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Sample records for resynchronization therapy devices

  1. Clinical management of a western lowland gorilla (Gorilla gorilla gorilla) with a cardiac resynchronization therapy device.

    PubMed

    Rush, Elizabeth Marie; Ogburn, Anna L; Monroe, Denise

    2011-06-01

    A 24-yr-old, male western lowland gorilla (Gorilla gorilla gorilla) was diagnosed with congestive heart failure using transesophageal and transthoracic echocardiology. New York Heart Association (NYHA) Class III was assigned to the severity of the condition. Over 16 mo, this progressed to NYHA Class IV despite increasing medical therapy. Repeated evaluations suggested that implantation of a cardiac resynchronization therapy device with a defibrillator (CRT-D) could benefit this animal based on clinical signs and underlying evidence of dyssynchrony and suspected fibrotic myocardial disease. Surgical implantation of leads into the right atrium, right ventricle, and left ventricle was accomplished. The CRT-D device was placed under the thoracic pectoral muscles during an initial surgical procedure. Improvement in the gorilla's clinical condition after implantation of the CRT-D device was immediate and dramatic. Subsequent scanning of the device was accomplished through operant conditioning. The data from these device interrogations included stored and real-time cardiac data, which were used to minimize recognized environmental stressors and change device settings. Over 4 yr, case management was critical to successful device use in treatment of the clinical disease. This involved medications, training for device interrogation, exercise to increase activity and improve body condition, and phlebotomy attempts. Dietary management was necessary to manipulate caloric and sodium intake and encourage medication compliance. Cardiac resynchronization therapy device implantation, although requiring specialized equipment and surgical skill, appears to be a viable option for treatment of fibrosing cardiomyopathy with systolic dysfunction in gorillas refractory to medical management. In addition to treatment, this device provides cardiovascular data at rest that could allow for early diagnosis and treatment of gorillas with this and other cardiac conditions in the future. This

  2. Optimization techniques in cardiac resynchronization therapy.

    PubMed

    Fischer, Avi

    2009-07-01

    Cardiac resynchronization therapy improves symptoms and cardiac function, as well as reduces mortality in patients with progressive congestive heart failure, reduced left ventricular ejection fraction and a left bundle branch block on the surface electrocardiogram. As many as 30% of patients fail to have an adequate response. The interplay between the atrioventricular delay and the contribution of a properly timed atrial contraction to ventricular filling along with a properly timed sequence of activation of the right and left ventricular is crucial to maximizing the benefits of cardiac resynchronization therapy devices.

  3. Cardiac Resynchronization Therapy Device Implantation in a Patient with Cardiogenic Shock under Percutaneous Mechanical Circulatory Support

    PubMed Central

    Lim, Kyunghee; Yang, Jeong Hoon; Park, Seung-Jung; Kim, Sun Hwa; Kang, Jiseok; Joh, Hyun Sung; Shin, Sun Hye

    2017-01-01

    65-year-old woman was admitted to our hospital with acute decompensated heart failure with reduced left ventricular ejection fraction and severe mitral regurgitation. Electrocardiography revealed a typical left bundle branch block and atrial fibrillation. Her condition deteriorated despite administering high-doses of inotropes and vasopressors. Pending a decision to therapy, venoarterial extracorporeal membrane oxygenation (ECMO) was performed when the patient underwent a cardiogenic shock. Although the hemodynamic status stabilized with ECMO support, weaning the patient from ECMO was not possible. Thus, we decided to perform cardiac resynchronization with defibrillator implantation as a “rescue” therapy. Five days post-implantation, the patient was successfully weaned from ECMO. PMID:28154601

  4. Septic Pulmonary Embolism Caused by Infected Pacemaker Leads After Replacement of a Cardiac Resynchronization Therapy Device

    PubMed Central

    Said, Salah A.M.; Nijhuis, Rogier; Derks, Anita; Droste, Herman

    2016-01-01

    Patient: Male, 70 Final Diagnosis: Pacemaker leads endocarditis Symptoms: Bacterial lead endocarditis • congestive heart failure • fever • pacemaker dysfunction Medication: — Clinical Procedure: Pacemaker box replacement due to end-of-service Specialty: Cardiology Objective: Unusual clinical course Background: Cardiac resynchronization therapy (CRT) has been demonstrated to reduce morbidity and mortality in patients with advanced, drug-refractory heart failure. Procedure-related mortality is less than 1% in larger studies. Approximately10% of CRT patients have to undergo surgical revision because of infections, dislocations, or unacceptable electrical behavior manifested as high threshold, unstable sensing, or unwanted phrenic nerve stimulation. Case Report: A 70-year-old man with symptomatic congestive heart failure underwent implantation of a biventricular pacemaker on the left anterior chest wall in 2003 and pulse generator exchange in August 2009. The patient responded well to CRT. At follow-up, the pacing system functioned normally. In September 2009, in the context of a predialysis program, an abdominal computed tomography (CT) scan was performed in another hospital for assessment and evaluation of chronic kidney disease. This procedure was complicated with peripheral thrombophlebitis that was managed appropriately with complete recovery. Eight months later (May 2010), the patient was admitted to our hospital with fever, anemia, and elevated infection parameters. During admission, blood cultures grew Staphylococcus epidermidis. The chest X-ray, lung perfusion scintigraphy, and CT scan depicted pulmonary embolism and infarction. The right ventricular lead threshold was found to be increased to 7 volts with unsuccessful capture. Echocardiography demonstrated vegetations on leads. The entire pacing system was explanted, but the patient expired few days later following percutaneous removal due to multiorgan failure. Conclusions: In heart failure

  5. Cardiac Resynchronization Therapy in Women.

    PubMed

    Costanzo, Maria Rosa

    2017-01-01

    The benefits of cardiac resynchronization therapy (CRT) on the outcomes of patients with heart failure are unquestionable. Women are under-represented in all CRT studies. Most of the available data show that CRT produces a greater clinical benefit in women than men. In several studies, women have left bundle branch block more frequently than men. Women have a remarkably high (90%) CRT response over a wide range of QRS lengths (130-175 milliseconds). Use of a QRS duration of 150 milliseconds as the threshold for CRT prescription may deny a life-saving therapy to many women likely to benefit from CRT.

  6. Cardiac Resynchronization Therapy in Women.

    PubMed

    Costanzo, Maria Rosa

    2015-12-01

    The benefits of cardiac resynchronization therapy (CRT) on the outcomes of patients with heart failure are unquestionable. Women are under-represented in all CRT studies. Most of the available data show that CRT produces a greater clinical benefit in women than men. In several studies, women have left bundle branch block more frequently than men. Women have a remarkably high (90%) CRT response over a wide range of QRS lengths (130-175 milliseconds). Use of a QRS duration of 150 milliseconds as the threshold for CRT prescription may deny a life-saving therapy to many women likely to benefit from CRT.

  7. Implementation study of an analog spiking neural network for assisting cardiac delay prediction in a cardiac resynchronization therapy device.

    PubMed

    Sun, Qing; Schwartz, François; Michel, Jacques; Herve, Yannick; Dalmolin, Renzo

    2011-06-01

    In this paper, we aim at developing an analog spiking neural network (SNN) for reinforcing the performance of conventional cardiac resynchronization therapy (CRT) devices (also called biventricular pacemakers). Targeting an alternative analog solution in 0.13- μm CMOS technology, this paper proposes an approach to improve cardiac delay predictions in every cardiac period in order to assist the CRT device to provide real-time optimal heartbeats. The primary analog SNN architecture is proposed and its implementation is studied to fulfill the requirement of very low energy consumption. By using the Hebbian learning and reinforcement learning algorithms, the intended adaptive CRT device works with different functional modes. The simulations of both learning algorithms have been carried out, and they were shown to demonstrate the global functionalities. To improve the realism of the system, we introduce various heart behavior models (with constant/variable heart rates) that allow pathologic simulations with/without noise on the signals of the input sensors. The simulations of the global system (pacemaker models coupled with heart models) have been investigated and used to validate the analog spiking neural network implementation.

  8. Surgical implantation of a cardiac resynchronization therapy device in a western lowland gorilla (Gorilla gorilla gorilla) with fibrosing cardiomyopathy.

    PubMed

    Rush, Elizabeth Marie; Ogburn, Anna L; Hall, Jeffrey; Rush, Dwain; Lau, Yung; Dillon, A R; Garmon, Linda; Tillson, D M; Kay, G Neal

    2010-09-01

    A 24-yr-old, male western lowland gorilla (Gorilla gorilla gorilla) was diagnosed in March of 2003 with congestive heart failure (CHF). Transesophageal and transthoracic echocardiography demonstrated global left and right ventricular hypokinesia with a left ventricular ejection fraction of 0.20. At the time of diagnosis, the animal exhibited symptoms and signs of CHF with minimal exertion (New York Heart Association class III). Over a 16-mo period, the severity of CHF progressed to class IV (resting signs and symptoms) despite angiotensin-converting enzyme inhibition, beta-blockers, and diuretics. Because of intractable CHF and a QRS duration that was markedly prolonged compared with the normal range for this species, a cardiac resynchronization therapy (CRT) device was implanted using implantation techniques based on human surgical procedures. Placement of the right ventricular, right atrial, and left ventricular leads and pulse generator were accomplished in 5.5 hr. Telemetry of the device postoperatively via wand or remote radio frequency has allowed for noninvasive programming and interrogation. The clinical improvement in CHF with this therapy was immediate and dramatic for this animal. Six months after CRT device implantation, the device leads became dislodged during an altercation with another gorilla, with the rapid development of CHF upon cessation of biventricular pacing. A second procedure to replace the leads returned the gorilla to his previous level of activity. In 2007, the pulse generator was electively replaced for battery depletion with a device capable of remote radiofrequency programming and interrogation. CRT implantation, although requiring specialized equipment and surgical skill, appears to be a viable option for treatment of dilated cardiomyopathy in gorillas.

  9. Biventricular Pacing (Cardiac Resynchronization Therapy)

    PubMed Central

    2005-01-01

    Executive Summary Issue In 2002, (before the establishment of the Ontario Health Technology Advisory Committee), the Medical Advisory Secretariat conducted a health technology policy assessment on biventricular (BiV) pacing, also called cardiac resynchronization therapy (CRT). The goal of treatment with BiV pacing is to improve cardiac output for people in heart failure (HF) with conduction defect on ECG (wide QRS interval) by synchronizing ventricular contraction. The Medical Advisory Secretariat concluded that there was evidence of short (6 months) and longer-term (12 months) effectiveness in terms of cardiac function and quality of life (QoL). More recently, a hospital submitted an application to the Ontario Health Technology Advisory Committee to review CRT, and the Medical Advisory Secretariat subsequently updated its health technology assessment. Background Chronic HF results from any structural or functional cardiac disorder that impairs the ability of the heart to act as a pump. It is estimated that 1% to 5% of the general population (all ages) in Europe have chronic HF. (1;2) About one-half of the patients with HF are women, and about 40% of men and 60% of women with this condition are aged older than 75 years. The incidence (i.e., the number of new cases in a specified period) of chronic HF is age dependent: from 1 to 5 per 1,000 people each year in the total population, to as high as 30 to 40 per 1,000 people each year in those aged 75 years and older. Hence, in an aging society, the prevalence (i.e., the number of people with a given disease or condition at any time) of HF is increasing, despite a reduction in cardiovascular mortality. A recent study revealed 28,702 patients were hospitalized for first-time HF in Ontario between April 1994 and March 1997. (3) Women comprised 51% of the cohort. Eighty-five percent were aged 65 years or older, and 58% were aged 75 years or older. Patients with chronic HF experience shortness of breath, a limited capacity

  10. European cardiac resynchronization therapy survey II: rationale and design.

    PubMed

    Dickstein, Kenneth; Normand, Camilla; Anker, Stefan D; Auricchio, Angelo; Blomström, Carina Lundqvist; Lundqvist, Carina Blomström; Bogale, Nigussie; Cleland, John; Filippatos, Gerasimos; Gasparini, Maurizio; Gitt, Anselm; Hindricks, Gerhard; Kuck, Karl-Heinz; Ponikowski, Piotr; Stellbrink, Christoph; Ruschitzka, Frank; Linde, Cecilia

    2015-01-01

    The Cardiac Resynchronization Therapy (CRT) Survey II is a 6 months snapshot survey initiated by two ESC Associations, the European Heart Rhythm Association and the Heart Failure Association, which is designed to describe clinical practice regarding implantation of CRT devices in a broad sample of hospitals in 47 ESC member countries. The large volume of clinical and demographic data collected should reflect current patient selection, implantation, and follow-up practice and provide information relevant for assessing healthcare resource utilization in connection with CRT. The findings of this survey should permit representative benchmarking both nationally and internationally across Europe.

  11. Device-measured physical activity versus six-minute walk test as a predictor of reverse remodeling and outcome after cardiac resynchronization therapy for heart failure.

    PubMed

    Vegh, Eszter Maria; Kandala, Jagdesh; Orencole, Mary; Upadhyay, Gaurav A; Sharma, Ajay; Miller, Alexandra; Merkely, Bela; Parks, Kimberly A; Singh, Jagmeet P

    2014-05-01

    Implanted devices can provide objective assessment of physical activity over prolonged periods. The purpose of this study was to investigate the prognostic value of device-measured physical activity data compared with a six-minute walk test (6MWT) in predicting clinical response to cardiac resynchronization therapy (CRT). This was a single-center study in which patients who underwent CRT for standard indications were evaluated. Daily physical activity and 6MWT were evaluated postimplant at 1, 3, and 6 months. The primary end point was a composite of heart failure hospitalization, transplant, left ventricular (LV) assist device, and all-cause death at 3 years. Echocardiographic response, defined as a ≥10% improvement in LV ejection fraction (LVEF), at 6 months was the secondary end point. About 164 patients were included: average age was 67.3 ± 12.9 years, 77% were men, baseline LVEF was 25% ± 7%. Kaplan-Meier curves showed superior freedom from the composite end point in the highest tertile of both 6MWT and physical activity compared with the lowest tertile (41 vs 23 cases, respectively, p <0.001) for 6MWT and for activity (22 vs 7 cases, respectively, p = 0.001). In an adjusted multivariate model, independent predictors of improved clinical outcome included 1-month physical activity (hazard ratio 0.546, 95% confidence interval [CI] 0.361 to 0.824, p = 0.004) and 6MWT (hazard ratio 0.581, 95% CI 0.425 to 0.795, p = 0.001). An additional hour of higher activity at 1 month translated to a 1.38 times (95% CI 1.075 to 1.753, p = 0.011) higher likelihood of improved echocardiographic response. In conclusion, device-based measures of physical activity may be useful in predicting echocardiographic reverse remodeling and long-term clinical outcome in patients receiving CRT.

  12. Cardiac resynchronization therapy in a patient with amyloid cardiomyopathy.

    PubMed

    Zizek, David; Cvijić, Marta; Zupan, Igor

    2013-06-01

    Cardiac involvement in systemic light chain amyloidosis carries poor prognosis. Amyloid deposition in the myocardium can alter regional left ventricular contraction and cause dyssynchrony. Cardiac resynchronization therapy (CRT) is an effective treatment strategy for patients with advanced heart failure and echocardiographic dyssynchrony. We report a clinical and echocardiographic response of a patient with amyloid cardiomyopathy, treated with a combination of chemotherapy and CRT.

  13. Interventional electrophysiology and cardiac resynchronization therapy: delivering electrical therapies for heart failure.

    PubMed

    Burkhardt, J David; Wilkoff, Bruce L

    2007-04-24

    Implantable devices have become a readily available option for patients with heart failure. Not only do these patients develop bradycardia and ventricular tachycardia, but their ventricular dysfunction can often improve with cardiac resynchronization therapy. However, this is a complex and rapidly developing clinical science for which the physician chooses techniques and selects patients on the basis of the results of clinical trials, clinical experience, and rapidly evolving tools. The results depend on the interplay of these complex variables. Placement of the left ventricular lead has forced the device physician to develop new skills and/or interdisciplinary relationships with physicians with vascular intervention, imaging, and surgical skills. Familiarity with the cardiac venous anatomy, occlusive venography, venoplasty, guide wire tools, guiding catheters, stenting, and new intracardiac visualization and magnetic intracardiac lead positioning tools are examples of just a few of the novel skills that are useful in the delivery of cardiac resynchronization therapy. Beyond implantation, these patients and devices require specialized follow-up with continued medical therapy and echo-guided adjustments of device programming. Finally, there are ongoing controversies and many as yet unanswered questions that are the subject of ongoing and planned clinical trials.

  14. Cardiac Resynchronization Therapy Leads to Improvements in Handgrip Strength

    PubMed Central

    Warriner, David R.; Lawford, Patricia; Sheridan, Paul J.

    2016-01-01

    Background A reduction in skeletal muscle performance measured by handgrip strength is common in heart failure. No trial has investigated the role of cardiac resynchronization therapy, which leads to improvements in cardiac performance, on the function of skeletal muscle in patients with heart failure. Methods Nineteen patients were recruited, 18 male, age 69 ± 8 years, New York Heart Association class II-IV, QRS duration 173 ± 21 ms and left ventricular ejection fraction 26±8%. Handgrip strength was measured at baseline before, and 6 and 12 months, following cardiac resynchronization therapy. Response was assessed using quality of life questionnaire, 6-minute walk distance, left ventricular end-diastolic volume, and cardiopulmonary exercise testing at the same time points. Results Fourteen patients were identified as responders, demonstrating significant improvements in all four markers of response. There was no significant difference at baseline in left or right handgrip strength between responders and non-responders. Compared to baseline, handgrip strength significantly increased in responders during follow-up, left (34.4 ± 11.4 to 40.3 ± 11.3 kgf, P < 0.001) and right (35.7 ± 12.5 to 42.2 ± 11.5 kgf, P < 0.001) at 12 months. No such improvement was seen in non-responders. Conclusions This study demonstrates that positive response to cardiac resynchronization therapy is associated with significant gains in handgrip strength, suggesting that cardiac resynchronization therapy may indirectly lead to secondary gains in skeletal muscle function. PMID:28197275

  15. Cardiac resynchronization therapy: a potential option for congenitally corrected transposition of the great vessels.

    PubMed

    Krishnan, Kousik; Avramovitch, Naomi A; Kim, Michael H; Trohman, Richard G

    2005-12-01

    The use of cardiac resynchronization therapy in patients with QRS prolongation (left-sided interventricular conduction delay) and symptomatic (New York Heart Association class III and IV) heart failure despite optimal medical therapy is well established. This case report describes the use of cardiac resynchronization therapy to treat symptomatic congestive heart failure in 2 patients with congenitally corrected transposition of the great vessels.

  16. Living with cardiac resynchronization therapy: Challenges for people with heart failure.

    PubMed

    Dehghanzadeh, Shadi; Dehghan Nayeri, Nahid; Varaei, Shokoh; Kheirkhah, Jalal

    2017-03-01

    The number of people with heart failure requiring implantation of a cardiac resynchronization device is increasing in Iran. Although this intervention is an effective life-saving treatment, several challenges are associated with patients' lifestyle after insertion. This study identified the challenges and coping mechanisms of Iranians with heart failure living with cardiac resynchronization therapy. A qualitative approach using conventional content analysis was adopted. Seventeen people with heart failure and three nurses were recruited between December 2014 and November 2015 from a teaching hospital and a private clinic in Rasht, Iran. Participants were interviewed using semi-structured interviews lasting 30-60 min. Five themes emerged: (i) fear of implantation, (ii) the panic of receiving a shock from the device, (iii) lack of control over life, (iv) inadequacies of the healthcare system, and (v) psychosocial coping. A heightened understanding of these challenges and coping strategies could prepare healthcare professionals to provide better routine care, education, and support to the recipients of cardiac resynchronization therapy prior to implantation, during the recovery period, and for long-term management.

  17. The Role of Atrioventricular and Interventricular Optimization for Cardiac Resynchronization Therapy.

    PubMed

    Cobb, Daniel B; Gold, Michael R

    2015-12-01

    Many patients with left ventricular systolic dysfunction may benefit from cardiac resynchronization therapy; however, approximately 30% of patients do not experience significant clinical improvement with this treatment. AV and VV delay optimization techniques have included echocardiography, device-based algorithms, and several other novel noninvasive techniques. Using these techniques to optimize device settings has been shown to improve hemodynamic function acutely; however, the long-term clinical benefit is limited. In most cases, an empiric AV delay with simultaneous biventricular or left ventricular pacing is adequate. The value of optimization of these intervals in "nonresponders" still requires further investigation.

  18. Successful treatment of a cardiac resynchronization therapy nonresponder by identifying lead malpositioning

    PubMed Central

    Prasad, Karthik Venkatesh; Ferreira, Scott Wayne; Mehdirad, Ali Akbar

    2017-01-01

    This case describes some of the commonly overlooked device-related issues in patients who have reportedly failed to respond to cardiac resynchronization therapy (CRT). The case demonstrates voltage-dependent right ventricular capture instead of right atrial capture by a subtly malpositioned right atrial lead. CRT therapy failed to improve symptoms of heart failure and the diagnosis of “CRT nonresponder” was made. With a detailed fact-finding approach, the mechanism behind this nonresponse was identified, and the outcome of CRT was significantly improved with rectification of the problems.

  19. An integrated platform for image-guided cardiac resynchronization therapy

    NASA Astrophysics Data System (ADS)

    Ma, Ying Liang; Shetty, Anoop K.; Duckett, Simon; Etyngier, Patrick; Gijsbers, Geert; Bullens, Roland; Schaeffter, Tobias; Razavi, Reza; Rinaldi, Christopher A.; Rhode, Kawal S.

    2012-05-01

    Cardiac resynchronization therapy (CRT) is an effective procedure for patients with heart failure but 30% of patients do not respond. This may be due to sub-optimal placement of the left ventricular (LV) lead. It is hypothesized that the use of cardiac anatomy, myocardial scar distribution and dyssynchrony information, derived from cardiac magnetic resonance imaging (MRI), may improve outcome by guiding the physician for optimal LV lead positioning. Whole heart MR data can be processed to yield detailed anatomical models including the coronary veins. Cine MR data can be used to measure the motion of the LV to determine which regions are late-activating. Finally, delayed Gadolinium enhancement imaging can be used to detect regions of scarring. This paper presents a complete platform for the guidance of CRT using pre-procedural MR data combined with live x-ray fluoroscopy. The platform was used for 21 patients undergoing CRT in a standard catheterization laboratory. The patients underwent cardiac MRI prior to their procedure. For each patient, a MRI-derived cardiac model, showing the LV lead targets, was registered to x-ray fluoroscopy using multiple views of a catheter looped in the right atrium. Registration was maintained throughout the procedure by a combination of C-arm/x-ray table tracking and respiratory motion compensation. Validation of the registration between the three-dimensional (3D) roadmap and the 2D x-ray images was performed using balloon occlusion coronary venograms. A 2D registration error of 1.2 ± 0.7 mm was achieved. In addition, a novel navigation technique was developed, called Cardiac Unfold, where an entire cardiac chamber is unfolded from 3D to 2D along with all relevant anatomical and functional information and coupled to real-time device detection. This allowed more intuitive navigation as the entire 3D scene was displayed simultaneously on a 2D plot. The accuracy of the unfold navigation was assessed off-line using 13 patient data sets

  20. Disease management: remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors.

    PubMed

    Abraham, William T

    2013-06-01

    Heart failure represents a major public health concern, associated with high rates of morbidity and mortality. A particular focus of contemporary heart failure management is reduction of hospital admission and readmission rates. While optimal medical therapy favourably impacts the natural history of the disease, devices such as cardiac resynchronization therapy devices and implantable cardioverter defibrillators have added incremental value in improving heart failure outcomes. These devices also enable remote patient monitoring via device-based diagnostics. Device-based measurement of physiological parameters, such as intrathoracic impedance and heart rate variability, provide a means to assess risk of worsening heart failure and the possibility of future hospitalization. Beyond this capability, implantable haemodynamic monitors have the potential to direct day-to-day management of heart failure patients to significantly reduce hospitalization rates. The use of a pulmonary artery pressure measurement system has been shown to significantly reduce the risk of heart failure hospitalization in a large randomized controlled study, the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial. Observations from a pilot study also support the potential use of a left atrial pressure monitoring system and physician-directed patient self-management paradigm; these observations are under further investigation in the ongoing LAPTOP-HF trial. All these devices depend upon high-intensity remote monitoring for successful detection of parameter deviations and for directing and following therapy.

  1. Cardiac resynchronization therapy in congenital heart disease.

    PubMed

    Janoušek, Jan; Kubuš, Peter

    2016-06-01

    Cardiac resynchronization therapy (CRT) is an established treatment option for adult patients suffering heart failure due to idiopathic or ischemic cardiomyopathy associated with electromechanical dyssynchrony. There is limited evidence suggesting similar efficacy of CRT in patients with congenital heart disease (CHD). Due to the heterogeneity of structural and functional substrates, CRT implantation techniques are different with a thoracotomy or hybrid approach prevailing. Efficacy of CRT in CHD seems to depend on the anatomy of the systemic ventricle with best results achieved in systemic left ventricular patients upgraded to CRT from conventional pacing. Indications for CRT in patients with CHD were recently summarized in the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS) Expert Consensus Statement on the Recognition and Management of Arrhythmias in Adult Congenital Heart Disease and are presented in the text.

  2. What is treatment success in cardiac resynchronization therapy?

    PubMed Central

    Foley, Paul W.X.; Leyva, Francisco; Frenneaux, Michael P.

    2009-01-01

    Cardiac resynchronization therapy (CRT) is an established treatment for symptomatic patients with heart failure, a prolonged QRS duration, and impaired left ventricular (LV) function. Identification of ‘responders’ and ‘non-responders’ to CRT has attracted considerable attention. The response to CRT can be measured in terms of symptomatic response or clinical outcome, or both. Alternatively, the response to CRT can be measured in terms of changes in surrogate measures of outcome, such as LV volumes, LV ejection fraction, invasive measures of cardiac performance, peak oxygen uptake, and neurohormones. This review explores whether these measures can be used in assessing the symptomatic and prognostic response to CRT. The role of these parameters to the management of individual patients is also discussed. PMID:19861392

  3. The use of nuclear imaging for cardiac resynchronization therapy.

    PubMed

    Chen, Ji; Boogers, Mark J; Boogers, Mark M; Bax, Jeroen J; Soman, Prem; Garcia, Ernest V

    2010-03-01

    Cardiac resynchronization therapy (CRT) has shown benefits in patients with end-stage heart failure, depressed left ventricular (LV) ejection fraction (< or = 35%), and prolonged QRS duration (> or = 120 ms). However, based on the conventional criteria, 20% to 40% of patients fail to respond to CRT. Studies have focused on important parameters for predicting CRT response, such as LV dyssynchrony, scar burden, LV lead position, and site of latest activation. Phase analysis allows nuclear cardiology modalities, such as gated blood-pool imaging and gated myocardial perfusion single photon emission computed tomography (GMPS), to assess LV dyssynchrony. Most importantly, GMPS with phase analysis has the potential of assessing LV dyssynchrony, scar burden, and site of late activation from a single acquisition, so that this technique may provide a one-stop shop for predicting CRT response. This article provides a summary on the role of nuclear cardiology in selecting patients for CRT, with emphasis on GMPS with phase analysis.

  4. Interactive visualization for scar transmurality in cardiac resynchronization therapy

    NASA Astrophysics Data System (ADS)

    Reiml, Sabrina; Toth, Daniel; Panayiotou, Maria; Fahn, Bernhard; Karim, Rashed; Behar, Jonathan M.; Rinaldi, Christopher A.; Razavi, Reza; Rhode, Kawal S.; Brost, Alexander; Mountney, Peter

    2016-03-01

    Heart failure is a serious disease affecting about 23 million people worldwide. Cardiac resynchronization therapy is used to treat patients suffering from symptomatic heart failure. However, 30% to 50% of patients have limited clinical benefit. One of the main causes is suboptimal placement of the left ventricular lead. Pacing in areas of myocardial scar correlates with poor clinical outcomes. Therefore precise knowledge of the individual patient's scar characteristics is critical for delivering tailored treatments capable of improving response rates. Current research methods for scar assessment either map information to an alternative non-anatomical coordinate system or they use the image coordinate system but lose critical information about scar extent and scar distribution. This paper proposes two interactive methods for visualizing relevant scar information. A 2-D slice based approach with a scar mask overlaid on a 16 segment heart model and a 3-D layered mesh visualization which allows physicians to scroll through layers of scar from endocardium to epicardium. These complementary methods enable physicians to evaluate scar location and transmurality during planning and guidance. Six physicians evaluated the proposed system by identifying target regions for lead placement. With the proposed method more target regions could be identified.

  5. Is speckle tracking actually helpful for cardiac resynchronization therapy?

    PubMed

    Tanaka, Hidekazu; Hirata, Ken-Ichi

    2016-06-01

    What is the specific role of echocardiography in cardiac resynchronization therapy (CRT)? CRT has proven to be highly effective for improving symptoms and survival of patients with advanced heart failure (HF) and wide QRS. However, a significant minority of patients do not respond favorably to CRT on the basis of standard clinical selection criteria, including the electrocardiographic QRS width. Subsequently, echocardiographic assessment of left ventricular (LV) dyssynchrony has been considered useful for CRT for selected responders, but findings by multicenter studies suggest that its predictive value was not sufficiently robust to replace routine selection criteria for CRT. A more recent approach, however, using speckle-tracking echocardiography yields more accurate quantification of regional wall contraction. Speckle-tracking approaches have therefore generated a great deal of interest about their clinical applications for CRT. Although reports on speckle tracking have not been included in any recommendations as to whether patients should undergo CRT based on the current guidelines, speckle tracking can play an important supplementary part in CRT on the basis of a case-by-case clinical decision for challenging cases. Here, we review the strengths of speckle-tracking methods, and their current potential for clinical use in CRT.

  6. Understanding the timing cycles of a cardiac resynchronization device designed with left ventricular sensing.

    PubMed

    Barold, S Serge; Kucher, Andreas

    2014-10-01

    Some devices used for cardiac resynchronization therapy (CRT) can sense from the left ventricular (LV) lead as in Biotronik CRT devices (Biotronik GmbH, Berlin, Germany), whose special LV timing cycles form the basis of this report. LV sensing (LVs) was designed to prevent competitive pacing outside the LV myocardial absolute refractory period. LVs works by inhibiting the release of an LV pacemaker stimulus (LVp) in the vulnerable period of the LV during a programmable period. LVs with stored LV electrograms may also provide recordings of diagnostic value in tachyarrhythmias. LVs has added a new dimension to the evaluation of the function of CRT devices, because it is manifested by unfamiliar timing cycles. In this respect, Biotronik devices can initiate an LV upper rate interval (URI) upon sensing a right-sided event when LVs is turned off. An inhibited LVp can also initiate an LVURI. The LVURI should generally be programmed to a relatively short duration and shorter than the right ventricular URI to prevent a special form of desynchronization arrhythmia sustained by LVs. This arrhythmia is characterized by recurring delayed LVs events in sequences associated with RV pacing followed by LVs events with loss of LVp.

  7. Echocardiographic Predictors of Worse Outcome After Cardiac Resynchronization Therapy

    PubMed Central

    Rocha, Eduardo Arrais; Pereira, Francisca Tatiana Moreira; Abreu, José Sebastião; Lima, José Wellington O.; Monteiro, Marcelo de Paula M.; Rocha Neto, Almino Cavalcante; Quidute, Ana Rosa Pinto; Goés, Camilla Viana A.; Rodrigues Sobrinho, Carlos Roberto Martins; Scanavacca, Maurício Ibrahim

    2015-01-01

    Background Cardiac resynchronization therapy (CRT) is the recommended treatment by leading global guidelines. However, 30%-40% of selected patients are non-responders. Objective To develop an echocardiographic model to predict cardiac death or transplantation (Tx) 1 year after CRT. Method Observational, prospective study, with the inclusion of 116 patients, aged 64.89 ± 11.18 years, 69.8% male, 68,1% in NYHA FC III and 31,9% in FC IV, 71.55% with left bundle-branch block, and median ejection fraction (EF) of 29%. Evaluations were made in the pre-implantation period and 6-12 months after that, and correlated with cardiac mortality/Tx at the end of follow-up. Cox and logistic regression analyses were performed with ROC and Kaplan-Meier curves. The model was internally validated by bootstrapping. Results There were 29 (25%) deaths/Tx during follow-up of 34.09 ± 17.9 months. Cardiac mortality/Tx was 16.3%. In the multivariate Cox model, EF < 30%, grade III/IV diastolic dysfunction and grade III mitral regurgitation at 6-12 months were independently related to increased cardiac mortality or Tx, with hazard ratios of 3.1, 4.63 and 7.11, respectively. The area under the ROC curve was 0.78. Conclusion EF lower than 30%, severe diastolic dysfunction and severe mitral regurgitation indicate poor prognosis 1 year after CRT. The combination of two of those variables indicate the need for other treatment options. PMID:26351981

  8. QRS duration versus morphology and survival after cardiac resynchronization therapy

    PubMed Central

    Khidir, Mand J.H.; Ajmone Marsan, Nina; Schalij, Martin J.; Bax, Jeroen J.

    2016-01-01

    Abstract Aims The prognostic implications of QRS duration and morphology in heart failure patients treated with cardiac resynchronization therapy (CRT) remains debated. The present evaluation investigated the association between QRS duration (<150 vs. ≥150 ms) and QRS morphology (left bundle brand block [LBBB] vs. non‐LBBB) and long‐term prognosis of a large cohort of unselected heart failure patients treated with CRT according to contemporary guidelines. Methods and results Of 973 heart failure patients treated with CRT (mean age 66.1 ± 9.8 years, 76% male), 658 patients (68%) showed QRS duration ≥150 ms, and 772 patients (79%) had LBBB configuration. Compared with patients with QRS duration <150 ms, patients with QRS duration ≥150 ms had less frequently ischaemic cardiomyopathy and atrial fibrillation and showed larger left ventricular volumes and lower left ventricular ejection fraction. Compared with patients with non‐LBBB configuration, patients with LBBB morphology were younger, less often males and less often had ischaemic cardiomyopathy and atrial fibrillation. On multivariable analysis, after correcting for relevant clinical and echocardiographic variables, LBBB morphology was significantly associated with better survival [hazard ratio (HR) 0.737; 95% confidence interval (CI) 0.584–0.931; P = 0.010], whereas there was no statistically significant association between QRS duration ≥150 ms and survival (HR 0.889; 95% CI 0.726–1.088; P = 0.252). Conclusions In this large population of heart failure patients treated with CRT, QRS morphology was independently associated with long‐term survival. The association between QRS duration and long‐term survival was not statistically significant. PMID:28217309

  9. Cardiac resynchronization therapy and atrial overdrive pacing for the treatment of central sleep apnoea

    PubMed Central

    Lüthje, Lars; Renner, Bernd; Kessels, Roger; Vollmann, Dirk; Raupach, Tobias; Gerritse, Bart; Tasci, Selcuk; Schwab, Jörg O.; Zabel, Markus; Zenker, Dieter; Schott, Peter; Hasenfuss, Gerd; Unterberg-Buchwald, Christina; Andreas, Stefan

    2009-01-01

    Aims The combined therapeutic impact of atrial overdrive pacing (AOP) and cardiac resynchronization therapy (CRT) on central sleep apnoea (CSA) in chronic heart failure (CHF) so far has not been investigated. We aimed to evaluate the effect of CRT alone and CRT + AOP on CSA in CHF patients and to compare the influence of CRT on CHF between CSA positive and CSA negative patients. Methods and results Thirty patients with CRT indication underwent full night polysomnography, echocardiography, exercise testing, and neurohumoral evaluation before and 3 months after CRT implantation. In CSA positive patients (60%), two additional sleep studies were conducted after 3 months of CRT, with CRT alone or CRT + AOP, in random order. Cardiac resynchronization therapy resulted in significant improvements of NYHA class, left ventricular ejection fraction, N-terminal pro-brain natriuretic peptide, VO2max, and quality of life irrespective of the presence of CSA. Cardiac resynchronization therapy also reduced the central apnoea–hypopnoea index (AHI) (33.6 ± 14.3 vs. 23.8 ± 16.9 h−1; P < 0.01) and central apnoea index (17.3 ± 14.1 vs. 10.9 ± 13.9 h−1; P < 0.01) without altering sleep stages. Cardiac resynchronization therapy with atrial overdrive pacing resulted in a small but significant additional decrease of the central AHI (23.8 ± 16.9 vs. 21.5 ± 16.9 h−1; P < 0.01). Conclusion In this study, CRT significantly improved CSA without altering sleep stages. Cardiac resynchronization therapy with atrial overdrive pacing resulted in a significant but minor additional improvement of CSA. Positive effects of CRT were irrespective of the presence of CSA. PMID:19147446

  10. Multispecialty approach: the need for heart failure disease management for refining cardiac resynchronization therapy.

    PubMed

    Tang, W H Wilson; Boehmer, John; Gras, Daniel

    2012-08-01

    Cardiac resynchronization therapy (CRT) has been proven in clinical trials to be a very effective therapy in appropriate patients. However, although the literature has primarily focused on appropriate implanting techniques and inclusion criteria for CRT devices by electrophysiologists, most patients who receive CRT are managed by their primary care providers with the help of general cardiologists and/or heart failure (HF) specialists. As CRT has been more broadly applied over the past decade, the fragmentation and specialization of care in the current health care system have created challenges in optimizing this otherwise invasive but potentially beneficial intervention in the complex HF patient. Furthermore, cost considerations as well as appropriate follow-up care continue to challenge the optimal application of these devices, particularly when evidence to support multidisciplinary approaches is lacking. The challenge begins with identification of appropriate candidates for CRT, which is an evolving concept due to data emerging from new studies with a wide range of inclusion and exclusion criteria coupled with increasing oversight from providers or even logistical hurdles from patients. Postimplant management practices and procedures are still evolving. The important and so-far unresolved concept of the "nonresponder" to CRT remains largely subjective and is variably defined in the literature, and the lack of understanding of the underlying mechanisms of "nonresponse" continues to challenge long-term management of CRT, even given the recent developments in advanced sensor technologies. Therefore, further investigations into HF disease management with a multispecialty approach, pre-CRT and post-CRT, are warranted.

  11. Clinical Assessment of Intraventricular Blood Transport in Patients Undergoing Cardiac Resynchronization Therapy

    NASA Astrophysics Data System (ADS)

    Rossini, Lorenzo; Martinez-Legazpi, P.; Benito, Y.; Perez Del Villar, C.; Gonzalez-Mansilla, A.; Barrio, A.; Yotti, R.; Kahn, A. M.; Shadden, S. C.; Fernandez-Aviles, F.; Bermejo, J.; Del Alamo, J. C.

    2015-11-01

    In the healthy heart, left ventricular (LV) filling generates flow patterns which have been proposed to optimize blood transport by coupling diastole and systole phases. We present a novel image-based method to assess how flow patterns influence LV blood transport in patients undergoing cardiac resynchronization therapy (CRT). Solving the advection equation with time-varying inflow boundary conditions allows to track the transport of blood entering the LV in the different filling waves, as well as the transport barriers which couple filling and ejection. The velocity fields were obtained using echocardiographic color Doppler velocimetry, which provides two-dimensional time-resolved flow maps in the apical long axis three-chamber view of the LV. We analyze flow transport in a group of patients with CRT devices as well as in healthy volunteers. In the patients under CRT, the device programming was varied to analyze flow transport under different values of the atrioventricular (AV) conduction delay and to model tachycardia. This analysis illustrates how CRT influences the transit of blood inside the LV, contributes to conserving kinetic energy and favors the generation of hemodynamic forces that accelerate blood in the direction of the LV outflow tract.

  12. Effect of Cardiac Resynchronization Therapy on Inflammation in Congestive Heart Failure: A Review.

    PubMed

    Lappegård, K T; Bjørnstad, H; Mollnes, T E; Hovland, A

    2015-09-01

    Congestive heart failure is associated with increased levels of several inflammatory mediators, and animal studies have shown that infusion of a number of cytokines can induce heart failure. However, several drugs with proven efficacy in heart failure have failed to affect inflammatory mediators, and anti-inflammatory therapy in heart failure patients has thus far been disappointing. Hence, to what extent heart failure is caused by or responsible for the increased inflammatory burden in the patient is still unclear. Over the past couple of decades, resynchronization therapy with a biventricular pacemaker has emerged as an effective treatment in a subset of heart failure patients, reducing both morbidity and mortality. Such treatment has also been shown to affect the inflammation associated with heart failure. In this study, we review recent data on the association between heart failure and inflammation, and in particular how resynchronization therapy can affect the inflammatory process.

  13. Cardiac Resynchronization Therapy Defibrillator Treatment in a Child with Heart Failure and Ventricular Arrhythmia

    PubMed Central

    Kim, Hak Ju; Cho, Sungkyu; Kim, Woong-Han

    2016-01-01

    Cardiac resynchronization therapy (CRT) is a new treatment for refractory heart failure. However, most patients with heart failure treated with CRT are adults, middle-aged or older with idiopathic or ischemic dilated cardiomyopathy. We treated a 12-year-old boy, who was transferred after cardiac arrest, with dilated cardiomyopathy, left bundle-branch block, and ventricular tachycardia. We performed cardiac resynchronization therapy with a defibrillator (CRT-D). After CRT-D, left ventricular ejection fraction improved from 22% to 44% assessed by echocardiogram 1 year postoperatively. On electrocardiogram, QRS duration was shortened from 206 to 144 ms. The patient’s clinical symptoms also improved. For pediatric patients with refractory heart failure and ventricular arrhythmia, CRT-D could be indicated as an effective therapeutic option. PMID:27525239

  14. Cardiac resynchronization therapy improves the uptake of MIBI-99mTc and cardiac function.

    PubMed

    Brandão, Simone Cristina Soares; Giorgi, Maria Clementina; Nishioka, Silvana D'Orio; Martinelli Filho, Martino; Soares, José; Meneghetti, José Cláudio

    2008-09-01

    This case shows the improvement promoted by cardiac resynchronization therapy (CRT) on myocardial perfusion and left ventricular (LV) performance assessed by gated myocardial perfusion scintigraphy. The patient had idiopathic dilated cardiomyopathy, left bundle branch block and severe heart failure despite optimized medical treatment. After CRT, clinical improvement, QRS reduction and improvement of previously hypoperfused anterior and septal walls were observed. There was also decrease in LV end-diastolic and systolic volumes and increase in LV ejection fraction.

  15. Dramatic Response to Cardiac Resynchronization Therapy With AV Delay Optimization in Narrow QRS Heart Failure.

    PubMed

    Kogawa, Rikitake; Nakai, Toshiko; Ikeya, Yukitoshi; Mano, Hiroaki; Sonoda, Kazumasa; Sasaki, Naoko; Iso, Kazuki; Okumura, Yasuo; Ohkubo, Kimie; Kunimoto, Satoshi; Watanabe, Ichiro; Hirayama, Atsushi

    2015-01-01

    Cardiac resynchronization therapy (CRT) has been shown to be effective for heart failure. However, as outlined in the AHA/ACC/HRS Appropriate Use Criteria, CRT is not strongly recommended for patients with a narrow QRS complex. We describe a case of dilated cardiomyopathy and narrow QRS complex in which we obtained a dramatic response to CRT by optimizing the atrioventricular (AV) delay. The patient was a 61-year-old man with intractable heart failure. Echocardiography showed a low ejection fraction of 22% but no dyssynchrony. Because he had been hospitalized many times for congestive heart failure despite β-blocker and diuretic treatment, we decided to use CRT. However, after implantation of the CRT device, the QRS complex widened abnormally, and his symptoms worsened. He was re-admitted 2 months after CRT implantation. We examined the pacemaker status and optimized the AV delay to obtain a "narrow" QRS complex. The patient's condition improved dramatically after the AV delay optimization. His clinical status has been good, and there has been no subsequent hospitalization. Our case points to the effectiveness of CRT in patients with a narrow QRS complex and to the importance of AV optimization for successful CRT.

  16. Echocardiography and cardiac resynchronization therapy in children and patients with congenital heart disease.

    PubMed

    Mertens, L; Friedberg, M K

    2012-10-01

    Cardiac resynchronization therapy (CRT) has been shown to improve mortality and morbidity in adults with refractory heart failure and prolonged QRS-duration. Recent research data suggest that the therapeutic benefit is related to the effect of CRT on interventricular and intraventricular dyssynchrony associated with electrical dyssynchrony. However, around 30-40% of the patients do not respond to CRT when device implantation is based only on QRS-duration. It was hoped that improved description of mechanical dyssynchrony using imaging techniques, might result in improved identification of patients who could benefit from CRT. Different methods have been proposed but a recent multicenter prospective echocardiographic study (PROSPECT) was disappointing. Applying adult criteria for CRT treatment to children and adults with acquired and congenital heart disease is even more challenging due to the age-dependency of QRS-duration and the wide variety of underlying diseases including different ventricular morphology that can result in heart failure. In this review we will overview the adult and pediatric data of CRT treatment and propose a mechanistic approach that could potentially be helpful in trying to identify those patients who might benefit from the treatment.

  17. Cardiac resynchronization therapy and phase resetting of the sinoatrial node: a conjecture.

    PubMed

    Cantini, Federico; Varanini, Maurizio; Macerata, Alberto; Piacenti, Marcello; Morales, Maria-Aurora; Balocchi, Rita

    2007-03-01

    Congestive heart failure is a severe chronic disease often associated with disorders that alter the mechanisms of excitation-contraction coupling that may result in an asynchronous left ventricular motion which may further impair the ability of the failing heart to eject blood. In recent years a therapeutic approach to resynchronize the ventricles (cardiac resynchronization therapy, CRT) has been performed through the use of a pacemaker device able to provide atrial-based biventricular stimulation. Atrial lead senses the spontaneous occurrence of cells depolarization and sends the information to the generator which, in turn, after a settled delay [atrioventricular (AV) delay], sends electrical impulses to both ventricles to stimulate their synchronous contraction. Recent studies performed on heart rate behavior of chronically implanted patients at different epochs after implantation have shown that CRT can lead to sustained overall improvement of heart function with a reduction in morbidity and mortality. At this moment, however, there are no studies about CRT effects on spontaneous heart activity of chronically implanted patients. We performed an experimental study in which the electrocardiographic signal of five subjects under chronic CRT was recorded during the activity of the pacemaker programmed at different AV delays and under spontaneous cardiac activity after pacemaker deactivation. The different behavior of heart rate variability during pacemaker activity and after pacemaker deactivation suggested the hypothesis of a phase resetting mechanism induced by the pacemaker stimulus on the sinoatrial (SA) node, a phenomenon already known in literature for aggregate of cardiac cells, but still unexplored in vivo. The constraints imposed by the nature of our study (in vivo tests) made it impossible to plan an experiment to prove our hypothesis directly. We therefore considered the best attainable result would be to prove the accordance of our data to the conjecture

  18. Cardiac Resynchronization Therapy and phase resetting of the sinoatrial node: A conjecture

    NASA Astrophysics Data System (ADS)

    Cantini, Federico; Varanini, Maurizio; Macerata, Alberto; Piacenti, Marcello; Morales, Maria-Aurora; Balocchi, Rita

    2007-03-01

    Congestive heart failure is a severe chronic disease often associated with disorders that alter the mechanisms of excitation-contraction coupling that may result in an asynchronous left ventricular motion which may further impair the ability of the failing heart to eject blood. In recent years a therapeutic approach to resynchronize the ventricles (cardiac resynchronization therapy, CRT) has been performed through the use of a pacemaker device able to provide atrial-based biventricular stimulation. Atrial lead senses the spontaneous occurrence of cells depolarization and sends the information to the generator which, in turn, after a settled delay [atrioventricular (AV) delay], sends electrical impulses to both ventricles to stimulate their synchronous contraction. Recent studies performed on heart rate behavior of chronically implanted patients at different epochs after implantation have shown that CRT can lead to sustained overall improvement of heart function with a reduction in morbidity and mortality. At this moment, however, there are no studies about CRT effects on spontaneous heart activity of chronically implanted patients. We performed an experimental study in which the electrocardiographic signal of five subjects under chronic CRT was recorded during the activity of the pacemaker programmed at different AV delays and under spontaneous cardiac activity after pacemaker deactivation. The different behavior of heart rate variability during pacemaker activity and after pacemaker deactivation suggested the hypothesis of a phase resetting mechanism induced by the pacemaker stimulus on the sinoatrial (SA) node, a phenomenon already known in literature for aggregate of cardiac cells, but still unexplored in vivo. The constraints imposed by the nature of our study (in vivo tests) made it impossible to plan an experiment to prove our hypothesis directly. We therefore considered the best attainable result would be to prove the accordance of our data to the conjecture

  19. Economic impact of longer battery life of cardiac resynchronization therapy defibrillators in Sweden

    PubMed Central

    Gadler, Fredrik; Ding, Yao; Verin, Nathalie; Bergius, Martin; Miller, Jeffrey D; Lenhart, Gregory M; Russell, Mason W

    2016-01-01

    Objective The objective of this study was to quantify the impact that longer battery life of cardiac resynchronization therapy defibrillator (CRT-D) devices has on reducing the number of device replacements and associated costs of these replacements from a Swedish health care system perspective. Methods An economic model based on real-world published data was developed to estimate cost savings and avoided device replacements for CRT-Ds with longer battery life compared with devices with industry-standard battery life expectancy. Base-case comparisons were performed among CRT-Ds of three manufacturers – Boston Scientific Corporation, St. Jude Medical, and Medtronic – over a 6-year time horizon, as per the available clinical data. As a sensitivity analysis, we evaluated CRT-Ds as well as single-chamber implantable cardioverter defibrillator (ICD-VR) and dual-chamber implantable cardioverter defibrillator (ICD-DR) devices over a longer 10-year period. All costs were in 2015 Swedish Krona (SEK) discounted at 3% per annum. Results Base-case analysis results show that up to 603 replacements and up to SEK 60.4 million cumulative-associated costs could be avoided over 6 years by using devices with extended battery life. The pattern of savings over time suggests that savings are modest initially but increase rapidly beginning in the third year of follow-up with each year’s cumulative savings two to three times the previous year. Evaluating CRT-D, ICD-VR, and ICD-DR devices together over a longer 10-year period, the sensitivity analysis showed 2,820 fewer replacement procedures and associated cost savings of SEK 249.3 million for all defibrillators with extended battery life. Conclusion Extended battery life is likely to reduce device replacements and associated complications and costs, which may result in important cost savings and a more efficient use of health care resources as well as a better quality of life for heart failure patients in Sweden. PMID:27826203

  20. Association of hypothyroidism with adverse events in patients with heart failure receiving cardiac resynchronization therapy.

