patient mobility and safety.

77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...

Overview of Robotic Devices for Nursing Care Project.

PubMed

Hirukawa, Hirohisa

2017-01-01

METI/AMED are conducting a project on the development and deployment of robotic devices for nursing care to enhance the autonomy of elderly persons and assist care givers. An evaluation protocol is presented and the devices developed in the project are introduced. The devices consist of transfer assist devices (wearable/non-wearable), walking assist devices (outdoor/indoor), safety surveillance sensors (nursing home/private home), bath lift and toilet assist.

Recent advances in computational methodology for simulation of mechanical circulatory assist devices

PubMed Central

Marsden, Alison L.; Bazilevs, Yuri; Long, Christopher C.; Behr, Marek

2014-01-01

Ventricular assist devices (VADs) provide mechanical circulatory support to offload the work of one or both ventricles during heart failure. They are used in the clinical setting as destination therapy, as bridge to transplant, or more recently as bridge to recovery to allow for myocardial remodeling. Recent developments in computational simulation allow for detailed assessment of VAD hemodynamics for device design and optimization for both children and adults. Here, we provide a focused review of the recent literature on finite element methods and optimization for VAD simulations. As VAD designs typically fall into two categories, pulsatile and continuous flow devices, we separately address computational challenges of both types of designs, and the interaction with the circulatory system with three representative case studies. In particular, we focus on recent advancements in finite element methodology that has increased the fidelity of VAD simulations. We outline key challenges, which extend to the incorporation of biological response such as thrombosis and hemolysis, as well as shape optimization methods and challenges in computational methodology. PMID:24449607

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2012 CFR

2012-07-01

... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired... 34 Education 2 2012-07-01 2012-07-01 false Assistive technology device. 300.5 Section 300.5...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2013 CFR

2013-07-01

... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired... 34 Education 2 2013-07-01 2013-07-01 false Assistive technology device. 300.5 Section 300.5...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2014 CFR

2014-07-01

... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired... 34 Education 2 2014-07-01 2013-07-01 true Assistive technology device. 300.5 Section 300.5...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2011 CFR

2011-07-01

... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired... 34 Education 2 2011-07-01 2010-07-01 true Assistive technology device. 300.5 Section 300.5...

34 CFR 300.5 - Assistive technology device.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 2 2010-07-01 2010-07-01 false Assistive technology device. 300.5 Section 300.5... CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.5 Assistive technology device. Assistive technology device means any item, piece of equipment, or product system, whether acquired...

Association between percutaneous hemodynamic support device and survival from cardiac arrest in the state of Michigan.

PubMed

Pressman, Andrew; Sawyer, Kelly N; Devlin, William; Swor, Robert

2018-05-01

The role of circulatory support in the post-cardiac arrest period remains controversial. Our objective was to investigate the association between treatment with a percutaneous hemodynamic support device and outcome after admission for cardiac arrest. We performed a retrospective study of adult patients with admission diagnosis of cardiac arrest or ventricular fibrillation (VF) from the Michigan Inpatient Database, treated between July 1, 2010, and June 30, 2013. Patient demographics, clinical characteristics, treatments, and disposition were electronically abstracted based on ICD-9 codes at the hospital level. Mixed-effects logistic regression models were fit to test the effect of percutaneous hemodynamic support device defined as either percutaneous left ventricular assist device (pLVAD) or intra-aortic balloon pump (IABP) on survival. These models controlled for age, sex, VF, myocardial infarction (MI), and cardiogenic shock with hospital modeled as a random effect. A total of 103 hospitals contributed 4393 patients for analysis, predominately male (58.8%) with a mean age of 64.1years (SD 15.5). On univariate analysis, younger age, male sex, VF as the initial rhythm, acute MI, percutaneous coronary intervention, percutaneous hemodynamic support device, and absence of cardiogenic shock were associated with survival to discharge (each p<0.001). Mixed-effects logistic regressions revealed use of percutaneous hemodynamic support device was significantly associated with survival among all patients (OR 1.8 (1.28-2.54)), and especially in those with acute MI (OR 1.95 (1.31-2.93)) or cardiogenic shock (OR 1.96 (1.29-2.98)). Treatment with percutaneous hemodynamic support device in the post-arrest period may provide left ventricular support and improve outcome. Copyright © 2017 Elsevier Inc. All rights reserved.

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 4 2012-10-01 2012-10-01 false Wireless video assist devices. 74.870 Section... Stations § 74.870 Wireless video assist devices. Television broadcast auxiliary licensees and motion picture and television producers, as defined in § 74.801 may operate wireless video assist devices on a...

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 4 2011-10-01 2011-10-01 false Wireless video assist devices. 74.870 Section... Stations § 74.870 Wireless video assist devices. Television broadcast auxiliary licensees and motion picture and television producers, as defined in § 74.801 may operate wireless video assist devices on a...

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 4 2014-10-01 2014-10-01 false Wireless video assist devices. 74.870 Section... Stations § 74.870 Wireless video assist devices. Television broadcast auxiliary licensees and motion picture and television producers, as defined in § 74.801 may operate wireless video assist devices on a...

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 4 2013-10-01 2013-10-01 false Wireless video assist devices. 74.870 Section... Stations § 74.870 Wireless video assist devices. Television broadcast auxiliary licensees and motion picture and television producers, as defined in § 74.801 may operate wireless video assist devices on a...

Developing an Anti-Xa-Based Anticoagulation Protocol for Patients with Percutaneous Ventricular Assist Devices.

PubMed

Sieg, Adam; Mardis, B Andrew; Mardis, Caitlin R; Huber, Michelle R; New, James P; Meadows, Holly B; Cook, Jennifer L; Toole, J Matthew; Uber, Walter E

2015-01-01

Because of the complexities associated with anticoagulation in temporary percutaneous ventricular assist device (pVAD) recipients, a lack of standardization exists in their management. This retrospective analysis evaluates current anticoagulation practices at a single center with the aim of identifying an optimal anticoagulation strategy and protocol. Patients were divided into two cohorts based on pVAD implanted (CentriMag (Thoratec; Pleasanton, CA) / TandemHeart (CardiacAssist; Pittsburgh, PA) or Impella (Abiomed, Danvers, MA)), with each group individually analyzed for bleeding and thrombotic complications. Patients in the CentriMag/TandemHeart cohort were subdivided based on the anticoagulation monitoring strategy (activated partial thromboplastin time (aPTT) or antifactor Xa unfractionated heparin (anti-Xa) values). In the CentriMag/TandemHeart cohort, there were five patients with anticoagulation titrated based on anti-Xa values; one patient developed a device thrombosis and a major bleed, whereas another patient experienced major bleeding. Eight patients received an Impella pVAD. Seven total major bleeds in three patients and no thrombotic events were detected. Based on distinct differences between the devices, anti-Xa values, and outcomes, two protocols were created to guide anticoagulation adjustments. However, anticoagulation in patients who require pVAD support is complex with constantly evolving anticoagulation goals. The ideal level of anticoagulation should be individually determined using several coagulation laboratory parameters in concert with hemodynamic changes in the patient's clinical status, the device, and the device cannulation.

Matrix-Assisted Three-Dimensional Printing of Cellulose Nanofibers for Paper Microfluidics.

PubMed

Shin, Sungchul; Hyun, Jinho

2017-08-09

A cellulose nanofiber (CNF), one of the most attractive green bioresources, was adopted for construction of microfluidic devices using matrix-assisted three-dimensional (3D) printing. CNF hydrogels can support structures printed using CAD design in a 3D hydrogel environment with the appropriate combination of rheological properties between the CNF hydrogel and ink materials. Amazingly, the structure printed freely in the bulky CNF hydrogels was able to retain its highly resolved 3D features in an ultrathin two-dimensional (2D) paper using a simple drying process. The dimensional change in the CNF hydrogels from 3D to 2D resulted from simple dehydration of the CNFs and provided transparent, stackable paper-based 3D channel devices. As a proof of principle, the rheological properties of the CNF hydrogels, the 3D structure of the ink, the formation of channels by evacuation of the ink, and the highly localized selectivity of the devices are described.

Animal Model Development for the Penn State Pediatric Ventricular Assist Device

PubMed Central

Carney, Elizabeth L.; Clark, J. Brian; Myers, John L.; Peterson, Rebecca; Wilson, Ronald P.; Weiss, William J.

2009-01-01

In March 2004, the National Heart, Lung, and Blood Institute (NHLBI) awarded five contracts to develop devices providing circulatory support for infants and small children with congenital and acquired cardiac disease. Since 2004, the team at Penn State College of Medicine has developed a pneumatically-actuated ventricular assist device (VAD) with mechanical tilting disk valves. To date, hemodynamic performance, thrombogenesis, and hemolysis have been chronically evaluated in 16 animals, including 4 pygmy goats and 12 sheep. Major complications, mainly respiratory failure, have been encountered and resolved by a multi-disciplinary team. Multi-modal analgesia, appropriate antibiotic therapy, and attentive animal care have contributed to successful outcomes. Time after implant has ranged from 0–40 days. Most recently, a sheep implanted with Version 3 Infant VAD was electively terminated at 35 days post-implant, with no major adverse events. This report describes a successful in vivo model for evaluating a pediatric VAD. PMID:19849686

Topical Polymyxin-Trimethoprim Prophylaxis May Decrease the Incidence of Driveline Infections in Patients With Continuous-Flow Left Ventricular Assist Devices.

PubMed

Durand, Marlene L; Ennis, Stephanie C; Baker, Joshua N; Camuso, Janice M; McEachern, Kathleen M; Kotton, Camille N; Lewis, Gregory D; Garcia, Jose P; MacGillivray, Thomas E

2017-02-01

This retrospective cohort study evaluated the effect of topical polymyxin-trimethoprim (poly) prophylaxis on the incidence of driveline infections (DLIs) in patients with continuous-flow left ventricular assist devices. All 84 cases implanted 2005-2014 with device support ≥30 days were reviewed; support ranged 1 m-5.2 yrs. Beginning 2008, poly was applied to the exit site with dressing changes. Sixty-five patients received poly (poly group) for duration of follow-up, 19 did not (no-poly); group baseline characteristics were similar. No patient developed side effects from poly. Nineteen DLIs (10 in no-poly) occurred; not using poly was a risk factor. 89% of poly group DLIs were superficial, 4 were culture-negative. DLI-related bacteremia occurred in 11% of no-poly group and 0% of poly group. Compared with no-poly, poly group demonstrated improved freedom from DLI by Kaplan-Meier analysis (P < 0.0001) and a 75% lower overall and 95% lower deep DLI incidence (P ≤ 0.001). Deep DLIs occurred in 31.6% of no-poly vs. 1.5% of poly patients (P = 0.0004), although mean support duration (1 yr) and % support >1 yr (38%) were similar. These findings, which should be confirmed with larger comparative studies, suggest that topical polymyxin-trimethoprim prophylaxis may be effective in preventing DLIs. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Brain-controlled body movement assistance devices and methods

DOE Office of Scientific and Technical Information (OSTI.GOV)

Leuthardt, Eric C.; Love, Lonnie J.; Coker, Rob

Methods, devices, systems, and apparatus, including computer programs encoded on a computer storage medium, for brain-controlled body movement assistance devices. In one aspect, a device includes a brain-controlled body movement assistance device with a brain-computer interface (BCI) component adapted to be mounted to a user, a body movement assistance component operably connected to the BCI component and adapted to be worn by the user, and a feedback mechanism provided in connection with at least one of the BCI component and the body movement assistance component, the feedback mechanism being configured to output information relating to a usage session of themore » brain-controlled body movement assistance device.« less

Passive control of a biventricular assist device with compliant inflow cannulae.

PubMed

Gregory, Shaun David; Pearcy, Mark John; Timms, Daniel

2012-08-01

Rotary ventricular assist device (VAD) support of the cardiovascular system is susceptible to suction events due to the limited preload sensitivity of these devices. This may be of particular concern with rotary biventricular support (BiVAD) where the native, flow balancing Starling response is diminished in both ventricles. The reliability of sensor and sensorless-based control systems which aim to control VAD flow based on preload has limitations, and, thus, an alternative solution is desired. This study introduces a compliant inflow cannula (CIC) which could improve the preload sensitivity of a rotary VAD by passively altering VAD flow depending on preload. To evaluate the design, both the CIC and a standard rigid inflow cannula were inserted into a mock circulation loop to enable biventricular heart failure support using configurations of atrial and ventricular inflow, and arterial outflow cannulation. A range of left (LVAD) and right VAD (RVAD) rotational speeds were tested as well as step changes in systemic/pulmonary vascular resistance to alter relative preloads, with resulting flow rates recorded. Simulated suction events were observed, particularly at higher VAD speeds, during support with the rigid inflow cannula, while the CIC prevented suction events under all circumstances. The compliant section passively restricted its internal diameter as preload was reduced, which increased the VAD circuit resistance and thus reduced VAD flow. Therefore, a CIC could potentially be used as a passive control system to prevent suction events in rotary left, right, and biventricular support. © 2012, Copyright the Authors. Artificial Organs © 2012, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Long-term left ventricular assist device use before transplantation.

PubMed

Sapirstein, J S; Pae, W E; Aufiero, T X; Boehmer, J P; Pierce, W S

1995-01-01

Between September 1992 and April 1995, 19 patients at the authors' institution received pneumatic, pulsatile left ventricular assist devices (LVADs) for bridging to cardiac transplantation. The mean (+/- SD) age of the patients was 51 +/- 14 years (range, 19-64 years). Nine (47%) patients had end-stage idiopathic cardiomyopathy, five (26%) had ischemic cardiomyopathy, and five (26%) other recipients were in cardiogenic shock caused by acute myocardial infarction (AMI). Fifteen (79%) patients were supported with an intraaortic balloon pump or centrifugal LVAD at the time of LVAD insertion (duration, 5.5 +/- 4.1 days). Aprotinin was given to limit bleeding; heparin, followed by warfarin sodium, was used for anticoagulation. A vigorous exercise and nutrition protocol was followed. Cardiac index averaged 2.94 +/- 0.87 L/min/m2 immediately after the implantation procedure. No patient required placement of a right VAD. Average duration of LVAD support was 45 +/- 39 days (range, 3-153 days). Major complications included bleeding requiring reoperation (three patients); cerebrovascular accident (three patients); and severe dysrhythmias requiring direct current cardioversion (four patients). Fourteen (74%) patients underwent transplantation, with one patient still being mechanically supported. All of the patients receiving transplants were discharged from the hospital. Of the individuals who died while supported with the LVAD, 75% were patients with AMI. Timely application of LVADs as part of the interdisciplinary management of end-stage heart disease has generated excellent results for transplant candidates. Right ventricular dysfunction has not necessitated right VAD placement in the authors' experience. Patients with AMI have a higher risk of death while being supported with the device than do more chronically ill recipients.

Artificial heart and assist devices: directions, needs, costs, societal and ethical issues.

PubMed

Van Citters, R L; Bauer, C B; Christopherson, L K; Eberhart, R C; Eddy, D M; Frye, R L; Jonsen, A R; Keller, K H; Levine, R J; McGoon, D C

1985-11-01

A Working Group appointed by the Director of the National Heart, Lung, and Blood Institute (NHBLI) has reviewed the current status of mechanical circulatory support systems (MCSS), and has examined the potential need for such devices, their cost, and certain societal and ethical issues related to their use. The media have reported the limited clinical investigative use of pneumatically energized total artificial hearts (which actually replace the patient's heart) and left ventricular assist devices (which support or replace the function of the left ventricle by pumping blood from the left heart to the aorta with the patient's heart in place). However, electrically energized systems, which will allow full implantation, permit relatively normal everyday activity, and involve battery exchange or recharge two or three times a day, are currently approaching long-term validation in animals prior to clinical testing. Such long-term left ventricular assist devices have been the primary goal of the NHLBI targeted artificial heart program. Although the ventricular assist device is regarded as an important step in the sequence of MCSS development, the Working Group believes that a fully implantable, long-term, total artificial heart will be a clinical necessity and recommends that the mission of the targeted program include the development of such systems. Past estimates of the potential usage of artificial hearts have been reviewed in the context of advances in medical care and in the prevention of cardiovascular disease. In addition, a retrospective analysis of needs was carried out within a defined population. The resulting projection of 17,000-35,000 cases annually, in patients below age 70, falls within the general range of earlier estimates, but is highly sensitive to many variables. In the absence of an actual base of data and experience with MCSS, projection of costs and prognoses was carried out using explicit sets of assumptions. The total cost of a left ventricular assist device, its implantation and maintenance for a projected average of 4 1/2 years of survival might be approximately $150,000 (in 1983 dollars). The gross annual cost to society could fall in the range of $2.5-$5 billion. Ethical issues associated with use of the artificial heart are not unique. For individual patients these relate primarily to risk-benefit, informed consent, patient selection, and privacy. However, for society as a whole, the larger concern relates to the distribution of national resources.(ABSTRACT TRUNCATED AT 400 WORDS)

Extracorporeal Membrane Oxygenation in Drug Overdose: A Clinical Case Series

PubMed Central

Vignesh, C.; Kumar, Madhan; Venkataraman, Ramesh; Rajagopal, Senthilkumar; Ramakrishnan, Nagarajan; Abraham, Babu K.

2018-01-01

Overdose of cardiovascular medications such as beta blockers and calcium channel blockers cause impaired cardiac contractility, vasoplegia, and/or rhythm disturbances. In addition to conventional management of limiting absorption, increasing elimination and hemodynamic support intravenous (IV) calcium infusion, hyperinsulinemia-euglycemia therapy, glucagon infusion, and IV lipid emulsion have been tried. Extracorporeal circulatory assist device support has been reported as a rescue therapy in overdose refractory to maximal medical therapy. We report three patients with cardiovascular medication overdose presenting with profound cardiovascular instability refractory to medical therapy. Venoarterial extracorporeal membrane oxygenation support (VA ECMO) was initiated to provide hemodynamic support. Despite the occurrence of device-associated complications, the outcome was good and all patients survived. VA ECMO may be considered in patients with severe refractory shock due to cardiotoxic medication overdose. PMID:29531453

Extracorporeal Membrane Oxygenation in Drug Overdose: A Clinical Case Series.

PubMed

Vignesh, C; Kumar, Madhan; Venkataraman, Ramesh; Rajagopal, Senthilkumar; Ramakrishnan, Nagarajan; Abraham, Babu K

2018-02-01

Overdose of cardiovascular medications such as beta blockers and calcium channel blockers cause impaired cardiac contractility, vasoplegia, and/or rhythm disturbances. In addition to conventional management of limiting absorption, increasing elimination and hemodynamic support intravenous (IV) calcium infusion, hyperinsulinemia-euglycemia therapy, glucagon infusion, and IV lipid emulsion have been tried. Extracorporeal circulatory assist device support has been reported as a rescue therapy in overdose refractory to maximal medical therapy. We report three patients with cardiovascular medication overdose presenting with profound cardiovascular instability refractory to medical therapy. Venoarterial extracorporeal membrane oxygenation support (VA ECMO) was initiated to provide hemodynamic support. Despite the occurrence of device-associated complications, the outcome was good and all patients survived. VA ECMO may be considered in patients with severe refractory shock due to cardiotoxic medication overdose.

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

PubMed

Kasparick, Martin; Schmitz, Malte; Andersen, Björn; Rockstroh, Max; Franke, Stefan; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2018-02-23

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

Peripheral Artery Disease and Continuous Flow Left Ventricle Assist Device: An Engaging Complement Analysis May Help to Guide Treatment.

PubMed

Falletta, Calogero; Pasta, Salvatore; Raffa, Giuseppe Maria; Crinò, Francesca; Sciacca, Sergio; Clemenza, Francesco

2018-02-13

Use of continuous flow left ventricle assist device (CF-LVAD) in advanced heart failure (HF) patients results in clinically relevant improvements in survival, functional capacity, and quality of life. Peripheral artery disease (PAD) can occur in patients with CF-LVAD due to the high rate of concomitance between risk factors for atherosclerosis and HF. Diagnosis of PAD can be difficult in the specific setting of a patient supported by this kind of device because of the marked alteration in waveform morphology and velocity created by the artificial physiology of an LVAD. We report the case of a 53-year-old man with HF secondary to ischemic cardiomyopathy supported by the HeartWare HVAD as bridge to transplant, who after the implant developed symptoms suggestive of PAD. We describe additional computational flow analysis for the study of PAD-related hemodynamic disturbances induced by a CF-LVAD. Flow simulations enhance the information of clinical image data, and may have an application in clinical investigations of the risk of hemodynamic disturbances induced by LVAD implantation. © 2018 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Ventricular Assist Device and Destination Therapy Candidates from Preoperative Selection Through End of Hospitalization.

PubMed

Doty, Diane

2015-12-01

Mechanical circulatory support (MCS) devices offer advanced heart failure patients a potential long-term solution. MCS devices implantation is increasing related to the increased volume of heart failure patients, the shortfall of suitable donors, and the advanced technology and smaller size of the devices. To ensure a successful outcome, some key elements must be taken into consideration and managed: patient selection, preoperative preparation, intraoperative care, postoperative care, and posthospital education. The ultimate success of an MCS implantation relies on a multidisciplinary approach and excellent patient/caregiver education in each phase of hospitalization. Copyright © 2015 Elsevier Inc. All rights reserved.

Navigation assistance: a trade-off between wayfinding support and configural learning support.

PubMed

Münzer, Stefan; Zimmer, Hubert D; Baus, Jörg

2012-03-01

Current GPS-based mobile navigation assistance systems support wayfinding, but they do not support learning about the spatial configuration of an environment. The present study examined effects of visual presentation modes for navigation assistance on wayfinding accuracy, route learning, and configural learning. Participants (high-school students) visited a university campus for the first time and took a predefined assisted tour. In Experiment 1 (n = 84, 42 females), a presentation mode showing wayfinding information from eye-level was contrasted with presentation modes showing wayfinding information included in views that provided comprehensive configural information. In Experiment 2 (n = 48, 24 females), wayfinding information was included in map fragments. A presentation mode which always showed north on top of the device was compared with a mode which rotated according to the orientation of the user. Wayfinding accuracy (deviations from the route), route learning, and configural learning (direction estimates, sketch maps) were assessed. Results indicated a trade-off between wayfinding and configural learning: Presentation modes providing comprehensive configural information supported the acquisition of configural knowledge at the cost of accurate wayfinding. The route presentation mode supported wayfinding at the cost of configural knowledge acquisition. Both presentation modes based on map fragments supported wayfinding. Individual differences in visual-spatial working memory capacity explained a considerable portion of the variance in wayfinding accuracy, route learning, and configural learning. It is concluded that learning about an unknown environment during assisted navigation is based on the integration of spatial information from multiple sources and can be supported by appropriate visualization. PsycINFO Database Record (c) 2012 APA, all rights reserved.

Ethical challenges with the left ventricular assist device as a destination therapy

PubMed Central

Rizzieri, Aaron G; Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan L

2008-01-01

The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder) from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1) direct participation of a multidisciplinary care team, including palliative care specialists, (2) a concise plan of care for anticipated device-related complications, (3) careful surveillance and counseling for caregiver burden, (4) advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5) a plan to address the long-term financial burden on patients, families, and caregivers. Short-term mechanical circulatory devices (e.g. percutaneous cardiopulmonary bypass, percutaneous ventricular assist devices, etc.) can be initiated in emergency situations as a bridge to permanent implantation of ventricular assist devices in chronic end-stage heart failure. In the absence of first-person (patient) consent, presumed consent or surrogate consent should be used cautiously for the initiation of short-term mechanical circulatory devices in emergency situations as a bridge to permanent implantation of left ventricular assist devices. Future clinical studies of destination therapy with left ventricular assist devices should include measures of recipients' quality of end-of-life care and caregivers' burden. PMID:18694496

Minimally Invasive Implantation of HeartWare Assist Device and Simultaneous Tricuspid Valve Reconstruction Through Partial Upper Sternotomy.

PubMed

Hillebrand, Julia; Hoffmeier, Andreas; Djie Tiong Tjan, Tonny; Sindermann, Juergen R; Schmidt, Christoph; Martens, Sven; Scherer, Mirela

2017-05-01

Left ventricular assist device (LVAD) implantation is a well-established therapy to support patients with end-stage heart failure. However, the operative procedure is associated with severe trauma. Third generation LVADs like the HeartWare assist device (HeartWare, Inc., Framingham, MA, USA) are characterized by enhanced technology despite smaller size. These devices offer new minimally invasive surgical options. Tricuspid regurgitation requiring valve repair is frequent in patients with the need for mechanical circulatory support as it is strongly associated with ischemic and nonischemic cardiomyopathy. We report on HeartWare LVAD implantation and simultaneous tricuspid valve reconstruction through minimally invasive access by partial upper sternotomy to the fifth left intercostal space. Four male patients (mean age 51.72 ± 11.95 years) suffering from chronic heart failure due to dilative (three patients) and ischemic (one patient) cardiomyopathy and also exhibiting concomitant tricuspid valve insufficiency due to annular dilation underwent VAD implantation and tricuspid valve annuloplasty. Extracorporeal circulation was established via the ascending aorta, superior vena cava, and right atrium. In all four cases the LVAD implantation and tricuspid valve repair via partial median sternotomy was successful. During the operative procedure, no conversion to full sternotomy was necessary. One patient needed postoperative re-exploration because of pericardial effusion. No postoperative focal neurologic injury was observed. New generation VADs are advantageous because of the possibility of minimally invasive implantation procedure which can therefore minimize surgical trauma. Concomitant tricuspid valve reconstruction can also be performed simultaneously through partial upper sternotomy. Nevertheless, minimally invasive LVAD implantation is a challenging operative technique. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Outcomes for Patients With Diabetes After Continuous-Flow Left Ventricular Assist Device Implantation.

PubMed

Vest, Amanda R; Mistak, Stanley M; Hachamovitch, Rory; Mountis, Maria M; Moazami, Nader; Young, James B

2016-10-01

Diabetes mellitus (DM) is a risk factor for mortality among patients with heart failure as well as for patients who undergo cardiothoracic surgery. However it is unknown whether DM is associated with increased mortality or major complications during continuous-flow left ventricular assist device (CF-LVAD) support. We retrospectively reviewed 300 consecutive adults who received CF-LVADs at a single center in the years 2006-2013; 129 patients had DM before LVAD, as defined by American Diabetes Association criteria (HbA1c ≥6.5% and/or taking DM medications). Compared with the non-DM group, DM patients were older, with a higher pre-LVAD body mass index, more ischemic heart failure etiology, and higher pre-LVAD creatinine. Ninety-three patients died on LVAD support, 43 with DM and 50 without DM (P = .4526). After control for 9 covariates in a Cox proportional hazards model, DM was unassociated with all-cause mortality (hazard ratio 0.883, 95% confidence interval 0.571-1.366; P = .5768). Diabetes was also unassociated with the adverse event end points of stroke/transient ischemic attack, intracerebral hemorrhage, pump thrombosis, and device-related infections. Diabetes is common in LVAD recipients (43% of the present cohort) but does not increase mortality or rates of major adverse events during CF-LVAD support. Copyright © 2016 Elsevier Inc. All rights reserved.

21 CFR 884.6140 - Assisted reproduction micropipette fabrication instruments.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Assisted reproduction micropipette fabrication... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction Devices § 884.6140 Assisted reproduction micropipette fabrication instruments. (a) Identification...

21 CFR 884.6140 - Assisted reproduction micropipette fabrication instruments.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Assisted reproduction micropipette fabrication... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction Devices § 884.6140 Assisted reproduction micropipette fabrication instruments. (a) Identification...

Simulation based efficiency prediction of a Brushless DC drive applied in ventricular assist devices.

PubMed

Pohlmann, André; Hameyer, Kay

2012-01-01

Ventricular Assist Devices (VADs) are mechanical blood pumps that support the human heart in order to maintain a sufficient perfusion of the human body and its organs. During VAD operation blood damage caused by hemolysis, thrombogenecity and denaturation has to be avoided. One key parameter causing the blood's denaturation is its temperature which must not exceed 42 °C. As a temperature rise can be directly linked to the losses occuring in the drive system, this paper introduces an efficiency prediction chain for Brushless DC (BLDC) drives which are applied in various VAD systems. The presented chain is applied to various core materials and operation ranges, providing a general overview on the loss dependencies.

Usefulness of Palliative Care to Complement the Management of Patients on Left Ventricular Assist Devices

PubMed Central

Luo, Nancy; Rogers, Joseph G.; Dodson, Gwen C.; Patel, Chetan B.; Galanos, Anthony N.; Milano, Carmelo A.; O’Connor, Christopher M.; Mentz, Robert J.

2016-01-01

Within the last decade, advancements in left ventricular assist device (LVAD) therapy have allowed end-stage heart failure patients to live longer and with better quality of life. Like other life-saving interventions, however, there remains the risk of complications including infections, bleeding episodes, and stroke. The candidate for LVAD therapy faces complex challenges going forward, both physical and psychological, many of which may benefit from the application of palliative care principles by trained specialists. Despite these advantages, palliative care remains underused in many advanced heart failure programs. Here, we describe the benefits of palliative care, barriers to use within heart failure, and specific applications to the integrated care of patients on mechanical circulatory support. PMID:27474339

American Nurses Association position statement on elimination of manual patient handling to prevent work-related musculoskeletal disorders.

PubMed

In order to establish a safe environment for nurses and patients, the American Nurses Association (ANA) supports actions and policies that result in the elimination of manual patient handling. Patient handling, such as lifting, repositioning, and transferring, has conventionally been performed by nurses. The performance of these tasks exposes nurses to increased risk for work-related musculoskeletal disorders. With the development of assistive equipment, such as lift and transfer devices, the risk of musculoskeletal injury can be significantly reduced. Effective use of assistive equipment and devices for patient handling creates a safe healthcare environment by separating the physical burden from the nurse and ensuring the safety, comfort, and dignity of the patient.

The Effect of Preoperative Cognitive Behavior and Exercise Therapy for a Patient With an Implanted Left Ventricular Assist Device in Korea.

PubMed

Seo, Yong Gon; Park, Won Hah; Jeon, Eun Seok; Sung, Ji Dong; Jang, Mi Ja

2017-10-01

Left ventricular assist devices (LVADs) are used in patients with progressive heart failure symptoms to provide circulatory support. Patients with LVADs are referred to inpatient cardiac rehabilitation to prevent postoperative complications and improve aerobic capacity and quality of life. Preoperative exercise therapy for cardiac patients is an emerging treatment modality, and several studies have reported that it improves postoperative outcomes, such as length of hospital stay and postoperative complications. This case report describes the benefits of preoperative cognitive behavioral and exercise therapy in a Korean patient undergoing LVAD implantation. V. Copyright © 2017 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Ventricular fibrillation in an ambulatory patient supported by a left ventricular assist device: highlighting the ICD controversy.

PubMed

Boilson, Barry A; Durham, Lucian A; Park, Soon J

2012-01-01

Left ventricular assist devices (LVADs) provide an effective means of managing advanced pump failure as a means of bridging to cardiac transplantation or as permanent therapy. Although ventricular arrhythmias remain common post-LVAD implantation, such therapy may allow malignant arrhythmias to be tolerated hemodynamically. This report describes the clinical findings in a patient who had likely been in a ventricular tachyarrhythmia for several days and presented in ventricular fibrillation, ambulatory, and mentating normally. This report, with previous similar reports, is additive to the body of evidence that LVADs alter the physiologic impact of ventricular arrhythmias in advanced heart failure and highlights the need for thoughtful programming of implantable cardioverter defibrillator therapies in these patients.

Exercise therapy for an older patient with left ventricular assist device.

PubMed

Park, Won Hah; Seo, Yong Gon; Sung, Ji Dong

2014-06-01

A left ventricular assist device (LVAD) is a mechanical circulation support implanted for patients with end-stage heart failure. It may be used either as a bridge to cardiac transplantation or as a destination therapy. The health of a 75-year-old man with a medical history of systolic heart failure worsened. Therefore, he was recommended to have implanted a LVAD (Thoratec Corp.) as a destination therapy. After the surgery, he was enrolled in patient cardiac rehabilitation for the improvement of dyspnea and exercise capacity. In results, there is an improvement on his exercise capacity and quality of life. For the first time in Korea, we reported a benefit of exercise therapy after being implanted with a LVAD.

Assistive devices alter gait patterns in Parkinson disease: advantages of the four-wheeled walker.

PubMed

Kegelmeyer, Deb A; Parthasarathy, Sowmya; Kostyk, Sandra K; White, Susan E; Kloos, Anne D

2013-05-01

Gait abnormalities are a hallmark of Parkinson's disease (PD) and contribute to fall risk. Therapy and exercise are often encouraged to increase mobility and decrease falls. As disease symptoms progress, assistive devices are often prescribed. There are no guidelines for choosing appropriate ambulatory devices. This unique study systematically examined the impact of a broad range of assistive devices on gait measures during walking in both a straight path and around obstacles in individuals with PD. Quantitative gait measures, including velocity, stride length, percent swing and double support time, and coefficients of variation were assessed in 27 individuals with PD with or without one of six different devices including canes, standard and wheeled walkers (two, four or U-Step). Data were collected using the GAITRite and on a figure-of-eight course. All devices, with the exception of four-wheeled and U-Step walkers significantly decreased gait velocity. The four-wheeled walker resulted in less variability in gait measures and had less impact on spontaneous unassisted gait patterns. The U-Step walker exhibited the highest variability across all parameters followed by the two-wheeled and standard walkers. Higher variability has been correlated with increased falls. Though subjects performed better on a figure-of-eight course using either the four-wheeled or the U-Step walker, the four-wheeled walker resulted in the most consistent improvement in overall gait variables. Laser light use on a U-Step walker did not improve gait measures or safety in figure-of-eight compared to other devices. Of the devices tested, the four-wheeled-walker offered the most consistent advantages for improving mobility and safety. Copyright © 2012 Elsevier B.V. All rights reserved.

Rail-Highway Crossing Warning Device Life Cycle Cost Analysis

DOT National Transportation Integrated Search

1980-09-01

The Highway Safety Acts of 1973 and 1976, and the Surface Transportation Assistance Act of 1978 provide funds to individual states to improve safety at public rail-highway crossings. This report was undertaken in support of a U.S. DOT effort to impro...

Discontinuation of antithrombotic therapy for a year or more in patients with continuous-flow left ventricular assist devices.

PubMed

Pereira, Naveen L; Chen, Dong; Kushwaha, Sudhir S; Park, Soon J

2010-10-01

The recommended anticoagulation regimen during continuous-flow axial left ventricular assist device (LVAD) support is aspirin and warfarin with a targeted international normalized ratio of 2.0-3.0. We report two patients in whom recurrent gastrointestinal bleeding during LVAD support necessitated discontinuation of this anti-thrombotic regimen for a year or more. Despite this, neither patients developed thrombotic complications during 29 patient-months of follow-up. An acquired von Willebrand factor (VWF) abnormality reflected by the absence or decreased abundance of the highest molecular weight multimers was demonstrated in both patients. The gold standard test for platelet function, light transmission platelet aggregometry was measured in one patient and was normal, indicative that the predominant abnormality in the coagulation profile of these patients is an acquired VWF syndrome. Clinical trials are required to address the question whether it is safe to discontinue anticoagulation in LVAD patients with acquired VWF abnormalities.

14 CFR 382.131 - Do baggage liability limits apply to mobility aids and other assistive devices?

Code of Federal Regulations, 2014 CFR

2014-01-01

... mobility aids and other assistive devices? 382.131 Section 382.131 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.131 Do baggage liability limits apply to mobility aids and other assistive devices? With...

14 CFR 382.131 - Do baggage liability limits apply to mobility aids and other assistive devices?

Code of Federal Regulations, 2013 CFR

2013-01-01

... mobility aids and other assistive devices? 382.131 Section 382.131 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.131 Do baggage liability limits apply to mobility aids and other assistive devices? With...

14 CFR 382.131 - Do baggage liability limits apply to mobility aids and other assistive devices?

Code of Federal Regulations, 2012 CFR

2012-01-01

... mobility aids and other assistive devices? 382.131 Section 382.131 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.131 Do baggage liability limits apply to mobility aids and other assistive devices? With...

Assistive Financing for Assistive Devices: Loan Guarantees for Purchase of Products by Persons with Disabilities. EIF/REC Review Paper.

ERIC Educational Resources Information Center

Reeb, Kenneth G., Jr.

This paper introduces the concept of assistive financing for assistive devices for persons with disabilities, and describes model programs that have pioneered implementation of the concept in the assistive device marketplace. The assistive financing or loan guarantee concept is presented as a partnership between a private financial institution and…

Hemodynamic Performance of a Novel Right Ventricular Assist Device (PERKAT).

PubMed

Kretzschmar, Daniel; Schulze, P Christian; Ferrari, Markus W

Acute right ventricular failure (RVF) is an increasing clinical problem and a life-threatening condition. Right ventricular assist devices represent a reasonable treatment option for patients with refractory RVF. We here present a novel percutaneously implantable device for right ventricular support. The PERKAT device is based on a nitinol stent cage, which is covered with valve-carrying foils. A flexible outlet trunk with a pigtail tip is connected to the distal part. The device is driven by an intra-aortic balloon pump (IABP) drive unit, which inflates/deflates a standard IABP-balloon placed within the stent cage. In-vitro evaluation was done in a liquid bath containing water or blood analog. The PERKAT device was tested in different afterload settings using two different IABP-balloons and varying inflation/deflation rates. We detected flow rates ranging from 1.97 to 3.93 L/min depending on the afterload setting, inflation/deflation rate, balloon size, and the medium used. Flow rates between water and blood analog were nearly comparable, and in the higher inflation/deflation rate settings slightly higher with water. Based on this promising in vitro data, the innovative percutaneously implantable PERKAT device has a potential to become a therapeutic option for patients with RVF refractory to medical treatment.

Multimedia CALLware: The Developer's Responsibility.

ERIC Educational Resources Information Center

Dodigovic, Marina

The early computer-assisted-language-learning (CALL) programs were silent and mostly limited to screen or printer supported written text as the prevailing communication resource. The advent of powerful graphics, sound and video combined with AI-based parsers and sound recognition devices gradually turned the computer into a rather anthropomorphic…

Fiber Bragg grating sensor-based communication assistance device

NASA Astrophysics Data System (ADS)

Padma, Srivani; Umesh, Sharath; Pant, Shweta; Srinivas, Talabattula; Asokan, Sundarrajan

2016-08-01

Improvements in emergency medicine in the form of efficient life supporting systems and intensive care have increased the survival rate in critically injured patients; however, in some cases, severe brain and spinal cord injuries can result in a locked-in syndrome or other forms of paralysis, and communication with these patients may become restricted or impossible. The present study proposes a noninvasive, real-time communication assistive methodology for those with restricted communication ability, employing a fiber Bragg grating (FBG) sensor. The communication assistive methodology comprises a breath pattern analyzer using an FBG sensor, which acquires the exhalation force that is converted into strain variations on a cantilever. The FBG breath pattern analyzer along with specific breath patterns, which are programmed to give specific audio output commands, constitutes the proposed fiber Bragg grating sensor-based communication assistive device. The basic communication can be carried out by instructing the patients with restricted communication ability to perform the specific breath patterns. The present approach is intended to be an alternative to the common approach of brain-computer interface in which an instrument is utilized for learning of brain responses.