    PubMed

    Sharma, Ajay K; Vegh, Eszter; Orencole, Mary; Miller, Alexandra; Blendea, Dan; Moore, Stephanie; Lewis, Gregory D; Singh, Jagmeet P; Parks, Kimberly A; Heist, E Kevin

    2015-05-01

    Hypothyroidism is associated with an adverse prognosis in cardiac patients in general and in particular in patients with heart failure (HF). The aim of this study was to evaluate the impact of hypothyroidism on patients with HF receiving cardiac resynchronization therapy (CRT). Additionally, the impact of level of control of hypothyroidism on risk of adverse events after CRT implantation was also evaluated. We included consecutive patients in whom a CRT device was implanted from April 2004 to April 2010 at our institution with sufficient follow-up data available for analysis; 511 patients were included (age 68.5±12.4 years, women 20.4%); 84 patients with a clinical history of hypothyroidism, on treatment with thyroid hormone repletion or serum thyroid-stimulating hormone level≥5.00 μU/ml, were included in the hypothyroid group. The patients were followed for up to 3 years after implant for a composite end point of hospitalization for HF, left ventricular assist device placement, or heart transplant and cardiac death; 215 composite end point events were noted in this period. In a multivariate model, hypothyroidism (hazard ratio [HR] 1.46, 95% confidence interval [CI] 1.027 to 2.085, p=0.035), female gender (HR 0.64, 95% CI 0.428 to 0.963, p=0.032), and creatinine (HR 1.26, 95% CI 1.145 to 1.382, p<0.001) were significantly associated with occurrence of the composite end point; 53.6% of patients with hypothyroidism at baseline developed the composite end point compared with 39.8% of those with euthyroidism (p=0.02). In conclusion, hypothyroidism is associated with a worse prognosis after CRT implantation.

  1. The Relationship of Myocardial Collagen Metabolism and Reverse Remodeling after Cardiac Resynchronization Therapy

    PubMed Central

    Stankovic, Ivan; Milasinovic, Goran; Nikcevic, Gabrijela; Kircanski, Bratislav; Jovanovic, Velibor; Raspopovic, Srdjan; Radovanovic, Nikola; Pavlovic, Sinisa U.

    2016-01-01

    Summary Background In the majority of patients with a wide QRS complex and heart failure resistant to optimal medical therapy, cardiac resynchronization therapy (CRT) leads to reverse ventricular remodeling and possibly to changes in cardiac collagen synthesis and degradation. We investigated the relationship of biomarkers of myocardial collagen metabolism and volumetric response to CRT. Methods We prospectively studied 46 heart failure patients (mean age 61±9 years, 87% male) who underwent CRT implantation. Plasma concentrations of amino-terminal propeptide type I (PINP), a marker of collagen synthesis, and carboxy-terminal collagen telopeptide (CITP), a marker of collagen degradation, were measured before and 6 months after CRT. Response to CRT was defined as 15% or greater reduction in left ventricular end-systolic volume at 6-month follow-up. Results Baseline PINP levels showed a negative correlation with both left ventricular end-diastolic volume (r=-0.51; p=0.032), and end-systolic diameter (r=-0.47; p=0.049). After 6 months of device implantation, 28 patients (61%) responded to CRT. No significant differences in the baseline levels of PINP and CITP between responders and nonresponders were observed (p>0.05 for both). During follow-up, responders demonstrated a significant increase in serum PINP level from 31.37±18.40 to 39.2±19.19 μg/L (p=0.049), whereas in non-responders serum PINP levels did not significantly change (from 28.12±21.55 to 34.47± 18.64 μg/L; p=0.125). There were no significant changes in CITP levels in both responders and non-responders (p>0.05). Conclusions Left ventricular reverse remodeling induced by CRT is associated with an increased collagen synthesis in the first 6 months of CRT implantation.

  2. Improvement of Right Ventricular Hemodynamics with Left Ventricular Endocardial Pacing during Cardiac Resynchronization Therapy

    PubMed Central

    HYDE, EOIN R.; BEHAR, JONATHAN M.; CROZIER, ANDREW; CLARIDGE, SIMON; JACKSON, TOM; SOHAL, MANAV; GILL, JASWINDER S.; O'NEILL, MARK D.; RAZAVI, REZA; RINALDI, CHRISTOPHER A.

    2016-01-01

    Background Cardiac resynchronization therapy (CRT) with biventricular epicardial (BV‐CS) or endocardial left ventricular (LV) stimulation (BV‐EN) improves LV hemodynamics. The effect of CRT on right ventricular function is less clear, particularly for BV‐EN. Our objective was to compare the simultaneous acute hemodynamic response (AHR) of the right and left ventricles (RV and LV) with BV‐CS and BV‐EN in order to determine the optimal mode of CRT delivery. Methods Nine patients with previously implanted CRT devices successfully underwent a temporary pacing study. Pressure wires measured the simultaneous AHR in both ventricles during different pacing protocols. Conventional epicardial CRT was delivered in LV‐only (LV‐CS) and BV‐CS configurations and compared with BV‐EN pacing in multiple locations using a roving decapolar catheter. Results Best BV‐EN (optimal AHR of all LV endocardial pacing sites) produced a significantly greater RV AHR compared with LV‐CS and BV‐CS pacing (P < 0.05). RV AHR had a significantly increased standard deviation compared to LV AHR (P < 0.05) with a weak correlation between RV and LV AHR (Spearman rs = −0.06). Compromised biventricular optimization, whereby RV AHR was increased at the expense of a smaller decrease in LV AHR, was achieved in 56% of cases, all with BV‐EN pacing. Conclusions BV‐EN pacing produces significant increases in both LV and RV AHR, above that achievable with conventional epicardial pacing. RV AHR cannot be used as a surrogate for optimizing LV AHR; however, compromised biventricular optimization is possible. The beneficial effect of endocardial LV pacing on RV function may have important clinical benefits beyond conventional CRT. PMID:27001004

  3. Is cardiac resynchronization therapy for right ventricular failure in pulmonary arterial hypertension of benefit?

    PubMed

    Rasmussen, Jason T; Thenappan, Thenappan; Benditt, David G; Weir, E Kenneth; Pritzker, Marc R

    2014-12-01

    Pulmonary arterial hypertension is a manifestation of a group of disorders leading to pulmonary vascular remodeling and increased pulmonary pressures. The right ventricular (RV) response to chronic pressure overload consists of myocardial remodeling, which is in many ways similar to that seen in left ventricular (LV) failure. Maladaptive myocardial remodeling often leads to intraventricular and interventricular dyssychrony, an observation that has led to cardiac resynchronization therapy (CRT) for LV failure. CRT has proven to be an effective treatment strategy in subsets of patients with LV failure resulting in improvement in LV function, heart failure symptoms, and survival. Current therapy for pulmonary arterial hypertension is based on decreasing pulmonary vascular resistance, and there is currently no effective therapy targeting the right ventricle or maladaptive ventricular remodeling in these patients. This review focuses on the RV response to chronic pressure overload, its effect on electromechanical coupling and synchrony, and how lessons learned from left ventricular cardiac resynchronization might be applied as therapy for RV dysfunction in the context of pulmonary arterial hypertension.

  4. Clinical Effectiveness of Cardiac Resynchronization Therapy Versus Medical Therapy Alone Among Patients With Heart Failure

    PubMed Central

    Khazanie, Prateeti; Hammill, Bradley G.; Qualls, Laura G.; Fonarow, Gregg C.; Hammill, Stephen C.; Heidenreich, Paul A.; Al-Khatib, Sana M.; Piccini, Jonathan P.; Masoudi, Frederick A.; Peterson, Pamela N.; Curtis, Jeptha P.; Hernandez, Adrian F.

    2014-01-01

    Background— Cardiac resynchronization therapy with defibrillator (CRT-D) reduces morbidity and mortality among selected patients with heart failure in clinical trials. The effectiveness of this therapy in clinical practice has not been well studied. Methods and Results— We compared a cohort of 4471 patients from the National Cardiovascular Data Registry’s Implantable Cardioverter-Defibrillator (ICD) Registry hospitalized primarily for heart failure and who received CRT-D between April 1, 2006, and December 31, 2009, to a historical control cohort of 4888 patients with heart failure without CRT-D from the Acute Decompensated Heart Failure National Registry (ADHERE) hospitalized between January 1, 2002, and March 31, 2006. Both registries were linked with Medicare claims to evaluate longitudinal outcomes. We included patients from the ICD Registry with left ventricular ejection fraction ≤35% and QRS duration ≥120 ms who were admitted for heart failure. We used Cox proportional hazards models to compare outcomes with and without CRT-D after adjustment for important covariates. After multivariable adjustment, CRT-D was associated with lower 3-year risks of death (hazard ratio, 0.52; 95% confidence interval, 0.48–0.56; P<0.001), all-cause readmission (hazard ratio, 0.69; 95% confidence interval, 0.65–0.73; P<0.001), and cardiovascular readmission (hazard ratio, 0.60; 95% confidence interval, 0.56–0.64; P<0.001). The association of CRT-D with mortality did not vary significantly among subgroups defined by age, sex, race, QRS duration, and optimal medical therapy. Conclusions— CRT-D was associated with lower risks of mortality, all-cause readmission, and cardiovascular readmission than medical therapy alone among patients with heart failure in community practice. PMID:25227768

  5. P-wave locking in the postventricular atrial refractory period of cardiac resynchronization devices. Management with the Biotronik system.

    PubMed

    Barold, S S; Stroobandt, R X; Herweg, B; Kucher, A

    2012-06-01

    Electrical desynchronization in cardiac resynchronization therapy (CRT) occurs when sinus P waves are continually locked in the postventricular atrial refractory period (PVARP). This process is characterized by sequences of a P wave as an atrial event in the PVARP followed by a conducted and sensed ventricular event. Such sequences are more common in patients with a prolonged PR interval, often initiated by premature ventricular complexes (PVC) and terminated by PVCs or slowing of the sinus rate. Specific algorithms automatically identify a recurring pattern of P wave locking in the PVARP, whereupon they shorten the PVARP temporarily until atrial tracking is restored with the programmed sensed AV interval. The Biotronik family of Lumax CRT devices use an AV control window which is not an algorithm that "unlocks" P waves trapped in the PVARP. Rather, it prevents P waves from becoming trapped in the PVARP. A ventricular sensed event occurring within the AV control interval does not start a PVARP so that P wave locking cannot occur when the AV conduction time is shorter than the AV control interval.

  6. Cardiac Resynchronization Therapy Outcomes in Type 2 Diabetic Patients: Role of MicroRNA Changes.

    PubMed

    Sardu, Celestino; Barbieri, Michelangela; Rizzo, Maria Rosaria; Paolisso, Pasquale; Paolisso, Giuseppe; Marfella, Raffaele

    2016-01-01

    Heart failure (HF) and type 2 diabetes mellitus (T2DM) are two growing and related diseases in general population and particularly in elderly people. In selected patients affected by HF and severe dysfunction of left ventricle ejection fraction (LVEF), with left bundle brunch block, the cardiac resynchronization therapy with a defibrillator (CRT) is the treatment of choice to improve symptoms, NYHA class, and quality of life. CRT effects are related to alterations in genes and microRNAs (miRs) expression, which regulate cardiac processes involved in cardiac apoptosis, cardiac fibrosis, cardiac hypertrophy and angiogenesis, and membrane channel ionic currents. Different studies have shown a different prognosis in T2DM patients and T2DM elderly patients treated by CRT-D. We reviewed the literature data on CRT-D effect on adult and elderly patients with T2DM as compared with nondiabetic patients.

  7. Cardiac Resynchronization Therapy Outcomes in Type 2 Diabetic Patients: Role of MicroRNA Changes

    PubMed Central

    Sardu, Celestino; Barbieri, Michelangela; Rizzo, Maria Rosaria; Paolisso, Pasquale; Paolisso, Giuseppe; Marfella, Raffaele

    2016-01-01

    Heart failure (HF) and type 2 diabetes mellitus (T2DM) are two growing and related diseases in general population and particularly in elderly people. In selected patients affected by HF and severe dysfunction of left ventricle ejection fraction (LVEF), with left bundle brunch block, the cardiac resynchronization therapy with a defibrillator (CRT) is the treatment of choice to improve symptoms, NYHA class, and quality of life. CRT effects are related to alterations in genes and microRNAs (miRs) expression, which regulate cardiac processes involved in cardiac apoptosis, cardiac fibrosis, cardiac hypertrophy and angiogenesis, and membrane channel ionic currents. Different studies have shown a different prognosis in T2DM patients and T2DM elderly patients treated by CRT-D. We reviewed the literature data on CRT-D effect on adult and elderly patients with T2DM as compared with nondiabetic patients. PMID:26636106

  8. Efficacy of medication directed by home-monitoring cardiac resynchronization therapy in chronic heart failure patients.

    PubMed

    Yang, Hao; Zhang, Fei-fei; Peng, Xin-hui; Zhao, Dong-hua; Peng, Jian

    2014-03-01

    PATIENTS with chronic heart failure (CHF) have a high incidence of atrial/ventricular arrhythmias which seriously affect life span and quality of life. Cardiac re-synchronization therapy (CRT) can improve cardiac function and reverse myocardial remodeling, therefore improving the quality of life and reducing mortality. CRT with Home-Monitoring (HM) can be used to monitor cardiac arrhythmias and other heart physiological indexes such as intrathoracic impedance and hemodynamics. Through wireless satellites, the data from the patients are sent to a monitor center for analysis. Doctors can identify emergent information and make a rapid diagnosis based on the information stored in the monitor center. CRT with HM has been verified as a valid method to optimize drug treatment according to individual parameters.

  9. Towards an atrio-ventricular delay optimization assessed by a computer model for cardiac resynchronization therapy

    NASA Astrophysics Data System (ADS)

    Ojeda, David; Le Rolle, Virginie; Tse Ve Koon, Kevin; Thebault, Christophe; Donal, Erwan; Hernández, Alfredo I.

    2013-11-01

    In this paper, lumped-parameter models of the cardiovascular system, the cardiac electrical conduction system and a pacemaker are coupled to generate mitral ow pro les for di erent atrio-ventricular delay (AVD) con gurations, in the context of cardiac resynchronization therapy (CRT). First, we perform a local sensitivity analysis of left ventricular and left atrial parameters on mitral ow characteristics, namely E and A wave amplitude, mitral ow duration, and mitral ow time integral. Additionally, a global sensitivity analysis over all model parameters is presented to screen for the most relevant parameters that a ect the same mitral ow characteristics. Results provide insight on the in uence of left ventricle and atrium in uence on mitral ow pro les. This information will be useful for future parameter estimation of the model that could reproduce the mitral ow pro les and cardiovascular hemodynamics of patients undergoing AVD optimization during CRT.

  10. Development and Validation of Predictive Models of Cardiac Mortality and Transplantation in Resynchronization Therapy

    PubMed Central

    Rocha, Eduardo Arrais; Pereira, Francisca Tatiana Moreira; Abreu, José Sebastião; Lima, José Wellington O.; Monteiro, Marcelo de Paula Martins; Rocha Neto, Almino Cavalcante; Goés, Camilla Viana Arrais; Farias, Ana Gardênia P.; Rodrigues Sobrinho, Carlos Roberto Martins; Quidute, Ana Rosa Pinto; Scanavacca, Maurício Ibrahim

    2015-01-01

    Background 30-40% of cardiac resynchronization therapy cases do not achieve favorable outcomes. Objective This study aimed to develop predictive models for the combined endpoint of cardiac death and transplantation (Tx) at different stages of cardiac resynchronization therapy (CRT). Methods Prospective observational study of 116 patients aged 64.8 ± 11.1 years, 68.1% of whom had functional class (FC) III and 31.9% had ambulatory class IV. Clinical, electrocardiographic and echocardiographic variables were assessed by using Cox regression and Kaplan-Meier curves. Results The cardiac mortality/Tx rate was 16.3% during the follow-up period of 34.0 ± 17.9 months. Prior to implantation, right ventricular dysfunction (RVD), ejection fraction < 25% and use of high doses of diuretics (HDD) increased the risk of cardiac death and Tx by 3.9-, 4.8-, and 5.9-fold, respectively. In the first year after CRT, RVD, HDD and hospitalization due to congestive heart failure increased the risk of death at hazard ratios of 3.5, 5.3, and 12.5, respectively. In the second year after CRT, RVD and FC III/IV were significant risk factors of mortality in the multivariate Cox model. The accuracy rates of the models were 84.6% at preimplantation, 93% in the first year after CRT, and 90.5% in the second year after CRT. The models were validated by bootstrapping. Conclusion We developed predictive models of cardiac death and Tx at different stages of CRT based on the analysis of simple and easily obtainable clinical and echocardiographic variables. The models showed good accuracy and adjustment, were validated internally, and are useful in the selection, monitoring and counseling of patients indicated for CRT. PMID:26559987

  11. Cardiac Resynchronization Therapy Restores Sympathovagal Balance in the Failing Heart by Differential Remodeling of Cholinergic Signaling

    PubMed Central

    DeMazumder, Deeptankar; Kass, David A.; O’Rourke, Brian; Tomaselli, Gordon F.

    2015-01-01

    Rationale Cardiac resynchronization therapy (CRT) is the only heart failure (HF) therapy documented to improve left ventricular (LV) function and reduce mortality. The underlying mechanisms are incompletely understood. While β-adrenergic signaling has been studied extensively, the effect of CRT on cholinergic signaling is unexplored. Objective We hypothesized that remodeling of cholinergic signaling plays an important role in the aberrant calcium signaling and depressed contractile and β-adrenergic responsiveness in dyssynchronous HF (DHF) that are restored by CRT. Methods and Results Canine tachypaced DHF and CRT models were generated to interrogate responses specific to dyssynchronous vs. resynchronized ventricular contraction during hemodynamic decompensation. Echocardiographic, electrocardiographic and invasive hemodynamic data were collected from normal controls, DHF and CRT models. LV tissue was used for biochemical analyses and functional measurements (calcium transient, sarcomere shortening) from isolated myocytes (N=42–104 myocytes/model; 6–9 hearts/model). Human LV myocardium was obtained for biochemical analyses from explanted failing (N=18) and non-failing (N=7) hearts. The M2 subtype of muscarinic acetylcholine receptors (M2-mAChR) was upregulated in human and canine HF compared to non-failing controls. CRT attenuated the increased M2-mAChR expression and Gαi-coupling, and enhanced M3-mAChR expression in association with enhanced calcium cycling, sarcomere shortening and β-adrenergic responsiveness. Despite model-dependent remodeling, cholinergic stimulation completely abolished isoproterenol-induced triggered activity in both DHF and CRT myocytes. Conclusions Remodeling of cholinergic signaling is a critical pathological component of human and canine HF. Differential remodeling of cholinergic signaling represents a novel mechanism for enhancing sympathovagal balance with CRT and may identify new targets for treatment of systolic HF. PMID

  12. [Cardiac resynchronization therapy in a patient with congenitally corrected transposition of the great arteries and 2:1 atrioventricular block].

    PubMed

    Conte, Giulio; Coppini, Lucia; Demola, Maria Antonietta; Zardini, Marco; Ardissino, Diego

    2012-12-01

    Congenitally corrected transposition of the great arteries (CCTGA) is a rare congenital heart disease with an atrioventricular and ventriculo-arterial discordance in which the morphological right ventricle supports the systemic circulation and the morphological tricuspid valve is the systemic atrioventricular valve. Heart rhythm disturbances and ventricular dysfunction related to electromechanical dyssynchrony are common in adult congenital heart disease patients with a systemic right ventricle. Thus, these patients may require conventional pacemaker implantation, which in the presence of ventricular dysfunction and conduction disease may further compromise cardiac performance. Indeed, cardiac resynchronization therapy may be an effective treatment option for these patients. We report the case of a patient with CCTGA and moderate depression of systemic ventricular systolic function who developed a 2:1 atrioventricular block and was treated with cardiac resynchronization therapy.

  13. Indications for cardiac resynchronization therapy: 2011 update from the Heart Failure Society of America Guideline Committee.

    PubMed

    Stevenson, William G; Hernandez, Adrian F; Carson, Peter E; Fang, James C; Katz, Stuart D; Spertus, John A; Sweitzer, Nancy K; Tang, W H Wilson; Albert, Nancy M; Butler, Javed; Westlake Canary, Cheryl A; Collins, Sean P; Colvin-Adams, Monica; Ezekowitz, Justin A; Givertz, Michael M; Hershberger, Ray E; Rogers, Joseph G; Teerlink, John R; Walsh, Mary N; Stough, Wendy Gattis; Starling, Randall C

    2012-02-01

    Cardiac resynchronization therapy (CRT) improves survival, symptoms, quality of life, exercise capacity, and cardiac structure and function in patients with New York Heart Association (NYHA) functional class II or ambulatory class IV heart failure (HF) with wide QRS complex. The totality of evidence supports the use of CRT in patients with less severe HF symptoms. CRT is recommended for patients in sinus rhythm with a widened QRS interval (≥150 ms) not due to right bundle branch block (RBBB) who have severe left ventricular (LV) systolic dysfunction and persistent NYHA functional class II-III symptoms despite optimal medical therapy (strength of evidence A). CRT may be considered for several other patient groups for whom evidence of benefit is clinically significant but less substantial, including patients with a QRS interval of ≥120 to <150 ms and severe LV systolic dysfunction who have persistent mild to severe HF despite optimal medical therapy (strength of evidence B), some patients with atrial fibrillation, and some with ambulatory class IV HF. Several evidence gaps remain that need to be addressed, including the ideal threshold for QRS duration, QRS morphology, lead placement, degree of myocardial scarring, and the modality for evaluating dyssynchrony. Recommendations will evolve over time as additional data emerge from completed and ongoing clinical trials.

  14. Cardiac resynchronization therapy for heart failure induced by left bundle branch block after transcatheter closure of ventricular septal defect.

    PubMed

    Du, Rong-Zeng; Qian, Jun; Wu, Jun; Liang, Yi; Chen, Guang-Hua; Sun, Tao; Zhou, Ye; Zhao, Yang; Yan, Jin-Chuan

    2014-12-01

    A 54-year-old female patient with congenital heart disease had a persistent complete left bundle branch block three months after closure by an Amplatzer ventricular septal defect occluder. Nine months later, the patient suffered from chest distress, palpitation, and sweating at daily activities, and her 6-min walk distance decreased significantly (155 m). Her echocardiography showed increased left ventricular end-diastolic diameter with left ventricular ejection fraction of 37%. Her symptoms reduced significantly one week after received cardiac resynchronization therapy. She had no symptoms at daily activities, and her echo showed left ventricular ejection fraction of 46% and 53%. Moreover, left ventricular end-diastolic diameter decreased 6 and 10 months after cardiac resynchronization therapy, and 6-min walk distance remarkably increased. This case demonstrated that persistent complete left bundle branch block for nine months after transcatheter closure with ventricular septal defect Amplatzer occluder could lead to left ventricular enlargement and a significant decrease in left ventricular systolic function. Cardiac resynchronization therapy decreased left ventricular end-diastolic diameter and increased left ventricular ejection fraction, thereby improving the patient's heart functions.

  15. Measurement of the Red Blood Cell Distribution Width Improves the Risk Prediction in Cardiac Resynchronization Therapy

    PubMed Central

    Boros, András Mihály; Perge, Péter; Jenei, Zsigmond; Karády, Júlia; Zima, Endre; Molnár, Levente; Becker, Dávid; Gellér, László; Prohászka, Zoltán; Merkely, Béla; Széplaki, Gábor

    2016-01-01

    Objectives. Increases in red blood cell distribution width (RDW) and NT-proBNP (N-terminal pro-B-type natriuretic peptide) predict the mortality of chronic heart failure patients undergoing cardiac resynchronization therapy (CRT). It was hypothesized that RDW is independent of and possibly even superior to NT-proBNP from the aspect of long-term mortality prediction. Design. The blood counts and serum NT-proBNP levels of 134 patients undergoing CRT were measured. Multivariable Cox regression models were applied and reclassification analyses were performed. Results. After separate adjustment to the basic model of left bundle branch block, beta blocker therapy, and serum creatinine, both the RDW > 13.35% and NT-proBNP > 1975 pg/mL predicted the 5-year mortality (n = 57). In the final model including all variables, the RDW [HR = 2.49 (1.27–4.86); p = 0.008] remained a significant predictor, whereas the NT-proBNP [HR = 1.18 (0.93–3.51); p = 0.07] lost its predictive value. On addition of the RDW measurement, a 64% net reclassification improvement and a 3% integrated discrimination improvement were achieved over the NT-proBNP-adjusted basic model. Conclusions. Increased RDW levels accurately predict the long-term mortality of CRT patients independently of NT-proBNP. Reclassification analysis revealed that the RDW improves the risk stratification and could enhance the optimal patient selection for CRT. PMID:26903690

  16. Role of echocardiography before cardiac resynchronization therapy: new advances and current developments.

    PubMed

    Marechaux, Sylvestre; Menet, Aymeric; Guyomar, Yves; Ennezat, Pierre-Vladimir; Guerbaai, Raphaëlle Ashley; Graux, Pierre; Tribouilloy, Christophe

    2016-11-01

    The role of echocardiography in improving the selection of patients who will benefit from cardiac resynchronization therapy (CRT) remains a source of debate. Although previous landmark reports have demonstrated a link between mechanical dyssynchrony, assessed by delays between left ventricle (LV) walls and response to CRT, the predictive value of these findings has not yet been confirmed in multicenter trials. Indeed, recent studies demonstrated that the classical assessment of LV mechanical dyssynchrony using delay between walls by echocardiography depends not only on LV electrical activation delay (electrical dyssynchrony), but also on abnormalities in regional contractility of the LV and/or loading conditions, which do not represent an appropriate target for CRT. Recent reports highlighted the value of new indices of electromechanical dyssynchrony obtained by echocardiography, to predict LV response and outcome after CRT including septal flash, left bundle branch block-typical pattern by longitudinal strain, apical rocking, septal strain patterns, and systolic stretch index. This was achieved using a mechanistic approach, based on the contractile consequences of electrical dyssynchrony. These indices are rarely found in patients with narrow QRS (<120 ms), whereas their frequency rises in patients with an increase in QRS duration (>120 ms). Theses indices should improve candidate selection for CRT in clinical practice, especially for patients in whom the benefit of CRT remains uncertain, for example, patients with intermediate QRS width (120-150 ms).

  17. X-ray and magnetic resonance imaging fusion for cardiac resynchronization therapy.

    PubMed

    Choi, Jinwoo; Radau, Perry; Xu, Robert; Wright, Graham A

    2016-07-01

    Cardiac Resynchronization Therapy (CRT) can effectively treat left ventricle (LV) driven Heart Failure (HF). However, 30% of the CRT recipients do not experience symptomatic benefit. Recent studies show that the CRT response rate can reach 95% when the LV pacing lead is placed at an optimal site at a region of maximal LV dyssynchrony and away from myocardial scars. Cardiac Magnetic Resonance (CMR) can identify the optimal site in three dimensions (3D). 3D CMR data can be registered to clinical standard x-ray fluoroscopy to achieve an optimal pacing of the LV. We have developed a 3D CMR to 2D x-ray image registration method for CRT procedures. We have employed the LV pacing lead on x-ray images and coronary sinus on MR data as landmarks. The registration method makes use of a guidewire simulation algorithm, edge based image registration technique and x-ray C-arm tracking to register the coronary sinus and pacing lead landmarks.

  18. Usefulness of hyponatremia as a predictor for adverse events in patients with heart failure receiving cardiac resynchronization therapy.

    PubMed

    Sharma, Ajay K; Vegh, Eszter M; Kandala, Jagdesh; Orencole, Mary; Januszkiewicz, Lukasz; Bose, Abhishek; Miller, Alexandra; Parks, Kimberly A; Heist, E Kevin; Singh, Jagmeet P

    2014-07-01

    Hyponatremia portends a poor prognosis in patients with heart failure (HF). The aim of this study was to evaluate prognostic implication of hyponatremia on adverse events in patients with HF receiving cardiac resynchronization therapy (CRT). Additionally, the impact of improvement of hyponatremia after CRT device implantation was also evaluated. In this retrospective analysis, we included patients in whom a CRT device was implanted between April 2004 and April 2010 at our institution and had a baseline sodium level obtained within 72 hours of implantation. The patients were followed up for 3 years after implantation for subsequent primary composite end points, that is, hospitalization for HF, left ventricular assist device or heart transplant, and all-cause death. Sodium levels were followed up at 3 to 6 months after device implantation. Hyponatremia was defined as a serum sodium level of <135 mmol/L. A total of 402 patients were included (age 68.7 ± 12.3 years, women 20.9%). One hundred seventy-nine adverse events were noted in this period. In a Cox proportional hazards univariate model, hyponatremia (hazard ratio [HR] 1.54, 95% confidence interval [CI] 1.113 to 2.131, p = 0.009), creatinine (HR 1.267, 95% CI 1.156 to 1.389, p <0.001), and diuretics (HR 2.652, 95% CI 1.401 to 5.019, p = 0.003) were associated with occurrence of the composite end point. A total of 57.9% of patients with hyponatremia at baseline had the composite end point compared with 40.7% of those with normal sodium concentration (p = 0.004). Kaplan-Meier curve showed that hyponatremic patients fared worse. Also, patients in whom hyponatremia resolved after CRT device implantation had lower incidence of the composite end point compared with patients who had normal pre-CRT sodium levels but developed hyponatremia later. In conclusion, baseline hyponatremia is associated with poor prognosis in patients with HF. CRT can resolve hyponatremia in some patients after device implantation

  19. Reparative resynchronization in ischemic heart failure: an emerging strategy

    PubMed Central

    Yamada, Satsuki; Terzic, Andre

    2014-01-01

    Cardiac dyssynchrony refers to disparity in cardiac wall motion, a serious consequence of myocardial infarction associated with poor outcome. Infarct-induced scar is refractory to device-based cardiac resynchronization therapy, which relies on viable tissue. Leveraging the prospect of structural and functional regeneration, reparative resynchronization has emerged as a potentially achievable strategy. In proof-of-concept studies, stem-cell therapy eliminates contractile deficit originating from infarcted regions and secures long-term synchronization with tissue repair. Limited clinical experience suggests benefit of cell interventions in acute and chronic ischemic heart disease as adjuvant to standard of care. A regenerative resynchronization option for dyssynchronous heart failure thus merits validation. PMID:24840208

  20. Importance of adjunctive heart failure optimization immediately after implantation to improve long-term outcomes with cardiac resynchronization therapy.

    PubMed

    Mullens, Wilfried; Kepa, Jacek; De Vusser, Philippe; Vercammen, Jan; Rivero-Ayerza, Maximo; Wagner, Patrick; Dens, Joseph; Vrolix, Mathias; Vandervoort, Pieter; Tang, W H Wilson

    2011-08-01

    Despite improvement in morbidity and mortality with cardiac resynchronization therapy (CRT), disease progression continues to affect a subset of patients and there is limited effort to identify contributing factors. Our objective was to investigate if a protocol-driven approach incorporated in a management strategy of heart failure immediately after implantation would provide incremental benefits beyond usual care after implantation. We reviewed 114 consecutive patients with CRT implanted from 2005 through 2009 who received usual care after implantation or underwent protocol-driven CRT care after implantation. Preimplantation characteristics in patients receiving usual versus protocol-driven care were similar in left ventricular (LV) dimension (LV internal diastolic diameter 6.2 ± 0.8 vs 6.4 ± 1.0 cm), LV ejection fraction (26 ± 8% vs 25% ± 8%), QRS width, and medication usage. Major adjustments during the protocol-driven approach were uptitration of neurohormonal blockers (64%), echocardiographically guided atrioventricular optimization (50%), heart failure education (42%), arrhythmia management (19%), and LV lead repositioning (7%). Although positive LV remodeling was noted in the 2 groups at 6 months, extent was significantly greater in the protocol-driven approach compared to usual care (change in LV internal diastolic diameter 0.7 ± 0.6 cm vs 0.2 ± 1.2 cm, p = 0.01; change in LV ejection fraction 11 ± 7% vs 7 ± 9%, p = 0.01), which was associated with fewer major adverse events (14% vs 53%, p <0.001). In conclusion, a protocol-driven approach for patients with CRT started immediately after implantation is associated with incremental favorable effects on reverse remodeling and fewer adverse events compared to usual care after implantation. These effects appeared to be driven not only by changes in device settings and arrhythmia management but also by concomitant medication optimization and heart failure education.

  1. Hemodynamic benefit of rest and exercise optimization of cardiac resynchronization therapy.

    PubMed

    Stanton, Tony; Haluska, Brian A; Leano, Rodel; Marwick, Thomas H

    2014-09-01

    The optimal method of cardiac resynchronization therapy (CRT) optimization is as yet unknown. We sought to investigate the responses of optimization at rest and on exercise. This 2 stage study involved 59 patients (age 65 ± 10, 75% male), who had all recently undergone successful CRT implantation. In the first stage, the 6-month response was compared between 30 individuals who underwent resting echocardiographic optimization of CRT [atrioventricular (AV delay) plus ventriculo-ventricular delays (VV delay)], compared with the 29 who did not. In the second stage, a subset of 37 patients from the original cohort were randomized (double-blind) to either resting echocardiographic optimization (n = 20) or exercise echocardiographic optimization (n = 17) and followed for a further 6 months. Clinical and echocardiographic data were collected at each stage. Patients undergoing rest optimization demonstrated improvement in almost all variables and significantly in B-type natriuretic peptide (BNP) in contrast to those without optimization. In a linear regression model, the only significant predictor of BNP change was whether an individual underwent resting optimization or not (β = 0.38, P = 0.04). In those undergoing resting optimization, the degree of change in AV delay was correlated with improvement in left ventricle (LV) end-diastolic volume (r(2)  = 0.33, P < 0.01). Optimization on exercise was associated with a significant decrease in 6-minute walk test compared to those randomized to rest optimization possibly due to inducing nonoptimization at rest. In conclusion, echocardiographic optimization of CRT at rest is superior to no optimization or optimization on exercise. Patients with the greatest change in AV delay to reach optimal may undergo greater LV remodeling.

  2. Agreement is Poor Amongst Current Criteria Used to Define Response to Cardiac Resynchronization Therapy

    PubMed Central

    Fornwalt, Brandon K.; Sprague, William W.; BeDell, Patrick; Suever, Jonathan D.; Gerritse, Bart; Merlino, John D.; Fyfe, Derek A.; León, Angel R.; Oshinski, John N.

    2010-01-01

    Background Numerous criteria believed to define a positive response to cardiac resynchronization therapy (CRT) have been utilized in the literature. No study has investigated agreement amongst these response criteria. We hypothesized that the agreement between the various response criteria would be poor. Methods and Results A literature search was conducted with the keywords “cardiac resynchronization” and “response”. The 50 publications with the most citations were reviewed. After excluding editorials and reviews, seventeen different primary response criteria were identified from 26 relevant articles. The agreement amongst fifteen of these seventeen response criteria was assessed in 426 patients from the PROSPECT study using Cohen's κ coefficient (two response criteria were not calculable from PROSPECT data). The overall response rate ranged from 32-91% for the fifteen response criteria. Ninety-nine percent of patients showed a positive response by at least one of the fifteen criteria while 94% were classified as a non-responder by at least one criterion. Kappa values were calculated for all 105 possible comparisons amongst the fifteen response criteria and classified into standard ranges: poor agreement (κ≤0.4), moderate agreement (0.4<κ<0.75) and strong agreement (κ≥0.75). Seventy-five percent of the comparisons showed poor agreement, 21% showed moderate agreement and only 4% showed strong agreement. Conclusions The 26 most cited publications on predicting response to CRT define response using 17 different criteria. Agreement between different methods to define response to CRT is poor 75% of the time and strong only 4% of the time, which severely limits the ability to generalize results over multiple studies. PMID:20421518

  3. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial

    PubMed Central

    Delnoy, Peter Paul; Brachmann, Johannes; Reynolds, Dwight; Padeletti, Luigi; Noelker, Georg; Kantipudi, Charan; Rubin Lopez, José Manuel; Dichtl, Wolfgang; Borri-Brunetto, Alberto; Verhees, Luc; Ritter, Philippe; Singh, Jagmeet P.

    2017-01-01

    Aims Although cardiac resynchronization therapy (CRT) is effective in patients with systolic heart failure (HF) and a wide QRS interval, a substantial proportion of patients remain non-responsive. The SonR contractility sensor embedded in the right atrial lead enables individualized automatic optimization of the atrioventricular (AV) and interventricular (VV) timings. The RESPOND-CRT study investigated the safety and efficacy of the contractility sensor system in HF patients undergoing CRT. Methods and results RESPOND-CRT was a prospective, randomized, double-blinded, multicentre, non-inferiority trial. Patients were randomized (2:1, respectively) to receive weekly, automatic CRT optimization with SonR vs. an Echo-guided optimization of AV and VV timings. The primary efficacy endpoint was the rate of clinical responders (patients alive, without adjudicated HF-related events, with improvement in New York Heart Association class or quality of life), at 12 months. The study randomized 998 patients. Responder rates were 75.0% in the SonR arm and 70.4% in the Echo arm (mean difference, 4.6%; 95% CI, −1.4% to 10.6%; P < 0.001 for non-inferiority margin −10.0%) (Table 2). At an overall mean follow-up of 548 ± 190 days SonR was associated with a 35% risk reduction in HF hospitalization (hazard ratio, 0.65; 95% CI, 0.46–0.92; log-rank P = 0.01). Conclusion Automatic AV and VV optimization using the contractility sensor was safe and as effective as Echo-guided AV and VV optimization in increasing response to CRT. ClinicalTrials.gov number NCT01534234 PMID:27941020

  4. Intracardiac impedance after cardiac resynchronization therapy is a novel predictor for worsening of heart failure.

    PubMed

    Suzuki, Hitoshi; Nodera, Minoru; Kamioka, Masashi; Kaneshiro, Takashi; Kamiyama, Yoshiyuki; Takeishi, Yasuchika

    2017-02-08

    Intrathoracic impedance measured by cardiac resynchronization therapy (CRT) varies because several factors other than pulmonary congestion may affect this parameter. Therefore, we hypothesized that changes in intracardiac impedance between the right and left ventricular leads would be more accurate to identify worsening heart failure in patients with CRT. The study enrolled 21 patients with CRT defibrillator (15 males, 70 ± 12 years). During the follow-up period (12 ± 7 months), the subjects experienced 37 fluid index threshold (60 ohm-days) crossing events. These events were divided into two groups whether hospitalization due to worsening heart failure was required (group-H, n = 14) or not (group-NH, n = 23). Based on the intracardiac impedance at the beginning of increasing fluid index (BI) and the crossing of 60 ohm-days (CI), the rate of impedance change (BI-CI/BI) was estimated. Then, the time elapsed from BI to CI (T) was evaluated. We calculated the rate of intracardiac impedance change per day (BI-CI/BI × T) in each group. The rate of intrathoracic impedance change per day was also determined using the same method. The median rate of intracardiac impedance change per day was 0.27 (IQR 0.22-0.54) %/day in group-H, and 0 (IQR 0-0.08) %/day in group-NH with a significant difference (P < 0.0001), whereas the rate of intrathoracic impedance change per day was similar between the two groups. By receiver operating characteristic curve for identification of hospitalization due to worsening heart failure, the best cutoff value of the rate of intracardiac impedance change per day was 0.20%/day (sensitivity 92%, specificity 88%, and AUC 0.98). In contrast, the best cutoff value of the rate of intrathoracic impedance change per day was 0.19%/day (sensitivity 86%, specificity 43%, and AUC 0.68). These results suggest that increased rate of change of decreasing intracardiac impedance measured by CRT is a novel useful predictor for

  5. Cardiac resynchronization therapy modulation of exercise left ventricular function and pulmonary O₂ uptake in heart failure.

    PubMed

    Tomczak, Corey R; Paterson, Ian; Haykowsky, Mark J; Lawrance, Richard; Martellotto, Andres; Pantano, Alfredo; Gulamhusein, Sajad; Haennel, Robert G

    2012-06-15

    To better understand the mechanisms contributing to improved exercise capacity with cardiac resynchronization therapy (CRT), we studied the effects of 6 mo of CRT on pulmonary O(2) uptake (Vo(2)) kinetics, exercise left ventricular (LV) function, and peak Vo(2) in 12 subjects (age: 56 ± 15 yr, peak Vo(2): 12.9 ± 3.2 ml·kg(-1)·min(-1), ejection fraction: 18 ± 3%) with heart failure. We hypothesized that CRT would speed Vo(2) kinetics due to an increase in stroke volume secondary to a reduction in LV end-systolic volume (ESV) and that the increase in peak Vo(2) would be related to an increase in cardiac output reserve. We found that Vo(2) kinetics were faster during the transition to moderate-intensity exercise after CRT (pre-CRT: 69 ± 21 s vs. post-CRT: 54 ± 17 s, P < 0.05). During moderate-intensity exercise, LV ESV reserve (exercise - resting) increased 9 ± 7 ml (vs. a 3 ± 9-ml decrease pre-CRT, P < 0.05), and steady-state stroke volume increased (pre-CRT: 42 ± 8 ml vs. post-CRT: 61 ± 12 ml, P < 0.05). LV end-diastolic volume did not change from rest to steady-state exercise post-CRT (P > 0.05). CRT improved heart rate, measured as a lower resting and steady-state exercise heart rate and as faster heart rate kinetics after CRT (pre-CRT: 89 ± 12 s vs. post-CRT: 69 ± 21 s, P < 0.05). For peak exercise, cardiac output reserve increased significantly post-CRT and was 22% higher at peak exercise post-CRT (both P < 0.05). The increase in cardiac output was due to both a significant increase in peak and reserve stroke volume and to a nonsignificant increase in heart rate reserve. Similar patterns in LV volumes as moderate-intensity exercise were observed at peak exercise. Cardiac output reserve was related to peak Vo(2) (r = 0.48, P < 0.05). These findings demonstrate the chronic CRT-mediated cardiac factors that contribute, in part, to the speeding in Vo(2) kinetics and increase in peak Vo(2) in clinically stable heart failure patients.

  6. The Impact of Cardiac Resynchronization Therapy on Obstructive Sleep Apnea in Heart Failure Patients*

    PubMed Central

    Stanchina, Michael L.; Ellison, Kristin; Malhotra, Atul; Anderson, Maria; Kirk, Malcolm; Benser, Michael E.; Tosi, Christine; Carlisle, Carol; Millman, Richard P.; Buxton, Alfred

    2008-01-01

    Background Cardiac resynchronization therapy (CRT) has been shown to improve cardiac function and reduce Cheyne-Stokes respiration but has not been evaluated in patients with obstructive sleep apnea (OSA). In this pilot study, we investigated the impact of both CRT and CRT plus increased rate pacing in heart failure (ie, congestive heart failure [CHF]) patients with OSA. We hypothesized that through increased cardiac output CRT/pacing would reduce obstructive events and daytime symptoms of sleepiness. Methods Full polysomnograms were performed on CHF patients who were scheduled for CRT, and those patients with an apnea-hypopnea index (AHI) of > 5 events per hour were approached about study enrollment. Patients had a pre-CRT implant baseline echocardiogram and an echocardiogram a mean (± SEM) duration of 6.6 ± 1.4 months post-CRT implant; polysomnography; and responded to the Minnesota Living with Heart Failure questionnaire, the Epworth sleepiness scale, and the Functional Outcomes of Sleep Questionnaire. An additional third polysomnography was performed combining CRT with a pacing rate of 15 beats/min above the baseline sleeping heart rate within 1 week of the second polysomnography. Assessments for the change in cardiac output during the polysomnography were performed using circulation time to pulse oximeter as a surrogate. Results Twenty-four patients were screened, and 13 patients (mean age, 68.6 years; body mass index, 28.7 kg/m2) had evidence of OSA. The mean AHI decreased from 40.9 ± 6.4 to 29.5 ± 5.9 events per hour with CRT (p = 0.04). The mean baseline ejection fraction was 22 ± 1.7% and increased post-CRT to 33.6 ± 2.0% (p < 0.05). The reduction in AHI with CRT closely correlated with a decrease in circulation time (r = 0.89; p < 0.001) with CRT. Increased rate pacing made no additional impact on the AHI or circulation time. CRT had a limited impact on sleep architecture or daytime symptom scores. Conclusions CRT improved cardiac function and

  7. Why QRS Duration Should Be Replaced by Better Measures of Electrical Activation to Improve Patient Selection for Cardiac Resynchronization Therapy.

    PubMed

    Engels, Elien B; Mafi-Rad, Masih; van Stipdonk, Antonius M W; Vernooy, Kevin; Prinzen, Frits W

    2016-08-01

    Cardiac resynchronization therapy (CRT) is a well-known treatment modality for patients with a reduced left ventricular ejection fraction accompanied by a ventricular conduction delay. However, a large proportion of patients does not benefit from this therapy. Better patient selection may importantly reduce the number of non-responders. Here, we review the strengths and weaknesses of the electrocardiogram (ECG) markers currently being used in guidelines for patient selection, e.g., QRS duration and morphology. We shed light on the current knowledge on the underlying electrical substrate and the mechanism of action of CRT. Finally, we discuss potentially better ECG-based biomarkers for CRT candidate selection, of which the vectorcardiogram may have high potential.

  8. Tailor-made heart simulation predicts the effect of cardiac resynchronization therapy in a canine model of heart failure.

    PubMed

    Panthee, Nirmal; Okada, Jun-ichi; Washio, Takumi; Mochizuki, Youhei; Suzuki, Ryohei; Koyama, Hidekazu; Ono, Minoru; Hisada, Toshiaki; Sugiura, Seiryo

    2016-07-01

    Despite extensive studies on clinical indices for the selection of patient candidates for cardiac resynchronization therapy (CRT), approximately 30% of selected patients do not respond to this therapy. Herein, we examined whether CRT simulations based on individualized realistic three-dimensional heart models can predict the therapeutic effect of CRT in a canine model of heart failure with left bundle branch block. In four canine models of failing heart with dyssynchrony, individualized three-dimensional heart models reproducing the electromechanical activity of each animal were created based on the computer tomographic images. CRT simulations were performed for 25 patterns of three ventricular pacing lead positions. Lead positions producing the best and the worst therapeutic effects were selected in each model. The validity of predictions was tested in acute experiments in which hearts were paced from the sites identified by simulations. We found significant correlations between the experimentally observed improvement in ejection fraction (EF) and the predicted improvements in ejection fraction (P<0.01) or the maximum value of the derivative of left ventricular pressure (P<0.01). The optimal lead positions produced better outcomes compared with the worst positioning in all dogs studied, although there were significant variations in responses. Variations in ventricular wall thickness among the dogs may have contributed to these responses. Thus CRT simulations using the individualized three-dimensional heart models can predict acute hemodynamic improvement, and help determine the optimal positions of the pacing lead.

  9. Comparison of Conventional versus Steerable-Catheter Guided Coronary Sinus Lead Positioning in Patients Undergoing Cardiac Resynchronization Device Implantation

    PubMed Central

    Er, Fikret; Yüksel, Dilek; Hellmich, Martin; Gassanov, Natig

    2015-01-01

    Objectives The aim of this study was to compare conventional versus steerable catheter guided coronary sinus (CS) cannulation in patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT). Background Steerable catheter guided coronary sinus cannulation could reduce fluoroscopy time and contrast medium use during CRT implantation. Methods 176 consecutive patients with ischemic and non-ischemic heart failure undergoing CRT implantation from January 2008 to December 2012 at the University Hospital of Cologne were identified. During the study period two concurrent CS cannulation techniques were used: standard CS cannulation technique (standard-group, n = 113) and CS cannulation using a steerable electrophysiology (EP) catheter (EPCath-group, n = 63). Propensity-score matched pairs of conventional and EP-catheter guided CS cannulation made up the study population (n = 59 pairs). Primary endpoints were total fluoroscopy time and contrast medium amount used during procedure. Results The total fluoroscopy time was 30.9 min (interquartile range (IQR), 19.9–44.0 min) in the standard-group and 23.4 min (IQR, 14.2-34-2 min) in the EPCath-group (p = 0.011). More contrast medium was used in the standard-group (60.0 ml, IQR, 30.0–100 ml) compared to 25.0 ml (IQR, 20.0–50.0 ml) in the EPCath-group (P<0.001). Conclusions Use of steerable EP catheter was associated with significant reduction of fluoroscopy time and contrast medium use in patients undergoing CRT implantation. PMID:26599637

  10. [From implantable cardioverter-defibrillator to cardiac resynchronization therapy with the use of epicardial left ventricular lead. The evolution of the treatment of post inflammatory heart failure--a case report].

    PubMed

    Gepner, Katarzyna; Sterliński, Maciej; Przybylski, Andrzej; Maciag, Aleksander; Kołsut, Piotr; Szwed, Hanna

    2006-10-01

    The authors present a case of a 77-year-old man with heart failure in the course of dilated cardiomyopathy (DCM) and atrial fibrillation (AF), after implantation of an automatic cardioverter-defibrillator (ICD) due to recurrent symptomatic ventricular tachycardia (VT). Addition of cardiac resynchronization therapy (CRT) was decided due to the heart-failure dependent intensification of the arrhythmia and poststimulation enlargement of QRS. CRT was led to withdraw patient's arrhythmia and to improvement of the general condition of the patient for approximately one year. After the arrhythmia reoccurred due to dislocation of the electrode in the coronary sinus with loss of left ventricle stimulation. Multiple attempts at restoration of resynchronization function via a transvenous approach failed. The patient was qualified for implantation of an epicardial left ventricle electrode. The surgery was combined with a planned exchange of ICD-CRT. Basing on a 6-month observation period an improvement heart performance and general state of health have been observed. No arrhythmic event has been noted in device memory. Performed procedures are picturing the evolution of in pacing techniques and automatic defibrillation in Poland over recent years.

  11. Parametric ultrasound and fluoroscopy image fusion for guidance of left ventricle lead placement in cardiac resynchronization therapy

    PubMed Central

    Babic, Aleksandar; Odland, Hans Henrik; Gérard, Olivier; Samset, Eigil

    2015-01-01

    Abstract. Recent studies show that the response rate to cardiac resynchronization therapy (CRT) could be improved if the left ventricle (LV) is paced at the site of the latest mechanical activation, but away from the myocardial scar. A prototype system for CRT lead placement guidance that combines LV functional information from ultrasound with live x-ray fluoroscopy was developed. Two mean anatomical models, each containing LV epi-, LV endo- and right ventricle endocardial surfaces, were computed from a database of 33 heart failure patients as a substitute for a patient-specific model. The sphericity index was used to divide the observed population into two groups. The distance between the mean and the patient-specific models was determined using a signed distance field metric (reported in mm). The average error values for LV epicardium were −0.4±4.6 and for LV endocardium were −0.3±4.4. The validity of using average LV models for a CRT procedure was tested by simulating coronary vein selection in a group of 15 CRT candidates. The probability of selecting the same coronary branch, when basing the selection on the average model compared to a patient-specific model, was estimated to be 95.3±2.9%. This was found to be clinically acceptable. PMID:26158110

  12. Long-term outcomes in patients with ambulatory new york heart association class III and IV heart failure undergoing cardiac resynchronization therapy.

    PubMed

    Rickard, John; Bassiouny, Mohammed; Tedford, Ryan J; Baranowski, Bryan; Spragg, David; Cantillon, Daniel; Varma, Niraj; Wilkoff, Bruce L; Tang, W H Wilson

    2015-01-01

    Patients with ambulatory New York Heart Association (NYHA) class IV heart failure were significantly underrepresented in clinical trials of cardiac resynchronization therapy (CRT). The natural long-term trajectory of survival free of left ventricular assist device (LVAD) or heart transplant in patients with ambulatory class IV symptoms who underwent CRT has not been established. We extracted clinical data on 723 consecutive patients with NYHA class III or ambulatory class IV heart failure, left ventricular ejection fraction ≤35%, and a QRS duration ≥120 ms who underwent CRT from September 30, 2003, to August 6, 2007. Chart notes immediately before CRT were reviewed to confirm NYHA class status before CRT. Kaplan-Meier curves and a multivariate Cox proportional hazards model were constructed to determine long-term survival free of heart transplant and LVAD based on NYHA class status. Of the 723 patients, 52 had ambulatory class IV symptoms. Over a mean follow-up of 5.0 ± 2.5 years controlling for many possible confounders, ambulatory NYHA class IV status was independently associated with poor long-term outcomes. The 1-, 2-, 3-, 4-, and 5-year survival free of LVAD or heart transplant for class III versus ambulatory class IV patients was 92.0%, 84.0%, 75.0%, 68.1%, and 63.2% versus 75.0%, 61.5%, 52.0%, 45%, and 40.4%, respectively. Although patients with ambulatory class IV heart failure receiving CRT have inferior long-term outcomes compared with those with class III symptoms, survival in class IV patients continues to parallel class III patients over an extended follow-up. At 5 years, survival free of LVAD or heart transplant in ambulatory class IV patients receiving CRT is 40%.

  13. Electro-echocardiographic Indices to Predict Cardiac Resynchronization Therapy Non-response on Non-ischemic Cardiomyopathy

    PubMed Central

    Yu, Ziqing; Chen, Xueying; Han, Fei; Qin, Shengmei; Li, Minghui; Wu, Yuan; Su, Yangang; Ge, Junbo

    2017-01-01

    Cardiac resynchronization therapy (CRT) threw lights on heart failure treatment, however, parts of patients showed nonresponse to CRT. Unfortunately, it lacks effective parameters to predict CRT non-response. In present study, we try to seek effective electro-echocardiographic predictors on CRT non-response. This is a retrospective study to review a total of 227 patients of dyssynchronous heart failure underwent CRT implantation. Logistic analysis was performed between CRT responders and CRT non-responders. The primary outcome was the occurrence of improved left ventricular ejection fraction 1 year after CRT implantation. We concluded that LVEDV > 255 mL (OR = 2.236; 95% CI, 1.016–4.923) rather than LVESV > 160 mL (OR = 1.18; 95% CI, 0.544–2.56) and TpTe/QTc > 0.203 (OR = 5.206; 95% CI, 1.89–14.34) significantly predicted CRT non-response. Oppositely, S wave > 5.7 cm/s (OR = 0.242; 95% CI, 0.089–0.657), E/A > 1 (OR = 0.211; 95% CI, 0.079–0.566), E’/A’ > 1 (OR = 0.054; 95% CI, 0.017–0.172), CLBBB (OR = 0.141; 95% CI, 0.048–0.409), and QRS duration >160 ms (OR = 0.52; 95% CI, 0.305–0.922) surprisingly predicted low-probability of CRT non-response. PMID:28281560

  14. Clinical Long-Term Response to Cardiac Resynchronization Therapy Is Independent of Persisting Echocardiographic Markers of Dyssynchrony

    PubMed Central

    Naegeli, Barbara; Brunner-La Rocca, Hans-Peter; Attenhofer Jost, Christine; Fah-Gunz, Anja; Maurer, Dominik; Bertel, Osmund; Scharf, Christoph

    2014-01-01

    Background The aim of the study was to prove the concept that correction of established parameters of dyssynchrony is a requirement for favorable long-term outcome in patients with cardiac resynchronization therapy (CRT), whereas patients with persisting dyssynchrony should have a less favorable response. Methods After CRT implantation and optimization of dyssynchrony parameters, we evaluated whether correction or persistence of dyssynchrony predicted long-term outcome. Primary endpoint was a combination of cardiac mortality/heart transplantation and hospitalization due to worsening heart failure, and secondary endpoint was NYHA class. Results One hundred twenty-eight consecutive patients (mean age 68 ± 10 years) undergoing CRT with a mean left ventricular ejection fraction of 27±9% were followed for 27 ± 19 months. All cause mortality was 17.2%, cardiac mortality was 7.8% and 3.1% had to undergo heart transplantation. Rehospitalization due to worsening heart failure was observed in 14.8%. NYHA class before CRT implantation was 2.8 ± 0.8 and improved during follow-up to 2.0 ± 0.8 (P < 0.001). A clinical response was observed in 76% (n = 97) and an echocardiographic response was documented in 66% (n = 85). After individually optimized AV and VV intervals with echocardiography, atrioventricular dyssynchrony was still present in 7.2%, interventricular dyssynchrony in 13.3% and intraventricular dyssynchrony in 16.4%. Despite persistent atrioventricular, interventricular and intraventricular dyssynchrony at long-term follow-up, the combined primary and secondary endpoints did not differ compared to the group without mechanical dyssynchrony (P = ns). QRS duration with biventricular stimulation did not differ between responders vs. nonresponders. Conclusion After successful CRT implantation, clinical long-term response is independent of correction of dyssynchrony measured by echocardiographic parameters and QRS width. PMID:28352448

  15. Utility of comprehensive assessment of strain dyssynchrony index by speckle tracking imaging for predicting response to cardiac resynchronization therapy.

    PubMed

    Tatsumi, Kazuhiro; Tanaka, Hidekazu; Yamawaki, Kouhei; Ryo, Keiko; Omar, Alaa Mabrouk Salem; Fukuda, Yuko; Norisada, Kazuko; Matsumoto, Kensuke; Onishi, Tetsuari; Gorcsan, John; Yoshida, Akihiro; Kawai, Hiroya; Hirata, Ken-ichi

    2011-02-01

    The strain delay index is reportedly a marker of dyssynchrony and residual myocardial contractility. The aim of this study was to test the hypothesis that a relatively simple version of the strain dyssynchrony index (SDI) can predict response to cardiac resynchronization therapy (CRT) and that combining assessment of radial, circumferential, and longitudinal SDI can further improve the prediction of responders. A total of 52 patients who underwent CRT were studied. The SDI was calculated as the average difference between peak and end-systolic strain from 6 segments for radial and circumferential SDI and 18 segments for longitudinal SDI. Conventional dyssynchrony measures were assessed by interventricular mechanical delay, the Yu index, and radial dyssynchrony by speckle tracking strain. Response was defined as a ≥15% decrease in end-systolic volume after 3 months. Of the individual parameters, radial SDI ≥6.5% was the best predictor of response to CRT, with sensitivity of 81%, specificity of 81%, and an area under the curve of 0.87 (p <0.001). Circumferential SDI ≥3.2% and longitudinal SDI ≥3.6% were also found to be predictive of response to CRT, with areas under the curve of 0.81 and 0.80, respectively (p <0.001). Moreover, radial, circumferential, and longitudinal SDI at baseline were correlated with reduction of end-systolic volume with CRT. In addition, the response rate in patients with 3 positive SDIs was 100%. In contrast, rates in patients with either 1 or no positive SDIs were 42% and 22%, respectively (p <0.005 and p <0.001 vs 3 positive SDIs). In conclusion, the SDI can successfully predict response to CRT, and the combined approach leads to more accurate prediction than using individual parameters.

  16. Cardiac resynchronization therapy with special focus on patency of coronary sinus and its branches: conceptual viewpoint and semi-theoretical considerations on lead-induced obstruction.

    PubMed

    Stirbys, Petras

    2006-01-01

    Cardiac resynchronization therapy appears to be useful for patients with severe chronic congestive heart failure. However, many questions still arise concerning the effectiveness of this kind of therapy since hemodynamic improvement is not observed in all patients. Heterogeneity of conclusions reported by several multicenter clinical trials and prominent experts demonstrates that many uncertainties related to cardiac resynchronization therapy still exist. We tried to reveal some inadequacies in clinical results by focusing on cardiac venous blood return which is likely complicated by the presence of lead inside the coronary sinus and its branches. Downstream traversing lead may occlude (partially or completely) the ostia of minor tributaries and target vein of lead final positioning. Thrombosis may also be incited within the coronary sinus itself. Remaining lumen predetermined by the lead body and subsequent thrombosis may be insufficient to provide adequate blood flow. Resulting detrimental venous return presumably may slightly depress myocardial contractility which may be significant in very sensitive group of patients assigned to the New York Heart Association class III or IV. Cardiac venous blood pumping conditions (or venous drainage) are likely also complicated by abnormal activation of left ventricle. The contributory role of these two subtle causes unfavorably influencing venous drainage is still unknown. It may be treated as a hypothetical attempt to find the clue and needs future studies for verification.

  17. A prospective evaluation of cardiovascular magnetic resonance measures of dyssynchrony in the prediction of response to cardiac resynchronization therapy

    PubMed Central

    2014-01-01

    Background Many patients with electrical dyssynchrony who undergo cardiac resynchronization therapy (CRT) do not obtain substantial benefit. Assessing mechanical dyssynchrony may improve patient selection. Results from studies using echocardiographic imaging to measure dyssynchrony have ultimately proved disappointing. We sought to evaluate cardiac motion in patients with heart failure and electrical dyssynchrony using cardiovascular magnetic resonance (CMR). We developed a framework for comparing measures of myocardial mechanics and evaluated how well they predicted response to CRT. Methods CMR was performed at 1.5 Tesla prior to CRT. Steady-state free precession (SSFP) cine images and complementary modulation of magnetization (CSPAMM) tagged cine images were acquired. Images were processed using a novel framework to extract regional ventricular volume-change, thickening and deformation fields (strain). A systolic dyssynchrony index (SDI) for all parameters within a 16-segment model of the ventricle was computed with high SDI denoting more dyssynchrony. Once identified, the optimal measure was applied to a second patient population to determine its utility as a predictor of CRT response compared to current accepted predictors (QRS duration, LBBB morphology and scar burden). Results Forty-four patients were recruited in the first phase (91% male, 63.3 ± 14.1 years; 80% NYHA class III) with mean QRSd 154 ± 24 ms. Twenty-one out of 44 (48%) patients showed reverse remodelling (RR) with a decrease in end systolic volume (ESV) ≥ 15% at 6 months. Volume-change SDI was the strongest predictor of RR (PR 5.67; 95% CI 1.95-16.5; P = 0.003). SDI derived from myocardial strain was least predictive. Volume-change SDI was applied as a predictor of RR to a second population of 50 patients (70% male, mean age 68.6 ± 12.2 years, 76% NYHA class III) with mean QRSd 146 ± 21 ms. When compared to QRSd, LBBB morphology and scar burden, volume

  18. Evaluation of synergistic effects of resynchronization therapy and a β-blocker up-titration strategy based on a predefined patient-management program: the RESTORE study.

    PubMed

    Palmisano, Pietro; Ammendola, Ernesto; D'Onofrio, Antonio; Accogli, Michele; Calò, Leonardo; Ruocco, Antonio; Rapacciuolo, Antonio; Del Giorno, Giuseppe; Bianchi, Valter; Malacrida, Maurizio; Valsecchi, Sergio; Gronda, Edoardo

    2015-01-01

    Prior studies have suggested that a substantial number of eligible heart failure (HF) patients fail to receive β-blocker therapy, or receive it at a suboptimal dose. The aim of this study is to assess the benefit of a predefined management program designed for β-blocker up-titration, evaluating the synergistic effect of cardiac resynchronization therapy (CRT) and β-blockers in a HF population. The Resynchronization Therapy and β-Blocker Titration (RESTORE) study is a prospective, case-control, multicenter cohort study designed to test the hypothesis that a β-blocker up-titration strategy based on a predefined management program maximizes the beneficial effect of CRT, increasing the number of patients reaching the target dose of β-blockers and improving their clinical outcome. All study patients receive an implantable defibrillator for CRT delivery in accordance with current guidelines. Enrollments started in December 2011 and are scheduled to end in December 2014. Approximately 250 consecutive patients will be prospectively enrolled in 6 Italian centers and followed up for 24 months after implantation. The primary endpoint is to demonstrate that CRT may allow titration of β-blockers until the optimal dose, or at least to the effective dose, in patients with HF. This study might provide important information about the benefit of a predefined management program for β-blocker up-titration in patients receiving CRT. Moreover, assessment of health-care utilization and the consumption of resources will allow estimating the potential utility of remote monitoring by means of an automated telemedicine system in facilitating the titration of β-blockers in comparison with a standard in-hospital approach.

  19. Cardiac Resynchronization Therapy (CRT)

    MedlinePlus

    ... Giving for Heart.org Media for Heart.org Arrhythmia About Arrhythmia Why Arrhythmia Matters Understand Your Risk for Arrhythmia Symptoms, Diagnosis & Monitoring of Arrhythmia Prevention & Treatment of ...

  20. Evaluation of five resynchronization methods using different combinations of PGF2α, GnRH, estradiol and an intravaginal progesterone device for insemination in Holstein cows.

    PubMed

    Sani, R Narenji; Farzaneh, N; Moezifar, M; Seifi, H A; Tabatabei, A Alavi

    2011-03-01

    The aim of this study was to evaluate five methods for the resynchronization of estrus in lactating dairy cows. One hundred and seventy-three Holstein cows were assigned at random to five treatments: Ovsynch-24, IPD+Ovsynch-24, Ovsynch-31, Heatsynch, and IPD+Heatsynch. The start of the resynchronization protocols, and all subsequent procedures, was timed in relation to the pre-enrolment AI (PAI) and ranged over 7 days for each treatment. The pregnancy status of all the animals was evaluated by ultrasound examination on day 31±3 PAI. In all treatments, the resynchronized AI (RAI) was at an observed estrus or at a fixed time after the completion of the resynchronization procedures. Cows were observed for estrus thrice daily and those observed in estrus were inseminated according to the AM-PM rule. Those cows diagnosed as not pregnant and not observed in estrus were inseminated at a fixed time. The average proportion of cows with an active CL was 31.2% (54/173) on day 14 PAI, 22.0% (38/173) on day 21 PAI, and 18.5% (32/173) on day 24 PAI (NS). The incidence of luteolysis averaged 12.7% (22/173) from day 21 to 24, and 28.9% (50/173) from day 14 to 24. The differences between individual treatments were not significant but there was a significantly greater incidence of luteolysis (P<0.0009) from day 14 to 21 for the IPD treatments combined (30.3%; 24/63) than for the non-IPD treatments combined (26.6%; 17/110). Conception rates at day 31 PAI ranged from 16.6% to 42.1% (NS), and at day 61 PAI ranged from 16.6% to 37.1% (NS). Also conception rates at day 31 and 61 RAI ranged from 5% to 25% (NS). Pregnancy losses between days 31 and 61 PAI varied from 0 to 25.0% (NS) between treatments for the pre-enrollment AI but were 0% for all treatments for the resynchronized AI. It was concluded that using IPD, PGF2α, estradiol and GnRH in different resynchronization methods had no effects on conception rate in this study. Also conception rate was not significantly different when

  1. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of...: ``Medtronic cardiac resynchronization therapy defibrillator (CRT-D) systems are indicated for heart...

  2. [Case with Emery-Dreifuss muscular dystrophy diagnosed forty-two years after onset and implanted with a cardiac resynchronization therapy defibrillator].

    PubMed

    Sakiyama, Yoshio; Watanabe, Eri; Otsuka, Mieko; Hirahara, Taishi; Momomura, Shinichi; Hayashi, Yukiko

    2014-01-01

    The patient was a 53-year-old male. He showed steppage gait at the age of 11 and equinus foot at 13. He walked unaided with shoe-insoles to support his heels. Atrial fibrillation and cardiac hypertrophy were found in his 30s, and ventricular tachycardia (VT) was observed at the age of 48. Electrophysiological studies were performed, but VT was not sustained, symptomatic, or showed signs of infra-Hisian block, and a pacemaker was not indicated. At 53, he was introduced to a neurologist because of tetraplegia after the first episode of syncope. A spinal MR showed ossification of posterior longitudinal ligament (OPLL) and central cervical cord injury. Furthermore, he presented not only contracture in his shoulder, elbow, and ankles but also atrophy in his scapulohumeral and gastrocnemius muscles. In accordance with a diagnosis of Emery-Dreifuss muscular dystrophy (EDMD), provocative testing of VT was carried out, and a cardiac resynchronization therapy defibrillator (CRT-D) was implanted. Later, a mutation analysis of the LMNA gene disclosed a known missense mutation of p.Arg377His, and we diagnosed him as EDMD2 (laminopathy). Contractures could be the clue to diagnose EDMD and indicate the need for pacemakers and defibrillators in patients with cardiac conduction disorders.

  3. Respiratory motion compensated overlay of surface models from cardiac MR on interventional x-ray fluoroscopy for guidance of cardiac resynchronization therapy procedures

    NASA Astrophysics Data System (ADS)

    Manzke, R.; Bornstedt, A.; Lutz, A.; Schenderlein, M.; Hombach, V.; Binner, L.; Rasche, V.

    2010-02-01

    Various multi-center trials have shown that cardiac resynchronization therapy (CRT) is an effective procedure for patients with end-stage drug invariable heart failure (HF). Despite the encouraging results of CRT, at least 30% of patients do not respond to the treatment. Detailed knowledge of the cardiac anatomy (coronary venous tree, left ventricle), functional parameters (i.e. ventricular synchronicity) is supposed to improve CRT patient selection and interventional lead placement for reduction of the number of non-responders. As a pre-interventional imaging modality, cardiac magnetic resonance (CMR) imaging has the potential to provide all relevant information. With functional information from CMR optimal implantation target sites may be better identified. Pre-operative CMR could also help to determine whether useful vein target segments are available for lead placement. Fused with X-ray, the mainstay interventional modality, improved interventional guidance for lead-placement could further help to increase procedure outcome. In this contribution, we present novel and practicable methods for a) pre-operative functional and anatomical imaging of relevant cardiac structures to CRT using CMR, b) 2D-3D registration of CMR anatomy and functional meshes with X-ray vein angiograms and c) real-time capable breathing motion compensation for improved fluoroscopy mesh overlay during the intervention based on right ventricular pacer lead tracking. With these methods, enhanced interventional guidance for left ventricular lead placement is provided.

  4. Incremental Value of Cystatin C Over Conventional Renal Metrics for Predicting Clinical Response and Outcomes in Cardiac Resynchronization Therapy: The BIOCRT Study

    PubMed Central

    Chatterjee, Neal A.; Singh, Jagmeet P.; Szymonifka, Jackie; Deaño, Roderick C.; Thai, Wai-ee; Wai, Bryan; Min, James K.; Januzzi, James L.; Truong, Quynh A.

    2015-01-01

    Background Despite the benefit of CRT in select patients with heart failure (HF), there remains significant need for predicting those at risk for adverse outcomes for this effective but costly therapy. CysC, an emerging marker of renal function, is predictive of worsening symptoms and mortality in patients with HF. This study assessed the utility of baseline and serial measures of cystatin C (CysC), compared to conventional creatinine-based measures of renal function (estimated glomerular filtration rate, eGFR), in predicting clinical outcomes following cardiac resynchronization therapy (CRT). Methods In 133 patients, we measured peripheral venous (PV) and coronary sinus (CS) CysC concentrations and peripheral creatinine levels at the time of CRT implant. Study endpoints included clinical response to CRT at 6 months and major adverse cardiac events (MACE) at 2 years. Results While all 3 renal metrics were predictive of MACE (all adjusted p≤0.02), only CysC was associated with CRT non-response at 6 months (adjusted odds ratio 3.6, p=0.02). CysC improved prediction of CRT non-response (p≤0.003) in net reclassification index analysis compared to models utilizing standard renal metrics. Serial CysC >1mg/L was associated with 6-month CRT non-response and reduced 6-minute walk distance as well as 2-year MACE (all p≤0.04). Conclusion In patients undergoing CRT, CysC demonstrated incremental benefit in the prediction of CRT non-response when compared to standard metrics of renal function. Baseline and serial measures of elevated CysC were predictive of CRT non-response and functional status at 6 months as well as long term clinical outcomes. PMID:26710332

  5. Device therapy for heart failure.

    PubMed

    Boehmer, John P

    2003-03-20

    Although pharmacologic therapy has made impressive advances in the past decade and is the mainstay of therapy for heart failure (HF), there is still a large unmet need, because morbidity and mortality remain unacceptably high. Implanted medical devices are gaining increasing utility in this group of patients and have the potential to revolutionize the treatment of HF. The majority of devices in clinical use or under active investigation in HF can be grouped into 1 of 4 categories: devices to monitor the HF condition, devices to treat rhythm disturbances, devices to improve the mechanical efficiency of the heart, and devices to replace part or all of the heart's function. There are several devices either approved or under development to monitor the HF condition, ranging from interactive weight scales to implantable continuous pressure monitors. The challenge is to demonstrate that this technology can improve patient outcomes. Pacemakers and implantable cardioverter defibrillators (ICDs) are used to treat heart rhythms in a broad range of patients with heart disease, but they now have a special place in HF management with the prophylactic use of ICDs in patients who have advanced systolic dysfunction. The Multicenter Automatic Defibrillator Implantation Trial (MADIT) II study demonstrated a 29% reduction in all-cause mortality with ICDs in patients with a history of a myocardial infarction and a left ventricular (LV) ejection fraction <0.30. LV and multisite pacing are means of improving the mechanical efficiency of the heart. The concept is to create a more coordinated contraction of the ventricles to overcome the inefficiency associated with conduction system delays, which are common in HF. The acute hemodynamic effect can be impressive and is immediate. Several studies of intermediate duration (3 to 6 months) have consistently demonstrated that biventricular pacing improves symptoms and exercise capacity. Mechanical methods of remodeling the heart into a more

  6. Relationship Between Changes in Pulse Pressure and Frequency Domain Components of Heart Rate Variability During Short-Term Left Ventricular Pacing in Patients with Cardiac Resynchronization Therapy

    PubMed Central

    Urbanek, Bożena; Ruta, Jan; Kudryński, Krzysztof; Ptaszyński, Paweł; Klimczak, Artur; Wranicz, Jerzy Krzysztof

    2016-01-01

    Background The aim of the study was to explore the relationship between changes in pulse pressure (PP) and frequency domain heart rate variability (HRV) components caused by left ventricular pacing in patients with implanted cardiac resynchronization therapy (CRT). Material/Methods Forty patients (mean age 63±8.5 years) with chronic heart failure (CHF) and implanted CRT were enrolled in the study. The simultaneous 5-minute recording of beat-to-beat arterial systolic and diastolic blood pressure (SBP and DBP) by Finometer and standard electrocardiogram with CRT switched off (CRT/0) and left ventricular pacing (CRT/LV) was performed. PP (PP=SBP-DBP) and low- and high-frequency (LF and HF) HRV components were calculated, and the relationship between these parameters was analyzed. Results Short-term CRT/LV in comparison to CRT/0 caused a statistically significant increase in the values of PP (P<0.05), LF (P<0.05), and HF (P<0.05). A statistically significant correlation between ΔPP and ΔHF (R=0.7384, P<0.05) was observed. The ΔHF of 6 ms2 during short-term CRT/LV predicted a PP increase of ≥10% with 84.21% sensitivity and 85.71% specificity. Conclusions During short-term left ventricular pacing in patients with CRT, a significant correlation between ΔPP and ΔHF was observed. ΔHF ≥6 ms2 may serve as a tool in the selection of a suitable site for placement of a left ventricular lead. PMID:27305349

  7. Comparison of different invasive hemodynamic methods for AV delay optimization in patients with cardiac resynchronization therapy: Implications for clinical trial design and clinical practice☆☆☆

    PubMed Central

    Whinnett, Zachary I.; Francis, Darrel P.; Denis, Arnaud; Willson, Keith; Pascale, Patrizio; van Geldorp, Irene; De Guillebon, Maxime; Ploux, Sylvain; Ellenbogen, Kenneth; Haïssaguerre, Michel; Ritter, Philippe; Bordachar, Pierre

    2013-01-01

    Background Reproducibility and hemodynamic efficacy of optimization of AV delay (AVD) of cardiac resynchronization therapy (CRT) using invasive LV dp/dtmax are unknown. Method and results 25 patients underwent AV delay (AVD) optimisation twice, using continuous left ventricular (LV) dp/dtmax, systolic blood pressure (SBP) and pulse pressure (PP). We compared 4 protocols for comparing dp/dtmax between AV delays:Immediate absolute: mean of 10 s recording of dp/dtmax acquired immediately after programming the tested AVD,Delayed absolute: mean of 10 s recording acquired 30 s after programming AVD,Single relative: relative difference between reference AVD and the tested AVD,Multiple relative: averaged difference, from multiple alternations between reference and tested AVD. We assessed for dp/dtmax, LVSBP and LVPP, test–retest reproducibility of the optimum. Optimization using immediate absolute dp/dtmax had poor reproducibility (SDD of replicate optima = 41 ms; R2 = 0.45) as did delayed absolute (SDD 39 ms; R2 = 0.50). Multiple relative had better reproducibility: SDD 23 ms, R2 = 0.76, and (p < 0.01 by F test). Compared with AAI pacing, the hemodynamic increment from CRT, with the nominal AV delay was LVSBP 2% and LVdp/dtmax 5%, while CRT with pre-determined optimal AVD gave 6% and 9% respectively. Conclusions Because of inevitable background fluctuations, optimization by absolute dp/dtmax has poor same-day reproducibility, unsuitable for clinical or research purposes. Reproducibility is improved by comparing to a reference AVD and making multiple consecutive measurements. More than 6 measurements would be required for even more precise optimization — and might be advisable for future study designs. With optimal AVD, instead of nominal, the hemodynamic increment of CRT is approximately doubled. PMID:23481908

  8. Combined baseline strain dyssynchrony index and its acute reduction predicts mid-term left ventricular reverse remodeling and long-term outcome after cardiac resynchronization therapy.

    PubMed

    Tatsumi, Kazuhiro; Tanaka, Hidekazu; Matsumoto, Kensuke; Miyoshi, Tatsuya; Hiraishi, Mana; Tsuji, Takayuki; Kaneko, Akihiro; Ryo, Keiko; Fukuda, Yuko; Norisada, Kazuko; Onishi, Tetsuari; Yoshida, Akihiro; Kawai, Hiroya; Hirata, Ken-ichi

    2014-04-01

    The objective of this study was to test the hypothesis that combining assessment of baseline radial strain dyssynchrony index (SDI), that expressed both left ventricular (LV) dyssynchrony and residual myocardial contractility, and of acute changes in this index can yield more accurate prediction of mid-term responders and long-term outcome after cardiac resynchronization therapy (CRT). Radial SDI for 75 CRT patients was calculated as the average difference between peak and end-systolic speckle tracking strain from 6 segments of the mid-LV short-axis view before and 8 ± 2 days after CRT. Mid-term responder was defined as ≥ 15% decrease in LV end-systolic volume 6 ± 2 months after CRT. Long-term outcome was tracked over 5 years. Baseline radial SDI ≥ 6.5% is considered predictive of responder and favorable outcome, as previously reported. Acute reduction in radial SDI ≥ 1.5% was found to be the best predictor of mid-term responders with CRT. Furthermore, patients with acute reductions in radial SDI ≥1.5% were associated with a significantly more favorable long-term outcome after CRT than those with radial SDI <1.5% (log rank P < 0.001). An important findings were that baseline radial SDI ≥6.5% and acute reductions in radial SDI ≥ 1.5% in 42 patients were associated with the highest event-free survival rate of 92%, whereas, 21 patients corresponding values of <6.5% and <1.5% were associated with low event-free survival rate of 46% (log rank P < 0.001). Combined assessment of baseline radial SDI and its acute reduction after CRT may have clinical implications for predicting responders and thus patients' care.

  9. Cardiac resynchronization therapy evaluated by myocardial scintigraphy with 99mTc-MIBI: changes in left ventricular uptake, dyssynchrony, and function

    PubMed Central

    Nishioka, Silvana A. D.; Giorgi, Maria C. P.; Chen, Ji; Abe, Rubens; Filho, Martino Martinelli; Hotta, Viviane T.; Vieira, Marcelo L.; Garcia, Ernest V.; Meneghetti, José C.

    2012-01-01

    Purpose 99mTc-MIBI gated myocardial scintigraphy (GMS) evaluates myocyte integrity and perfusion, left ventricular (LV) dyssynchrony and function. Cardiac resynchronization therapy (CRT) may improve the clinical symptoms of heart failure (HF), but its benefits for LV function are less pronounced. We assessed whether changes in myocardial 99mTc-MIBI uptake after CRT are related to improvement in clinical symptoms, LV synchrony and performance, and whether GMS adds information for patient selection for CRT. Methods A group of 30 patients with severe HF were prospectively studied before and 3 months after CRT. Variables analysed were HF functional class, QRS duration, LV ejection fraction (LVEF) by echocardiography, myocardial 99mTc-MIBI uptake, LV end-diastolic volume (EDV) and end-systolic volume (ESV), phase analysis LV dyssynchrony indices, and regional motion by GMS. After CRT, patients were divided into two groups according to improvement in LVEF: group 1 (12 patients) with increase in LVEF of 5 or more points, and group 2 (18 patients) without a significant increase. Results After CRT, both groups showed a significant improvement in HF functional class, reduced QRS width and increased septal wall 99mTc-MIBI uptake. Only group 1 showed favourable changes in EDV, ESV, LV dyssynchrony indices, and regional motion. Before CRT, EDV, and ESV were lower in group 1 than in group 2. Anterior and inferior wall 99mTc-MIBI uptakes were higher in group 1 than in group 2 (p<0.05). EDV was the only independent predictor of an increase in LVEF (p=0.01). The optimal EDV cut-off point was 315 ml (sensitivity 89%, specificity 94%). Conclusion The evaluation of EDV by GMS added information on patient selection for CRT. After CRT, LVEF increase occurred in hearts less dilated and with more normal 99mTc-MIBI uptake. PMID:19145431

  10. Relation between strain dyssynchrony index determined by comprehensive assessment using speckle-tracking imaging and long-term outcome after cardiac resynchronization therapy for patients with heart failure.

    PubMed

    Tatsumi, Kazuhiro; Tanaka, Hidekazu; Matsumoto, Kensuke; Kaneko, Akihiro; Tsuji, Takayuki; Ryo, Keiko; Fukuda, Yuko; Norisada, Kazuko; Onishi, Tetsuari; Yoshida, Akihiro; Kawai, Hiroya; Hirata, Ken-Ichi

    2012-04-15

    Strain dyssynchrony index (SDI), which was a marker of dyssynchrony and residual myocardial contractility, can predict left ventricular reverse remodeling short-term after cardiac resynchronization therapy (CRT). We investigated SDI-predicted long-term outcome after CRT in patients with heart failure (HF). We studied 74 patients with HF who underwent CRT. SDI was calculated as the average difference between peak and end-systolic strain from 6 segments for radial and circumferential SDIs and 18 segments for longitudinal SDI using 2-dimensional speckle-tracking strain. Based on our previous findings, the predefined cutoff for significant dyssynchrony and residual myocardial contractility was a radial SDI ≥6.5%, a circumferential SDI ≥3.2%, and a longitudinal SDI ≥3.6%. The predefined principal outcome variable was the combined end point of death or hospitalization owing to deteriorating HF. Long-term follow-up after CRT was tracked over 4 years. The primary end point of prespecified events occurred in 14 patients (19%). An association with a favorable long-term outcome after CRT was observed in patients with significant radial, circumferential, and longitudinal SDIs (p <0.001, <0.005, and 0.010 vs patients without significant SDIs, respectively). Furthermore, cardiovascular event-free rate after CRT in patients with positivity of 3 for the 3 SDIs was 100% better than that in patients with positivity of 1 (52%, p <0.005) or 0 (31%, p <0.001) for the 3 SDIs. In conclusion, SDIs can successfully predict long-term outcome after CRT in patients with HF. Moreover, the approach combining the 3 types of SDI leads to a more accurate prediction than the use of individual parameters. These findings may have clinical implications in patients with CRT.

  11. Cardiac resynchronization therapy and bone marrow cell transplantation in patients with ischemic heart failure and electromechanical dyssynchrony: a randomized pilot study.

    PubMed

    Pokushalov, Evgeny; Romanov, Alexander; Corbucci, Giorgio; Prohorova, Darya; Chernyavsky, Alexander; Larionov, Petr; Terekhov, Igor; Artyomenko, Sergey; Kliver, Elena; Shirokova, Natalya; Karaskov, Alexander; Dib, Nabil

    2011-12-01

    Most studies have confirmed the beneficial effects of autologous bone marrow mononuclear cell (BMMC) transplantation on angina, myocardial perfusion, regional wall motion, and LV ejection fraction (LVEF). Cardiac resynchronization therapy (CRT) has also shown a beneficial effect in patients with heart failure (HF) and electrical/mechanical dyssynchrony. However, the relative contribution of BMMC and CRT in patients with ischemic HF and electromechanical dyssynchrony has never been investigated. The aim of this study was to evaluate the benefit of combining BMMC transplantation with CRT in patients with severe ischemic HF, left bundle branch block (LBBB), and mechanical dyssynchrony. Patients with ischemic HF, LVEF < 35%, LBBB, and mechanical dyssynchrony underwent intramyocardial transplantation of BMMC and CRTD system implantation. This randomized, single-blind, crossover study compared clinical and echocardiographic parameters during two follow-up periods: 6 months of active CRT (BMMC + CRTact) and 6 months of inactive CRT (BMMC + CRTinact). Physical performance was assessed by means of a 6-min walking test. Myocardial perfusion was evaluated by SPECT. Quality of Life (QoL) was assessed through the Minnesota Living with HF Questionnaire (MLwHFQ). Twenty-six patients (64 ± 7 years) were enrolled in the study. The distance covered by the patients during the 6-min walking test significantly increased in the BMMC + CRTinact phase (BMMC therapy only) in comparison with the baseline (269 ± 68 vs 206 ± 51; p = 0.007) and in the BMMC + CRTact phase (BMMC therapy + CRT) in comparison with the BMMC + CRTinact (378 ± 59 vs 269 ± 68; p < 0.001). The summed rest and stress score (SPECT) decreased significantly in the BMMC + CRTact and BMMC + CRTinact phases in comparison with the baseline (p ≤ 0.03). Both phases showed equivalent myocardial perfusion in the segments into which BMMC had been injected. QoL score was significantly lower in the BMMC

  12. An ontology-based annotation of cardiac implantable electronic devices to detect therapy changes in a national registry.

    PubMed

    Rosier, Arnaud; Mabo, Philippe; Chauvin, Michel; Burgun, Anita

    2015-05-01

    The patient population benefitting from cardiac implantable electronic devices (CIEDs) is increasing. This study introduces a device annotation method that supports the consistent description of the functional attributes of cardiac devices and evaluates how this method can detect device changes from a CIED registry. We designed the Cardiac Device Ontology, an ontology of CIEDs and device functions. We annotated 146 cardiac devices with this ontology and used it to detect therapy changes with respect to atrioventricular pacing, cardiac resynchronization therapy, and defibrillation capability in a French national registry of patients with implants (STIDEFIX). We then analyzed a set of 6905 device replacements from the STIDEFIX registry. Ontology-based identification of therapy changes (upgraded, downgraded, or similar) was accurate (6905 cases) and performed better than straightforward analysis of the registry codes (F-measure 1.00 versus 0.75 to 0.97). This study demonstrates the feasibility and effectiveness of ontology-based functional annotation of devices in the cardiac domain. Such annotation allowed a better description and in-depth analysis of STIDEFIX. This method was useful for the automatic detection of therapy changes and may be reused for analyzing data from other device registries.

  13. Are changes in the extent of left ventricular dyssynchrony as assessed by speckle tracking associated with response to cardiac resynchronization therapy?

    PubMed

    Ghani, Abdul; Delnoy, Peter Paul H M; Ottervanger, Jan Paul; Ramdat Misier, Anand R; Smit, Jaap Jan J; Adiyaman, Ahmet; Elvan, Arif

    2016-04-01

    Echocardiographic assessment of left ventricular (LV) dyssynchrony is used to predict response to cardiac resynchronization therapy (CRT). However, the association between reduction in the extent of speckle tracking based LV-dyssynchrony and echocardiographic response to CRT has not been explored yet. The aim of this study was to assess the changes in the extent of LV dyssynchrony as a result of CRT and its association with echocardiographic response to CRT in a large consecutive series of patients. We studied 138 patients with standard CRT indication. Time-based speckle tracking longitudinal strain (maximal delay between 6-segments in 4-chamber view) was performed to assess LV-dyssynchrony at baseline and after a mean follow-up of 22 ± 8 months. Echocardiographic CRT response was defined as a reduction in LV end-systolic volume ≥15 %. Mean age was 68 ± 8 years (30 % female). Mean LV ejection fraction (LVEF) was 26 ± 7 %. Ninety six patients (70 %) were classified as echocardiographic responders. In the total study group, LV-dyssynchrony decreased from 196 ± 89 ms at baseline to 180 ± 105 ms during follow-up, P = 0.01. Of note, in responders there was a pronounced reduction in LV dyssynchrony (198 ± 88 ms at baseline vs 154 ± 50 ms after CRT, P < 0.001), whereas in non-responders there was a significant increase (191 ± 92 ms at baseline vs 243 ± 160 ms after CRT, P = 0.04). After multivariate analysis, decreased in LV-dyssynchrony, wider QRS duration and non-ischemic etiology were independently and significantly associated with CRT response. Changes in the extent of LV dyssynchrony as measured by speckle tracking after CRT are independently associated with response to CRT.

  14. Causes-of-death analysis of patients with cardiac resynchronization therapy: an analysis of the CeRtiTuDe cohort study

    PubMed Central

    Marijon, Eloi; Leclercq, Christophe; Narayanan, Kumar; Boveda, Serge; Klug, Didier; Lacaze-Gadonneix, Jonathan; Defaye, Pascal; Jacob, Sophie; Piot, Olivier; Deharo, Jean-Claude; Perier, Marie-Cecile; Mulak, Genevieve; Hermida, Jean-Sylvain; Milliez, Paul; Gras, Daniel; Cesari, Olivier; Hidden-Lucet, Françoise; Anselme, Frederic; Chevalier, Philippe; Maury, Philippe; Sadoul, Nicolas; Bordachar, Pierre; Cazeau, Serge; Chauvin, Michel; Empana, Jean-Philippe; Jouven, Xavier; Daubert, Jean-Claude; Le Heuzey, Jean-Yves

    2015-01-01

    Aims The choice of resynchronization therapy between with (CRT-D) and without (CRT-P) a defibrillator remains a contentious issue. Cause-of-death analysis among CRT-P, compared with CRT-D, patients could help evaluate the extent to which CRT-P patients would have additionally benefited from a defibrillator in a daily clinical practice. Methods and results A total of 1705 consecutive patients implanted with a CRT (CRT-P: 535 and CRT-D: 1170) between 2008 and 2010 were enrolled in CeRtiTuDe, a multicentric prospective follow-up cohort study, with specific adjudication for causes of death at 2 years. Patients with CRT-P compared with CRT-D were older (P < 0.0001), less often male (P < 0.0001), more symptomatic (P = 0.0005), with less coronary artery disease (P = 0.003), wider QRS (P = 0.002), more atrial fibrillation (P < 0.0001), and more co-morbidities (P = 0.04). At 2-year follow-up, the annual overall mortality rate was 83.80 [95% confidence interval (CI) 73.41–94.19] per 1000 person-years. The crude mortality rate among CRT-P patients was double compared with CRT-D (relative risk 2.01, 95% CI 1.56–2.58). In a Cox proportional hazards regression analysis, CRT-P remained associated with increased mortality (hazard ratio 1.54, 95% CI 1.07–2.21, P = 0.0209), although other potential confounders may persist. By cause-of-death analysis, 95% of the excess mortality among CRT-P subjects was related to an increase in non-sudden death. Conclusion When compared with CRT-D patients, excess mortality in CRT-P recipients was mainly due to non-sudden death. Our findings suggest that CRT-P patients, as currently selected in routine clinical practice, would not potentially benefit with the addition of a defibrillator. PMID:26330420

  15. Cooling Devices in Laser therapy

    PubMed Central

    Das, Anupam; Sarda, Aarti; De, Abhishek

    2016-01-01

    Cooling devices and methods are now integrated into most laser systems, with a view to protecting the epidermis, reducing pain and erythema and improving the efficacy of laser. On the basis of method employed, it can be divided into contact cooling and non-contact cooling. With respect to timing of irradiation of laser, the nomenclatures include pre-cooling, parallel cooling and post-cooling. The choice of the cooling device is dictated by the laser device, the physician's personal choice with respect to user-friendliness, comfort of the patient, the price and maintenance costs of the device. We hereby briefly review the various techniques of cooling, employed in laser practice. PMID:28163450

  16. Long-term efficacy of implantable cardiac resynchronization therapy plus defibrillator for primary prevention of sudden cardiac death in patients with mild heart failure: an updated meta-analysis.

    PubMed

    Sun, Wei-Ping; Li, Chun-Lei; Guo, Jin-Cheng; Zhang, Li-Xin; Liu, Ran; Zhang, Hai-Bin; Zhang, Ling

    2016-07-01

    Previous studies of implantable cardiac resynchronization therapy plus defibrillator (CRT-D) therapy used for primary prevention of sudden cardiac death have suggested that CRT-D therapy is less effective in patients with mild heart failure and a wide QRS complex. However, the long-term benefits are variable. We performed a meta-analysis of randomized trials identified in systematic searches of MEDLINE, EMBASE, and the Cochrane Database. Three studies (3858 patients) with a mean follow-up of 66 months were included. Overall, CRT-D therapy was associated with significantly lower all-cause mortality than was implantable cardioverter defibrillator (ICD) therapy (OR, 0.78; 95 % CI, 0.63-0.96; P = 0.02; I (2) = 19 %). However, the risk of cardiac mortality was comparable between two groups (OR, 0.74; 95 % CI, 0.53-1.01; P = 0.06). CRT-D treatment was associated with a significantly lower risk of hospitalization for heart failure (OR, 0.67; 95 % CI, 0.50-0.89; P = 0.005; I (2) = 55 %). The composite outcome of all-cause mortality and hospitalization for heart failure was also markedly lower with CRT-D therapy than with ICD treatment alone (OR, 0.67; 95 % CI, 0.57-0.77; P < 0.0001; I (2) = 0 %). CRT-D therapy decreased the long-term risk of mortality and heart failure events in patients with mild heart failure with a wide QRS complex. However, long-term risk of cardiac mortality was similar between two groups. More randomized studies are needed to confirm these findings, especially in patients with NYHA class I heart failure or patients without LBBB.

  17. Induced pluripotent stem cell intervention rescues ventricular wall motion disparity, achieving biological cardiac resynchronization post-infarction

    PubMed Central

    Yamada, Satsuki; Nelson, Timothy J; Kane, Garvan C; Martinez-Fernandez, Almudena; Crespo-Diaz, Ruben J; Ikeda, Yasuhiro; Perez-Terzic, Carmen; Terzic, Andre

    2013-01-01

    Dyssynchronous myocardial motion aggravates cardiac pump function. Cardiac resynchronization using pacing devices is a standard-of-care in the management of heart failure. Post-infarction, however, scar tissue formation impedes the efficacy of device-based therapy. The present study tests a regenerative approach aimed at targeting the origin of abnormal motion to prevent dyssynchronous organ failure. Induced pluripotent stem (iPS) cells harbour a reparative potential, and were here bioengineered from somatic fibroblasts reprogrammed with the stemness factors OCT3/4, SOX2, KLF4, and c-MYC. In a murine infarction model, within 30 min of coronary ligation, iPS cells were delivered to mapped infarcted areas. Focal deformation and dysfunction underlying progressive heart failure was resolved prospectively using speckle-tracking imaging. Tracked at high temporal and spatial resolution, regional iPS cell transplantation restored, within 10 days post-infarction, the contractility of targeted infarcted foci and nullified conduction delay in adjacent non-infarcted regions. Local iPS cell therapy, but not delivery of parental fibroblasts or vehicle, prevented or normalized abnormal strain patterns correcting the decrease in peak strain, disparity of time-to-peak strain, and pathological systolic stretch. Focal benefit of iPS cell intervention translated into improved left ventricular conduction and contractility, reduced scar, and reversal of structural remodelling, protecting from organ decompensation. Thus, in ischaemic cardiomyopathy, targeted iPS cell transplantation synchronized failing ventricles, offering a regenerative strategy to achieve biological resynchronization. PMID:23568891

  18. Whom should I refer in 2014 for cardiac resynchronization?

    PubMed

    Manlucu, Jaimie; Tang, Anthony S L

    2014-06-01

    Heart failure continues to be a significant source of morbidity and mortality amongst Canadians. Many patients remain symptomatic despite guideline-directed medical therapy. For drug-refractory patients with dyssynchronous systolic heart failure, cardiac resynchronization therapy (CRT) has reliably reduced heart failure hospitalizations and related deaths. Unfortunately, despite significant advancements in technology and our understanding of its clinical effect, the CRT nonresponder rate remains approximately 30%. Great efforts have been invested into identifying clinical predictors of CRT response. Left bundle branch block conduction delay and wider QRS (> 150 ms) have consistently been associated with clinical response to CRT, earning them the strongest recommendations in the revised guidelines in Canada and across the world. Due in large part to the benefit observed in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) trial, patients with mild heart failure symptoms (New York Heart Association class II) are now also candidates for resynchronization therapy. Patients with atrial fibrillation, non-left bundle branch block conduction patterns, and chronic right ventricular pacing have historically been associated with poor response. However, these populations remain grossly underrepresented in the large trials. In the absence of more data, these patients continue to receive weaker recommendations for CRT in the guidelines.

  19. Diode-laser-based therapy device

    NASA Astrophysics Data System (ADS)

    Udrea, Mircea V.; Nica, Adriana S.; Florian, Mariana; Poenaru, Daniela; Udrea, Gabriela; Lungeanu, Mihaela; Sporea, Dan G.; Vasiliu, Virgil V.; Vieru, Roxana

    2004-10-01

    A new therapy laser device is presented. The device consists of a central unit and different types of laser probes. The laser probe model SL7-650 delivers seven red (650 nm), 5 mW diode lasers convergent beams. The beams converge at about 30 cm in front of the laser probe and the irradiated area might be varied by simple displacement of the laser probe with respect to the target. The laser probe SL1-808 emits single infrared laser beam up to 500 mW. The efficiency of the use of this device in physiotherapy, and rheumatology, has been put into evidence after years of testing. Dermatology and microsurgery are users of infrared powerful laser probes. The device has successfully passed technical and clinical tests in order to be certified. The laser device design and some medical results are given.

  20. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used...

  1. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used...

  2. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used...

  3. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used...

  4. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used...

  5. A systematic approach to designing reliable VV optimization methodology: Assessment of internal validity of echocardiographic, electrocardiographic and haemodynamic optimization of cardiac resynchronization therapy

    PubMed Central

    Kyriacou, Andreas; Li Kam Wa, Matthew E.; Pabari, Punam A.; Unsworth, Beth; Baruah, Resham; Willson, Keith; Peters, Nicholas S.; Kanagaratnam, Prapa; Hughes, Alun D.; Mayet, Jamil; Whinnett, Zachary I.; Francis, Darrel P.

    2013-01-01

    Background In atrial fibrillation (AF), VV optimization of biventricular pacemakers can be examined in isolation. We used this approach to evaluate internal validity of three VV optimization methods by three criteria. Methods and results Twenty patients (16 men, age 75 ± 7) in AF were optimized, at two paced heart rates, by LVOT VTI (flow), non-invasive arterial pressure, and ECG (minimizing QRS duration). Each optimization method was evaluated for: singularity (unique peak of function), reproducibility of optimum, and biological plausibility of the distribution of optima. The reproducibility (standard deviation of the difference, SDD) of the optimal VV delay was 10 ms for pressure, versus 8 ms (p = ns) for QRS and 34 ms (p < 0.01) for flow. Singularity of optimum was 85% for pressure, 63% for ECG and 45% for flow (Chi2 = 10.9, p < 0.005). The distribution of pressure optima was biologically plausible, with 80% LV pre-excited (p = 0.007). The distributions of ECG (55% LV pre-excitation) and flow (45% LV pre-excitation) optima were no different to random (p = ns). The pressure-derived optimal VV delay is unaffected by the paced rate: SDD between slow and fast heart rate is 9 ms, no different from the reproducibility SDD at both heart rates. Conclusions Using non-invasive arterial pressure, VV delay optimization by parabolic fitting is achievable with good precision, satisfying all 3 criteria of internal validity. VV optimum is unaffected by heart rate. Neither QRS minimization nor LVOT VTI satisfy all validity criteria, and therefore seem weaker candidate modalities for VV optimization. AF, unlinking interventricular from atrioventricular delay, uniquely exposes resynchronization concepts to experimental scrutiny. PMID:22459364

  6. When is an optimization not an optimization? Evaluation of clinical implications of information content (signal-to-noise ratio) in optimization of cardiac resynchronization therapy, and how to measure and maximize it.

    PubMed

    Pabari, Punam A; Willson, Keith; Stegemann, Berthold; van Geldorp, Irene E; Kyriacou, Andreas; Moraldo, Michela; Mayet, Jamil; Hughes, Alun D; Francis, Darrel P

    2011-05-01

    Impact of variability in the measured parameter is rarely considered in designing clinical protocols for optimization of atrioventricular (AV) or interventricular (VV) delay of cardiac resynchronization therapy (CRT). In this article, we approach this question quantitatively using mathematical simulation in which the true optimum is known and examine practical implications using some real measurements. We calculated the performance of any optimization process that selects the pacing setting which maximizes an underlying signal, such as flow or pressure, in the presence of overlying random variability (noise). If signal and noise are of equal size, for a 5-choice optimization (60, 100, 140, 180, 220 ms), replicate AV delay optima are rarely identical but rather scattered with a standard deviation of 45 ms. This scatter was overwhelmingly determined (ρ = -0.975, P < 0.001) by Information Content, [Formula: see text], an expression of signal-to-noise ratio. Averaging multiple replicates improves information content. In real clinical data, at resting, heart rate information content is often only 0.2-0.3; elevated pacing rates can raise information content above 0.5. Low information content (e.g. <0.5) causes gross overestimation of optimization-induced increment in VTI, high false-positive appearance of change in optimum between visits and very wide confidence intervals of individual patient optimum. AV and VV optimization by selecting the setting showing maximum cardiac function can only be accurate if information content is high. Simple steps to reduce noise such as averaging multiple replicates, or to increase signal such as increasing heart rate, can improve information content, and therefore viability, of any optimization process.