Effect of Caregiver Driven Robot-Assisted In-Ward Training in Subacute Stroke Patients: A Case Series

PubMed Central

2018-01-01

Objective To evaluate the effect of caregiver driven robot-assisted in-ward training in subacute stroke patients. Methods A retrospective evaluation was performed for patients treated with caregiver driven robot-assisted in-ward training to retain gait function from June 2014 and December 2016. All patients received more than 2 weeks of caregiver driven robot-assisted in-ward training after undergoing conventional programs. The robot was used as a sitting device, a standing frame, or a high-walker depending on functional status of the patient. Patients were evaluated before and after robot training. Patient records were assessed by Korean version of Modified Barthel Index (K-MBI), Functional Independence Measure (FIM), and Functional Ambulation Category (FAC). Results Initially, patients used the robot as a sitting device (n=6), a standing frame (n=7), or a partial body-weight support high-walker (n=2). As patient functions were improved, usage level of the robot was changed to the next level. At the end of the treatment, the robot was used as a sitting device (n=1), a standing frame (n=6), or high-walker (n=8). Scores of K-MBI (Δ17.47±10.72) and FIM (Δ19.80±12.34) were improved in all patients. Conclusion Patients' usage level of the robot and functional scores were improved. Therefore, performing additional caregiver driven robot-assisted in-ward training is feasible and beneficial for subacute stroke patients. PMID:29765872

Effect of Caregiver Driven Robot-Assisted In-Ward Training in Subacute Stroke Patients: A Case Series.

PubMed

Kim, Sang Beom; Lee, Kyeong Woo; Lee, Jong Hwa; Lee, Sook Joung; Park, Jin Gee; Park, Joo Won

2018-04-01

To evaluate the effect of caregiver driven robot-assisted in-ward training in subacute stroke patients. A retrospective evaluation was performed for patients treated with caregiver driven robot-assisted in-ward training to retain gait function from June 2014 and December 2016. All patients received more than 2 weeks of caregiver driven robot-assisted in-ward training after undergoing conventional programs. The robot was used as a sitting device, a standing frame, or a high-walker depending on functional status of the patient. Patients were evaluated before and after robot training. Patient records were assessed by Korean version of Modified Barthel Index (K-MBI), Functional Independence Measure (FIM), and Functional Ambulation Category (FAC). Initially, patients used the robot as a sitting device (n=6), a standing frame (n=7), or a partial body-weight support high-walker (n=2). As patient functions were improved, usage level of the robot was changed to the next level. At the end of the treatment, the robot was used as a sitting device (n=1), a standing frame (n=6), or high-walker (n=8). Scores of K-MBI (Δ17.47±10.72) and FIM (Δ19.80±12.34) were improved in all patients. Patients' usage level of the robot and functional scores were improved. Therefore, performing additional caregiver driven robot-assisted in-ward training is feasible and beneficial for subacute stroke patients.

Water surface assisted synthesis of large-scale carbon nanotube film for high-performance and stretchable supercapacitors.

PubMed

Yu, Minghao; Zhang, Yangfan; Zeng, Yinxiang; Balogun, Muhammad-Sadeeq; Mai, Kancheng; Zhang, Zishou; Lu, Xihong; Tong, Yexiang

2014-07-16

A kind of multiwalled carbon-nanotube (MWCNT)/polydimethylsiloxane (PDMS) film with excellent conductivity and mechanical properties is developed using a facile and large-scale water surface assisted synthesis method. The film can act as a conductive support for electrochemically active PANI nano fibers. A device based on these PANI/MWCNT/PDMS electrodes shows good and stable capacitive behavior, even under static and dynamic stretching conditions. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support).

PubMed

Jorde, Ulrich P; Kushwaha, Sudhir S; Tatooles, Antone J; Naka, Yoshifumi; Bhat, Geetha; Long, James W; Horstmanshof, Douglas A; Kormos, Robert L; Teuteberg, Jeffrey J; Slaughter, Mark S; Birks, Emma J; Farrar, David J; Park, Soon J

2014-05-06

A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. New device technology developed in the clinical research setting requires validation in a real-world setting. The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Assistive Listening Devices: A Report of the National Task Force on Quality of Services in the Postsecondary Education of Deaf and Hard of Hearing Students.

ERIC Educational Resources Information Center

Warick, Ruth; Clark, Catherine; Dancer, Jesse; Sinclair, Stephen

This report examines the use of auditory assistive listening devices by students who are hard of hearing or deaf in the postsecondary educational setting. Individual sections address the following topics: (1) distinctions between hearing aids and assistive listening devices; (2) assistive listening devices and the college student; (3) types of…

Comparative Study of Continuous and Pulsatile Left Ventricular Assist Devices on Hemodynamics of a Pediatric End-to-Side Anastomotic Graft

PubMed Central

Yang, Ning; Deutsch, Steven; Paterson, Eric G.; Manning, Keefe B.

2013-01-01

Although there are many studies that focus on understanding the consequence of pumping mode (continuous vs. pulsatile) associated with ventricular assist devices (VADs) on pediatric vascular pulsatility, the impact on local hemodynamics has been largely ignored. Hence, we compare not only the hemodynamic parameters indicative of pulsatility but also the local flow fields in the aorta and the great vessels originating from the aortic arch. A physiologic graft anastomotic model is constructed based on a pediatric, patient specific, aorta with a graft attached on the ascending aorta. The flow is simulated using a previously validated second-order accurate Navier–Stokes flow solver based upon a finite volume approach. The major findings are: (1) pulsatile support provides a greater degree of vascular pulsatility when compared to continuous support, which, however, is still 20% less than pulsatility in the healthy aorta; (2) pulsatile support increases the flow in the great vessels, while continuous support decreases it; (3) complete VAD support results in turbulence in the aorta, with maximum principal Reynolds stresses for pulsatile support and continuous support of 7081 and 249 dyn/cm2, respectively; (4) complete pulsatile support results in a significant increase in predicted hemolysis in the aorta; and (5) pulsatile support causes both higher time-averaged wall shear stresses (WSS) and oscillatory shear indices (OSI) in the aorta than does continuous support. These findings will help to identify the risk of graft failure for pediatric patients with pulsatile and continuous VADs. PMID:24348881

Pruning a decision tree for selecting computer-related assistive devices for people with disabilities.

PubMed

Chi, Chia-Fen; Tseng, Li-Kai; Jang, Yuh

2012-07-01

Many disabled individuals lack extensive knowledge about assistive technology, which could help them use computers. In 1997, Denis Anson developed a decision tree of 49 evaluative questions designed to evaluate the functional capabilities of the disabled user and choose an appropriate combination of assistive devices, from a selection of 26, that enable the individual to use a computer. In general, occupational therapists guide the disabled users through this process. They often have to go over repetitive questions in order to find an appropriate device. A disabled user may require an alphanumeric entry device, a pointing device, an output device, a performance enhancement device, or some combination of these. Therefore, the current research eliminates redundant questions and divides Anson's decision tree into multiple independent subtrees to meet the actual demand of computer users with disabilities. The modified decision tree was tested by six disabled users to prove it can determine a complete set of assistive devices with a smaller number of evaluative questions. The means to insert new categories of computer-related assistive devices was included to ensure the decision tree can be expanded and updated. The current decision tree can help the disabled users and assistive technology practitioners to find appropriate computer-related assistive devices that meet with clients' individual needs in an efficient manner.

Levitronix bilateral ventricular assist device, a bridge to recovery in a patient with acute fulminant myocarditis and concomitant cerebellar infarction.

PubMed

Huang, Yi-Fan; Hsu, Po-Shun; Tsai, Chien-Sung; Tsai, Yi-Ting; Lin, Chih-Yuan; Ke, Hong-Yan; Lin, Yi-Chang; Yang, Hsiang-Yu

2018-02-07

We report on the case of a 27-year-old male who presented to our emergency room with chest tightness, dyspnoea and cold sweats. The 12-lead electrocardiogram showed diffuse ventricular tachycardia with wide QRS complexes. Troponin-I level was elevated to 100 ng/ml. The coronary angiogram showed good patency of all three coronary vessels, and acute fulminant myocarditis was suspected. The patient underwent cardiopulmonary resuscitation in the catheter room and high-dose inotropic support was initiated to stabilise his haemodynamic status. After resuscitation, the patient was in a coma and acute stroke was highly suspected. In addition, deteriorating cardiogenic shock with acute renal failure and pulmonary oedema were also detected. Due to haemodynamic compromise despite high-dose inotropic support, a Levitronix ® bilateral ventricular assist device (Bi-VAD) was implanted on an emergency basis for circulatory support. Postoperative brain computed tomography revealed acute left cerebellar infarction. Because the patient had left cerebellar infarction with right hemiplegia, heart transplantation was contraindicated. Eventually, cardiac systolic function recovered well and the patient underwent successful Bi-VAD removal after a total of 18 days on Levitronix ® haemodynamic support. He was weaned from the ventilator two weeks later and was discharged 10 days later.

Content Analysis of Social Media Related to Left Ventricular Assist Devices.

PubMed

Kostick, Kristin M; Blumenthal-Barby, Jennifer S; Wilhelms, Lidija A; Delgado, Estevan D; Bruce, Courtenay R

2015-09-01

Social media have the potential to offer important benefits for patient education, support, and shared decision making. Despite the proliferation of social media use during the past decade, little is known about the scope and quality of available information, or the purposes that social media sites serve for patient decisional and support needs. We conducted a mixed method study, including content analysis of social media and principal components analysis analysis of data sites discussing left ventricular assist device treatment for heart failure. This study explored aspects of interactivity, user-friendliness, appeal, medium, purpose, audience, and accuracy of information. Higher levels of interactivity (eg, posting comments) seem to enhance the appeal and usability of available information but also introduce greater potential for inaccuracy and inconsistency. The current lack of oversight into the content and quality of available information constitute a challenge for the reliable use of social media as forums for information-seeking and social network-based support. We conclude that social media outlets constitute a promising source of informational and psychosocial support for patients, caregivers, and candidates, and if used in conjunction with patient-provider dialog, can contribute to informed decision making by facilitating reflection and discussion of personal concerns, values, and informational needs. © 2015 American Heart Association, Inc.

Effects of continuous and pulsatile flows generated by ventricular assist devices on renal function and pathology.

PubMed

Miyamoto, Takuma; Karimov, Jamshid H; Fukamachi, Kiyotaka

2018-03-01

Continuous-flow (CF) left ventricular assist devices (LVADs) are widely used to treat end-stage heart failure. Despite substantial improvement in clinical results, numerous complications remain associated with this technology. Worsening renal function is one, associated with morbidity and mortality in patients supported by CF LVADs. The effects of CF LVAD support on renal function have been investigated since the mid-1990s by many research groups. Area covered: We review the current status of LVAD therapy, experimental results regarding the effects of types of flow generated by LVADs on renal function and pathology, changes in renal function after LVAD implant, the influence of renal function on outcomes, and risk factors for renal dysfunction post implant. This information was obtained through online databases and direct extraction of single studies. Expert commentary: Immediately after CF LVAD implantation, renal function improves temporarily as patients recover from the kidneys' previously low perfusion and congestive state. However, many studies have shown that this initially recovered renal function gradually declines during long-term CF LVAD support. Although it is known that CF LVAD support adversely affects renal function over the long term, just how it does has not yet been clearly defined in terms of clinical symptoms or signs.

Long-Term Survival in Patients Receiving a Continuous-Flow Left Ventricular Assist Device.

PubMed

Gosev, Igor; Kiernan, Michael S; Eckman, Peter; Soleimani, Behzad; Kilic, Ahmet; Uriel, Nir; Rich, Jonathan D; Katz, Jason N; Cowger, Jennifer; Lima, Brian; McGurk, Siobhan; Brisco-Bacik, Meredith A; Lee, Sanjin; Joseph, Susan M; Patel, Chetan B

2018-03-01

Long-term survivors after implantation of left ventricular assist devices (LVADs) are increasing in prevalence. We describe the characteristics and outcomes in patients surviving longer than 4 years on LVAD support. We performed a multicenter, retrospective analysis of patients surviving at least 4 years on continuous-flow LVAD (CF-LVAD) support with a HeartMate II at centers participating in the Evolving Mechanical support Research Group. Between 2005 and 2010, 156 long-term survivors were identified with a mean survival of 7.1 years (95% confidence interval: 6.7 to 7.5 years). The mean age was 58.2 ± 15.2 years and 30.1% were women. Readmission rate was low at 1.1 events per patient per year with the most common reasons leading to readmission being infection (0.10 readmissions per patient per year) and gastrointestinal bleeding (0.07 readmissions per patient per year). Two years after implantation, 97% of patients were either New York Heart Association functional class I or II, with 92% at 4 years. Patients surviving 4 years on CF-LVAD support can anticipate ongoing long-term survival with sustained improvements in functionality and low rates of rehospitalization. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

The Ventricular Assist Device in the Life of the Child: A Phenomenological Pediatric Study.

PubMed

van Manen, Michael A

2017-05-01

What is it like for a child to live with an artificial heart? The use of some medical therapies in children requires developmental considerations, is associated with psychosocial consequences, and calls for ethical sensitivities. A critical case is the ventricular assist device (VAD), a mechanical pump used to support the functioning of a failing heart. As a pediatric therapy, the device can be used as a temporary solution for poor heart function, a bridge to transplantation or recovery, or as a destination therapy. While the mechanical-technical operation of the VAD is well understood, the clinical-technical aspects of young people living with this device are largely unexplored. Drawing on interviews of school-aged children, the aim of this phenomenological study is to explore how a VAD may structure or condition a child's meaningful experience of their world outside the hospital. The driveline of an implanted VAD is the peripheral attachment, extruding through the skin to connect the controller-power supply. The materiality of the device may be interruptive, restrictive, and disturbing to the psycho-physical being and sense of self-identity of the child as a child. And while a child equipped with a VAD is not necessarily conspicuous among other children, the child may experience the device as an exposing presence, while living with the worry of a caregiver who takes on the role not simply of parent but of watchful health professional. A phenomenological understanding of the VAD should assist parents and caregiving health professionals knowing how to deal with specific issues arising in the life of the VAD child.

Impella 5.0 Support in INTERMACS II Cardiogenic Shock Patients Using Right and Left Axillary Artery Access.

PubMed

Schibilsky, David; Lausberg, Henning; Haller, Christoph; Lenglinger, Matthias; Woernle, Barbara; Haeberle, Helene; Rosenberger, Peter; Walker, Tobias; Schlensak, Christian

2015-08-01

The catheter-based Impella 5.0 left ventricular assist device (LVAD) is a powerful and less invasive alternative for patients in cardiogenic shock. The use of this device as a primary mechanical circulatory support strategy in INTERMACS II patients should be evaluated. From April 2014 to August 2014, eight Impella 5.0 devices were implanted in seven patients via the axillary artery access (six right and two left). We analyzed the outcome of the four patients in whom the Impella 5.0 device was implanted for the purpose of primary stabilization of cardiogenic shock (INTERMACS II). The remaining three patients had a contraindication for a permanent LVAD and received the device for prolonged weaning from extracorporeal life support (ECLS) system. The implantation of the Impella 5.0 was technically successful in all patients and resulted in the stabilization of the clinical situation. All four patients could be bridged to a long-term device (n = 3) or to cardiac recovery (n = 1). In one patient, 2 days of ECLS support was necessary because of pump thrombosis after 31 days of Impella 5.0 support. One patient with bronchopneumonia had the Impella 5.0 exchanged from the right to the left axillary artery after 22 days of support because of the progressive loss of purge flow and the need for longer bridging to a permanent LVAD. The last patient was supported for giant-cell myocarditis for 22 days and bridged to cardiac recovery. All patients were transferred to the intensive care unit with the Impella device in place. In INTERMACS II situations, the implantation of the Impella 5.0 via the right or left axillary access allowed additional time for decision making. Early patient mobilization, including walking with the Impella device in place, optimized the conditions for either weaning or the implantation of a permanent LVAD. This novel technique of left axillary approach leads to more flexibility in the case of anatomical- or device-related contraindications to right-side access, or when the device needs to be exchanged while continuous support is necessary. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Management of pump thrombosis in patients with left ventricular assist devices.

PubMed

Stulak, John M; Sharma, Shashank; Maltais, Simon

2015-04-01

The gradual evolution of left ventricular assist device (LVAD) therapy has resulted in a durable option for patients as either a bridge to transplantation (BTT) or a destination therapy (DT). Outcomes with current continuous-flow devices continue to demonstrate significant patient benefit, not only in enhanced survival but also in improved functional capacity and quality of life. While the lessening of adverse events through time has resulted in more widespread adoption of this therapy, there continues to be unintended consequences, including, most notably, infection, bleeding, and thrombosis. Beginning in 2011, centers and collaborative groups began to observe a significant increase in the incidence of pump thrombosis with the HeartMate II LVAD (Thoratec Corp., Pleasanton, CA, USA). However, this clinical scourge is not limited to the HeartMate II, as the HeartWare Ventricular Assist System (HVAD; HeartWare Inc., Framingham, MA, USA) has also had these same issues, which led to pump modifications and the appreciation of more strict control of blood pressure and anticoagulation with this pump design. We review the current status of the field of mechanical circulatory support in its approach to diagnosis, management, and prevention of LVAD pump thrombosis.

Design of Mechanism for Assisting Standing Movement Using Planar Linkage and Gear Train

NASA Astrophysics Data System (ADS)

Nango, Jun; Yoshizawa, Hisato; Liu, Jiajun

The number of people who are in need of nursing care due to difficulties they experience with performing various activities of daily living is increasing. In particular, the action of standing up is performed frequently in daily life, and this action starts to induce pain in joints as people age. In this research, we develop a device whose seat plate follows the movement of the thigh in the action of standing up for the purpose of relieving the burden from the joints and reducing the effort associated with nursing care. The device is designed by using a planar five-link mechanism and a gear train, and only a single input is needed to drive the device. The respective lengths of the links are determined by comparing the movement of the seat plate of the device with the movement of the human thigh in the action of standing up. In addition, this device is expected to be useful for assisting users in standing up in a natural manner, including in the case when the body remains supported by the seat plate, as well as for guiding the individual movements of users in the action of standing up.

Hemodynamic guidelines for design and control of a turbodynamic pediatric ventricular assist device.

PubMed

Uber, Bronwyn E; Webber, Steven A; Morell, Victor O; Antaki, James F

2006-01-01

The design of mechanical circulatory support devices typically requires a priori knowledge of the hemodynamic requirements of their intended use. These requirements are difficult to determine because of limited clinical experience. This is especially true for the pediatric population, for whom there is a dearth of longitudinal data. This report aims to provide both engineers and physicians with benchmarks for determining the optimal flow requirements and settings for pediatric ventricular assist devices that are currently being developed. Criteria were developed on the basis of estimates derived from various sources. The potential patient population was estimated by using the prevalence of children on the heart transplant waiting list and those placed on extracorporeal membrane oxygenation. Cardiac outputs were determined for individual weights and body surface areas, using published values for healthy and sick pediatric patients. The recommended pump range was optimized to include the most patients, while considering the design constraints. This study identifies a significant population of patients who would benefit from a device providing 0.52 to 1.92 l/min.

Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA

PubMed Central

Gallas, Brandon D.; Chan, Heang-Ping; D’Orsi, Carl J.; Dodd, Lori E.; Giger, Maryellen L.; Gur, David; Krupinski, Elizabeth A.; Metz, Charles E.; Myers, Kyle J.; Obuchowski, Nancy A.; Sahiner, Berkman; Toledano, Alicia Y.; Zuley, Margarita L.

2017-01-01

This report summarizes the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices. The purpose of the workshop was to gather information on the current state of the science and facilitate consensus development on statistical methods and study designs for the evaluation of imaging devices to support US Food and Drug Administration submissions. Additionally, participants expected to identify gaps in knowledge and unmet needs that should be addressed in future research. This summary is intended to document the topics that were discussed at the meeting and disseminate the lessons that have been learned through past studies of imaging and computer-aided detection and diagnosis device performance. PMID:22306064

Left ventricular assist device exchange: the Toronto General Hospital experience.

PubMed

Tsubota, Hideki; Ribeiro, Roberto V P; Billia, Filio; Cusimano, Robert J; Yau, Terrence M; Badiwala, Mitesh V; Stansfield, William E; Rao, Vivek

2017-08-01

As support times for left ventricular assist devices (LVADs) become longer, several complications requiring device exchange may occur. To our knowledge, this is the first Canadian report regarding implantable LVAD exchange. We retrospectively reviewed the cases of consecutive, unique patients implanted with an LVAD between June 2006 and October 2015 at Toronto General Hospital. In total, 122 patients were impanted with an LVAD during the study period. Eight patients required LVAD exchange, and 1 patient had 2 replacements (9 of 122, 7.3%). There were 7 HeartMate II (HMII), 1 HVAD and 1 DuraHeart pumps exchanged. Two of these exchanges occurred early at the time of initial implant, whereas 7 occurred late (range 8-623 d). Six exchanges were made owing to pump thrombosis. Of the 3 exchanges made for other causes, 1 HMII exchange was owing to a driveline fracture, 1 DuraHeart patient had early inflow obstruction requiring exchange to HMII at the initial implant, and the third had a suspected inflow obstruction with no evidence of thrombosis at the time of the procedure. The mean support time before exchange was 225 days, and time from exchange to transplant, death or ongoing support was 245 days. Three patients were successfully bridged to transplant, and at the time of data collection 2 were supported awaiting transplant. Three patients died after a mean duration of 394.3 days (range 78-673 d) of support postreplacement. Four cases were successfully performed using a subcostal approach. Pump thrombosis is the most common cause for LVAD exchange, which can be performed with acceptable morbidity and mortality. The subcostal approach may be the preferred procedure for an HMII exchange when indicated.

Driveline infections in left ventricular assist devices: implications for destination therapy.

PubMed

Sharma, Vikas; Deo, Salil V; Stulak, John M; Durham, Lucian A; Daly, Richard C; Park, Soon J; Baddour, Larry M; Mehra, Kashish; Joyce, Lyle D

2012-11-01

Infection is one of the major limitations to successful long-term support after ventricular assist device implantation. There are limited data specifically examining the incidence and predictors of driveline infections (DLI), with a changing treatment paradigm toward destination therapy (DT) and longer duration of support. Between January 2007 and 2011, 143 patients underwent HeartMate II (Thoratec, Pleasanton, CA) implantation, with 87 (61%) as DT. Driveline maintenance strategy included sterile dressing changes with chlorhexidine and saline application, without prophylactic oral antibiotics. DLI developed in 18 patients (12%) at a median of 182 days (range, 26 to 1,138 days) after implantation, among which 12 (66%) were from the DT cohort. Infections were superficial in 15 (82%) and deep in 3 (18%). Trauma was documented in 6 patients (33%). Seven patients (38%) needed readmission for DLI. Surgical debridement was needed in 3 (17%). All patients were managed successfully, without the need for device explantation or urgent cardiac transplantation. No patient required continuous antibiotic prophylaxis after the infection subsided. Risk factor analysis identified duration of support as the only independent predictor of infection (mean. 600 vs 390 days; p = 0.03). The odds of having a DLI rose by 4% for every month of support. Longer duration of support significantly increased the risk of DLI and hence increased the risk of DLI in patients with DT. DLI may be successfully managed with antibiotics and local wound care. Most of the infections were superficial, and progression to deep pocket or pump infection is rare in our experience. Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

[Psychological evaluation and support in patients with left ventricular assist devices: preliminary data at 6-month follow-up].

PubMed

Voltolini, Alessandra; Minotti, Anna; Verde, Alessandro; Cipriani, Manlio; Garascia, Andrea; Turazza, Fabio; Macera, Francesca; Perna, Enrico; Russo, Claudio F; Fumagalli, Emilia; Frigerio, Maria

2016-11-01

Heart disease has an impact on patient's identity and self-perception. Taking into account the wide literature about psychological aspects before and after heart transplant, it clearly emerges that there is a lack of data and results for patients up to implantation of ventricular assist devices (VAD). The aim of the present study was to explore quality of life and factors correlated with psychological adjustment in patients supported with VAD. From February 2013 to August 2014, 18 patients (17 male, mean age 57 years) under clinical evaluation before and after VAD implantation were enrolled. During interviews, patients were assessed with EuroQoL-5D questionnaire to monitor improvement of quality of life before implantation and at 3 and 6 months; critical issues, needs and point of views of patients have been described. A significant improvement in the quality of life score was observed at 3 (score 38 [interquartile range 30-40] vs 75 [60-80], p<0.05) and 6 months (38 [30-40] vs 70 [60-80], p<0.05). Overall, patients' psychological state investigated by the test showed a clear and positive trend. All patients need to empower through complete information about the device, related risks and life expectancy. Interdisciplinary approach improved compliance with therapy. Successful treatment and efficient psychological care are closely related to assessment and continuous clinical support. This approach ensures a better selection of patients and improves their compliance. Further data are needed to support our preliminary observations and to explore long-term quality of life.

50 CFR 300.21 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... North America along the 40° N. latitude parallel, and connecting the following coordinates: 40° N. lat... device (FAD) means a manmade raft or other floating object used to attract tuna and make them available... assisting or supporting a vessel engaged in fishing, except purse seine skiffs. Floating object means any...

Designing e-Education Supports in e-Health Based Systems

ERIC Educational Resources Information Center

Nicholas, Ikhu-Omoregbe

2008-01-01

The inadequate availability of medical information has often made health care services in many developing countries cumbersome with enormous paper work, waste of life, time and resources, long queues, and ineffective treatment procedures. The use of mobile technology devices such as Personal Digital Assistants, Cell phone, Tablet PCs, etc. for…

Optoelectronic Workshops. 11. Superlattice Disordering

DTIC Science & Technology

1988-12-07

modulator ref.: Wood, JLWT §9, p743 (6/88) AaMQW =50x &acGaAs bulk (is comparable to LINbO3) residual aborption for typical device = 2 dB typical device...band edge due to unacceptable aborption losses Far from band edge, 10-4 -An-c10)-3 with minimum chirp Dominant electro-optic effect is quadratic- with...Bratton for technical support and KJ. Mackey for many helpful discussions. T.D. Golding would like to thank Prof. M. Pepper for assistance, and

Continuous-Flow Left Ventricular Assist Device Support Improves Myocardial Supply:Demand in Chronic Heart Failure.

PubMed

Soucy, Kevin G; Bartoli, Carlo R; Phillips, Dustin; Giridharan, Guruprasad A; Sobieski, Michael A; Wead, William B; Dowling, Robert D; Wu, Zhongjun J; Prabhu, Sumanth D; Slaughter, Mark S; Koenig, Steven C

2017-06-01

Continuous-flow left ventricular assist devices (CF LVADs) are rotary blood pumps that improve mean blood flow, but with potential limitations of non-physiological ventricular volume unloading and diminished vascular pulsatility. In this study, we tested the hypothesis that left ventricular unloading with increasing CF LVAD flow increases myocardial flow normalized to left ventricular work. Healthy (n = 8) and chronic ischemic heart failure (IHF, n = 7) calves were implanted with CF LVADs. Acute hemodynamics and regional myocardial blood flow were measured during baseline (LVAD off, clamped), partial (2-4 L/min) and full (>4 L/min) LVAD support. IHF calves demonstrated greater reduction of cardiac energy demand with increasing LVAD support compared to healthy calves, as calculated by rate-pressure product. Coronary artery flows (p < 0.05) and myocardial blood flow (left ventricle (LV) epicardium and myocardium, p < 0.05) decreased with increasing LVAD support in normal calves. In the IHF model, blood flow to the septum, LV, LV epicardium, and LV myocardium increased significantly with increasing LVAD support when normalized to cardiac energy demand (p < 0.05). In conclusion, myocardial blood flow relative to cardiac demand significantly increased in IHF calves, thereby demonstrating that CF LVAD unloading effectively improves cardiac supply and demand ratio in the setting of ischemic heart failure.

Successful continuous-flow left ventricular assist device implantation with adjuvant tricuspid valve repair for advanced heart failure.

PubMed

Lee, Chih-Hsien; Wei, Jeng

The prevalence of end-stage heart failure (HF) is on the increase, however, the availability of donor hearts remains limited. Left ventricular assist devices (LVADs) are increasingly being used for treating patients with end-stage HF. LVADs are not only used as a bridge to transplantation but also as a destination therapy. HeartMate II, a new-generation, continuous-flow LVAD (cf-LVAD), is currently an established treatment option for patients with HF. Technological progress and increasing implantation of cf-LVADs have significantly improved survival in patients with end-stage HF. Here we report a case of a patient with end-stage HF who was successfully supported using cf-LVAD implantation with adjuvant tricuspid valve repair in a general district hospital.

Comparison of spatiotemporal and energy cost of the use of 3 different walkers and unassisted walking in older adults.

PubMed

Protas, Elizabeth J; Raines, Mary Lynn; Tissier, Sandrine

2007-06-01

To compare temporal, spatial, and oxygen costs of gait while elderly subjects walked without an assistive device, with a new assistive device, and with 2 other commercially available assistive devices. Descriptive, repeated measures. University-based research laboratory. Thirteen healthy older subjects who could walk without an assistive device. Not applicable. Gait speed, normalized gait speed, cadence, stride lengths, 5-minute walk distance and gait speed, oxygen consumption (Vo2) per meter walked, respiratory exchange ratio (RER) per meter walked, and minute ventilation per meter walked. Gait speed, normalized gait speed, and stride lengths decreased when the Merry Walker device was used, compared with walking without an assistive device. Outcome measures when walking with either the wheeled walker or the WalkAbout did not differ significantly from walking without a device except for a faster cadence with the WalkAbout. The distance walked and gait speed were decreased and the RER and minute ventilation were increased during the 5-minute walk with the Merry Walker compared with normal walking. The Vo2 was higher with the wheeled walker and Merry Walker than when walking without an assistive device, but there was no difference when the WalkAbout was used. Older adults walked in the new assistive device, the WalkAbout, with parameters that did not differ significantly from their gait without a device. The oxygen demands of walking were similar to unassisted walking for the WalkAbout, but were higher for the wheeled walker and Merry Walker. These results may help guide the prescription of assistive devices for older adults.

Mobile Ocean Test Berth Support: Cooperative Research and Development Final Report, CRADA Number CRD-10-413

DOE Office of Scientific and Technical Information (OSTI.GOV)

LiVecchi, Albert

The Northwest National Marine Renewable Energy Center (NNMREC), headquartered at the Oregon State University, is establishing the capabilities to test prototype wave energy conversion devices in the ocean. This CRADA will leverage the technical expertise and resources at NREL in the wind industry and in ocean engineering to support and enhance the development of the NNMREC Mobile Ocean Test Berth (MOTB). This CRADA will provide direct support to NNMREC by providing design evaluation and review of the MOTB, developing effective protocols for testing of the MOTB and wave energy conversion devices in the ocean, assisting in the specification of appropriatemore » instrumentation and data acquisition packages, and providing guidance on obtaining and maintaining A2LA (American Association for Laboratory Accreditation) accreditation.« less

The Psychosocial Impact of Assistive Devices Scale (PIADS): translation and psychometric evaluation of a Chinese (Taiwanese) version.

PubMed

Hsieh, Yi-Ju; Lenker, James A

2006-01-01

Chinese language instruments for measuring the impact of assistive technology are needed. This article reports on the development and preliminary evaluation of a Chinese (Taiwanese) translation of the Psychosocial Impact of Assistive Devices Scale. The language translation process followed standard procedures for cross-cultural adaptation, including: two versions of forward and backward translations, committee review, and pilot testing with bilingual participants. Test-retest reliability, internal consistency, and concurrent validity of the Chinese PIADS (C-PIADS) were evaluated with 60 participants from Taiwan who wear eyeglasses or contact lenses. Cronbach's alpha values for internal consistency ranged from 0.72 to 0.93 for the C-PIADS total scale and three subscales. Test-retest reliability was evaluated using intraclass correlation coefficient analysis, which produced values ranging from 0.79 to 0.88 for the overall C-PIADS score and three sub-scales. Overall C-PIADS scores were not statistically different from data obtained from a similar device user population in the original PIADS validation study. The results of our preliminary psychometric assessment support continued development of the C-PIADS. Future research should focus on three things: additional data collection from a similar participant population, data collection from people with disabilities using assistive technology in Taiwan; and modification of the C-PIADS for use in other Mandarin-speaking regions, e.g., China and Hong Kong.

Development of zwitterionic sulfobetaine block copolymer conjugation strategies for reduced platelet deposition in respiratory assist devices.

PubMed

Malkin, Alexander D; Ye, Sang-Ho; Lee, Evan J; Yang, Xiguang; Zhu, Yang; Gamble, Lara J; Federspiel, William J; Wagner, William R

2018-02-09

Respiratory assist devices, that utilize ∼2 m 2 of hollow fiber membranes (HFMs) to achieve desired gas transfer rates, have been limited in their adoption due to such blood biocompatibility limitations. This study reports two techniques for the functionalization and subsequent conjugation of zwitterionic sulfobetaine (SB) block copolymers to polymethylpentene (PMP) HFM surfaces with the intention of reducing thrombus formation in respiratory assist devices. Amine or hydroxyl functionalization of PMP HFMs (PMP-A or PMP-H) was accomplished using plasma-enhanced chemical vapor deposition. The generated functional groups were conjugated to low molecular weight SB block copolymers with N-hydroxysuccinimide ester or siloxane groups (SBNHS or SBNHSi) that were synthesized using reversible addition fragmentation chain transfer polymerization. The modified HFMs (PMP-A-SBNHS or PMP-H-SBNHSi) showed 80-95% reduction in platelet deposition from whole ovine blood, stability under the fluid shear of anticipated operating conditions, and uninhibited gas exchange performance relative to non-modified HFMs (PMP-C). Additionally, the functionalization and SBNHSi conjugation technique was shown to reduce platelet deposition on polycarbonate and poly(vinyl chloride), two other materials commonly found in extracorporeal circuits. The observed thromboresistance and stability of the SB modified surfaces, without degradation of HFM gas transfer performance, indicate that this approach is promising for longer term pre-clinical testing in respiratory assist devices and may ultimately allow for the reduction of anticoagulation levels in patients being supported for extended periods. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2018. © 2018 Wiley Periodicals, Inc.

Pulmonary function tests do not predict mortality in patients undergoing continuous-flow left ventricular assist device implantation.

PubMed

Bedzra, Edo K S; Dardas, Todd F; Cheng, Richard K; Pal, Jay D; Mahr, Claudius; Smith, Jason W; Shively, Kent; Masri, S Carolina; Levy, Wayne C; Mokadam, Nahush A

2017-12-01

To investigate the effect of pulmonary function testing on outcomes after continuous flow left ventricular assist device implantation. A total of 263 and 239 patients, respectively, had tests of forced expiratory volume in 1 second and diffusing capacity of the lungs for carbon monoxide preoperatively for left ventricular assist device implantations between July 2005 and September 2015. Kaplan-Meier analysis and multivariable Cox regressions were performed to evaluate mortality. Patients were analyzed in a single cohort and across 5 groups. Postoperative intensive care unit and hospital lengths of stay were evaluated with negative binomial regressions. There is no association of forced expiratory volume in 1 second and diffusing capacity of the lungs for carbon monoxide with survival and no difference in mortality at 1 and 3 years between the groups (log rank P = .841 and .713, respectively). Greater values in either parameter were associated with decreased hospital lengths of stay. Only diffusing capacity of the lungs for carbon monoxide was associated with increased intensive care unit length of stay in the group analysis (P = .001). Ventilator times, postoperative pneumonia, reintubation, and tracheostomy rates were similar across the groups. Forced expiratory volume in 1 second and diffusing capacity of the lungs for carbon monoxide are not associated with operative or long-term mortality in patients undergoing continuous flow left ventricular assist device implantation. These findings suggest that these abnormal pulmonary function tests alone should not preclude mechanical circulatory support candidacy. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Orthotopic heart transplant versus left ventricular assist device: A national comparison of cost and survival

PubMed Central

Mulloy, Daniel P.; Bhamidipati, Castigliano M.; Stone, Matthew L.; Ailawadi, Gorav; Kron, Irving L.; Kern, John A.

2012-01-01

Objectives Orthotopic heart transplantation is the standard of care for end-stage heart disease. Left ventricular assist device implantation offers an alternative treatment approach. Left ventricular assist device practice has changed dramatically since the 2008 Food and Drug Administration approval of the HeartMate II (Thoratec, Pleasanton, Calif), but at what societal cost? The present study examined the cost and efficacy of both treatments over time. Methods All patients who underwent either orthotopic heart transplantation (n = 9369) or placement of an implantable left ventricular assist device (n = 6414) from 2005 to 2009 in the Nationwide Inpatient Sample were selected. The trends in treatment use, mortality, and cost were analyzed. Results The incidence of orthotopic heart transplantation increased marginally within a 5-year period. In contrast, the annual left ventricular assist device implantation rates nearly tripled. In-hospital mortality from left ventricular assist device implantation decreased precipitously, from 42% to 17%. In-hospital mortality for orthotopic heart transplantation remained relatively stable (range, 3.8%–6.5%). The mean cost per patient increased for both orthotopic heart transplantation and left ventricular assist device placement (40% and 17%, respectively). With the observed increase in both device usage and cost per patient, the cumulative Left ventricular assist device cost increased 232% within 5 years (from $143 million to $479 million). By 2009, Medicare and Medicaid were the primary payers for nearly one half of all patients (orthotopic heart transplantation, 45%; left ventricular assist device, 51%). Conclusions Since Food and Drug Administration approval of the HeartMate II, mortality after left ventricular assist device implantation has decreased rapidly, yet has remained greater than that after orthotopic heart transplantation. The left ventricular assist device costs have continued to increase and have been significantly greater than those for orthotopic heart transplantation. Because of the evolving healthcare economics climate, with increasing emphasis on the costs and comparative effectiveness, a concerted effort at LVAD cost containment and judicious usage is essential to preserve the viability of this invaluable treatment. PMID:23246055

Low-back electromyography (EMG) data-driven load classification for dynamic lifting tasks.

PubMed

Totah, Deema; Ojeda, Lauro; Johnson, Daniel D; Gates, Deanna; Mower Provost, Emily; Barton, Kira

2018-01-01

Numerous devices have been designed to support the back during lifting tasks. To improve the utility of such devices, this research explores the use of preparatory muscle activity to classify muscle loading and initiate appropriate device activation. The goal of this study was to determine the earliest time window that enabled accurate load classification during a dynamic lifting task. Nine subjects performed thirty symmetrical lifts, split evenly across three weight conditions (no-weight, 10-lbs and 24-lbs), while low-back muscle activity data was collected. Seven descriptive statistics features were extracted from 100 ms windows of data. A multinomial logistic regression (MLR) classifier was trained and tested, employing leave-one subject out cross-validation, to classify lifted load values. Dimensionality reduction was achieved through feature cross-correlation analysis and greedy feedforward selection. The time of full load support by the subject was defined as load-onset. Regions of highest average classification accuracy started at 200 ms before until 200 ms after load-onset with average accuracies ranging from 80% (±10%) to 81% (±7%). The average recall for each class ranged from 69-92%. These inter-subject classification results indicate that preparatory muscle activity can be leveraged to identify the intent to lift a weight up to 100 ms prior to load-onset. The high accuracies shown indicate the potential to utilize intent classification for assistive device applications. Active assistive devices, e.g. exoskeletons, could prevent back injury by off-loading low-back muscles. Early intent classification allows more time for actuators to respond and integrate seamlessly with the user.