  7. Cone positioning device for oral radiation therapy.

    PubMed

    Mahanna, G K; Ivanhoe, J R; Attanasio, R A

    1994-06-01

    This article describes the fabrication and modification of a peroral cone-positioning device. The modification provides added cone stability and prevents tongue intrusion into the radiation field. This device provides a repeatable accurate cone/lesion relationship and the fabrication technique is simplified, accurate, and minimizes patient discomfort.

  8. Implantable drug therapy device: A concept

    NASA Technical Reports Server (NTRS)

    Feldstein, C.

    1972-01-01

    Design is described of small, rechargeable, implantable infusor which contains fluid medicament stored under pressure and which dispenses fluid continuously through catheter. Body of infusor is covered by pliable silicone rubber sheath attached to suture pad for securing device.

  9. Perioperative management of patients with cardiac implantable electronic devices.

    PubMed

    Poveda-Jaramillo, R; Castro-Arias, H D; Vallejo-Zarate, C; Ramos-Hurtado, L F

    2017-05-01

    The use of implantable cardiac devices in people of all ages is increasing, especially in the elderly population: patients with pacemakers, cardioverter-defibrillators or cardiac resynchronization therapy devices regularly present for surgery for non-cardiac causes. This review was made in order to collect and analyze the latest evidence for the proper management of implantable cardiac devices in the perioperative period. Through a detailed exploration of PubMed, Academic Search Complete (EBSCO), ClinicalKey, Cochrane (Ovid), the search software UpToDate, textbooks and patents freely available to the public on Google, we selected 33 monographs, which matched the objectives of this publication.

  10. Novel Silicon Devices for Radiation Therapy Monitoring

    NASA Astrophysics Data System (ADS)

    Bruzzi, Mara

    2016-02-01

    Modern radiotherapy techniques pose specific constraints in radiation-monitoring and dosimetry due to the occurrence of small radiation fields with high dose gradients, variation in space and time of the dose rate, variation in space and time of the beam energy spectrum. Novel devices coping with these strict conditions are needed. This paper reviews the most advanced technologies developed with silicon-based materials for clinical radiotherapy. Novel Si diodes as Pt-doped Si, epitaxial Si as well as thin devices have optimized performance, their response being independent of the accumulated dose, thus ensuring radiation tolerance and no need of recalibration. Monolithic devices based on segmented Si detectors can be easily tailored to optimize spatial resolution in the large active areas required in clinical radiotherapy. In particular, a monolithic device based on epitaxial p-type silicon, characterized by high spatial resolution and ability to directly measure temporal variations in dose modulation proved to be best viable solution for pre-treatment verifications in IMRT fields.

  11. Resynchronization of the Asynchronous Polar CD Ind

    NASA Astrophysics Data System (ADS)

    Myers, Gordon; Patterson, Joseph; de Miguel, Enrique; Hambsch, Franz-Josef; Monard, Berto; Bolt, Greg; McCormick, Jennie; Rea, Robert; Allen, William

    2017-04-01

    CD Ind is one of only four confirmed asynchronous polars (APs). APs are strongly magnetic cataclysmic variables of the AM Herculis subclass with the characteristic that their white dwarfs rotate a few percent out of synchronism with their binary orbit. Theory suggests that nova eruptions disrupt previously synchronized states. Following the eruption, the system is expected to rapidly resynchronize over a timescale of centuries. The other three asynchronous polars—V1432 Aql, BY Cam, and V1500 Cyg—have resynchronization time estimates ranging from 100 to more than 3500 years, with all but one being less than 1200 years. We report on the analysis of over 46,000 observations of CD Ind taken between 2007 and 2016, combined with previous observations from 1996, and estimate a CD Ind resynchronization time of 6400 ± 800 years. We also estimate an orbital period of 110.820(1) minutes and a current (2016.4) white dwarf spin period of 109.6564(1) minutes.

  12. [Organ replacement therapy - extracorporeal liver assist devices].

    PubMed

    Sinner, Barbara; Kirchner, Gabriele I

    2016-09-01

    Liver failure is a disease with a high mortality rate. Often liver transplantation is the sole therapeutic option. On the one hand, liver support systems probably support the liver to allow regeneration, on the other hand they are an option to bridge for transplantation. This article gives an overview on the clinically used liver assist devices (molecular adsorbent recirculating system [MARS], Prometheus system, single-pass albumin dialysis [SPAD], plasmapheresis) and discusses the applications in liver failure.

  13. Development of device therapy for ventricular arrhythmias.

    PubMed

    Holley, Loraine K

    2007-06-01

    The past 25 years have seen the implantable cardioverter defibrillator emerge as the treatment of choice for ventricular arrhythmias with reduction in size but increased therapeutic options. Understanding the complex mechanisms of ventricular arrhythmias and defibrillation in normal and diseased hearts has been the focus of many research teams including that of John Uther at the Westmead Hospital Department of Cardiology. Marked improvements in capacitor and battery technologies, arrhythmia discrimination, pacing algorithms, shock waveforms and monitoring capabilities enable wider use and patient acceptance. Emergence of cardiac resynchronisation therapy and the implantable defibrillator for treatment of chronic heart failure is not only giving quality of life and extended survival for heart failure patients but has also cast new light on the evolution of heart failure.

  14. Sunshine Heart C-Pulse: device for NYHA Class III and ambulatory Class IV heart failure.

    PubMed

    Black, Matthew C; Schumer, Erin M; Rogers, Michael; Trivedi, Jaimin; Slaughter, Mark S

    2016-09-01

    Advanced heart failure (HF) patients not meeting criteria for ventricular assist device or heart transplant with life-limiting symptoms are limited to medical and resynchronization therapy. The Sunshine Heart C-Pulse, based on intra-aortic balloon pump physiology, provides implantable, on-demand, extra-aortic counterpulsation, which reduces afterload and improves cardiac perfusion in New York Heart Association Class III and ambulatory Class IV HF. The C-Pulse reduces New York Heart Association Class, improves 6-min walk distances, inotrope requirements and HF symptom questionnaires. Advantages include shorter operative times without cardiopulmonary bypass, no reported strokes or thrombosis and no need for anticoagulation. Driveline exit site infections, inability to provide full circulatory support and poor function with intractable arrhythmias remain concerns. Current randomized controlled studies will evaluate long-term efficacy and safety compared with medical and resynchronization therapy.

  15. Alternative programs for synchronizing and resynchronizing ovulation in beef cattle.

    PubMed

    Bó, Gabriel A; de la Mata, José Javier; Baruselli, Pietro S; Menchaca, Alejo

    2016-07-01

    Fixed-time artificial insemination (FTAI) has been regarded as the most useful method to increase the number of cows inseminated in a given herd. The main treatments for FTAI in beef cattle are based on the use of progesterone-releasing devices and GnRH or estradiol to synchronize follicle wave emergence, with a mean pregnancy per AI (P/AI) around 50%. However, more recent protocols based on GnRH (named 5-day Co-Synch) or estradiol (named J-Synch) that reduce the period of progesterone device insertion and extend the period from device removal to FTAI have been reported to improve P/AI in beef cattle. Furthermore, treatments to resynchronize ovulation for a second FTAI in nonpregnant cows have provided the opportunity to do sequential inseminations and achieve high P/AI in a breeding season, reducing or even eliminating the need for clean-up bulls. In summary, FTAI protocols have facilitated the widespread application of AI in beef cattle, primarily by eliminating the necessity of estrus detection in beef herds.

  16. Cardiac device-associated lead infection: a diagnosis not to be missed

    PubMed Central

    Marquette, Malcolm; Budhdeo, Sanjay; Rajagopal, Vivek; Marinescu, Mirela

    2015-01-01

    A 66-year-old gentleman was admitted to hospital with a history of general malaise for 5 months. His symptoms worsened 2 weeks prior to presentation. He experienced swinging pyrexia, night sweats and shortness of breath on exertion. Initial evaluation did not reveal any source of infection. Subsequent investigation revealed infection with vegetation affecting the intra-cardiac leads of cardiac resynchronization therapy device (CRT-D). The patient was treated with prolonged intravenous antibiotics and removal of the device and indwelling leads. The patient made a full recovery and a new device was implanted. PMID:26421154

  17. Cellular and Molecular Aspects of Dyssynchrony and Resynchronization

    PubMed Central

    Kirk, Jonathan A.; Kass, David A.

    2015-01-01

    Synopsis Dyssynchronous contraction of the ventricle, arising from electrical activation delays, significantly worsens morbidity and mortality in heart failure (HF) patients. Approximately one third of HF patients have cardiac dyssynchrony and are candidates for the pacemaker therapy Cardiac Resynchronization Therapy (CRT), which uses bi-ventricular pacing to recoordinate contraction. The initial understanding of both dyssynchrony and CRT was in terms of global mechanics and hemodynamics, but lack of clinical benefit in a sizable sub-group of recipients who appear otherwise appropriate has challenged this paradigm. Using large animal models and some human data, a framework of complex molecular and cellular mechanisms of cardiac dyssynchrony and CRT is emerging. Heart failure with dyssynchrony exhibits depressed myocyte and myofilament function, calcium handling, survival signaling, interstitial remolding, altered mitochondrial function, bioenergetics, myocyte structure, and other defects. Many of these are improved by CRT, and in a manner that seems unique to this treatment. Here we review current understanding of these cellular and sub-cellular mechanisms, making the case that these aspects are key to improving CRT utilization, as well as translating its benefits to a wider heart failure population. PMID:26596804

  18. Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump

    MedlinePlus

    ... and Consumer Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump ... therapy. What do you do before using your infusion pump? Read your pump's Instructions for Use and ...

  19. Negative pressure wound therapy limits downgrowth in percutaneous devices

    PubMed Central

    Mitchell, Saranne J.; Jeyapalina, Sujee; Nichols, Francesca R.; Agarwal, Jayant; Bachus, Kent N.

    2016-01-01

    Maintenance of a soft tissue seal around percutaneous devices is challenged by the downgrowth of periprosthetic tissues—a gateway to potential infection. As negative pressure wound therapy (NPWT) is used clinically to facilitate healing of complex soft tissue pathologies, it was hypothesized that NPWT could limit downgrowth of periprosthetic tissues. To test this hypothesis, 20 hairless guinea pigs were randomly assigned into four groups (n = 5/group). Using a One-Stage (Groups 1 and 3) or a Two-Stage (Groups 2 and 4) surgical procedure, each animal was implanted with a titanium-alloy subdermal device porous-coated with commercially pure, medical grade titanium. Each subdermal device had a smooth titanium-alloy percutaneous post. The One-Stage procedure encompassed insertion of a fully assembled device during a single surgery. The Two-Stage procedure involved the implantation of a subdermal device during the first surgery, and then three weeks later, insertion of a percutaneous post. Groups 1 and 2 served as untreated controls and Groups 3 and 4 received NPWT. Four weeks postimplantation of the post, the devices and surrounding tissues were harvested, and histologically evaluated for downgrowth. Within the untreated control groups, the Two-Stage surgical procedure significantly decreased downgrowth (p = 0.027) when compared with the One-Stage procedure. Independent of the surgical procedures performed, NPWT significantly limited downgrowth (p ≤ 0.05) when compared with the untreated controls. PMID:26487170

  20. Acoustic and Cavitation Fields of Shock Wave Therapy Devices

    NASA Astrophysics Data System (ADS)

    Chitnis, Parag V.; Cleveland, Robin O.

    2006-05-01

    Extracorporeal shock wave therapy (ESWT) is considered a viable treatment modality for orthopedic ailments. Despite increasing clinical use, the mechanisms by which ESWT devices generate a therapeutic effect are not yet understood. The mechanistic differences in various devices and their efficacies might be dependent on their acoustic and cavitation outputs. We report acoustic and cavitation measurements of a number of different shock wave therapy devices. Two devices were electrohydraulic: one had a large reflector (HMT Ossatron) and the other was a hand-held source (HMT Evotron); the other device was a pneumatically driven device (EMS Swiss DolorClast Vet). Acoustic measurements were made using a fiber-optic probe hydrophone and a PVDF hydrophone. A dual passive cavitation detection system was used to monitor cavitation activity. Qualitative differences between these devices were also highlighted using a high-speed camera. We found that the Ossatron generated focused shock waves with a peak positive pressure around 40 MPa. The Evotron produced peak positive pressure around 20 MPa, however, its acoustic output appeared to be independent of the power setting of the device. The peak positive pressure from the DolorClast was about 5 MPa without a clear shock front. The DolorClast did not generate a focused acoustic field. Shadowgraph images show that the wave propagating from the DolorClast is planar and not focused in the vicinity of the hand-piece. All three devices produced measurable cavitation with a characteristic time (cavitation inception to bubble collapse) that varied between 95 and 209 μs for the Ossatron, between 59 and 283 μs for the Evotron, and between 195 and 431 μs for the DolorClast. The high-speed camera images show that the cavitation activity for the DolorClast is primarily restricted to the contact surface of the hand-piece. These data indicate that the devices studied here vary in acoustic and cavitation output, which may imply that the

  1. Luminous fabric devices for wearable low-level light therapy

    PubMed Central

    Shen, Jing; Chui, Chunghin; Tao, Xiaoming

    2013-01-01

    In this paper, a flexible luminous fabric device was developed and investigated for wearable three-dimensionally fitted low-level light therapy. The fabric device exhibited excellent optical and thermal properties. Its optical power density and operating temperature were stable during usage for 10 hours. In vitro experiments demonstrated a significant increase in collagen production in human fibroblast irradiated by the fabric device, compared with the fibroblast without light irradiation. A series of tests were conducted for the safety of the fabric for human skin contact according to ISO standard ISO 10993-1:2003. The results showed that there was no potential hazard when the luminous fabrics were in direct contact with human skin. PMID:24409391

  2. Management of antithrombotic therapy in patients undergoing electrophysiological device surgery.

    PubMed

    Zacà, Valerio; Marcucci, Rossella; Parodi, Guido; Limbruno, Ugo; Notarstefano, Pasquale; Pieragnoli, Paolo; Di Cori, Andrea; Bongiorni, Maria Grazia; Casolo, Giancarlo

    2015-06-01

    The aim of this review is to formulate practical recommendations for the management of antithrombotic therapy in patients undergoing cardiac implantable electronic device (CIED) surgery by providing indications for a systematic approach to the problem integrating general technical considerations with patient-specific elements based on a careful evaluation of the balance between haemorrhagic and thromboembolic risk. Hundreds of thousands patients undergo implantation or replacement of CIEDs annually in Europe, and up to 50% of these subjects receive antiplatelet agents or oral anticoagulants. The rate of CIED-related complications, mainly infective, has also significantly increased so that transvenous lead extraction procedures are, consequently, often required. Cardiac implantable electronic device surgery is peculiar and portends specific intrinsic risks of developing potentially fatal haemorrhagic complications; on the other hand, the periprocedural suspension of antithrombotic therapy in patients with high thromboembolic risk cardiac conditions may have catastrophic consequences. Accordingly, the management of the candidate to CIED surgery receiving concomitant antithrombotic therapy is a topic of great clinical relevance yet controversial and only partially, if at all, adequately addressed in evidence-based current guidelines. In spite of the fact that in many procedures it seems reasonably safe to proceed with aspirin only or without interruption of anticoagulants, restricting to selected cases the use of bridging therapy with parenteral heparins, there are lots of variables that may make the therapeutic choices challenging. The decision-making process applied in this document relies on the development of a stratification of the procedural haemorrhagic risk and of the risk deriving from the suspension of antiplatelet or anticoagulant therapy combined to generate different clinical scenarios with specific indications for optimal management of periprocedural

  3. Frequency of atrial tachyarrhythmias in patients treated by cardiac resynchronization (from the Prospective, Multicenter Mona Lisa Study).

    PubMed

    Marijon, Eloi; Jacob, Sophie; Mouton, Elisabeth; Defaye, Pascal; Piot, Olivier; Delarche, Nicolas; Dennetiere, Stéphane; Galley, Daniel; Le Franc, Pierre; Appl, Ursula; Guyomar, Yves; Albenque, Jean Paul; Chevalier, Philippe; Boveda, Serge

    2010-09-01

    The continuous measurement of sustained atrial tachyarrhythmia (AT) is now possible with some permanently implanted devices. Data on this subject remain controversial. The aim of this study was to evaluate the incidence of sustained AT in patients treated with cardiac resynchronization therapy using pacemakers without backup defibrillators (CRT-P), within the first year after implantation, using strict definition criteria for sustained AT and a systematic review of all high-quality electrographically recorded episodes. The Mona Lisa study was a prospective, multicenter, cohort study carried out from February 2004 to February 2006, with a 12-month follow-up period. Sustained AT was defined as an episode lasting > or =5 minutes; episodes were confirmed by a systematic review of electrograms in the whole study population. Of the 198 patients who underwent CRT-P device implantation and were enrolled in the study, 173 were in stable sinus rhythm at baseline and were included in the analysis (mean age 70 +/- 9 years, 66% men, 91% in New York Heart Association class III, mean QRS duration 164 +/- 26 ms, mean left ventricular ejection fraction 25 +/- 7%). During a mean follow-up period of 9.9 +/- 3.6 months, 34 patients experienced > or =1 episode of sustained AT, for an incidence rate of 27.5% (95% confidence interval 18.2 to 36.7). Only a history of AT was independently associated with the occurrence of sustained AT within the 12 months after CRT-P device implantation (hazard ratio 2.3, 95% confidence interval 1.2 to 4.4, p = 0.02). In conclusion, this first prospective electrogram-based evaluation of AT incidence demonstrated that 27% of patients developed > or =1 episode of sustained AT lasting > or =5 minutes in the 12 months after CRT-P device implantation.

  4. [Experience using the isocenter verification device in proton therapy equipment].

    PubMed

    Fuse, Hiraku; Sakae, Takeji; Terunuma, Toshiyuki; Kamizawa, Satoshi; Segawa, Tatsuya; Yoshimura, Yosuke; Yamanashi, Koichi; Sato, Masaru; Sakurai, Hideyuki

    2013-01-01

    In this study, we developed an isocenter verification device for use in proton therapy. Radiation and mechanical isocenters were verified for treatment equipment including room lasers, a digital radiography system and the beam axis of a rotational gantry. The special feature of this device is its ability to correlate the position of the three isocenters in one measurement and thus improve accuracy compared to the conventional method using three separate devices. The reproducibility of the method and the fluctuation of the position of the beam axis isocenter were both investigated using this device for almost a year. Monthly measurements of the isocenter position were acquired for two gantries and it was found that the fluctuation was +/- 0.10mm for the up-to-down direction and +/- 0.16mm for the right-to-left direction in Gantry 1 and was +/-0.14mm for the up-to-down direction and +/-0.18mm for the right-to-left direction in Gantry 2. We could be measured with a repeatability of +/-0.18 mm or less by using developed device for the relative positional relationship between each isocenters. Because we can confirm results in approximately 30 minutes, we can perform a quality control after a clinical practice.

  5. Emerging medical devices for minimally invasive cell therapy.

    PubMed

    O'Cearbhaill, Eoin D; Ng, Kelvin S; Karp, Jeffrey M

    2014-02-01

    The past decade has seen the first wave of cell-based therapeutics undergo clinical trials with varying degrees of success. Although attention is increasingly focused on clinical trial design, owing to spiraling regulatory costs, tools used in delivering cells and sustaining the cells' viability and functions in vivo warrant careful scrutiny. While the clinical administration of cell-based therapeutics often requires additional safeguarding and targeted delivery compared with traditional therapeutics, there is significant opportunity for minimally invasive device-assisted cell therapy to provide the physician with new regenerative options at the point of care. Herein we detail exciting recent advances in medical devices that will aid in the safe and efficacious delivery of cell-based therapeutics.

  6. [Device-aided therapies in advanced Parkinson's disease].

    PubMed

    Timofeeva, A A

    2016-01-01

    Advanced stages of Parkinson's disease (PD) is a consequence of the severe neurodegenerative process and are characterized by the development of motor fluctuations and dyskinesia, aggravation of non-motor symptoms. Treatment with peroral and transdermal drugs can't provide an adequate control of PD symptoms and quality-of-life of the patients at this stage of disease. Currently, three device-aided therapies: deep brain stimulation (DBS), intrajejunal infusion of duodopa, subcutaneous infusion of apomorphine can be used in treatment of patients with advanced stages of PD. Timely administration of device-aided therapies and right choice of the method determine, to a large extent, the efficacy and safety of their use. Despite the high efficacy of all three methods with respect to the fluctuation of separate symptoms, each method has its own peculiarities. The authors reviewed the data on the expediency of using each method according to the severity of motor and non-motor symptoms, patient's age, PD duration, concomitant pathology and social support of the patients.

  7. Non-CPAP therapies in obstructive sleep apnoea: mandibular advancement device therapy.

    PubMed

    Marklund, Marie; Verbraecken, Johan; Randerath, Winfried

    2012-05-01

    Mandibular advancement devices (MADs) represent the main non-continuous positive airway pressure (non-CPAP) therapy for patients with obstructive sleep apnoea (OSA). The aim of the European Respiratory Society Task Force was to review the evidence in favour of MAD therapy. Effects of tongue-retaining devices are not included in this report. Custom-made MADs reduce apnoea/hypopnoea index (AHI) and daytime sleepiness compared with placebo devices. CPAP more effectively diminishes AHI, while increasing data suggest fairly similar outcomes in relation to symptoms and cardiovascular health from these treatments. Patients often prefer MADs to CPAP. Milder cases and patients with a proven increase in upper airway size as a result of mandibular advancement are most likely to experience treatment success with MADs. A custom-made device titrated from an initial 50% of maximum mandibular advancement has been recommended. More research is needed to define the patients who will benefit from MAD treatment compared with CPAP, in terms of the effects on sleep-disordered breathing and on other diseases related to OSA. In conclusion, MADs are recommended for patients with mild to moderate OSA (Recommendation Level A) and for those who do not tolerate CPAP. The treatment must be followed up and the device adjusted or exchanged in relation to the outcome.

  8. [Efficacy of new devices for behavior modification therapy for obesity].

    PubMed

    Ookuma, K

    2001-03-01

    In the treatment of obesity, the behavior modification therapy has aimed at maintaining weight reduction by reforming wrong daily habitual eating behavior which leads obesity. However, a distorted cognitive pattern or a deviated physical lies behind the problematic eating behavior. In that aspect, we have developed new devices as belows. The ingestive behavioral questionnaire discloses problematic eating behavior and its related cognitive and sensational pattern at an early stage of the treatment. The charting of daily weight pattern is convenient for both therapist and patient himself to visually look out an actual ingestive pattern and reinforces maintenance of weight reduction by long term self-monitoring. The chewing chart recording is useful for the recovery of physical satiety sensation, and prevents over eating.

  9. Detecting cavitation in vivo from shock-wave therapy devices

    NASA Astrophysics Data System (ADS)

    Matula, Thomas J.; Yu, Jinfei; Bailey, Michael R.

    2005-04-01

    Extracorporeal shock-wave therapy (ESWT) has been used as a treatment for plantar faciitis, lateral epicondylitis, shoulder tendonitis, non-unions, and other indications where conservative treatments have been unsuccessful. However, in many areas, the efficacy of SW treatment has not been well established, and the mechanism of action, particularly the role of cavitation, is not well understood. Research indicates cavitation plays an important role in other ultrasound therapies, such as lithotripsy and focused ultrasound surgery, and in some instances, cavitation has been used as a means to monitor or detect a biological effect. Although ESWT can generate cavitation easily in vitro, it is unknown whether or not cavitation is a significant factor in vivo. The purpose of this investigation is to use diagnostic ultrasound to detect and monitor cavitation generated by ESWT devices in vivo. Diagnostic images are collected at various times during and after treatment. The images are then post-processed with image-processing algorithms to enhance the contrast between bubbles and surrounding tissue. The ultimate goal of this research is to utilize cavitation as a means for optimizing shock wave parameters such as amplitude and pulse repetition frequency. [Work supported by APL internal funds and NIH DK43881 and DK55674.

  10. Acoustic field of a ballistic shock wave therapy device.

    PubMed

    Cleveland, Robin O; Chitnis, Parag V; McClure, Scott R

    2007-08-01

    Shock wave therapy (SWT) refers to the use of focused shock waves for treatment of musculoskeletal indications including plantar fascitis and dystrophic mineralization of tendons and joint capsules. Measurements were made of a SWT device that uses a ballistic source. The ballistic source consists of a handpiece within which compressed air (1-4 bar) is used to fire a projectile that strikes a metal applicator placed on the skin. The projectile generates stress waves in the applicator that transmit as pressure waves into tissue. The acoustic fields from two applicators were measured: one applicator was 15 mm in diameter and the surface slightly convex and the second was 12 mm in diameter the surface was concave. Measurements were made in a water tank and both applicators generated a similar pressure pulse consisting of a rectangular positive phase (4 micros duration and up to 8 MPa peak pressure) followed by a predominantly negative tail (duration of 20 micros and peak negative pressure of -6 MPa), with many oscillations. The rise times of the waveforms were around 1 micros and were shown to be too long for the pulses to be considered shock waves. Measurements of the field indicated that region of high pressure was restricted to the near-field (20-40 mm) of the source and was consistent with the Rayleigh distance. The measured acoustic field did not display focusing supported by calculations, which demonstrated that the radius of curvature of the concave surface was too large to effect a focusing gain. Other SWT devices use electrohydraulic, electromagnetic and piezoelectric sources that do result in focused shock waves. This difference in the acoustic fields means there is potentially a significant mechanistic difference between a ballistic source and other SWT devices.

  11. [Anaesthetic management in left ventricular assist device implantation as destination therapy: Our first experience].

    PubMed

    del Barrio Gómez, E; Rodríguez, J M; Martínez, S; García, E; Vargas, M C; Sastre, J A

    2016-03-01

    Left ventricular assist devices have emerged as one of the main therapies of advanced cardiac failure due the increase of this disease and lack of organ supply for cardiac transplantation. The anaesthetic management is described on a patient without cardiac transplantation criteria. The device was successfully implanted as a destination therapy.

  12. Dissimilar ventricular rhythms: implications for ICD therapy.

    PubMed

    Barold, S Serge; Kucher, Andreas; Nägele, Herbert; Buenfil Medina, José Carlos; Brodsky, Michael; Van Heuverswyn, Frederic E; Stroobandt, Roland X

    2013-04-01

    Sensing of left ventricular (LV) activity in some devices used for cardiac resynchronization therapy (CRT) was designed primarily to prevent the delivery of an LV stimulus into the LV vulnerable period. Such a sensing function of the LV channel is not universally available in contemporary CRT devices. Recordings of LV electrograms may provide special diagnostic data unavailable solely from the standard right ventricular electrogram and corresponding marker channel. We used the LV sensing function of Biotronik CRT defibrillators to find 3 cases of dissimilar ventricular rhythms or tachyarrhythmias. Such arrhythmias are potentially important because concomitant slower right ventricular activity may prevent or delay implantable cardioverter-defibrillator therapy for a life-threatening situation involving a faster and more serious LV tachyarrhythmia. Dissimilar ventricular rhythms may not be rare and may account for cases of unexplained sudden death with a normally functioning implantable cardioverter-defibrillator and no recorded terminal arrhythmia.

  13. Is coronary vein angioplasty necessary to provide cardiac resynchronization in selected patients? A case report.

    PubMed

    Sterliński, Maciej; Sosnowski, Cezary; Zajac, Dariusz; Ruzyłło, Witold; Szwed, Hanna

    2008-09-01

    Cardiac resynchronization therapy (CRT) has become a recommended method for patients with congestive heart failure (CHF) and cardiac dyssynchrony. In some cases, CRT implantation procedure can be complicated because of anatomic and technical reasons. Some reports describe balloon angioplasty of stenotic heart veins as a method to achieve the target vessel. We present a case of a 58-year-old male with permanent atrial fibrillation and CHF who was referred for CRT. During the implantation of the pacemaker, the diaphragmatic obstacle in coronary sinus (CS) has been passed after many attempts using a balloon catheter with no inflation. The aim of the report is to discuss, in short, the real necessity of venous angioplasty in the CS bed during CRT implantation.

  14. Method and devices for performing stereotactic microbeam radiation therapy

    DOEpatents

    Dilmanian, F. Avraham

    2010-01-05

    A radiation delivery system generally includes either a synchrotron source or a support frame and a plurality of microbeam delivery devices supported on the support frame, both to deliver a beam in a hemispherical arrangement. Each of the microbeam delivery devices or synchrotron irradiation ports is adapted to deliver at least one microbeam of radiation along a microbeam delivery axis, wherein the microbeam delivery axes of the plurality of microbeam delivery devices cross within a common target volume.

  15. Devices in the management of advanced, chronic heart failure

    PubMed Central

    Abraham, William T.; Smith, Sakima A.

    2013-01-01

    Heart failure (HF) is a global phenomenon, and the overall incidence and prevalence of the condition are steadily increasing. Medical therapies have proven efficacious, but only a small number of pharmacological options are in development. When patients cease to respond adequately to optimal medical therapy, cardiac resynchronization therapy has been shown to improve symptoms, reduce hospitalizations, promote reverse remodelling, and decrease mortality. However, challenges remain in identifying the ideal recipients for this therapy. The field of mechanical circulatory support has seen immense growth since the early 2000s, and left ventricular assist devices (LVADs) have transitioned over the past decade from large, pulsatile devices to smaller, more-compact, continuous-flow devices. Infections and haematological issues are still important areas that need to be addressed. Whereas LVADs were once approved only for ‘bridge to transplantation’, these devices are now used as destination therapy for critically ill patients with HF, allowing these individuals to return to the community. A host of novel strategies, including cardiac contractility modulation, implantable haemodynamic-monitoring devices, and phrenic and vagus nerve stimulation, are under investigation and might have an impact on the future care of patients with chronic HF. PMID:23229137

  16. Legal issues related to vascular access devices and infusion therapy.

    PubMed

    Masoorli, Sue

    2005-01-01

    Infusion therapies are being delivered in many healthcare settings including hospitals, homecare settings, long-term care facilities, occupational health facilities, outpatient units, and physician offices. Nurses who infuse medications must be properly educated to recognize vascular access complications and initiate the proper interventions. This article discusses the high-risk areas of nursing malpractice related to infusion therapies.

  17. The Joint Commission's disease-specific care certification for destination therapy ventricular assist devices.

    PubMed

    Lockard, Kathleen L; Weimer, Ashley; O'Shea, Genevieve; Driggers, Erin; Conroy, Linda; Teuteberg, Jeffrey J; Winowich, Stephen; Lohmann, Douglas; Schaub, Richard D; Severyn, Donald A; Kormos, Robert L

    2010-06-01

    The Centers for Medicare and Medicaid Services announced that all hospitals implanting ventricular assist devices are required to have certification from the The Joint Commission for disease-specific care destination therapy with a ventricular assist device effective March 27, 2009, in order to receive Medicare reimbursement for services rendered to patients who have devices implanted for destination therapy. On February 23, 2007, The Joint Commission released the certification requirements for ventricular assist devices implanted for destination therapy in an 8-page document so that hospitals could prepare to meet the 2009 certification deadline. The Artificial Heart Program of the University of Pittsburgh Medical Center undertook a multidisciplinary project, under the guidance of the nurse coordinator, to prepare the hospital and program for a precertification survey by The Joint Commission for disease-specific destination therapy ventricular assist device certification. The Presbyterian Hospital Artificial Heart Program was awarded The Joint Commission's device-specific certification for destination therapy with ventricular assist devices in June 2008.

  18. An early proof-of-concept of cardiac resynchronization therapy

    PubMed Central

    Bourassa, Martial G; Khairy, Paul; Roy, Denis

    2011-01-01

    Almost 50 years ago, we published detailed hemodynamic findings in a patient with heart failure and intermittent left bundle branch block. Delayed intraventricular conduction was consistently accompanied by an increased duration of left ventricular (LV) isometric contraction, a drop in systolic blood pressure, a rise in heart rate, and a drop in cardiac output. To our knowledge, this observation provided the first ever evidence that delayed mechanical LV contraction was associated with deterioration, and return to a normal pre-ejection phase with improvement in LV function. PMID:22216372

  19. 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

  20. The fusion band in V1: a simple ECG guide to optimal resynchronization? An echocardiographic case report

    PubMed Central

    Gianfranchi, Lorella; Bettiol, Katia; Pacchioni, Federico; Corbucci, Giorgio; Alboni, Paolo

    2005-01-01

    Background Patients with left bundle branch block have a preserved right bundle branch conduction and the efficacy of left ventricular pacing could be explained with the fusion between artificial pulse delivered in the left lateral wall and the spontaneous right ventricular activation. Moreover, the efficacy of left ventricular pacing could be enhanced with an optimal timing between the spontaneous right ventricular activation and the left ventricular pulse. Case presentation We evaluated a patient (male, 47 yrs) with surgically corrected mitral regurgitation, sinus rhythm and left bundle branch block, heart failure (NYHA class III) despite medical therapy and low ejection fraction (25%): he was implanted with a biventricular device. We programmed ventricular pacing only through the left ventricular lead. We defined what we called electrocardiographic "fusion band" as follow: programming OFF the stimulator, we recorded the native electrocardiogram and measured, through the device, the intrinsic atrioventricular interval. Then, atrioventricular interval was progressively shortened by steps of 20 ms down to 100 ms. Twelve leads electrocardiogram was recorded at each step. The fusion band is the range of AV intervals at which surface electrocardiogram (mainly in V1 lead) presents an intermediate morphology between the native left bundle branch block (upper limit of the band) and the fully paced right bundle branch block (lower limit). The patient underwent echocardiographic examination at each atrioventricular interval chosen inside the fusion band. The following parameters were evaluated: ejection fraction, diastolic filling time, E wave deceleration time, aortic velocity time integral and myocardial performance index. All the echocardiographic parameters showed an improvement inside the fusion band, with a "plateau" behaviour. As the fusion band in this patient ranged from an atrioventricular delay of 200 ms to an atrioventricular delay of 120 ms, we chose an

  1. Materials, Devices and Systems of Soft Bioelectronics for Precision Therapy.

    PubMed

    Wu, Hao; Gao, Wei; Yin, Zhouping

    2017-03-29

    The potential applications of soft bioelectronics in biomedical research and clinical trials have inspired a great deal of research interest in the past decade. While there has been significant amount of work in the fabrication and characterization of soft and stretchable sensors for monitoring of physical conditions and vital signs of human body, the development of soft bioelectronics based medical treatment and intervention systems has just begun. In addition to health monitoring, active treatments are essential for disease control in the healthcare domain, and medical therapy and surgery realized by sophisticated soft bioelectronic systems are better demonstrations of their utility in healthcare. In this Research News, we summarize recent key research achievements in soft bioelectronics enabled precision therapy, with emphasis on drug delivery, therapeutic and surgical mechanisms and tools enabled by integrated systems. Challenges in technology development and prospects for commercialization are also discussed.

  2. Thoratec paracorporeal biventricular assist device therapy: the Freiburg experience†

    PubMed Central

    Brehm, Kerstin; Heilmann, Claudia; Siepe, Matthias; Benk, Christoph; Beyersdorf, Friedhelm; Schlensak, Christian

    2012-01-01

    OBJECTIVE The treatment of severe biventricular (BV) contractile failure using mechanical circulatory support is challenging. We analyzed our center’s results following implantation of a biventricular assist device (BVAD). METHODS We implanted 39 BVADs between September 2001 and January 2009. All patients were qualified candidates for heart transplantation, without an organ available at time of BVAD implantation. Fifteen patients without a history of chronic cardiomyopathy suffered from acute BV failure (group 1), whereas the other 24 suffered from severe chronic cardiomyopathy (group 2). The indication for BVAD implantation was determined in reference to echocardiography, the degree of end-organ damage, and whether the patient qualified for a heart transplant or was a candidate for bridge to recovery. RESULTS Both groups were similar regarding their preoperative hemodynamics, intraoperative and early postoperative findings, and adverse events. Patients in group 1 were younger (mean age 37 ± 17 years) than those in group 2 (51 ± 12 years). Mean duration of support in group 1 was 137 ± 109 days, and 65 ± 61 days in group 2. In group 1, 33% (5/15) were weaned off the device and 53% (8/15) underwent heart transplantation, whereas 8/24 patients (42%) in the chronic group were transplanted. Group 1’s mortality on the device was lower than that of group 2 (13% vs 67%). Furthermore, 11 patients of group 1 survived for 1 year compared with four in group 2 (73% vs 17%). CONCLUSION Implantation of a BVAD in patients with chronic heart failure and acute decompensation is associated with a high mortality and morbidity rate. By contrast, BVAD implantation can achieve excellent results in patients with acute BV failure without a history of chronic cardiomyopathy, even if they are in cardiogenic shock upon admission. PMID:21592811

  3. Hydrogel microfluidic co-culture device for photothermal therapy and cancer migration.

    PubMed

    Lee, Jong Min; Seo, Hye In; Bae, Jun Hyuk; Chung, Bong Geun

    2017-02-07

    We developed the photo-crosslinkable hydrogel microfluidic co-culture device to study photothermal therapy and cancer cell migration. To culture MCF7 human breast carcinoma cells and metastatic U87MG human glioblastoma in the microfluidic device, we used 10 w/v% gelatin methacrylate (GelMA) hydrogels as a semi-permeable physical barrier. We demonstrated the effect of gold nanorod on photothermal therapy of cancer cells in the microfluidic co-culture device. Interestingly, we observed that metastatic U87MG human glioblastoma largely migrated toward vascular endothelial growth factor (VEGF)-treated GelMA hydrogel-embedding microchannels. The main advantage of this hydrogel microfluidic co-culture device is to simultaneously analyze the physiological migration behaviors of two cancer cells with different physiochemical motilities and study gold nanorod-mediated photothermal therapy effect. Therefore, this hydrogel microfluidic co-culture device could be a potentially powerful tool for photothermal therapy and cancer cell migration applications. This article is protected by copyright. All rights reserved.

  4. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Non-Powered suction apparatus device intended for... Surgical Devices § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy. (a) Identification. A non-powered suction apparatus device intended for negative pressure...

  5. Multifunctional wearable devices for diagnosis and therapy of movement disorders.

    PubMed

    Son, Donghee; Lee, Jongha; Qiao, Shutao; Ghaffari, Roozbeh; Kim, Jaemin; Lee, Ji Eun; Song, Changyeong; Kim, Seok Joo; Lee, Dong Jun; Jun, Samuel Woojoo; Yang, Shixuan; Park, Minjoon; Shin, Jiho; Do, Kyungsik; Lee, Mincheol; Kang, Kwanghun; Hwang, Cheol Seong; Lu, Nanshu; Hyeon, Taeghwan; Kim, Dae-Hyeong

    2014-05-01

    Wearable systems that monitor muscle activity, store data and deliver feedback therapy are the next frontier in personalized medicine and healthcare. However, technical challenges, such as the fabrication of high-performance, energy-efficient sensors and memory modules that are in intimate mechanical contact with soft tissues, in conjunction with controlled delivery of therapeutic agents, limit the wide-scale adoption of such systems. Here, we describe materials, mechanics and designs for multifunctional, wearable-on-the-skin systems that address these challenges via monolithic integration of nanomembranes fabricated with a top-down approach, nanoparticles assembled by bottom-up methods, and stretchable electronics on a tissue-like polymeric substrate. Representative examples of such systems include physiological sensors, non-volatile memory and drug-release actuators. Quantitative analyses of the electronics, mechanics, heat-transfer and drug-diffusion characteristics validate the operation of individual components, thereby enabling system-level multifunctionalities.

  6. A Survey of Insulin-Dependent Diabetes—Part I: Therapies and Devices

    PubMed Central

    Takahashi, Daisuke; Xiao, Yang; Hu, Fei; Lewis, Michael

    2008-01-01

    This paper surveys diabetes therapies from telemedicine viewpoint. In type 1 diabetes therapies, the exogenous insulin replacement is generally considered as a primary treatment. However, the complete replacement of exogenous insulin is still a challenging issue because of its complexity of modeling the dynamics, which is typically modeled nonlinearly. On the other hand, thanks to the progress of medical devices, currently the diabetes therapies are being automated. These medical devices include automated insulin pumps and blood glucose sensors. Insulin pumps are designed to create artificial insulin perfusion while they largely rely on the blood glucose profile measurements and these measurements are achieved by one or more blood glucose sensors. The blood glucose measurements are also important for the insulin-dependent diabetes therapies. An insulin pump along with sensors establishes a good feedback system providing the appropriate amount of the exogenous insulin on demand. Controlling the amount of exogenous insulin to suppress the blood glucose levels requires complicated computations. This paper mostly explains both type 1 and 2 diabetes and their mechanisms accompanied by descriptions of diabetes therapy and medical devices currently utilized in the therapy. PMID:18437199

  7. The Effectiveness of Cervical Spondylosis Therapy with Saunders Traction Device and High-Intensity Laser Therapy: A Randomized Controlled Trial

    PubMed Central

    Haładaj, Robert; Pingot, Mariusz; Topol, Mirosław

    2017-01-01

    Background Among all spinal therapies, treatment of the cervical segment is the most difficult. The cervical segment is particularly sensitive to injuries and pain, and it also requires special care due to its great mobility and most delicate construction. The aim of this research was to evaluate analgesic efficacy and improvement of active mobility of the cervical spine after traction therapy with the Saunders device and high-intensity laser therapy (HILT) immediately after therapy, and in short-, medium-, and long-term follow-up in patients with cervical spondylosis. Material/Methods The study included 174 patients (114 women and 60 men) aged 24–67 years. The patients were divided into two randomized groups. In group I (88 subjects) traction therapy with the Saunders device was applied, and in group II (86 subjects) HILT was applied. The measurement of the range of cervical spine movement, a subjective visual scale for pain (Visual Analog Scale [VAS]), and the Neck Disability Index-Polish Version (NDI) questionnaire were used. Results The results obtained by the Saunders and HILT methods were similar immediately after the therapy and after 4 weeks (the medium-term follow-up). However, in long-term follow-up, there was a significant increase in the maintenance of positive therapeutic effects with the HILT method. Conclusions Both therapeutic methods improved the efficiency and demonstrated analgesic efficacy in patients with cervical spondylosis immediately and in the medium term after the therapy. HILT was more effective than the Saunders method in long-term follow-up. PMID:28104903

  8. Acoustic regulation of extracorporeal shock wave (ESW) therapy devices in the U.S

    NASA Astrophysics Data System (ADS)

    Maruvada, Subha; Harris, Gerald R.

    2005-04-01

    The focused, large amplitude pressure fields produced by ESW lithotripsy devices were shown in the early 1980s to provide an efficient means for fragmenting urinary tract calculi. More recently, orthopedic applications of intense pressure pulses for pain relief and fracture healing have been developed. Under the US Medical Device Amendments of 1976, ESW therapy devices were deemed Class III, meaning that a pre-market application typically would be supported by both pre-clinical and clinical studies. This classification still applies, except for ESW lithotripters indicated for fragmenting kidney and ureteral calculi. These devices were reclassified to Class II in 2000, resulting in a simpler path to market in which a demonstration of substantial equivalence to a currently marketed device is sufficient. As part of its regulatory responsibility to address the safety and effectiveness of these devices, particularly with regard to acoustic output, the US Food and Drug Administration has recognized two International Electrotechnical Commission (IEC) standards for ESW lithotripters, one covering field measurements (IEC 61846) and the other dealing with labeling and other safety aspects (IEC 60601-2-36). Although these standards were designed primarily for lithotripsy, the FDA has used them where applicable in the regulatory analysis of other ESW therapy devices.

  9. Technologies for Prolonging Cardiac Implantable Electronic Device Longevity.

    PubMed

    Lau, Ernest W

    2017-01-01

    Prolonged longevity of cardiac implantable electronic devices (CIEDs) is needed not only as a passive response to match the prolonging life expectancy of patient recipients, but will also actively prolong their life expectancy by avoiding/deferring the risks (and costs) associated with device replacement. CIEDs are still exclusively powered by nonrechargeable primary batteries, and energy exhaustion is the dominant and an inevitable cause of device replacement. The longevity of a CIED is thus determined by the attrition rate of its finite energy reserve. The energy available from a battery depends on its capacity (total amount of electric charge), chemistry (anode, cathode, and electrolyte), and internal architecture (stacked plate, folded plate, and spiral wound). The energy uses of a CIED vary and include a background current for running electronic circuitry, periodic radiofrequency telemetry, high-voltage capacitor reformation, constant ventricular pacing, and sporadic shocks for the cardiac resynchronization therapy defibrillators. The energy use by a CIED is primarily determined by the patient recipient's clinical needs, but the energy stored in the device battery is entirely under the manufacturer's control. A larger battery capacity generally results in a longer-lasting device, but improved battery chemistry and architecture may allow more space-efficient designs. Armed with the necessary technical knowledge, healthcare professionals and purchasers will be empowered to make judicious selection on device models and maximize the utilization of all their energy-saving features, to prolong device longevity for the benefits of their patients and healthcare systems.

  10. Development of an accurate fluid management system for a pediatric continuous renal replacement therapy device

    PubMed Central

    SANTHANAKRISHNAN, ARVIND; NESTLE, TRENT T.; MOORE, BRIAN L.; YOGANATHAN, AJIT P.; PADEN, MATTHEW L.

    2013-01-01

    Acute kidney injury is common in critically ill children and renal replacement therapies provide a life saving therapy to a subset of these children. However, there is no Food and Drug Administration approved device to provide pediatric continuous renal replacement therapy (CRRT). Consequently, clinicians adapt approved adult CRRT devices for use in children due to lack of safer alternatives. Complications occur using adult CRRT devices in children due to inaccurate fluid balance (FB) between the volumes of ultrafiltrate (UF) removed and replacement fluid (RF) delivered. We demonstrate the design and validation of a pediatric fluid management system for obtaining accurate instantaneous and cumulative FB. Fluid transport was achieved via multiple novel pulsatile diaphragm pumps. The conservation of volume principle leveraging the physical property of fluid incompressibility along with mechanical coupling via a crankshaft was used for FB. Accuracy testing was conducted in vitro for 8-hour long continuous operation of the coupled UF and RF pumps. The mean cumulative FB error was <1% across filtration flows from 300 mL/hour to 3000 mL/hour. This approach of FB control in a pediatric specific CRRT device would represent a significant accuracy improvement over currently used clinical implementations. PMID:23644618

  11. An analysis of implantable cardiac device reliability. The case for improved postmarketing risk assessment and surveillance.

    PubMed

    Laskey, Warren; Awad, Khaled; Lum, Jeremy; Skodacek, Ken; Zimmerman, Barbara; Selzman, Kimberly; Zuckerman, Bram

    2012-07-01

    Implantable cardiac devices have become the mainstay of the treatment of patients with heart disease. However, data regarding their reliability and, inferentially, safety have been called into question. We reviewed annual reports submitted to the Food and Drug Administration Office of Device Evaluation by device manufacturers from 2003 to 2007. The annual number of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-D) implants, explants, and returned devices were tabulated along with the cumulative (Cum) number of implants for each device. We derived an annual explantation rate (AER) defined as the ratio of the annual number of explants less the number of normal battery depletions/Cum (×1000). From 2003 to 2007, 256,392 CRT-D and 459,300 ICD devices were implanted in the United States. The overall mean (±SD) AERs for ICD and CRT-D devices were, respectively, 49.5 (15.6) per 1000 ICD devices and 82.6 (35.5) per 1000 CRT-D devices. The AER for each device type significantly decreased over the study period (P for trend <0.001) although the AER for CRT-D devices was 38% higher than that for ICD devices (P < 0.001). On average, 20.3% of CRT-D devices and 22.6% of ICD devices were returned to the manufacturer for analysis after explantation. The rates of explanted CRT-D and ICD devices decreased from 2003 to 2007. Notwithstanding this favorable trend, the AER for CRT-D devices was higher than that for ICD devices. Improved methods for tracking individual device histories are needed for more precise estimates of the risk of device explantation for suspected malfunction. The proportion of devices returned to the manufacturer is suboptimal and needs to be improved to better understand the mechanisms of device malfunction.

  12. Silk-based resorbable electronic devices for remotely controlled therapy and in vivo infection abatement.

    PubMed

    Tao, Hu; Hwang, Suk-Won; Marelli, Benedetto; An, Bo; Moreau, Jodie E; Yang, Miaomiao; Brenckle, Mark A; Kim, Stanley; Kaplan, David L; Rogers, John A; Omenetto, Fiorenzo G

    2014-12-09

    A paradigm shift for implantable medical devices lies at the confluence between regenerative medicine, where materials remodel and integrate in the biological milieu, and technology, through the use of recently developed material platforms based on biomaterials and bioresorbable technologies such as optics and electronics. The union of materials and technology in this context enables a class of biomedical devices that can be optically or electronically functional and yet harmlessly degrade once their use is complete. We present here a fully degradable, remotely controlled, implantable therapeutic device operating in vivo to counter a Staphylococcus aureus infection that disappears once its function is complete. This class of device provides fully resorbable packaging and electronics that can be turned on remotely, after implantation, to provide the necessary thermal therapy or trigger drug delivery. Such externally controllable, resorbable devices not only obviate the need for secondary surgeries and retrieval, but also have extended utility as therapeutic devices that can be left behind at a surgical or suturing site, following intervention, and can be externally controlled to allow for infection management by either thermal treatment or by remote triggering of drug release when there is retardation of antibiotic diffusion, deep infections are present, or when systemic antibiotic treatment alone is insufficient due to the emergence of antibiotic-resistant strains. After completion of function, the device is safely resorbed into the body, within a programmable period.

  13. Silk-based resorbable electronic devices for remotely controlled therapy and in vivo infection abatement

    PubMed Central

    Tao, Hu; Hwang, Suk-Won; Marelli, Benedetto; An, Bo; Moreau, Jodie E.; Yang, Miaomiao; Brenckle, Mark A.; Kim, Stanley; Kaplan, David L.; Rogers, John A.; Omenetto, Fiorenzo G.