A NOVEL WEARABLE PUMP-LUNG DEVICE: IN-VITRO AND ACUTE IN-VIVO STUDY

PubMed Central

Zhang, Tao; Wei, Xufeng; Bianchi, Giacomo; Wong, Philip M.; Biancucci, Brian; Griffith, Bartley P.; Wu, Zhongjun J.

2011-01-01

Background To provide long-term ambulatory cardiopulmonary and respiratory support for adult patients, a novel wearable artificial pump-lung device has been developed. The design features, in-vitro and acute in-vivo performance of this device are reported in this paper. Methods This device features a uniquely designed hollow fiber membrane bundle integrated with a magnetically levitated impeller together to form one ultra-compact pump-lung device, which can be placed like current paracorporeal ventricular assist devices to allow ambulatory support. The device is 117 mm in length and 89 mm in diameter and has a priming volume of 115 ml. In-vitro hydrodynamic, gas transfer and biocompatibility experiments were carried out in mock flow loops using ovine blood. Acute in-vivo characterization was conducted in ovine by surgically implanting the device between right atrium and pulmonary artery. Results The in-vitro results showed that the device with a membrane surface area of 0.8 m2 was capable of pumping blood from 1 to 4 L/min against a wide range of pressures and transferring oxygen at a rate of up to 180 ml/min at a blood flow of 3.5 L/min. Standard hemolysis tests demonstrated low hemolysis at the targeted operating condition. The acute in-vivo results also confirmed that the device can provide sufficient oxygen transfer with excellent biocompatibility. Conclusions Base on the in-vitro and acute in-vivo study, this highly integrated wearable pump-lung device can provide efficient respiratory support with good biocompatibility and it is ready for long-term evaluation. PMID:22014451

Evaluation of the effectiveness of a novel gait trainer in increasing the functionality of individuals with motor impairment: A case series.

PubMed

Raveh, Eitan; Schwartz, Isabella; Karniel, Naama; Portnoy, Sigal

2017-10-16

Regaining the ability to independently ambulate following a physical disability can increase functional ability and participation of patients in daily life. Gait trainers are assistive devices that enable body support and provide safety during gait. However, most conventional gait trainers are pre-configured to a constant position, therefore not suitable for practicing sit-to-stand function, and require assistance from a caregiver in order to mount the device from a sitting position. We therefore evaluated the effectiveness of a dynamically-adjusting gait trainer, designed to provide independence and safety during gait and various activities, in both lab setting and at home in four subjects (one female, three males, ages 32-79 years) with limited ambulation. Spatiotemporal parameters and gait symmetry were recorded, as well as activity levels, actual use of device, and satisfaction. Although gait parameters and physical activity levels were not notably improved, and in one case were worsened, three subjects reported positive experience with the gait trainer. The new gait trainer may have advantages in supporting users with limited mobility during walking and various functions and decrease the risk for falls. A longer practice time and individual fitting process are recommended for better accommodation to the new possibilities.

Scheduling Accessory Assists Patients with Cognitive Disorders

NASA Technical Reports Server (NTRS)

2007-01-01

Recom Technologies Inc. received initial funding from NASA to research the commercial potential of an artificially intelligent planning reaction model to serve as a tool to help individuals suffering from various forms and levels of brain impairment. In 1993, the chief of the Artificial Intelligence Research Branch at Ames Research Center suggested collaborative research with Santa Clara Valley Medical Center. This partnership led to further development of the technology and funding to support clinical research from the U.S. Department of Education's National Institute on Disability and Rehabilitation Research. In 1996, Attention Control Systems Inc. was founded to market the finished device, called the Planning and Execution Assistant and Trainer (PEAT). PEAT is a pocket-sized PDA-like device with a graphical display, touchscreen controls, an electronic calendar, an address book, and a built-in phone, that cues users to start or stop scheduled activities, monitors their progress, and adjusts schedules as necessary in response to delays or calendar changes. It uses an automatic planning model developed for NASA to adjust daily plans when a situation changes. PEAT is sold as a complete system that includes software, hardware, documentation, and technical support. In addition to the flagship Pocket PEAT device, there is PEAT Phone, PC PEAT, and PEAT Link. Clinical studies of PEAT continue at Santa Clara Valley Medical Center

Integrating mobile devices into nursing curricula: opportunities for implementation using Rogers' Diffusion of Innovation model.

PubMed

Doyle, Glynda J; Garrett, Bernie; Currie, Leanne M

2014-05-01

To identify studies reporting mobile device integration into undergraduate and graduate nursing curricula. To explore the potential use of Rogers' Diffusion of Innovation model as a framework to guide implementation of mobile devices into nursing curricula. Literature review and thematic categorization. Literature published up until June 2013 was searched using EBSCO, PubMed, and Google Scholar. The literature was reviewed for research articles pertaining to mobile device use in nursing education. Research articles were grouped by study design, and articles were classified by: 1) strategies for individual adopters and 2) strategies for organizations. Rogers' Diffusion of Innovation theory was used to categorize reported implementation strategies. Fifty-two research studies were identified. Strategies for implementation were varied, and challenges to integrating mobile devices include lack of administrative support and time/funding to educate faculty as well as students. Overall, the use of mobile devices appears to provide benefits to nursing students; however the research evidence is limited. Anticipating challenges and ensuring a well laid out strategic plan can assist in supporting successful integration of mobile devices. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Verifying placement of small-bore feeding tubes: electromagnetic device images versus abdominal radiographs.

PubMed

Bryant, Vera; Phang, Jean; Abrams, Kevin

2015-11-01

Clinicians are unsure if radiography is needed to confirm correct positioning of feeding tubes inserted with assistance from an electromagnetic system. To compare radiographic reports of feeding tube placement with images generated by an electromagnetic feeding tube placement device. The medical records of 200 consecutive patients who had feeding tubes inserted with assistance from an electromagnetic feeding tube placement device were reviewed retrospectively. Radiographic reports of tube site were compared with images generated by the device. Radiographic evidence of tube sites was available in 188 cases: 184 tubes were located in portions of the gastrointestinal tract. Ninety of the 188 tubes were situated in the optimal site (distal duodenum or jejunum) radiographically. Images generated by the electromagnetic device were available in 176 cases; of these, 52 tubes appeared to end in the expected left lower quadrant. Tubes shown on radiographs to be in other sites also occasionally appeared to end in the left lower quadrant. Nurses using the device did not recognize 4 of the 188 tubes (2.1%) that were inadvertently placed in the lung. No consistent pattern of quadrant distribution was found for tubes positioned in the stomach or proximal duodenum. Images generated by the electromagnetic tube placement device provided inconsistent results regarding tube location. A small percentage of seriously malpositioned tubes were not detected by using the electromagnetic device. These findings do not support eliminating radiographs to confirm correct tube placement following use of an electromagnetic tube placement device. ©2015 American Association of Critical-Care Nurses.

A difficult decision: what should we do when malignant tumours are diagnosed in patients supported by left ventricular assist devices?

PubMed

Smail, Hassiba; Pfister, Christian; Baste, Jean-Marc; Nafeh-Bizet, Catherine; Gay, Arnaud; Barbay, Virginie; Bessou, Jean-Paul; Peillon, Christophe; Litzler, Pierre-Yves

2015-09-01

Left ventricular assist devices (LVADs) are used as a bridge to heart transplantation. During the preimplantation or pretransplantation screening, malignant tumours can be discovered. Owing to the lack of guidelines, the management is difficult. We describe our perioperative approach and the patients' outcomes. Between 2006 and 2014, 55 patients underwent implantation of HeartMate II LVAD. Five were diagnosed with malignant tumours: 2 renal, 2 lung and 1 breast tumours. The renal tumours were diagnosed during the preimplantation screening. An LVAD was implanted in both followed by partial nephrectomies 8 and 9 months later. The lung cancers were diagnosed after device implantation, a left pulmonary segmentectomy and a right upper sleeve lobectomy were performed. The breast cancer was diagnosed few months after support and a tumourectomy with lymphadenectomy was performed. Tumour resection was performed successfully in all patients. Prior to surgery haemostasis, device and heart function were evaluated. During surgery, haemodynamics and anticoagulation were monitored. Reoperations were necessary to evacuate haemothorax after lobectomy and an abdominal haematoma post-nephrectomy. After discussion with oncologists, 3 patients were relisted for heart transplantation. Two were successfully transplanted 2 and 3 years after partial nephrectomy with an actual survival of 56 and 59 months after the cancer diagnosis. The follow-up revealed no cancer recurrences. Malignant tumours during support with LVAD can be successfully resected. A multidisciplinary evaluation in these high-risk patients is mandatory. After careful evaluation, regaining the patient's heart transplant candidacy is possible. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Assessing mouse alternatives to access to computer: a case study of a user with cerebral palsy.

PubMed

Pousada, Thais; Pareira, Javier; Groba, Betania; Nieto, Laura; Pazos, Alejandro

2014-01-01

The purpose of this study is to describe the process of assessment of three assistive devices to meet the needs of a woman with cerebral palsy (CP) in order to provide her with computer access and use. The user has quadriplegic CP, with anarthria, using a syllabic keyboard. Devices were evaluated through a three-step approach: (a) use of a questionnaire to preselect potential assistive technologies, (b) use of an eTAO tool to determine the effectiveness of each devised, and (c) a conducting semi-structured interview to obtain qualitative data. Touch screen, joystick, and trackball were the preselected devices. The best device that met the user's needs and priorities was joystick. The finding was corroborated by both the eTAO tool and the semi-structured interview. Computers are a basic form of social participation. It is important to consider the special needs and priorities of users and to try different devices when undertaking a device-selection process. Environmental and personal factors have to be considered, as well. This leads to a need to evaluate new tools in order to provide the appropriate support. The eTAO could be a suitable instrument for this purpose. Additional research is also needed to understand how to better match devices with different user populations and how to comprehensively evaluate emerging technologies relative to users with disabilities.

KineAssist: design and development of a robotic overground gait and balance therapy device.

PubMed

Patton, James; Brown, David A; Peshkin, Michael; Santos-Munné, Julio J; Makhlin, Alex; Lewis, Ela; Colgate, Edward J; Schwandt, Doug

2008-01-01

Balance and mobility training consists of activities that carry a high risk for falling. The purpose of this article is to describe a novel robotic system for allowing challenging, yet safe, balance and mobility training in persons at high risk for falls. With no initial preconceptions of what device we would build, a user-needs analysis led us to focus on increasing the level of challenge to a patient's ability to maintain balance during gait training and also on maintaining direct involvement of a physical therapist (rather than attempting robotic replacement). The KineAssist is a robotic device for gait and balance training that has emerged from a unique design process of a start-up product of a small company and a team of therapists, engineers, mechanical design experts, and rehabilitation scientists. The KineAssist provides partial body weight support and postural control on the torso; allows many axes of motion of the trunk and pelvis; leaves the patient's legs accessible to a physical therapist's manipulation during walking; follows a patient's walking motions overground in forward, rotation, and sidestepping directions; and catches an individual who loses balance and begins to fall. Design and development of the KineAssist proceeded more rapidly in the context of a small company than would have been possible in most institutional research contexts. A prototype KineAssist has been constructed and has received US Food and Drug Administration (FDA) classification and institutional review board clearance for initial human studies. The acceptance of KineAssist will ultimately depend on improved patient outcomes, the use of this new tool by therapists, the ease of use of the system, and the recognition of the unique value it brings to therapeutic recovery.

14 CFR 382.125 - What procedures do carriers follow when wheelchairs, other mobility aids, and other assistive...

Code of Federal Regulations, 2012 CFR

2012-01-01

... wheelchairs, other mobility aids, and other assistive devices must be stowed in the cargo compartment? 382.125... Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.125 What procedures do carriers follow when wheelchairs, other mobility aids, and other assistive devices must be stowed in the cargo...

14 CFR 382.125 - What procedures do carriers follow when wheelchairs, other mobility aids, and other assistive...

Code of Federal Regulations, 2013 CFR

2013-01-01

... wheelchairs, other mobility aids, and other assistive devices must be stowed in the cargo compartment? 382.125... Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.125 What procedures do carriers follow when wheelchairs, other mobility aids, and other assistive devices must be stowed in the cargo...

14 CFR 382.125 - What procedures do carriers follow when wheelchairs, other mobility aids, and other assistive...

Code of Federal Regulations, 2014 CFR

2014-01-01

... wheelchairs, other mobility aids, and other assistive devices must be stowed in the cargo compartment? 382.125... Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.125 What procedures do carriers follow when wheelchairs, other mobility aids, and other assistive devices must be stowed in the cargo...

Cardiac transplantation after bridged therapy with continuous flow left ventricular assist devices.

PubMed

Deo, Salil V; Sung, Kiick; Daly, Richard C; Shah, Ishan K; Altarabsheh, Salah E; Stulak, John M; Joyce, Lyle D; Boilson, Barry A; Kushwaha, Sudhir S; Park, Soon J

2014-03-01

Cardiac transplantation is an effective surgical therapy for end-stage heart failure. Patients (pts) may need to be bridged with a continuous flow left ventricular assist device (CF-LVAD) while on the transplant list as logistic factors like organ availability are unknown. Cardiac transplantation post-LVAD can be a surgically challenging procedure and outcome in these pts is perceived to be poorer based on experience with earlier generation pulsatile flow pumps. Data from a single institution comparing these pts with those undergoing direct transplantation in the present era of continuous flow device therapy are limited. Evaluate results of cardiac transplantation in pts bridged with a CF-LVAD (BTx) and compare outcomes with pts undergoing direct transplantation (Tx) in a single institution. From June 2007 till January 2012, 106 pts underwent cardiac transplantation. Among these, 37 (35%) pts (51±11 years; 85% male) were bridged with a CF-LVAD (BTx), while 70 (65%) comprised the Tx group (53±12 years; 72% males). The median duration of LVAD support was 227 (153,327) days. During the period of LVAD support, 10/37 (27%) pts were upgraded to status 1A and all were successfully transplanted. Median hospital stay in the BTx (14 days) was slightly longer than the Tx group (12 days) but not statistically significant (p=0.21). In-hospital mortality in the BTx (5%) and Tx (1%) were comparable (p=0.25). Estimated late survival in the BTx cohort was 94±7, 90±10 and 83±16% at the end of one, two and three years, respectively which was comparable to 97±4%, 93±6% and 89±9% for the Tx group (p=0.50). Cardiac transplantation after LVAD implant can be performed with excellent results. Patients can be supported on the left ventricular assist device even for periods close to a year with good outcome after cardiac transplantation. Copyright © 2013 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Driving Control for Electric Power Assisted Wheelchair Based on Regenerative Brake

NASA Astrophysics Data System (ADS)

Seki, Hirokazu; Takahashi, Kazuki; Tadakuma, Susumu

This paper describes a novel safety driving control scheme for electric power assisted wheelchairs based on the regenerative braking system. “Electric power assisted wheelchair” which assists the driving force by electric motors is expected to be widely used as a mobility support system for elderly people and disabled people, however, the safe and secure driving performance especially on downhill roads must be further improved because electric power assisted wheelchairs have no braking devices. The proposed control system automatically switches the driving mode, from “assisting mode” to “braking mode”, based on the wheelchair's velocity and the declined angle and smoothly suppresses the wheelchair's acceleration based on variable duty ratio control in order to realize the safety driving and to improve the ride quality. Some experiments on the practical roads and subjective evaluation show the effectiveness of the proposed control system.

Mechanical cardiac support in children with congenital heart disease with intention to bridge to heart transplantation†.

PubMed

De Rita, Fabrizio; Hasan, Asif; Haynes, Simon; Crossland, David; Kirk, Richard; Ferguson, Lee; Peng, Edward; Griselli, Massimo

2014-10-01

A significant number of children affected by congenital heart disease (CHD) develop heart failure early or late after surgery, and heart transplantation (OHTx) remains the last treatment option. Due to shortage of donor organs in paediatric group, mechanical circulatory support (MCS) is now routinely applied as bridging strategy to increase survival on the waiting list for OTHx. We sought to assess the impact of MCS as intention to bridge to OHTx in patients with CHD less than 16 years of age. From 1998 to 2013, 106 patients received 113 episodes of MCS with paracorporeal devices as intention to bridge to OHTx. Twenty-nine had CHD, 15 (52%) with two-ventricle (Group A) and 14 (48%) with single-ventricle physiology (Group B). In Group A, 5 children had venoarterial extracorporeal membrane oxygenation (VA ECMO), 6 left ventricular assist device (LVAD), 2 biventricular assist device (BIVAD), 1 VA ECMO followed by BIVAD and 1 BIVAD followed by VA ECMO. In Group B, VA ECMO was used in 7 children, univentricular assist device (UVAD) changed to VA ECMO in 4, UVAD in 2 and surgical conversion to two-ventricles physiology with BIVAD support changed to VA ECMO in 1. Twenty-one of 29 (72%) children survived to recovery/OHTx. Seven of 29 (59%) survived to discharge. In Group A, 11/15 (73%) survived to recovery/OHTx and 9/15 (60%) survived to discharge. Four of 15 (27%) died awaiting OHTx. One child had graft failure requiring VA ECMO and was bridged successfully to retransplantation. One child dying after OHTx had acute rejection, was supported with VA ECMO and then BIVAD but did not recover. One patient had an unsuccessful second run on BIVAD 1 year after recovery from VA ECMO. In Group B, 10/14 (71%) survived to recovery/OHTx and 8/14 (57%) survived to discharge. Four of 14 (29%) died awaiting OHTx. Of deaths after OHTx, 1 occurred intraoperatively and 1 was consequent to graft failure and had an unsuccessful second run with VA ECMO. Children with CHD can be successfully bridged with MCS to heart transplantation. Single-ventricle circulation compared with biventricular physiology does not increase the risk of death before transplant or before hospital discharge. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Approach to the Phenomenon of M-Learning in English Teaching

ERIC Educational Resources Information Center

García, Sergio; Fombona, Javier

2015-01-01

This research analyzes the situation of mobile devices and some specific options of support for the teaching of the English language. The features of this complex and novel phenomenon of Mobile-Assisted Language Learning (MALL) are addressed with an exploratory descriptive methodology. The article is part of a more extensive research which deals…

Technology and Transition in the 21st Century

ERIC Educational Resources Information Center

Kellems, Ryan O.; Grigal, Meg; Unger, Darlene D.; Simmons, Thomas J.; Bauder, Debra; Williams, Caroline

2015-01-01

Devices like smartphones, tablets, and MP3 players are becoming everyday tools for the majority of the population. Technology can assist students with disabilities in many self-determination activities, such as choice making, decision making, and self-management. In addition, technology tools can support them in a wide range of transition-related…

Ventricular assist devices and sleep-disordered breathing.

PubMed

Akkanti, Bindu; Castriotta, Richard J; Sayana, Pavani; Nunez, Emmanuel; Rajapreyar, Indranee; Kumar, Sachin; Nathan, Sriram; Majid, Ruckshanda

2017-10-01

Congestive heart failure is one of the leading causes of morbidity and mortality in the United States, and left ventricular assist devices have revolutionized treatment of end-stage heart failure. Given that sleep apnea results in significant morbidity in these patients with advanced heart failure, practicing sleep physicians need to have an understanding of left ventricular assist devices. In this review, we summarize what is known about ventricular assist devices as they relate to sleep medicine. Copyright © 2016 Elsevier Ltd. All rights reserved.

Tracking down a solution: exploring the acceptability and value of wearable GPS devices for older persons, individuals with a disability and their support persons.

PubMed

Williamson, Brittany; Aplin, Tammy; de Jonge, Desleigh; Goyne, Matthew

2017-11-01

To explore the acceptability and value of three wearable GPS devices for older persons and individuals with a disability and safety concerns when accessing the community. This pilot study explored six wearers' and their support persons' experience of using three different wearable GPS devices (a pendant, watch, and mini GPS phone), each for a two-week period. Participants identified safety as the main value of using a wearable GPS device. The acceptability and value of these devices was strongly influenced by device features, ease of use, cost, appearance, the reliability of the GPS coordinates, the wearer's health condition and the users familiarity with technology. Overall, participants indicated that they preferred the pendant. Wearable GPS devices are potentially useful in providing individuals who have safety concerns with reassurance and access to assistance as required. To ensure successful utilization, future device design and device selection should consider the user's familiarity with technology and their health condition. This study also revealed that not all wearable GPS devices provide continuous location tracking. It is therefore critical to ensure that the device's location tracking functions address the wearer's requirements and reason for using the device. Implications for Rehabilitation The acceptability and usability of wearable GPS devices is strongly influenced by the device features, ease of use, cost, appearance, the reliability of the device to provide accurate and timely GPS coordinates, as well as the health condition of the wearer and their familiarity with technology. Wearable GPS devices need to be simple to use and support and training is essential to ensure they are successfully utilized. Not all wearable GPS devices provide continuous location tracking and accuracy of location is impacted by line of sight to satellites. Therefore, care needs to be taken when choosing a suitable device, to ensure that the device's location tracking features are based on the wearer's requirements and value behind using the device.

The Ventricular Assist Device in the Life of the Child: A Phenomenological Pediatric Study

PubMed Central

van Manen, Michael A.

2017-01-01

What is it like for a child to live with an artificial heart? The use of some medical therapies in children requires developmental considerations, is associated with psychosocial consequences, and calls for ethical sensitivities. A critical case is the ventricular assist device (VAD), a mechanical pump used to support the functioning of a failing heart. As a pediatric therapy, the device can be used as a temporary solution for poor heart function, a bridge to transplantation or recovery, or as a destination therapy. While the mechanical-technical operation of the VAD is well understood, the clinical-technical aspects of young people living with this device are largely unexplored. Drawing on interviews of school-aged children, the aim of this phenomenological study is to explore how a VAD may structure or condition a child’s meaningful experience of their world outside the hospital. The driveline of an implanted VAD is the peripheral attachment, extruding through the skin to connect the controller-power supply. The materiality of the device may be interruptive, restrictive, and disturbing to the psycho-physical being and sense of self-identity of the child as a child. And while a child equipped with a VAD is not necessarily conspicuous among other children, the child may experience the device as an exposing presence, while living with the worry of a caregiver who takes on the role not simply of parent but of watchful health professional. A phenomenological understanding of the VAD should assist parents and caregiving health professionals knowing how to deal with specific issues arising in the life of the VAD child. PMID:28682718

The role of implantable cardioverter defibrillators in patients bridged to transplantation with a continuous-flow left ventricular assist device: A propensity score matched analysis.

PubMed

Clerkin, Kevin J; Topkara, Veli K; Mancini, Donna M; Yuzefpolskaya, Melana; Demmer, Ryan T; Dizon, Jose M; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C; Garan, A Reshad

2017-06-01

Implantable cardioverter defibrillators (ICDs) provide a significant mortality benefit for appropriately selected patients with advanced heart failure. ICDs are associated with a mortality benefit when used in patients with a pulsatile left ventricular assist device (LVAD). It is unclear whether patients with a continuous-flow LVAD (CF-LVAD) derive the same benefit. We sought to determine if the presence of an ICD provided a mortality benefit during CF-LVAD support as a bridge to transplantation. Patients were identified in the United Network for Organ Sharing (UNOS) registry who underwent LVAD implantation as bridge to transplantation between May 2004 and April 2014, with follow-up through June 2014. Primary outcome was freedom from death while on CF-LVAD support with adjustment for complications requiring UNOS listing status upgrade. Secondary end-points included freedom from delisting while on CF-LVAD support and incidence of transplantation. The study cohort comprised 2,990 patients, and propensity score matching identified 1,012 patients with similar propensity scores. There was no difference in survival during device support between patients with and without an ICD (hazard ratio [HR] = 1.20; 95% confidence interval [CI], 0.66-2.17; p = 0.55). Adjusting for device complications requiring a UNOS listing status upgrade had minimal influence (HR = 1.11; 95% CI, 0.60-2.05; p = 0.74). There was no increased risk of delisting owing to being too sick for patients with an ICD (HR = 1.08; 95% CI, 0.63-1.86; p = 0.78). Likewise, the probability of transplantation was similar (HR = 1.05; 95% CI, 0.87-1.27; p = 0.62). Among patients bridged to transplantation with a CF-LVAD, the presence of an ICD did not reduce mortality. Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

The Role of Implantable Cardioverter Defibrillators in Patients Bridged to Transplantation with a Continuous Flow Left Ventricular Assist Device: A Propensity Score Matched Analysis

PubMed Central

Clerkin, Kevin J.; Topkara, Veli K.; Mancini, Donna M.; Yuzefpolskaya, Melana; Demmer, Ryan T.; Dizon, Jose M.; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C.; Garan, A. Reshad

2016-01-01

Background Implantable cardioverter defibrillators (ICD) provide a significant mortality benefit for appropriately selected patients with advanced heart failure. ICDs are associated with a mortality benefit when used in patients with a pulsatile left ventricular assist device (LVAD). However it is unclear whether patients with a continuous flow LVAD (CF-LVAD) derive the same benefit. This study sought to determine if the presence of an ICD provided a mortality benefit during CFLVAD support as a bridge to transplantation. Methods Patients were identified in the United Network for Organ Sharing (UNOS) registry that underwent LVAD implantation as bridge to transplantation from May 2004 and April 2014, with follow-up through June 2014. The primary outcome was freedom from death while on CF-LVAD support with adjustment for complications requiring UNOS listing status upgrade. Secondary endpoints included freedom from delisting while on CF-LVAD support and incidence of transplantation. Results 2,990 patients composed the study cohort and propensity score matching identified 1,012 patients with similar propensity scores. There was no difference in survival during device support between patients with and without an ICD (Hazard Ratio [HR] 1.20, 95% Confidence Interval [CI] 0.66-2.17, p=0.55). Adjusting for device complications requiring a UNOS listing status upgrade had minimal influence (HR 1.11, 95% CI 0.60-2.05, p=0.74). There was no increased risk of delisting due to being too sick for those with an ICD (HR 1.08, 95% CI 0.63-1.86, p=0.78). Likewise, the probability of transplantation was similar (HR 1.05, 95% CI 0.87-1.27, p=0.62). Conclusions Among patients bridged to transplantation with a CF-LVAD, the presence of an ICD did not reduce mortality. PMID:28089072

14 CFR 382.121 - What mobility aids and other assistive devices may passengers with a disability bring into the...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false What mobility aids and other assistive... Aids, and Other Assistive Devices § 382.121 What mobility aids and other assistive devices may... or collapsible wheelchairs; (2) Other mobility aids, such as canes (including those used by persons...

14 CFR 382.121 - What mobility aids and other assistive devices may passengers with a disability bring into the...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false What mobility aids and other assistive... Aids, and Other Assistive Devices § 382.121 What mobility aids and other assistive devices may... or collapsible wheelchairs; (2) Other mobility aids, such as canes (including those used by persons...

14 CFR 382.121 - What mobility aids and other assistive devices may passengers with a disability bring into the...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false What mobility aids and other assistive... Aids, and Other Assistive Devices § 382.121 What mobility aids and other assistive devices may... or collapsible wheelchairs; (2) Other mobility aids, such as canes (including those used by persons...

Translation and validation of the assistive technology device predisposition assessment in Greek in order to assess satisfaction with use of the selected assistive device.

PubMed

Koumpouros, Yiannis; Papageorgiou, Effie; Karavasili, Alexandra; Alexopoulou, Despoina

2017-07-01

To examine the Assistive Technology Device Predisposition Assessment scale and provide evidence of validity and reliability of the Greek version. We translated and adapted the original instrument in Greek according to the most well-known guidelines recommendations. Field test studies were conducted in a rehabilitation hospital to validate the appropriateness of the final results. Ratings of the different items were statistically analyzed. We recruited 115 subjects who were administered the Form E of the original questionnaire. The experimental analysis conducted revealed a three subscales structure: (i) Adaptability, (ii) Fit to Use, and (iii) Socializing. According to the results of our study the three subscales measure different constructs. Reliability measures (ICC = 0.981, Pearson's correlation = 0.963, Cronbach's α = 0.701) yielded high values. Test-retest outcome showed great stability. This is the first study, at least to the knowledge of the authors, which focuses merely on measuring the satisfaction of the users from the used assistive device, while exploring the Assistive Technology Device Predisposition Assessment - Device Form in such depth. According to the results, it is a stable, valid and reliable instrument and applicable to the Greek population. Thus, it can be used to measure the satisfaction of patients with assistive devices. Implications for Rehabilitation The paper explores the cultural adaptability and applicability of ATD PA - Device Form. ATD PA - Device Form can be used to assess user satisfaction by the selected assistive device. ATD PA - Device Form is a valid and reliable instrument in measuring users' satisfaction in Greekreality.

Study of the Physics of Insulating Films as Related to the Reliability of Metal-Oxide Semiconductor Devices

DTIC Science & Technology

1980-05-01

York 10598 Technical assistance of F.L. Pesavento and J.A. Calse Typed by Steila B. Havreluk (3277) Abstract: Chemically vapor deposited (CVD) Si rich...wish to acknowledge the critical reading of this manuscript by D.R. Young and M.I. Nathan; the technical assistance of F.L. Pesavento and L.A. Calise...rendered by J.A. Calise and F.L. Pesavento . Samples have been prepared by the I.B.M. Yorktown Si Process Facility and the work has been supported in part

76 FR 48563 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2011...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...-7205 Ventricular Assist Device (Destination Therapy) Facilities. XIII Medicare-Approved Lung JoAnna...-Approved Ventricular Assist Device (Destination Therapy) Facilities, Addendum XIII: Lung Volume Reduction...-Approved Ventricular Assist Device (Destination Therapy) Facilities (January Through March 2011) Addendum...

47 CFR 74.870 - Wireless video assist devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... wireless video assist devices may not be transferred or assigned. (i) The product literature that... 47 Telecommunication 4 2010-10-01 2010-10-01 false Wireless video assist devices. 74.870 Section... EXPERIMENTAL RADIO, AUXILIARY, SPECIAL BROADCAST AND OTHER PROGRAM DISTRIBUTIONAL SERVICES Low Power Auxiliary...

An Internet of Things platform architecture for supporting ambient assisted living environments.

PubMed

Tsirmpas, Charalampos; Kouris, Ioannis; Anastasiou, Athanasios; Giokas, Kostas; Iliopoulou, Dimitra; Koutsouris, Dimitris

2017-01-01

Internet of Things (IoT) is the logical further development of today's Internet, enabling a huge amount of devices to communicate, compute, sense and act. IoT sensors placed in Ambient Assisted Living (AAL) environments, enable the context awareness and allow the support of the elderly in their daily routines, ultimately allowing an independent and safe lifestyle. The vast amount of data that are generated and exchanged between the IoT nodes require innovative context modeling approaches that go beyond currently used models. Current paper presents and evaluates an open interoperable platform architecture in order to utilize the technical characteristics of IoT and handle the large amount of generated data, as a solution to the technical requirements of AAL applications.

21 CFR 884.6150 - Assisted reproduction micromanipulators and microinjectors.

Code of Federal Regulations, 2011 CFR

2011-04-01

... controls) (design specifications, labeling requirements, and clinical testing). .... Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or...

21 CFR 884.6150 - Assisted reproduction micromanipulators and microinjectors.

Code of Federal Regulations, 2013 CFR

2013-04-01

... controls) (design specifications, labeling requirements, and clinical testing). .... Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or...

21 CFR 884.6150 - Assisted reproduction micromanipulators and microinjectors.

Code of Federal Regulations, 2010 CFR

2010-04-01

... controls) (design specifications, labeling requirements, and clinical testing). .... Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or...

21 CFR 884.6150 - Assisted reproduction micromanipulators and microinjectors.

Code of Federal Regulations, 2012 CFR

2012-04-01

... controls) (design specifications, labeling requirements, and clinical testing). .... Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or...

21 CFR 884.6150 - Assisted reproduction micromanipulators and microinjectors.

Code of Federal Regulations, 2014 CFR

2014-04-01

... controls) (design specifications, labeling requirements, and clinical testing). .... Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or...

Design and Development of a Miniaturized Percutaneously Deployable Wireless Left Ventricular Assist Device: Early Prototypes and Feasibility Testing.

PubMed

Letzen, Brian; Park, Jiheum; Tuzun, Zeynep; Bonde, Pramod

The current left ventricular assist devices (LVADs) are limited by a highly invasive implantation procedure in a severely unstable group of advanced heart failure patients. Additionally, the current transcutaneous power drive line acts as a nidus for infection resulting in significant morbidity and mortality. In an effort to decrease this invasiveness and eliminate drive line complications, we have conceived a wireless miniaturized percutaneous LVAD, capable of being delivered endovascularly with a tether-free operation. The system obviates the need for a transcutaneous fluid purge line required in existing temporary devices by utilizing an incorporated magnetically coupled impeller for a complete seal. The objective of this article was to demonstrate early development and proof-of-concept feasibility testing to serve as the groundwork for future formalized device development. Five early prototypes were designed and constructed to iteratively minimize the pump size and improve fluid dynamic performance. Various magnetic coupling configurations were tested. Using SolidWorks and ANSYS software for modeling and simulation, several geometric parameters were varied. HQ curves were constructed from preliminary in vitro testing to characterize the pump performance. Bench top tests showed no-slip magnetic coupling of the impeller to the driveshaft up to the current limit of the motor. The pump power requirements were tested in vitro and were within the appropriate range for powering via a wireless energy transfer system. Our results demonstrate the proof-of-concept feasibility of a novel endovascular cardiac assist device with the potential to eventually offer patients an untethered, minimally invasive support.

The cost of assistive devices for children with mobility limitation.

PubMed

Korpela, R A; Siirtola, T O; Koivikko, M J

1992-10-01

This study evaluated the costs of assistive devices for children with motor limitations at home, in day care, and in school, and the effect of diagnosis and severity of disabilities on costs. 201 children (mean age 7.4 years) who used 1274 various assistive devices (85.7% at home, 6.1% in day care, and 8.2% in school) were studied. The cost per device varied from $8.14 to $8138 with an average value of $539 per device. The distribution of costs per capita was unequal: 52.2% of children used 15.6% of total costs and 4.5% of children used 20.8% of total costs. The severity of motor impairment and the age of the child were the most important indicators associated with the need and cost of assistive devices. Assistive devices for basic needs, such as sitting, mobility, and personal hygiene, had a relatively low effect on costs in comparison with the high-technology devices, like powered wheelchairs and computers. Better cooperation with day care and school professionals, better assessment of needs, follow-up and recirculation of assistive devices are ways to promote rehabilitation services and partly solve the discrepancies between the costs of available technology and the resources to pay for it.

To move as a human. Comment on "The embodiment of assistive devices-from wheelchair to exoskeleton" by M. Pazzaglia and M. Molinari

NASA Astrophysics Data System (ADS)

Papadimitriou, Christina

2016-03-01

I agree with the authors, that ;there have been very few attempts to develop user-centered medical technologies; [1] in the field of rehabilitation for persons with disabilities and wheelchair users in particular. The human-environment context in which humans plan and inhabit their actions as wheelchair users has not been extensively studied. The authors' unique work explores how a person embodies an exoskeleton (robotic legs or a wheelchair) in their everyday life and focuses on proprioception and brain's capacity to enlarge one's body schema in order to understand users' perspectives. Ultimately, Pazzaglia and Molinari wish to support persons who use assistive devices adapt and have successful, meaningful lives. The work is neuro-scientifically grounded, but doesn't forget the emotional or affective aspects of the user.

Bridge to transplantation with a left ventricular assist device.

PubMed

Jung, Jae Jun; Sung, Kiick; Jeong, Dong Seop; Kim, Wook Sung; Lee, Young Tak; Park, Pyo Won

2012-04-01

A 61-year-old female patient was diagnosed with dilated cardiomyopathy with severe left ventricle dysfunction. Two days after admission, continuous renal replacement therapy was performed due to oliguria and lactic acidosis. On the fifth day, an intra-aortic balloon pump was inserted due to low cardiac output syndrome. Beginning 4 days after admission, she was supported for 15 days thereafter with an extracorporeal left ventricular assist device (LVAD) because of heart failure with multi-organ failure. A heart transplant was performed while the patient was stabilized with the LVAD. She developed several complications after the surgery, such as cytomegalovirus pneumonia, pulmonary tuberculosis, wound dehiscence, and H1N1 infection. On postoperative day 19, she was discharged from the hospital with close follow-up and treatment for infection. She received follow-up care for 10 months without any immune rejection reaction.

Simulating Ideal Assistive Devices to Reduce the Metabolic Cost of Running

PubMed Central

Uchida, Thomas K.; Seth, Ajay; Pouya, Soha; Dembia, Christopher L.; Hicks, Jennifer L.; Delp, Scott L.

2016-01-01

Tools have been used for millions of years to augment the capabilities of the human body, allowing us to accomplish tasks that would otherwise be difficult or impossible. Powered exoskeletons and other assistive devices are sophisticated modern tools that have restored bipedal locomotion in individuals with paraplegia and have endowed unimpaired individuals with superhuman strength. Despite these successes, designing assistive devices that reduce energy consumption during running remains a substantial challenge, in part because these devices disrupt the dynamics of a complex, finely tuned biological system. Furthermore, designers have hitherto relied primarily on experiments, which cannot report muscle-level energy consumption and are fraught with practical challenges. In this study, we use OpenSim to generate muscle-driven simulations of 10 human subjects running at 2 and 5 m/s. We then add ideal, massless assistive devices to our simulations and examine the predicted changes in muscle recruitment patterns and metabolic power consumption. Our simulations suggest that an assistive device should not necessarily apply the net joint moment generated by muscles during unassisted running, and an assistive device can reduce the activity of muscles that do not cross the assisted joint. Our results corroborate and suggest biomechanical explanations for similar effects observed by experimentalists, and can be used to form hypotheses for future experimental studies. The models, simulations, and software used in this study are freely available at simtk.org and can provide insight into assistive device design that complements experimental approaches. PMID:27656901

Influences on selection of assistive technology for young children in South Africa: perspectives from rehabilitation professionals.

PubMed

van Niekerk, Karin; Dada, Shakila; Tönsing, Kerstin

2017-12-20

Selection of assistive technology for young children is a complex process. Within a context with limited resources, such as South Africa, research is needed to determine the factors influencing the assistive technology selection process, as these could ultimately either facilitate or hinder the availability and accessibility of affordable, adaptable, acceptable, and high quality assistive technology for this age group. Two asynchronous online focus groups were conducted with 16 rehabilitation professionals to identify the factors they perceived to influence the selection and provision of assistive technology to young children within the South African context. A process of deductive thematic analysis was followed by inductive analysis of the data. Components of the Assistive Technology Device Selection Framework were used as themes to guide the deductive analysis, followed by inductive analysis to create subthemes. The important role of the professional was highlighted in negotiating all the factors to consider in the assistive technology selection and provision process. Adaptation of the Assistive Technology Device Selection Framework is suggested in order to facilitate application to low resourced contexts, such as South Africa. Implications for rehabilitation Assistive technology selection is a complex process with factors pertaining to the users (child and family) of the assistive technology, as well as the rehabilitation professional recommending the assistive technology influencing the process. Although it may be an important factor, the availability of financial resources to purchase assistive technology is not the only determining factor in providing appropriate assistive technology to young children in contexts with limited resources. Formalized support, such as reflective supervision or mentorship programs should be facilitated and utilized by recommending professionals. Home and school visits during assessment ensure a good match between assistive technology and users within the particular context. Facilitating the availability of assistive technology for trial during assessment and/or for a period afterwards will increase the likelihood that appropriate recommendations for assistive technology are made.

Mechanical Circulatory Support of the Right Ventricle for Adult and Pediatric Patients With Heart Failure.

PubMed

Chopski, Steven G; Murad, Nohra M; Fox, Carson S; Stevens, Randy M; Throckmorton, Amy L

2018-05-10

The clinical implementation of mechanical circulatory assistance for a significantly dysfunctional or failing left ventricle as a bridge-to-transplant or bridge-to-recovery is on the rise. Thousands of patients with left-sided heart failure are readily benefitting from these life-saving technologies, and left ventricular failure often leads to severe right ventricular dysfunction or failure. Right ventricular failure (RVF) has a high rate of mortality caused by the risk of multisystem organ failure and prolonged hospitalization for patients after treatment. The use of a blood pump to support the left ventricle also typically results in an increase in right ventricular preload and may impair right ventricular contractility during left ventricular unloading. Patients with RVF might also suffer from severe pulmonary dysfunction, cardiac defects, congenital heart disease states, or a heterogeneity of cardiophysiologic challenges because of symptomatic congestive heart failure. Thus, the uniqueness and complexity of RVF is emerging as a new domain of significant clinical interest that motivates the development of right ventricular assist devices. In this review, we present the current state-of-the-art for clinically used blood pumps to support adults and pediatric patients with right ventricular dysfunction or failure concomitant with left ventricular failure. New innovative devices specifically for RVF are also highlighted. There continues to be a compelling need for novel treatment options to support patients with significant right heart dysfunction or failure.

Hearing on Assistive Devices for Americans with Disabilities. Hearing before the Subcommittee on Select Education of the Committee on Education and Labor. House of Representatives, One Hundredth Congress, Second Session.

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. House Committee on Education and Labor.

Some forms of assistive device technology are not available to many disabled children or adults because there is not a centralized system to link the technology with those who need it. This hearing explores ways to promote widespread availability of assistive devices. Examined are types of devices, the costs of such devices, methods of…

Impact of Socioeconomic Status on Patients Supported With a Left Ventricular Assist Device: An Analysis of the UNOS Database (United Network for Organ Sharing).

PubMed

Clerkin, Kevin J; Garan, Arthur Reshad; Wayda, Brian; Givens, Raymond C; Yuzefpolskaya, Melana; Nakagawa, Shunichi; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Mancini, Donna M; Colombo, Paolo C; Topkara, Veli K

2016-10-01

Low socioeconomic status (SES) is a known risk factor for heart failure, mortality among those with heart failure, and poor post heart transplant (HT) outcomes. This study sought to determine whether SES is associated with decreased waitlist survival while on left ventricular assist device (LVADs) support and after HT. A total of 3361 adult patients bridged to primary HT with an LVAD between May 2004 and April 2014 were identified in the UNOS database (United Network for Organ Sharing). SES was measured using the Agency for Healthcare Research and Quality SES index using data from the 2014 American Community Survey. In the study cohort, SES did not have an association with the combined end point of death or delisting on LVAD support (P=0.30). In a cause-specific unadjusted model, those in the top (hazard ratio, 1.55; 95% confidence interval, 1.14-2.11; P=0.005) and second greatest SES quartile (hazard ratio 1.50; 95% confidence interval, 1.10-2.04; P=0.01) had an increased risk of death on device support compared with the lowest SES quartile. Adjusting for clinical risk factors mitigated the increased risk. There was no association between SES and complications. Post-HT survival, both crude and adjusted, was decreased for patients in the lowest quartile of SES index compared with all other SES quartiles. Freedom from waitlist death or delisting was not affected by SES. Patients with a higher SES had an increased unadjusted risk of waitlist mortality during LVAD support, which was mitigated by adjusting for increased comorbid conditions. Low SES was associated with worse post-HT outcomes. Further study is needed to confirm and understand a differential effect of SES on post-transplant outcomes that was not seen during LVAD support before HT. © 2016 American Heart Association, Inc.

Extracorporeal liver assist device to exchange albumin and remove endotoxin in acute liver failure: Results of a pivotal pre-clinical study.

PubMed

Lee, Karla C L; Baker, Luisa A; Stanzani, Giacomo; Alibhai, Hatim; Chang, Yu Mei; Jimenez Palacios, Carolina; Leckie, Pamela J; Giordano, Paola; Priestnall, Simon L; Antoine, Daniel J; Jenkins, Rosalind E; Goldring, Christopher E; Park, B Kevin; Andreola, Fausto; Agarwal, Banwari; Mookerjee, Rajeshwar P; Davies, Nathan A; Jalan, Rajiv

2015-09-01

In acute liver failure, severity of liver injury and clinical progression of disease are in part consequent upon activation of the innate immune system. Endotoxaemia contributes to innate immune system activation and the detoxifying function of albumin, critical to recovery from liver injury, is irreversibly destroyed in acute liver failure. University College London-Liver Dialysis Device is a novel artificial extracorporeal liver assist device, which is used with albumin infusion, to achieve removal and replacement of dysfunctional albumin and reduction in endotoxaemia. We aimed to test the effect of this device on survival in a pig model of acetaminophen-induced acute liver failure. Pigs were randomised to three groups: Acetaminophen plus University College London-Liver Dialysis Device (n=9); Acetaminophen plus Control Device (n=7); and Control plus Control Device (n=4). Device treatment was initiated two h after onset of irreversible acute liver failure. The Liver Dialysis Device resulted in 67% reduced risk of death in acetaminophen-induced acute liver failure compared to Control Device (hazard ratio=0.33, p=0.0439). This was associated with 27% decrease in circulating irreversibly oxidised human non-mercaptalbumin-2 throughout treatment (p=0.046); 54% reduction in overall severity of endotoxaemia (p=0.024); delay in development of vasoplegia and acute lung injury; and delay in systemic activation of the TLR4 signalling pathway. Liver Dialysis Device-associated adverse clinical effects were not seen. The survival benefit and lack of adverse effects would support clinical trials of University College London-Liver Dialysis Device in acute liver failure patients. Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

The Influence of Different Operating Conditions on the Blood Damage of a Pulsatile Ventricular Assist Device.

PubMed

Xu, Zihao; Yang, Ming; Wang, Xianghui; Wang, Zhong

2015-01-01

Because of pulsatile blood flow's benefit for myocardial recovery, perfusion of coronary arteries and end organs, pulsatile ventricular assist devices (VADs) are still widely used as paracorporeal mechanical circulatory support devices in clinical applications, especially in pediatric heart failure patients. However, severe blood damage limits the VAD's service period. Besides optimizing the VAD geometry to reduce blood damage, the blood damage may also be decreased by changing the operating conditions. In this article, a pulsatile VAD was used to investigate the influence of operating conditions on its blood damage, including hemolysis, platelet activation, and platelet deposition. Three motion profiles of pusher plate (sine, cosine, and polynomial), three stroke volumes (ejection fractions) (56 ml [70%], 42 ml [52.5%], and 28 ml [35%]), three pulsatile rates (75, 100, and 150 bpm), and two assist modes (copulsation and counterpulsation) were implemented respectively in VAD fluid-structure interaction simulations to calculate blood damage. The blood damage indices indicate that cosine motion profile, higher ejection fraction, higher pulsatile rate, and counterpulsation can decrease platelet deposition whereas increase hemolysis and platelet activation, and vice versa. The results suggest that different operating conditions have different effects on pulsatile VAD's blood damage and may be beneficial to choose suitable operating condition to reduce blood damage in clinical applications.

“We can’t get along without each other”: Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety

PubMed Central

Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia

2017-01-01

Objectives Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. Design A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. Results Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as “symbiotic”, but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. Conclusions Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard. PMID:28358886

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

PubMed

Gagliardi, Anna R; Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia; Urbach, David R

2017-01-01

Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard.

High early event rates in patients with questionable eligibility for advanced heart failure therapies: Results from the Medical Arm of Mechanically Assisted Circulatory Support (Medamacs) Registry.

PubMed

Ambardekar, Amrut V; Forde-McLean, Rhondalyn C; Kittleson, Michelle M; Stewart, Garrick C; Palardy, Maryse; Thibodeau, Jennifer T; DeVore, Adam D; Mountis, Maria M; Cadaret, Linda; Teuteberg, Jeffrey J; Pamboukian, Salpy V; Cantor, Ryan S; Lindenfeld, JoAnn

2016-06-01

The prognosis of ambulatory patients with advanced heart failure (HF) who are not yet inotrope dependent and implications for evaluation and timing for transplant or destination therapy with a left ventricular assist device (DT-LVAD) are unknown. We hypothesized that the characteristics defining eligibility for advanced HF therapies would be a primary determinant of outcomes in these patients. Ambulatory patients with advanced HF (New York Heart Association class III-IV, Interagency Registry for Mechanically Assisted Circulatory Support profiles 4-7) were enrolled across 11 centers from May 2013 to February 2015. Patients were stratified into 3 groups: likely transplant eligible, DT-LVAD eligible, and ineligible for both transplant and DT-LVAD. Clinical characteristics were collected, and patients were prospectively followed for death, transplant, and left ventricular assist device implantation. The study enrolled 144 patients with a mean follow-up of 10 ± 6 months. Patients in the ineligible cohort (n = 43) had worse congestion, renal function, and anemia compared with transplant (n = 51) and DT-LVAD (n = 50) eligible patients. Ineligible patients had higher mortality (23.3% vs 8.0% in DT-LVAD group and 5.9% in transplant group, p = 0.02). The differences in mortality were related to lower rates of transplantation (11.8% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p = 0.02) and left ventricular assist device implantation (15.7% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p < 0.01). Ambulatory patients with advanced HF who were deemed ineligible for transplant and DT-LVAD had markers of greater HF severity and a higher rate of mortality compared with patients eligible for transplant or DT-LVAD. The high early event rate in this group emphasizes the need for timely evaluation and decision making regarding lifesaving therapies. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Value of wireless personal digital assistants for practice: perceptions of advanced practice nurses.

PubMed

Garrett, Bernard; Klein, Gerri

2008-08-01

The aims were to explore advanced practice nurses' perceptions on wireless Personal Digital Assistant technologies, to establish the type and range of tools that would be useful to support their practice and to identify any requirements and limitations that may impact the implementation of wireless Personal Digital Assistants in practice. The wireless Personal Digital Assistant is becoming established as a hand-held computing tool for healthcare professionals. The reflections of advanced practice nurses' about the value of wireless Personal Digital Assistants and its potential to contribute to improved patient care has not been investigated. A qualitative interpretivist design was used to explore advanced practice nurses' perceptions on the value of wireless Personal Digital Assistant technologies to support their practice. The data were collected using survey questionnaires and individual and focus group interviews with nurse practitioners, clinical nurse specialists and information technology managers based in British Columbia, Canada. An open-coding content analysis was performed using qualitative data analysis software. Wireless Personal Digital Assistant's use supports the principles of pervasivity and is a technology rapidly being adopted by advanced practice nurses. Some nurses indicated a reluctance to integrate wireless Personal Digital Assistant technologies into their practices because of the cost and the short technological life cycle of these devices. Many of the barriers which precluded the use of wireless networks within facilities are being removed. Nurses demonstrated a complex understanding of wireless Personal Digital Assistant technologies and gave good rationales for its integration in their practice. Nurses identified improved client care as the major benefit of this technology in practice and the type and range of tools they identified included clinical reference tools such as drug and diagnostic/laboratory reference applications and wireless communications. Nurses in this study support integrating wireless mobile computing technologies into their practice to improve client care.

Perioperative Care of the Patient With the Total Artificial Heart.

PubMed

Yaung, Jill; Arabia, Francisco A; Nurok, Michael

2017-05-01

Advanced heart failure continues to be a leading cause of morbidity and mortality despite improvements in pharmacologic therapy. High demand for cardiac transplantation and shortage of donor organs have led to an increase in the utilization of mechanical circulatory support devices. The total artificial heart is an effective biventricular assist device that may be used as a bridge to transplant and that is being studied for destination therapy. This review discusses the history, indications, and perioperative management of the total artificial heart with emphasis on the postoperative concerns.

Human-Robot Interaction: Does Robotic Guidance Force Affect Gait-Related Brain Dynamics during Robot-Assisted Treadmill Walking?

PubMed

Knaepen, Kristel; Mierau, Andreas; Swinnen, Eva; Fernandez Tellez, Helio; Michielsen, Marc; Kerckhofs, Eric; Lefeber, Dirk; Meeusen, Romain

2015-01-01

In order to determine optimal training parameters for robot-assisted treadmill walking, it is essential to understand how a robotic device interacts with its wearer, and thus, how parameter settings of the device affect locomotor control. The aim of this study was to assess the effect of different levels of guidance force during robot-assisted treadmill walking on cortical activity. Eighteen healthy subjects walked at 2 km.h-1 on a treadmill with and without assistance of the Lokomat robotic gait orthosis. Event-related spectral perturbations and changes in power spectral density were investigated during unassisted treadmill walking as well as during robot-assisted treadmill walking at 30%, 60% and 100% guidance force (with 0% body weight support). Clustering of independent components revealed three clusters of activity in the sensorimotor cortex during treadmill walking and robot-assisted treadmill walking in healthy subjects. These clusters demonstrated gait-related spectral modulations in the mu, beta and low gamma bands over the sensorimotor cortex related to specific phases of the gait cycle. Moreover, mu and beta rhythms were suppressed in the right primary sensory cortex during treadmill walking compared to robot-assisted treadmill walking with 100% guidance force, indicating significantly larger involvement of the sensorimotor area during treadmill walking compared to robot-assisted treadmill walking. Only marginal differences in the spectral power of the mu, beta and low gamma bands could be identified between robot-assisted treadmill walking with different levels of guidance force. From these results it can be concluded that a high level of guidance force (i.e., 100% guidance force) and thus a less active participation during locomotion should be avoided during robot-assisted treadmill walking. This will optimize the involvement of the sensorimotor cortex which is known to be crucial for motor learning.

Implantable Cardioverter-Defibrillators in Patients With a Continuous-Flow Left Ventricular Assist Device: An Analysis of the INTERMACS Registry.

PubMed

Clerkin, Kevin J; Topkara, Veli K; Demmer, Ryan T; Dizon, Jose M; Yuzefpolskaya, Melana; Fried, Justin A; Mai, Xingchen; Mancini, Donna M; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C; Garan, A Reshad

2017-12-01

This study sought to determine if the presence of implantable cardioverter-defibrillators (ICD) provided a mortality benefit during continuous-flow left ventricular assist device (LVAD) support. An ICD decreases mortality in selected patients with advanced heart failure and have been associated with reduced mortality in patients with pulsatile LVAD. However, it is unclear whether that benefit extends to patients with a contemporary continuous-flow LVAD. Propensity score matching was used to generate a cohort of patients with similar baseline characteristics. The primary outcome was freedom from death during LVAD support. Secondary endpoints included freedom from unexpected death, likelihood of transplantation and recovery, and adverse events. Among 16,384 eligible patients in the Interagency Registry for Mechanically Assisted Circulatory Support registry, 2,209 patients with an ICD and 2,209 patients without one had similar propensity scores and were included. The presence of an ICD was associated with an increased mortality risk (hazard ratio: 1.20; 95% confidence interval [CI]: 1.04 to 1.39; p = 0.013) and an increased risk of unexpected death during device support (HR: 1.33; 95% CI: 1.03 to 1.71; p = 0.03). Patients with an ICD were more likely to undergo transplantation (HR: 1.16; 95% CI: 0.99 to 1.35; p = 0.06) and less likely to have LVAD explant for recovery (HR: 0.53, 95% CI: 0.29 to 0.98; p = 0.04). Patients with an ICD had a higher rate of treated ventricular arrhythmias (rate ratio: 1.27; 95% CI: 1.10 to 1.48; p = 0.001) and rehospitalization (rate ratio: 1.08; 95% CI: 1.04 to 1.12; p < 0.0001), but rates of hemorrhagic stroke were similar (rate ratio: 1.01; 95% CI: 0.81 to 1.26; p = 0.98). Among patients with a continuous flow LVAD, the presence of an ICD was not associated with reduced mortality. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Institutional Cost Comparison Between Heart Transplants and Left Ventricular Assist Device Implantations.

PubMed

Chimanji, Neeraj; Kilic, Arman; Hasan, Ayesha; Higgins, Robert S D; Whitson, Bryan A; Kilic, Ahmet

2016-12-01

Increased numbers of end-stage heart failure patients and improved technology have led to increased use of left ventricular assist devices as a viable alternative to heart transplants. Given the current economic climate, we compared costs of heart transplant versus device placement. Medical records of patients who received heart transplants or left ventricular assist devices were cross-referenced with institutional financial data. The device cohort was limited to those receiving durable (not temporary) devices. Index admission, 1-year readmission, and overall 1-year charges were compared using standard statistical methods. Of 184 identified patients with end-stage heart failure surgical therapy, 121 received left ventricular assist devices, 43 had heart transplants, and 20 received left ventricular assist devices as bridge to heart transplant; these latter patients were excluded from our analyses. At index admission, mean charges were $863 433 ± $398 427 for device patients and $725 877 ± $488 685 for transplant patients (P = .05). One-year mean readmission rates were similar (4.65/transplant patient and 4.53/device patient; P = .94), with corresponding 1-year survival rates of 87.8% and 78.0% (P = .04). Total readmission charges during year 1 were $169 732 ± $242 366 for device patients and $201 682 ± $297 565 for transplant patients (P = .08), with corresponding overall charges at 1 year of $1 029 732 ± $450 498 and $927 559 ± $562 404 (P = .49). During the first year, heart transplant and left ventricular assist device placement have similar costs. Initial index admission costs seem to favor heart transplant, with device pump costs accounting for some of the difference. From a 1-year survival perspective, heart transplant may be more effective; however, with lack of suitable donors, left ventricular assist devices are valuable in the armamentarium of advanced heart failure surgical options.

14 CFR 382.129 - What other requirements apply when passengers' wheelchairs, other mobility aids, and other...

Code of Federal Regulations, 2013 CFR

2013-01-01

... passengers' wheelchairs, other mobility aids, and other assistive devices must be disassembled for stowage... Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.129 What other requirements apply when passengers' wheelchairs, other mobility aids, and other assistive devices must be...

14 CFR 382.129 - What other requirements apply when passengers' wheelchairs, other mobility aids, and other...

Code of Federal Regulations, 2012 CFR

2012-01-01

... passengers' wheelchairs, other mobility aids, and other assistive devices must be disassembled for stowage... Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.129 What other requirements apply when passengers' wheelchairs, other mobility aids, and other assistive devices must be...

14 CFR 382.129 - What other requirements apply when passengers' wheelchairs, other mobility aids, and other...

Code of Federal Regulations, 2014 CFR

2014-01-01

... passengers' wheelchairs, other mobility aids, and other assistive devices must be disassembled for stowage... Stowage of Wheelchairs, Other Mobility Aids, and Other Assistive Devices § 382.129 What other requirements apply when passengers' wheelchairs, other mobility aids, and other assistive devices must be...

Concept and Design of a 3D Printed Support to Assist Hand Scanning for the Realization of Customized Orthosis.

PubMed

Baronio, Gabriele; Volonghi, Paola; Signoroni, Alberto

2017-01-01

In the rehabilitation field, the use of additive manufacturing techniques to realize customized orthoses is increasingly widespread. Obtaining a 3D model for the 3D printing phase can be done following different methodologies. We consider the creation of personalized upper limb orthoses, also including fingers, starting from the acquisition of the hand geometry through accurate 3D scanning. However, hand scanning procedure presents differences between healthy subjects and patients affected by pathologies that compromise upper limb functionality. In this work, we present the concept and design of a 3D printed support to assist hand scanning of such patients. The device, realized with FDM additive manufacturing techniques in ABS material, allows palmar acquisitions, and its design and test are motivated by the following needs: (1) immobilizing the hand of patients during the palmar scanning to reduce involuntary movements affecting the scanning quality and (2) keeping hands open and in a correct position, especially to contrast the high degree of hypertonicity of spastic subjects. The resulting device can be used indifferently for the right and the left hand; it is provided in four-dimensional sizes and may be also suitable as a palmar support for the acquisition of the dorsal side of the hand.

Concept and Design of a 3D Printed Support to Assist Hand Scanning for the Realization of Customized Orthosis

PubMed Central

Volonghi, Paola

2017-01-01

In the rehabilitation field, the use of additive manufacturing techniques to realize customized orthoses is increasingly widespread. Obtaining a 3D model for the 3D printing phase can be done following different methodologies. We consider the creation of personalized upper limb orthoses, also including fingers, starting from the acquisition of the hand geometry through accurate 3D scanning. However, hand scanning procedure presents differences between healthy subjects and patients affected by pathologies that compromise upper limb functionality. In this work, we present the concept and design of a 3D printed support to assist hand scanning of such patients. The device, realized with FDM additive manufacturing techniques in ABS material, allows palmar acquisitions, and its design and test are motivated by the following needs: (1) immobilizing the hand of patients during the palmar scanning to reduce involuntary movements affecting the scanning quality and (2) keeping hands open and in a correct position, especially to contrast the high degree of hypertonicity of spastic subjects. The resulting device can be used indifferently for the right and the left hand; it is provided in four-dimensional sizes and may be also suitable as a palmar support for the acquisition of the dorsal side of the hand. PMID:29234219

[Orthoses and assistive devices in rheumatology : Prevention of disability, support of residual function].

PubMed

Fikentscher, T; Springorum, H R; Grifka, J; Götz, J

2017-04-01

Due to the frequent presence of comorbidities in patients suffering from rheumatism with increased perioperative risk factors, conservative treatment is often needed. Besides pharmacological treatment, physiotherapy and occupational therapy, a variety of orthoses are available depending on the individual indications. They can be used to stabilize or support joints, limit the range of motion, prevent unphysiological movements or provide relief for affected limbs. In order to choose the right kind of orthosis, the physician should know the underlying cause of disease. Furthermore, for patients with rheumatism many devices are available for daily living that use ergonomic handles or improved leverage effects to compensate for the often severe limitations and to improve the quality of life.

Low-back electromyography (EMG) data-driven load classification for dynamic lifting tasks

PubMed Central

Ojeda, Lauro; Johnson, Daniel D.; Gates, Deanna; Mower Provost, Emily; Barton, Kira

2018-01-01

Objective Numerous devices have been designed to support the back during lifting tasks. To improve the utility of such devices, this research explores the use of preparatory muscle activity to classify muscle loading and initiate appropriate device activation. The goal of this study was to determine the earliest time window that enabled accurate load classification during a dynamic lifting task. Methods Nine subjects performed thirty symmetrical lifts, split evenly across three weight conditions (no-weight, 10-lbs and 24-lbs), while low-back muscle activity data was collected. Seven descriptive statistics features were extracted from 100 ms windows of data. A multinomial logistic regression (MLR) classifier was trained and tested, employing leave-one subject out cross-validation, to classify lifted load values. Dimensionality reduction was achieved through feature cross-correlation analysis and greedy feedforward selection. The time of full load support by the subject was defined as load-onset. Results Regions of highest average classification accuracy started at 200 ms before until 200 ms after load-onset with average accuracies ranging from 80% (±10%) to 81% (±7%). The average recall for each class ranged from 69–92%. Conclusion These inter-subject classification results indicate that preparatory muscle activity can be leveraged to identify the intent to lift a weight up to 100 ms prior to load-onset. The high accuracies shown indicate the potential to utilize intent classification for assistive device applications. Significance Active assistive devices, e.g. exoskeletons, could prevent back injury by off-loading low-back muscles. Early intent classification allows more time for actuators to respond and integrate seamlessly with the user. PMID:29447252

Fabrication of three-dimensional scaffolds using precision extrusion deposition with an assisted cooling device.

PubMed

Hamid, Q; Snyder, J; Wang, C; Timmer, M; Hammer, J; Guceri, S; Sun, W

2011-09-01

In the field of biofabrication, tissue engineering and regenerative medicine, there are many methodologies to fabricate a building block (scaffold) which is unique to the target tissue or organ that facilitates cell growth, attachment, proliferation and/or differentiation. Currently, there are many techniques that fabricate three-dimensional scaffolds; however, there are advantages, limitations and specific tissue focuses of each fabrication technique. The focus of this initiative is to utilize an existing technique and expand the library of biomaterials which can be utilized to fabricate three-dimensional scaffolds rather than focusing on a new fabrication technique. An expanded library of biomaterials will enable the precision extrusion deposition (PED) device to construct three-dimensional scaffolds with enhanced biological, chemical and mechanical cues that will benefit tissue generation. Computer-aided motion and extrusion drive the PED to precisely fabricate micro-scaled scaffolds with biologically inspired, porosity, interconnectivity and internal and external architectures. The high printing resolution, precision and controllability of the PED allow for closer mimicry of tissues and organs. The PED expands its library of biopolymers by introducing an assisting cooling (AC) device which increases the working extrusion temperature from 120 to 250 °C. This paper investigates the PED with the integrated AC's capabilities to fabricate three-dimensional scaffolds that support cell growth, attachment and proliferation. Studies carried out in this paper utilized a biopolymer whose melting point is established to be 200 °C. This polymer was selected to illustrate the newly developed device's ability to fabricate three-dimensional scaffolds from a new library of biopolymers. Three-dimensional scaffolds fabricated with the integrated AC device should illustrate structural integrity and ability to support cell attachment and proliferation.

Magnetic manipulation device for the optimization of cell processing conditions.

PubMed

Ito, Hiroshi; Kato, Ryuji; Ino, Kosuke; Honda, Hiroyuki

2010-02-01

Variability in human cell phenotypes make it's advancements in optimized cell processing necessary for personalized cell therapy. Here we propose a strategy of palm-top sized device to assist physically manipulating cells for optimizing cell preparations. For the design of such a device, we combined two conventional approaches: multi-well plate formatting and magnetic cell handling using magnetite cationic liposomes (MCLs). From our previous works, we showed the labeling applications of MCL on adhesive cells for various tissue engineering approaches. To feasibly transfer cells in multi-well plate, we here evaluated the magnetic response of MCL-labeled suspension type cells. The cell handling performance of Jurkat cells proved to be faster and more robust compared to MACS (Magnetic Cell Sorting) bead methods. To further confirm our strategy, prototype palm-top sized device "magnetic manipulation device (MMD)" was designed. In the device, the actual cell transportation efficacy of Jurkat cells was satisfying. Moreover, as a model of the most distributed clinical cell processing, primary peripheral blood mononuclear cells (PBMCs) from different volunteers were evaluated. By MMD, individual PBMCs indicated to have optimum Interleukin-2 (IL-2) concentrations for the expansion. Such huge differences of individual cells indicated that MMD, our proposing efficient and self-contained support tool, could assist the feasible and cost-effective optimization of cell processing in clinical facilities. Copyright (c) 2009 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

Development of mechanical circulatory support devices in China.

PubMed

Wang, Wei; Zhu, De-Ming; Ding, Wen-Xiang

2009-11-01

Myocardial dysfunction leading to low cardiac output syndrome is a common clinical pathophysiological state. Currently, the use of mechanical circulatory support (MCS) is an essential aspect of the treatment of patients with cardiac failure. Several groups in China are engaged in the design and development of MCS devices. These devices can be classified as pulsatile, rotary, and total artificial heart (TAH). There are two types of pulsatile pump, which are driven by air (pneumatic). One of these pumps, the Luo-Ye pump, has been used clinically for short-term support since 1998. The other is a push-plate left ventricular device, which has a variable rate mode. Various rotary devices are classified into axial and centrifugal pumps, depending on the impeller geometry. Most rotary pumps are based on the maglev principle, and some types have been used clinically. Others are still being studied in the laboratory or in animal experiments. Furthermore, certain types of total implantable pump, such as the UJS-III axial pump and the UJS-IV aortic valvo-pump, have been developed. Only one type of TAH has been developed in China. The main constituents of this artificial heart are two axial pumps, two reservoir tanks mimicking the right and left atria, flow meters, two pressure gauges, and a resistance adaptor. Although the development of mechanical assist devices in China is still in a nascent stage, a number of different types of MCS devices are currently being studied.

Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults.

PubMed

Lee, Su-Hyun; Lee, Hwang-Jae; Chang, Won Hyuk; Choi, Byung-Ok; Lee, Jusuk; Kim, Jeonghun; Ryu, Gyu-Ha; Kim, Yun-Hee

2017-11-28

A robotic exoskeleton device is an intelligent system designed to improve gait performance and quality of life for the wearer. Robotic technology has developed rapidly in recent years, and several robot-assisted gait devices were developed to enhance gait function and activities of daily living in elderly adults and patients with gait disorders. In this study, we investigated the effects of the Gait-enhancing Mechatronic System (GEMS), a new wearable robotic hip-assist device developed by Samsung Electronics Co, Ltd., Korea, on gait performance and foot pressure distribution in elderly adults. Thirty elderly adults who had no neurological or musculoskeletal abnormalities affecting gait participated in this study. A three-dimensional (3D) motion capture system, surface electromyography and the F-Scan system were used to collect data on spatiotemporal gait parameters, muscle activity and foot pressure distribution under three conditions: free gait without robot assistance (FG), robot-assisted gait with zero torque (RAG-Z) and robot-assisted gait (RAG). We found increased gait speed, cadence, stride length and single support time in the RAG condition. Reduced rectus femoris and medial gastrocnemius muscle activity throughout the terminal stance phase and reduced effort of the medial gastrocnemius muscle throughout the pre-swing phase were also observed in the RAG condition. In addition, walking with the assistance of GEMS resulted in a significant increase in foot pressure distribution, specifically in maximum force and peak pressure of the total foot, medial masks, anterior masks and posterior masks. The results of the present study reveal that GEMS may present an alternative way of restoring age-related changes in gait such as gait instability with muscle weakness, reduced step force and lower foot pressure in elderly adults. In addition, GEMS improved gait performance by improving push-off power and walking speed and reducing muscle activity in the lower extremities. NCT02843828 .

Quality of Life, Depression, and Anxiety in Ventricular Assist Device Therapy: Longitudinal Outcomes for Patients and Family Caregivers.

PubMed

Bidwell, Julie T; Lyons, Karen S; Mudd, James O; Gelow, Jill M; Chien, Christopher V; Hiatt, Shirin O; Grady, Kathleen L; Lee, Christopher S

Patients who receive ventricular assist device (VAD) therapy typically rely on informal caregivers (family members or friends) to assist them in managing their device. The purpose of this study is to characterize changes in person-oriented outcomes (quality of life [QOL], depression, and anxiety) for VAD patients and their caregivers together from pre-implantation to 3 months post-implantation. This was a formal interim analysis from an ongoing prospective study of VAD patients and caregivers (n = 41 dyads). Data on person-oriented outcomes (QOL: EuroQol 5 Dimensions Visual Analog Scale; depression: Patient Health Questionnaire-8; anxiety: Brief Symptom Inventory) were collected at 3 time points (just prior to implantation and at 1 and 3 months post-implantation). Trajectories of change for patients and caregivers on each measure were estimated using latent growth modeling with parallel processes. Patients' QOL improved significantly over time, whereas caregiver QOL worsened. Depression and anxiety also improved significantly among patients but did not change among caregivers. There was substantial variability in change on all outcomes for both patients and their caregivers. This is the first quantitative study of VAD patient-caregiver dyads in modern devices that describes change in person-oriented outcomes from pre-implantation to post-implantation. This work supports the need for future studies that account for the inherent relationships between patient and caregiver outcomes and examine variability in patient and caregiver responses to VAD therapy.

21 CFR 870.3545 - Ventricular bypass (assist) device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ventricular bypass (assist) device. 870.3545 Section 870.3545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3545 Ventricular...

21 CFR 870.3545 - Ventricular bypass (assist) device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ventricular bypass (assist) device. 870.3545 Section 870.3545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3545 Ventricular...

A compliant, banded outflow cannula for decreased afterload sensitivity of rotary right ventricular assist devices.

PubMed

Gregory, Shaun D; Schummy, Emma; Pearcy, Mark; Pauls, Jo P; Tansley, Geoff; Fraser, John F; Timms, Daniel

2015-02-01

Biventricular support with dual rotary ventricular assist devices (VADs) has been implemented clinically with restriction of the right VAD (RVAD) outflow cannula to artificially increase afterload and, therefore, operate within recommended design speed ranges. However, the low preload and high afterload sensitivity of these devices increase the susceptibility of suction events. Active control systems are prone to sensor drift or inaccurate inferred (sensor-less) data, therefore an alternative solution may be of benefit. This study presents the in vitro evaluation of a compliant outflow cannula designed to passively decrease the afterload sensitivity of rotary RVADs and minimize left-sided suction events. A one-way fluid-structure interaction model was initially used to produce a design with suitable flow dynamics and radial deformation. The resultant geometry was cast with different initial cross-sectional restrictions and concentrations of a softening diluent before evaluation in a mock circulation loop. Pulmonary vascular resistance (PVR) was increased from 50 dyne s/cm(5) until left-sided suction events occurred with each compliant cannula and a rigid, 4.5 mm diameter outflow cannula for comparison. Early suction events (PVR ∼ 300 dyne s/cm(5) ) were observed with the rigid outflow cannula. Addition of the compliant section with an initial 3 mm diameter restriction and 10% diluent expanded the outflow restriction as PVR increased, thus increasing RVAD flow rate and preventing left-sided suction events at PVR levels beyond 1000 dyne s/cm(5) . Therefore, the compliant, restricted outflow cannula provided a passive control system to assist in the prevention of suction events with rotary biventricular support while maintaining pump speeds within normal ranges of operation. Copyright © 2014 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

The current status of mHealth for diabetes: will it be the next big thing?

PubMed

Klonoff, David C

2013-05-01

mHealth is an emerging concept in health care and uses mobile communications devices for health services and information. Mobile phones, patient monitoring devices, tablets, personal digital assistants, and other wireless devices can be part of mHealth systems. With mHealth systems, glucose data can now be automatically collected, transmitted, aggregated with other physiologic data, analyzed, stored, and presented as actionable information. mHealth systems use mobile decision support software applications (or apps) to assist or direct health care professionals to make decisions, or they can assist or direct patients to make decisions without waiting for input from a clinician. With real-time decision support for patients, appropriate actions can be taken in real time without waiting to see a clinician. Decisions can be personalized if individual treatment goals and personal preferences for treatment are inputted into an app. Few mHealth apps for diabetes have been rigorously tested. Outcome studies of the use of mHealth for diabetes from the literature have shown the potential for benefits, but higher-quality studies are needed. Regulatory approval of mHealth products will require demonstration of safety and effectiveness, especially where information and trends are not just presented to patients, but used to make treatment recommendations. Three additional hurdles must be overcome to facilitate widespread adoption of this technology, including demonstration of the following: (1) privacy to satisfy regulators, (2) clinical benefit to satisfy clinicians, and (3) economic benefit to satisfy payers. mHealth for diabetes is making rapid strides and is expected to be a transforming technology that will be the next big thing. © 2013 Diabetes Technology Society.

[Provision of assistive devices in amyotrophic lateral sclerosis. Analysis of 3 years case management in an internet-based supply network].

PubMed

Funke, A; Grehl, T; Großkreutz, J; Münch, C; Walter, B; Kettemann, D; Karnapp, C; Gajewski, N; Meyer, R; Maier, A; Gruhn, K M; Prell, T; Kollewe, K; Abdulla, S; Kobeleva, X; Körner, S; Petri, S; Meyer, T

2015-08-01

The provision of assistive devices (PAD) is a key element of care in amyotrophic lateral sclerosis (ALS). Since 2011, assistive devices (AD) have been coordinated in an internet-supported care network at university-based ALS centers in Berlin, Bochum, Hannover and Jena. The digitization of PAD processes has facilitated the evaluation of real-life ALS care. Orthotics (OT), augmentative and alternative communication (AAC), supported treadmill (ST) and powered wheelchair (PW) were the PAD groups analyzed for delivery rates (proportion of delivered AD vs. medically indicated AD), rejection by patients and payers and latency of provision of care. Between June 2011 and October 2014 a total of 1479 patients and 12,478 AD were coordinated, among which 3313 PAD were related to OT, AAC, ST or EM. The median delivery rate was 64.3 %. The mean rejection rate by patients was 9.8 % (OT 5.4 %, AAC 9.8 %, ST 10.2 % and PW 15.6 %). Marked differences were noted in the rejection rate by payers and in care provision latency: OT (16.2 %, 68 days, n = 734), AAC (30.4 %, 96 days, n = 392), ST (34.8 %, 113 days, n = 164) and PW (35.6 %, 129 days, n = 259). Analysis of rejection rates showed significant differences among insurers. Only two thirds of the medically indicated AD reached the patients. Rejection rates by patients and payers and latency of provision of care were high. The PAD can substantially vary among health insurance companies. The establishment of consented criteria for PAD and their integration into treatment regimens and guidelines are crucial tasks for the future.

The Current Status of mHealth for Diabetes: Will It Be the Next Big Thing?

PubMed Central

Klonoff, David C.

2013-01-01

mHealth is an emerging concept in health care and uses mobile communications devices for health services and information. Mobile phones, patient monitoring devices, tablets, personal digital assistants, and other wireless devices can be part of mHealth systems. With mHealth systems, glucose data can now be automatically collected, transmitted, aggregated with other physiologic data, analyzed, stored, and presented as actionable information. mHealth systems use mobile decision support software applications (or apps) to assist or direct health care professionals to make decisions, or they can assist or direct patients to make decisions without waiting for input from a clinician. With real-time decision support for patients, appropriate actions can be taken in real time without waiting to see a clinician. Decisions can be personalized if individual treatment goals and personal preferences for treatment are inputted into an app. Few mHealth apps for diabetes have been rigorously tested. Outcome studies of the use of mHealth for diabetes from the literature have shown the potential for benefits, but higher-quality studies are needed. Regulatory approval of mHealth products will require demonstration of safety and effectiveness, especially where information and trends are not just presented to patients, but used to make treatment recommendations. Three additional hurdles must be overcome to facilitate widespread adoption of this technology, including demonstration of the following: (1) privacy to satisfy regulators, (2) clinical benefit to satisfy clinicians, and (3) economic benefit to satisfy payers. mHealth for diabetes is making rapid strides and is expected to be a transforming technology that will be the next big thing. PMID:23759409

Personal digital assistant-based, internet-enabled remote communication system for a wearable pneumatic biventricular assist device.