    2014-01-01

    A paradigm shift for implantable medical devices lies at the confluence between regenerative medicine, where materials remodel and integrate in the biological milieu, and technology, through the use of recently developed material platforms based on biomaterials and bioresorbable technologies such as optics and electronics. The union of materials and technology in this context enables a class of biomedical devices that can be optically or electronically functional and yet harmlessly degrade once their use is complete. We present here a fully degradable, remotely controlled, implantable therapeutic device operating in vivo to counter a Staphylococcus aureus infection that disappears once its function is complete. This class of device provides fully resorbable packaging and electronics that can be turned on remotely, after implantation, to provide the necessary thermal therapy or trigger drug delivery. Such externally controllable, resorbable devices not only obviate the need for secondary surgeries and retrieval, but also have extended utility as therapeutic devices that can be left behind at a surgical or suturing site, following intervention, and can be externally controlled to allow for infection management by either thermal treatment or by remote triggering of drug release when there is retardation of antibiotic diffusion, deep infections are present, or when systemic antibiotic treatment alone is insufficient due to the emergence of antibiotic-resistant strains. After completion of function, the device is safely resorbed into the body, within a programmable period. PMID:25422476

  14. Water equivalent thickness analysis of immobilization devices for clinical implementation in proton therapy.

    PubMed

    Wroe, A J; Ghebremedhin, A; Gordon, I R; Schulte, R W; Slater, J D

    2014-10-01

    Immobilization devices can impact not only the inter- and intra-fraction motion of the patient, but also the range uncertainty of the treatment beam in proton therapy. In order to limit additional range uncertainty, the water equivalent thickness (WET) of the immobilization device needs to be well known and accurately reflected in the calculations by the treatment planning system (TPS). The method presented here focusses on the use of a nozzle-mounted variable range shifter and precision-machined polystyrene blocks of known WET to evaluate commercial immobilization devices prior to clinical implementation. CT studies were also completed to evaluate the internal uniformity of the immobilization devices under study. Mul- tiple inserts of the kVue platform (Qfix Systems, Avondale, PA) were evaluated as part of this study. The results indicate that the inserts are largely interchangeable across a given design type and that the measured WET values agree with those generated by the TPS with a maxi- mum difference less than 1 mm. The WET of the devices, as determined by the TPS, was not impacted by CT beam hardening normally experienced during clinical use. The reproduc- ibility of the WET method was also determined to be better than ±0.02 mm. In conclusion, the testing of immobilization prior to implementation in proton therapy is essential in order to ascertain their impact on the proton treatment and the methodology described here can also be applied to other immobilization systems.

  15. Lightpipe device for delivery of uniform illumination for photodynamic therapy of the oral cavity

    PubMed Central

    Canavesi, Cristina; Cassarly, William J.; Foster, Thomas H.; Rolland, Jannick P.

    2011-01-01

    A compact and efficient lightpipe device to deliver light to the human oral cavity for photodynamic therapy was designed and fabricated, having dimensions 6.8 mm × 6.8 mm × 46 mm. An average irradiance of 76 mW/cm2 with an average deviation of 5% was measured on a square 25 mm2 treatment field for an input power of 100 mW. The device limits irradiation of healthy tissue and offers potential for improvement over the current treatment procedure, which requires shielding of the whole cavity to avoid damage to healthy tissue. PMID:21629308

  16. Catheter-based ultrasound devices and MR thermal monitoring for conformal prostate thermal therapy.

    PubMed

    Diederich, Chris J; Nau, Will H; Kinsey, Adam; Ross, Tony; Wootton, Jeff; Juang, Titania; Butts-Pauly, Kim; Rieke, Viola; Chen, Jing; Bouley, Donna M; Sommer, Graham

    2008-01-01

    Catheter-based ultrasound applicators have been developed for delivering hyperthermia or high-temperature thermal ablation of cancer and benign disease of the prostate. These devices allow for control of heating along the length and angular expanse during therapy delivery. Four types of transurethral applicators were devised for thermal treatment of prostate combined with MR thermal monitoring: sectored tubular transducer devices with directional heating patterns and rotation; planar and curvilinear devices with narrow heating patterns and rotation; and multi-sectored tubular devices capable of dynamic angular control without applicator movement. Interstitial devices (2.4 mm OD) have been developed for percutaneous implantation with directional or dynamic angular control. In vivo experiments in canine prostate under MR temperature imaging were used to evaluate these devices and develop treatment delivery strategies. MR thermal imaging was used to monitor temperature and thermal dose in multiple slices through the target volume. Multi-sectored transurethral applicators can dynamically control the angular heating profile and target large regions of the gland in short treatment times without applicator manipulation. The sectored tubular, planar, and curvilinear transurethral devices produce directional coagulation zones, extending 15-20 mm radial distance to the outer prostate capsule. Sequential rotation under motor control and modulated dwell time can be used to tightly conform thermal ablation to selected regions. Interstitial implants with directional devices can be used to effectively ablate targeted regions of the gland while protecting the rectum. The MR derived 52 degrees C and lethal thermal dose contours (t43=240 min) effectively defined the extent of thermal damage and provided a means for real-time control of the applicators. Catheter-based ultrasound devices, combined with MR thermal monitoring, can produce relatively fast (5-40 min) and precise thermal

  17. Developing robust, hydrogel-based, nanofiber-enabled encapsulation devices (NEEDs) for cell therapies.

    PubMed

    An, Duo; Ji, Yewei; Chiu, Alan; Lu, Yen-Chun; Song, Wei; Zhai, Lei; Qi, Ling; Luo, Dan; Ma, Minglin

    2015-01-01

    Cell encapsulation holds enormous potential to treat a number of hormone deficient diseases and endocrine disorders. We report a simple and universal approach to fabricate robust, hydrogel-based, nanofiber-enabled encapsulation devices (NEEDs) with macroscopic dimensions. In this design, we take advantage of the well-known capillary action that holds wetting liquid in porous media. By impregnating the highly porous electrospun nanofiber membranes of pre-made tubular or planar devices with hydrogel precursor solutions and subsequent crosslinking, we obtained various nanofiber-enabled hydrogel devices. This approach is broadly applicable and does not alter the water content or the intrinsic chemistry of the hydrogels. The devices retained the properties of both the hydrogel (e.g. the biocompatibility) and the nanofibers (e.g. the mechanical robustness). The facile mass transfer was confirmed by encapsulation and culture of different types of cells. Additional compartmentalization of the devices enabled paracrine cell co-cultures in single implantable devices. Lastly, we provided a proof-of-concept study on potential therapeutic applications of the devices by encapsulating and delivering rat pancreatic islets into chemically-induced diabetic mice. The diabetes was corrected for the duration of the experiment (8 weeks) before the implants were retrieved. The retrieved devices showed minimal fibrosis and as expected, live and functional islets were observed within the devices. This study suggests that the design concept of NEEDs may potentially help to overcome some of the challenges in the cell encapsulation field and therefore contribute to the development of cell therapies in future.

  18. Effect of Mandibular Advancement Device Therapy on the Signs and Symptoms of Temporomandibular Disorders

    PubMed Central

    Raunio, Antti; Sipilä, Kirsi; Raustia, Aune

    2012-01-01

    ABSTRACT Objectives Mandibular advancement device therapy is effectively used in the treatment of obstructive sleep apnea, but also several side effects in the masticatory system have been reported. The aim of this study was to evaluate the subjective symptoms and clinical signs of temporomandibular disorders connected to mandibular advancement device therapy. Material and Methods The material consisted of 15 patients (9 men and 6 women, mean age 51.1 years, range 21 to 70 years) diagnosed with obstructive sleep apnea (OSA). Subjective symptoms and clinical temporomandibular disorders (TMD) signs were recorded at the beginning of the treatment (baseline) and at 1-month, 3-month, 6-month and 24-month follow-ups. The degree of TMD was assessed using the anamnestic (Ai) and the clinical dysfunction index (Di) of Helkimo. For assessing the effect of TMD the patients were divided in discontinuing and continuing groups. Results According to Ai and Di, the severity of TMD remained unchanged during the follow-up in most of the patients. Temporomandibular joint (TMJ) crepitation was found more frequently in discontinuing patients at all follow-ups. The difference was statistically significant (P < 0.05) at the six-month follow-up. Masticatory muscle pain during palpation was a frequent clinical sign at the baseline and during the follow-up period but the difference between discontinuing and continuing patients was not significant. Conclusions It seems that signs and symptoms of temporomandibular disorders do not necessarily increase during long-term mandibular advancement device therapy. However, it seems that patients with clinically assessed temporomandibular joint crepitation may discontinue their mandibular advancement device therapy due to temporomandibular disorders. PMID:24422023

  19. Inappropriate implantable cardioverter defibrillator shock from a transcutaneous muscle stimulation device therapy.

    PubMed

    Siu, Chung-Wah; Tse, Hung-Fat; Lau, Chu-Pak

    2005-06-01

    Inappropriate shock from implantable cardioverter defibrillator (ICD) may result from external electromagnetic interference (EMI), especially for unipolar ventricle sensing. Previous case reports and small in-vitro safety study suggested that endocardial bipolar lead system may be immune from EMI resulting from transcutaneous electrical neuromuscle stimulation (TENS) therapy. This report presents an unusual case of inappropriate discharge in a patient with ICD of endocardial bipolar lead system, receiving TENS from a commercially available device.

  20. [Complex therapy of occupational respiratory tract diseases using multifunctional massage device: clinical criteria of efficiency].

    PubMed

    Artemova, L V; Sorkina, N S; Rumiantseva, O I; Komarova, S G; Rudyĭ, S S; Petrykina, M V

    2011-01-01

    Level of efficiency of CERAGEM MASTER CGM-M3500 treatment device applied for occupational patients suffering from bronchi and lung pathological states has been shown in the paper. Positive effects of treatment have been assessed as reliably high and were proved by improvement of clinical and functional indices, subjunctive self-evaluation of health by patients and positive signs in the clinical course of the diseases. Diagnostic complex has been analyzed, including hematological indicators of the peripheral blood, oxygenation of the capillary blood, immunology. Also dynamics of the clinical course has been studied along with the data on self-assessment of health by patients prior and after the therapy by the device. Prospects on treatment of occupational bronchi and lung pathologies with the help of multifunctional massage device are being discussed in the paper.

  1. 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.

  2. Implantable left ventricular assist devices: an evolving long-term cardiac replacement therapy.

    PubMed Central

    DeRose, J J; Argenziano, M; Sun, B C; Reemtsma, K; Oz, M C; Rose, E A

    1997-01-01

    OBJECTIVE: The authors' 8-year experience with both inpatient and outpatient left ventricular assist device (LVAD) support is presented to show the possibilities and limitations of long-term outpatient mechanical circulatory assistance. SUMMARY BACKGROUND DATA: The limitation of suitable cardiac donors has led to the use of LVADs as a temporizing measure for patients awaiting cardiac transplantation. The success of such devices in the short and medium term as a bridge to transplantation has led to their evaluation as a long-term destination therapy for end-stage heart disease. METHODS: Between August 1990 and February 1997, 85 patients with end-stage heart disease underwent insertion of implantable LVADs. Fifty-two patients underwent pneumatic device insertion and 32 patients received a vented electric device. RESULTS: Patients were supported for a mean of 109+/-13 days for an overall survival to transplant (54) or explant (3) of 73%. Nineteen patients were discharged from the hospital on a mean of postoperative day 41+/-4 (range, 17-68) for an outpatient support time of 108+/-30 days (range, 2-466). Of 12 patients supported after postcardiotomy cardiogenic shock, 10 (82%) survived to hospital discharge. Perioperative right ventricular failure was treated in most patients with inotropic agents and inhaled nitric oxide with only six patients requiring right ventricular assist device support. Thromboembolic rate was low (0.016 events/patient-month) despite minimal or no anticoagulation in all cases. CONCLUSIONS: Left ventricular assist device support has evolved to become an outpatient therapy with excellent survival rates and an acceptable morbidity. Accordingly, wearable LVADs should be studied as permanent treatment options for patients who are not transplant candidates. Images Figure 2. PMID:9351714

  3. The mismatch between patient life expectancy and the service life of implantable devices in current cardioverter-defibrillator therapy: a call for larger device batteries.

    PubMed

    Neuzner, Jörg

    2015-06-01

    In 2005, Bob Hauser published a paper in the Journal of the American College of Cardiology entitled "The growing mismatch between patient longevity and the service life of Implantable Cardioverter-Defibrillators". Now, nearly a decade later, I would like to perform a second look on the problem of a mismatching between ICD device service life and the survival of ICD recipients. Since 2005, the demographics of the ICD population has changed significantly. Primary prevention has become the dominant indication in defibrillator therapy and device implantation is indicated more and more in earlier stages of cardiac diseases. In former larger scale ICD trials, the patient average 5-year survival probability was in a range of 68-71%; in newer CRT-D trials in a range of 72-88%. Due to a progressively widened ICD indication and implantation preferentially performed in patients with better life expectancy, the problem of inadequate device service life is of growing importance. The early days of defibrillator therapy started with a generator volume of 145 ccm and a device service life <18 months. In this early period, the device miniaturization and extension of service life were similar challenges for the technicians. Today, we have reached a formerly unexpected extent of device miniaturization. However, technologic improvements were often preferentially translated in further device miniaturization and not in prolonging device service life. In his analysis, Bob Hauser reported a prolonged device service life of 2.3 years in ICD models with a larger battery capacity of 0.54 up to 0.69 Ah. Between 2008 and 2014, several studies had been published on the problem of ICD longevity in clinical scenarios. These analyses included "older" and currently used single chamber, dual chamber and CRT devices. The reported average 5-year device service life ranged from 0 to 75%. Assuming today technology, larger battery capacities will only result in minimal increase in device volume. Selected

  4. Left Ventricular Assist Devices for Destination Therapy: A Health Technology Assessment

    PubMed Central

    2016-01-01

    Background Left ventricular assist devices (LVADs) provide circulatory support to assist the damaged left ventricle in patients with end-stage heart failure. Implantation of an LVAD is sometimes a last resort for patients with end stage heart failure who are ineligible for heart transplantation (destination therapy). First-generation LVADs used pulsatile pumps to mimic the natural pulsing action of the heart. Implanted second-generation LVADs use a rapidly spinning rotor to produce a continuous flow of blood into the systemic arterial system. Objectives Our objectives were to: Determine the clinical effectiveness of LVADs for destination therapy for patients with end-stage heart failure who are ineligible for heart transplantation Estimate the cost-effectiveness of destination-therapy LVAD for patients with end-stage heart failure who are ineligible for heart transplantation and to estimate the potential budget impact for the Ontario Ministry of Health and Long-Term Care over the next 5 years Methods We performed a narrative review of the clinical and economic literature for effectiveness and cost-effectiveness and a budget impact analysis from the perspective of the Ministry of Health and Long-Term Care. We did not conduct a meta-analysis of the clinical evidence owing to differences in the type of LVADs included in the studies. Results Three systematic reviews and one observational study contributed to the clinical evidence. Three economic reviews contributed to the economic evidence. There is moderate quality evidence that treatment with continuous-flow LVADs improves survival but has higher adverse events rates compared with drug therapy. Low quality evidence suggests treatment with a continuous-flow LVADs improves quality of life. The incremental cost-effectiveness ratio associated with destination-therapy LVAD over optimal medical management is relatively high and exceeds the traditionally accepted thresholds ($50,000 to $100,000 per quality-adjusted life

  5. An isocenter detection and verification device for use in proton therapy.

    PubMed

    Fuse, H; Sakae, T; Terunuma, T; Sato, M; Aoki, S

    2012-12-01

    We developed a new device for isocenter detection and verification for use in proton therapy. This device can be used to confirm the isocenters of a room laser, a digital radiography system, and a rotational gantry. Agreement between the isocenters of a room laser and a digital radiography system was examined visually. We used the star-shots method for detecting and verifying the rotational gantry isocenter. The gafchromic film could be irradiated with this method using a 2 mm slitted 200 MeV proton beam. The isocenters of a room laser and digital radiography system were in good agreement. The size distribution of the isocenter by the star-shots method was <2 mm, which is the value recommended by the American Association of Physicists in Medicine Task Group 142. This new device can be used to evaluate comprehensive isocenter detection and verification for related equipment. Subsequent checking using this new device will decrease the uncertainty in measuring an isocenter. When using this device, the working time was significantly reduced to about 30 min, including preparation. These measurements should be useful for high accuracy daily treatments.

  6. An isocenter detection and verification device for use in proton therapy

    SciTech Connect

    Fuse, H.; Sakae, T.; Terunuma, T.; Sato, M.; Aoki, S.

    2012-12-15

    We developed a new device for isocenter detection and verification for use in proton therapy. This device can be used to confirm the isocenters of a room laser, a digital radiography system, and a rotational gantry. Agreement between the isocenters of a room laser and a digital radiography system was examined visually. We used the star-shots method for detecting and verifying the rotational gantry isocenter. The gafchromic film could be irradiated with this method using a 2 mm slitted 200 MeV proton beam. The isocenters of a room laser and digital radiography system were in good agreement. The size distribution of the isocenter by the star-shots method was <2 mm, which is the value recommended by the American Association of Physicists in Medicine Task Group 142. This new device can be used to evaluate comprehensive isocenter detection and verification for related equipment. Subsequent checking using this new device will decrease the uncertainty in measuring an isocenter. When using this device, the working time was significantly reduced to about 30 min, including preparation. These measurements should be useful for high accuracy daily treatments.

  7. A novel vacuum assisted closure therapy model for use with percutaneous devices

    PubMed Central

    Cook, Saranne J.; Nichols, Francesca R.; Brunker, Lucille B.; Bachus, Kent N.

    2016-01-01

    Long-term maintenance of a dermal barrier around a percutaneous prosthetic device remains a common clinical problem. A technique known as Negative Pressure Wound Therapy (NPWT) uses negative pressure to facilitate healing of impaired and complex soft tissue wounds. However, the combination of using negative pressure with percutaneous prosthetic devices has not been investigated. The goal of this study was to develop a methodology to apply negative pressure to the tissues surrounding a percutaneous device in an animal model; no tissue healing outcomes are presented. Specifically, four hairless rats received percutaneous porous coated titanium devices implanted on the dorsum and were bandaged with a semi occlusive film dressing. Two of these animals received NPWT; two animals received no NPWT and served as baseline controls. Over a 28-day period, both the number of dressing changes required between the two groups as well as the pressures were monitored. Negative pressures were successfully applied to the periprosthetic tissues in a clinically relevant range with a manageable number of dressing changes. This study provides a method for establishing, maintaining, and quantifying controlled negative pressures to the tissues surrounding percutaneous devices using a small animal model. PMID:24685323

  8. A NOVEL SUPPORT DEVICE FOR HEAD IMMOBILIZATION DURING RADIATION THERAPY THAT IS APPLICABLE TO BOTH CATS AND DOGS.

    PubMed

    Nemoto, Yuki; Maruo, Takuya; Fukuyama, Yasuhiro; Kawarai, Shinpei; Shida, Takuo; Nakayama, Tomohiro

    2015-01-01

    Repeatable head immobilization is important for minimizing positioning error during radiation therapy for veterinary patients with head neoplasms. The purpose of this retrospective cross-sectional study was to describe a novel technique for head immobilization (Device II) and compare this technique with a previously described technique (Device I). Device II provided additional support by incorporating three teeth (vs. two teeth with Device I). Between 2011 and 2013, both devices were applied in clinically affected cats (Device I, n = 17; Device II, n = 11) and dogs (Device I, n = 85; Device II, n = 22) of various breeds and sizes. The following data were recorded for each included patient: variability in the angle of the skull (roll, yaw, and pitch), coordinates of the isocenter, and distance from the reference mark to the tumor. Devices I and II differed for skull angle variability during the treatment of dogs (roll, P = 0.0007; yaw, P = 0.0018; pitch, P = 0.0384) and for yaw of during the treatment of cats (P < 0.0001). In each case, Device II was superior to Device I. The distance from the reference mark to the center of the tumor was significantly decreased for Device II vs. Device I (dogs, P < 0.0001; cats, P = 0.0002). Device II also provided more accurate coordinates for the isocenter. Authors recommend the use of, Device II for future clinical patients.

  9. Objective assessment of biomagnetic devices and alternative clinical therapies using infrared thermal imaging

    NASA Astrophysics Data System (ADS)

    Rockley, Graham J.

    2001-03-01

    The overwhelming introduction of magnetic devices and other alternative therapies into the health care market prompts the need for objective evaluation of these techniques through the use of infrared thermal imaging. Many of these therapies are reported to promote the stimulation of blood flow or the relief of pain conditions. Infrared imaging is an efficient tool to assess such changes in the physiological state. Therefore, a thermal imager can help document and substantiate whether these therapies are in fact providing an effective change to the local circulation. Thermal images may also indicate whether the change is temporary or sustained. As a specific case example, preliminary findings will be presented concerning the use of magnets and the effect they have on peripheral circulation. This will include a discussion of the recommended protocols for this type of infrared testing. This test model can be applied to the evaluation of other devices and therapeutic procedures which are reputed to affect circulation such as electro acupuncture, orthopedic footwear and topical ointments designed to relieve pain or inflammation.

  10. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Non-Powered suction apparatus device intended for negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  11. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Non-Powered suction apparatus device intended for negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  12. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Non-Powered suction apparatus device intended for negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY...

  13. Clinical Implementation of Cardiac Resynchronization Therapy—Regional Disparities across Selected ESC Member Countries

    PubMed Central

    Hatala, R; Lunati, M; Calvi, V; Favale, S; Goncalvesová, E; Haim, M; Jovanovic, V; Kaczmarek, K; Kautzner, J; Merkely, B; Pokushalov, E; Revishvili, A; Theodorakis, G; Vatasescu, R; Zalevsky, V; Zupan, I; Vicini, I; Corbucci, G

    2015-01-01

    Background The present analysis aimed to estimate the penetration of cardiac resynchronization therapy (CRT) on the basis of the prevalence and incidence of eligible patients in selected European countries and in Israel. Methods and Results The following countries were considered: Italy, Slovakia, Greece, Israel, Slovenia, Serbia, the Czech Republic, Poland, Romania, Hungary, Ukraine, and the Russian Federation. CRT penetration was defined as the number of patients treated with CRT (CRT patients) divided by the prevalence of patients eligible for CRT. The number of CRT patients was estimated as the sum of CRT implantations in the last 5 years, the European Heart Rhythm Association (EHRA) White Book being used as the source. The prevalence of CRT indications was derived from the literature by applying three epidemiologic models, a synthesis of which indicates that 10% of heart failure (HF) patients are candidates for CRT. HF prevalence was considered to range from 1% to 2% of the general population, resulting in an estimated range of prevalence of CRT indication between 1000 and 2000 patients per million inhabitants. Similarly, the annual incidence of CRT indication, representing the potential target population once CRT has fully penetrated, was estimated as between 100 and 200 individuals per million. The results showed the best CRT penetration in Italy (47–93%), while in some countries it was less than 5% (Romania, Russian Federation, and Ukraine). Conclusion CRT penetration differs markedly among the countries analyzed. The main barriers are the lack of reimbursement for the procedure and insufficient awareness of guidelines by the referring physicians. PMID:25546696

  14. Evidence-based practice in the management of vascular access devices for home parenteral nutrition therapy.

    PubMed

    Ryder, Marcia

    2006-01-01

    Catheter-related bloodstream infection and catheter occlusion are potential significant complications of parenteral nutrition therapy. The increased incidence and associated morbidity, mortality, increased costs, and quality-of-life issues experienced with these adverse events necessitate specialized management of vascular access devices. The host coagulation response to biomaterials and the associated development of biofilm on vascular devices are complex phenomena. Multiple interventions are required to prevent access of bacteria to both intraluminal and extraluminal catheter surfaces, and the occurrence of catheter occlusion. The discovery of the biofilm form of microbial life and the associated recalcitrance of biofilm bacteria to antimicrobials has provided insight into the failure of current prevention, diagnostic, and treatment protocols. Critical interventions are presented correlating current evidence with new discoveries in pathogenesis.

  15. Spectral matching technology for light-emitting diode-based jaundice photodynamic therapy device

    NASA Astrophysics Data System (ADS)

    Gan, Ru-ting; Guo, Zhen-ning; Lin, Jie-ben

    2015-02-01

    The objective of this paper is to obtain the spectrum of light-emitting diode (LED)-based jaundice photodynamic therapy device (JPTD), the bilirubin absorption spectrum in vivo was regarded as target spectrum. According to the spectral constructing theory, a simple genetic algorithm as the spectral matching algorithm was first proposed in this study. The optimal combination ratios of LEDs were obtained, and the required LEDs number was then calculated. Meanwhile, the algorithm was compared with the existing spectral matching algorithms. The results show that this algorithm runs faster with higher efficiency, the switching time consumed is 2.06 s, and the fitting spectrum is very similar to the target spectrum with 98.15% matching degree. Thus, blue LED-based JPTD can replace traditional blue fluorescent tube, the spectral matching technology that has been put forward can be applied to the light source spectral matching for jaundice photodynamic therapy and other medical phototherapy.

  16. Narrowing of the Coronary Sinus: A Device-Based Therapy for Persistent Angina Pectoris.

    PubMed

    Konigstein, Maayan; Verheye, Stefan; Jolicœur, E Marc; Banai, Shmuel

    2016-01-01

    Alongside the remarkable advances in medical and invasive therapies for the treatment of ischemic heart disease, an increasing number of patients with advanced coronary artery disease unsuitable for revascularization continue to suffer from angina pectoris despite optimal medical therapy. Patients with chronic angina have poor quality of life and increased levels of anxiety and depression. A considerable number of innovative therapeutic modalities for the treatment of chronic angina have been investigated over the years; however, none of these therapeutic options has become a standard of care, and none are widely utilized. Current treatment options for refractory angina focus on medical therapy and secondary risk factor modification. Interventions to create increased pressure in the coronary sinus may alleviate myocardial ischemia by forcing redistribution of coronary blood flow from the less ischemic subepicardium to the more ischemic subendocardium, thus relieving symptoms of ischemia. Percutaneous, transvenous implantation of a balloon expandable, hourglass-shaped, stainless steel mesh in the coronary sinus to create a fixed focal narrowing and to increase backwards pressure, may serve as a new device-based therapy destined for the treatment of refractory angina pectoris.

  17. Malfunctions of Implantable Cardiac Devices in Patients Receiving Proton Beam Therapy: Incidence and Predictors

    SciTech Connect

    Gomez, Daniel R.; Poenisch, Falk; Pinnix, Chelsea C.; Sheu, Tommy; Chang, Joe Y.; Memon, Nada; Mohan, Radhe; Rozner, Marc A.; Dougherty, Anne H.

    2013-11-01

    Purpose: Photon therapy has been reported to induce resets of implanted cardiac devices, but the clinical sequelae of treating patients with such devices with proton beam therapy (PBT) are not well known. We reviewed the incidence of device malfunctions among patients undergoing PBT. Methods and Materials: From March 2009 through July 2012, 42 patients with implanted cardiac implantable electronic devices (CIED; 28 pacemakers and 14 cardioverter-defibrillators) underwent 42 courses of PBT for thoracic (23, 55%), prostate (15, 36%), liver (3, 7%), or base of skull (1, 2%) tumors at a single institution. The median prescribed dose was 74 Gy (relative biological effectiveness; range 46.8-87.5 Gy), and the median distance from the treatment field to the CIED was 10 cm (range 0.8-40 cm). Maximum proton and neutron doses were estimated for each treatment course. All CIEDs were checked before radiation delivery and monitored throughout treatment. Results: Median estimated peak proton and neutron doses to the CIED in all patients were 0.8 Gy (range 0.13-21 Gy) and 346 Sv (range 11-1100 mSv). Six CIED malfunctions occurred in 5 patients (2 pacemakers and 3 defibrillators). Five of these malfunctions were CIED resets, and 1 patient with a defibrillator (in a patient with a liver tumor) had an elective replacement indicator after therapy that was not influenced by radiation. The mean distance from the proton beam to the CIED among devices that reset was 7.0 cm (range 0.9-8 cm), and the mean maximum neutron dose was 655 mSv (range 330-1100 mSv). All resets occurred in patients receiving thoracic PBT and were corrected without clinical incident. The generator for the defibrillator with the elective replacement indicator message was replaced uneventfully after treatment. Conclusions: The incidence of CIED resets was about 20% among patients receiving PBT to the thorax. We recommend that PBT be avoided in pacing-dependent patients and that patients with any type of CIED receiving

  18. Clinical Relevance Of Systematic CRT Device Optimization.

    PubMed

    Lunati, Maurizio; Magenta, Giovanni; Cattafi, Giuseppe; Moreo, Antonella; Falaschi, Giacomo; Contardi, Danilo; Locati, Emanuela

    2014-01-01

    Cardiac Resynchronization Therapy (CRT) is known as a highly effective therapy in advanced heart failure patients with cardiac dyssynchrony. However, still one third of patients do not respond (or sub-optimally respond) to CRT. Among the many contributors for the high rate of non-responders, the lack of procedures dedicated to CRT device settings optimization (parameters to regulate AV synchrony and VV synchrony) is known as one of the most frequent. The most recent HF/CRT Guidelines do not recommend to carry-out optimization procedures in every CRT patient; they simply state those procedures "could be useful in selected patients", even though their role in improving response has not been proven. Echocardiography techniques still remain the gold-standard reference method to the purpose of CRT settings optimization. However, due to its severe limitations in the routine of CRT patients management (time and resource consuming, scarce reproducibility, inter and intra-operator dependency), echocardiography optimization is widely under-utilized in the real-world of CRT follow-up visits. As a consequence, device-based techniques have been developed to by-pass the need for repeated echo examinations to optimize CRT settings. In this report the available device-based optimization techniques onboard on CRT devices are shortly reviewed, with a specific focus on clinical outcomes observed in trials comparing these methods vs. clinical practice or echo-guided optimization methods. Particular emphasis is dedicated to hemodynamic methods and automaticity of optimization algorithms (making real the concept of "ambulatory CRT optimization"). In fact a hemodynamic-based approach combined with a concept of frequent re-optimization has been associated - although retrospectively - with a better clinical outcome on the long-term follow-up of CRT patients. Large randomized trials are ongoing to prospectively clarify the impact of automatic optimization procedures.

  19. SU-E-J-48: Development of An Abdominal Compression Device for Respiratory Correlated Radiation Therapy

    SciTech Connect

    Kim, T; Kang, S; Kim, D; Suh, T; Kim, S

    2014-06-01

    Purpose: The aim of this study is to develop the abdominal compression device which could control pressure level according to the abdominal respiratory motion and evaluate its feasibility. Methods: In this study, we focused on developing the abdominal compression device which could control pressure level at any point of time so the developed device is possible to use a variety of purpose (gating technique or respiratory training system) while maintaining the merit of the existing commercial device. The compression device (air pad form) was designed to be able to compress the front and side of abdomen and the pressure level of the abdomen is controlled by air flow. Pressure level of abdomen (air flow) was determined using correlation data between external abdominal motion and respiratory volume signal measured by spirometer. In order to verify the feasibility of the device, it was necessary to confirm the correlation between the abdominal respiratory motion and respiratory volume signal and cooperation with respiratory training system also checked. Results: In the previous study, we could find that the correlation coefficient ratio between diaphragm and respiratory volume signal measured by spirometer was 0.95. In this study, we confirmed the correlation between the respiratory volume signal and the external abdominal motion measured by belt-transducer (correlation coefficient ratio was 0.92) and used the correlated respiratory volume data as an abdominal pressure level. It was possible to control the pressure level with negligible time delay and respiratory volume data based guiding waveforms could be properly inserted into the respiratory training system. Conclusion: Through this feasibility study, we confirmed the correlation between the respiratory volume signal and the external abdominal motion. Also initial assessment of the device and its compatibility with the respiratory training system were verified. Further study on application in respiratory gated

  20. Resynchronization of circadian sleep-wake and temperature cycles in the squirrel monkey following phase shifts of the environmental light-dark cycle

    SciTech Connect

    Wexler, D.B.; Moore-ede, M.C.

    1986-12-01

    Circadian rhythms in physiological and behavioral functions gradually resynchronize after phase shifts in environmental time cues. In order to characterize the rate of circadian resynchronization in a diurnal primate model, the temperature, locomotor activity, and polygraphically determined sleep-wake states were monitored in squirrel monkeys before and after 8-h phase shifts of an environmental light-dark cycle of 12 h light and 12 h dark (LD 12:12). For the temperature rhythm, resynchronization took 4 d after phase delay shift and 5 d after phase advance shift; for the rest-activity cycle, resynchronization times were 3 d and 6 d, respectively. The activity acrophase shifted more rapidly than the temperature acrophase early in the post-delay shift interval, but this internal desynchronization between rhythms disappeared during the course of resynchronization. Further study of the early resynchronization process requires emphasis on identifying evoked effects and measuring circadian pacemaker function. 13 references.

  1. Resynchronization of circadian sleep-wake and temperature cycles in the squirrel monkey following phase shifts of the environmental light-dark cycle

    NASA Technical Reports Server (NTRS)

    Wexler, D. B.; Moore-Ede, M. C.

    1986-01-01

    Circadian rhythms in physiological and behavioral functions gradually resynchronize after phase shifts in environmental time cues. In order to characterize the rate of circadian resynchronization in a diurnal primate model, the temperature, locomotor activity, and polygraphically determined sleep-wake states were monitored in squirrel monkeys before and after 8-h phase shifts of an environmental light-dark cycle of 12 h light and 12 h dark (LD 12:12). For the temperature rhythm, resynchronization took 4 d after phase delay shift and 5 d after phase advance shift; for the rest-activity cycle, resynchronization times were 3 d and 6 d, respectively. The activity acrophase shifted more rapidly than the temperature acrophase early in the post-delay shift interval, but this internal desynchronization between rhythms disappeared during the course of resynchronization. Further study of the early resynchronization process requires emphasis on identifying evoked effects and measuring circadian pacemaker function.

  2. Quantification of the rates of resynchronization of heart rate with body temperature rhythms in man following a photoperiod shift

    NASA Technical Reports Server (NTRS)

    Hetherington, N. W.; Rosenblatt, L. S.; Higgins, E. A.; Winget, C. M.

    1973-01-01

    A mathematical model previously presented by Rosenblatt et al. (1973) for estimating the rates of resynchronization of individual biorhythms following transmeridian flights or photoperiod shifts is extended to estimation of rates at which two biorythms resynchronize with respect to each other. Such quantification of the rate of restoration of the initial phase relationship of the two biorhythms is pointed out as a valuable tool in the study of internal desynchronosis.

  3. Iatrogenic oesophageal perforation during placement of an endoscopic vacuum therapy device.

    PubMed

    Halliday, Edwin; Patel, Anant; Hindmarsh, Andrew; Sujendran, Vijay

    2016-07-28

    Endoscopic vacuum-assisted closure (VAC) is increasingly being used as a means of managing perforations or anastomotic leaks of the upper gastrointestinal (GI) tract. Published outcomes are favourable, with few mentions of complications or morbidity. We present a case in which the management of a gastric perforation with endoscopic vacuum therapy was complicated by cervical oesophageal perforation. The case highlights the risks of such endoscopic therapeutic procedures and is the first report in the literature to describe significant visceral injury during placement of a VAC device for upper GI perforation. Iatrogenic oesophageal perforation is an inherent risk to upper GI endoscopy and the risk increases in therapeutic endoscopic procedures. Complications may be reduced by management under a multidisciplinary team in a centre with specialist upper GI services. There is no doubt that the endoscopic VAC approach is becoming established practice, and training in its use must reflect its increasingly widespread adoption.

  4. A graphene-based electrochemical device with thermoresponsive microneedles for diabetes monitoring and therapy

    NASA Astrophysics Data System (ADS)

    Lee, Hyunjae; Choi, Tae Kyu; Lee, Young Bum; Cho, Hye Rim; Ghaffari, Roozbeh; Wang, Liu; Choi, Hyung Jin; Chung, Taek Dong; Lu, Nanshu; Hyeon, Taeghwan; Choi, Seung Hong; Kim, Dae-Hyeong

    2016-06-01

    Owing to its high carrier mobility, conductivity, flexibility and optical transparency, graphene is a versatile material in micro- and macroelectronics. However, the low density of electrochemically active defects in graphene synthesized by chemical vapour deposition limits its application in biosensing. Here, we show that graphene doped with gold and combined with a gold mesh has improved electrochemical activity over bare graphene, sufficient to form a wearable patch for sweat-based diabetes monitoring and feedback therapy. The stretchable device features a serpentine bilayer of gold mesh and gold-doped graphene that forms an efficient electrochemical interface for the stable transfer of electrical signals. The patch consists of a heater, temperature, humidity, glucose and pH sensors and polymeric microneedles that can be thermally activated to deliver drugs transcutaneously. We show that the patch can be thermally actuated to deliver Metformin and reduce blood glucose levels in diabetic mice.

  5. Speech therapy and communication device: impact on quality of life and mood in patients with amyotrophic lateral sclerosis.

    PubMed

    Körner, Sonja; Sieniawski, Michael; Siniawski, Michael; Kollewe, Katja; Rath, Klaus Jan; Krampfl, Klaus; Zapf, Antonia; Dengler, Reinhard; Petri, Susanne

    2013-01-01

    Dysarthria has a drastic impact on the quality of life of ALS patients. Most patients suffering from dysarthria are offered speech therapy. Communication devices are prescribed less frequently. In the present study we investigated the impact of these therapeutic arrangements on quality of life in ALS patients. Thirty-eight ALS patients with dysarthria or anarthria, who underwent speech therapy and/or used communication devices answered three standardized questionnaires (Beck Depression Inventory - II (BDI), SF-36 Health Survey questionnaire (SF-36) and ALS Functional Rating Scale-revised (ALSFRS-R)) and were further interviewed about their experience with and benefit of speech therapy and communication devices. Most of the patients described a high impact of the communication device on their quality of life while the influence of speech therapy was rated less. By multiple regression analysis we confirmed an independent positive effect of communication device use on depression and psychological distress. In conclusion, communication systems improve or at least stabilize quality of life and mood in dysarthric ALS patients, and should be provided early in the disease course.

  6. The first clinical case in Japan of destination therapy using the Jarvik 2000 left ventricular assist device.

    PubMed

    Kamata, Sokichi; Sakaguchi, Taichi; Miyagawa, Shigeru; Yoshikawa, Yasushi; Yamauchi, Takashi; Takeda, Koji; Saito, Shunsuke; Ueno, Takayoshi; Kuratani, Toru; Sawa, Yoshiki

    2010-09-01

    A 73-year-old female with a history of surgical ventricular restoration for ischemic cardiomyopathy presented with biventricular heart failure symptoms. After a Toyobo paracorporeal left ventricular assist device (LVAD) was implanted as a bridge, she underwent successful implantation of a Jarvik 2000 LVAD. This device provided excellent symptomatic improvement. This is the first case in Japan of destination therapy using an implantable LVAD.

  7. Acoustic field characterization of the Duolith: Measurements and modeling of a clinical shock wave therapy device

    PubMed Central

    Perez, Camilo; Chen, Hong; Matula, Thomas J.; Karzova, Maria; Khokhlova, Vera A.

    2013-01-01

    Extracorporeal shock wave therapy (ESWT) uses acoustic pulses to treat certain musculoskeletal disorders. In this paper the acoustic field of a clinical portable ESWT device (Duolith SD1) was characterized. Field mapping was performed in water for two different standoffs of the electromagnetic head (15 or 30 mm) using a fiber optic probe hydrophone. Peak positive pressures at the focus ranged from 2 to 45 MPa, while peak negative pressures ranged from −2 to −11 MPa. Pulse rise times ranged from 8 to 500 ns; shock formation did not occur for any machine settings. The maximum standard deviation in peak pressure at the focus was 1.2%, indicating that the Duolith SD1 generates stable pulses. The results compare qualitatively, but not quantitatively with manufacturer specifications. Simulations were carried out for the short standoff by matching a Khokhlov-Zabolotskaya-Kuznetzov equation to the measured field at a plane near the source, and then propagating the wave outward. The results of modeling agree well with experimental data. The model was used to analyze the spatial structure of the peak pressures. Predictions from the model suggest that a true shock wave could be obtained in water if the initial pressure output of the device were doubled. PMID:23927207

  8. Development and comparison of two devices for treatment of onychomycosis by photodynamic therapy

    NASA Astrophysics Data System (ADS)

    Silva, Ana Paula da; Chiandrone, Daniel José; Tinta, Jefferson Wanderson Rossi; Kurachi, Cristina; Inada, Natalia Mayumi; Bagnato, Vanderlei Salvador

    2015-06-01

    Onychomycosis is the most common nail disorder. The treatment for this type of infection is one of the main difficult ones in clinical practice, due to the fact that the nails are nonvascularized structures, which compromise the penetration of drugs delivered systemically and favor slow nail growth. We present two devices based on light-emitting diode arrays as light sources for the treatment of onychomycosis by photodynamic therapy (PDT). PDT is an emerging technique that uses a photosensitizer (PS) activated by light in the presence of oxygen. The PS absorbs energy from light and transfers it to oxygen, producing reactive oxygen species such as hydroxyl radicals, superoxide, and singlet oxygen which inactivate fungi and bacteria. Our proposal is the use of a portable and secure light source device in patients with onychomycosis. Additional advantages are the low cost involved, the possibility of topical treatment rather than systemic and the simplicity of operation. These advantages are important to ensure the implementation of this technology for the treatment of an impacting health problem.

  9. Simplified Negative Pressure Wound Therapy Device for Application in Low-Resource Settings

    PubMed Central

    Zurovcik, Danielle R; Mody, Gita N; Riviello, Robert; Slocum, Alexander

    2015-01-01

    Negative pressure wound therapy (NPWT) provides proven wound healing benefits and is often a desirable wound treatment. Unfortunately, NPWT devices are not widely available in low-resource settings (LRSs). In order to overcome identified NPWT barriers, a simplified NPWT (sNPWT) system was designed and iteratively improved during field-based testing. The sNPWT technology, our device design iterations, and the design-based results of our field tests are described. The sNPWT system includes a bellows hand pump, an occlusive drape, and a tube with tube connectors, connecting the drape to the pump. The most critical property of a sNPWT system is that it must be airtight. The details of the design iterations needed to achieve an occlusive system are explained. During the design process, the sNPWT system was tested during the earthquake relief in Haiti. This testing found that a liquid sealant was necessary to seal the drape to the peri-wound skin. A study conducted in Rwanda verified that a liquid latex sealant was safe to use and that the tube connector must be connected to the drape with an airtight method during the manufacturing process. This work has shown that sNPWT is feasible in LRSs. Since the completion of the clinical testing, the design has been further evolved and the developers are working with contract manufactures to produce the final design and preparing for regulatory approval applications. PMID:26356213

  10. Antithrombotic Therapy in a Prospective Trial of a Pediatric Ventricular Assist Device

    PubMed Central

    Bomgaars, Lisa R.; Massicotte, M. Patricia

    2016-01-01

    Efficacious ventricular assist device (VAD) support in pediatric patients depends on successful antithrombotic management. The experience with antithrombotic management for the EXCOR Pediatric VAD Investigational Device Exemption (IDE) study is described. All 68 children in North America enrolled in the IDE study from May 9, 2007 to December 10, 2010 are included. The Edmonton Anticoagulation and Platelet Inhibition Protocol was provided for management guidance. Monitoring parameters, drug dosing, targeted serious adverse events, and pump changes were reviewed. Major bleeding occurred in 43% of all subjects with most events occurring within 14 days of implantation. Bleeding events were probably/definitely related in 24% to antithrombotic management. Neurologic events occurred in 28% of subjects and were probably/definitely related in 9% to antithrombotic therapy intensity. Most neurologic events occurred between 4 and 30 days postimplantation and sporadically thereafter. Pump change occurred in 56% of subjects. Use of an antithrombotic protocol for enrolled subjects was possible in this multicenter study. Incidence of significant bleeding and thromboembolic events was acceptable when balanced against life-saving benefits of VADs. Further studies are needed to optimize the antithrombotic management of this patient population. PMID:27556152

  11. A new method and device of aligning patient setup lasers in radiation therapy.

    PubMed

    Hwang, Ui-Jung; Jo, Kwanghyun; Lim, Young Kyung; Kwak, Jung Won; Choi, Sang Hyuon; Jeong, Chiyoung; Kim, Mi Young; Jeong, Jong Hwi; Shin, Dongho; Lee, Se Byeong; Park, Jeong-Hoon; Park, Sung Yong; Kim, Siyong

    2016-01-08

    The aim of this study is to develop a new method to align the patient setup lasers in a radiation therapy treatment room and examine its validity and efficiency. The new laser alignment method is realized by a device composed of both a metallic base plate and a few acrylic transparent plates. Except one, every plate has either a crosshair line (CHL) or a single vertical line that is used for alignment. Two holders for radiochromic film insertion are prepared in the device to find a radiation isocenter. The right laser positions can be found optically by matching the shadows of all the CHLs in the gantry head and the device. The reproducibility, accuracy, and efficiency of laser alignment and the dependency on the position error of the light source were evaluated by comparing the means and the standard deviations of the measured laser positions. After the optical alignment of the lasers, the radiation isocenter was found by the gantry and collimator star shots, and then the lasers were translated parallel to the isocenter. In the laser position reproducibility test, the mean and standard deviation on the wall of treatment room were 32.3 ± 0.93 mm for the new method whereas they were 33.4 ± 1.49 mm for the conventional method. The mean alignment accuracy was 1.4 mm for the new method, and 2.1 mm for the conventional method on the walls. In the test of the dependency on the light source position error, the mean laser position was shifted just by a similar amount of the shift of the light source in the new method, but it was greatly magnified in the conventional method. In this study, a new laser alignment method was devised and evaluated successfully. The new method provided more accurate, more reproducible, and faster alignment of the lasers than the conventional method.

  12. The Rematee Bumper Belt(®) positional therapy device for snoring and obstructive sleep apnea: Positional effectiveness in healthy subjects.

    PubMed

    Matthews, Les; Fortier, Normand

    2013-01-01

    The present study was designed to investigate body position changes resulting from wearing a Rematee Bumper Belt (Rematee, Canada) during sleep. The majority of obstructive sleep apnea (OSA) patients will experience up to two times as many apneas and hypopneas while supine relative to lateral or prone body positions during sleep. It has been suggested that a positional therapy device could reduce the number of apneas and hypopneas in such patients. The present study was conducted to determine whether the Rematee Bumper Belt positional therapy device could prevent healthy subjects from sleeping in the supine position. Test subjects wore the belt for one to two nights. Each belt was equipped with an accelerometer that was used to measure the orientation of the belt relative to the horizontal plane. The results suggest that the belt creates an exclusion zone approximately 80° wide centred near the supine orientation, where subjects are effectively prevented to enter. Results of the present preliminary study suggests that the Rematee Bumper Belt positional therapy device is effective at limiting healthy subjects from sleeping in a supine position. The device appears to be most effective between 150° and 230°. A device with this capability may provide an inexpensive and potentially effective alternative treatment option for patients with OSA. This device has the capacity for reducing snoring and the apnea-hypopnea index in individuals with positional OSA.

  13. Single LED-based device to perform widefield fluorescence imaging and photodynamic therapy

    NASA Astrophysics Data System (ADS)

    Grecco, Clovis; Buzzá, Hilde H.; Stringasci, Mirian D.; Andrade, Cintia T.; Vollet-Filho, Jose D.; Pratavieira, Sebastião.; Zanchin, Anderson L.; Tuboy, Aparecida M.; Bagnato, Vanderlei S.

    2015-06-01

    Photodynamic therapy (PDT) is a treatment modality that can be indicated for several cancer types and pre-cancer lesions. One of the main applications of PDT is the treatment of superficial skin lesions such as basal cell carcinoma, Bowen's disease and actinic keratosis. Three elements are necessary in PDT, a photosensitizer (PS); light at specific wavelength to be absorbed by the PS, and molecular oxygen. A typical PS used for skin lesion is protoporphyrin IX (PpIX), which is an intrinsic PS; its production is stimulated by a pro-drug, such as 5-aminolevulinic acid (ALA). Before starting a treatment, it is very important to follow up the PpIX production (to ensure that enough PS was produced prior to a PDT application) and, during a PDT session, to monitor its photodegradation (as it is evidence of the photodynamic effect taking place). The aim of this paper is to present a unique device, LINCE (MMOptics - São Carlos, Brazil), that brings together two probes that can, respectively, allow for fluorescence imaging and work as a light source for PDT treatment. The fluorescence probe of the system is optically based on 400 nm LED (light emitting diodes) arrays that allow observing the fluorescence emission over 450 nm. The PDT illumination probe options are constituted of 630 nm LED arrays for small areas and, for large areas, of both 630 nm and 450 nm LED arrays. Joining both functions at the same device makes PDT treatment simpler, properly monitorable and, hence, more clinically feasible. LINCE has been used in almost 1000 PDT treatments of superficial skin lesions in Brazil, with 88.4% of clearance of superficial BCC.

  14. Fluence rate variability among light delivery devices for esophageal photodynamic therapy

    NASA Astrophysics Data System (ADS)

    Finlay, Jarod C.; Ginsberg, Gregory G.; Hahn, Stephen M.

    2007-02-01

    Esophageal photodynamic therapy (PDT) is performed using a photosensitizing agent activated by light delivered via a cylindrically symmetric delivery device containing a diffusing optical fiber. In PDT treatment of dysplastic Barrett's esophagus, considerable variability in results is observed due to the non-uniform delivery of treatment light caused by source geometry and by luminal collapse. We compare the fluence rate at the tissue surface resulting from illumination with bare fiber, a centering balloon catheter (X-Cell, Cooke, Inc), and a fixed diameter transparent dilating catheter (Optical Dilator, Inscope, Ethicon ES). Measurements were made in a solid esophagus-simulating phantom illuminated by 2.5 and 5 cm diffusing fibers with and without each delivery device. The diffuser was coupled to a 630 nm dye laser pumped by a 532 nm KTP laser (LaserScope, Inc.) The total power emitted by the diffuser was 1W. The fluence rate as a function of position along the cavity was measured by a calibrated photodiode connected to an optical fiber with a 0.5 mm isotropic scattering tip, which was moved by a computer-controlled positioner. The mean fluence rate measured when the phantom was illuminated using either the centering balloon or the rigid dilator was approximately 50% less than that measured with a bare fiber. The decrease in fluence rate is due to attenuation of the primary light beam and to reduction in scattering from laterally adjacent points in the phantom. The importance of each of these effects as a function of tissue optical properties was confirmed using Monte Carlo simulation.