PubMed

Nam, Kyoung Won; Lee, Jung Joo; Hwang, Chang Mo; Choi, Seong Wook; Son, Ho Sung; Sun, Kyung

2007-11-01

Currently, personal mobile communication devices have become quite common, and the applications of such devices have expanded quickly. Remote communication systems might be employed for the telemonitoring of patients or the operating status of their medical devices. In this article, we describe the development of a mobile-based artificial heart telemanagement system for use in a wearable extracorporeal pneumatic biventricular assist device, which is capable of telemonitoring and telecontrolling the operating status of the ventricular assist device from any site. The system developed herein utilized small mobile phones for the client device and adopted a standard transmission control protocol/Internet protocol communication protocol for the purposes of telecommunication. The results of in vitro and animal experiments showed that the telemanagement system developed herein operated in accordance with the desired parameters.

Assessment of Cardiac Device Position on Supine Chest Radiograph in the ICU: Introduction and Applicability of the Aortic Valve Location Ratio.

PubMed

Ouweneel, Dagmar M; Sjauw, Krischan D; Wiegerinck, Esther M A; Hirsch, Alexander; Baan, Jan; de Mol, Bas A J M; Lagrand, Wim K; Planken, R Nils; Henriques, José P S

2016-10-01

The use of intracardiac assist devices is expanding, and correct position of these devices is required for optimal functioning. The aortic valve is an important landmark for positioning of those devices. It would be of great value if the device position could be easily monitored on plain supine chest radiograph in the ICU. We introduce a ratio-based tool for determination of the aortic valve location on plain supine chest radiograph images, which can be used to evaluate intracardiac device position. Retrospective observational study. Large academic medical center. Patients admitted to the ICU and supported by an intracardiac assist device. We developed a ratio to determine the aortic valve location on supine chest radiograph images. This ratio is used to assess the position of a cardiac assist device and is compared with echocardiographic findings. Supine anterior-posterior chest radiographs of patients with an aortic valve prosthesis (n = 473) were analyzed to determine the location of the aortic valve. We calculated several ratios with the potential to determine the position of the aortic valve. The aortic valve location ratio, defined as the distance between the carina and the aortic valve, divided by the thoracic width, was found to be the best performing ratio. The aortic valve location ratio determines the location of the aortic valve caudal to the carina, at a distance of 0.25 ± 0.05 times the thoracic width for male patients and 0.28 ± 0.05 times the thoracic width for female patients. The aortic valve location ratio was validated using CT images of patients with angina pectoris without known valvular disease (n = 95). There was a good correlation between cardiac device position (Impella) assessed with the aortic valve location ratio and with echocardiography (n = 53). The aortic valve location ratio enables accurate and reproducible localization of the aortic valve on supine chest radiograph. This tool is easily applicable and can be used for assessment of cardiac device position in patients on the ICU.

Assistive Technology: Issues and Trends.

ERIC Educational Resources Information Center

Scherer, Marcia J.

This paper discusses current issues regarding assistive technology devices and services, especially in relation to the roles and responsibilities of the rehabilitation psychologist. Following an introductory section which defines an assistive technology device and an assistive technology service, the following sections discuss: (1) past…

Optimising Service Delivery of AAC AT Devices and Compensating AT for Dyslexia.

PubMed

Roentgen, Uta R; Hagedoren, Edith A V; Horions, Katrien D L; Dalemans, Ruth J P

2017-01-01

To promote successful use of Assistive Technology (AT) supporting Augmentative and Alternative Communication (AAC) and compensating for dyslexia, the last steps of their provision, delivery and instruction, use, maintenance and evaluation, were optimised. In co-creation with all stakeholders based on a list of requirements an integral method and tools were developed.

76 FR 75887 - SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Incorporated's...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-05

... advisory committee was slated to discuss the Center for Devices and Radiological Health's (CDRH's) denial..., CDRH issued a letter to EES indicating that PMA P080009 for SEDASYS was not approvable under Sec. 814.44(f) (21 CFR 814.44(f)) because CDRH concluded that the data and information offered in support of...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

21 CFR 890.5050 - Daily activity assist device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

Chronic In Vivo Testing of the Penn State Infant Ventricular Assist Device

PubMed Central

Weiss, William J.; Carney, Elizabeth L.; Clark, J. Brian; Peterson, Rebecca; Cooper, Timothy K.; Nifong, Thomas P.; Siedlecki, Christopher A; Hicks, Dennis; Doxtater, Bradley; Lukic, Branka; Yeager, Eric; Reibson, John; Cysyk, Joshua; Rosenberg, Gerson; Pierce, William S.

2011-01-01

The Penn State Infant Ventricular Assist Device is a 12-14 ml stroke volume pneumatically actuated pump, with custom Björk-Shiley monostrut valves, developed under the National Heart, Lung, and Blood Institute (NHLBI) Pediatric Circulatory Support program. In this report we describe the 7 most recent chronic animal studies of the Infant VAD in the juvenile ovine model, with a mean body weight of 23.5 +/- 4.1 kg. The goal of 4-6 weeks survival was achieved in 5 of 7 studies, with support duration ranging from 5 to 41 days; mean 26.1 days. Anticoagulation was accomplished using unfractionated heparin, and study animals were divided into 2 protocol groups: the first based on a target activated partial thromboplastin time of 1.5 to 2 times normal, and a second group using a target thromboelastography R-time of 2 times normal. The second group required significantly less heparin, which was verified by barely detectable heparin activity (anti-Xa). In both groups, there was no evidence of thromboembolism except in one animal with a chronic infection and fever. Device thrombi were minimal, and were further reduced by introduction of the custom valve. These results are consistent with results of adult VAD testing in animals, and are encouraging given the extremely low levels of anticoagulation in the second group. PMID:22157073

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2012-07-01 2012-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2014-07-01 2014-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2011-07-01 2011-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

38 CFR 17.152 - Devices to assist in overcoming the handicap of deafness.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Devices to assist in overcoming the handicap of deafness. 17.152 Section 17.152 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... in overcoming the handicap of deafness. Devices for assisting in overcoming the handicap of deafness...

Simulating ideal assistive devices to reduce the metabolic cost of walking with heavy loads.

PubMed

Dembia, Christopher L; Silder, Amy; Uchida, Thomas K; Hicks, Jennifer L; Delp, Scott L

2017-01-01

Wearable robotic devices can restore and enhance mobility. There is growing interest in designing devices that reduce the metabolic cost of walking; however, designers lack guidelines for which joints to assist and when to provide the assistance. To help address this problem, we used musculoskeletal simulation to predict how hypothetical devices affect muscle activity and metabolic cost when walking with heavy loads. We explored 7 massless devices, each providing unrestricted torque at one degree of freedom in one direction (hip abduction, hip flexion, hip extension, knee flexion, knee extension, ankle plantarflexion, or ankle dorsiflexion). We used the Computed Muscle Control algorithm in OpenSim to find device torque profiles that minimized the sum of squared muscle activations while tracking measured kinematics of loaded walking without assistance. We then examined the metabolic savings provided by each device, the corresponding device torque profiles, and the resulting changes in muscle activity. We found that the hip flexion, knee flexion, and hip abduction devices provided greater metabolic savings than the ankle plantarflexion device. The hip abduction device had the greatest ratio of metabolic savings to peak instantaneous positive device power, suggesting that frontal-plane hip assistance may be an efficient way to reduce metabolic cost. Overall, the device torque profiles generally differed from the corresponding net joint moment generated by muscles without assistance, and occasionally exceeded the net joint moment to reduce muscle activity at other degrees of freedom. Many devices affected the activity of muscles elsewhere in the limb; for example, the hip flexion device affected muscles that span the ankle joint. Our results may help experimentalists decide which joint motions to target when building devices and can provide intuition for how devices may interact with the musculoskeletal system. The simulations are freely available online, allowing others to reproduce and extend our work.

Simulating ideal assistive devices to reduce the metabolic cost of walking with heavy loads

PubMed Central

Silder, Amy; Uchida, Thomas K.; Hicks, Jennifer L.; Delp, Scott L.

2017-01-01

Wearable robotic devices can restore and enhance mobility. There is growing interest in designing devices that reduce the metabolic cost of walking; however, designers lack guidelines for which joints to assist and when to provide the assistance. To help address this problem, we used musculoskeletal simulation to predict how hypothetical devices affect muscle activity and metabolic cost when walking with heavy loads. We explored 7 massless devices, each providing unrestricted torque at one degree of freedom in one direction (hip abduction, hip flexion, hip extension, knee flexion, knee extension, ankle plantarflexion, or ankle dorsiflexion). We used the Computed Muscle Control algorithm in OpenSim to find device torque profiles that minimized the sum of squared muscle activations while tracking measured kinematics of loaded walking without assistance. We then examined the metabolic savings provided by each device, the corresponding device torque profiles, and the resulting changes in muscle activity. We found that the hip flexion, knee flexion, and hip abduction devices provided greater metabolic savings than the ankle plantarflexion device. The hip abduction device had the greatest ratio of metabolic savings to peak instantaneous positive device power, suggesting that frontal-plane hip assistance may be an efficient way to reduce metabolic cost. Overall, the device torque profiles generally differed from the corresponding net joint moment generated by muscles without assistance, and occasionally exceeded the net joint moment to reduce muscle activity at other degrees of freedom. Many devices affected the activity of muscles elsewhere in the limb; for example, the hip flexion device affected muscles that span the ankle joint. Our results may help experimentalists decide which joint motions to target when building devices and can provide intuition for how devices may interact with the musculoskeletal system. The simulations are freely available online, allowing others to reproduce and extend our work. PMID:28700630

U.S. national response assets for radiological incidents.

PubMed

Remick, Alan L; Crapo, John L; Woodruff, Charles R

2005-11-01

The federal government has had the ability to respond to incidents of national significance for decades. Since 11 September 2001, there have been enhancements to existing federal assets and the creation of new federal assets. This presentation will provide an overview of the more significant federal assets. Pivotal to a response of national significance is the U.S. Department of Energy (DOE) Federal Radiological Monitoring and Assessment Center, which organizes and coordinates federal agency monitoring activities during an emergency. DOE manages the Federal Radiological Monitoring and Assessment Center during the emergency phase, and the Environmental Protection Agency (EPA) manages the response during the recovery phase once the emergency is terminated. EPA monitoring teams provide support during both the emergency and recovery phases of an emergency. Other DOE teams are available to respond to major nuclear power plant events, transportation accidents, or terrorism events involving the use of radiological materials, including the Radiological Assistance Program, the Aerial Measuring System, the National Atmospheric Release Advisory Center, and the Radiation Emergency Assistance Center/Training Site. For incidents involving a nuclear weapon, an improvised nuclear device, or a radiological dispersal device, DOE assets such as the Nuclear Emergency Support Team and the Accident Response Group could provide capabilities for weapon or device search, recovery, and removal. The Radiological Triage System harnesses the weapons scientists and engineers at the DOE national laboratories to provide gamma spectroscopy interpretation for agencies responding to an incident. In recent years, National Guard Weapons of Mass Destruction-Civil Support Teams have been created to support state and local response to terrorism events. The Civil Support Teams normally come under direct control of the state and can respond without requiring authorization from the U.S. Department of Defense (DoD). Changes brought about by the events of September 11 also extend to changing federal response policy and planning. Therefore, the Catastrophic Incident Response Annex to the National Response Plan is discussed. DoD also provides specifically designated radiological response capabilities that can be utilized within the guidelines of the National Response Plan. While optimally designed to support military missions, these resources also help provide for a well-equipped set of national assets to temporarily support and augment the local, state, and federal civil agencies that have primary authority and responsibility for domestic disaster assistance. The military's role in domestic emergencies is well defined in military regulations, as well as the national plan.

Percutaneous Repair of Postoperative Mitral Regurgitation After Left Ventricular Assist Device Implant.

PubMed

Cork, David P; Adamson, Robert; Gollapudi, Raghava; Dembitsky, Walter; Jaski, Brian

2018-02-01

Mitral regurgitation commonly improves after implantation of a left ventricular assist device without concomitant valvular repair owing to the mechanical unloading of the left ventricle. However, the development (or persistence) of significant mitral regurgitation after implantation of a left ventricular assist device is associated with adverse clinical events. We present a case of a left ventricular assist device patient who successfully underwent a percutaneous MitraClip procedure for repair of persistent late postoperative mitral insufficiency with demonstrable clinical and hemodynamic improvement. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Self-Fitting Hearing Aids

PubMed Central

Convery, Elizabeth

2016-01-01

A self-contained, self-fitting hearing aid (SFHA) is a device that enables the user to perform both threshold measurements leading to a prescribed hearing aid setting and fine-tuning, without the need for audiological support or access to other equipment. The SFHA has been proposed as a potential solution to address unmet hearing health care in developing countries and remote locations in the developed world and is considered a means to lower cost and increase uptake of hearing aids in developed countries. This article reviews the status of the SFHA and the evidence for its feasibility and challenges and predicts where it is heading. Devices that can be considered partly or fully self-fitting without audiological support were identified in the direct-to-consumer market. None of these devices are considered self-contained as they require access to other hardware such as a proprietary interface, computer, smartphone, or tablet for manipulation. While there is evidence that self-administered fitting processes can provide valid and reliable results, their success relies on user-friendly device designs and interfaces and easy-to-interpret instructions. Until these issues have been sufficiently addressed, optional assistance with the self-fitting process and on-going use of SFHAs is recommended. Affordability and a sustainable delivery system remain additional challenges for the SFHA in developing countries. Future predictions include a growth in self-fitting products, with most future SFHAs consisting of earpieces that connect wirelessly with a smartphone and providers offering assistance through a telehealth infrastructure, and the integration of SFHAs into the traditional hearing health-care model. PMID:27072929

Assistive Devices for Students with Disabilities.

ERIC Educational Resources Information Center

Wisniewski, Lech; Sedlak, Robert

1992-01-01

Describes a variety of devices that can assist students with disabilities. Highlights recently developed devices for students with specific learning disabilities, and with vision, hearing, health, physical, and speech and language impairments. The devices can help rehabilitate, reeducate, facilitate normalcy, or augment current functioning. (GLR)

Computational Fluid Dynamics Analysis of Thrombosis Potential In Left Ventricular Assist Device Drainage Cannulae

PubMed Central

Fraser, Katharine H; Zhang, Tao; Taskin, M Ertan; Griffith, Bartley P; Wu, Zhongjun J

2010-01-01

Cannulation is necessary when blood is removed from the body, for example in hemodialysis, cardiopulmonary bypass, blood oxygenators, and ventricular assist devices. Artificial blood contacting surfaces are prone to thrombosis, especially in the presence of stagnant or recirculating flow. In this work, computational fluid dynamics was used to investigate the blood flow fields in three clinically available cannulae (Medtronic DLP 12, 16 and 24 F), used as drainage for pediatric circulatory support, and to calculate parameters which may be indicative of thrombosis potential. The results show that using the 24 F cannula below flow rates of about 0.75 l/min produces hemodynamic conditions which may increase the risk of blood clotting within the cannula. No reasons are indicated for not using the 12 or 16 F cannulae with flow rates between 0.25 and 3.0 l/min. PMID:20400890

Fall prevention walker during rehabilitation

NASA Astrophysics Data System (ADS)

Tee, Kian Sek; E, Chun Zhi; Saim, Hashim; Zakaria, Wan Nurshazwani Wan; Khialdin, Safinaz Binti Mohd; Isa, Hazlita; Awad, M. I.; Soon, Chin Fhong

2017-09-01

This paper proposes on the design of a walker for the prevention of falling among elderlies or patients during rehabilitation whenever they use a walker to assist them. Fall happens due to impaired balance or gait problem. The assistive device is designed by applying stability concept and an accelerometric fall detection system is included. The accelerometric fall detection system acts as an alerting device that acquires body accelerometric data and detect fall. Recorded accelerometric data could be useful for further assessment. Structural strength of the walker was verified via iterations of simulation using finite element analysis, before being fabricated. Experiments were conducted to identify the fall patterns using accelerometric data. The design process and detection of fall pattern demonstrates the design of a walker that could support the user without fail and alerts the helper, thus salvaging the users from injuries due to fall and unattended situation.

Linking the global positioning system (GPS) to a personal digital assistant (PDA) to support tuberculosis control in South Africa: a pilot study

PubMed Central

Dwolatzky, Barry; Trengove, Estelle; Struthers, Helen; McIntyre, James A; Martinson, Neil A

2006-01-01

Background Tuberculosis (TB) is the leading clinical manifestation of HIV infection and caseloads continue to increase in high HIV prevalence settings. TB treatment is prolonged and treatment interruption has serious individual and public health consequences. We assessed the feasibility of using a handheld computing device programmed with customised software and linked to a GPS receiver, to assist TB control programmes to trace patients who interrupt treatment in areas without useful street maps. In this proof of concept study, we compared the time taken to re-find a home comparing given residential addresses with a customised personalised digital assistant linked to a global positioning system (PDA/GPS) device. Additionally, we assessed the feasibility of using aerial photographs to locate homes. Results The study took place in two communities in Greater Johannesburg, South Africa: Wheillers Farm, a relatively sparsely populated informal settlement, and a portion of Alexandra, an urban township with densely populated informal settlements. Ten participants in each community were asked to locate their homes on aerial photographs. Nine from Wheillers Farm and six from Alexandra were able to identify their homes. The total time taken by a research assistant, unfamiliar with the area, to locate 10 homes in each community using the given addresses was compared with the total time taken by a community volunteer with half an hour of training to locate the same homes using the device. Time taken to locate the ten households was reduced by 20% and 50% in each community respectively using the PDA/GPS device. Conclusion In this pilot study we show that it is feasible to use a simple PDA/GPS device to locate the homes of patients. We found that in densely populated informal settlements, GPS technology is more accurate than aerial photos in identifying homes and more efficient than addresses provided by participants. Research assessing issues of, confidentiality and cost effectiveness would have to be undertaken before implementing PDA/GPS – based technology for this application. However, this PDA/GPS device could be used to reduce part of the burden on TB control programs. PMID:16911806

Accurate Fall Detection in a Top View Privacy Preserving Configuration.

PubMed

Ricciuti, Manola; Spinsante, Susanna; Gambi, Ennio

2018-05-29

Fall detection is one of the most investigated themes in the research on assistive solutions for aged people. In particular, a false-alarm-free discrimination between falls and non-falls is indispensable, especially to assist elderly people living alone. Current technological solutions designed to monitor several types of activities in indoor environments can guarantee absolute privacy to the people that decide to rely on them. Devices integrating RGB and depth cameras, such as the Microsoft Kinect, can ensure privacy and anonymity, since the depth information is considered to extract only meaningful information from video streams. In this paper, we propose an accurate fall detection method investigating the depth frames of the human body using a single device in a top-view configuration, with the subjects located under the device inside a room. Features extracted from depth frames train a classifier based on a binary support vector machine learning algorithm. The dataset includes 32 falls and 8 activities considered for comparison, for a total of 800 sequences performed by 20 adults. The system showed an accuracy of 98.6% and only one false positive.

What Are Some Types of Assistive Devices and How Are They Used?

MedlinePlus

... in persons with hearing problems. Cognitive assistance, including computer or electrical assistive devices, can help people function following brain injury. Computer software and hardware, such as voice recognition programs, ...

Percutaneous assist devices in acute myocardial infarction with cardiogenic shock: Review, meta-analysis

PubMed Central

Romeo, Francesco; Acconcia, Maria Cristina; Sergi, Domenico; Romeo, Alessia; Francioni, Simona; Chiarotti, Flavia; Caretta, Quintilio

2016-01-01

AIM: To assess the impact of percutaneous cardiac support in cardiogenic shock (CS) complicating acute myocardial infarction (AMI), treated with percutaneous coronary intervention. METHODS: We selected all of the studies published from January 1st, 1997 to May 15st, 2015 that compared the following percutaneous mechanical support in patients with CS due to AMI undergoing myocardial revascularization: (1) intra-aortic balloon pump (IABP) vs Medical therapy; (2) percutaneous left ventricular assist devices (PLVADs) vs IABP; (3) complete extracorporeal life support with extracorporeal membrane oxygenation (ECMO) plus IABP vs IABP alone; and (4) ECMO plus IABP vs ECMO alone, in patients with AMI and CS undergoing myocardial revascularization. We evaluated the impact of the support devices on primary and secondary endpoints. Primary endpoint was the inhospital mortality due to any cause during the same hospital stay and secondary endpoint late mortality at 6-12 mo of follow-up. RESULTS: One thousand two hundred and seventy-two studies met the initial screening criteria. After detailed review, only 30 were selected. There were 6 eligible randomized controlled trials and 24 eligible observational studies totaling 15799 patients. We found that the inhospital mortality was: (1) significantly higher with IABP support vs medical therapy (RR = +15%, P = 0.0002); (2) was higher, although not significantly, with PLVADs compared to IABP (RR = +14%, P = 0.21); and (3) significantly lower in patients treated with ECMO plus IABP vs IABP (RR = -44%, P = 0.0008) or ECMO (RR = -20%, P = 0.006) alone. In addition, Trial Sequential Analysis showed that in the comparison of IABP vs medical therapy, the sample size was adequate to demonstrate a significant increase in risk due to IABP. CONCLUSION: Inhospital mortality was significantly higher with IABP vs medical therapy. PLVADs did not reduce early mortality. ECMO plus IABP significantly reduced inhospital mortality compared to IABP. PMID:26839661

FleXConf: A Flexible Conference Assistant Using Context-Aware Notification Services

NASA Astrophysics Data System (ADS)

Armenatzoglou, Nikos; Marketakis, Yannis; Kriara, Lito; Apostolopoulos, Elias; Papavasiliou, Vicky; Kampas, Dimitris; Kapravelos, Alexandros; Kartsonakis, Eythimis; Linardakis, Giorgos; Nikitaki, Sofia; Bikakis, Antonis; Antoniou, Grigoris

Integrating context-aware notification services to ubiquitous computing systems aims at the provision of the right information to the right users, at the right time, in the right place, and on the right device, and constitutes a significant step towards the realization of the Ambient Intelligence vision. In this paper, we present FlexConf, a semantics-based system that supports location-based, personalized notification services for the assistance of conference attendees. Its special features include an ontology-based representation model, rule-based context-aware reasoning, and a novel positioning system for indoor environments.

21 CFR 884.6170 - Assisted reproduction water and water purification systems.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Assisted reproduction water and water purification... Devices § 884.6170 Assisted reproduction water and water purification systems. (a) Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality...

21 CFR 884.6170 - Assisted reproduction water and water purification systems.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Assisted reproduction water and water purification... Devices § 884.6170 Assisted reproduction water and water purification systems. (a) Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality...

21 CFR 884.6170 - Assisted reproduction water and water purification systems.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Assisted reproduction water and water purification... Devices § 884.6170 Assisted reproduction water and water purification systems. (a) Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality...

21 CFR 884.6170 - Assisted reproduction water and water purification systems.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Assisted reproduction water and water purification... Devices § 884.6170 Assisted reproduction water and water purification systems. (a) Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality...

21 CFR 884.6170 - Assisted reproduction water and water purification systems.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Assisted reproduction water and water purification... Devices § 884.6170 Assisted reproduction water and water purification systems. (a) Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality...

Effect of Bathroom Aids and Age on Balance Control During Bathing Transfers.

PubMed

King, Emily C; Novak, Alison C

Bathroom assistive devices are used to improve safety during bathing transfers, but biomechanical evidence to support clinical recommendations is lacking. This study evaluated the effectiveness of common bathroom aids in promoting balance control during bathing transfers. Twenty-six healthy adults (12 young, 14 older) stepped into and out of a slippery bathtub while using a vertical grab bar on the side wall, a horizontal grab bar on the back wall, a bath mat, a side wall touch, or no assistance. Balance control was characterized using center of pressure measures and showed greater instability for older adults. The vertical grab bar and wall touch resulted in the safest (best controlled) transfers. The bath mat provided improved balance control in the axis parallel to the bathtub rim but was equivalent to no assistance perpendicular to the rim, in the direction of obstacle crossing. These results can support clinical recommendations for safe bathing transfers. Copyright © 2017 by the American Occupational Therapy Association, Inc.

Scaling the low-shear pulsatile TORVAD for pediatric heart failure

PubMed Central

Gohean, Jeffrey R.; Larson, Erik R.; Hsi, Brian H.; Kurusz, Mark; Smalling, Richard W.; Longoria, Raul G.

2016-01-01

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 to 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 using a finite element model (FEM) resulting in increased heat transfer to the blood while reducing the overall size of TORVAD. Motor FEM has also been used to reduce motor size and improve motor efficiency and heat transfer. FEM analysis predicts no more than 1°C temperature rise on any blood or tissue contacting surface of the device. The iterative computational approach established provides a methodology for developing a TORVAD platform technology with various device sizes for supporting the circulation of infants to adults. PMID:27832001

Scaling the Low-Shear Pulsatile TORVAD for Pediatric Heart Failure.

PubMed

Gohean, Jeffrey R; Larson, Erik R; Hsi, Brian H; Kurusz, Mark; Smalling, Richard W; Longoria, Raul G

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 m. 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 using a finite element model (FEM) resulting in increased heat transfer to the blood while reducing the overall size of TORVAD. Motor FEM has also been used to reduce motor size and improve motor efficiency and heat transfer. FEM analysis predicts no more than 1°C temperature rise on any blood or tissue contacting surface of the device. The iterative computational approach established provides a methodology for developing a TORVAD platform technology with various device sizes for supporting the circulation of infants to adults.

Temporary Mechanical Circulatory Support: A Review of the Options, Indications, and Outcomes

PubMed Central

Gilotra, Nisha A; Stevens, Gerin R

2014-01-01

Cardiogenic shock remains a challenging disease entity and is associated with significant morbidity and mortality. Temporary mechanical circulatory support (MCS) can be implemented in an acute setting to stabilize acutely ill patients with cardiomyopathy in a variety of clinical situations. Currently, several options exist for temporary MCS. We review the indications, contraindications, clinical applications, and evidences for a variety of temporary circulatory support options, including the intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), CentriMag blood pump, and percutaneous ventricular assist devices (pVADs), specifically the TandemHeart and Impella. PMID:25674024

Providers with Limited Experience Perform Better in Advanced Life Support with Assistance Using an Interactive Device with an Automated External Defibrillator Linked to a Ventilator.

PubMed

Busch, Christian Werner; Qalanawi, Mohammed; Kersten, Jan Felix; Kalwa, Tobias Johannes; Scotti, Norman Alexander; Reip, Wikhart; Doehn, Christoph; Maisch, Stefan; Nitzschke, Rainer

2015-10-01

Medical teams with limited experience in performing advanced life support (ALS) or with a low frequency of cardiopulmonary resuscitation (CPR) while on duty, often have difficulty complying with CPR guidelines. This study evaluated whether the quality of CPR of trained medical students, who served as an example of teams with limited experience in ALS, could be improved with device assistance. The primary outcome was the hands-off time (i.e., the percentage of the entire CPR time without chest compressions). The secondary outcome was seven time intervals, which should be as short as possible, and the quality of ventilations and chest compressions on the mannequin. We compared standard CPR equipment to an interactive device with visual and acoustic instructions for ALS workflow measures to guide briefly trained medical students through the ALS algorithm in a full-scale mannequin simulation study with a randomized crossover study design. The study equipment consisted of an automatic external defibrillator and ventilator that were electronically linked and communicating as a single system. Included were regular medical students in the third to sixth years of medical school of one class who provided written informed consent for voluntary participation and for the analysis of their CPR performance data. No exclusion criteria were applied. For statistical measures of evaluation we used an analysis of variance for crossover trials accounting for treatment effect, sequence effect, and carry-over effect, with adjustment for prior practical experience of the participants. Forty-two medical students participated in 21 CPR sessions, each using the standard and study equipment. Regarding the primary end point, the study equipment reduced the hands-off time from 40.1% (95% confidence interval [CI] 36.9-43.4%) to 35.6% (95% CI 32.4-38.9%, p = 0.031) compared with the standard equipment. Within the prespecified secondary end points, study equipment reduced the time interval until the first rescuer changeover from 273 s (95% CI 244-302 s) to 223 s (95% CI 194-253 s, p = 0.001) and increased the percentage of ventilations with a correct tidal volume of 400-600 mL from 34.3% (95% CI 19.0-49.6%) to 60.9% (95% CI 45.6-76.2%, p = 0.018). The assist device increased the rescuers' CPR quality. CPR providers with limited experience or a limited frequency of CPR performance (i.e., rural Emergency Medical Services crew) may potentially benefit from this assist device. Copyright © 2015 Elsevier Inc. All rights reserved.

Efficacy of a hybrid assistive limb in post-stroke hemiplegic patients: a preliminary report

PubMed Central

2011-01-01

Background Robotic devices are expected to be widely used in various applications including support for the independent mobility of the elderly with muscle weakness and people with impaired motor function as well as support for nursing care that involves heavy laborious work. We evaluated the effects of a hybrid assistive limb robot suit on the gait of stroke patients undergoing rehabilitation. Methods The study group comprised 16 stroke patients with severe hemiplegia. All patients underwent gait training. Four patients required assistance, and 12 needed supervision while walking. The stride length, walking speed and physiological cost index on wearing the hybrid assistive limb suit and a knee-ankle-foot orthosis were compared. Results The hybrid assistive limb suit increased the stride length and walking speed in 4 of 16 patients. The patients whose walking speed decreased on wearing the hybrid assistive limb suit either had not received sufficient gait training or had an established gait pattern with a knee-ankle-foot orthosis using a quad cane. The physiological cost index increased after wearing the hybrid assistive limb suit in 12 patients, but removal of the suit led to a decrease in the physiological cost index values to equivalent levels prior to the use of the suit. Conclusions Although the hybrid assistive limb suit is not useful for all hemiplegic patients, it may increase the walking speed and affect the walking ability. Further investigation would clarify its indication for the possibility of gait training. PMID:21943320

Computer methods in designing tourist equipment for people with disabilities

NASA Astrophysics Data System (ADS)

Zuzda, Jolanta GraŻyna; Borkowski, Piotr; Popławska, Justyna; Latosiewicz, Robert; Moska, Eleonora

2017-11-01

Modern technologies enable disabled people to enjoy physical activity every day. Many new structures are matched individually and created for people who fancy active tourism, giving them wider opportunities for active pastime. The process of creating this type of devices in every stage, from initial design through assessment to validation, is assisted by various types of computer support software.

Simple and Inexpensive 3D Printed Filter Fluorometer Designs: User-Friendly Instrument Models for Laboratory Learning and Outreach Activities

ERIC Educational Resources Information Center

Porter, Lon A., Jr.; Chapman, Cole A.; Alaniz, Jacob A.

2017-01-01

In this work, a versatile and user-friendly selection of stereolithography (STL) files and computer-aided design (CAD) models are shared to assist educators and students in the production of simple and inexpensive 3D printed filter fluorometer instruments. These devices are effective resources for supporting active learners in the exploration of…

Pedagogies, Perspectives, and Practices: Mobile Learning through the Experiences of Faculty Developers and Instructional Designers in Centers for Teaching and Learning

ERIC Educational Resources Information Center

Hosler, Kim A.

2013-01-01

The purpose of this qualitative case study was to explore the experiences, perceptions, and pedagogy of nine self-identified faculty developers and instructional designers who work in centers for teaching and learning supporting faculty members requesting assistance with mobile learning. With the ever-increasing use of mobile devices across…

[A comparison of various supraglottic airway devices for fiberoptical guided tracheal intubation].

PubMed

Metterlein, Thomas; Dintenfelder, Anna; Plank, Christoph; Graf, Bernhard; Roth, Gabriel

Fiberoptical assisted intubation via placed supraglottic airway devices has been described as safe and easy procedure to manage difficult airways. However visualization of the glottis aperture is essential for fiberoptical assisted intubation. Various different supraglottic airway devices are commercially available and might offer different conditions for fiberoptical assisted intubation. The aim of this study was to compare the best obtainable view of the glottic aperture using different supraglottic airway devices. With approval of the local ethics committee 52 adult patients undergoing elective anesthesia were randomly assigned to a supraglottic airway device (Laryngeal Tube, Laryngeal Mask Airway I-Gel, Laryngeal Mask Airway Unique, Laryngeal Mask Airway Supreme, Laryngeal Mask Airway Aura-once). After standardized induction of anaesthesia the supraglottic airway device was placed according to the manufacturers recommendations. After successful ventilation the position of the supraglottic airway device in regard to the glottic opening was examined with a flexible fiberscope. A fully or partially visible glottic aperture was considered as suitable for fiberoptical assisted intubation. Suitability for fiberoptical assisted intubation was compared between the groups (H-test, U-test; p<0.05). Demographic data was not different between the groups. Placement of the supraglottic airway device and adequate ventilation was successful in all attempts. Glottic view suitable for fiberoptical assisted intubation differed between the devices ranging from 40% for the laringeal tube (LT), 66% for the laryngeal mask airway Supreme, 70% for the Laryngeal Mask Airway I-Gel and 90% for both the Laryngeal Mask Airway Unique and the Laryngeal Mask Airway Aura-once. None of the used supraglottic airway devices offered a full or partial glottic view in all cases. However the Laryngeal Mask Airway Unique and the Laryngeal Mask Airway Aura-once seem to be more suitable for fiberoptical assisted intubation compared to other devices. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

A comparison of various supraglottic airway devices for fiberoptical guided tracheal intubation.

PubMed

Metterlein, Thomas; Dintenfelder, Anna; Plank, Christoph; Graf, Bernhard; Roth, Gabriel

Fiberoptical assisted intubation via placed supraglottic airway devices has been described as safe and easy procedure to manage difficult airways. However visualization of the glottis aperture is essential for fiberoptical assisted intubation. Various different supraglottic airway devices are commercially available and might offer different conditions for fiberoptical assisted intubation. The aim of this study was to compare the best obtainable view of the glottic aperture using different supraglottic airway devices. With approval of the local ethics committee 52 adult patients undergoing elective anesthesia were randomly assigned to a supraglottic airway device (Laryngeal Tube, Laryngeal Mask Airway I-Gel, Laryngeal Mask Airway Unique, Laryngeal Mask Airway Supreme, Laryngeal Mask Airway Aura-once). After standardized induction of anesthesia the supraglottic airway device was placed according to the manufacturers recommendations. After successful ventilation the position of the supraglottic airway device in regard to the glottic opening was examined with a flexible fiberscope. A fully or partially visible glottic aperture was considered as suitable for fiberoptical assisted intubation. Suitability for fiberoptical assisted intubation was compared between the groups (H-test, U-test; p<0.05). Demographic data was not different between the groups. Placement of the supraglottic airway device and adequate ventilation was successful in all attempts. Glottic view suitable for fiberoptical assisted intubation differed between the devices ranging from 40% for the laringeal tube (LT), 66% for the laryngeal mask airway Supreme, 70% for the Laryngeal Mask Airway I-Gel and 90% for both the Laryngeal Mask Airway Unique and the Laryngeal Mask Airway Aura-once. None of the used supraglottic airway devices offered a full or partial glottic view in all cases. However the Laryngeal Mask Airway Unique and the Laryngeal Mask Airway Aura-once seem to be more suitable for fiberoptical assisted intubation compared to other devices. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

A BLE-Based Pedestrian Navigation System for Car Searching in Indoor Parking Garages

PubMed Central

Wang, Sheng-Shih

2018-01-01

The continuous global increase in the number of cars has led to an increase in parking issues, particularly with respect to the search for available parking spaces and finding cars. In this paper, we propose a navigation system for car owners to find their cars in indoor parking garages. The proposed system comprises a car-searching mobile app and a positioning-assisting subsystem. The app guides car owners to their cars based on a “turn-by-turn” navigation strategy, and has the ability to correct the user’s heading orientation. The subsystem uses beacon technology for indoor positioning, supporting self-guidance of the car-searching mobile app. This study also designed a local coordinate system to support the identification of the locations of parking spaces and beacon devices. We used Android as the platform to implement the proposed car-searching mobile app, and used Bytereal HiBeacon devices to implement the proposed positioning-assisting subsystem. We also deployed the system in a parking lot in our campus for testing. The experimental results verified that the proposed system not only works well, but also provides the car owner with the correct route guidance information. PMID:29734753

Devices for hearing loss

MedlinePlus

... NIDCD). Assistive devices for people with hearing, voice, speech, or language disorders. Nidcd.nih.gov Web site. www.nidcd.nih.gov/health/assistive-devices-people-hearing-voice-speech-or-language-disorders . Updated March 6, 2017. Accessed July 5, 2017. ...

An overview of robotic/mechanical devices for post-stroke thumb rehabilitation.

PubMed

Suarez-Escobar, Marian; Rendon-Velez, Elizabeth

2018-01-15

This article aims to clarify the current state-of-the-art of robotic/mechanical devices for post-stroke thumb rehabilitation as well as the anatomical characteristics and motions of the thumb that are crucial for the development of any device that aims to support its motion. A systematic literature search was conducted to identify robotic/mechanical devices for post-stroke thumb rehabilitation. Specific electronic databases and well-defined search terms and inclusion/exclusion criteria were used for such purpose. A reasoning model was devised to support the structured abstraction of relevant data from the literature of interest. Following the main search and after removing duplicated and other non-relevant studies, 68 articles (corresponding to 32 devices) were left for further examination. These articles were analyzed to extract data relative to (i) the motions assisted/permitted - either actively or passively - by the device per anatomical joint of the thumb and (ii) mechanical-related aspects (i.e., architecture, connections to thumb, other fingers supported, adjustability to different hand sizes, actuators - type, quantity, location, power transmission and motion trajectory). Most articles describe preliminary design and testing of prototypes, rather than the thorough evaluation of commercially ready devices. Defining appropriate kinematic models of the thumb upon which to design such devices still remains a challenging and unresolved task. Further research is needed before these devices can actually be implemented in clinical environments to serve their intended purpose of complementing the labour of therapists by facilitating intensive treatment with precise and repeatable exercises. Implications for Rehabilitation Post-stroke functional disability of the hand, and particularly of the thumb, significantly affects the capability to perform activities of daily living, threatening the independence and quality of life of the stroke survivors. The latest studies show that a high-dose intensive therapy (in terms of frequency, duration and intensity/effort) is the key to effectively modify neural organization and recover the motor skills that were lost after a stroke. Conventional therapy based on manual interaction with physical therapists makes the procedure labour intensive and increases the costs. Robotic/mechanical devices hold promise for complementing conventional post-stroke therapy. Specifically, these devices can provide reliable and accurate therapy for long periods of time without the associated fatigue. Also, they can be used as a means to assess patients? performance and progress in an objective and consistent manner. The full potential of robot-assisted therapy is still to be unveiled. Further exploration will surely lead to devices that can be well accepted equally by therapists and patients and that can be useful both in clinical and home-based rehabilitation practice such that motor recovery of the hand becomes a common outcome in stroke survivors. This overview provides the reader, possibly a designer of such a device, with a complete overview of the state-of-the-art of robotic/mechanical devices consisting of or including features for the rehabilitation of the thumb. Also, we clarify the anatomical characteristics and motions of the thumb that are crucial for the development of any device that aims to support its motion. Hopefully, this?combined with the outlined opportunities for further research?leads to the improvement of current devices and the development of new technology and knowledge in the field.

General surgical complications associated with the use of long-term mechanical circulatory support devices: are we 'under-reporting' problems?