  15. A new method and device of aligning patient setup lasers in radiation therapy.

    PubMed

    Hwang, Ui-Jung; Jo, Kwanghyun; Lim, Young Kyung; Kwak, Jung Won; Choi, Sang Hyoun; Jeong, Chiyoung; Kim, Mi Young; Jeong, Jong Hwi; Shin, Dongho; Lee, Se Byeong; Park, Jeong-Hoon; Park, Sung Yong; Kim, Siyong

    2016-01-01

    The aim of this study is to develop a new method to align the patient setup lasers in a radiation therapy treatment room and examine its validity and efficiency. The new laser alignment method is realized by a device composed of both a metallic base plate and a few acrylic transparent plates. Except one, every plate has either a crosshair line (CHL) or a single vertical line that is used for alignment. Two holders for radiochromic film insertion are prepared in the device to find a radiation isocenter. The right laser positions can be found optically by matching the shadows of all the CHLs in the gantry head and the device. The reproducibility, accuracy, and efficiency of laser alignment and the dependency on the position error of the light source were evaluated by comparing the means and the standard deviations of the measured laser positions. After the optical alignment of the lasers, the radiation isocenter was found by the gantry and collimator star shots, and then the lasers were translated parallel to the isocenter. In the laser position reproducibility test, the mean and standard deviation on the wall of treatment room were 32.3±0.93 mm for the new method whereas they were 33.4±1.49 mm for the conventional method. The mean alignment accuracy was 1.4 mm for the new method, and 2.1 mm for the conventional method on the walls. In the test of the dependency on the light source position error, the mean laser position was shifted just by a similar amount of the shift of the light source in the new method, but it was greatly magnified in the conventional method. In this study, a new laser alignment method was devised and evaluated successfully. The new method provided more accurate, more reproducible, and faster alignment of the lasers than the conventional method. PACS numbers: 87.56.Fc, 87.53.Bn, 87.53.Kn, 87.53.Ly, 87.55.Gh.

  16. Clinical outcomes associated with chronic antimicrobial suppression therapy in patients with continuous-flow left ventricular assist devices.

    PubMed

    Jennings, Douglas L; Chopra, Anuvrat; Chambers, Rachel; Morgan, Jeffrey A

    2014-10-01

    This retrospective cohort study evaluates the effect of chronic antimicrobial suppression (CAS) therapy on clinical outcomes in patients with continuous-flow left ventricular assist devices (CF-LVADs) and a history of device-related infection. Patients with CF-LVAD implantation between January 2008 and August 2011 who received systemic CAS after index antibiotic treatment of a device-related infection were included. Chronic suppression was defined as continuation of antibiotics for longer than 6 weeks after the index infection. Standard International Society for Heart and Lung Transplantation definitions were used. The primary outcome is failure of CAS, defined as a clinical deterioration resulting in the need for transition from oral to intravenous (IV) therapy or a need to change to a different IV antibiotic, elevation to status 1A on the transplant list as a result of ongoing infection, or device/driveline exchange. Of 140 patients screened, 16 patients were included (69% male, 63% African American, median age 52 years). The driveline was the most common site of infection (69%). Organisms isolated included Gram-positive cocci (n = 7), Gram-negative bacilli (n = 10), and Candida (n = 1). Oral trimethoprim/sulfamethoxazole treatment was most commonly used for suppression (37.5%). Failure of CAS occurred in 5/16 (31%) patients after a mean time of 175 days on therapy (range 10-598). The majority of failures (60%) required device exchanges. Side effects of nausea, vomiting, or diarrhea were reported in three patients; all required changes in oral suppression regimen. Clostridium difficile infection was noted in two patients. These results, which must be confirmed by a larger analysis, suggest that one-third of CF-LVAD patients may develop recurrent infections while on CAS therapy.

  17. A novel microfluidic anti-factor Xa assay device for monitoring anticoagulant therapy at the point-of-care

    NASA Astrophysics Data System (ADS)

    Harris, Leanne F.; Rainey, Paul; Castro-López, Vanessa; O'Donnell, James S.; Killard, Anthony J.

    2013-05-01

    Millions of patients worldwide are receiving anticoagulant therapy to treat hypercoagulable diseases. While standard testing is still performed in the central laboratory, point-of-care (POC) diagnostics are being developed due to the increasing number of patients requiring long-term anticoagulation and with a need for more personalized and targeted therapy. Many POC devices on the market focus on clot measurement, a technique which is limited in terms of variability, highlighting the need for more reliable assays of anticoagulant status. The anti-Xa assay, a factor specific optical assay, was developed to measure the extent to which exogenous factor Xa (FXa) is inhibited by heparinantithrombin complexes. We have developed a novel microfluidic device and assay for monitoring the effect of heparin anticoagulant therapy at the point-of-care. The assay which was also developed in our institute is based on the anti-Xa assay principle but uses fluorescence as the method of detection. Our device is a disposable laminate microfluidic strip, fabricated from the cyclic polyolefin (COP), Zeonor®, which is extremely suitable for application to fluorescent device platforms. We present data on the execution of the anti-Xa assay in this microfluidic format, demonstrating that the assay can be used to measure heparin in human plasma samples from 0 to 0.8 U/ml, with average assay reproducibility of 8% and a rapid result obtained within 60 seconds. Results indicate that with further development, the fluorogenic anti-Xa assay and device could become a successful method for monitoring anticoagulant therapy.

  18. Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy. Final order; technical correction.

    PubMed

    2015-10-13

    The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device "nonthermal shortwave therapy'' (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices.

  19. B-type natriuretic peptide-guided therapy and length of hospital stay post left ventricular assist device implantation.

    PubMed

    Hellman, Yaron; Malik, Adnan S; Lin, Hongbo; Shen, Changyu; Wang, I-Wen; Wozniak, Thomas C; Hashmi, Zubair A; Shaukat, Arslan; Pickrell, Jeanette; Caccamo, Marco A; Gradus-Pizlo, Irmina; Hadi, Azam

    2015-01-01

    B-type natriuretic peptide (BNP)-guided therapy during the early postoperative period following left ventricular assist device (LVAD) implantation has not been well described in the literature. We conducted a retrospective cohort study consisting of consecutive patients who underwent LVAD implantation at our institution during May 2009 to March 2013. The study was limited to patients receiving HeartMate II (Thoratec) or HVAD (HeartWare) LVADs. Patients with acute myocardial infarction were excluded. We compared between patients with multiple postoperative BNP tests (BNP-guided therapy) and earlier period patients who typically had only a baseline BNP measurement (non-BNP-guided therapy). A total of 85 patients underwent LVAD implantation during the study period. Eight patients were excluded (five acute myocardial infarction, three without BNP measurements). The only differences in the baseline characteristics of BNP versus non-BNP-guided therapy included age and female gender. The postoperative length of hospital stay (LOS) in the BNP-guided therapy group was 5 days shorter when compared with the non-BNP-guided therapy group. In multivariate analysis, BNP-guided therapy remained a significant predictor of reduced LOS. The use of repeated BNP measurements during the early postoperative period was associated with a significantly lower LOS post LVAD implantation.

  20. Wound healing and catheter thrombosis after implantable venous access device placement in 266 breast cancers treated with bevacizumab therapy.

    PubMed

    Kriegel, Irène; Cottu, Paul H; Fourchotte, Virginie; Sanchez, Sebastian; Fromantin, Isabelle; Kirov, Krassen; Guillaume, Alain; Pelloquin, Anne; Esteve, Marc; Salmon, Remy J

    2011-11-01

    The aim of this study was to determine, in a population with metastatic breast cancer treated with bevacizumab therapy, the incidence of wound dehiscence after placement of an implantable venous access device (VAD) and to study the risk of catheter thrombosis. This study enrolled all VADs placed by 14 anesthetists between 1 January 2007 and 31 December 2009: 273 VADs in patients treated with bevacizumab therapy and 4196 VADs in patients not treated with bevacizumab therapy. In the bevacizumab therapy group, 13 cases of wound dehiscence occurred in 12 patients requiring removal of the VAD (4.76%). All cases of dehiscence occurred when bevacizumab therapy was initiated less than 7 days after VAD placement. Bevacizumab therapy was initiated less than 7 days after VAD placement in 150 cases (13 of 150: 8.6%). The risk of dehiscence was the same from 0 to 7 days. In parallel, the VAD wound dehiscence rate in patients not receiving bevacizumab therapy was eight of 4197 cases (0.19%) (Fisher's test significant, P<0.001). No risk factors of dehiscence were identified: anesthetists, learning curves, and irradiated patients. VAD thrombosis occurred in four patients (1.5%). In parallel, VAD thrombosis occurred in 51 of 4197 patients (1.2%) not receiving bevacizumab therapy (Fisher's test not significant; P=0.43). Bevacizumab therapy was permanently discontinued in five patients related to wound dehiscence and in one patient due to extensive skin necrosis. These data suggest the need to observe an interval of at least 7 days between VAD placement and initiation of bevacizumab therapy to avoid the risk of a wound dehiscence requiring chest wall port explant. The risk of VAD thrombosis does not require any particular primary prevention.

  1. Assessment of Haptic Interaction for Home-Based Physical Tele-Therapy using Wearable Devices and Depth Sensors.

    PubMed

    Barmpoutis, Angelos; Alzate, Jose; Beekhuizen, Samantha; Delgado, Horacio; Donaldson, Preston; Hall, Andrew; Lago, Charlie; Vidal, Kevin; Fox, Emily J

    2016-01-01

    In this paper a prototype system is presented for home-based physical tele-therapy using a wearable device for haptic feedback. The haptic feedback is generated as a sequence of vibratory cues from 8 vibrator motors equally spaced along an elastic wearable band. The motors guide the patients' movement as they perform a prescribed exercise routine in a way that replaces the physical therapists' haptic guidance in an unsupervised or remotely supervised home-based therapy session. A pilot study of 25 human subjects was performed that focused on: a) testing the capability of the system to guide the users in arbitrary motion paths in the space and b) comparing the motion of the users during typical physical therapy exercises with and without haptic-based guidance. The results demonstrate the efficacy of the proposed system.

  2. Durable left ventricular assist device therapy in advanced heart failure: Patient selection and clinical outcomes

    PubMed Central

    Shah, Sachin P.; Mehra, Mandeep R.

    2016-01-01

    The increasing adoption of left ventricular assist devices (LVADs) into clinical practice is related to a combination of engineering advances in pump technology and improvements in understanding the appropriate clinical use of these devices in the management of patients with advanced heart failure. This review intends to assist the clinician in identifying candidates for LVAD implantation, to examine long-term outcomes and provide an overview of the common complications related to use of these devices. PMID:27056652

  3. Reduction in stray radiation dose using a body-shielding device during external radiation therapy.

    PubMed

    Zhang, Shuxu; Jiang, Shaohui; Zhang, Quanbin; Lin, Shengqu; Wang, Ruihao; Zhou, Xiang; Zhang, Guoqian; Lei, Huaiyu; Yu, Hui

    2017-03-01

    With the purpose of reducing stray radiation dose (SRD) in out-of-field region (OFR) during radiotherapy with 6 MV intensity-modulated radiation therapy (IMRT), a body-shielding device (BSD) was prepared according to the measurements obtained in experimental testing. In experimental testing, optimal shielding conditions, such as 1 mm lead, 2 mm lead, and 1 mm lead plus 10 mm bolus, were investigated along the medial axis of a phantom using thermoluminescent dosimeters (TLDs). The SRDs at distances from field edge were then measured and analyzed for a clinical IMRT treatment plan for nasopharyngeal carcinoma before and after shielding using the BSD. In addition, SRDs in anterior, posterior, left and right directions of phantom were investigated with and without shielding, respectively. Also, the SRD at the bottom of treatment couch was measured. SRD decreased exponentially to a constant value with increasing distance from field edge. The shielding rate was 50%-80%; however, there were no significant differences in SRDs when shielded by 1 mm lead, 2 mm lead, or 1 mm lead plus 10 mm bolus (P>0.05). Importantly, the 10 mm bolus absorbed back-scattering radiation due to the interaction between photons and lead. As a result, 1 mm lead plus 10 mm bolus was selected to prepare the BSD. After shielding with BSD, total SRDs in the OFR decreased to almost 50% of those without shielding when irradiated with IMRT beams. Due to the effects of treatment couch and gantry angle, SRDs at distances were not identical in anterior, posterior, left and right direction of phantom without BSD. As higher dose in anterior and lower dose in posterior, SRDs were substantial similarities after shielding. There was no significant difference in SRDs for left and right directions with or without shielding. Interestingly, SRDs in the four directions were similar after shielding. From these results, the BSD developed in this study may significantly reduce SRD in the OFR during

  4. A New Handheld Device for the Detection of Falsified Medicines: Demonstration on Falsified Artemisinin-Based Therapies from the Field.

    PubMed

    Wilson, Benjamin K; Kaur, Harparkash; Allan, Elizabeth Louise; Lozama, Anthony; Bell, David

    2017-02-20

    Poor-quality medicines are a major problem for health-care systems in resource-poor settings as identifying falsified medicines requires a complex laboratory infrastructure such as a Medicines Quality Control Laboratory. We report here an evaluation of a low-cost, handheld near-infrared spectrometer (NIRS) device by analyzing a library of artemisinin-based combination therapy (ACT) medicines to determine its usefulness as a drug-screening tool. The "SCiO" research prototype device was used to collect NIR spectra of a library of ACT and artesunate monotherapy medicine samples previously collected in Bioko Island and Equatorial Guinea and Kintampo, Ghana. The quality of these samples had been categorized as falsified, substandard, and quality assured based on the amount of stated active pharmaceutical ingredients detected using high-performance liquid chromatography photodiode array. Numerical analyses were performed on the NIR spectra to assess the usefulness of NIR to identify falsified and substandard medicines. The NIRS device was successful at detecting falsified medicines in all cases where the library contained both quality assured and falsified medicines of the same stated brand of medicines. The NIRS device was successful at identifying substandard amounts of artesunate but not amodiaquine in the ACT samples (N = 15) of artesunate-amodiaquine. This work reveals that this low-cost, portable NIRS device is promising for screening ACTs for falsified samples and could enable widespread drug screening at all points of the health system.

  5. A Fiberoptic (Photodynamic Therapy Type) Device with a Photosensitizer and Singlet Oxygen Delivery Probe Tip for Ovarian Cancer Cell Killing

    PubMed Central

    Bartusik, Dorota; Aebisher, David; Ghogare, Ashwini; Ghosh, Goutam; Abramova, Inna; Hasan, Tayyaba; Greer, Alexander

    2013-01-01

    A portable “fiber optic-based sensitizer delivery” device has been developed and studied. Before there might be success in photodynamic therapy (PDT) and anti-bacterial ambitions, an understanding of basic factors on device performance were needed. Thus, the device was examined for the localized delivery of sensitizer molecules in ovarian cancer cells and production of high concentrations of singlet oxygen for their eradication in vitro. The device-tip releases stored pheophorebide by attack of singlet oxygen from sensitized oxygen gas delivered through the hollow fiber using 669-nm laser light. The performance of the device was enhanced when configured with a fluorosiliane tip by virtue of its Teflon-like property compared to a conventional glass tip (greater sensitizer quantities photoreleased and laterally diffused, and greater amounts of ovarian OVCAR-5 cancer cell killing). No cell damage was observed at 2.2 N of force applied by the probe tip itself, an amount used for many of the experiments described here. PMID:23495787

  6. The additional effect of orthotic devices on exercise therapy for patients with patellofemoral pain syndrome: a systematic review.

    PubMed

    Swart, Nynke M; van Linschoten, Robbart; Bierma-Zeinstra, Sita M A; van Middelkoop, Marienke

    2012-06-01

    The aim of the study is to determine "the additional effect of... function" for patellofemoral pain syndrome (PFPS). The additional effect of orthotic devices over exercise therapy on pain and function. A systematic literature search was conducted in MEDLINE, CINAHL, EMBASE, Cochrane and PEDro. Randomised controlled trials and controlled clinical trials of patients diagnosed with PFPS evaluating a clinically relevant outcome were included. Treatment had to include exercise therapy combined with orthotics, compared with an identical exercise programme with or without sham orthotics. Data were summarised using a best evidence synthesis. Eight trials fulfilled the inclusion criteria, of which three had a low risk of bias. There is moderate evidence for no additive effectiveness of knee braces to exercise therapy on pain (effect sizes (ES) varied from -0.14 to 0.04) and conflicting evidence on function (ES -0.33). There is moderate evidence for no difference between knee braces and exercise therapy versus placebo knee braces and exercise therapy on pain and function (ES -0.1-0.10). More studies of high methodological quality are needed to draw definitive conclusions.

  7. Biolite: A Patented Ultra-Low-Level Laser-Therapy Device for Treating Musculoskeletal Pain and Associated Impairments.

    PubMed

    Gallamini, Michele; D'Angelo, Giovanni; Belloni, Gabriele

    2015-08-01

    After an excursus on state-of-the-art knowledge for low-level laser therapy (LLLT), Biolite, a patented ultra-low-level laser therapy device used to treat musculoskeletal pain and associated impairments, is presented. The application protocols include short stimulation of sequences of acupuncture points. The observed effects seem, however, to be far from those that might be expected after acupuncture. The primary effect seems more likely to be an extracellular soft-tissue matrix reaction. The development of the technique, the studies performed, and the evidence collected over > 10 years suggest that specifically modulated laser light can interact with human tissues at light fluences well under those previously considered as being capable of having any effect. Musculoskeletal pain very often becomes an autonomous dysfunction that is independent of the original injury and that can be effectively treated using specific peripheral acupuncture-like stimulation. Because such acupuncture is capable of reducing motor control "interferences" from noxious stimuli, it can improve motor control performance, thereby reducing the risk of falls in the elderly individuals. The proposal of acupuncture-derived protocols to be applied by Western physiotherapists using an ultra-low-level laser therapy device is a further "bridge" between two different, and sometimes very different, clinical worlds to better serve our patients.

  8. Reversible Motor Paralysis and Early Cardiac Rehabilitation in Patients With Advanced Heart Failure Receiving Left Ventricular Assist Device Therapy.

    PubMed

    Amao, Rie; Imamura, Teruhiko; Nakahara, Yasuo; Noguchi, Satoko; Kinoshita, Osamu; Yamauchi, Haruo; Ono, Minoru; Haga, Nobuhiko

    2016-12-02

    Advanced heart failure (HF) is sometimes complicated with brain impairment because of a microthrombosis caused by decreased left ventricular contraction or reduced brain circulation. Some patients may recover after left ventricular assist device (LVAD) implantation. However, little is known about the perioperative therapeutic strategy in patients suffering from such complications, particularly from a cardiac rehabilitation viewpoint. We report on a 58-year-old male patient with a previous history of poliomyelitis and a light paralysis in the left upper extremity, who suffered left hemiplegia with no evidence of stroke after hemodynamic deterioration. The combination therapy of perioperative cardiac rehabilitation and LVAD therapy improved his left hemiplegia as well as activities of daily living, and the patient was discharged on foot on postoperative day 72 after briefing the family on LVAD home management. Early initiation of cardiac rehabilitation before LVAD implantation may be a key for the smooth discharge and resocialization of patients suffering from brain impairment complicated with advanced HF.

  9. Patient-specific flexible and stretchable devices for cardiac diagnostics and therapy.

    PubMed

    Gutbrod, Sarah R; Sulkin, Matthew S; Rogers, John A; Efimov, Igor R

    2014-08-01

    Advances in material science techniques and pioneering circuit designs have led to the development of electronic membranes that can form intimate contacts with biological tissues. In this review, we present the range of geometries, sensors, and actuators available for custom configurations of electronic membranes in cardiac applications. Additionally, we highlight the desirable mechanics achieved by such devices that allow the circuits and substrates to deform with the beating heart. These devices unlock opportunities to collect continuous data on the electrical, metabolic, and mechanical state of the heart as well as a platform on which to develop high definition therapeutics.

  10. Maintaining Control of Chronic Obstructive Airway Disease: Adherence to Inhaled Therapy and Risks and Benefits of Switching Devices.

    PubMed

    Melani, Andrea S; Paleari, Davide

    2016-01-01

    Asthma and chronic obstructive pulmonary disease (COPD) are major obstructive airway diseases that involve underlying airway inflammation. The most widely used pharmacotherapies for asthma and COPD are inhaled agents that have been shown to be effective and safe in these patients. However, despite the availability of effective pharmacologic treatment and comprehensive treatment guidelines, the prevalence of inadequately controlled asthma and COPD is high. A main reason for this is poor adherence. Adherence is a big problem for all chronic diseases, but in asthma and COPD patients there are some additional difficulties because of poor inhalation technique and inhaler choice. Easier-to-use devices and educational strategies on proper inhaler use from health caregivers can improve inhaler technique. The type of device used and the concordance between patient and physician in the choice of inhaler can also improve adherence and are as important as the drug. Adherence to inhaled therapy is absolutely necessary for optimizing patient control. If disease control is not adequate despite good adherence, switching to a more appropriate inhaled therapy is recommended. By contrast, uninformed switching or switching to less user-friendly inhaler may impact disease control negatively. This critical review of the available literature is aimed to provide a guidance protocol on when a switch may be recommended in individual patients.

  11. Development of transfer standard devices for ensuring the accurate calibration of ultrasonic physical therapy machines in clinical use

    NASA Astrophysics Data System (ADS)

    Hekkenberg, R. T.; Richards, A.; Beissner, K.; Zeqiri, B.; Prout, G.; Cantrall, Ch; Bezemer, R. A.; Koch, Ch; Hodnett, M.

    2004-01-01

    Physical therapy ultrasound is widely applied to patients. However, many devices do not comply with the relevant standard stating that the actual power output shall be within +/-20% of the device indication. Extreme cases have been reported: from delivering effectively no ultrasound or operating at maximum power at all powers indicated. This can potentially lead to patient injury as well as mistreatment. The present European (EC) project is an ongoing attempt to improve the quality of the treatment of patients being treated with ultrasonic physical-therapy. A Portable ultrasound Power Standard (PPS) is being developed and accurately calibrated. The PPS includes: Ultrasound transducers (including one exhibiting an unusual output) and a driver for the ultrasound transducers that has calibration and proficiency test functions. Also included with the PPS is a Cavitation Detector to determine the onset of cavitation occurring within the propagation medium. The PPS will be suitable for conducting in-the-field accreditation (proficiency testing and calibration). In order to be accredited it will be important to be able to show traceability of the calibration, the calibration process and qualification of testing staff. The clinical user will benefit from traceability because treatments will be performed more reliably.

  12. [Use of Intramag devices with Intraterm and LAST-02 attachments in complex therapy of chronic prostatitis].

    PubMed

    Shaplygin, L V; Begaev, A I; V'iushina, V V

    2006-01-01

    The examination of the patients exposed to physical factors (magnetotherapy, laser therapy and thermotherapy) has demonstrated that Intramag unit with attachments Intraterm and LAST-02 for local physiotherapy is effective in patients with chronic prostatitis and can be used in urological hospitals and outpatient clinics.

  13. Development of a Decision Aid for Patients with Advanced Heart Failure Considering a Destination Therapy Left Ventricular Assist Device

    PubMed Central

    Thompson, Jocelyn S.; Matlock, Daniel D.; McIlvennan, Colleen K.; Jenkins, Amy R.; Allen, Larry A.

    2015-01-01

    STRUCTURED ABSTRACT Objective We aimed to create decision aids (DAs) for patients considering destination therapy left ventricular assist device (DT LVAD). Background DT LVAD is a major decision for patients with end-stage heart failure. Patients facing decisions with complex tradeoffs may benefit from high-quality decision support resources. Methods Following the International Patient Decision Aid Standards (IPDAS) guidelines and based on a needs assessment with stakeholders, we developed drafts of paper and video DAs. With input from patients, caregivers, and clinicians through alpha testing, we iteratively modified the DAs to ensure acceptability. Results We conducted semi-structured interviews with 24 patients, 20 caregivers, and 24 clinicians to assess readability, bias, and usability of the DAs. Stakeholder feedback allowed us to integrate aspects critical to decision-making around highly invasive therapies for life-threatening diseases, including addressing emotion and fear of death, using gain frames for all options that focus on living, highlighting palliative and hospice care, integrating the caregiver role, and utilizing a range of balanced testimonials. After 19 iterative versions of the paper DA and four versions of the video DA, final materials were made available for wider use. Conclusion We developed the first IPDAS-level DAs for DT LVAD. Given the extreme nature of this medical decision, we augmented traditional DA characteristics with non-traditional DA features to address a spectrum of cognitive, automatic, and emotional aspects of end-of-life decision-making. Not only are the DAs important tools for those confronting end-stage heart failure, but the lessons learned will likely inform decision support for other invasive therapies. UNSTRUCTURED ABSTRACT Destination therapy left ventricular assist device (DT LVAD) is a major decision for patients with end-stage heart failure. We aimed to create decision aids (DAs) to support patients and their

  14. Risk Factors Influencing Complications of Cardiac Implantable Electronic Device Implantation: Infection, Pneumothorax and Heart Perforation

    PubMed Central

    Lin, Yu-Sheng; Hung, Sheng-Ping; Chen, Pei-Rung; Yang, Chia-Hung; Wo, Hung-Ta; Chang, Po-Cheng; Wang, Chun-Chieh; Chou, Chung-Chuan; Wen, Ming-Shien; Chung, Chang-Ming; Chen, Tien-Hsing

    2014-01-01

    Abstract As the number of cardiac implantable electronic devices (CIEDs) is increasing annually, CIED-related complications are becoming increasingly important. The aim of the study was to assess the risks associated with CIEDs by a nationwide database. Patients were selected from the Taiwan National Health Insurance Database. Admissions for CIED implantation, replacement, and revision were evaluated and the evaluation period was 14 years. Endpoints included CIED-related infection, pneumothorax, and heart perforation. The study included 40,608 patients with a mean age of 71.8 ± 13.3 years. Regarding infection, the incidence rate was 2.45 per 1000 CIED-years. Male gender, younger age, device replacement, and previous infection were risks for infection while old age and high-volume centers (>200 per year) were protectors. The incidence of pneumothorax was 0.6%, with an increased risk in individuals who had chronic obstructive lung disease (COPD) and cardiac resynchronized therapy (CRT). The incidence of heart perforation was 0.09%, with an increased risk in individuals who had pre-operation temporal pacing and steroid use. High-volume center was found to decrease infection rate while male gender, young people, and individuals who underwent replacements were associated with an increased risk of infection. Additionally, pre-operation temporal pacing and steroid use should be avoided if possible. Furthermore, COPD patients or those who accept CRTs should be monitored closely. PMID:25501080

  15. Intravenous thrombolytic therapy for patients with ventricular assist device thrombosis: An attempt to avoid reoperation

    PubMed Central

    Webber, Beth T.; Panos, Anthony L.; Rodriguez-Blanco, Yiliam F.

    2016-01-01

    A growing number of patients are undergoing prolonged management of advanced heart failure with the use of continuous flow left ventricular assist devices (LVADs). Subsequently, an increasing number of patients are presenting with complications associated with these devices. Based on an analysis of three major LVAD institutions, the number of patients developing LVAD pump thrombosis may be much higher than originally projected.[12] The management of this highly feared complication continues to be challenging, as the population of LVAD patients is very heterogeneous and heavily burdened with comorbidities. The standard protocol of increasing anticoagulation may fail to achieve successful resolution of thrombus. Difficulty and poor prognosis may make reoperation less than desirable. Here, we present a case of successful thrombolysis following intravenous administration of tissue plasminogen activator in the Intensive Care Unit setting. PMID:26750701

  16. Predicting therapy response in live tumor cells isolated with the flexible micro spring array device

    PubMed Central

    Gallant, Jean-Nicolas; Matthew, Elizabeth M; Cheng, Hairong; Harouaka, Ramdane; Lamparella, Nicholas E.; Kunkel, Miriam; Yang, Zhaohai; Harvey, Harold A.; Cream, Leah V.; Kumar, Suresh M.; Robertson, Gavin P.; Zheng, Siyang; Drabick, Joseph J.; Truica, Cristina I.; El-Deiry, Wafik S.

    2013-01-01

    Cells disseminated from primary epithelial tumors into peripheral blood, called circulating tumor cells (CTCs), can be monitored to assess metastases and to provide a surrogate marker of treatment response. Here, we demonstrate how the flexible micro spring array (FMSA) device—a novel microfluidic device that enriches CTCs by two physical parameters: size and deformability—could be used in the rational development of treatment intervention and as a method to study the fundamental biology of CTCs. Cancer cells of different origins were spiked into healthy samples of donor blood to mimic blood samples of metastatic cancer patients. This spiked human blood was filtered using the FMSA device, and the recovered cells were successfully expanded in vitro and in a novel in vivo system. A series of experiments were performed to characterize these cells and to investigate the effect of chemotherapy on the resulting cultures. As few as 20 colon cancer cells in 7.5 mL blood could be isolated with the FMSA device, expanded both in vitro and in vivo and used at 25 cells per well to obtain significant and reliable chemosensitivity data. We also show that isolating a low number of viable patient CTCs and maintaining them in culture for a few weeks is possible. The isolation of viable cancer cells from human blood using the FMSA device provides a novel and realistic means for studying the biology of viable CTCs and for testing drug efficacy on these rare cells—a hypothesis that can be tested in future clinical trials. PMID:23759587

  17. A simple device for checking the acoustic beam of ultrasonic therapy equipment.

    PubMed

    Breyer, B; Devcić, B

    1984-11-01

    Ultrasound of time average acoustic intensities between 0.5 and 3 W cm-2 is widely used in physiotherapy. A simple device for semiquantitative checking of output power and beam shape has been designed. The beam tester consists of an absorbing plate and a sheath liquid crystal thermometer for temperature distribution display. The ultrasonic beam is fed to the absorber through a simple water tank.

  18. MotionTherapy@Home - First results of a clinical study with a novel robotic device for automated locomotion therapy at home.

    PubMed

    Rupp, Rüdiger; Plewa, Harry; Schuld, Christian; Gerner, Hans Jürgen; Hofer, Eberhard P; Knestel, Markus

    2011-02-01

    In incomplete spinal cord injured subjects, task-oriented training regimes are applied for enhancement of neuroplasticity to improve gait capacity. However, a sufficient training intensity can only be achieved during the inpatient phase, which is getting shorter and shorter due to economic restrictions. In the clinical environment, complex and expensive robotic devices have been introduced to maintain the duration and the intensity of the training, but up to now only a few exist for continuation of automated locomotion training at home. For continuation of the automated locomotion training at home prototypes of the compact, pneumatically driven orthosis MoreGait have been realized, which generate the key afferent stimuli for activation of the spinal gait pattern generator. Artificial pneumatic muscles with excellent weight-to-force ratio and safety characteristics have been integrated as joint actuators. Additionally, a Stimulative Shoe for generation of the appropriate foot loading pattern has been developed without the need for verticalization of the user. The first results of the pilot study in eight chronic incomplete spinal cord injured subjects indicate that the home-based therapy is safe and feasible. The therapy related improvements of the walking capacity are in the range of locomotion robots used in clinical settings.

  19. Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the health economics committee of the European Heart Rhythm Association.

    PubMed

    Mairesse, Georges H; Braunschweig, Frieder; Klersy, Katherine; Cowie, Martin R; Leyva, Francisco

    2015-05-01

    Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias, device, and lead failure and may also be useful in risk-predicting patient-related outcomes. Financial benefits for patients and healthcare organizations have also been shown. We sought to assess the implementation and funding of RM of CIEDs, including conventional pacemakers (PMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in Europe. Electronic survey from 43 centres in 15 European countries. In the study sample, RM was available in 22% of PM patients, 74% of ICD patients, and 69% of CRT patients. The most significant perceived benefits were the early detection of atrial arrhythmias in pacemaker patients, lead failure in ICD patients, and worsening heart failure in CRT patients. Remote monitoring was reported to lead a reduction of in-office follow-ups for all devices. The most important reported barrier to the implementation of RM for all CIEDs was lack of reimbursement (80% of centres). Physicians regard RM of CIEDs as a clinically useful technology that affords significant benefits for patients and healthcare organizations. Remote monitoring, however, is perceived as increasing workload. Reimbursement for RM is generally perceived as a major barrier to implementation.

  20. Efficacy of biofeedback therapy via a mini wireless device on sleep bruxism contrasted with occlusal splint: a pilot study

    PubMed Central

    Gu, WeiPing; Yang, Jie; Zhang, FeiMin; Yin, XinMin; Wei, XiaoLong; Wang, Chen

    2015-01-01

    Abstract The putative causes of bruxism are multifactorial and there are no definite measures for bruxism management. The aim of this study was to evaluate the efficacy of biofeedback therapy on sleep bruxism, compared with occlusal splint. Twenty-four volunteers with sleep bruxism were divided into two groups: the GTB group that were treated with biofeedback therapy (n  = 12) and the GTO group that were treated with occlusal splint (n  = 12). A mini pressure sensor integrated with a monitoring circuit by use of a maxillary biofeedback splint was fabricated. To foster the relaxation of the masticatory muscles and the nervous system, the wireless device received signals from bruxism events and vibrations alerted the bruxer when the threshold was exceeded. Total episodes and average duration of bruxism events during 8 hours of sleep were analyzed with the monitoring program (TRMY1.0). After 6 and 12 weeks, the episodes (P  =  0.001) and duration (P < 0.05) in the GTB group declined dramatically. In contrast, there were no significant differences in the GTO group after the treatment (P > 0.05). Furthermore, the episodes had significant differences between the GTB group and the GTO group after the same period of treatment (P  =  0.000). The results suggest that biofeedback therapy may be an effective and convenient measure for mild bruxers, when compared with occlusal splint therapy. The mini wireless biofeedback method may be of value for the diagnosis and management of bruxism in the future. PMID:25859272

  1. A device for conducting a dynamic modes of UIAB therapy with automatic process testing

    NASA Astrophysics Data System (ADS)

    Barylo, Hryhoriy I.; Hotra, Zenon Yu.; Kozhukhar, Oleksandr T.; Ivakh, Mariya S.; Surtel, Wojciech; Maciejewski, Marcin

    2016-09-01

    The structure and circuit of the implemented device is using an environmentally friendly radiation sources and pulse photo stimulus modes with frequencies that correspond frequencies processes in BL to create bio resonance effects to accelerate the procedures. Proposed one of the possible hardware solutions are based on usage of dynamic irradiation modes and automatic continuous optical testing procedures UIAB and PP. The changes of the optical characteristics of BL provides the doctor continuous information on the effectiveness of the procedure on the patient's condition.

  2. [Using AELTIS-synchro-02 device in the therapy of chronic bacterial prostatitis].

    PubMed

    Orlov, V N; Kozboda, A S; Kravchenko, V V; Kalinina, S A

    2006-01-01

    The treatment of chronic bacterial prostatitis combined antibacterial drugs and physiotherapy (low-energy laser radiation, electrostimulation of the prostate). Treatment of chronic bacterial prostatitis with medication and complex two-channel bio-synchronized electrolaser therapy with application of the unit AELTIS-synchro-02 raises efficacy of treatment with chronic bacterial prostatitis due to combined effect of antibacterial drugs and bacteriostatic and immunomodulating actions of the physical factors applied. These normalize microcirculation in the region of the prostatic gland, improve a draining function of the prostatic ducts, allows achievement of good results in 88.2% patients.

  3. Integrated Interventional Devices For Real Time 3D Ultrasound Imaging and Therapy

    NASA Astrophysics Data System (ADS)

    Smith, Stephen W.; Lee, Warren; Gentry, Kenneth L.; Pua, Eric C.; Light, Edward D.

    2006-05-01

    Two recent advances have expanded the potential of medical ultrasound: the introduction of real-time 3-D ultrasound imaging with catheter, transesophageal and laparoscopic probes and the development of interventional ultrasound therapeutic systems for focused ultrasound surgery, ablation and ultrasound enhanced drug delivery. This work describes devices combining both technologies. A series of transducer probes have been designed, fabricated and tested including: 1) a 12 French side scanning catheter incorporating a 64 element matrix array for imaging at 5MHz and a piston ablation transducer operating at 10 MHz. 2) a 14 Fr forward-scanning catheter integrating a 112 element 2-D array for imaging at 5 MHz encircled by an ablation annulus operating at 10 MHz. Finite element modeling was then used to simulate catheter annular and linear phased array transducers for ablation. 3) Linear phased array transducers were built to confirm the finite element analysis at 4 and 8 MHz including a mechanically focused 86 element 9 MHz array which transmits an ISPTA of 29.3 W/cm2 and creates a lesion in 2 minutes. 4) 2-D arrays of 504 channels operating at 5 MHz have been developed for transesophageal and laparascopic 3D imaging as well as therapeutic heating. All the devices image the heart anatomy including atria, valves, septa and en face views of the pulmonary veins.

  4. The VANILLA sensor as a beam monitoring device for X-ray radiation therapy.

    PubMed

    Velthuis, J J; Hugtenburg, R P; Cussans, D; Perry, M; Hall, C; Stevens, P; Lawrence, H; McKenzie, A

    2014-01-01

    Cancer treatments such as intensity-modulated radiotherapy (IMRT) require increasingly complex methods to verify the accuracy and precision of the treatment delivery. In vivo dosimetry based on measurements made in an electronic portal imaging device (EPID) has been demonstrated. The distorting effect of the patient anatomy on the beam intensity means it is difficult to separate changes in patient anatomy from changes in the beam intensity profile. Alternatively, upstream detectors scatter and attenuate the beam, changing the energy spectrum of the beam, and generate contaminant radiation such as electrons. We used the VANILLA device, a Monolithic Active Pixel Sensor (MAPS), to measure the 2D beam profile of a 6 MV X-ray beam at Bristol Hospital in real-time in an upstream position to the patient without clinically significant disturbance of the beam (0.1% attenuation). MAPSs can be made very thin (~20 μm) with still a very good signal-to-noise performance. The VANILLA can reconstruct the collimated beam edge with approximately 64 μm precision.

  5. Biological in situ Dose Painting for Image-Guided Radiation Therapy Using Drug-Loaded Implantable Devices

    SciTech Connect

    Cormack, Robert A.; Sridhar, Srinivas; Suh, W. Warren; D'Amico, Anthony V.; Makrigiorgos, G. Mike

    2010-02-01

    Purpose: Implantable devices routinely used for increasing spatial accuracy in modern image-guided radiation treatments (IGRT), such as fiducials or brachytherapy spacers, encompass the potential for in situ release of biologically active drugs, providing an opportunity to enhance the therapeutic ratio. We model this new approach for two types of treatment. Methods and Materials: Radiopaque fiducials used in IGRT, or prostate brachytherapy spacers ('eluters'), were assumed to be loaded with radiosensitizer for in situ drug slow release. An analytic function describing the concentration of radiosensitizer versus distance from eluters, depending on diffusion-elimination properties of the drug in tissue, was developed. Tumor coverage by the drug was modeled for tumors typical of lung stereotactic body radiation therapy treatments for various eluter dimensions and drug properties. Six prostate {sup 125}I brachytherapy cases were analyzed by assuming implantation of drug-loaded spacers. Radiosensitizer-induced subvolume boost was simulated from which biologically effective doses for typical radiosensitizers were calculated in one example. Results: Drug distributions from three-dimensional arrangements of drug eluters versus eluter size and drug properties were tabulated. Four radiosensitizer-loaded fiducials provide adequate radiosensitization for {approx}4-cm-diameter lung tumors, thus potentially boosting biologically equivalent doses in centrally located stereotactic body treated lesions. Similarly, multiple drug-loaded spacers provide prostate brachytherapy with flexible shaping of 'biologically equivalent doses' to fit requirements difficult to meet by using radiation alone, e.g., boosting a high-risk region juxtaposed to the urethra while respecting normal tissue tolerance of both the urethra and the rectum. Conclusions: Drug loading of implantable devices routinely used in IGRT provides new opportunities for therapy modulation via biological in situ dose painting.

  6. TCP Resynchronization

    DTIC Science & Technology

    1976-01-11

    CÄ 92664 California, University Los Angeles Professo» Gerald Es^rin Computer Sciences Department School of Engineering and Applied Science Los...UNIVERSITY Digital Systems Laboratory Mr. Ilona!d Crane Mr. Yogen Dalai Ms. Judith Estrin Professor Michael Flynn Mr. Richard Karp Mr. James

  7. Development of low-cost devices for image-guided photodynamic therapy treatment of oral cancer in global health settings

    NASA Astrophysics Data System (ADS)

    Liu, Hui; Rudd, Grant; Daly, Liam; Hempstead, Joshua; Liu, Yiran; Khan, Amjad P.; Mallidi, Srivalleesha; Thomas, Richard; Rizvi, Imran; Arnason, Stephen; Cuckov, Filip; Hasan, Tayyaba; Celli, Jonathan P.

    2016-03-01

    Photodynamic therapy (PDT) is a light-based modality that shows promise for adaptation and implementation as a cancer treatment technology in resource-limited settings. In this context PDT is particularly well suited for treatment of pre-cancer and early stage malignancy of the oral cavity, that present a major global health challenge, but for which light delivery can be achieved without major infrastructure requirements. In recent reports we demonstrated that a prototype low-cost batterypowered 635nm LED light source for ALA-PpIX PDT achieves tumoricidal efficacy in vitro and vivo, comparable to a commercial turn-key laser source. Here, building on these reports, we describe the further development of a prototype PDT device to enable intraoral light delivery, designed for ALA- PDT treatment of precancerous and cancerous lesions of the oral cavity. We evaluate light delivery via fiber bundles and customized 3D printed light applicators for flexible delivery to lesions of varying size and position within the oral cavity. We also briefly address performance requirements (output power, stability, and light delivery) and present validation of the device for ALA-PDT treatment in monolayer squamous carcinoma cell cultures.

  8. Perspectives from Mechanical Circulatory Support Coordinators on the Pre-Implantation Decision Process for Destination Therapy Left Ventricular Assist Devices

    PubMed Central

    McIlvennan, Colleen K.; Matlock, Daniel D.; Narayan, Madhav P.; Nowels, Carolyn; Thompson, Jocelyn S.; Cannon, Anne; Bradley, William J.; Allen, Larry A.

    2015-01-01

    Objective To understand mechanical circulatory support (MCS) coordinators’ perspectives related to destination therapy left ventricular assist devices (DT LVAD) decision making Background MCS coordinators are central to the team that interacts with patients considering DT LVAD, and are well positioned to comment upon the pre-implantation process. Methods From August 2012–January 2013, MCS coordinators were recruited to participate in semi-structured, in-depth interviews. Established qualitative approaches were used to analyze and interpret data. Results Eighteen MCS coordinators from 18 programs were interviewed. We found diversity in coordinators’ roles and high programmatic variability in how DT LVAD decisions are approached. Despite these differences, three themes were consistently recommended: 1) DT LVAD is a major patient-centered decision: “you’re your best advocate…this may not be the best choice for you”; 2) this decision benefits from an iterative, multidisciplinary process: “It is not a one-time conversation”; and 3) this process involves a tension between conveying enough detail about the process yet not overwhelming patients: “It’s sometimes hard to walk that line to not scare them but not paint a rainbow and butterflies picture.” Conclusions MCS coordinators endorsed a shared decision-making process that starts early, uses non-biased educational materials, and involves a multidisciplinary team sensitive to the tension between conveying enough detail about the therapy yet not overwhelming patients. PMID:25724116

  9. Vacuum sealing drainage therapy in the presence of an external fixation device

    PubMed Central

    Sun, Dahui; Ju, Weina; Wang, Tiejun; Yu, Tiecheng; Qi, Baochang

    2016-01-01

    Abstract Rationale: Vacuum sealing drainage (VSD) is widely utilized for treating traumatic wounds. Patient concerns: It is particularly difficult and time consuming to use in combination with an external fixator. Diagnoses: This is because the hardware or pins used for fixation interfere with maintaining a seal, resulting in poor adhesion and subsequent air leakage. Interventions: To resolve this problem, we have devised a new method for sealing the wound dressing, while maintaining the required vacuum.When using this technique, a rubber strip is wrapped around each pin in 3 circles outside the plastic drape, and then tightly tied. Outcomes: After completing this procedure, a vacuum is obtained, and any air leakage stops. We employed this technique to treat a cohort of patients in our department over a period of two years, and obtained good healing of soft tissue without air leakage, as well as good clinical outcomes. Lessons: We have observed that patients treated with this method experienced good clinical outcomes without air leakage, and we recommend its use in treating cases where an external fixation device is present. PMID:27861393

  10. Renal replacement therapy in special settings: extracorporeal support devices in liver failure.

    PubMed

    Cerdá, Jorge; Tolwani, Ashita; Gibney, Noel; Tiranathanagul, Khajohn

    2011-01-01

    Hepatorenal syndrome (HRS) type I is a unique form of acute kidney injury resulting from renal vasoconstriction in the setting of systemic and splanchnic arterial vasodilation in patients with end-stage liver disease. The only definitive treatment currently available is liver or liver-kidney transplantation. The goal of extracorporeal support (ECS) systems in HRS is to bridge eligible liver failure patients to transplantation or functional recovery by means of detoxification, assistance with biosynthesis of key metabolic products, and regulation of inflammation. ECS systems in liver disease can be divided into two broad categories: cell-based and noncell-based systems. While cell-based systems aim to provide functions similar to those of normal hepatocytes, noncell-based systems do not incorporate tissue; they provide detoxification utilizing membranes and adsorbents. There are no standard guidelines for the application of ECS systems. Published studies are too small and show considerable differences in primary indication, primary endpoint, and treatment protocols for "intervention" and "standard" treatment groups. This article reviews the available evidence regarding the optimal use of ECS devices in HRS, makes evidence-based practice recommendations, and delineates key questions for future studies.

  11. [A device for fluorescence diagnosis and photodynamic therapy of eye diseases, by using photosense].

    PubMed

    Shevchik, S A; Loshchenov, M V; Meerovich, G A; Budzinskaia, M V; Ermakova, N A; Kharnas, S S; Loshchenov, V B

    2005-01-01

    By having a high photodynamic effectiveness and an ability of fluorescence, a Photosense photosensibilizer provides a way of combining photodynamic therapy (PDT) and monitoring its control within a session, which enhances the efficiency of treatment for the subretinal neovascular membrane. A slit lamp-based apparatus complex has been developed to employ the methods of fluorescence diagnosis (FD) and PDT, by applying this photosensitizer. The complex comprises an optical adapter that focusing laser radiation on the fundus of the eye in a range of 100-1000 microm, a video adapter that includes color and high-sensitive monochromic video cameras, as well as a personal computer and software that processes video information from the high-sensitive camera and displays the obtained images in real time. The original system of filters provides an image of the eye fundus in the fluorescent and usual color light at once during a FR procedure. The spatial resolution of the developed apparatus was tested on the test object specially devised for these purposes, which was 10 microm. The sensitivity of the complex is sufficient to record slightly fluorescent objects on the fundus of the eye.

  12. Two decades of an indigenously developed brief-pulse electroconvulsive therapy device: A review of research work from National Institute of Mental Health and Neurosciences

    PubMed Central

    Sinha, Preeti; ShyamSundar, A.; Thirthalli, Jagadisha; Gangadhar, B. N.; Candade, Vittal S.

    2016-01-01

    In 1993, a device to administer brief-pulse electroconvulsive therapy was indigenously developed through collaboration between the National Institution for Quality and Reliability and the National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, India. The additional feature of computerized recording of the electroencephalograph and electrocardiograph for both online and offline use had substantial clinical and research implications. Over the past two decades, this device has been used extensively in different academic and nonacademic settings. A considerable body of research with clinical and heuristic interest has also emanated using this device. In this paper, we present the development of this device and follow it up with a review of research conducted at NIMHANS that validate the features and potentials of this device. PMID:26985102

  13. Preferred tools and techniques for implantation of cardiac electronic devices in Europe: results of the European Heart Rhythm Association survey.

    PubMed

    Bongiorni, Maria Grazia; Proclemer, Alessandro; Dobreanu, Dan; Marinskis, Germanas; Pison, Laurent; Blomstrom-Lundqvist, Carina

    2013-11-01

    The aim of this European Heart Rhythm Association (EHRA) survey was to assess clinical practice in relation to the tools and techniques used for cardiac implantable electronic devices procedures in the European countries. Responses to the questionnaire were received from 62 members of the EHRA research network. The survey involved high-, medium-, and low-volume implanting centres, performing, respectively, more than 200, 100-199 and under 100 implants per year. The following topics were explored: the side approach for implantation, surgical techniques for pocket incision, first venous access for lead implantation, preference of lead fixation, preferred coil number for implantable cardioverter-defibrillator (ICD) leads, right ventricular pacing site, generator placement site, subcutaneous ICD implantation, specific tools and techniques for cardiac resynchronization therapy (CRT), lead implantation sequence in CRT, coronary sinus cannulation technique, target site for left ventricular lead placement, strategy in left ventricular lead implant failure, mean CRT implantation time, optimization of the atrioventricular (AV) and ventriculo-ventricular intervals, CRT implants in patients with permanent atrial fibrillation, AV node ablation in patients with permanent AF. This panoramic view allows us to find out the operator preferences regarding the techniques and tools for device implantation in Europe. The results showed different practices in all the fields we investigated, nevertheless the survey also outlines a good adherence to the common standards and recommendations.

  14. Safety and feasibility of biventricular devices reuse in general and elderly population – a single-center retrospective cohort study

    PubMed Central

    Şoşdean, Raluca; Mornoş, Cristian; Enache, Bogdan; Macarie, Răzvan I; Ianoş, Raluca; Ştefea, Ana-Maria; Pescariu, Sorin

    2015-01-01

    Introduction Cardiac resynchronization therapy (CRT) is known to have very important beneficial effects on heart failure patients. Unfortunately, biventricular implantable cardiac devices (CRT devices), through which this therapy is implemented, are very expensive and sometimes hard to achieve, especially in underdeveloped/developing economies, making this an important problem of public health. As a possible solution, CRT reuse is of great interest nowadays, but unlike simple devices, data in the literature are scarce about biventricular device reuse. Aim To address safety concerns, we aimed to analyze infection burden in the general and elderly population and also early battery depletion and generator malfunction of resterilized biventricular devices compared to new devices. Methods A cohort of 261 CRT patients (286 devices), who underwent implantation between 2000 and 2014, was retrospectively analyzed. The study group included 115 patients and 127 resterilized devices, that was divided into a subgroup of 69 elderly patients (≥60 years) and 74 devices and a subgroup of 47 younger patients (<60 years) and 53 devices, and the control group included 146 patients and 159 new devices. The groups were compared using a multivariate logistic regression model. Results A number of 12 (4.2%) infectious complications were encountered, five (3.9%) in the study group and seven (4.4%) in the control group (odds ratio, 2.83 [0.59–13.44], P=0.189), one (1.3%) in the elderly and four (7.5%) in the younger subgroup (odds ratio, 3.80 [0.36–40.30], P=0.266), with no statistically significant difference between them. There was only one case of early battery depletion, after 17 months, in one study group patient. No generator malfunction was detected. Conclusion Reuse of biventricular cardiac implantable electronics seems feasible and safe in both the general population and the elderly population, and it could be a promising alternative when new devices cannot be obtained in a

  15. End-of-life discontinuation of destination therapy with cardiac and ventilatory support medical devices: physician-assisted death or allowing the patient to die?

    PubMed Central

    2010-01-01

    Background Bioethics and law distinguish between the practices of "physician-assisted death" and "allowing the patient to die." Discussion Advances in biotechnology have allowed medical devices to be used as destination therapy that are designed for the permanent support of cardiac function and/or respiration after irreversible loss of these spontaneous vital functions. For permanent support of cardiac function, single ventricle or biventricular mechanical assist devices and total artificial hearts are implanted in the body. Mechanical ventilators extrinsic to the body are used for permanent support of respiration. Clinical studies have shown that destination therapy with ventricular assist devices improves patient survival compared to medical management, but at the cost of a substantial alteration in end-of-life trajectories. The moral and legal assessment of the appropriateness and permissibility of complying with a patient's request to electively discontinue destination therapy in a life-terminating act in non-futile situations has generated controversy. Some argue that complying with this request is ethically justified because patients have the right to request withdrawal of unwanted treatment and be allowed to die of preexisting disease. Other commentators reject the argument that acceding to an elective request for death by discontinuing destination therapy is 'allowing a patient to die' because of serious flaws in interpreting the intention, causation, and moral responsibility of the ensuing death. Summary Destination therapy with cardiac and/or ventilatory medical devices replaces native physiological functions and successfully treats a preexisting disease. We posit that discontinuing cardiac and/or ventilatory support at the request of a patient or surrogate can be viewed as allowing the patient to die if--and only if--concurrent lethal pathophysiological conditions are present that are unrelated to those functions already supported by medical devices in

  16. SU-E-T-557: Measuring Neutron Activation of Cardiac Devices Irradiated During Proton Therapy Using Indium Foils

    SciTech Connect

    Avery, S; Christodouleas, J; Delaney, K; Diffenderfer, E; Brown, K

    2014-06-01

    Purpose: Measuring Neutron Activation of Cardiac devices Irradiated during Proton Therapy using Indium Foils Methods: The foils had dimensions of 25mm x 25mm x 1mm. After being activated, the foils were placed in a Canberra Industries well chamber utilizing a NaI(Tl) scintillation detector. The resulting gamma spectrum was acquired and analyzed using Genie 2000 spectroscopy software. One activation foil was placed over the upper, left chest of RANDO where a pacemaker would be. The rest of the foils were placed over the midline of the patient at different distances, providing a spatial distribution over the phantom. Using lasers and BBs to align the patient, 200 MU square fields were delivered to various treatment sites: the brain, the pancreas, and the prostate. Each field was shot at least a day apart, giving more than enough time for activity of the foil to decay (t1=2 = 54.12 min). Results: The net counts (minus background) of the three aforementioned peaks were used for our measurements. These counts were adjusted to account for detector efficiency, relative photon yields from decay, and the natural abundance of 115-In. The average neutron flux for the closed multi-leaf collimator irradiation was measured to be 1.62 x 106 - 0.18 x 106 cm2 s-1. An order of magnitude estimate of the flux for neutrons up to 1 keV from Diffenderfer et al. gives 3 x 106 cm2 s-1 which does agree on the order of magnitude. Conclusion: Lower energy neutrons have higher interaction cross-sections and are more likely to damage pacemakers. The thermal/slow neutron component may be enough to estimate the overall risk. The true test of the applicability of activation foils is whether or not measurements are capable of predicting cardiac device malfunction. For that, additional studies are needed to provide clinical evidence one way or the other.

  17. Automatic Prostate Tracking and Motion Assessment in Volumetric Modulated Arc Therapy With an Electronic Portal Imaging Device

    SciTech Connect

    Azcona, Juan Diego; Li, Ruijiang; Mok, Edward; Hancock, Steven; Xing, Lei

    2013-07-15

    Purpose: To assess the prostate intrafraction motion in volumetric modulated arc therapy treatments using cine megavoltage (MV) images acquired with an electronic portal imaging device (EPID). Methods and Materials: Ten prostate cancer patients were treated with volumetric modulated arc therapy using a Varian TrueBeam linear accelerator equipped with an EPID for acquiring cine MV images during treatment. Cine MV images acquisition was scheduled for single or multiple treatment fractions (between 1 and 8). A novel automatic fiducial detection algorithm that can handle irregular multileaf collimator apertures, field edges, fast leaf and gantry movement, and MV image noise and artifacts in patient anatomy was used. All sets of images (approximately 25,000 images in total) were analyzed to measure the positioning accuracy of implanted fiducial markers and assess the prostate movement. Results: Prostate motion can vary greatly in magnitude among different patients. Different motion patterns were identified, showing its unpredictability. The mean displacement and standard deviation of the intrafraction motion was generally less than 2.0 ± 2.0 mm in each of the spatial directions. In certain patients, however, the percentage of the treatment time in which the prostate is displaced more than 5 mm from its planned position in at least 1 spatial direction was 10% or more. The maximum prostate displacement observed was 13.3 mm. Conclusion: Prostate tracking and motion assessment was performed with MV imaging and an EPID. The amount of prostate motion observed suggests that patients will benefit from its real-time monitoring. Megavoltage imaging can provide the basis for real-time prostate tracking using conventional linear accelerators.

  18. Guidelines for the diagnosis, prevention and management of implantable cardiac electronic device infection. Report of a joint Working Party project on behalf of the British Society for Antimicrobial Chemotherapy (BSAC, host organization), British Heart Rhythm Society (BHRS), British Cardiovascular Society (BCS), British Heart Valve Society (BHVS) and British Society for Echocardiography (BSE).

    PubMed

    Sandoe, Jonathan A T; Barlow, Gavin; Chambers, John B; Gammage, Michael; Guleri, Achyut; Howard, Philip; Olson, Ewan; Perry, John D; Prendergast, Bernard D; Spry, Michael J; Steeds, Richard P; Tayebjee, Muzahir H; Watkin, Richard

    2015-02-01

    Infections related to implantable cardiac electronic devices (ICEDs), including pacemakers, implantable cardiac defibrillators and cardiac resynchronization therapy devices, are increasing in incidence in the USA and are likely to increase in the UK, because more devices are being implanted. These devices have both intravascular and extravascular components and infection can involve the generator, device leads and native cardiac structures or various combinations. ICED infections can be life-threatening, particularly when associated with endocardial infection, and all-cause mortality of up to 35% has been reported. Like infective endocarditis, ICED infections can be difficult to diagnose and manage. This guideline aims to (i) improve the quality of care provided to patients with ICEDs, (ii) provide an educational resource for all relevant healthcare professionals, (iii) encourage a multidisciplinary approach to ICED infection management, (iv) promote a standardized approach to the diagnosis, management, surveillance and prevention of ICED infection through pragmatic evidence-rated recommendations, and (v) advise on future research projects/audit. The guideline is intended to assist in the clinical care of patients with suspected or confirmed ICED infection in the UK, to inform local infection prevention and treatment policies and guidelines and to be used in the development of educational and training material by the relevant professional societies. The questions covered by the guideline are presented at the beginning of each section.

  19. Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy

    PubMed Central

    2009-01-01

    Executive Summary Subject of the Evidence-Based Analysis The purpose of this evidence based analysis report is to examine the safety and effectiveness of point-of-care (POC) international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy (OAT). Clinical Need: Target Population and Condition Long-term OAT is typically required by patients with mechanical heart valves, chronic atrial fibrillation, venous thromboembolism, myocardial infarction, stroke, and/or peripheral arterial occlusion. It is estimated that approximately 1% of the population receives anticoagulation treatment and, by applying this value to Ontario, there are an estimated 132,000 patients on OAT in the province, a figure that is expected to increase with the aging population. Patients on OAT are regularly monitored and their medications adjusted to ensure that their INR scores remain in the therapeutic range. This can be challenging due to the narrow therapeutic window of warfarin and variation in individual responses. Optimal INR scores depend on the underlying indication for treatment and patient level characteristics, but for most patients the therapeutic range is an INR score of between 2.0 and 3.0. The current standard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics (ACCs). Patients also regularly visit a hospital or community-based facility to provide a venous blood samples (venipuncture) that are then sent to a laboratory for INR analysis. Experts, however, have commented that there may be under-utilization of OAT due to patient factors, physician factors, or regional practice variations and that sub-optimal patient management may also occur. There is currently no population-based Ontario data to permit the assessment of patient care, but recent systematic reviews have estimated that less that 50% of patients receive OAT on a

  20. Effect of early or late resynchronization based on different methods of pregnancy diagnosis on reproductive performance of dairy cows.

    PubMed

    Sinedino, L D P; Lima, F S; Bisinotto, R S; Cerri, R L A; Santos, J E P

    2014-01-01

    The aim of this study was to compare the reproductive performance of dairy cows subjected to early (ER) or late (LR) resynchronization programs after nonpregnancy diagnoses based on either pregnancy-associated glycoproteins (PAG) ELISA or transrectal palpation, respectively. In addition, the accuracy of the PAG ELISA for early pregnancy diagnosis was assessed. Lactating Holstein cows were subjected to a Presynch-Ovsynch protocol with timed artificial insemination (AI) performed between 61 and 74 DIM. On the day of the first postpartum AI, 1,093 cows were blocked by parity and assigned randomly to treatments; however, because of attrition, 452 ER and 520 LR cows were considered for the statistical analyses. After the first postpartum AI, cows were observed daily for signs of estrus and inseminated on the same day of detected estrus. Cows from ER that were not reinseminated in estrus received the first GnRH injection of the Ovsynch protocol for resynchronization 2d before pregnancy diagnosis. On d 28 after the previous AI (d 27 to 34), pregnancy status was determined by PAG ELISA, and nonpregnant cows continued on the Ovsynch protocol for reinsemination. Pregnant cows had pregnancy status reconfirmed on d 46 after AI (d 35 to 52) by transrectal palpation, and those that lost the pregnancies were resynchronized. Cows assigned to LR had pregnancy diagnosed by transrectal palpation on d 46 after AI (d 35 to 52) and nonpregnant cows were resynchronized with the Ovsynch protocol. Blood was sampled on d 28 after AI (d 27 to 34) from cows in both treatments that had not been reinseminated on estrus and again on d 46 after AI (d 35 to 52) for assessment of PAG ELISA to determine the accuracy of the test. Cows were subjected to treatments for 72d after the first insemination. Pregnancy per AI (P/AI) at first postpartum timed AI did not differ between treatments and averaged 28.9%. The proportion of nonpregnant cows that were resynchronized and received timed AI was greater

  1. SU-E-T-242: Design of a Novel Afterloader Clearance QA Device for Biliary HDR Therapy

    SciTech Connect

    Mullins, JP; Deufel, CL

    2015-06-15

    Purpose: Bile duct cancer affects 2–3 thousand people annually in the United States. Radiation therapy has been shown to double median survival, with combined external beam and intraluminal high dose-rate (HDR) brachytherapy being most effective. Endoscopic retrograde cholangiopancreatography (ERCP) biliary HDR, a less-invasive alternative to trans-hepatic brachytherapy, is delivered through a catheter that travels a tortuous path from nose to bile duct, requiring wire drive force and dexterity beyond typical afterloader performance specifications. Thus, specific afterloader quality assurance(QA) is recommended for this procedure. Our aim was to create a device and process for Varisource afterloader clearance QA with objectives that it be quantitative and can monitor afterloader performance over time, compare performance between two distinct afterloaders and potentially Result in a predictive nomogram for patient-specific clearance. Methods: Based on retrospective reconstruction of 20 ERCP patient anatomies, we designed a phantom to test afterloader ability to drive the source wire along an intended treatment path. The ability of the afterloader to fully extend the intended treatment path is a function of number and diameters of turns. We have determined experimentally that relative position of the turns does not impact performance. Results: Both patient and QA paths involve three common turns/loops: a large turn representing the stomach(10.8cm±2.0cm), an elliptical loop representing the duodenum(7.3cm±1.5cmx4.8cm±0.7cm), and a final turn at the end of the bile duct that may be tight for some patient-specific anatomies and absent in others(3.7cm±0.7cm, where present). Our phantom design uses anatomical average turn diameters for the stomach and duodenum then terminates in a turn of quantitatively selectable diameter. The smallest final turn diameter that an afterloader can pass is recorded as the QA parameter. Conclusion: With this device and QA process, we

  2. MO-C-BRB-05: Translating NIH funding to a [potential] clinical device in breast cancer radiation therapy

    SciTech Connect

    Yu, C.

    2015-06-15

    Diagnostic radiology and radiation oncology are arguably two of the most technologically advanced specialties in medicine. The imaging and radiation medicine technologies in clinical use today have been continuously improved through new advances made in the commercial and academic research arenas. This symposium explores the translational path from research through clinical implementation. Dr. Pettigrew will start this discussion by sharing his perspectives as director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The NIBIB has focused on promoting research that is technological in nature and has high clinical impact. We are in the age of precision medicine, and the technological innovations and quantitative tools developed by engineers and physicists working with physicians are providing innovative tools that increase precision and improve outcomes in health care. NIBIB funded grants lead to a very high patenting rate (per grant dollar), and these patents have higher citation rates by other patents, suggesting greater clinical impact, as well. Two examples of clinical translation resulting from NIH-funded research will be presented, in radiation therapy and diagnostic imaging. Dr. Yu will describe a stereotactic radiotherapy device developed in his laboratory that is designed for treating breast cancer with the patient in the prone position. It uses 36 rotating Cobalt-60 sources positioned in an annular geometry to focus the radiation beam at the system’s isocenter. The radiation dose is delivered throughout the target volume in the breast by constantly moving the patient in a planned trajectory relative to the fixed isocenter. With this technique, the focal spot dynamically paints the dose distribution throughout the target volume in three dimensions. Dr. Jackson will conclude this symposium by describing the RSNA Quantitative Imaging Biomarkers Alliance (QIBA), which is funded in part by NIBIB and is a synergistic collaboration

  3. A migrant left ventricular lead.

    PubMed

    Malagù, Michele; Marcantoni, Lina; Scalone, Antonella; Toselli, Tiziano; Pratola, Claudio; Bertini, Matteo

    2014-07-25

    We report the case of 70-year-old woman with Reel syndrome and cardiac resynchronization therapy device who experienced severe device malfunction. Reel syndrome was misdiagnosed for several months and the patient manifested fatigue, discomfort and diaphragmatic stimulation.

  4. The use of modern electronic flat panel devices for image guided radiation therapy:. Image quality comparison, intra fraction motion monitoring and quality assurance applications

    NASA Astrophysics Data System (ADS)

    Nill, S.; Stützel, J.; Häring, P.; Oelfke, U.

    2008-06-01

    With modern radiotherapy delivery techniques like intensity modulated radiotherapy (IMRT) it is possible to delivery a more conformal dose distribution to the tumor while better sparing the organs at risk (OAR) compared to 3D conventional radiation therapy. Due to the theoretically high dose conformity achievable it is very important to know the exact position of the target volume during the treatment. With more and more modern linear accelerators equipped with imaging devices this is now almost possible. These imaging devices are using energies between 120kV and 6MV and therefore different detector systems are used but the vast majority is using amorphous silicon flat panel devices with different scintilator screens and build up materials. The technical details and the image quality of these systems are discussed and first results of the comparison are presented. In addition new methods to deal with motion management and quality assurance procedures are shortly discussed.

  5. Drug-induced sleep endoscopy as a selection tool for mandibular advancement therapy by oral device in patients with mild to moderate obstructive sleep apnoea.

    PubMed

    De Corso, E; Bastanza, G; Della Marca, G; Grippaudo, C; Rizzotto, G; Marchese, M R; Fiorita, A; Sergi, B; Meucci, D; Di Nardo, W; Paludetti, G; Scarano, E

    2015-12-01

    Nowadays oral appliance therapy is recognised as an effective therapy for many patients with primary snoring and mild to moderate obstructive sleep apnoea (OSA), as well as those with more severe OSA who cannot tolerate positive airway pressure (PAP) therapies. For this reason, it is important to focus on objective criteria to indicate which subjects may benefit from treatment with a mandibular advancement device (MAD). Various anthropometric and polysomnographic predictors have been described in the literature, whereas there are still controversies about the role of drug-induced sleep endoscopy (DISE) and advancement bimanual manoeuvre as predictor factors of treatment outcome by oral device. Herein, we report our experience in treatment of mild moderate OSA by oral appliance selected by DISE. We performed a single institution, longitudinal prospective evaluation of a consecutive group of mild moderate patients with obstructive sleep apnoea syndrome who underwent DISE. During sleep endoscopy, gentle manoeuvre of mandibular advancement less than 5 mm was performed. In 30 of 65 patients (46.2%) we obtained an unsuccessful improvement of airway patency whereas in 35 of 65 patients (53.8%) the improvement was successful and patients were considered suitable for oral device application. Because 7 of 35 patients were excluded due to conditions interfering with oral appliance therapy, we finally treated 28 patients. After 3 months of treatment, we observed a significant improvement in the Epworth medium index [(7.35 ± 2.8 versus 4.1 ± 2.2 (p < 0.05)], in mean AHI [(21.4 ± 6 events per hour versus 8.85 ± 6.9 (p < 0.05)] and in mean ODI [(18.6 ± 8 events per hour to 7 ± 5.8 (p < 0.05)]. We observed that the apnoea/hypopnoea index (AHI) improved by up to 50% from baseline in 71.4% of patients selected after DISE for MAD therapy. In the current study, mandibular advancement splint therapy was successfully prescribed on the basis not only of severity of disease, as

  6. The ADMIT series - Issues in inhalation therapy. 4) How to choose inhaler devices for the treatment of COPD.

    PubMed

    Vincken, Walter; Dekhuijzen, Pn Richard; Barnes, Peter

    2010-03-01

    For patients with COPD, inhalation is the preferred route of administration of respiratory drugs for both maintenance and acute treatment. Numerous inhaler types and devices have been developed, each with their own particularities, advantages and disadvantages. Nevertheless, published COPD management guidelines pay little attention to the optimal choice of inhaler devices for COPD patients. Although efficacy and safety are the primary factors determining the choice of an inhaler device, randomised controlled trials (RCTs) directly comparing the efficacy and safety of different inhalers in COPD patients are scarce. Systematic reviews on this subject failed to find significant differences between devices for any of the clinical outcomes studied. When selecting a device for the delivery of inhaled drugs in 'real life' patients with COPD, other factors should be considered. These include availability and affordability of the inhaled drugs and inhaler devices, the uniformity of inhaler devices when several drugs are to be inhaled, the ability of patients to handle correctly the selected device - in particular taking into account the advanced age of the average COPD patient, and finally the patient's preference. The prescribing clinician's task is to provide comprehensive instructions for correct handling of the device and to review regularly the patient's inhalation technique.

  7. Dosimetric verification of radiation therapy including intensity modulated treatments, using an amorphous-silicon electronic portal imaging device

    NASA Astrophysics Data System (ADS)

    Chytyk-Praznik, Krista Joy

    Radiation therapy is continuously increasing in complexity due to technological innovation in delivery techniques, necessitating thorough dosimetric verification. Comparing accurately predicted portal dose images to measured images obtained during patient treatment can determine if a particular treatment was delivered correctly. The goal of this thesis was to create a method to predict portal dose images that was versatile and accurate enough to use in a clinical setting. All measured images in this work were obtained with an amorphous silicon electronic portal imaging device (a-Si EPID), but the technique is applicable to any planar imager. A detailed, physics-motivated fluence model was developed to characterize fluence exiting the linear accelerator head. The model was further refined using results from Monte Carlo simulations and schematics of the linear accelerator. The fluence incident on the EPID was converted to a portal dose image through a superposition of Monte Carlo-generated, monoenergetic dose kernels specific to the a-Si EPID. Predictions of clinical IMRT fields with no patient present agreed with measured portal dose images within 3% and 3 mm. The dose kernels were applied ignoring the geometrically divergent nature of incident fluence on the EPID. A computational investigation into this parallel dose kernel assumption determined its validity under clinically relevant situations. Introducing a patient or phantom into the beam required the portal image prediction algorithm to account for patient scatter and attenuation. Primary fluence was calculated by attenuating raylines cast through the patient CT dataset, while scatter fluence was determined through the superposition of pre-calculated scatter fluence kernels. Total dose in the EPID was calculated by convolving the total predicted incident fluence with the EPID-specific dose kernels. The algorithm was tested on water slabs with square fields, agreeing with measurement within 3% and 3 mm. The

  8. [Therapy with implantable cardioverter-defibrillators (ICD) in the early of third millenium].

    PubMed

    Kozák, M

    2010-08-01

    The patients without ventricular arrhythmias with markers of high risk of sudden cardiac death are indicated for ICD implantation today. Last generation of ICD systems are equipped with high capacity batteries, with many automatic functions, capabilities of data sending and possibilities of prediction of worsening of heart failure. Nowadays ICD systems offers not only elimination of the risk of sudden cardiac death but reduction of symptoms of chronic heart failure through the resynchronization therapy, too.

  9. Computational cardiology: how computer simulations could be used to develop new therapies and advance existing ones

    PubMed Central

    Trayanova, Natalia A.; O'Hara, Thomas; Bayer, Jason D.; Boyle, Patrick M.; McDowell, Kathleen S.; Constantino, Jason; Arevalo, Hermenegild J.; Hu, Yuxuan; Vadakkumpadan, Fijoy

    2012-01-01

    This article reviews the latest developments in computational cardiology. It focuses on the contribution of cardiac modelling to the development of new therapies as well as the advancement of existing ones for cardiac arrhythmias and pump dysfunction. Reviewed are cardiac modelling efforts aimed at advancing and optimizing existent therapies for cardiac disease (defibrillation, ablation of ventricular tachycardia, and cardiac resynchronization therapy) and at suggesting novel treatments, including novel molecular targets, as well as efforts to use cardiac models in stratification of patients likely to benefit from a given therapy, and the use of models in diagnostic procedures. PMID:23104919

  10. Reproductive performance of dairy cows resynchronized after pregnancy diagnosis at 31 (±3 days) after artificial insemination (AI) compared with resynchronization at 31 (±3 days) after AI with pregnancy diagnosis at 38 (±3 days) after AI.

    PubMed

    Pereira, R V; Caixeta, L S; Giordano, J O; Guard, C L; Bicalho, R C

    2013-01-01

    An important part of reproductive management programs on dairy farms is identification of nonpregnant cows and early re-insemination to achieve higher pregnancy rates. The objective of this study was to compare the effect on reproductive performance and pregnancy loss of 2 pregnancy diagnosis protocols: (1) pregnancy diagnosis performed 31±3 d after artificial insemination (AI) by ultrasonography (ULTRA), and (2) resynchronization started 31±3 d after AI but with pregnancy diagnosis performed 38±3 d after AI by palpation per rectum (PALP). Cows were randomly allocated into 1 of the 2 management programs. For cows enrolled in ULTRA, the initial pregnancy diagnosis (P1) was performed by transrectal ultrasonography at 31±3 d after AI, and nonpregnant cows were enrolled in the Ovsynch protocol for resynchronization of ovulation to receive timed AI (TAI). For cows enrolled in PALP, the Ovsynch protocol for resynchronization of ovulation to receive TAI was initiated at 31±3 d after AI regardless of pregnancy status, with the initial pregnancy diagnosis (P1) performed by palpation per rectum at 38±3 d after AI. For both groups, reconfirmation of pregnancy was performed by palpation per rectum at 63±3 d after AI (P2). Cows were inseminated after detection of estrus by use of activity monitors at any time during the study. Two levels of activity were used as a reference for cows AI after detection of estrus based on activity: an activity level of ≥2 when a cow was coded in DairyComp 305 (Valley Agricultural Software, Tulare, CA) as open (nonpregnant) and an activity level of ≥3 when the pregnancy status of the cow was unknown. Our findings showed that the odds of pregnancy loss cows in ULTRA was 2 times higher between P1 and P2 compared with that of cows in PALP. Furthermore, pregnancy diagnosis method (ULTRA vs. PALP) did not have a significant effect on the Cox proportional hazard of pregnancy at P2. The occurrence of assisted parturition, metritis, or retained

  11. Posterior Wall Capture and Femoral Artery Stenosis Following Use of StarClose Closing Device: Diagnosis and Therapy

    SciTech Connect

    Stefanczyk, Ludomir; Elgalal, Marcin T.; Szubert, Wojciech; Grzelak, Piotr; Szopinski, Piotr; Majos, Agata

    2013-10-15

    A case of femoral artery obstruction following application of a StarClose type arterial puncture closing device (APCD) is presented. Ultrasonographic and angiographic imaging of this complication was obtained. The posterior wall of the vessel was accidentally caught in the anchoring element of the nitinol clip. This complication was successfully resolved by endovascular treatment and the implantation of a stent.

  12. Beneficial triple-site cardiac resynchronization in a patient supported with an intra-aortic balloon pump for end-stage heart failure

    PubMed Central

    Ciszewski, Jan; Maciąg, Aleksander; Gepner, Katarzyna; Smolis-Bąk, Edyta

    2014-01-01

    The authors present the case of a 62-year-old male patient with an implantable cardioverter-defibrillator and end-stage heart failure supported with an intra-aortic balloon pump. Implantation of a triple-site cardiac resynchronization system and complex heart failure treatment brought a significant improvement, return to home activity and 17-month survival. The patient died due to heart failure aggravation. Within this time he was rehospitalized and successfully treated twice for an electrical storm. PMID:24799927

  13. Beneficial triple-site cardiac resynchronization in a patient supported with an intra-aortic balloon pump for end-stage heart failure.

    PubMed

    Ciszewski, Jan; Maciąg, Aleksander; Gepner, Katarzyna; Smolis-Bąk, Edyta; Sterliński, Maciej

    2014-01-01

    The authors present the case of a 62-year-old male patient with an implantable cardioverter-defibrillator and end-stage heart failure supported with an intra-aortic balloon pump. Implantation of a triple-site cardiac resynchronization system and complex heart failure treatment brought a significant improvement, return to home activity and 17-month survival. The patient died due to heart failure aggravation. Within this time he was rehospitalized and successfully treated twice for an electrical storm.

  14. A D-optimal design to model the performances of dressings and devices for negative pressure wound therapy.

    PubMed

    Salvo, P; Smajda, R; Dini, V; Saxby, C; Voirin, G; Romanelli, M; Di Francesco, F

    2016-05-01

    A D-optimal design was used to identify and model variables that affect the transit time of wound exudate through an illustrative dressing used for negative pressure wound therapy. Many authors have addressed the clinical benefits of negative pressure wound therapy, but limited information is available on how to assess performances of dressings. In this paper, the transit time of wound exudate through a dressing was chosen as a model parameter to show how experimental design (DOE) can be used for this purpose. Results demonstrated that rate of exudate production, temperature and dressing thickness were the variables with the largest impact on transit time. The DOE approach could be used to model other dressing properties, like for example capability of absorbing excess exudate or breathability.

  15. Distribution of guidance models for cardiac resynchronization therapy in the setting of multi-center clinical trials

    NASA Astrophysics Data System (ADS)

    Rajchl, Martin; Abhari, Kamyar; Stirrat, John; Ukwatta, Eranga; Cantor, Diego; Li, Feng P.; Peters, Terry M.; White, James A.

    2014-03-01

    Multi-center trials provide the unique ability to investigate novel techniques across a range of geographical sites with sufficient statistical power, the inclusion of multiple operators determining feasibility under a wider array of clinical environments and work-flows. For this purpose, we introduce a new means of distributing pre-procedural cardiac models for image-guided interventions across a large scale multi-center trial. In this method, a single core facility is responsible for image processing, employing a novel web-based interface for model visualization and distribution. The requirements for such an interface, being WebGL-based, are minimal and well within the realms of accessibility for participating centers. We then demonstrate the accuracy of our approach using a single-center pacemaker lead implantation trial with generic planning models.

  16. Left phrenic nerve anatomy relative to the coronary venous system: Implications for phrenic nerve stimulation during cardiac resynchronization therapy.

    PubMed

    Spencer, Julianne H; Goff, Ryan P; Iaizzo, Paul A

    2015-07-01

    The objective of this study was to quantitatively characterize anatomy of the human phrenic nerve in relation to the coronary venous system, to reduce undesired phrenic nerve stimulation during left-sided lead implantations. We obtained CT scans while injecting contrast into coronary veins of 15 perfusion-fixed human heart-lung blocs. A radiopaque wire was glued to the phrenic nerve under CT, then we created three-dimensional models of anatomy and measured anatomical parameters. The left phrenic nerve typically coursed over the basal region of the anterior interventricular vein, mid region of left marginal veins, and apical region of inferior and middle cardiac veins. There was large variation associated with the average angle between nerve and veins. Average angle across all coronary sinus tributaries was fairly consistent (101.3°-111.1°). The phrenic nerve coursed closest to the middle cardiac vein and left marginal veins. The phrenic nerve overlapped a left marginal vein in >50% of specimens.

  17. Optimizing Cardiac Resynchronization Therapy in Heart Failure Patients by Measuring Transient Changes in Sinus Rate During Pacing

    DTIC Science & Technology

    2001-10-25

    degree heart block, wide QRS complex (≥ 120 ms), normal sinus rhythm, and no history of arrhythmia. The PATH-CHF main exclusion criteria [3] were...intravenous inotrope dependence, or indications for pacemaker implantation. Additional exclusion criteria for this analysis were frequent premature

  18. Health Care Utilization and Expenditures Associated With Remote Monitoring in Patients With Implantable Cardiac Devices.

    PubMed

    Ladapo, Joseph A; Turakhia, Mintu P; Ryan, Michael P; Mollenkopf, Sarah A; Reynolds, Matthew R

    2016-05-01

    Several randomized trials and decision analysis models have found that remote monitoring may reduce health care utilization and expenditures in patients with cardiac implantable electronic devices (CIEDs), compared with in-office monitoring. However, little is known about the generalizability of these findings to unselected populations in clinical practice. To compare health care utilization and expenditures associated with remote monitoring and in-office monitoring in patients with CIEDs, we used Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases. We selected patients newly implanted with an implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy defibrillator (CRT-D), or permanent pacemaker (PPM), in 2009, who had continuous health plan enrollment 2 years after implantation. Generalized linear models and propensity score matching were used to adjust for confounders and estimate differences in health care utilization and expenditures in patients with remote or in-office monitoring. We identified 1,127; 427; and 1,295 pairs of patients with a similar propensity for receiving an ICD, CRT-D, or PPM, respectively. Remotely monitored patients with ICDs experienced fewer emergency department visits resulting in discharge (p = 0.050). Remote monitoring was associated with lower health care expenditures in office visits among patients with PPMs (p = 0.025) and CRT-Ds (p = 0.006) and lower total inpatient and outpatient expenditures in patients with ICDs (p <0.0001). In conclusion, remote monitoring of patients with CIEDs may be associated with reductions in health care utilization and expenditures compared with exclusive in-office care.

  19. Bariatric surgery for a patient with a HeartMate II ventricular assist device for destination therapy.

    PubMed

    Lockard, Kathleen L; Allen, Carrie; Lohmann, Douglas; Severyn, Donald A; Schaub, Richard D; Kauffman, Kelly E; Hodges, Jeffrey R; Woodhall, Lorna; Ramanathan, Ramesh; Teuteberg, Jeffrey J; Eckert, Chad E; Kormos, Robert L

    2013-03-01

    A patient with a HeartMate II left ventricular assist device who had a body mass index of 52 needed gastric bypass surgery in order to qualify for a heart transplant. Unlike previous experience in which the surgery was performed at the implant hospital, the gastric bypass surgery in this case was performed at a bariatric center of excellence that was a separate facility from the implant hospital. The artificial heart program of the University of Pittsburgh Medical Center worked with the bariatric center of excellence in scheduling the gastric bypass surgery using a multidisciplinary team approach at 2 hospitals to coordinate safe, high-quality patient care in a unique situation.

  20. Application of the Single Use Negative Pressure Wound Therapy Device (PICO) on a Heterogeneous Group of Surgical and Traumatic Wounds

    PubMed Central

    Payne, Caroline; Edwards, Daren

    2014-01-01

    Objectives: Traumatic wounds and surgery inherently have their complications. Localized infections, wound dehiscence, and excessive wound leakage can be devastating to the patient with a prolonged recovery, but it is also costly to the hospital with an increased length of stay, extra workload, and dressing changes. The single use PICO (Smith and Nephew Healthcare, Hull, United Kingdom) negative pressure wound therapy (NPWT) dressing has revolutionized our management of various acute, chronic, and high output wounds. It requires fewer dressing changes than conventional practice, is used in the outpatient setting, and is a necessary adjuvant therapy to hasten wound healing. Aims: To observe the efficacy of the PICO vacuum-assisted healing within a cost improvement programme. Settings: Plastic surgery department, Royal London Hospital. Materials and Methods: Twenty-one patients with a diversity of postoperative or posttraumatic wounds were considered suitable for PICO application and treated totally on an outpatient basis once the PICO dressing was applied. All wounds were then subjected to continued PICO dressings until healed. Results: All patients tolerated the PICO well with no dressing failure or failure to comply. The number of dressings per patient ranged from 1 to 7. The cost per patient of treatment ranged from £120 to £1578. Estimated cost of all PICO dressing for 21 patients including plastic surgery dressing clinic appointments = £13,345. Median length of treatment to healing (days) = 16; standard deviation = 9.5. Eight patients would have had an inpatient bed stay with conventional therapy, total 24 bed days saved at Bartshealth @£325 per day. Conclusions: The outpatient application of a disposable NPWT can benefit a wide range of clinical wounds that optimizes patient care, promotes rapid wound healing, and importantly helps manage costs. PMID:24917894

  1. Biological processes, quantum mechanics and electromagnetic fields: the possibility of device-encapsulated human intention in medical therapies.

    PubMed

    Kohane, M J; Tiller, W A

    2001-06-01

    The general hypothesis that quantum mechanics (QM) and thermodynamic concepts relate to biological systems is discussed and applied to the biological influence of: (1) electromagnetic fields (EMFs); and (2) EMFs that have been exposed to human intention. We illustrate our hypothesis with experiments involving four simultaneous treatments: exposure to ambient EMFs in the laboratory environment (C), exposure in a Faraday cage (F) and exposure in a Faraday cage with either: (i) an electronic device (IIED) which had been exposed to a specific human intention (d,j); or (ii) a non-exposed, physically identical, device (d,o). Experimental systems were fitness and energy metabolism in Drosophila melanogaster, in vitro enzyme activity and molecular concentration variability over time. Results indicated that shielding from ambient EMFs via a Faraday cage (F) made a significant difference relative to the unshielded control (C). Further, (d,o) had a significant lowering effect in the shielded environment. Finally, there was a strong 'intention' effect with the IIED (d,j) producing significant and positive effects in comparison to (d,o) in each experimental system.

  2. Neutron production from beam-modifying devices in a modern double scattering proton therapy beam delivery system

    PubMed Central

    Pérez-Andújar, Angélica; Newhauser, Wayne D; DeLuca, Paul M

    2014-01-01

    In this work the neutron production in a passive beam delivery system was investigated. Secondary particles including neutrons are created as the proton beam interacts with beam shaping devices in the treatment head. Stray neutron exposure to the whole body may increase the risk that the patient develops a radiogenic cancer years or decades after radiotherapy. We simulated a passive proton beam delivery system with double scattering technology to determine the neutron production and energy distribution at 200 MeV proton energy. Specifically, we studied the neutron absorbed dose per therapeutic absorbed dose, the neutron absorbed dose per source particle and the neutron energy spectrum at various locations around the nozzle. We also investigated the neutron production along the nozzle's central axis. The absorbed doses and neutron spectra were simulated with the MCNPX Monte Carlo code. The simulations revealed that the range modulation wheel (RMW) is the most intense neutron source of any of the beam spreading devices within the nozzle. This finding suggests that it may be helpful to refine the design of the RMW assembly, e.g., by adding local shielding, to suppress neutron-induced damage to components in the nozzle and to reduce the shielding thickness of the treatment vault. The simulations also revealed that the neutron dose to the patient is predominated by neutrons produced in the field defining collimator assembly, located just upstream of the patient. PMID:19147903

  3. [Interatrial electromechanic resynchronization by dual atrial pacing in the prevention of paroxysmal atrial fibrillation --report of a case].

    PubMed

    Rodrigues, J C; Figueiredo, H; Correia, J M

    2000-12-01

    We presented the case of a 78 year old woman who five years ago underwent myectomic surgery, and aortic valvular replacement, for obstructive cardiomyopathy and valvular aortic stenosis. After surgery, the aortic transvalvular gradient was insignificant (20 mm/Hg). In spite of this she suffers from frequent AF crises, (3 times a month), with a cardiac frequency of 140-150/min. She was in sinus bradycardia (40-45/min), which was a clear counter-indication for the use of antiarrhythmic drugs. Her ECG showed sinusal bradycardia with 45/min, a two-phase P-wave (positive-negative) in DII, DIII aVF, and bimodal P-wave in DI. Furthermore, she showed a 1st degree auriculo-ventricular block with complete left-branch block. In her echocardiogram there was concentric left ventricular hypertrophy, with diastolic disfunction and left atrial dilatation. In the auricular IEGM we observed a slowed-down interauricular conduction (right atrium-left atrium = 120 msecs); The A-wave was fragmented. The auriculo-ventricular Wenckbach point was at 90/min. In view of these findings we proceeded with the implantation of a DDD-pacemaker with biauricular stimulation, as follows: 1. We used two auricular electrodes, one with an active fixation to the crista terminalis of the right atrium and the other (having in mind the stimulation of the left atrium) applied to the proximal coronary sinus. These two electrodes were connected to the auricular pin of the pacemaker by means of an "Y"--type Biotronick adaptor. 2. The right ventricular stimulation was done with a normal, bipolar ventricular electrode, on the apex of the ventricle. After biauricular, simultaneous, stimulation, we proceeded with interauricular re-synchronization. After this procedure, the A-wave no longer appeared fragmented, and the right auricular--left auricular waves were then simultaneous and with two-phase morphology. Three months later the interauricular resynchronization procedure was induced and without any antiarrhythmic

  4. Low-cost photodynamic therapy devices for global health settings: Characterization of battery-powered LED performance and smartphone imaging in 3D tumor models

    NASA Astrophysics Data System (ADS)

    Hempstead, Joshua; Jones, Dustin P.; Ziouche, Abdelali; Cramer, Gwendolyn M.; Rizvi, Imran; Arnason, Stephen; Hasan, Tayyaba; Celli, Jonathan P.

    2015-05-01

    A lack of access to effective cancer therapeutics in resource-limited settings is implicated in global cancer health disparities between developed and developing countries. Photodynamic therapy (PDT) is a light-based treatment modality that has exhibited safety and efficacy in the clinic using wavelengths and irradiances achievable with light-emitting diodes (LEDs) operated on battery power. Here we assess low-cost enabling technology to extend the clinical benefit of PDT to regions with little or no access to electricity or medical infrastructure. We demonstrate the efficacy of a device based on a 635 nm high-output LED powered by three AA disposable alkaline batteries, to achieve strong cytotoxic response in monolayer and 3D cultures of A431 squamous carcinoma cells following photosensitization by administering aminolevulinic acid (ALA) to induce the accumulation of protoporphyrin IX (PpIX). Here we characterize challenges of battery-operated device performance, including battery drain and voltage stability specifically over relevant PDT dose parameters. Further motivated by the well-established capacity of PDT photosensitizers to serve as tumour-selective fluorescence contrast agents, we demonstrate the capability of a consumer smartphone with low-cost add-ons to measure concentration-dependent PpIX fluorescence. This study lays the groundwork for the on-going development of image-guided ALA-PDT treatment technologies for global health applications.

  5. Miniature Swine for Preclinical Modeling of Complexities of Human Disease for Translational Scientific Discovery and Accelerated Development of Therapies and Medical Devices.

    PubMed

    Schomberg, Dominic T; Tellez, Armando; Meudt, Jennifer J; Brady, Dane A; Dillon, Krista N; Arowolo, Folagbayi K; Wicks, Joan; Rousselle, Serge D; Shanmuganayagam, Dhanansayan

    2016-04-01

    Noncommunicable diseases, including cardiovascular disease, diabetes, chronic respiratory disease, and cancer, are the leading cause of death in the world. The cost, both monetary and time, of developing therapies to prevent, treat, or manage these diseases has become unsustainable. A contributing factor is inefficient and ineffective preclinical research, in which the animal models utilized do not replicate the complex physiology that influences disease. An ideal preclinical animal model is one that responds similarly to intrinsic and extrinsic influences, providing high translatability and concordance of preclinical findings to humans. The overwhelming genetic, anatomical, physiological, and pathophysiological similarities to humans make miniature swine an ideal model for preclinical studies of human disease. Additionally, recent development of precision gene-editing tools for creation of novel genetic swine models allows the modeling of highly complex pathophysiology and comorbidities. As such, the utilization of swine models in early research allows for the evaluation of novel drug and technology efficacy while encouraging redesign and refinement before committing to clinical testing. This review highlights the appropriateness of the miniature swine for modeling complex physiologic systems, presenting it as a highly translational preclinical platform to validate efficacy and safety of therapies and devices.

  6. Use of a portable, single-use negative pressure wound therapy device in home care patients with low to moderately exuding wounds: a case series.

    PubMed

    Hurd, Theresa; Trueman, Paul; Rossington, Alan

    2014-03-01

    Negative pressure wound therapy (NPWT) is widely used in the management of acute and chronic wounds. The purpose of this 8-week study was to evaluate outcomes of using a new canisterless, portable, single-use NPWT system in patients with wounds treated in a Canadian community healthcare setting. The device is designed to provide negative pressure at 80±20 mm Hg, 24 hours a day of continuous usage, for a maximum wear time of 7 days. Data on wound outcomes, including exudate levels, wound appearance, and wound area, were collected weekly by a Registered Nurse as part of routine practice. When treatment was discontinued, patients and nurses were asked to rate their satisfaction with the device. Data from patients who had used a conventional NPWT device to manage their wounds were retrospectively abstracted from their medical records. In the prospective study, conducted between October 2011 and July 2012, 326 patients (median age=61 years; range 17-91 years) with wounds of mixed etiology (53 pressure ulcers, 21 venous leg ulcers, 16 diabetic foot ulcers, and 15 traumatic and 221 surgical wounds) were treated for a maximum of 8 weeks with the portable NPWT device. The majority of patients (228 out of 326; 68%) achieved complete wound closure within 8 weeks of treatment. The Kaplan-Meier estimate of median time to healing of all wounds was 9 weeks. The majority of patients (318 patients, 97%) reported they were pleased or satisfied with the dressing performance. Nurses indicated satisfaction with the dressing performance for all but two patients (99%). The majority (89%) of patients managed with conventional NPWT (n=539) had an open surgical wound with moderate or high levels of exudate. Healing rates in the portable and conventional NPWT group were similar (10% to 11% per week). Portable, single-use NPWT has the potential to deliver good wound outcomes in community care settings and simplify the use of negative pressure for nurses and patients. Additional research is

  7. A safe procedure for connecting a continuous renal replacement therapy device into an extracorporeal membrane oxygenation circuit.

    PubMed

    Suga, Natsumi; Matsumura, Yosuke; Abe, Ryuzo; Hattori, Noriyuki; Nakada, Taka-Aki; Oda, Shigeto

    2017-03-24

    Patients receiving extracorporeal membrane oxygenation (ECMO) often require continuous renal replacement therapy (CRRT). The intra-circuit pressure of adult ECMO usually deviates from the physiological range. We investigated the use of CRRT connected to an ECMO circuit with physiological intra-circuit pressures (0-150 mmHg, defined as the "safety range") using an in vitro experiment involving a water-filled ECMO circuit. The intra-circuit pressure pre-pump, post-pump, and post-oxygenator were measured while varying the height of the pump or ECMO flow. The bypass conduit pressure and distance from the post-oxygenator port were measured to find the "safety point", where the bypass pressure remained within the safety range. Both drainage and return limbs of the CRRT machine were connected to the safety point and the inlet and outlet pressures of the hemofilter were recorded while varying the ECMO and CRRT flow. The pre-pump pressure only remained within the safety range for heights >75 cm (ECMO flow = 4 L/min) or ECMO flow <3.5 L min (height = 50 cm). The post-pump and post-oxygenator pressure was generally outside of the safety range. The bypass pressure decreased according to the distance from the post-oxygenator port and the safety point was found at 60 or 75 cm (in a 90-cm length conduit) regardless of ECMO flow. The hemofilter inlet and outlet pressures remained within the safety range for all conditions of ECMO and CRRT flow, findings validated in clinical cases. The bypass conduit within an ECMO circuit can be connected to a CRRT machine safely under physiological pressures in adult patients receiving ECMO.

  8. Feasibility study of particulate extracellular matrix (P-ECM) and left ventricular assist device (HVAD) therapy in chronic ischemic heart failure bovine model.

    PubMed

    Soucy, Kevin G; Smith, Erin F; Monreal, Gretel; Rokosh, Gregg; Keller, Brad B; Yuan, Fangping; Matheny, Robert G; Fallon, Anna M; Lewis, Beecher C; Sherwood, Leslie C; Sobieski, Michael A; Giridharan, Guruprasad A; Koenig, Steven C; Slaughter, Mark S

    2015-01-01

    Myocardial recovery with left ventricular assist device (LVAD) support is uncommon and unpredictable. We tested the hypothesis that injectable particulate extracellular matrix (P-ECM) with LVAD support promotes cell proliferation and improves cardiac function. LVAD, P-ECM, and P-ECM + LVAD therapies were investigated in chronic ischemic heart failure (IHF) calves induced using coronary embolization. Particulate extracellular matrix emulsion (CorMatrix, Roswell, GA) was injected intramyocardially using a 7 needle pneumatic delivery tool. Left ventricular assist devices (HVAD, HeartWare) were implanted in a left ventricle (LV) apex to proximal descending aorta configuration. Cell proliferation was identified using BrdU (5 mg/kg) injections over the last 45 treatment days. Echocardiography was performed weekly. End-organ regional blood flow (RBF) was quantified at study endpoints using fluorescently labeled microspheres. Before treatment, IHF calves had an ejection fraction (EF) of 33 ± 2% and left ventricular end-diastolic volume of 214 ± 18 ml with cardiac cachexia (0.69 ± 0.06 kg/day). Healthy weight gain was restored in all groups (0.89 ± 0.03 kg/day). EF increased with P-ECM + HVAD from 36 ± 5% to 75 ± 2%, HVAD 38 ± 4% to 58 ± 5%, and P-ECM 27 ± 1% to 66 ± 6%. P-ECM + HVAD demonstrated the largest increase in cell proliferation and end-organ RBF. This study demonstrates the feasibility of combined LVAD support with P-ECM injection to stimulate new cell proliferation and improve cardiac function, which warrants further investigation.

  9. Decision Making for Destination Therapy Left Ventricular Assist Devices: “There was no choice” versus “I thought about it an awful lot”

    PubMed Central

    McIlvennan, Colleen K.; Allen, Larry A.; Nowels, Carolyn; Brieke, Andreas; Cleveland, Joseph C.; Matlock, Daniel D.

    2014-01-01

    Background Destination therapy left ventricular assist devices (DT LVAD) are one of the most invasive medical interventions for end-stage illness. How patients decide whether or not to proceed with device implantation is unknown. We aimed to understand the decision-making processes of patients who either accept or decline DT LVADs. Methods and Results Between October 2012–September 2013, we conducted semi-structured, in-depth interviews to understand patients’ decision-making experiences. Data were analyzed using a mixed inductive and deductive approach. Twenty-two eligible patients were interviewed, 15 with DT LVADs and 7 who declined. We found a strong dichotomy between decision processes with some patients (11 accepters) being “automatic” and others (3 accepters, 7 decliners) being “reflective” in their approach to decision making. The automatic group was characterized by a fear of dying and an overriding desire to live as long as possible: “[LVAD] was the only option I had…that or push up daisies…so I automatically took this”. In contrast, the reflective group went through a reasoned process of weighing risks, benefits, and burdens: “There are worse things than death.” Irrespective of approach, most patients experienced the DT LVAD decision as a highly emotional process and many sought support from their families or spiritually. Conclusion Some patients offered a DT LVAD face the decision by reflecting on a process and reasoning through risks and benefits. For others, the desire to live supersedes such reflective processing. Acknowledging this difference is important when considering how to support patients who are faced with this complex decision. PMID:24823949

  10. Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal Therapy on Swallowing and Health-Related Outcomes in Older Adults with Dysphagia.

    PubMed

    Rogus-Pulia, Nicole; Rusche, Nicole; Hind, Jacqueline A; Zielinski, Jill; Gangnon, Ronald; Safdar, Nasia; Robbins, JoAnne

    2016-02-01

    Swallowing disorders (dysphagia) are associated with malnutrition, aspiration pneumonia, and mortality in older adults. Strengthening interventions have shown promising results, but the effectiveness of treating dysphagia in older adults remains to be established. The Swallow STRengthening OropharyNGeal (Swallow STRONG) Program is a multidisciplinary program that employs a specific approach to oropharyngeal strengthening-device-facilitated (D-F) isometric progressive resistance oropharyngeal (I-PRO) therapy-with the goal of reducing health-related sequelae in veterans with dysphagia. Participants completed 8 weeks of D-F I-PRO therapy while receiving nutritional counseling and respiratory status monitoring. Assessments were completed at baseline, 4, and 8 weeks. At each visit, videofluoroscopic swallowing studies were performed. Dietary and swallowing-related quality of life questionnaires were administered. Long-term monitoring for 6-17 months after enrollment allowed for comparison of pneumonia incidence and hospitalizations to the 6-17 months before the program. Veterans with dysphagia confirmed with videofluoroscopy (N = 56; 55 male, 1 female; mean age 70) were enrolled. Lingual pressures increased at anterior (effect estimate = 92.5, P < .001) and posterior locations (effect estimate = 85.4, P < .001) over 8 weeks. Statistically significant improvements occurred on eight of 11 subscales of the Quality of Life in Swallowing Disorders (SWAL-QOL) Questionnaire (effect estimates = 6.5-19.5, P < .04) and in self-reported sense of effort (effect estimate = -18.1, P = .001). Higher Functional Oral Intake Scale scores (effect estimate = 0.4, P = .02) indicated that participants were able to eat less-restrictive diets. There was a 67% reduction in pneumonia diagnoses, although the difference was not statistically significant. The number of hospital admissions decreased significantly (effect estimate = 0.96; P = .009) from before to after enrollment. Findings suggest

  11. Cardiac Health Risk Stratification System (CHRiSS): a Bayesian-based decision support system for left ventricular assist device (LVAD) therapy.