PubMed

Tchantchaleishvili, Vakhtang; Umakanthan, Ramanan; Karp, Seth; Stulak, John M; Keebler, Mary E; Maltais, Simon

2013-05-01

Multiple complications are associated with use of ventricular assist devices (VADs). Cardiac-related complications and infections are most frequently reported. VADs, however, can also lead to a number of general surgical complications equally significant in terms of morbidity and mortality. The authors performed a systematic literature search to review current data that specifically relate general surgical complications to patients who undergo left VAD implantation. The review provides a relatively clear understanding of the spectrum of general surgical complications and shows that they contribute significantly to morbidity and mortality in these patients.

14 CFR Appendix B to Part 382 - Cross-Reference Table

Code of Federal Regulations, 2012 CFR

2012-01-01

... assistive devices, POCs and other respiratory assistive devices. 43(a) 129(b) Timely return of assistive...) 45 Availability of copy of rule. 47(a) 43 TTY's and reservations systems. 47(b) 69 Accessibility of...

14 CFR Appendix B to Part 382 - Cross-Reference Table

Code of Federal Regulations, 2013 CFR

2013-01-01

... assistive devices, POCs and other respiratory assistive devices. 43(a) 129(b) Timely return of assistive...) 45 Availability of copy of rule. 47(a) 43 TTY's and reservations systems. 47(b) 69 Accessibility of...

14 CFR Appendix B to Part 382 - Cross-Reference Table

Code of Federal Regulations, 2014 CFR

2014-01-01

... assistive devices, POCs and other respiratory assistive devices. 43(a) 129(b) Timely return of assistive...) 45 Availability of copy of rule. 47(a) 43 TTY's and reservations systems. 47(b) 69 Accessibility of...

Assistive Devices for People with Hearing, Voice, Speech, or Language Disorders

MedlinePlus

... sleepy. What research is being conducted on assistive technology? The National Institute on Deafness and Other Communication ... NIDCD) funds research into several areas of assistive technology, such as those described below. Improved devices for ...

An assistance device to help people with trunk impairment maintain posture.

PubMed

Ogura, Tomoka; Itami, Taku; Yano, Ken'ichi; Mori, Ichidai; Kameda, Kazuhiro

2017-07-01

People with trunk impairment cannot lean forward because of the dysfunction of the trunk resulting from events such as cervical cord injury (CCI). It is therefore difficult for such people to work at a table because they may easily fall from their wheelchair, and it is also hard for them to return to their original position. This limits the activities of daily living (ADLs) of people with trunk impairment. These problems can be solved to some extent with equipment such as a wheelchair belt or a spinal orthosis that can help the person to maintain his or her posture. However, people cannot move freely with this equipment. Furthermore, if this equipment is used for a long time, there is a risk of physical pain and skin issues. In this study, we developed a device that assists the trunk of people with trunk impairment when they lean forward. This device supports people with trunk impairment so that they may take their meals at the table and prevents them from falling over their wheelchair without hindering their daily performance when they are sitting normally. The effectiveness of our proposed device was verified by experiments involving having a meal, operating a wheelchair, and colliding with a curb. Our device can help people with trunk impairment by improving their ADLs and quality of life (QOL).

Total artificial heart in the pediatric patient with biventricular heart failure.

PubMed

Park, S S; Sanders, D B; Smith, B P; Ryan, J; Plasencia, J; Osborn, M B; Wellnitz, C M; Southard, R N; Pierce, C N; Arabia, F A; Lane, J; Frakes, D; Velez, D A; Pophal, S G; Nigro, J J

2014-01-01

Mechanical circulatory support emerged for the pediatric population in the late 1980s as a bridge to cardiac transplantation. The Total Artificial Heart (TAH-t) (SynCardia Systems Inc., Tuscon, AZ) has been approved for compassionate use by the Food and Drug Administration for patients with end-stage biventricular heart failure as a bridge to heart transplantation since 1985 and has had FDA approval since 2004. However, of the 1,061 patients placed on the TAH-t, only 21 (2%) were under the age 18. SynCardia Systems, Inc. recommends a minimum patient body surface area (BSA) of 1.7 m(2), thus, limiting pediatric application of this device. This unique case report shares this pediatric institution's first experience with the TAH-t. A 14-year-old male was admitted with dilated cardiomyopathy and severe biventricular heart failure. The patient rapidly decompensated, requiring extracorporeal life support. An echocardiogram revealed severe biventricular dysfunction and diffuse clot formation in the left ventricle and outflow tract. The decision was made to transition to biventricular assist device. The biventricular failure and clot formation helped guide the team to the TAH-t, in spite of a BSA (1.5 m(2)) below the recommendation of 1.7 m(2). A computed tomography (CT) scan of the thorax, in conjunction with a novel three-dimensional (3D) modeling system and team, assisted in determining appropriate fit. Chest CT and 3D modeling following implantation were utilized to determine all major vascular structures were unobstructed and the bronchi were open. The virtual 3D model confirmed appropriate device fit with no evidence of compression to the left pulmonary veins. The postoperative course was complicated by a left lung opacification. The left lung anomalies proved to be atelectasis and improved with aggressive recruitment maneuvers. The patient was supported for 11 days prior to transplantation. Chest CT and 3D modeling were crucial in assessing whether the device would fit, as well as postoperative complications in this smaller pediatric patient.

Adult extracorporeal life support: a failed or forgotten concept?

PubMed

Colafranceschi, Alexandre Siciliano; Monteiro, Andrey José de Oliveira; Canale, Leonardo Secchin; Campos, Luiz Antonio de Almeida; Montera, Marcelo Westerlund; Silva, Paulo Roberto Dutra da; Fernandes, Marcelo Ramalho; Pinto, Alexandre de Araújo; Molas, Stelmar Moura; Mesquita, Evandro Tinoco

2008-07-01

The extracorporeal membrane oxygenation (ECMO) has been used in the neonatal and childhood periods with excellent results. The adult experience has been modest with inferior immediate results. The intermediate survival, however, has been promising. We have been using the extracorporeal membrane oxygenation for temporary mechanical circulatory support of adults that present with acute refractory cardiogenic shock in our institution. There is no other published experience of the use of this system in this scenario in Brazil. To describe our experience with the use of the extracorporeal membrane oxygenation for circulatory support in adults. Retrospective analysis of the medical files of patients submitted to the implant of extracorporeal membrane oxygenation system for circulatory assistance in acute and refractory cardiogenic shock. Eleven patients (63,5 yo; 45,5% male) were considered for analysis from 2005 to 2007. Median support time was 77 hours (10-240 h) and 5 patients have survived 30 days (45,5%). Two patients were subsequently submitted to prolonged paracorporeal circulatory assistance. Mortality on ECMO (6 patients) was due to multiple organ failure (66,6%) and refractory bleeding (33,4%). ECMO system is an option to be used in acute refractory cardiogenic shock as a bridge to recovery or selecting patients that might benefit from prolonged paracorporeal assist devices (bridge to bridge).

Assistive Technology Devices and Home Accessibility Features: Prevalence, Payment, Need, and Trends.

ERIC Educational Resources Information Center

LaPlante, Mitchell P.; And Others

1992-01-01

Presented is a report of findings of a 1990 National Health Interview Survey on Assistive Devices which indicated that about 5.3 percent of the American population are using assistive technology to accommodate physical impairments. Background information defines "assistive technology," describe uses, and reviews recent federal legislative and…

Self-Control of Haptic Assistance for Motor Learning: Influences of Frequency and Opinion of Utility

PubMed Central

Williams, Camille K.; Tseung, Victrine; Carnahan, Heather

2017-01-01

Studies of self-controlled practice have shown benefits when learners controlled feedback schedule, use of assistive devices and task difficulty, with benefits attributed to information processing and motivational advantages of self-control. Although haptic assistance serves as feedback, aids task performance and modifies task difficulty, researchers have yet to explore whether self-control over haptic assistance could be beneficial for learning. We explored whether self-control of haptic assistance would be beneficial for learning a tracing task. Self-controlled participants selected practice blocks on which they would receive haptic assistance, while participants in a yoked group received haptic assistance on blocks determined by a matched self-controlled participant. We inferred learning from performance on retention tests without haptic assistance. From qualitative analysis of open-ended questions related to rationales for/experiences of the haptic assistance that was chosen/provided, themes emerged regarding participants’ views of the utility of haptic assistance for performance and learning. Results showed that learning was directly impacted by the frequency of haptic assistance for self-controlled participants only and view of haptic assistance. Furthermore, self-controlled participants’ views were significantly associated with their requested haptic assistance frequency. We discuss these findings as further support for the beneficial role of self-controlled practice for motor learning. PMID:29255438

Postoperative ambulation in thoracic surgery patients: standard versus modern ambulation methods.

PubMed

Nesbitt, Jonathan C; Deppen, Stephen; Corcoran, Richard; Cogdill, Shari; Huckabay, Sarah; McKnight, Drew; Osborne, Breanne F; Werking, Kristin; Gardner, Megan; Perrigo, Laurel

2012-01-01

A single-subject study of two methods of postoperative ambulation of patients recovering from thoracic surgery. During the postoperative setting, patients are often burdened by their condition that reduces their ability to ambulate. This problem is compounded by the addition of devices that make walking more cumbersome. To simplify the process of ambulation during the postoperative period, an intravenous pole/walker (IVPW) was specifically designed to allow all patient devices and attachments to accompany the patient during ambulation, without the need for supplemental caregiver assistance. The IVPW method of ambulation was compared with standard method of ambulation (SMA) in a single-subject clinical trial. Thirty-nine consecutive thoracic surgery patients with at least an IV and chest tube were ambulated using alternatively either the IVPW or the SMA. Immediately following the ambulation periods, the patient and patient's health care worker assessed both methods using satisfaction surveys consisting of several questions about the episodes of ambulation and the number of health care workers needed to assist during ambulation. Patient satisfaction was significantly higher in the ability of the IVPW to provide support and assist in ambulation in comparison with the SMA (p < 0·001). Nurses felt the IVPW both facilitated and provided a safer method for ambulation compared with the SMA (p < 0·001). On average, one less employee was required during ambulation with the IVPW (p < 0·001). The IVPW provided better support and was perceived as a safer method for ambulation compared with the SMA. The IVPW also required one less person to assist with ambulation. Facilitation of ambulation in the postoperative setting can impact nursing care and patient satisfaction. © 2012 The Authors. Nursing in Critical Care © 2012 British Association of Critical Care Nurses.

Magnetic design for the PediaFlow ventricular assist device.

PubMed

Noh, Myounggyu D; Antaki, James F; Ricci, Michael; Gardiner, Jeff; Paden, Dave; Wu, Jingchun; Prem, Ed; Borovetz, Harvey; Paden, Bradley E

2008-02-01

This article describes a design process for a new pediatric ventricular assist device, the PediaFlow. The pump is embodied in a magnetically levitated turbodynamic design that was developed explicitly based on the requirements for chronic support of infants and small children. The procedure entailed the consideration of multiple pump topologies, from which an axial mixed-flow configuration was chosen for further development. The magnetic design includes permanent-magnet (PM) passive bearings for radial support of the rotor, an actively controlled thrust actuator for axial support, and a brushless direct current (DC) motor for rotation. These components are closely coupled both geometrically and magnetically, and were therefore optimized in parallel, using electromagnetic, rotordynamic models and fluid models, and in consideration of hydrodynamic requirements. Multiple design objectives were considered, including efficiency, size, and margin between critical speeds to operating speed. The former depends upon the radial and yaw stiffnesses of the PM bearings. Analytical expressions for the stiffnesses were derived and verified through finite element analysis (FEA). A toroidally wound motor was designed for high efficiency and minimal additional negative radial stiffness. The design process relies heavily on optimization at the component level and system level. The results of this preliminary design optimization yielded a pump design with an overall stability margin of 15%, based on a pressure rise of 100 mm Hg at 0.5 lpm running at 16,000 rpm.

AsTeRICS.

PubMed

Drajsajtl, Tomáš; Struk, Petr; Bednárová, Alice

2013-01-01

AsTeRICS - "The Assistive Technology Rapid Integration & Construction Set" is a construction set for assistive technologies which can be adapted to the motor abilities of end-users. AsTeRICS allows access to different devices such as PCs, cell phones and smart home devices, with all of them integrated in a platform adapted as much as possible to each user. People with motor disabilities in the upper limbs, with no cognitive impairment, no perceptual limitations (neither visual nor auditory) and with basic skills in using technologies such as PCs, cell phones, electronic agendas, etc. have available a flexible and adaptable technology which enables them to access the Human-Machine-Interfaces (HMI) on the standard desktop and beyond. AsTeRICS provides graphical model design tools, a middleware and hardware support for the creation of tailored AT-solutions involving bioelectric signal acquisition, Brain-/Neural Computer Interfaces, Computer-Vision techniques and standardized actuator and device controls and allows combining several off-the-shelf AT-devices in every desired combination. Novel, end-user ready solutions can be created and adapted via a graphical editor without additional programming efforts. The AsTeRICS open-source framework provides resources for utilization and extension of the system to developers and researches. AsTeRICS was developed by the AsTeRICS project and was partially funded by EC.

Use of the robot assisted gait therapy in rehabilitation of patients with stroke and spinal cord injury.

PubMed

Sale, P; Franceschini, M; Waldner, A; Hesse, S

2012-03-01

Difficulty in walking is a major feature of neurological disease, and loss of mobility is the activity of daily living on which patients place the greatest value. The impact on patients is enormous, with negative ramifications on their participation in social, vocational, and recreational activities. In current clinical practice the gait restoration with robotic device is an integral part of rehabilitation program. Robot therapy involves the use of a robot exoskeleton device or end-effector device to help the patient retrain motor coordination by performing well-focused and carefully directed repetitive practice. The exoskeleton, as an assistive device, is also an external structural mechanism with joints and links corresponding to those of the human body. These robots use joint trajectories of the entire gait cycle and offer a uniform (more or less) stiff control along this trajectory. In this field the new powered exoskeleton ReWalk (Argo Medical Technologies Ltd) was developed to have an alternative mobility solution to the wheelchair and rehabilitation treatment for individuals with severe walking impairments, enabling them to stand, walk, ascend/descent stairs and more. The end-effector-based robot is a device with footplates placed on a double crank and rocker gear system. Alternatives to powered exoskeletons are devices that use movable footplates to which the patient's feet are attached. All devices include some form of body weight support. Prominent goals in the field include: developing implementable technologies that can be easily used by patients, therapists, and clinicians; enhancing the efficacy of clinician's therapies and increasing the ease of activities in the daily lives of patients.

Integrating medical, assistive, and universal design products and technologies: Assistive Technology Service Method (ATSM).

PubMed

Elsaesser, Linda-Jeanne; Bauer, Stephen

2012-07-01

ISO26000 provides guidance on effective organizational performance that recognizes social responsibility (including rights of persons with disabilities (PWD)), engages stakeholders, and contributes to sustainable development [1]. Millennium Development Goals 2010 state: while progress has been made, insufficient dedication to sustainable development, and inequalities to the most vulnerable people require attention [2]. World Report on Disability 2011 recommendations includes improved data collection and removal of barriers to rehabilitation that empower PWD [3]. The Assistive Technology Service Method (ATSM), Assistive Technology Device Classification (ATDC) and Matching Person and Technology (MPT) provide an evidence-based, standardized, internationally comparable framework to improve rehabilitation interventions [4-6]. The ATSM and ATDC support universal design (UD) principles and provision of universal technology. The MPT assures interventions are effective and satisfactory to end-users [7]. The ICF conceptual framework and common language are used throughout [8]. Research findings on healthcare needs are translated. ATSM applications in support of these findings are presented. National initiatives demonstrate the need and value of the ATSM as an evidence-based, user-centric, interdisciplinary method to improve individual and organizational performance for rehabilitation [including AT] services. Two Disability & Rehabilitation: Assistive Technology articles demonstrate ATSM and ATDC use to strengthen rehabilitation services and integrate Universal Design principles for socially responsible behavior.

Calculation of the ALMA Risk of Right Ventricular Failure After Left Ventricular Assist Device Implantation.

PubMed

Loforte, Antonio; Montalto, Andrea; Musumeci, Francesco; Amarelli, Cristiano; Mariani, Carlo; Polizzi, Vincenzo; Lilla Della Monica, Paola; Grigioni, Francesco; Di Bartolomeo, Roberto; Marinelli, Giuseppe

2018-05-08

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 patients were randomly divided into derivation (79.8%, n = 206) and validation (20.1%, n = 52) cohorts. Fifty-seven preoperative risk factors were compared between patients who were successfully managed with an LVAD and those who required a BVAD. Nineteen variables demonstrated statistical significance on univariable analysis. Multivariable logistic regression analysis identified destination therapy (odds ratio [OR] 2.0 [1.7-3.9], p = 0.003), a pulmonary artery pulsatility index <2 (OR 3.3 [1.7-6.1], p = 0.001), a right ventricle/left ventricle end-diastolic diameter ratio >0.75 (OR 2.7 [1.5-5.5], p = 0.001), an right ventricle stroke work index <300 mm Hg/ml/m (OR 4.3 [2.5-7.3], p < 0.001), and a United Network for Organ Sharing modified Model for End-Stage Liver Disease Excluding INR score >17 (OR 3.5 [1.9-6.9], p < 0.001) as the major predictors of the need for BVAD. Using these data, we propose a simple risk calculator to determine the suitability of patients for isolated LVAD support in the era of continuous-flow mechanical circulatory support devices.

Ventricular Recovery and Pump Explantation in Patients Supported by Left Ventricular Assist Devices: A Systematic Review.

PubMed

Phan, Kevin; Huo, Ya Ruth; Zhao, Dong Fang; Yan, Tristan D; Tchantchaleishvili, Vakhtang

2016-01-01

Several studies have reported that a portion of patients who exhibit cardiac recovery during left ventricular assist device (LVAD) support can have their device explanted with reasonable long-term survival. The aim of this systematic review is to assess the survival and cardiac function in patients with explanted LVADs from the current literature. Electronic search was performed to identify all studies in English literature assessing LVAD explantation. All identified articles were systematically assessed using the inclusion and exclusion criteria. Selected studies were subjected to quantitative assessment. From 5 electronic databases, 11 studies (213 patients) were included. Pooled mean perioperative mortality rate of those explanted was 9.2% (95% CI, 5.0-14.5%; I = 0). Pooled mean late mortality rate was 15% (95% CI, 9.0-22.1%; I = 31%). The pooled 1, 5, and 10 year survival postexplant was 91, 76, and 65.7%, respectively. Pooled postweaning freedom from heart failure (HF) recurrence reached 81.3%. Subset analysis demonstrated that patients explanted from a continuous-flow LVAD versus pulsatile LVAD had a lower rate of HF recurrence (6.6 vs. 28.3%, p = 0.03) and LVAD reimplantation (7.5 vs. 37%, p = 0.001). Before LVAD explantation, overall mean left ventricular ejection fraction (LVEF) was 49%. Weighted pooled early and late postexplantation mean LVEF was 47.3 and 41.2%, respectively. Late postexplantation LVEF was significantly higher in the continuous-flow versus pulsatile LVAD subgroup (41.5 vs. 24%, p = 0.001). This review shows encouraging safety and 10 year survival outcomes after explantation of LVADs in carefully selected patients, with rates better than expected after a heart transplant. Recovery of the native heart is the most desirable clinical outcome in patients supported with LVADs and should be actively sought.

A Computer Spreadsheet for Locating Assistive Devices.

ERIC Educational Resources Information Center

Palmer, Catherine V.; Garstecki, Dean C.

1988-01-01

The article presents a directory of assistive devices for persons with hearing impairments in a grid format by distributor and type of device (alerting devices, telephone, TV/radio/stereo, personal communication, group communication, and other). The product locator is also available in spreadsheet form for either the Macintosh or IBM-PC computers.…

EXTRACORPOREAL MEMBRANE OXYGENATION vs. COUNTERPULSATILE, PULSATILE, AND CONTINUOUS LEFT VENTRICULAR UNLOADING FOR PEDIATRIC MECHANICAL CIRCULATORY SUPPORT

PubMed Central

Bartoli, Carlo R.; Koenig, Steven C.; Ionan, Constantine; Gillars, Kevin J.; Mitchell, Mike E.; Austin, Erle H.; Gray, Laman A.; Pantalos, George M.

2014-01-01

OBJECTIVE Despite progress with adult ventricular assist devices (VADs), limited options exist to support pediatric patients with life-threatening heart disease. Extracorporeal membrane oxygenation (ECMO) remains the clinical standard. To characterize (patho)physiologic responses to different modes of mechanical unloading of the failing pediatric heart, ECMO was compared to either intraaortic balloon pump (IABP), pulsatile-flow (PF)VAD, or continuous-flow (CF)VAD support in a pediatric heart failure model. DESIGN Experimental. SETTING Large animal laboratory operating room. SUBJECTS Yorkshire piglets (n=47, 11.7±2.6 kg). INTERVENTIONS In piglets with coronary ligation-induced cardiac dysfunction, mechanical circulatory support devices were implanted and studied during maximum support. MEASUREMENTS and MAIN RESULTS Left ventricular, right ventricular, coronary, carotid, systemic arterial, and pulmonary arterial hemodynamics were measured with pressure and flow transducers. Myocardial oxygen consumption and total-body oxygen consumption (VO2) were calculated from arterial, venous, and coronary sinus blood sampling. Blood flow was measured in 17 organs with microspheres. Paired student t-tests compared baseline and heart failure conditions. One-way repeated-measures ANOVA compared heart failure, device support mode(s), and ECMO. Statistically significant (p<0.05) findings included: 1) improved left ventricular blood supply/demand ratio during PFVAD, CFVAD, and ECMO but not IABP support, 2) improved global myocardial blood supply/demand ratio during PFVAD, and CFVAD but not IABP or ECMO support, and 3) diminished pulsatility during ECMO and CFVAD but not IABP and PFVAD support. A profile of systems-based responses was established for each type of support. CONCLUSIONS Each type of pediatric VAD provided hemodynamic support by unloading the heart with a different mechanism that created a unique profile of physiological changes. These data contribute novel, clinically relevant insight into pediatric mechanical circulatory support and establish an important resource for pediatric device development and patient selection. PMID:24108116

First successful combination of ECMO with cytokine removal therapy in cardiogenic septic shock: a case report.

PubMed

Bruenger, Frank; Kizner, Lukasz; Weile, Jan; Morshuis, Michael; Gummert, Jan F

2015-02-01

A new hemoadsorption device intended as adjunctive treatment for patients with elevated cytokine levels in the setting of SIRS and sepsis has shown promising results. We report on the beneficial application of the device in a patient with cardiogenic septic shock receiving combined extracorporeal life support with rECMO, LVAD, and CVVH despite his highly septic condition. A 39-year-old patient presented with fulminant ARDS and cardiogenic septic shock. A veno-arterial ECMO was implanted for circulatory support. During the course of illness, the patient developed acute renal failure in addition to his chronic renal insufficiency, making initiation of CVVH necessary. Due to a complete cardiac arrest in both ventricles, a left ventricular assist device (LVAD) in combination with right ECMO (rECMO) was implanted despite manifest septic conditions. In the post-operative course IL-6 levels and vasopressor dosages increased drastically. A CytoSorb hemoadsorption device was therefore installed in the CVVH circuit and 3 sessions were run during the following 4 days. During CytoSorb treatment, inflammatory markers IL-6, procalcitonin, and C-reactive protein decreased concomitant with significantly reduced vasopressor support. No adverse device-related side effects were documented during or after the treatment sessions. This is the first clinical case report of a highly septic patient treated with the combined use of LVAD, rECMO, CVVH, and CytoSorb. The combination was practical, technically feasible, and beneficial for the patient. This combination represents a reasonable approach to improve survival in patients with multiple organ dysfunction necessitating several organ supportive techniques.

Body weight support during robot-assisted walking: influence on the trunk and pelvis kinematics.

PubMed

Swinnen, Eva; Baeyens, Jean-Pierre; Hens, Gerrit; Knaepen, Kristel; Beckwée, David; Michielsen, Marc; Clijsen, Ron; Kerckhofs, Eric

2015-01-01

Efficacy studies concerning robot assisted gait rehabilitation showed limited clinical benefits. A changed kinematic pattern might be responsible for this. Little is known about the kinematics of the trunk and pelvis during robot assisted treadmill walking (RATW). The aim of this study was to assess the trunk and pelvis kinematics of healthy subjects during RATW, with different amounts of body weight support (BWS) compared to regular treadmill walking (TW). Eighteen healthy participants walked on a treadmill, while kinematics were registered by an electromagnetic tracking device. Hereafter, the kinematics of pelvis and trunk were registered during RATW (guidance force 30%) with 0%, 30% and 50% BWS. Compared to TW, RATW showed a decrease in the following trunk movements: axial rotation, anteroposterior flexion, lateral and anteroposterior translation. Besides, a decrease in lateral tilting and all translation of the pelvis was found when comparing RATW with TW. Furthermore, the anteroposterior tilting of the pelvis increased during RATW. In general, there was a decrease in trunk and pelvis movement amplitude during RATW compared with regular TW. Though, it is not known if these changes are responsible for the limited efficacy of robot assisted gait rehabilitation. Further research is indicated.

Assistive obstacle detection and navigation devices for vision-impaired users.

PubMed

Ong, S K; Zhang, J; Nee, A Y C

2013-09-01

Quality of life for the visually impaired is an urgent worldwide issue that needs to be addressed. Obstacle detection is one of the most important navigation tasks for the visually impaired. In this research, a novel range sensor placement scheme is proposed in this paper for the development of obstacle detection devices. Based on this scheme, two prototypes have been developed targeting at different user groups. This paper discusses the design issues, functional modules and the evaluation tests carried out for both prototypes. Implications for Rehabilitation Visual impairment problem is becoming more severe due to the worldwide ageing population. Individuals with visual impairment require assistance from assistive devices in daily navigation tasks. Traditional assistive devices that assist navigation may have certain drawbacks, such as the limited sensing range of a white cane. Obstacle detection devices applying the range sensor technology can identify road conditions with a higher sensing range to notify the users of potential dangers in advance.

Cardiopulmonary Resuscitation in Adults and Children With Mechanical Circulatory Support: A Scientific Statement From the American Heart Association.

PubMed

Peberdy, Mary Ann; Gluck, Jason A; Ornato, Joseph P; Bermudez, Christian A; Griffin, Russell E; Kasirajan, Vigneshwar; Kerber, Richard E; Lewis, Eldrin F; Link, Mark S; Miller, Corinne; Teuteberg, Jeffrey J; Thiagarajan, Ravi; Weiss, Robert M; O'Neil, Brian

2017-06-13

Cardiac arrest in patients on mechanical support is a new phenomenon brought about by the increased use of this therapy in patients with end-stage heart failure. This American Heart Association scientific statement highlights the recognition and treatment of cardiovascular collapse or cardiopulmonary arrest in an adult or pediatric patient who has a ventricular assist device or total artificial heart. Specific, expert consensus recommendations are provided for the role of external chest compressions in such patients. © 2017 American Heart Association, Inc.

iOS--Worthy of the Hype as Assistive Technology for Visual Impairments? A Phenomenological Study of iOS Device Use by Individuals with Visual Impairments

ERIC Educational Resources Information Center

Scott, Shari

2013-01-01

This qualitative study sought to explore the shared essence of the lived experiences of early adopters of iOS devices as assistive technology by persons with visual impairments. The capstone question addressed the idea of whether any one device could fully meet the assistive technology needs of this population. Purposeful sampling methods were…

Near-infrared Spectroscopy to Reduce the Prophylactic Fasciotomies for and Missed Cases of Acute Compartment Syndrome in Soldiers Injured in OEF/OIF

DTIC Science & Technology

2010-10-01

and Consumer Assistance at its loll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/ cdrh /industrv/support...21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH , Office of Device

Human-Robot Interaction: Does Robotic Guidance Force Affect Gait-Related Brain Dynamics during Robot-Assisted Treadmill Walking?

PubMed Central

Knaepen, Kristel; Mierau, Andreas; Swinnen, Eva; Fernandez Tellez, Helio; Michielsen, Marc; Kerckhofs, Eric; Lefeber, Dirk; Meeusen, Romain

2015-01-01

In order to determine optimal training parameters for robot-assisted treadmill walking, it is essential to understand how a robotic device interacts with its wearer, and thus, how parameter settings of the device affect locomotor control. The aim of this study was to assess the effect of different levels of guidance force during robot-assisted treadmill walking on cortical activity. Eighteen healthy subjects walked at 2 km.h-1 on a treadmill with and without assistance of the Lokomat robotic gait orthosis. Event-related spectral perturbations and changes in power spectral density were investigated during unassisted treadmill walking as well as during robot-assisted treadmill walking at 30%, 60% and 100% guidance force (with 0% body weight support). Clustering of independent components revealed three clusters of activity in the sensorimotor cortex during treadmill walking and robot-assisted treadmill walking in healthy subjects. These clusters demonstrated gait-related spectral modulations in the mu, beta and low gamma bands over the sensorimotor cortex related to specific phases of the gait cycle. Moreover, mu and beta rhythms were suppressed in the right primary sensory cortex during treadmill walking compared to robot-assisted treadmill walking with 100% guidance force, indicating significantly larger involvement of the sensorimotor area during treadmill walking compared to robot-assisted treadmill walking. Only marginal differences in the spectral power of the mu, beta and low gamma bands could be identified between robot-assisted treadmill walking with different levels of guidance force. From these results it can be concluded that a high level of guidance force (i.e., 100% guidance force) and thus a less active participation during locomotion should be avoided during robot-assisted treadmill walking. This will optimize the involvement of the sensorimotor cortex which is known to be crucial for motor learning. PMID:26485148

Talking with caregivers of children living in the community with ventricular assist devices.

PubMed

Petruik, Courtney; Mack, Cheryl; Conway, Jennifer; Buchholz, Holger; van Manen, Michael

2017-11-01

A VAD is a mechanical pump used to support the functioning of a failing heart. As a pediatric therapy, a VAD is used as a temporary solution for poor heart function, a bridge to transplantation or recovery, or a destination therapy. The goal of this qualitative study was to explore the perspectives of family and professional caregivers of children who are supported by VADs in outpatient settings. Semi-structured interviews were conducted with 22 caregivers of school-aged children discharged home on VAD support. Interviews were transcribed, and data were analyzed using qualitative content analysis. Caregivers identified issues facing children on VAD support in the contexts of home, school, and other childhood places including being physically connected to a device; experiencing changes; living a medical life; negotiating restrictions; cost of care; family, kinship, and community; and, present and future living. While a child with a VAD may have much in common with other medically complex children, the technological complications and risks of living with a VAD are uniquely identified by caregivers as an issue, especially when considering the way that children with a VAD are connected to their device-implanted yet exterior, mobile yet restricted, and autonomous yet dependent. © 2017 The Authors. Pediatric Transplantation Published by Wiley Periodicals, Inc.

The Resonating Arm Exerciser: design and pilot testing of a mechanically passive rehabilitation device that mimics robotic active assistance

PubMed Central

2013-01-01

Background Robotic arm therapy devices that incorporate actuated assistance can enhance arm recovery, motivate patients to practice, and allow therapists to deliver semi-autonomous training. However, because such devices are often complex and actively apply forces, they have not achieved widespread use in rehabilitation clinics or at home. This paper describes the design and pilot testing of a simple, mechanically passive device that provides robot-like assistance for active arm training using the principle of mechanical resonance. Methods The Resonating Arm Exerciser (RAE) consists of a lever that attaches to the push rim of a wheelchair, a forearm support, and an elastic band that stores energy. Patients push and pull on the lever to roll the wheelchair back and forth by about 20 cm around a neutral position. We performed two separate pilot studies of the device. In the first, we tested whether the predicted resonant properties of RAE amplified a user’s arm mobility by comparing his or her active range of motion (AROM) in the device achieved during a single, sustained push and pull to the AROM achieved during rocking. In a second pilot study designed to test the therapeutic potential of the device, eight participants with chronic stroke (35 ± 24 months since injury) and a mean, stable, initial upper extremity Fugl-Meyer (FM) score of 17 ± 8 / 66 exercised with RAE for eight 45 minute sessions over three weeks. The primary outcome measure was the average AROM measured with a tilt sensor during a one minute test, and the secondary outcome measures were the FM score and the visual analog scale for arm pain. Results In the first pilot study, we found people with a severe motor impairment after stroke intuitively found the resonant frequency of the chair, and the mechanical resonance of RAE amplified their arm AROM by a factor of about 2. In the second pilot study, AROM increased by 66% ± 20% (p = 0.003). The mean FM score increase was 8.5 ± 4 pts (p = 0.009). Subjects did not report discomfort or an increase in arm pain with rocking. Improvements were sustained at three months. Conclusions These results demonstrate that a simple mechanical device that snaps onto a manual wheelchair can use resonance to assist arm training, and that such training shows potential for safely increasing arm movement ability for people with severe chronic hemiparetic stroke. PMID:23597303

The Resonating Arm Exerciser: design and pilot testing of a mechanically passive rehabilitation device that mimics robotic active assistance.

PubMed

Zondervan, Daniel K; Palafox, Lorena; Hernandez, Jorge; Reinkensmeyer, David J

2013-04-18

Robotic arm therapy devices that incorporate actuated assistance can enhance arm recovery, motivate patients to practice, and allow therapists to deliver semi-autonomous training. However, because such devices are often complex and actively apply forces, they have not achieved widespread use in rehabilitation clinics or at home. This paper describes the design and pilot testing of a simple, mechanically passive device that provides robot-like assistance for active arm training using the principle of mechanical resonance. The Resonating Arm Exerciser (RAE) consists of a lever that attaches to the push rim of a wheelchair, a forearm support, and an elastic band that stores energy. Patients push and pull on the lever to roll the wheelchair back and forth by about 20 cm around a neutral position. We performed two separate pilot studies of the device. In the first, we tested whether the predicted resonant properties of RAE amplified a user's arm mobility by comparing his or her active range of motion (AROM) in the device achieved during a single, sustained push and pull to the AROM achieved during rocking. In a second pilot study designed to test the therapeutic potential of the device, eight participants with chronic stroke (35 ± 24 months since injury) and a mean, stable, initial upper extremity Fugl-Meyer (FM) score of 17 ± 8 / 66 exercised with RAE for eight 45 minute sessions over three weeks. The primary outcome measure was the average AROM measured with a tilt sensor during a one minute test, and the secondary outcome measures were the FM score and the visual analog scale for arm pain. In the first pilot study, we found people with a severe motor impairment after stroke intuitively found the resonant frequency of the chair, and the mechanical resonance of RAE amplified their arm AROM by a factor of about 2. In the second pilot study, AROM increased by 66% ± 20% (p = 0.003). The mean FM score increase was 8.5 ± 4 pts (p = 0.009). Subjects did not report discomfort or an increase in arm pain with rocking. Improvements were sustained at three months. These results demonstrate that a simple mechanical device that snaps onto a manual wheelchair can use resonance to assist arm training, and that such training shows potential for safely increasing arm movement ability for people with severe chronic hemiparetic stroke.

14 CFR 382.121 - What mobility aids and other assistive devices may passengers with a disability bring into the...

Code of Federal Regulations, 2010 CFR

2010-01-01

... with impaired vision), crutches, and walkers; and (3) Other assistive devices for stowage or use within... syringes or auto-injectors, vision-enhancing devices, and POCs, ventilators and respirators that use non...

IDEA. VOCES: A Mnemonic Device to Cue Mood Selection after Impersonal Expressions.

ERIC Educational Resources Information Center

Chandler, Paul Michael

1996-01-01

Providing language learners with mnemonic devices assists retention and recall of vocabulary and structural items. This idea provides one such memory device to assist beginning and intermediate students who struggle with mood selection after impersonal expressions. (five references) (Author)

Studies to determine the effectiveness of automated flagger assistance devices and school crossing devices.

DOT National Transportation Integrated Search

2012-01-01

This report describes the methodology and results of analyses performed to determine motorist understanding, as well as : the operational and safety effectiveness, of automated flagger assistance devices (AFADs) relative to the use of flaggers at lan...

The Importance of Trust in the Adoption and Use of Intelligent Assistive Technology by Older Adults to Support Aging in Place: Scoping Review Protocol

PubMed Central

Strudwick, Gillian; Forchuk, Cheryl; Morse, Adam; Lachance, Jessica; Baskaran, Arani; Allison, Lauren

2017-01-01

Background Intelligent assistive technologies that complement and extend human abilities have proliferated in recent years. Service robots, home automation equipment, and other digital assistant devices possessing artificial intelligence are forms of assistive technologies that have become popular in society. Older adults (>55 years of age) have been identified by industry, government, and researchers as a demographic who can benefit significantly from the use of intelligent assistive technology to support various activities of daily living. Objective The purpose of this scoping review is to summarize the literature on the importance of the concept of “trust” in the adoption of intelligent assistive technologies to assist aging in place by older adults. Methods Using a scoping review methodology, our search strategy will examine the following databases: ACM Digital Library, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline, PsycINFO, Scopus, and Web of Science. Two reviewers will independently screen the initial titles obtained from the search, and these results will be further inspected by other members of the research team for inclusion in the review. Results This review will provide insights into how the concept of trust is actualized in the adoption of intelligent assistive technology by older adults. Preliminary sensitization to the literature suggests that the concept of trust is fluid, unstable, and intimately tied to the type of intelligent assistive technology being examined. Furthermore, a wide range of theoretical lenses that include elements of trust have been used to examine this concept. Conclusions This review will describe the concept of trust in the adoption of intelligent assistive technology by older adults, and will provide insights for practitioners, policy makers, and technology vendors for future practice. PMID:29097354

Motor and psychosocial impact of robot-assisted gait training in a real-world rehabilitation setting: A pilot study.

PubMed

Fundarò, Cira; Giardini, Anna; Maestri, Roberto; Traversoni, Silvia; Bartolo, Michelangelo; Casale, Roberto

2018-01-01

In the last decade robotic devices have been applied in rehabilitation to overcome walking disability in neurologic diseases with promising results. Robot assisted gait training (RAGT) using the Lokomat seems not only to improve gait parameters but also the perception of well-being. Data on the psychosocial patient-robot impact are limited, in particular in the real-world of RAGT, in the rehabilitation setting. During rehabilitation training, the Lokomat can be considered an "assistive device for movement". This allowed the use of the Psychosocial Impact of Assistive Device Scale- PIADS to describe patient interaction with the Lokomat. The primary aim of this pilot study was to evaluate the psychosocial impact of the Lokomat in an in-patient rehabilitation setting using the PIADS; secondary aims were to assess whether the psychosocial impact of RAGT is different between pathological sub-groups and if the Lokomat influenced functional variables (Functional Independence Measure scale-FIM and parameters provided by the Lokomat itself). Thirty-nine consecutive patients (69% males, 54.0±18.0 years) eligible for Lokomat training, with etiologically heterogeneous walking disabilities (Parkinson's Disease, n = 10; Spinal Cord Injury, n = 21; Ictus Event, n = 8) were enrolled. Patients were assessed with the FIM before and after rehabilitation with Lokomat, and the PIADS was administered after the rehabilitative period with Lokomat. Overall the PIADS score was positive (35.8±21.6), as well as the three sub-scales, pertaining to "ability", "adaptability" and "self-esteem" (17.2±10.4, 8.9±5.5 and 10.1±6.6 respectively) with no between-group differences. All patients significantly improved in gait measure and motor FIM scale (difference after-before treatment values: 11.7±9.8 and 11.2±10.3 respectively), increased treadmill speed (0.4 ± 0.2m/s), reduced body weight support (-14.0±9.5%) and guidance force (-13.1 ± 10.7%). This pilot study indicates that Lokomat, in a real-world in-patient setting, may have a generalised approval, independent of disease, underlining the importance of the psycho-social framework for patients training with assistive robotic-devices.

Early application of an intermittent pneumatic compression device is safe and results in proximal arteriovenous fistula enlargement.

PubMed

Desai, Sanjay; Mitra, Amit; Arkans, Ed; Singh, Tej M

2018-05-01

Delays in arteriovenous fistula maturation can cause care delays and increased costs. Increased distention pressure and intermittent wall shear stress may dilate veins based on prior research. Early use of non-invasive devices may help assist clinical arteriovenous fistula dilation. This was an Institutional Review Board approved study. After arteriovenous fistula creation, a novel, intermittent pneumatic compression device (Fist Assist ® ) was applied 15 cm proximal to arteriovenous fistula enabling 60 mmHg of cyclic compression for 6 h daily for 30 days. Among the patients who completed 1 month follow-up, 30 (n = 30) arteriovenous fistula patients were in the study arm to test vein dilation with Fist Assist. Controls (n = 16) used a sham device. Vein size was measured and recorded at baseline and after 30 days by duplex measurement. Clinical results (percentage increase) were recorded and tested for significance. No patients experienced thrombosis or adverse effects. Patient compliance and satisfaction was high. After 1 month, the mean percentage increase in vein diameter in the Fist Assist treatment group was significantly larger (p = 0.026) than controls in the first 5 mm segment of the fistula after the anastomosis. All fistulas treated with Fist Assist are still functional with no reported thrombosis or extravasations. Early application of an intermittent pneumatic compression device may assist in arteriovenous fistula dilation and are safe. Non-invasive devices like Fist Assist may have clinical utility to help fistulae development and decrease costs as they may eventually assist maturation.

34 CFR 303.12 - Early intervention services.

Code of Federal Regulations, 2010 CFR

2010-07-01

... technology device means any item, piece of equipment, or product system, whether acquired commercially off... capabilities of children with disabilities. Assistive technology service means a service that directly assists a child with a disability in the selection, acquisition, or use of an assistive technology device...

The pharmacotherapy implications of ventricular assist device in the patient with end-stage heart failure.

PubMed

Von Ruden, Serena A S; Murray, Margaret A; Grice, Jennifer L; Proebstle, Amy K; Kopacek, Karen J

2012-04-01

Advances in mechanical circulatory support, such as the use of ventricular assist devices (VADs), have become a means for prolonging survival in end-stage heart failure (HF). VADs decrease the symptoms of HF and improve quality of life by replacing some of the work of a failing heart. They unload the ventricle to provide improved cardiac output and end-organ perfusion, resulting in improvement in cardiorenal syndromes and New York Heart Association functional class rating. VADs are currently used asa bridge to heart transplantation, a bridge to recovery of cardiac function, or as destination therapy. Complications of VAD include bleeding, infections, arrhythmias, multiple organ failure, right ventricular failure, and neurological dysfunction. Patients with VAD have unique pharmacotherapeutic requirements in terms of anticoagulation, appropriate antibiotic selection, and continuation of HF medications. Pharmacists in acute care and community settings are well prepared to care for the patient with VAD. These patients require thorough counseling and follow-up with regard to prevention and treatment of infections, appropriate levels of anticoagulation, and maintenance of fluid balance. A basic understanding of this unique therapy can assist pharmacists in attending to the needs of patients with VAD.

Implementation of an ergonomics intervention in a Swedish flight baggage handling company—A process evaluation

PubMed Central

Mathiassen, Svend Erik; Larsson, Johan; Kwak, Lydia

2018-01-01

Objective To conduct a process evaluation of the implementation of an ergonomics training program aimed at increasing the use of loading assist devices in flight baggage handling. Methods Feasibility related to the process items recruitment, reach, context, dose delivered (training time and content); dose received (participants’ engagement); satisfaction with training; intermediate outcomes (skills, confidence and behaviors); and barriers and facilitators of the training intervention were assessed by qualitative and quantitative methods. Results Implementation proved successful regarding dose delivered, dose received and satisfaction. Confidence among participants in the training program in using and talking about devices, observed use of devices among colleagues, and internal feedback on work behavior increased significantly (p<0.01). Main facilitators were self-efficacy, motivation, and perceived utility of training among the trainees. Barriers included lack of peer support, opportunities to observe and practice behaviors, and follow-up activities; as well as staff reduction and job insecurity. Conclusions In identifying important barriers and facilitators for a successful outcome, this study can help supporting the effectiveness of future interventions. Our results suggest that barriers caused by organizational changes may likely be alleviated by recruiting motivated trainees and securing strong organizational support for the implementation. PMID:29513671

Kinematic, muscular, and metabolic responses during exoskeletal-, elliptical-, or therapist-assisted stepping in people with incomplete spinal cord injury.

PubMed

Hornby, T George; Kinnaird, Catherine R; Holleran, Carey L; Rafferty, Miriam R; Rodriguez, Kelly S; Cain, Julie B

2012-10-01

Robotic-assisted locomotor training has demonstrated some efficacy in individuals with neurological injury and is slowly gaining clinical acceptance. Both exoskeletal devices, which control individual joint movements, and elliptical devices, which control endpoint trajectories, have been utilized with specific patient populations and are available commercially. No studies have directly compared training efficacy or patient performance during stepping between devices. The purpose of this study was to evaluate kinematic, electromyographic (EMG), and metabolic responses during elliptical- and exoskeletal-assisted stepping in individuals with incomplete spinal cord injury (SCI) compared with therapist-assisted stepping. Design A prospective, cross-sectional, repeated-measures design was used. Participants with incomplete SCI (n=11) performed 3 separate bouts of exoskeletal-, elliptical-, or therapist-assisted stepping. Unilateral hip and knee sagittal-plane kinematics, lower-limb EMG recordings, and oxygen consumption were compared across stepping conditions and with control participants (n=10) during treadmill stepping. Exoskeletal stepping kinematics closely approximated normal gait patterns, whereas significantly greater hip and knee flexion postures were observed during elliptical-assisted stepping. Measures of kinematic variability indicated consistent patterns in control participants and during exoskeletal-assisted stepping, whereas therapist- and elliptical-assisted stepping kinematics were more variable. Despite specific differences, EMG patterns generally were similar across stepping conditions in the participants with SCI. In contrast, oxygen consumption was consistently greater during therapist-assisted stepping. Limitations Limitations included a small sample size, lack of ability to evaluate kinetics during stepping, unilateral EMG recordings, and sagittal-plane kinematics. Despite specific differences in kinematics and EMG activity, metabolic activity was similar during stepping in each robotic device. Understanding potential differences and similarities in stepping performance with robotic assistance may be important in delivery of repeated locomotor training using robotic or therapist assistance and for consumers of robotic devices.

78 FR 34922 - Definition of Auditory Assistance Device

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... Report and Order will apply to small businesses that choose to use, manufacture, design, import, or sell... production and marketing, and introduce more competition for such devices. The Commission decided that this... assistance devices using industry standard components employing relatively straight-forward designs at a...

Experiences with using a pushrim-activated power-assisted wheelchair for community-based occupations: a qualitative exploration.

PubMed

Giesbrecht, Ed M; Ripat, Jacquie D; Cooper, Juliette E; Quanbury, Arthur O

2011-04-01

Occupational therapists strive to engage individuals in occupation and enhance community access through wheelchair prescription. Previous research with pushrim-activated, power-assisted wheelchairs identifies a reduction in the physical demands of manual wheelchair propulsion but limited evidence exists regarding user evaluation in context. This study explored the experience of using a power-assisted wheelchair in the community. Eight individuals who used both a power and manual device participated in focus groups after trialing a power-assist wheelchair for three weeks. Data were analyzed using a qualitative description approach. Three themes emerged from our analysis: relative advantages and disadvantages; environmental factors that affect accessibility; and evaluation of mobility device. Participants perceived the power-assist as improving performance and accessibility compared with the manual wheelchair, increasing the potential scope of occupations and environments, but not replacing their power mobility device. Sufficient time for adjustment of both user and device was important.

Association of HeartMate II left ventricular assist device flow estimate with thermodilution cardiac output.

PubMed

Hasin, Tal; Huebner, Marianne; Li, Zhuo; Brown, Daniel; Stulak, John M; Boilson, Barry A; Joyce, Lyle; Pereira, Naveen L; Kushwaha, Sudhir S; Park, Soon J

2014-01-01

Cardiac output (CO) assessment is important in treating patients with heart failure. Durable left ventricular assist devices (LVADs) provide essentially all CO. In currently used LVADs, estimated device flow is generated by a computerized algorithm. However, LVAD flow estimate may be inaccurate in tracking true CO. We correlated LVAD (HeartMate II) flow with thermodilution CO during postoperative care (day 2-10 after implant) in 81 patients (5,616 paired measurements). Left ventricular assist device flow and CO correlated with a low correlation coefficient (r = 0.42). Left ventricular assist device readings were lower than CO measurements by approximately 0.36 L/min, trending for larger difference with higher values. Left ventricular assist device flow measurements showed less temporal variability compared with CO. Grouping for simultaneous measured blood pressure (BP < 60, 60-70, 70-80, 80-90, and ≥90), the correlation of CO with LVAD flow differed (R = 0.42, 0.67, 0.48, 0.32, 0.32, respectively). Indicating better correlation when mean blood pressure is 60 to 70 mm Hg. Left ventricular assist device flow generally trends with measured CO, but large variability exists, hence flow measures should not be assumed to equal with CO. Clinicians should take into account variables such as high CO, BP, and opening of the aortic valve when interpreting LVAD flow readout. Direct flow sensors incorporated in the LVAD system may allow for better estimation.

Comparative evaluation of user interfaces for robot-assisted laser phonomicrosurgery.

PubMed

Dagnino, Giulio; Mattos, Leonardo S; Becattini, Gabriele; Dellepiane, Massimo; Caldwell, Darwin G

2011-01-01

This research investigates the impact of three different control devices and two visualization methods on the precision, safety and ergonomics of a new medical robotic system prototype for assistive laser phonomicrosurgery. This system allows the user to remotely control the surgical laser beam using either a flight simulator type joystick, a joypad, or a pen display system in order to improve the traditional surgical setup composed by a mechanical micromanipulator coupled with a surgical microscope. The experimental setup and protocol followed to obtain quantitative performance data from the control devices tested are fully described here. This includes sets of path following evaluation experiments conducted with ten subjects with different skills, for a total of 700 trials. The data analysis method and experimental results are also presented, demonstrating an average 45% error reduction when using the joypad and up to 60% error reduction when using the pen display system versus the standard phonomicrosurgery setup. These results demonstrate the new system can provide important improvements in terms of surgical precision, ergonomics and safety. In addition, the evaluation method presented here is shown to support an objective selection of control devices for this application.

Non-Invasive Mapping of Intraventricular Flow Patterns in Patients Treated with Left Ventricular Assist Devices

NASA Astrophysics Data System (ADS)

Miramontes, Marissa; Rossini, Lorenzo; Braun, Oscar; Brambatti, Michela; Almeida, Shone; Mizeracki, Adam; Martinez-Legazpi, Pablo; Benito, Yolanda; Bermejo, Javier; Kahn, Andrew; Adler, Eric; Del Álamo, Juan C.

2017-11-01

In heart failure patients, left ventricular (LV) assist devices (LVADs) decrease mortality and improve quality of life. We hypothesize echo color Doppler velocimetry (echo-CDV), an echocardiographic flow mapping modality, can non-invasively characterize the effect of LVAD support, optimize the device, thereby decreasing the stoke rate present in these patients. We used echo-CDV to image LV flow at baseline LVAD speed and during a ramp test in LVAD patients (Heartmate II, N =10). We tracked diastolic vortices and mapped blood stasis and cumulative shear. Compared to dilated cardiomyopathy (DCM) patients without LVADs, the flow had a less prominent diastolic vortex ring, and transited directly from mitral valve to cannula. Residence time and shear were significantly lower compared to healthy controls and DCMs. Aortic regurgitation and a large LV vortex presence or a direct mitral jet towards the cannula affected blood stasis region location and size. Flow patterns, residence time and shear depended on LV geometry, valve function and LVAD speed in a patient specific manner. This new methodology could be used with standard echo, hemodynamics and clinical information to find the flow optimizing LAVD setting minimizing stasis for each patient.

The Use of Pediatric Ventricular Assist Devices in Children's Hospitals From 2000 to 2010: Morbidity, Mortality, and Hospital Charges.

PubMed

Mansfield, Robert T; Lin, Kimberly Y; Zaoutis, Theoklis; Mott, Antonio R; Mohamad, Zeinab; Luan, Xianqun; Kaufman, Beth D; Ravishankar, Chitra; Gaynor, J William; Shaddy, Robert E; Rossano, Joseph W

2015-07-01

The use of ventricular assist devices has increased dramatically in adult heart failure patients. However, the overall use, outcome, comorbidities, and resource utilization of ventricular assist devices in pediatric patients have not been well described. We sought to demonstrate that the use of ventricular assist devices in pediatric patients has increased over time and that mortality has decreased. A retrospective study of the Pediatric Health Information System database was performed for patients 20 years old or younger undergoing ventricular assist device placement from 2000 to 2010. None. Four hundred seventy-five pediatric patients were implanted with ventricular assist devices during the study period: 69 in 2000-2003 (era 1), 135 in 2004-2006 (era 2), and 271 in 2007-2010 (era 3). Median age at ventricular assist device implantation was 6.0 years (interquartile range, 0.5-13.8), and the proportion of children who were 1-12 years old increased from 29% in era 1 to 47% in era 3 (p = 0.002). The majority of patients had a diagnosis of cardiomyopathy; this increased from 52% in era 1 to 72% in era 3 (p = 0.003). Comorbidities included arrhythmias (48%), pulmonary hypertension (16%), acute renal failure (34%), cerebrovascular disease (28%), and sepsis/systemic inflammatory response syndrome (34%). Two hundred forty-seven patients (52%) underwent heart transplantation and 327 (69%) survived to hospital discharge. Hospital mortality decreased from 42% in era 1 to 25% in era 3 (p = 0.004). Median hospital length of stay increased (37 d [interquartile range, 12-64 d] in era 1 vs 69 d [interquartile range, 35-130] in era 3; p < 0.001) and median adjusted hospital charges increased ($630,630 [interquartile range, $227,052-$853,318] in era 1 vs $1,577,983 [interquartile range, $874,463-$2,280,435] in era 3; p < 0.001). Factors associated with increased mortality include age less than 1 year (odds ratio, 2.04; 95% CI, 1.01-3.83), acute renal failure (odds ratio, 2.1; 95% CI, 1.26-3.65), cerebrovascular disease (odds ratio, 2.1; 95% CI, 1.25-3.62), and extracorporeal membrane oxygenation (odds ratio, 3.16; 95% CI, 1.79-5.60). Ventricular assist device placement in era 3 (odds ratio, 0.3; 95% CI, 0.15-0.57) and a diagnosis of cardiomyopathy (odds ratio, 0.5; 95% CI, 0.32-0.84), were associated with decreased mortality. Large-volume centers had lower mortality (odds ratio, 0.55; 95% CI, 0.34-0.88), lower use of extracorporeal membrane oxygenation, and higher charges. The use of ventricular assist devices and survival after ventricular assist device placement in pediatric patients have increased over time, with a concomitant increase in resource utilization. Age under 1 year, certain noncardiac morbidities, and the use of extracorporeal membrane oxygenation are associated with worse outcomes. Lower mortality was seen at larger volume ventricular assist device centers.

An experimental comparison of the relative benefits of work and torque assistance in ankle exoskeletons.

PubMed

Jackson, Rachel W; Collins, Steven H

2015-09-01

Techniques proposed for assisting locomotion with exoskeletons have often included a combination of active work input and passive torque support, but the physiological effects of different assistance techniques remain unclear. We performed an experiment to study the independent effects of net exoskeleton work and average exoskeleton torque on human locomotion. Subjects wore a unilateral ankle exoskeleton and walked on a treadmill at 1.25 m·s(-1) while net exoskeleton work rate was systematically varied from -0.054 to 0.25 J·kg(-1)·s(-1), with constant (0.12 N·m·kg(-1)) average exoskeleton torque, and while average exoskeleton torque was systematically varied from approximately zero to 0.18 N·m·kg(-1), with approximately zero net exoskeleton work. We measured metabolic rate, center-of-mass mechanics, joint mechanics, and muscle activity. Both techniques reduced effort-related measures at the assisted ankle, but this form of work input reduced metabolic cost (-17% with maximum net work input) while this form of torque support increased metabolic cost (+13% with maximum average torque). Disparate effects on metabolic rate seem to be due to cascading effects on whole body coordination, particularly related to assisted ankle muscle dynamics and the effects of trailing ankle behavior on leading leg mechanics during double support. It would be difficult to predict these results using simple walking models without muscles or musculoskeletal models that assume fixed kinematics or kinetics. Data from this experiment can be used to improve predictive models of human neuromuscular adaptation and guide the design of assistive devices. Copyright © 2015 the American Physiological Society.

Non-Exposure, Device-Assisted Endoscopic Full-thickness Resection.

PubMed

Bauder, Markus; Schmidt, Arthur; Caca, Karel

2016-04-01

Recent developments have expanded the frontier of interventional endoscopy toward more extended resections following surgical principles. This article presents two new device-assisted techniques for endoscopic full-thickness resection in the upper and lower gastrointestinal tract. Both methods are nonexposure techniques avoiding exposure of gastrointestinal contents to the peritoneal cavity by a "close first-cut later" principle. The full-thickness resection device is a novel over-the-scope device designed for clip-assisted full-thickness resection of colorectal lesions. Endoscopic full-thickness resection of gastric subepithelial tumors can be performed after placing transmural sutures underneath the tumor with a suturing device originally designed for endoscopic antireflux therapy. Copyright © 2016 Elsevier Inc. All rights reserved.

The COACH prompting system to assist older adults with dementia through handwashing: An efficacy study

PubMed Central

Mihailidis, Alex; Boger, Jennifer N; Craig, Tammy; Hoey, Jesse

2008-01-01

Background Many older adults with dementia require constant assistance from a caregiver when completing activities of daily living (ADL). This study examines the efficacy of a computerized device intended to assist people with dementia through ADL, while reducing caregiver burden. The device, called COACH, uses artificial intelligence to autonomously guide an older adult with dementia through the ADL using audio and/or audio-video prompts. Methods Six older adults with moderate-to-severe dementia participated in this study. Handwashing was chosen as the target ADL. A single subject research design was used with two alternating baseline (COACH not used) and intervention (COACH used) phases. The data were analyzed to investigate the impact of COACH on the participants' independence and caregiver burden as well as COACH's overall performance for the activity of handwashing. Results Participants with moderate-level dementia were able to complete an average of 11% more handwashing steps independently and required 60% fewer interactions with a human caregiver when COACH was in use. Four of the participants achieved complete or very close to complete independence. Interestingly, participants' MMSE scores did not appear to robustly coincide with handwashing performance and/or responsiveness to COACH; other idiosyncrasies of each individual seem to play a stronger role. While the majority (78%) of COACH's actions were considered clinically correct, areas for improvement were identified. Conclusion The COACH system shows promise as a tool to help support older adults with moderate-levels of dementia and their caregivers. These findings reinforce the need for flexibility and dynamic personalization in devices designed to assist older adults with dementia. After addressing identified improvements, the authors plan to run clinical trials with a sample of community-dwelling older adults and caregivers. PMID:18992135

Operations manual for the patient assist device. [to handle electrical appliances

NASA Technical Reports Server (NTRS)

Schrader, M. A.

1973-01-01

Quadriplegic patients and multiple amputee patients are almost totally dependent on nursing personnel for any activities or interests in which they participate. A patient assist device is reported which provides patient control over electrical devices in his environment. The patient operates three switches to acquire control over a desired electrical appliance. The type switches employed are chosen to conform to patient capabilities, even when such capabilities are as limited as eye or head movements. The switch operations are sensed and converted into command signals by the patient assist device to control ten electrical appliances simulataneously and independently.

Mechanical Circulatory Support for Advanced Heart Failure: Are We about to Witness a New "Gold Standard"?

PubMed

Capoccia, Massimo

2016-12-12

The impact of left ventricular assist devices (LVADs) for the treatment of advanced heart failure has played a significant role as a bridge to transplant and more recently as a long-term solution for non-eligible candidates. Continuous flow left ventricular assist devices (CF-LVADs), based on axial and centrifugal design, are currently the most popular devices in view of their smaller size, increased reliability and higher durability compared to pulsatile flow left ventricular assist devices (PF-LVADs). The trend towards their use is increasing. Therefore, it has become mandatory to understand the physics and the mathematics behind their mode of operation for appropriate device selection and simulation set up. For this purpose, this review covers some of these aspects. Although very successful and technologically advanced, they have been associated with complications such as pump thrombosis, haemolysis, aortic regurgitation, gastro-intestinal bleeding and arterio-venous malformations. There is perception that the reduced arterial pulsatility may be responsible for these complications. A flow modulation control approach is currently being investigated in order to generate pulsatility in rotary blood pumps. Thrombus formation remains the most feared complication that can affect clinical outcome. The development of a preoperative strategy aimed at the reduction of complications and patient-device suitability may be appropriate. Patient-specific modelling based on 3D reconstruction from CT-scan combined with computational fluid dynamic studies is an attractive solution in order to identify potential areas of stagnation or challenging anatomy that could be addressed to achieve the desired outcome. The HeartMate II (axial) and the HeartWare HVAD (centrifugal) rotary blood pumps have been now used worldwide with proven outcome. The HeartMate III (centrifugal) is now emerging as the new promising device with encouraging preliminary results. There are now enough pumps on the market: it is time to focus on the complications in order to achieve the full potential and selling-point of this type of technology for the treatment of the increasing heart failure patient population.

Using the Nintendo Wii Fit and body weight support to improve aerobic capacity, balance, gait ability, and fear of falling: two case reports.

PubMed

Miller, Carol A; Hayes, Dawn M; Dye, Kelli; Johnson, Courtney; Meyers, Jennifer

2012-01-01

Lower limb amputation in older adults has a significant impact on balance, gait, and cardiovascular fitness, resulting in diminished community participation. The purpose of this case study was to describe the effects of a balance training program utilizing the Nintendo Wii™ Fit (Nintendo of America, Inc, Redmond, Washington) balance board and body-weight supported gait training on aerobic capacity, balance, gait, and fear of falling in two persons with transfemoral amputation. Participant A, a 62 year-old male 32 months post traumatic transfemoral amputation, reported fear of falling and restrictions in community activity. Participant B, a 58 year-old male 9 years post transfemoral amputation, reported limited energy and balance deficits during advanced gait activities. 6-weeks, 2 supervised sessions per week included 20 minutes of Nintendo™ Wii Fit Balance gaming and 20 minutes of gait training using Body Weight Support. Measures included oxygen uptake efficiency slope (OUES), economy of movement, dynamic balance (Biodex platform system), Activities-Specific Balance Confidence (ABC) Scale, and spatial-temporal parameters of gait (GAITRite). Both participants demonstrated improvement in dynamic balance, balance confidence, economy of movement, and spatial-temporal parameters of gait. Participant A reduced the need for an assistive device during community ambulation. Participant B improved his aerobic capacity, indicated by an increase in OUES. This case study illustrated that the use of Nintendo Wii™ Fit training and Body Weight Support were effective interventions to achieve functional goals for improving balance confidence, reducing use of assistive devices, and increasing energy efficiency when ambulating with a transfemoral prosthesis.

Effect of Neurohormonal Blockade Drug Therapy on Outcomes and Left Ventricular Function and Structure After Left Ventricular Assist Device Implantation.

PubMed

Grupper, Avishay; Zhao, Yanjun M; Sajgalik, Pavol; Joyce, Lyle D; Park, Soon J; Pereira, Naveen L; Stulak, John M; Burnett, John C; Edwards, Brooks S; Daly, Richard C; Kushwaha, Sudhir S; Schirger, John A

2016-06-01

Neurohormonal blockade drug therapy (NHBDT) is the cornerstone therapy in heart failure (HF) management for promoting reverse cardiac remodeling and improving outcomes. It's utility in left ventricular assist device (LVAD) supported patients remains undefined. Sixty-four patients who received continuous flow LVAD at our institution were retrospectively reviewed and divided into 2 groups: no-NHBDT group (n = 33) received LVAD support only and NHBDT group (n = 31) received concurrent NHBDT based on the clinical judgment of the attending physicians. Cardiac remodeling (echocardiographic parameters and biomarkers) and clinical outcome (functional status, HF-related hospital readmissions, and mortality) data were collected. A statistically significant increase in ejection fraction, decrease in LV end-diastolic diameter index and LV mass index, and a sustained reduction in N-terminal pro B-type natriuretic peptide (NTproBNP) were observed in the NHBDT group at 6 months after LVAD implant (p <0.05). NHBDT-treated patients experienced significantly greater improvement in New York Heart Association functional classification and 6-minute-walk distance throughout the study. The combined end point of cardiovascular death or HF hospitalization was significantly reduced in patients receiving NHBDT (p = 0.013) associated primarily with a 12.1% absolute reduction in HF-related hospitalizations (p = 0.046). In conclusion, NHBDT in LVAD-supported patients is associated with a significant reversal in adverse cardiac remodeling and a reduction in morbidity and mortality compared with LVAD support alone. Copyright © 2016 Elsevier Inc. All rights reserved.

A novel pediatric treatment intensity score: development and feasibility in heart failure patients with ventricular assist devices.

PubMed

May, Lindsay J; Ploutz, Michelle; Hollander, Seth A; Reinhartz, Olaf; Almond, Christopher S; Chen, Sharon; Maeda, Katsuhide; Kaufman, Beth D; Yeh, Justin; Rosenthal, David N

2015-04-01

The evolution of pharmacologic therapies and mechanical support including ventricular assist devices (VADs) has broadened the scope of care available to children with advanced heart failure. At the present time, there are only limited means of quantifying disease severity or the concomitant morbidity for this population. This study describes the development of a novel pediatric treatment intensity score (TIS), designed to quantify the burden of illness and clinical trajectory in children on VAD support. There were 5 clinical domains assessed: nutrition, respiratory support, activity level, cardiovascular medications, and care environment. A scale was developed through expert consensus. Higher scores indicate greater morbidity as reflected by intensity of medical management. To evaluate feasibility and face validity, the TIS was applied retrospectively to a subset of pediatric inpatients with VADs. The Bland-Altman method was used to assess limits of agreement. The study comprised 39 patients with 42 implantations. Bland-Altman interobserver and intraobserver comparisons showed good agreement (mean differences in scores of 0.02, limits of agreement ±0.12). Trends in TIS were concordant with the overall clinical impression of improvement. Scores remained ≥0.6 preceding VAD implantation and peaked at 0.71 3 days after VAD implantation. We describe a pediatric VAD scoring tool, to assess global patient morbidity and clinical recovery. We demonstrate feasibility of using this TIS in a test population of inpatients on VAD support. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Implantable physiologic controller for left ventricular assist devices with telemetry capability.

PubMed

Asgari, Siavash S; Bonde, Pramod

2014-01-01

Rotary type left ventricular assist devices have mitigated the problem of durability associated with earlier pulsatile pumps and demonstrated improved survival. However, the compromise is the loss of pulsatility due to continuous flow and retained percutaneous driveline leading to increased mortality and morbidity. Lack of pulsatility is implicated in increased gastrointestinal bleeding, aortic incompetence, and diastolic hypertension. We present a novel, wirelessly powered, ultra-compact, implantable physiologic controller capable of running a left ventricular assist device in a pulsatile mode with wireless power delivery. The schematic of our system was laid out on a circuit board to wirelessly receive power and run a left ventricular assist device with required safety and backup measures. We have embedded an antenna and wireless network for telemetry. Multiple signal processing steps and controlling algorithm were incorporated. The controller was tested in in vitro and in vivo experiments. The controller drove left ventricular assist devices continuously for 2 weeks in an in vitro setup and in vivo without any failure. Our controller is more power efficient than the current Food and Drug Administration-approved left ventricular assist device controllers. When used with electrocardiography synchronization, the controller allowed on-demand customization of operation with instantaneous flow and revolutions per minute changes, resulting in a pulsatile flow with adjustable pulse pressure. Our test results prove the system to be remarkably safe, accurate, and efficient. The unique combination of wireless powering and small footprint makes this system an ideal totally implantable physiologic left ventricular assist device system. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Surgical approach to end-stage heart failure.

PubMed

Klotz, Stefan; Scheld, Hans H

2011-02-01

End-stage heart failure is a challenging disease with growing incidence. With decreasing heart transplant rates worldwide organ preserving therapies become, again, of interest. The purpose of the present review is to examine the potential challenges of surgical therapies in patients with end-stage heart failure. The gold-standard for end-stage heart failure is and will be cardiac transplantation. However, due to organ shortage this therapy is limited to a few patients. Therefore implantation of ventricular assist devices (VADs) or long-term minimal-invasive partial support devices will increase. Improvements in device design with smaller devices, easier implantation techniques, and modified anticoagulation outcome and long-term success will likely improve. In addition, good quality of life as destination therapy is almost available. Organ conservation surgery (coronary artery bypass grafting and surgical ventricular restoration or surgical repair of mitral valve regurgitation) in end-stage heart failure patients could not prove the expected results. Transcatheter or minimal-invasive approaches of these therapies might become routine in the near future. Due to the overwhelming outcome rates, cardiac transplantation is the most established surgical therapy for end-stage heart failure. VAD therapy is increasing and minimized VADs might further open the market for destination therapy/permanent support.

Interoperable End-to-End Remote Patient Monitoring Platform Based on IEEE 11073 PHD and ZigBee Health Care Profile.

PubMed

Clarke, Malcolm; de Folter, Joost; Verma, Vivek; Gokalp, Hulya

2018-05-01

This paper describes the implementation of an end-to-end remote monitoring platform based on the IEEE 11073 standards for personal health devices (PHD). It provides an overview of the concepts and approaches and describes how the standard has been optimized for small devices with limited resources of processor, memory, and power that use short-range wireless technology. It explains aspects of IEEE 11073, including the domain information model, state model, and nomenclature, and how these support its plug-and-play architecture. It shows how these aspects underpin a much larger ecosystem of interoperable devices and systems that include IHE PCD-01, HL7, and BlueTooth LE medical devices, and the relationship to the Continua Guidelines, advocating the adoption of data standards and nomenclature to support semantic interoperability between health and ambient assisted living in future platforms. The paper further describes the adaptions that have been made in order to implement the standard on the ZigBee Health Care Profile and the experiences of implementing an end-to-end platform that has been deployed to frail elderly patients with chronic disease(s) and patients with diabetes.

Programs to optimize adherence in glaucoma.

PubMed

Kowing, Dianne; Messer, Dawn; Slagle, Scott; Wasik, Alyon

2010-07-01

This study was designed to raise awareness of the materials, devices, and Internet resources available to improve adherence to use of medications for the treatment of glaucoma and to review new devices under development. A review of current indexed literature and Internet resources was conducted. A variety of educational brochures, pamphlets, and fact sheets promoting adherence to ocular hypotensive medications are available through multiple organizations and are easily accessed and ordered on the Internet. Video and Web-based patient educational tools have been designed to support patient adherence to glaucoma management plans and promote open dialogue between patients and providers. Reminder and recall systems that integrate with office software can be sent to cell phones as well as e-mails and personal digital assistant (PDAs), alerting patients to upcoming appointments and reminding them to instill their drops. Bottle devices with dosing support (timers with audible and visual signals and dispensing aids) and electronic monitoring have been shown to promote adherence. New products currently under development to improve the delivery of medications include nanoparticles, punctal plugs, and contact lenses that release glaucoma medications. Many educational materials, services, Internet resources, and devices are available to optometrists to encourage patient adherence to glaucoma treatment and management. Published by Elsevier Inc.

The total artificial heart.

PubMed

Cook, Jason A; Shah, Keyur B; Quader, Mohammed A; Cooke, Richard H; Kasirajan, Vigneshwar; Rao, Kris K; Smallfield, Melissa C; Tchoukina, Inna; Tang, Daniel G

2015-12-01

The total artificial heart (TAH) is a form of mechanical circulatory support in which the patient's native ventricles and valves are explanted and replaced by a pneumatically powered artificial heart. Currently, the TAH is approved for use in end-stage biventricular heart failure as a bridge to heart transplantation. However, with an increasing global burden of cardiovascular disease and congestive heart failure, the number of patients with end-stage heart failure awaiting heart transplantation now far exceeds the number of available hearts. As a result, the use of mechanical circulatory support, including the TAH and left ventricular assist device (LVAD), is growing exponentially. The LVAD is already widely used as destination therapy, and destination therapy for the TAH is under investigation. While most patients requiring mechanical circulatory support are effectively treated with LVADs, there is a subset of patients with concurrent right ventricular failure or major structural barriers to LVAD placement in whom TAH may be more appropriate. The history, indications, surgical implantation, post device management, outcomes, complications, and future direction of the TAH are discussed in this review.

Environmentally-assisted technique for transferring devices onto non-conventional substrates

DOEpatents

Lee, Chi-Hwan; Kim, Dong Rip; Zheng, Xiaolin

2016-05-10

A device fabrication method includes: (1) providing a growth substrate including an oxide layer; (2) forming a metal layer over the oxide layer; (3) forming a stack of device layers over the metal layer; (4) performing fluid-assisted interfacial debonding of the metal layer to separate the stack of device layers and the metal layer from the growth substrate; and (5) affixing the stack of device layers to a target substrate.

49 CFR 27.72 - Boarding assistance for aircraft.

Code of Federal Regulations, 2011 CFR

2011-10-01

... assistance to individuals with disabilities using mechanical lifts, ramps, or other devices that do not require employees to lift or carry passengers up stairs. Paragraph (c) of this section applies to aircraft... to be unsuitable for boarding assistance by lift, ramp or other suitable device on the basis of a...

49 CFR 27.72 - Boarding assistance for aircraft.

Code of Federal Regulations, 2010 CFR

2010-10-01

... assistance to individuals with disabilities using mechanical lifts, ramps, or other devices that do not require employees to lift or carry passengers up stairs. Paragraph (c) of this section applies to aircraft... to be unsuitable for boarding assistance by lift, ramp or other suitable device on the basis of a...

Assistive Technology in the Schools: A Guide for Idaho Educators.

ERIC Educational Resources Information Center

Doty, Michelle; Seiler, Ron; Rhoads, LaRae

This manual is designed to provide Idaho educators, parents, students with disabilities, and related service providers with assistance in identifying, selecting, and acquiring assistive technology (AT) devices and services. The consideration of AT devices and services is required during the development of every Individualized Family Service Plan…

Payment for Assistive Devices by the Veterans Administration.

ERIC Educational Resources Information Center

Reeb, Kenneth G., Jr.; Stripling, Thomas E.

This report provides an overview of the Veterans Administration (VA) and how it pays for assistive devices for veterans. It explains the VA payment structure and decision-making responsibilities concerning assistive equipment. Following an introductory section, the report provides background on the VA system, summarizing its legislative origins,…

An ultimate, compact, seal-less centrifugal ventricular assist device: Baylor C-Gyro pump.

PubMed

Ohara, Y; Makinouchi, K; Orime, Y; Tasai, K; Naito, K; Mizuguchi, K; Shimono, T; Damm, G; Glueck, J; Takatani, S

1994-01-01

We have developed a compact, seal-less, all-purpose centrifugal pump, the Baylor C-Gyro pump, which is intended as a long-term ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. In attaining this goal, we began with eliminating the shaft seals by adopting a pivot bearing system at the impeller shaft. In addition, a ring magnet encased in the bottom of the impeller was coupled magnetically to a driver magnet placed outside the pump housing (C1 Prototype). This first model yielded satisfactory performance in vitro with a flow rate of 8 L/min against 250 mm Hg at 2,400 rpm, and an index of hemolysis (IH) of 0.0083 g/100 L using bovine blood. In the second model, the C1 Eccentric Inlet Port Model, the inlet bearing support bar in the prototype were eliminated without reducing the prototype's performance. These designs for antithrombogenicity are being tested by the first in vivo experiment, which has lasted for more than 2 weeks.

Comparison of the effects of continuous and pulsatile left ventricular-assist devices on ventricular unloading using a cardiac electromechanics model

PubMed Central

Lim, Ki Moo; Constantino, Jason; Gurev, Viatcheslav; Zhu, Renjun; Trayanova, Natalia A.

2012-01-01

Left ventricular-assist devices (LVADs) are used to supply blood to the body of patients with heart failure. Pressure unloading is greater for counter-pulsating LVADs than for continuous LVADs. However, several clinical trials have demonstrated that myocardial recovery is similar for both types of LVAD. This study examined the contractile energy consumption of the myocardium with continuous and counter-pulsating LVAD support to ascertain the effect of the different LVADs on myocardial recovery. We used a three-dimensional electromechanical model of canine ventricles, with models of the circulatory system and an LVAD. We compared the left ventricular peak pressure (LVPP) and contractile ATP consumption between pulsatile and continuous LVADs. With the continuous and counter-pulsating LVAD, the LVPP decreased to 46 and 10%, respectively, and contractile ATP consumption decreased to 60 and 50%. The small difference between the contractile ATP consumption of these two types of LVAD may explain the comparable effects of the two types on myocardial recovery. PMID:22076841

Creating a mobile subject guide to improve access to point-of-care resources for medical students: a case study

PubMed Central

Boruff, Jill T; Bilodeau, Edward

2012-01-01

Question: Can a mobile optimized subject guide facilitate medical student access to mobile point-of-care tools? Setting: The guide was created at a library at a research-intensive university with six teaching hospital sites. Objectives: The team created a guide facilitating medical student access to point-of-care tools directly on mobile devices to provide information allowing them to access and set up resources with little assistance. Methods: Two librarians designed a mobile optimized subject guide for medicine and conducted a survey to test its usefulness. Results: Web analytics and survey results demonstrate that the guide is used and the students are satisfied. Conclusion: The library will continue to use the subject guide as its primary means of supporting mobile devices. It remains to be seen if the mobile guide facilitates access for those who do not need assistance and want direct access to the resources. Internet access in the hospitals remains an issue. PMID:22272160

Ergonomic evaluation of a wearable assistive device for overhead work.

PubMed

Rashedi, Ehsan; Kim, Sunwook; Nussbaum, Maury A; Agnew, Michael J

2014-01-01

Overhead work is an important risk factor for upper extremity (UE) musculoskeletal disorders. We examined the potential of a mechanical arm and an exoskeletal vest as a wearable assistive device (WADE) for overhead work. Twelve participants completed 10 minutes of simulated, intermittent overhead work, using each of three payloads (1.1, 3.4 and 8.1 kg) and with/without the WADE. Ratings of perceived discomfort (RPDs) and electromyography (EMG) were obtained for the upper arms, shoulders and low back. Using the WADE, UE RPDs decreased by ∼50% with the heavier payloads, whereas smaller (∼25%) and non-significant increases in low-back RPDs were found and were relatively independent of payload. Changes in RPDs with WADE use were consistent with physical demands indicated by EMG, though EMG-based differences in fatigue were less apparent. Participants generally preferred using the WADE, particularly with heavier payloads. These results supported the potential utility of a WADE as an intervention for overhead work.

Controversies and Challenges of Ventricular Assist Device Therapy.

PubMed

Lima, Brian; Bansal, Aditya; Abraham, Jacob; Rich, Jonathan D; Lee, Sangjin S; Soleimani, Behzad; Katz, Jason N; Kilic, Ahmet; Young, John S; Patel, Chetan B; Joseph, Susan M

2018-05-15

Left ventricular assist device (LVAD) therapy has emerged as an increasingly vital facet of the treatment algorithm for advanced heart failure. Growing experience with LVAD support has led to substantial improvements in outcomes, with 1-year survival rates approaching that of cardiac transplantation. These therapeutic refinements have engendered growing interests in the potential for expanding the clinical indications for LVAD therapy to patients with less advanced heart failure. The primary obstacles to this evolution of care center largely on the prevention and/or management of the adverse events associated with LVAD therapy along with patient preference. Many programs also face the mounting difficulty of balancing quality outcomes with the increased volume of implants. During the recently assembled Users Meeting organized by St. Jude Medical, heart failure clinicians from nearly 50 LVAD implanting centers discussed these and other challenges and controversies impacting the field. The present review summarizes the key insights gleaned from this meeting. Copyright © 2018 Elsevier Inc. All rights reserved.

Creating a mobile subject guide to improve access to point-of-care resources for medical students: a case study.

PubMed

Boruff, Jill T; Bilodeau, Edward

2012-01-01

Can a mobile optimized subject guide facilitate medical student access to mobile point-of-care tools? The guide was created at a library at a research-intensive university with six teaching hospital sites. The team created a guide facilitating medical student access to point-of-care tools directly on mobile devices to provide information allowing them to access and set up resources with little assistance. Two librarians designed a mobile optimized subject guide for medicine and conducted a survey to test its usefulness. Web analytics and survey results demonstrate that the guide is used and the students are satisfied. The library will continue to use the subject guide as its primary means of supporting mobile devices. It remains to be seen if the mobile guide facilitates access for those who do not need assistance and want direct access to the resources. Internet access in the hospitals remains an issue.

On the tip of the tongue: learning typing and pointing with an intra-oral computer interface.

PubMed

Caltenco, Héctor A; Breidegard, Björn; Struijk, Lotte N S Andreasen

2014-07-01

To evaluate typing and pointing performance and improvement over time of four able-bodied participants using an intra-oral tongue-computer interface for computer control. A physically disabled individual may lack the ability to efficiently control standard computer input devices. There have been several efforts to produce and evaluate interfaces that provide individuals with physical disabilities the possibility to control personal computers. Training with the intra-oral tongue-computer interface was performed by playing games over 18 sessions. Skill improvement was measured through typing and pointing exercises at the end of each training session. Typing throughput improved from averages of 2.36 to 5.43 correct words per minute. Pointing throughput improved from averages of 0.47 to 0.85 bits/s. Target tracking performance, measured as relative time on target, improved from averages of 36% to 47%. Path following throughput improved from averages of 0.31 to 0.83 bits/s and decreased to 0.53 bits/s with more difficult tasks. Learning curves support the notion that the tongue can rapidly learn novel motor tasks. Typing and pointing performance of the tongue-computer interface is comparable to performances of other proficient assistive devices, which makes the tongue a feasible input organ for computer control. Intra-oral computer interfaces could provide individuals with severe upper-limb mobility impairments the opportunity to control computers and automatic equipment. Typing and pointing performance of the tongue-computer interface is comparable to performances of other proficient assistive devices, but does not cause fatigue easily and might be invisible to other people, which is highly prioritized by assistive device users. Combination of visual and auditory feedback is vital for a good performance of an intra-oral computer interface and helps to reduce involuntary or erroneous activations.

Ambulation and complications related to assistive devices after spinal cord injury

PubMed Central

Saunders, Lee L.; Krause, James S.; DiPiro, Nicole D.; Kraft, Sara; Brotherton, Sandra

2013-01-01

Objective To evaluate long-term health outcomes including pain intensity, pain interference, and fatigue among ambulatory persons with spinal cord injury (SCI). Design Prospective cohort study. Setting Data were analyzed at a major medical university in the southeast USA. Participants Participants included 783 ambulatory adults with SCI of traumatic origin, who were at least 1-year post-injury. Participants were identified through three sources of records at a large specialty hospital in the southeastern USA. Interventions Not applicable. Outcome measures Pain intensity and interference (Brief Pain Inventory) and fatigue (Modified Fatigue Impact Scale Abbreviated Version 5). Results Examining assistive devices used for ambulation, 66% of the population used at least one device. In the logistic model, wheelchair and cane usage were significantly related to the outcomes after controlling for age, gender, and race. Wheelchair usage 50% of the time or less was significantly related to pain intensity (odds ratio (OR) 2.05, 95% confidence interval (CI) = 1.39–3.03), pain interference (OR 2.11, 95% CI = 1.43–3.12), and fatigue (OR 1.99, 95% CI = 1.12–1.43). Additionally, unilateral cane use was significantly related to the outcomes; pain intensity (OR 1.86, 95% CI = 1.35–2.56), pain interference (OR 2.11, 95% CI = 1.52–2.93), and fatigue (OR 2.49, 95% CI = 1.52–4.08). Conclusions Among ambulatory persons with SCI, increased pain intensity, pain interference, and fatigue are associated with minimal wheelchair usage (50% or less) and less supportive assistive device (unilateral cane) usage. PMID:24090470

21 CFR 884.6190 - Assisted reproductive microscopes and microscope accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction... or embryos. Variations of microscopes and accessories used for these purposes would include phase...

Assistive device use and mobility-related factors among adults aged≥65years.

PubMed

West, Bethany A; Bhat, Geeta; Stevens, Judy; Bergen, Gwen

2015-12-01

Examining how assistive device (cane, walker) use relates to other mobility factors can provide insight into older adults' future mobility needs. Data come from the Second Injury Control and Risk Survey, Phase 2 (ICARIS2-P2), conducted from March 2007 to May 2008. Prevalence estimates were calculated for older adults (aged ≥65) and multivariable logistic regression was used to explore associations between assistive device use and mobility-related characteristics. Compared with non-users, assistive device users were more likely to report a recent fall (AOR 12.0; 95% CI 4.9-29.3), limit walking outside due to concerns about falling (AOR 7.1; 95% CI 2.6-19.1), be unable to walk outside for 10min without resting (AOR 3.3; 95% CI 1.1-9.3), and be no longer driving (AOR 6.7; 95% CI 2.0-22.3). Assistive device users have limited mobility and an increased risk for fall injury compared with non-users. Effective fall prevention interventions, and innovative transportation options, are needed to protect the mobility of this high-risk group. Published by Elsevier Ltd.

Risk Stratification of Patients With Current Generation Continuous-Flow Left Ventricular Assist Devices Being Bridged to Heart Transplantation.

PubMed

Guha, Ashrith; Nguyen, Duc; Cruz-Solbes, Ana S; Amione-Guerra, Javier; Schutt, Robert C; Bhimaraj, Arvind; Trachtenberg, Barry H; Park, Myung H; Graviss, Edward A; Gaber, Osama; Suarez, Erik; Montane, Eva; Torre-Amione, Guillermo; Estep, Jerry D

Patients bridged to transplant (BTT) with continuous-flow left ventricular assist devices (CF-LVADs) have increased in the past decade. Decision support tools for these patients are limited. We developed a risk score to estimate prognosis and guide decision-making. We included heart transplant recipients bridged with CF-LVADs from the United Network for Organ Sharing (UNOS) database and divided them into development (2,522 patients) and validation cohorts (1,681 patients). Univariate and multivariate Cox proportional hazards models were performed. Variables that independently predicted outcomes (age, African American race, recipient body mass index [BMI], intravenous [IV] antibiotic use, pretransplant dialysis, and total bilirubin) were assigned weight using linear transformation, and risk scores were derived. Patients were grouped by predicted posttransplant mortality: low risk (≤ 38 points), medium risk (38-41 points), and high risk (≥ 42 points). We performed Cox proportional hazards analysis on wait-listed CF-LVAD patients who were not transplanted. Score significantly discriminated survival among the groups in the development cohort (6.7, 12.9, 20.7; p = 0.001), validation cohort (6.4, 10.1, 13.6; p < 0.001), and ambulatory cohort (6.4, 11.5, 17.2; p < 0.001). We derived a left ventricular assist device (LVAD) BTT risk score that effectively identifies CF-LVAD patients who are at higher risk for worse outcomes after heart transplant. This score may help physicians weigh the risks of transplantation in patients with CF-LVAD.

The role of cerebral hyperperfusion in postoperative neurologic dysfunction after left ventricular assist device implantation for end-stage heart failure.

PubMed

Lietz, Katherine; Brown, Kevin; Ali, Syed S; Colvin-Adams, Monica; Boyle, Andrew J; Anderson, David; Weinberg, Alan D; Miller, Leslie W; Park, Soon; John, Ranjit; Lazar, Ronald M

2009-04-01

Cerebral hyperperfusion is a life-threatening syndrome that can occur in patients with chronically hypoperfused cerebral vasculature whose normal cerebral circulation was re-established after carotid endarterectomy or angioplasty. We sought to determine whether the abrupt restoration of perfusion to the brain after left ventricular assist device (LVAD) implantation produced similar syndromes. We studied the role of increased systemic flow after LVAD implantation on neurologic dysfunction in 69 consecutive HeartMate XVE LVAD (Thoratec, Pleasanton, Calif) recipients from October 2001 through June 2006. Neurologic dysfunction was defined as postoperative permanent or transient central change in neurologic status, including confusion, focal neurologic deficits, visual changes, seizures, or coma for more than 24 hours within 30 days after LVAD implantation. We found that 19 (27.5%) patients had neurologic dysfunction, including encephalopathy (n = 11), coma (n = 3), and other complications (n = 5). The multivariate analysis showed that an increase in cardiac index from the preoperative baseline value (relative risk, 1.33 per 25% cardiac index increase; P = .01) and a previous coronary bypass operation (relative risk, 4.53; P = .02) were the only independent predictors of neurologic dysfunction. Reduction of left ventricular assist device flow in 16 of the 19 symptomatic patients led to improvement of symptoms in 14 (87%) patients. Our findings showed that normal flow might overwhelm cerebral autoregulation in patients with severe heart failure, suggesting that cerebral hyperperfusion is possible in recipients of mechanical circulatory support with neurologic dysfunction.

The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy.

PubMed

Pagani, Francis D; Aaronson, Keith D; Kormos, Robert; Mann, Douglas L; Spino, Cathie; Jeffries, Neal; Taddei-Peters, Wendy C; Mancini, Donna M; McNamara, Dennis M; Grady, Kathleen L; Gorcsan, John; Petrucci, Ralph; Anderson, Allen S; Glick, Henry A; Acker, Michael A; Eduardo Rame, J; Goldstein, Daniel J; Pamboukian, Salpy V; Miller, Marissa A; Timothy Baldwin, J

2016-11-01

The National Institutes of Health National Heart, Lung, and Blood Institute convened a working group in March 2008 to discuss how therapies for heart failure (HF) might be best advanced using clinical trials involving left ventricular assist devices (LVAD). This group opined that the field was ready for a trial to assess the use of long-term ventricular assist device therapy in patients who are less ill than patients currently eligible for destination therapy, which resulted in the Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) pilot study. The specific objective of REVIVE-IT was to compare LVAD therapy with optimal medical management in patients with less advanced HF than current LVAD indications to determine if wider application of permanent LVAD use to less ill patients would be associated with improved survival, quality of life, or functional capacity. REVIVE-IT represented an extraordinary effort to provide data from a randomized clinical trial to inform clinicians, scientists, industry, and regulatory agencies about the efficacy and safety of LVAD therapy in a population with less advanced HF. Despite significant support from the medical community, industry, and governmental agencies, REVIVE-IT failed to accomplish its goal. The reasons for its failure are instructive, and the lessons learned from the REVIVE-IT experience are likely to be relevant to any future study of LVAD therapy in a population with less advanced HF. Copyright © 2016 International Society for Heart and Lung Transplantation. All rights reserved.

Looking Back, Looking Forward: Understanding the Impact of Using an Assistive Technology Device (ATD)--Participatory Visual Methods

ERIC Educational Resources Information Center

Bartlett, Sue; Lorenz, Laura; Rankin, Theresa; Elias, Eileen; Mustafa, Ruman; Weider, Katie

2011-01-01

This article is the eighth of a multi-part series on traumatic brain injury (TBI). This is a continuation from part A of "Looking Back, Looking Forward," published in Exceptional Parent's February issue. Managing the cost of rehabilitation for a child, teenager or young adult who has incurred a TBI can be supported through the use of an Assistive…

Performance of a continuous flow ventricular assist device: magnetic bearing design, construction, and testing.

PubMed

Allaire, P; Hilton, E; Baloh, M; Maslen, E; Bearnson, G; Noh, D; Khanwilkar, P; Olsen, D

1998-06-01

A new centrifugal continuous flow ventricular assist device, the CFVAD III, which is fully magnetic bearing suspended, has been developed. It has only one moving part (the impeller), has no contact (magnetic suspension), is compact, and has minimal heating. A centrifugal impeller of 2 inch outer diameter is driven by a permanent magnet brushless DC motor. This paper discusses the design, construction, testing, and performance of the magnetic bearings in the unit. The magnetic suspension consists of an inlet side magnetic bearing and an outlet side magnetic bearing, each divided into 8 pole segments to control axial and radial displacements as well as angular displacements. The magnetic actuators are composed of several different materials to minimize size and weight while having sufficient load capacity to support the forces on the impeller. Flux levels in the range of 0.1 T are employed in the magnetic bearings. Self sensing electronic circuits (without physical sensors) are employed to determine the impellar position and provide the feedback control signal needed for the magnetic bearing control loops. The sensors provide position sensitivity of approximately 0.025 mm. A decentralized 5 axis controller has been developed using modal control techniques. Proportional integral derivative controls are used for each axis to levitate the magnetically supported impeller.

Computational design and in vitro characterization of an integrated maglev pump-oxygenator.

PubMed

Zhang, Juntao; Taskin, M Ertan; Koert, Andrew; Zhang, Tao; Gellman, Barry; Dasse, Kurt A; Gilbert, Richard J; Griffith, Bartley P; Wu, Zhongjun J

2009-10-01

For the need for respiratory support for patients with acute or chronic lung diseases to be addressed, a novel integrated maglev pump-oxygenator (IMPO) is being developed as a respiratory assist device. IMPO was conceptualized to combine a magnetically levitated pump/rotor with uniquely configured hollow fiber membranes to create an assembly-free, ultracompact system. IMPO is a self-contained blood pump and oxygenator assembly to enable rapid deployment for patients requiring respiratory support or circulatory support. In this study, computational fluid dynamics (CFD) and computer-aided design were conducted to design and optimize the hemodynamics, gas transfer, and hemocompatibility performances of this novel device. In parallel, in vitro experiments including hydrodynamic, gas transfer, and hemolysis measurements were conducted to evaluate the performance of IMPO. Computational results from CFD analysis were compared with experimental data collected from in vitro evaluation of the IMPO. The CFD simulation demonstrated a well-behaved and streamlined flow field in the main components of this device. The results of hydrodynamic performance, oxygen transfer, and hemolysis predicted by computational simulation, along with the in vitro experimental data, indicate that this pump-lung device can provide the total respiratory need of an adult with lung failure, with a low hemolysis rate at the targeted operating condition. These detailed CFD designs and analyses can provide valuable guidance for further optimization of this IMPO for long-term use.

Cross-cultural adaptation and validation of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): the development of the Taiwanese version.

PubMed

Mao, Hui-Fen; Chen, Wan-Yin; Yao, Grace; Huang, Sheau-Ling; Lin, Chia-Chi; Huang, Wen-Ni Wennie

2010-05-01

To develop and validate a cross-cultural version of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) for users of assistive technology devices in Taiwan. A cross-sectional survey. The standard cultural adaptation procedure was used for questionnaire translation and cultural item design. A field test was then conducted for item selection and psychometric properties testing. One hundred and five volunteer assistive device users in community. A questionnaire comprising 12 items of the QUEST 2.0 and 16 culture-specific items. One culture-specific item, 'Cost', was selected based on eight criteria and added to the QUEST 2.0 (12 items) to formulate the Taiwanese version of QUEST 2.0 (T-QUEST). The T-QUEST consisted of 13 items which were classified into two domains: device (8 items) and service (5 items). The internal consistencies of the device, service and total T-QUEST scores were 0.87, 0.84 and 0.90, respectively. The device, services and total T-QUEST scores achieved good test-retest stability (intraclass correlation coefficient (ICC) 0.90, 0.97, 0.95). Exploratory factor analysis revealed that T-QUEST had a two-factor structure for device and service in the construct of user satisfaction (53.42% of the variance explained). Users of assistive device in different culture may have different concerns regarding satisfaction. T-QUEST is the first published version of QUEST with culture-specific items added to the original translated items of QUEST 2.0. T-QUEST was a valid and reliable tool for measuring user satisfaction among Mandarin-speaking individuals using various kinds of assistive devices.

Recent trends in the development and evaluation of assistive robotic manipulation devices.

PubMed

Allin, Sonya; Eckel, Emily; Markham, Heather; Brewer, Bambi R

2010-02-01

This review explores recent trends in the development and evaluation of assistive robotic arms, both prosthetic and externally mounted. Evaluations have been organized according to the CATOR taxonomy of assistive device outcomes, which takes into consideration device effectiveness, social significance, and impact on subjective well-being. Questions that have informed the review include: (1) Are robotic arms being comprehensively evaluated along axes of the CATOR taxonomy? (2) Are definitions of effectiveness in accordance with the priorities of users? (3) What gaps in robotic arm evaluation exist, and how might these best be addressed? (4) What further advances can be expected in the next 15 years? Results highlight the need for increased standardization of evaluation methods, increased emphasis on the social significance (i.e., social cost) of devices, and increased emphasis on device impact on quality of life. Several open areas for future research, in terms of both device evaluation and device development, are also discussed.

Monitoring patients with continuous-flow ventricular assist devices outside of the intensive care unit: novel challenges to bedside nursing.

PubMed

O'Shea, Genevieve; Teuteberg, Jeffrey J; Severyn, Donald A

2013-03-01

Ventricular assist devices provide therapeutic options for patients with severe heart failure who have exhausted available medical therapies. With restoration of organ perfusion with ventricular assist devices, the heart failure resolves and quality of life and functional status improve. The current generation of continuous-flow devices present novel challenges to the clinical assessment of patients by substantially reducing or nearly eliminating any palpable pulse. Patients therefore generally have inadequate arterial pulsatility for most noninvasive monitoring devices such as pulse oximeters or automated blood pressure cuffs to work accurately. This article describes the function of continuous-flow devices and how this function affects common monitoring options, as well as how to clinically assess recipients of continuous-flow devices to promptly identify those whose condition may be deteriorating or who may be receiving inadequate perfusion.

Walking with robot assistance: the influence of body weight support on the trunk and pelvis kinematics.

PubMed

Swinnen, Eva; Baeyens, Jean-Pierre; Knaepen, Kristel; Michielsen, Marc; Hens, Gerrit; Clijsen, Ron; Goossens, Maggie; Buyl, Ronald; Meeusen, Romain; Kerckhofs, Eric

2015-05-01

The goal was to assess in healthy participants the three-dimensional kinematics of the pelvis and the trunk during robot-assisted treadmill walking (RATW) at 0%, 30% and 50% body weight support (BWS), compared with treadmill walking (TW). 18 healthy participants walked (2 kmph) on a treadmill with and without robot assistance (Lokomat; 60% guidance force; 0%, 30% and 50% BWS). After an acclimatisation period (four minutes), trunk and pelvis kinematics were registered in each condition (Polhemus Liberty [240 Hz]). The results were analysed using a repeated measures analysis of variance with Bonferroni correction, with the level of suspension as within-subject factor. During RATW with BWS, there were significantly (1) smaller antero-posterior and lateral translations of the trunk and the pelvis; (2) smaller antero-posterior flexion and axial rotation of the trunk; (3) larger lateral flexion of the trunk; and (4) larger antero-posterior tilting of the pelvis compared with TW. There are significant differences in trunk and pelvis kinematics in healthy persons during TW with and without robot assistance. These data are relevant in gait rehabilitation, relating to normal balance regulation. Additional research is recommended to further assess the influence of robot assistance on human gait. The trunk and pelvis moves in a different way during walking with robot assistance. The data suggest that the change in movement is due to the robot device and the harness of the suspension system more than due to the level of suspension itself.

Robotic Technology Efforts at the NASA/Johnson Space Center

NASA Technical Reports Server (NTRS)

Diftler, Ron

2017-01-01

The NASA/Johnson Space Center has been developing robotic systems in support of space exploration for more than two decades. The goal of the Center’s Robotic Systems Technology Branch is to design and build hardware and software to assist astronauts in performing their mission. These systems include: rovers, humanoid robots, inspection devices and wearable robotics. Inspection systems provide external views of space vehicles to search for surface damage and also maneuver inside restricted areas to verify proper connections. New concepts in human and robotic rovers offer solutions for navigating difficult terrain expected in future planetary missions. An important objective for humanoid robots is to relieve the crew of “dull, dirty or dangerous” tasks allowing them more time to perform their important science and exploration missions. Wearable robotics one of the Center’s newest development areas can provide crew with low mass exercise capability and also augment an astronaut’s strength while wearing a space suit.This presentation will describe the robotic technology and prototypes developed at the Johnson Space Center that are the basis for future flight systems. An overview of inspection robots will show their operation on the ground and in-orbit. Rovers with independent wheel modules, crab steering, and active suspension are able to climb over large obstacles, and nimbly maneuver around others. Humanoid robots, including the First Humanoid Robot in Space: Robonaut 2, demonstrate capabilities that will lead to robotic caretakers for human habitats in space, and on Mars. The Center’s Wearable Robotics Lab supports work in assistive and sensing devices, including exoskeletons, force measuring shoes, and grasp assist gloves.

Robotic Technology Efforts at the NASA/Johnson Space Center

NASA Technical Reports Server (NTRS)

Diftler, Ron

2017-01-01

The NASA/Johnson Space Center has been developing robotic systems in support of space exploration for more than two decades. The goal of the Center's Robotic Systems Technology Branch is to design and build hardware and software to assist astronauts in performing their mission. These systems include: rovers, humanoid robots, inspection devices and wearable robotics. Inspection systems provide external views of space vehicles to search for surface damage and also maneuver inside restricted areas to verify proper connections. New concepts in human and robotic rovers offer solutions for navigating difficult terrain expected in future planetary missions. An important objective for humanoid robots is to relieve the crew of "dull, dirty or dangerous" tasks allowing them more time to perform their important science and exploration missions. Wearable robotics one of the Center's newest development areas can provide crew with low mass exercise capability and also augment an astronaut's strength while wearing a space suit. This presentation will describe the robotic technology and prototypes developed at the Johnson Space Center that are the basis for future flight systems. An overview of inspection robots will show their operation on the ground and in-orbit. Rovers with independent wheel modules, crab steering, and active suspension are able to climb over large obstacles, and nimbly maneuver around others. Humanoid robots, including the First Humanoid Robot in Space: Robonaut 2, demonstrate capabilities that will lead to robotic caretakers for human habitats in space, and on Mars. The Center's Wearable Robotics Lab supports work in assistive and sensing devices, including exoskeletons, force measuring shoes, and grasp assist gloves.

Steroid therapy attenuates acute phase reactant response among children on ventricular assist device support.

PubMed

Byrnes, Jonathan W; Bhutta, Adnan T; Rettiganti, Mallikarjuna Rao; Gomez, Alberto; Garcia, Xiomara; Dyamenahalli, Umesh; Johnson, Charles; Jaquiss, Robert D B; Imamura, Michiaki; Prodhan, Parthak

2015-04-01

Hyperfibrinogenemia, which can create a procoagulant milieu, is frequently observed in patients supported with the Berlin EXCOR (Berlin Heart GmbH, Berlin, Germany) ventricular assist device (VAD). We began initiating corticosteroids in patients with systemic inflammatory response syndrome (SIRS) episodes to mitigate hyperfibrinogenemia. We set forth to describe the impact of corticosteroids on the hyperfibrinogenemic state in our institutional experience. Retrospective data was collected on 44 consecutive patients implanted with the Berlin EXCOR VAD from April 15, 2005 through May 6, 2013. Pertinent information was abstracted from the electronic medical record. The reduction of C-reactive protein (CRP) and fibrinogen levels among days from corticosteroid treatment were described. Infections and insulin use were reported based on whether patients received steroids and if steroids were given for SIRS. Over the initial 44 Berlin EXCOR VAD implantations, 14 patients were treated with 21 courses of corticosteroids for SIRS episodes as identified by clinical features and rise in CRP. Treatment with corticosteroids reduced fibrinogen levels by day 2 to a statistically significant degree (p = 0.008). No difference in hyperglycemia or infections occurred among patients receiving corticosteroids for SIRS. Treatment with corticosteroids can potentially mitigate the SIRS response among children supported on the Berlin EXCOR VAD. In patients who received corticosteroids to mitigate inflammation, there was no increase in infections or hyperglycemia requiring insulin administration compared with patients who did not receive steroids. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Experimental Validation of Motor Primitive-Based Control for Leg Exoskeletons during Continuous Multi-Locomotion Tasks

PubMed Central

Ruiz Garate, Virginia; Parri, Andrea; Yan, Tingfang; Munih, Marko; Molino Lova, Raffaele; Vitiello, Nicola; Ronsse, Renaud

2017-01-01

An emerging approach to design locomotion assistive devices deals with reproducing desirable biological principles of human locomotion. In this paper, we present a bio-inspired controller for locomotion assistive devices based on the concept of motor primitives. The weighted combination of artificial primitives results in a set of virtual muscle stimulations. These stimulations then activate a virtual musculoskeletal model producing reference assistive torque profiles for different locomotion tasks (i.e., walking, ascending stairs, and descending stairs). The paper reports the validation of the controller through a set of experiments conducted with healthy participants. The proposed controller was tested for the first time with a unilateral leg exoskeleton assisting hip, knee, and ankle joints by delivering a fraction of the computed reference torques. Importantly, subjects performed a track involving ground-level walking, ascending stairs, and descending stairs and several transitions between these tasks. These experiments highlighted the capability of the controller to provide relevant assistive torques and to effectively handle transitions between the tasks. Subjects displayed a natural interaction with the device. Moreover, they significantly decreased the time needed to complete the track when the assistance was provided, as compared to wearing the device with no assistance. PMID:28367121

Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

PubMed

Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

2016-04-01

The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662 patients will be enrolled to reach a total of 1,028 patients for evaluation of the secondary end-point of pump replacement at 2 years. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Mobile Learning as Alternative to Assistive Technology Devices for Special Needs Students

ERIC Educational Resources Information Center

Ismaili, Jalal; Ibrahimi, El Houcine Ouazzani

2017-01-01

Assistive Technology (AT) revolutionized the process of learning for special needs students during the past three decades. Thanks to this technology, accessibility and educational inclusion became attainable more than any time in the history of special education. Meanwhile, assistive technology devices remain unreachable for a large number of…

Rehabilitation robotics for the upper extremity: review with new directions for orthopaedic disorders.

PubMed

Hakim, Renée M; Tunis, Brandon G; Ross, Michael D

2017-11-01

The focus of research using technological innovations such as robotic devices has been on interventions to improve upper extremity function in neurologic populations, particularly patients with stroke. There is a growing body of evidence describing rehabilitation programs using various types of supportive/assistive and/or resistive robotic and virtual reality-enhanced devices to improve outcomes for patients with neurologic disorders. The most promising approaches are task-oriented, based on current concepts of motor control/learning and practice-induced neuroplasticity. Based on this evidence, we describe application and feasibility of virtual reality-enhanced robotics integrated with current concepts in orthopaedic rehabilitation shifting from an impairment-based focus to inclusion of more intense, task-specific training for patients with upper extremity disorders, specifically emphasizing the wrist and hand. The purpose of this paper is to describe virtual reality-enhanced rehabilitation robotic devices, review evidence of application in patients with upper extremity deficits related to neurologic disorders, and suggest how this technology and task-oriented rehabilitation approach can also benefit patients with orthopaedic disorders of the wrist and hand. We will also discuss areas for further research and development using a task-oriented approach and a commercially available haptic robotic device to focus on training of grasp and manipulation tasks. Implications for Rehabilitation There is a growing body of evidence describing rehabilitation programs using various types of supportive/assistive and/or resistive robotic and virtual reality-enhanced devices to improve outcomes for patients with neurologic disorders. The most promising approaches using rehabilitation robotics are task-oriented, based on current concepts of motor control/learning and practice-induced neuroplasticity. Based on the evidence in neurologic populations, virtual reality-enhanced robotics may be integrated with current concepts in orthopaedic rehabilitation shifting from an impairment-based focus to inclusion of more intense, task-specific training for patients with UE disorders, specifically emphasizing the wrist and hand. Clinical application of a task-oriented approach may be accomplished using commercially available haptic robotic device to focus on training of grasp and manipulation tasks.

Motivations for Participation in an Online Social Media Community for Diabetes.

PubMed

White, Katherine; Gebremariam, Achamyeleh; Lewis, Dana; Nordgren, Weston; Wedding, James; Pasek, Josh; Garrity, Ashley; Hirschfeld, Emily; Lee, Joyce M

2018-05-01

Our objectives were to describe individuals' motivations for participation in an online social media community and to assess their level of trust in medical information provided by medical professionals and community members. A purposive survey was delivered to participants recruited through posts on the CGM in the Cloud group, Twitter, and blogs. Individuals were asked a series of demographic and social media use questions. A total of 1268 members of the CGM in the Cloud community responded to the survey. The majority were non-Hispanic White (92.1%) and caregivers of an individual with diabetes (80.9%). Mean age was 41 years old, and 74.8% were female. Primary goals of the Facebook group were to learn more about Nightscout technology and to receive technological assistance. Individuals provided assistance to the community through spreading awareness, technical assistance, support, and donation. Respondents put a high level of trust in their peers versus health professionals in many health situations with nearly 40% of individuals reported to be helped by following advice found in the Facebook group, and 99% reported no harm. Our findings suggest that patients with diabetes and their caregivers use social media for many health-related purposes including medical recommendations and technical support for medical devices and systems as well as emotional support.

Utilising three-dimensional printing techniques when providing unique assistive devices: A case report.

PubMed

Day, Sarah Jane; Riley, Shaun Patrick

2018-02-01

The evolution of three-dimensional printing into prosthetics has opened conversations about the availability and cost of prostheses. This report will discuss how a prosthetic team incorporated additive manufacture techniques into the treatment of a patient with a partial hand amputation to create and test a unique assistive device which he could use to hold his French horn. Case description and methods: Using a process of shape capture, photogrammetry, computer-aided design and finite element analysis, a suitable assistive device was designed and tested. The design was fabricated using three-dimensional printing. Patient satisfaction was measured using a Pugh's Matrix™, and a cost comparison was made between the process used and traditional manufacturing. Findings and outcomes: Patient satisfaction was high. The three-dimensional printed devices were 56% cheaper to fabricate than a similar laminated device. Computer-aided design and three-dimensional printing proved to be an effective method for designing, testing and fabricating a unique assistive device. Clinical relevance CAD and 3D printing techniques can enable devices to be designed, tested and fabricated cheaper than when using traditional techniques. This may lead to improvements in quality and accessibility.

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

7 CFR 1430.310 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false Misrepresentation and scheme or device. 1430.310... Disaster Assistance Payment Program § 1430.310 Misrepresentation and scheme or device. (a) In addition to... assistance under this program if the producer is determined by FSA or CCC to have: (1) Adopted any scheme or...

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

7 CFR 1430.310 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false Misrepresentation and scheme or device. 1430.310... Disaster Assistance Payment Program § 1430.310 Misrepresentation and scheme or device. (a) In addition to... assistance under this program if the producer is determined by FSA or CCC to have: (1) Adopted any scheme or...

7 CFR 1430.310 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false Misrepresentation and scheme or device. 1430.310... Disaster Assistance Payment Program § 1430.310 Misrepresentation and scheme or device. (a) In addition to... assistance under this program if the producer is determined by FSA or CCC to have: (1) Adopted any scheme or...

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

7 CFR 1430.310 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false Misrepresentation and scheme or device. 1430.310... Disaster Assistance Payment Program § 1430.310 Misrepresentation and scheme or device. (a) In addition to... assistance under this program if the producer is determined by FSA or CCC to have: (1) Adopted any scheme or...

7 CFR 1430.310 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false Misrepresentation and scheme or device. 1430.310... Disaster Assistance Payment Program § 1430.310 Misrepresentation and scheme or device. (a) In addition to... assistance under this program if the producer is determined by FSA or CCC to have: (1) Adopted any scheme or...

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

Worldwide Experience with the Syncardia Total Artificial Heart in the Pediatric Population.

PubMed

Morales, David L S; Lorts, Angela; Rizwan, Raheel; Zafar, Farhan; Arabia, Francisco A; Villa, Chet R

Individual centers have documented the use of the Syncardia Total Artificial Heart (TAH) in adolescents with heart failure; however, the number of patients at any given center is small. Herein, we describe the worldwide experience for all patients ≤21 years old supported with the TAH between May 2005 and May 2015 (n = 43). The number of patients experiencing a positive outcome at 60, 90, and 120 days were 30 (70%), 27 (63%), and 25 (58%), respectively. Successful bridge to transplantation varied by diagnosis, but outcomes reported are similar to adults supported with the TAH or biventricular assist devices.

Impella 5.0 as a Second-Line Mechanical Circulatory Support Strategy After Extracorporeal Life Support.

PubMed

Schibilsky, David; Kruger, Tobias; Lausberg, Henning F; Eisenlohr, Christoph; Haller, Christoph; Nemeth, Attila; Schibilsky, Barbara; Haeberle, Helene; Rosenberger, Peter; Walker, Tobias; Schlensak, Christian

2016-09-01

The catheter-based Impella 5.0 left ventricular assist device is a powerful and less invasive alternative for patients in cardiogenic shock. The use as second-line therapy in patients with precedent extracorporeal life support (ECLS) has not been described before now. We analyzed our experience of consecutive patients treated with this alternative strategy. From April 2014 to December 2014, eight patients had been implanted as a second-line option after ECLS support. The reason for the change from ECLS to Impella 5.0 was absence of cardiac recovery for primary weaning and complications of ECLS therapy. The mean time of ECLS support prior to Impella implantation was 12 ± 7 days. The implantation of the Impella 5.0/CP was technically successful in all patients, and the ECLS could be explanted in all eight patients who received Impella implantation as a second-line treatment. The second-line Impella 5.0 therapy resulted in two patients who turned into left ventricular assist device (LVAD) candidates, two primary weaning candidates, and four patients who died in the setting of sepsis or absent cardiac recovery and contraindications for durable LVAD therapy. Thereby, the overall hospital discharge survival as well as the 180-day survival was 50% for Impella 5.0 implantations as second-line procedure after ECLS. The latest follow-up survival of this second-line strategy after ECLS was three out of eight, as one patient died after 299 days of LVAD support due to sepsis. The use of Impella 5.0 constitutes a possible second-line therapeutic option for those patients who do not show cardiac recovery during prolonged ECLS support or suffer from complications of ECLS therapy. This treatment allows additional time for decisions regarding cardiac recovery or indication for durable LVAD therapy. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Advantages and disadvantages of using intravenous tissue Plasminogen activator as salvage therapy for inoperable HeartWare thrombosis.

PubMed

Basken, Robyn; Bazzell, Charles M; Smith, Richard; Janardhanan, Rajesh; Khalpey, Zain

2017-07-01

Device thrombosis is a devastating complication of left ventricular assist devices. The definitive treatment has been device exchange or explant. Evidence of increasing morbidity and mortality with device exchange has shifted strategies toward conservative management. In this report, we detail the use of thrombolytics as salvage therapy in a patient with an occlusive HeartWare ventricular assist device (HeartWare Inc., Framingham, MA) thrombus, resulting in long-term survival without further intervention. © 2017 Wiley Periodicals, Inc.

Development of an implantable ventricular assist system.

PubMed

Macris, M P; Parnis, S M; Frazier, O H; Fuqua, J M; Jarvik, R K

1997-02-01

This study describes the present state of progress in the development of the Jarvik 2000 ventricular assist system. Designed for implantation in the human thorax, the system consists of a small (25 cm3, 90 g) intraventricular axial-flow blood pump that transmits power and data via internal electronics and a transcutaneous energy transfer system. The pump is powered by portable internal and external polymer lithium ion batteries. The only moving part, the pump rotor, contains a permanent magnet of a brushless direct-current motor that mounts an axial-flow impeller and partial magnetic thrust support, with blood-immersed radial and thrust bearings. The motor uses a redundant coil and electric lead design, which permits continued operation in case of wire breakage. Seven calves have been supported for an average of 107 days (range, 40 to 162 days) with prototypes of the Jarvik 2000 ventricular assist system. No physiologic complications have occurred. When its user is at rest, the pump produces flows of 5 to 6 L/min with a decreased arterial pulse contour. Renal and hepatic functions have remained normal throughout the duration of all studies. Mean plasma free hemoglobin levels ranged from 4.3 to 11.4 mg/dL (mean, 6.3 mg/dL) for each study. Pathologic analyses of the heart and kidneys revealed no damage related to the device. These studies indicate that the Jarvik 2000 ventricular assist system is feasible in animals and holds promise for long-term support of patients.

Cost-Benefit Performance Simulation of Robot-Assisted Thoracic Surgery As Required for Financial Viability under the 2016 Revised Reimbursement Paradigm of the Japanese National Health Insurance System.

PubMed

Kajiwara, Naohiro; Kato, Yasufumi; Hagiwara, Masaru; Kakihana, Masatoshi; Ohira, Tatsuo; Kawate, Norihiko; Ikeda, Norihiko

2018-04-20

To discuss the cost-benefit performance (CBP) and establish a medical fee system for robotic-assisted thoracic surgery (RATS) under the Japanese National Health Insurance System (JNHIS), which is a system not yet firmly established. All management steps for RATS are identical, such as preoperative and postoperative management. This study examines the CBP based on medical fees of RATS under the JNHIS introduced in 2016. Robotic-assisted laparoscopic prostatectomy (RALP) and robotic-assisted partial nephrectomy (RAPN) now receive insurance reimbursement under the category of use of support devices for endoscopic surgery ($5420 and $3485, respectively). If the same standard amount were to be applied to RATS, institutions would need to perform at least 150 or 300 procedures thoracic operation per year to show a positive CBP ($317 per procedure as same of RALP and $130 per procedure as same of RAPN, respectively). Robotic surgery in some areas receives insurance reimbursement for its "supportive" use for endoscopic surgery as for RALP and RAPN. However, at present, it is necessary to perform da Vinci Surgical System Si (dVSi) surgery at least 150-300 times in a year in a given institution to prevent a deficit in income.