    PubMed

    Loghmanpour, Natasha A; Druzdzel, Marek J; Antaki, James F

    2014-01-01

    This study investigated the use of Bayesian Networks (BNs) for left ventricular assist device (LVAD) therapy; a treatment for end-stage heart failure that has been steadily growing in popularity over the past decade. Despite this growth, the number of LVAD implants performed annually remains a small fraction of the estimated population of patients who might benefit from this treatment. We believe that this demonstrates a need for an accurate stratification tool that can help identify LVAD candidates at the most appropriate point in the course of their disease. We derived BNs to predict mortality at five endpoints utilizing the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database: containing over 12,000 total enrolled patients from 153 hospital sites, collected since 2006 to the present day, and consisting of approximately 230 pre-implant clinical variables. Synthetic minority oversampling technique (SMOTE) was employed to address the uneven proportion of patients with negative outcomes and to improve the performance of the models. The resulting accuracy and area under the ROC curve (%) for predicted mortality were 30 day: 94.9 and 92.5; 90 day: 84.2 and 73.9; 6 month: 78.2 and 70.6; 1 year: 73.1 and 70.6; and 2 years: 71.4 and 70.8. To foster the translation of these models to clinical practice, they have been incorporated into a web-based application, the Cardiac Health Risk Stratification System (CHRiSS). As clinical experience with LVAD therapy continues to grow, and additional data is collected, we aim to continually update these BN models to improve their accuracy and maintain their relevance. Ongoing work also aims to extend the BN models to predict the risk of adverse events post-LVAD implant as additional factors for consideration in decision making.

  12. Cardiac Health Risk Stratification System (CHRiSS): A Bayesian-Based Decision Support System for Left Ventricular Assist Device (LVAD) Therapy

    PubMed Central

    Loghmanpour, Natasha A.; Druzdzel, Marek J.; Antaki, James F.

    2014-01-01

    This study investigated the use of Bayesian Networks (BNs) for left ventricular assist device (LVAD) therapy; a treatment for end-stage heart failure that has been steadily growing in popularity over the past decade. Despite this growth, the number of LVAD implants performed annually remains a small fraction of the estimated population of patients who might benefit from this treatment. We believe that this demonstrates a need for an accurate stratification tool that can help identify LVAD candidates at the most appropriate point in the course of their disease. We derived BNs to predict mortality at five endpoints utilizing the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database: containing over 12,000 total enrolled patients from 153 hospital sites, collected since 2006 to the present day, and consisting of approximately 230 pre-implant clinical variables. Synthetic minority oversampling technique (SMOTE) was employed to address the uneven proportion of patients with negative outcomes and to improve the performance of the models. The resulting accuracy and area under the ROC curve (%) for predicted mortality were 30 day: 94.9 and 92.5; 90 day: 84.2 and 73.9; 6 month: 78.2 and 70.6; 1 year: 73.1 and 70.6; and 2 years: 71.4 and 70.8. To foster the translation of these models to clinical practice, they have been incorporated into a web-based application, the Cardiac Health Risk Stratification System (CHRiSS). As clinical experience with LVAD therapy continues to grow, and additional data is collected, we aim to continually update these BN models to improve their accuracy and maintain their relevance. Ongoing work also aims to extend the BN models to predict the risk of adverse events post-LVAD implant as additional factors for consideration in decision making. PMID:25397576

  13. Canadian Cardiovascular Society Consensus Conference guidelines on heart failure, update 2009: Diagnosis and management of right-sided heart failure, myocarditis, device therapy and recent important clinical trials

    PubMed Central

    Howlett, Jonathan G; McKelvie, Robert S; Arnold, J Malcolm O; Costigan, Jeannine; Dorian, Paul; Ducharme, Anique; Estrella-Holder, Estrellita; Ezekowitz, Justin A; Giannetti, Nadia; Haddad, Haissam; Heckman, George A; Herd, Anthony M; Isaac, Debra; Jong, Philip; Kouz, Simon; Liu, Peter; Mann, Elizabeth; Moe, Gordon W; Tsuyuki, Ross T; Ross, Heather J; White, Michel

    2009-01-01

    The Canadian Cardiovascular Society published a comprehensive set of recommendations on the diagnosis and management of heart failure in January 2006. Based on feedback obtained through a national program of heart failure workshops and through active solicitation of stakeholders, several topics were identified because of their importance to the practicing clinician. Topics chosen for the present update include best practices for the diagnosis and management of right-sided heart failure, myocarditis and device therapy, and a review of recent important or landmark clinical trials. These recommendations were developed using the structured approach for the review and assessment of evidence adopted and previously described by the Society. The present update has been written from a clinical perspective to provide a user-friendly and practical approach. Specific clinical questions that are addressed include: What is right-sided heart failure and how should one approach the diagnostic work-up? What other clinical entities may masquerade as this nebulous condition and how can we tell them apart? When should we be concerned about the presence of myocarditis and how quickly should patients with this condition be referred to an experienced centre? Among the myriad of recently published landmark clinical trials, which ones will impact our standards of clinical care? The goals are to aid physicians and other health care providers to optimally treat heart failure patients, resulting in a measurable impact on patient health and clinical outcomes in Canada. PMID:19214293

  14. MR guided thermal therapy of pancreatic tumors with endoluminal, intraluminal and interstitial catheter-based ultrasound devices: preliminary theoretical and experimental investigations

    NASA Astrophysics Data System (ADS)

    Prakash, Punit; Salgaonkar, Vasant A.; Scott, Serena J.; Jones, Peter; Hensley, Daniel; Holbrook, Andrew; Plata, Juan; Sommer, Graham; Diederich, Chris J.

    2013-02-01

    Image-guided thermal interventions have been proposed for potential palliative and curative treatments of pancreatic tumors. Catheter-based ultrasound devices offer the potential for temporal and 3D spatial control of the energy deposition profile. The objective of this study was to apply theoretical and experimental techniques to investigate the feasibility of endogastric, intraluminal and transgastric catheter-based ultrasound for MR guided thermal therapy of pancreatic tumors. The transgastric approach involves insertion of a catheter-based ultrasound applicator (array of 1.5 mm OD x 10 mm transducers, 360° or sectored 180°, ~7 MHz frequency, 13-14G cooling catheter) directly into the pancreas, either endoscopically or via image-guided percutaneous placement. An intraluminal applicator, of a more flexible but similar construct, was considered for endoscopic insertion directly into the pancreatic or biliary duct. An endoluminal approach was devised based on an ultrasound transducer assembly (tubular, planar, curvilinear) enclosed in a cooling balloon which is endoscopically positioned within the stomach or duodenum, adjacent to pancreatic targets from within the GI tract. A 3D acoustic bio-thermal model was implemented to calculate acoustic energy distributions and used a FEM solver to determine the transient temperature and thermal dose profiles in tissue during heating. These models were used to determine transducer parameters and delivery strategies and to study the feasibility of ablating 1-3 cm diameter tumors located 2-10 mm deep in the pancreas, while thermally sparing the stomach wall. Heterogeneous acoustic and thermal properties were incorporated, including approximations for tumor desmoplasia and dynamic changes during heating. A series of anatomic models based on imaging scans of representative patients were used to investigate the three approaches. Proof of concept (POC) endogastric and transgastric applicators were fabricated and experimentally

  15. Percutaneous Ventricular Restoration Therapy Using the Parachute Device in Chinese Patients with Ischemic Heart Failure: Three-Month Primary End-point Results of PARACHUTE China Study

    PubMed Central

    Yang, Yue-Jin; Huo, Yong; Xu, Ya-Wei; Wang, Jian-An; Han, Ya-Ling; Ge, Jun-Bo; Zhang, Rui-Yan; Yan, Xiao-Yan; Gao, Run-Lin

    2016-01-01

    Background: The primary cause of ischemic heart failure (HF) is myocardial infarction (MI) resulting in left ventricle (LV) wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device (CardioKinetix, Inc., CA, USA) in ischemic HF patients as a result of LV remodeling after anterior wall MI. Methods: Thirty-one patients with New York Heart Association (NYHA) Class II, III ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin for at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index (LVESVI) against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-5D and visual analog scale (VAS). For quantitative data comparison, paired t-test (normality data) and signed-rank test (abnormality data) were used; application of signed-rank test was for the ranked data comparison. Results: A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ± 20.0 ml/m2 to 53.1 ± 17.0 ml/m2 (P < 0.0001). The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than half a class at 3 months (P < 0.001). Quality of life assessed by the VAS value increased 11.5 points (P < 0.01), demonstrating

  16. SU-E-T-145: Effects of Temporary Tachytherapy Inhibition Magnet On MOSFET Dose Measurements of Cardiovascular Implantable Electronic Devices (CIED) in Radiation Therapy Patients

    SciTech Connect

    P, Joshi; Salomons, G; Kerr, A; Peters, C; Lalonde, M

    2014-06-01

    Purpose: To determine the effects of temporary tachytherapy inhibition magnet on MOSFET dose measurements of cardiovascular implantable electronic devices (CIED) in radiation therapy patients. Methods: Infield and peripheral MOSFET dose measurements with 6MV photon beams were performed to evaluate dose to a CIED in the presence of a doughnut shaped temporary tachytherapy inhibition magnet. Infield measurements were done to quantify the effects of the magnetic field alone and shielding by the magnet. MOSFETs were placed inside a 20×20cm{sup 2} field at a depth of 3cm in the isocentre plane in the presence and absence of the magnet. Peripheral dose measurements were done to determine the impact of the magnet on dose to the CIED in a clinical setting. These measurements were performed at the centre, under the rim and half way between a 10×10cm{sup 2} field edge and the magnet with MOSFETS placed at the surface, 0.5cm and 1cm depths in the presence and absence of the magnet. Results: Infield measurements showed that effects of magnetic field on the MOSFET readings were within the 2% MOSFET dose measurement uncertainty; a 20% attenuation of dose under the magnet rim was observed. Peripheral dose measurements at the centre of the magnet show an 8% increase in surface dose and a 6% decrease in dose at 1cm depth. Dose under the magnet rim was reduced by approximately 68%, 45% and 25% for MOSFET placed at 0.0, 0.5 and 1.0cm bolus depths, respectively. Conclusions: The magnetic field has an insignificant effect on MOSFET dose measurements. Dose to the central region of CIED represented by centre of the magnet doughnut increases at the surface, and decreases at depths due to low energy scattering contributions from the magnet. Dose under the magnet rim, representing CIED edges, decreased significantly due to shielding.

  17. Usefulness of cardiac resynchronisation therapy devices and implantable cardioverter defibrillators in the treatment of heart failure due to severe systolic dysfunction: systematic review of clinical trials and network meta-analysis

    PubMed Central

    García García, M A; Rosero Arenas, M A; Ruiz Granell, R; Chorro Gascó, F J; Martínez Cornejo, A

    2016-01-01

    Aim To assess the effectiveness of cardiac resynchronisation therapy (CRT), implantable cardioverter defibrillator (ICD) therapy, and the combination of these devices (CRT+ICD) in adult patients with left ventricular dysfunction and symptomatic heart failure. Methods A comprehensive systematic review of randomised clinical trials was conducted. Several electronic databases (PubMed, Embase, Ovid, Cochrane, ClinicalTrials.gov) were reviewed. The mortality rates between treatments were compared. A network was established comparing the various options, and direct, indirect and mixed comparisons were made using multivariate meta-regression. The degree of clinical and statistical homogeneity was assessed. Results 43 trials involving 13 017 patients were reviewed. Resynchronisation therapy, defibrillators, and combined devices (CRT+ICD) are clearly beneficial compared to optimal medical treatment, showing clear benefit in all of these cases. In a theoretical order of efficiency, the first option is combined therapy (CRT+ICD), the second is CRT, and the third is defibrillator implantation (ICD). Given the observational nature of these comparisons, and the importance of the overlapping CIs, we cannot state that the combined option (CRT+ICD) offers superior survival benefit compared to the other two options. Conclusions The combined option of CRT+ICD seems to be better than the option of CRT alone, although no clear improvement in survival was found for the combined option. It would be advisable to perform a direct comparative study of these two options. PMID:27326223

  18. Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry

    PubMed Central

    Ricci, Renato Pietro; Morichelli, Loredana; D'Onofrio, Antonio; Calò, Leonardo; Vaccari, Diego; Zanotto, Gabriele; Curnis, Antonio; Buja, Gianfranco; Rovai, Nicola; Gargaro, Alessio

    2013-01-01

    Aims The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management. Methods and results The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5–86.0%] and 97.4% (CI, 96.5–98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1–14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53–0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0–107.0) min × health personnel/100 patients. Conclusion Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption. PMID:23362021

  19. Socio-Economic Status: A Barrier to Access to Mandibular Advancement Device Therapy for Patients with Obstructive Sleep Apnea Syndrome in France

    PubMed Central

    Fleury, Marion; Le Vaillant, Marc; Pelletier-Fleury, Nathalie

    2015-01-01

    Background Obstructive sleep apnea syndrome (OSAS) is a major public health problem which affects between 5 to 10% of the general population. OSAS is known to be associated with high rates of morbidity and mortality mainly due to cardiovascular diseases and traffic accidents. The burden of illness is high for the individual and society. There are 2 treatment options for OSAS, Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Device therapy (MAD). CPAP is known to be an effective but very constraining treatment. Patients are usually poorly adherent. MAD is a more recent treatment easier to use and consequently better tolerated, but MAD can only be prescribed to patients with satisfactory oral hygiene. Oral health constitutes a real issue particularly among underprivileged groups in France. Through this link, the question of whether low socio-economic status constitutes a barrier to access to care for patients with OSAS is raised. Methods and Principal Findings In a multicenter prospective cohort of 2822 consecutive OSAS patients in whom MAD has been proposed as an alternative to CPAP between May 15, 2007 and December 1st, 2014, we identified the factors that lead to a patient diagnosed with OSAS to be treated by MAD instead of CPAP. A logistic regression was performed using a stepwise forward procedure. The main outcome of the study was that treatment by MAD was significantly associated with both educational attainment, as determined by the age at which the patient left full-time education, ≥18 years compared with <18 (adjusted odds ratio (aOR): 1.64, 95% CI 1.23 to 2.20), and the patient's occupational category. Executives and higher intellectual professions, intermediate professions, technicians, foremen and employees were significantly more likely to be treated by MAD than workers (aOR: 2.21, 95% CI 1.88 to 2.58; aOR: 1.74, 95% CI 1.15 to 2.63; aOR: 1.96, 95% CI 1.11 to 3.47, respectively). Conclusions Overall, these results suggest that low

  20. Wound Healing Devices Brief Vignettes

    PubMed Central

    Anderson, Caesar A.; Hare, Marc A.; Perdrizet, George A.

    2016-01-01

    Significance: The demand for wound care therapies is increasing. New wound care products and devices are marketed at a dizzying rate. Practitioners must make informed decisions about the use of medical devices for wound healing therapy. This paper provides updated evidence and recommendations based on a review of recent publications. Recent Advances: The published literature on the use of medical devices for wound healing continues to support the use of hyperbaric oxygen therapy, negative pressure wound therapy, and most recently electrical stimulation. Critical Issue: To inform wound healing practitioners of the evidence for or against the use of medical devices for wound healing. This information will aid the practitioner in deciding which technology should be accepted or rejected for clinical use. Future Directions: To produce high quality, randomized controlled trials or acquire outcome-based registry databases to further test and improve the knowledge base as it relates to the use of medical devices in wound care. PMID:27076996

  1. The effect of X-ray scattering by water in the irradiation of cell cultures for the dosimetric characterization of a new prototype of IORT (Intra-Operative Radiation Therapy) device: Monte Carlo simulation and experimental validation.

    PubMed

    Ceccolini, E; Ferrari, P; Castelluccio, D M; Mostacci, D; Sumini, M

    2013-10-01

    The electron beam emitted backward by plasma focus devices is being considered as a radiation source for Intra-Operative Radiation Therapy (IORT) applications. Radiobiological investigations have been conducted to assess the potential of this new prototype of IORT device. A standard x-ray beam, ISO-H60, was used for comparison, irradiating cell cultures in a holder filled with an aqueous solution. The influence of scattering by the culture water and by the walls of the holder was investigated to determine their influence on the dose delivered to the cell culture. MCNPX simulations were run and experimental measurements conducted. The effect of scattering by the holder was found to be negligible; scattering by the culture water was determined to give an increase in dose of the order of 10%.

  2. Should women have different ECG criteria for CRT than men?

    PubMed

    Lee, Noel S; Lin, Felice; Birgersdotter-Green, Ulrika

    2017-01-31

    One of the key aspects of heart failure management is whether patients should be considered for device therapy. Clinical trials, which have employed QRS duration and morphology as measures of left ventricular dyssynchrony, have demonstrated the morbidity and mortality benefit of cardiac resynchronization therapy. Women, however, are underrepresented in these trials, the basis of which current guidelines and standards of care are derived. Despite low enrollment of women, several studies highlight the statistically significant improvement in risk reduction that women gain from cardiac resynchronization therapy compared to men. This review discusses the foundation for current guidelines and the building evidence that women may reap more benefit from cardiac resynchronization therapy than men. Given these data, a more individualized approach should be considered in prescribing this device therapy in the future, particularly in women.

  3. Future devices and directions.

    PubMed

    Clark, R E; Zafirelis, Z

    2000-01-01

    This article summarizes the status of left ventricular assist devices currently in the stages of bench testing, animal experiments, and pilot clinical trials. The major design features and estimate of costs for 17 devices are described under 3 major categories of indications for use: destination therapy, bridge to transplant, and bridge to recovery. A sleeved piston pump located in the aorta and a unique, magnetically suspended centrifugal pump are described in the destination therapy section. Eight centrifugal and 4 axial flow devices are listed in the bridge to transplant category, and an external cup and a very low-cost centrifugal pump with a left atrium-to-aorta circuit are described in the bridge to recovery section. The key design features of the future, which will be required for success in both the clinical and marketplace arenas, will be simplicity, safety, low-power requirements, and low cost.

  4. The NTI-tss device for the therapy of bruxism, temporomandibular disorders, and headache – Where do we stand? A qualitative systematic review of the literature

    PubMed Central

    Stapelmann, Henrike; Türp, Jens C

    2008-01-01

    Background The NTI-tss device is an anterior bite stop, which, according to the manufacturer, is indicated for the prevention and treatment of bruxism, temporomandibular disorders (TMDs), tension-type headaches, and migraine. The aim of this systematic review was to appraise the currently available evidence regarding the efficacy and safety of the NTI-tss splint. Methods We performed a systematic search in nine electronic databases and in NTI-tss-associated websites (last update: December 31, 2007). The reference lists of all relevant articles were perused. Five levels of scientific quality were distinguished. Reporting quality of articles about randomized controlled trials (RCTs) was evaluated using the Jadad score. To identify adverse events, we searched in the identified publications and in the MAUDE database. Results Nine of 68 relevant publications reported about the results of five different RCTs. Two RCTs concentrated on electromyographic (EMG) investigations in patients with TMDs and concomitant bruxism (Baad-Hansen et al 2007, Jadad score: 4) or with bruxism alone (Kavaklı 2006, Jadad score: 2); in both studies, compared to an occlusal stabilization splint the NTI-tss device showed significant reduction of EMG activity. Two RCTs focused exclusively on TMD patients; in one trial (Magnusson et al 2004, Jadad score: 3), a stabilization appliance led to greater improvement than an NTI-tss device, while in the other study (Jokstad et al 2005, Jadad score: 5) no difference was found. In one RCT (Shankland 2002, Jadad score: 1), patients with tension-type headache or migraine responded more favorably to the NTI-tss splint than to a bleaching tray. NTI-tss-induced complications related predominantly to single teeth or to the occlusion. Conclusion Evidence from RCTs suggests that the NTI-tss device may be successfully used for the management of bruxism and TMDs. However, to avoid potential unwanted effects, it should be chosen only if certain a patient will be

  5. Photovoltaic device

    DOEpatents

    Reese, Jason A; Keenihan, James R; Gaston, Ryan S; Kauffmann, Keith L; Langmaid, Joseph A; Lopez, Leonardo; Maak, Kevin D; Mills, Michael E; Ramesh, Narayan; Teli, Samar R

    2017-03-21

    The present invention is premised upon an improved photovoltaic device ("PV device"), more particularly to an improved photovoltaic device with a multilayered photovoltaic cell assembly and a body portion joined at an interface region and including an intermediate layer, at least one interconnecting structural member, relieving feature, unique component geometry, or any combination thereof.

  6. Photovoltaic device

    DOEpatents

    Reese, Jason A.; Keenihan, James R.; Gaston, Ryan S.; Kauffmann, Keith L.; Langmaid, Joseph A.; Lopez, Leonardo C.; Maak, Kevin D.; Mills, Michael E.; Ramesh, Narayan; Teli, Samar R.

    2015-06-02

    The present invention is premised upon an improved photovoltaic device ("PV device"), more particularly to an improved photovoltaic device with a multilayered photovoltaic cell assembly and a body portion joined at an interface region and including an intermediate layer, at least one interconnecting structural member, relieving feature, unique component geometry, or any combination thereof.

  7. Photovoltaic device

    DOEpatents

    Reese, Jason A.; Keenihan, James R.; Gaston, Ryan S.; Kauffmann, Keith L.; Langmaid, Joseph A.; Lopez, Leonardo C.; Maak, Kevin D.; Mills, Michael E.; Ramesh, Narayan; Teli, Samar R.

    2015-09-01

    The present invention is premised upon an improved photovoltaic device ("PV device"), more particularly to an improved photovoltaic device (10) with a multilayered photovoltaic cell assembly (100) and a body portion (200) joined at an interface region (410) and including an intermediate layer (500), at least one interconnecting structural member (1500), relieving feature (2500), unique component geometry, or any combination thereof.

  8. 21 CFR 892.5300 - Medical neutron radiation therapy system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical neutron radiation therapy system. 892.5300... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron radiation therapy system. (a) Identification. A medical neutron radiation therapy system is a device intended...

  9. 21 CFR 892.5300 - Medical neutron radiation therapy system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical neutron radiation therapy system. 892.5300... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron radiation therapy system. (a) Identification. A medical neutron radiation therapy system is a device intended...

  10. 21 CFR 892.5300 - Medical neutron radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical neutron radiation therapy system. 892.5300... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron radiation therapy system. (a) Identification. A medical neutron radiation therapy system is a device intended...

  11. 21 CFR 892.5300 - Medical neutron radiation therapy system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical neutron radiation therapy system. 892.5300... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron radiation therapy system. (a) Identification. A medical neutron radiation therapy system is a device intended...

  12. 21 CFR 892.5300 - Medical neutron radiation therapy system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical neutron radiation therapy system. 892.5300... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron radiation therapy system. (a) Identification. A medical neutron radiation therapy system is a device intended...

  13. 21 CFR 892.5750 - Radionuclide radiation therapy system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radionuclide radiation therapy system. 892.5750... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5750 Radionuclide radiation therapy system. (a) Identification. A radionuclide radiation therapy system is a device intended to permit...

  14. The importance of chemistry in creating well-defined nanoscopic embedded therapeutics: devices capable of the dual functions of imaging and therapy.

    PubMed

    Nyström, Andreas M; Wooley, Karen L

    2011-10-18

    Nanomedicine is a rapidly evolving field, for which polymer building blocks are proving useful for the construction of sophisticated devices that provide enhanced diagnostic imaging and treatment of disease, known as theranostics. These well-defined nanoscopic objects have high loading capacities, can protect embedded therapeutic cargo, and offer control over the conditions and rates of release. Theranostics also offer external surface area for the conjugation of ligands to impart stealth characteristics and/or direct their interactions with biological receptors and provide a framework for conjugation of imaging agents to track delivery to diseased site(s). The nanoscopic dimensions allow for extensive biological circulation. The incorporation of such multiple functions is complicated, requiring exquisite chemical control during production and rigorous characterization studies to confirm the compositions, structures, properties, and performance. We are particularly interested in the study of nanoscopic objects designed for treatment of lung infections and acute lung injury, urinary tract infections, and cancer. This Account highlights our work over several years to tune the assembly of unique nanostructures. We provide examples of how the composition, structure, dimensions, and morphology of theranostic devices can tune their performance as drug delivery agents for the treatment of infectious diseases and cancer. The evolution of nanostructured materials from relatively simple overall shapes and internal morphologies to those of increasing complexity is driving the development of synthetic methodologies for the preparation of increasingly complex nanomedicine devices. Our nanomedicine devices are derived from macromolecules that have well-defined compositions, structures, and topologies, which provide a framework for their programmed assembly into nanostructures with controlled sizes, shapes, and morphologies. The inclusion of functional units within selective

  15. Magnetic therapy in physics?

    NASA Astrophysics Data System (ADS)

    Welsh, Gail S.

    2000-03-01

    A critical thinking activity focused on students' understanding of magnets is described. The activity includes a short written paper about the validity of advertisements for alternative medical therapy devices based on magnets. It includes also self assessment through peer interaction.

  16. SU-F-BRA-16: Development of a Radiation Monitoring Device Using a Low-Cost CCD Camera Following Radionuclide Therapy

    SciTech Connect

    Taneja, S; Fru, L Che; Desai, V; Lentz, J; Lin, C; Scarpelli, M; Simiele, E; Trestrail, A; Bednarz, B

    2015-06-15

    Purpose: It is now commonplace to handle treatments of hyperthyroidism using iodine-131 as an outpatient procedure due to lower costs and less stringent federal regulations. The Nuclear Regulatory Commission has currently updated release guidelines for these procedures, but there is still a large uncertainty in the dose to the public. Current guidelines to minimize dose to the public require patients to remain isolated after treatment. The purpose of this study was to use a low-cost common device, such as a cell phone, to estimate exposure emitted from a patient to the general public. Methods: Measurements were performed using an Apple iPhone 3GS and a Cs-137 irradiator. The charge-coupled device (CCD) camera on the phone was irradiated to exposure rates ranging from 0.1 mR/hr to 100 mR/hr and 30-sec videos were taken during irradiation with the camera lens covered by electrical tape. Interactions were detected as white pixels on a black background in each video. Both single threshold (ST) and colony counting (CC) methods were performed using MATLAB®. Calibration curves were determined by comparing the total pixel intensity output from each method to the known exposure rate. Results: The calibration curve showed a linear relationship above 5 mR/hr for both analysis techniques. The number of events counted per unit exposure rate within the linear region was 19.5 ± 0.7 events/mR and 8.9 ± 0.4 events/mR for the ST and CC methods respectively. Conclusion: Two algorithms were developed and show a linear relationship between photons detected by a CCD camera and low exposure rates, in the range of 5 mR/hr to 100-mR/hr. Future work aims to refine this model by investigating the dose-rate and energy dependencies of the camera response. This algorithm allows for quantitative monitoring of exposure from patients treated with iodine-131 using a simple device outside of the hospital.

  17. Determination of the International Sensitivity Index of a new near-patient testing device to monitor oral anticoagulant therapy--overview of the assessment of conformity to the calibration model.

    PubMed

    Tripodi, A; Chantarangkul, V; Clerici, M; Negri, B; Mannucci, P M

    1997-08-01

    A key issue for the reliable use of new devices for the laboratory control of oral anticoagulant therapy with the INR is their conformity to the calibration model. In the past, their adequacy has mostly been assessed empirically without reference to the calibration model and the use of International Reference Preparations (IRP) for thromboplastin. In this study we reviewed the requirements to be fulfilled and applied them to the calibration of a new near-patient testing device (TAS, Cardiovascular Diagnostics) which uses thromboplastin-containing test cards for determination of the INR. On each of 10 working days citrated whole blood and plasma samples were obtained from 2 healthy subjects and 6 patients on oral anticoagulants. PT testing on whole blood and plasma was done with the TAS and parallel testing for plasma by the manual technique with the IRP CRM 149S. Conformity to the calibration model was judged satisfactory if the following requirements were met: (i) there was a linear relationship between paired log-PTs (TAS vs CRM 149S); (ii) the regression line drawn through patients data points, passed through those of normals; (iii) the precision of the calibration expressed as the CV of the slope was <3%. A good linear relationship was observed for calibration plots for plasma and whole blood (r = 0.98). Regression lines drawn through patients data points, passed through those of normals. The CVs of the slope were in both cases 2.2% and the ISIs were 0.965 and 1.000 for whole blood and plasma. In conclusion, our study shows that near-patient testing devices can be considered reliable tools to measure INR in patients on oral anticoagulants and provides guidelines for their evaluation.

  18. Microfluidic Device

    NASA Technical Reports Server (NTRS)

    Tai, Yu-Chong (Inventor); Zheng, Siyang (Inventor); Lin, Jeffrey Chun-Hui (Inventor); Kasdan, Harvey L. (Inventor)

    2017-01-01

    Described herein are particular embodiments relating to a microfluidic device that may be utilized for cell sensing, counting, and/or sorting. Particular aspects relate to a microfabricated device that is capable of differentiating single cell types from dense cell populations. One particular embodiment relates a device and methods of using the same for sensing, counting, and/or sorting leukocytes from whole, undiluted blood samples.

  19. Microfluidic Device

    NASA Technical Reports Server (NTRS)

    Tai, Yu-Chong (Inventor); Zheng, Siyang (Inventor); Lin, Jeffrey Chun-Hui (Inventor); Kasdan, Harvey (Inventor)

    2015-01-01

    Described herein are particular embodiments relating to a microfluidic device that may be utilized for cell sensing, counting, and/or sorting. Particular aspects relate to a microfabricated device that is capable of differentiating single cell types from dense cell populations. One particular embodiment relates a device and methods of using the same for sensing, counting, and/or sorting leukocytes from whole, undiluted blood samples.

  20. Microfluidic Device

    NASA Technical Reports Server (NTRS)

    Tai, Yu-Chong (Inventor); Zheng, Siyang (Inventor); Lin, Jeffrey Chun-Hui (Inventor); Kasdan, Harvey L. (Inventor)

    2016-01-01

    Described herein are particular embodiments relating to a microfluidic device that may be utilized for cell sensing, counting, and/or sorting. Particular aspects relate to a microfabricated device that is capable of differentiating single cell types from dense cell populations. One particular embodiment relates a device and methods of using the same for sensing, counting, and/or sorting leukocytes from whole, undiluted blood samples.

  1. Sealing device

    SciTech Connect

    Garcia-Crespo, Andres Jose

    2013-12-10

    A sealing device for sealing a gap between a dovetail of a bucket assembly and a rotor wheel is disclosed. The sealing device includes a cover plate configured to cover the gap and a retention member protruding from the cover plate and configured to engage the dovetail. The sealing device provides a seal against the gap when the bucket assemply is subjected to a centrifugal force.

  2. BRAKE DEVICE

    DOEpatents

    O'Donnell, T.J.

    1959-03-10

    A brake device is described for utilization in connection with a control rod. The device comprises a pair of parallelogram link mechanisms, a control rod moveable rectilinearly therebetween in opposite directions, and shoes resiliently supported by the mechanism for frictional engagement with the control rod.

  3. Josephson Devices

    NASA Astrophysics Data System (ADS)

    Barone, Antonio; Pagano, Sergio

    In this chapter we briefly review the main applications of Josephson effect together with the most successful devices realized. We will give an overview of the various devices, providing also some basic concepts of the underlying physical mechanisms involved, and the associated limit performances. Some considerations on the concrete possibilities of successful "market ready" implementation will also be given.

  4. Electrochromic devices

    DOEpatents

    Allemand, Pierre M.; Grimes, Randall F.; Ingle, Andrew R.; Cronin, John P.; Kennedy, Steve R.; Agrawal, Anoop; Boulton, Jonathan M.

    2001-01-01

    An electrochromic device is disclosed having a selective ion transport layer which separates an electrochemically active material from an electrolyte containing a redox active material. The devices are particularly useful as large area architectural and automotive glazings due to there reduced back reaction.

  5. Optoelectronic devices

    NASA Astrophysics Data System (ADS)

    Sperling, Leslie H.; Murphy, Clarence J.; Rosen, Warren A.; Jain, Himanshu

    1990-07-01

    This invention relates to acrylic polymers and more specifically to polyacrylamides and polyacrylates such as poly(2-((N-2-methyl-5-nitrophenylamino) ethyl acrylate)) and poly((N-2-methyl-4-nitrophenyl)acrylamide). These acrylic polymers are particularly useful as nonlinear optical components in various electrical devices for processing optical signals including interferometors, optical switches, optical amplifiers, generators, computational devices and the like.

  6. PLASMA DEVICE

    DOEpatents

    Gow, J.D.; Wilcox, J.M.

    1961-12-26

    A device is designed for producing and confining highenergy plasma from which neutrons are generated in copious quantities. A rotating sheath of electrons is established in a radial electric field and axial magnetic field produced within the device. The electron sheath serves as a strong ionizing medium to gas introdueed thereto and also functions as an extremely effective heating mechanism to the resulting plasma. In addition, improved confinement of the plasma is obtained by ring magnetic mirror fields produced at the ends of the device. Such ring mirror fields are defined by the magnetic field lines at the ends of the device diverging radially outward from the axis of the device and thereafter converging at spatial annular surfaces disposed concentrically thereabout. (AFC)

  7. 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

  8. Device Performance

    SciTech Connect

    Not Available

    2006-06-01

    In the Device Performance group, within the National Center for Photovoltaic's Measurements and Characterization Division, we measure the performance of PV cells and modules with respect to standard reporting conditions--defined as a reference temperature (25 C), total irradiance (1000 Wm-2), and spectral irradiance distribution (IEC standard 60904-3). Typically, these are ''global'' reference conditions, but we can measure with respect to any reference set. To determine device performance, we conduct two general categories of measurements: spectral responsivity (SR) and current versus voltage (I-V). We usually perform these measurements using standard procedures, but we develop new procedures when required by new technologies. We also serve as an independent facility for verifying device performance for the entire PV community. We help the PV community solve its special measurement problems, giving advice on solar simulation, instrumentation for I-V measurements, reference cells, measurement procedures, and anomalous results. And we collaborate with researchers to analyze devices and materials.

  9. Device Demonstration

    DTIC Science & Technology

    2006-12-31

    effecting change in the electrical properties of the material. Due to the heating requirement in setting the state, stray radiation does not affect the...device as in traditional binary RAM, thus giving the device radiation-hard properties . Uniformity of the heater elements at a small size below 100 nm is...Molybdenum was chosen for the cathode tube material because it has a low sputtering coefficient, and it’s high temperature properties .. The tubes are

  10. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiation therapy simulation system. 892.5840... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy simulation system. (a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic...

  11. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiation therapy simulation system. 892.5840... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy simulation system. (a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic...

  12. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiation therapy simulation system. 892.5840... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy simulation system. (a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic...

  13. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiation therapy simulation system. 892.5840... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy simulation system. (a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic...

  14. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiation therapy simulation system. 892.5840... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy simulation system. (a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic...

  15. Analysis of different device-based intrathoracic impedance vectors for detection of heart failure events (from the Detect Fluid Early from Intrathoracic Impedance Monitoring study).

    PubMed

    Heist, E Kevin; Herre, John M; Binkley, Philip F; Van Bakel, Adrian B; Porterfield, James G; Porterfield, Linda M; Qu, Fujian; Turkel, Melanie; Pavri, Behzad B

    2014-10-15

    Detect Fluid Early from Intrathoracic Impedance Monitoring (DEFEAT-PE) is a prospective, multicenter study of multiple intrathoracic impedance vectors to detect pulmonary congestion (PC) events. Changes in intrathoracic impedance between the right ventricular (RV) coil and device can (RVcoil→Can) of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs (CRT-Ds) are used clinically for the detection of PC events, but other impedance vectors and algorithms have not been studied prospectively. An initial 75-patient study was used to derive optimal impedance vectors to detect PC events, with 2 vector combinations selected for prospective analysis in DEFEAT-PE (ICD vectors: RVring→Can + RVcoil→Can, detection threshold 13 days; CRT-D vectors: left ventricular ring→Can + RVcoil→Can, detection threshold 14 days). Impedance changes were considered true positive if detected <30 days before an adjudicated PC event. One hundred sixty-two patients were enrolled (80 with ICDs and 82 with CRT-Ds), all with ≥1 previous PC event. One hundred forty-four patients provided study data, with 214 patient-years of follow-up and 139 PC events. Sensitivity for PC events of the prespecified algorithms was as follows: ICD: sensitivity 32.3%, false-positive rate 1.28 per patient-year; CRT-D: sensitivity 32.4%, false-positive rate 1.66 per patient-year. An alternative algorithm, ultimately approved by the US Food and Drug Administration (RVring→Can + RVcoil→Can, detection threshold 14 days), resulted in (for all patients) sensitivity of 21.6% and a false-positive rate of 0.9 per patient-year. The CRT-D thoracic impedance vector algorithm selected in the derivation study was not superior to the ICD algorithm RVring→Can + RVcoil→Can when studied prospectively. In conclusion, to achieve an acceptably low false-positive rate, the intrathoracic impedance algorithms studied in DEFEAT-PE resulted in low sensitivity for the prediction of heart

  16. PLASMA DEVICE

    DOEpatents

    Baker, W.R.; Brathenahl, A.; Furth, H.P.

    1962-04-10

    A device for producing a confined high temperature plasma is described. In the device the concave inner surface of an outer annular electrode is disposed concentrically about and facing the convex outer face of an inner annular electrode across which electrodes a high potential is applied to produce an electric field there between. Means is provided to create a magnetic field perpendicular to the electric field and a gas is supplied at reduced pressure in the area therebetween. Upon application of the high potential, the gas between the electrodes is ionized, heated, and under the influence of the electric and magnetic fields there is produced a rotating annular plasma disk. The ionized plasma has high dielectric constant properties. The device is useful as a fast discharge rate capacitor, in controlled thermonuclear research, and other high temperature gas applications. (AEC)

  17. Electrooptical Devices

    DTIC Science & Technology

    1977-03-31

    LEXINGTON MASSACHUSETTS ABSTRACT The current objectives of the electrooptical device program are: (1) to perform life tests on GalnAsP/lnP double...DH GalnAsP/lnP lasers, operating contin- uously at room temperature, have been placed on life test . The first three devices, fabricated from one...on life tests of DH GalnAsP/lnP lasers. The first three lasers to be put on life test have been in continuous operation at room tempera- ture in an

  18. Therapeutic Devices for Epilepsy

    PubMed Central

    Fisher, Robert S.

    2011-01-01

    Therapeutic devices provide new options for treating drug-resistant epilepsy. These devices act by a variety of mechanisms to modulate neuronal activity. Only vagus nerve stimulation, which continues to develop new technology, is approved for use in the United States. Deep brain stimulation (DBS) of anterior thalamus for partial epilepsy recently was approved in Europe and several other countries. Responsive neurostimulation, which delivers stimuli to one or two seizure foci in response to a detected seizure, recently completed a successful multicenter trial. Several other trials of brain stimulation are in planning or underway. Transcutaneous magnetic stimulation (TMS) may provide a noninvasive method to stimulate cortex. Controlled studies of TMS split on efficacy, and may depend on whether a seizure focus is near a possible region for stimulation. Seizure detection devices in the form of “shake” detectors via portable accelerometers can provide notification of an ongoing tonic-clonic seizure, or peace of mind in the absence of notification. Prediction of seizures from various aspects of EEG is in early stages. Prediction appears to be possible in a subpopulation of people with refractory seizures and a clinical trial of an implantable prediction device is underway. Cooling of neocortex or hippocampus reversibly can attenuate epileptiform EEG activity and seizures, but engineering problems remain in its implementation. Optogenetics is a new technique that can control excitability of specific populations of neurons with light. Inhibition of epileptiform activity has been demonstrated in hippocampal slices, but use in humans will require more work. In general, devices provide useful palliation for otherwise uncontrollable seizures, but with a different risk profile than with most drugs. Optimizing the place of devices in therapy for epilepsy will require further development and clinical experience. PMID:22367987

  19. Pediatric ventricular assist devices

    PubMed Central

    Burki, Sarah; Zafar, Farhan; Morales, David Luis Simon

    2015-01-01

    The domain of pediatric ventricular assist device (VAD) has recently gained considerable attention. Despite the fact that, historically, the practice of pediatric mechanical circulatory support (MCS) has lagged behind that of adult patients, this gap between the two groups is narrowing. Currently, the Berlin EXCOR VAD is the only pediatric-specific durable VAD approved by the U.S Food and Drug Administration (FDA). The prospective Berlin Heart trial demonstrated a successful outcome, either bridge to transplantation (BTT), or in rare instances, bridge to recovery, in approximately 90% of children. Also noted during the trial was, however, a high incidence of adverse events such as embolic stroke, bleeding and infection. This has incentivized some pediatric centers to utilize adult implantable continuous-flow devices, for instance the HeartMate II and HeartWare HVAD, in children. As a result of this paradigm shift, the outlook of pediatric VAD support has dramatically changed: Treatment options previously unavailable to children, including outpatient management and even destination therapy, have now been becoming a reality. The sustained demand for continued device miniaturization and technological refinements is anticipated to extend the range of options available to children—HeartMate 3 and HeartWare MVAD are two examples of next generation VADs with potential pediatric application, both of which are presently undergoing clinical trials. A pediatric-specific continuous-flow device is also on the horizon: the redesigned Infant Jarvik VAD (Jarvik 2015) is undergoing pre-clinical testing, with a randomized clinical trial anticipated to follow thereafter. The era of pediatric VADs has begun. In this article, we discuss several important aspects of contemporary VAD therapy, with a particular focus on challenges unique to the pediatric population. PMID:26793341

  20. Detection device

    DOEpatents

    Smith, Jay E.

    1984-01-01

    The present invention is directed to a detection device comprising: (1) an entrance chamber, (2) a central chamber, and (3) an exit chamber. The central chamber includes an ionizing gas, anode, and means for connecting the anode with an external power supply and pulse counter.

  1. Detection device

    DOEpatents

    Smith, J.E.

    1981-02-27

    The present invention is directed to a detection device comprising: (1) an entrance chamber; (2) a central chamber; and (3) an exit chamber. The central chamber includes an ionizing gas, anode, and means for connecting the anode with an external power supply and pulse counter.

  2. Electrochemical device

    DOEpatents

    Grimes, Patrick G.; Einstein, Harry; Bellows, Richard J.

    1988-01-12

    A tunnel protected electrochemical device features channels fluidically communicating between manifold, tunnels and cells. The channels are designed to provide the most efficient use of auxiliary power. The channels have a greater hydraulic pressure drop and electrical resistance than the manifold. This will provide a design with the optimum auxiliary energy requirements.

  3. Cleaning devices

    NASA Technical Reports Server (NTRS)

    Schneider, Horst W. (Inventor)

    1981-01-01

    Cleaning devices are described which include a vacuum cleaner nozzle with a sharp rim for directing incoming air down against the floor; a vacuum cleaner wherein electrostatically charged brushes that brush dirt off a floor, are electrically grounded to remove charges that could tend to hold dirt to the brushes; a vacuum cleaner head having slots that form a pair of counter-rotating vortices, and that includes an outlet that blows a stream of air at the floor region which lies between the vortices; a cleaning device that sweeps a group of brushes against the ground along a first direction, and then sweeps them along the same ground area but in a second direction angled from the first by an amount such as 90.degree., to sweep up particles lying in crevices extending along any direction; a device that gently cleans a surface to remove bacteria for analysis, including an inclined wall along which cleaning fluid flows onto the surface, a vacuum chamber for drawing in the cleaning fluid, and a dividing wall spaced slightly from the surface to separate the fluid source from the vacuum cleaner chamber; and a device for providing pulses of pressured air including a chamber to which pressured air is supplied, a ball that circulates around the chamber to repeatedly close an outlet, and an air source that directs air circumferentially to move the ball around the chamber.

  4. [Intrauterine devices].

    PubMed

    Delavest, P; Engelmann, P

    1980-12-11

    Medicated IUDs such as copper IUDs and progesterone-releasing IUDs represent a new development in this form of contraception. All IUDs act by causing an inflammatory reaction at the endometrial level. Techniques of insertion vary from one model to the other; insertion always requires an experienced practitioner, and postabortion or midmenstruation insertions are to be preferred. Pregnancy with IUD in situ is a rare occurrence; the IUD must then be immediately removed. Ectopic pregnancies are about 5-10% of all pregnancies with the device in situ. IUD complications are uterine perforation, mostly done at time of insertion, and pelvic infection which, if untreated, can cause infertility; this is the reason why an IUD is never recommended to a nullipara. Pain and bleeding are the most common side effects. When the strings of the device are not visible, translocation of the device inside the uterine cavity must be suspected. The choice of the wrong type of IUD or a bad insertion can cause spontaneous expulsion of the device. IUD wearers must be regularly seen by a doctor; there is no correlation between IUD use and cervical or endometrial carcinoma.

  5. 21 CFR 892.5710 - Radiation therapy beam-shaping block.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiation therapy beam-shaping block. 892.5710... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy beam-shaping block. (a) Identification. A radiation therapy beam-shaping block is a device made of a...

  6. 21 CFR 892.5710 - Radiation therapy beam-shaping block.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiation therapy beam-shaping block. 892.5710... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy beam-shaping block. (a) Identification. A radiation therapy beam-shaping block is a device made of a...

  7. 21 CFR 892.5900 - X-ray radiation therapy system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false X-ray radiation therapy system. 892.5900 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5900 X-ray radiation therapy system. (a) Identification. An x-ray radiation therapy system is a device intended to produce and control...

  8. 21 CFR 892.5900 - X-ray radiation therapy system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false X-ray radiation therapy system. 892.5900 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5900 X-ray radiation therapy system. (a) Identification. An x-ray radiation therapy system is a device intended to produce and control...

  9. 21 CFR 892.5710 - Radiation therapy beam-shaping block.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiation therapy beam-shaping block. 892.5710... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy beam-shaping block. (a) Identification. A radiation therapy beam-shaping block is a device made of a...

  10. 21 CFR 892.5900 - X-ray radiation therapy system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false X-ray radiation therapy system. 892.5900 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5900 X-ray radiation therapy system. (a) Identification. An x-ray radiation therapy system is a device intended to produce and control...

  11. 21 CFR 892.5710 - Radiation therapy beam-shaping block.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiation therapy beam-shaping block. 892.5710... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy beam-shaping block. (a) Identification. A radiation therapy beam-shaping block is a device made of a...

  12. 21 CFR 892.5900 - X-ray radiation therapy system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false X-ray radiation therapy system. 892.5900 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5900 X-ray radiation therapy system. (a) Identification. An x-ray radiation therapy system is a device intended to produce and control...

  13. 21 CFR 892.5900 - X-ray radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false X-ray radiation therapy system. 892.5900 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5900 X-ray radiation therapy system. (a) Identification. An x-ray radiation therapy system is a device intended to produce and control...

  14. 21 CFR 892.5710 - Radiation therapy beam-shaping block.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiation therapy beam-shaping block. 892.5710... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy beam-shaping block. (a) Identification. A radiation therapy beam-shaping block is a device made of a...

  15. LOADING DEVICE

    DOEpatents

    Ohlinger, L.A.

    1958-10-01

    A device is presented for loading or charging bodies of fissionable material into a reactor. This device consists of a car, mounted on tracks, into which the fissionable materials may be placed at a remote area, transported to the reactor, and inserted without danger to the operating personnel. The car has mounted on it a heavily shielded magazine for holding a number of the radioactive bodies. The magazine is of a U-shaped configuration and is inclined to the horizontal plane, with a cap covering the elevated open end, and a remotely operated plunger at the lower, closed end. After the fissionable bodies are loaded in the magazine and transported to the reactor, the plunger inserts the body at the lower end of the magazine into the reactor, then is withdrawn, thereby allowing gravity to roll the remaining bodies into position for successive loading in a similar manner.

  16. Laser device

    DOEpatents

    Scott, Jill R.; Tremblay, Paul L.

    2008-08-19

    A laser device includes a virtual source configured to aim laser energy that originates from a true source. The virtual source has a vertical rotational axis during vertical motion of the virtual source and the vertical axis passes through an exit point from which the laser energy emanates independent of virtual source position. The emanating laser energy is collinear with an orientation line. The laser device includes a virtual source manipulation mechanism that positions the virtual source. The manipulation mechanism has a center of lateral pivot approximately coincident with a lateral index and a center of vertical pivot approximately coincident with a vertical index. The vertical index and lateral index intersect at an index origin. The virtual source and manipulation mechanism auto align the orientation line through the index origin during virtual source motion.

  17. Electrooptical Devices.

    DTIC Science & Technology

    1980-03-31

    Si N ’or Pl. The surface-related nature of the leakage currents was confirmed by testing the uncoated devices in several gaseous environments (O, NH ...later- tinre. Z-I.. Liau D. E. Mull .1. J. Ilsiebl J. N. Walpole T. A. Lind 711 G&InkA.P/ p I 643 6-C Fig. IV- t. Intensity distribution of an X-ray beam

  18. Closure device

    SciTech Connect

    Sable, D. E.

    1985-06-11

    A closure device connectible to a well head through which the polished rod of a rod string extends into a well tubing for operating pump means for moving well fluids to a surface flow conductor, the closure device having a tubular ram provided with a packing or plug for closing an annular passage between the polished rod and a tubular body connected to the well head above a lateral port of the tubular body, the tubular ram and the tubular body having thread means for moving the plug between an operative lower position wherein it closes the annular passage when the rod string is stationary and on inoperative upper position; seal means between the ram and the polished rod spaced above the plug; and a plurality of independent seal means between the ram and the tubular body operative when the plug is in its inoperative position. The plug of the closure device is especially adapted to operate under high temperature and pressure conditions of the well, as during steam injection operations when the rod string is stationary, to protect the seal means from high pressures and temperatures as well as any fluids which may be corrosive or otherwise deleterious to the substance of which the seal means are made.

  19. Medical Device Safety

    MedlinePlus

    ... Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing options ... 17 More Medical Device Recalls Recent Medical Device Safety Communications FDA analyses and recommendations for patients and ...

  20. External incontinence devices

    MedlinePlus

    ... devices; Urinary incontinence - devices; Fecal incontinence - devices; Stool incontinence - devices ... of these different products are listed below. FECAL INCONTINENCE DEVICES There are many types of products for managing long-term diarrhea or fecal incontinence . ...

  1. [Cardiac contractility modulation. A new form of therapy for patients with heart failure and narrow QRS complex?].

    PubMed

    Kleemann, T

    2015-11-01

    Cardiac contractility modulation (CCM) is a stimulation therapy by an implantable impulse generator, which enhances ventricular contractile performance by delivering CCM impulses to the right ventricle during the absolute refractory period. The CCM signals mediate increased inotropy by prolonging the duration of the action potential, which leads to an enhanced influx of calcium into cardiomyocytes and a greater release of calcium by the sarcoplasmic reticulum. The increase of cardiac contractility is not associated with increased oxygen consumption. Several small studies have shown that CCM therapy can safely improve symptoms of heart failure and peak oxygen consumption in patients with moderate to severe heart failure who are not eligible for resynchronization therapy. Therefore, CCM is a novel potential therapy for patients with heart failure, an ejection fraction ≤ 35 % and a normal QRS duration < 130 ms. However, apart from selecting appropriate patients for CCM therapy there are still unanswered questions, such as the impact of CCM therapy on established clinical endpoints. At present no data are available which have shown that CCM therapy leads to reduction of hospitalization for heart failure or mortality.

  2. Mechanical circulatory devices in acute heart failure.

    PubMed

    Teuteberg, Jeffrey J; Chou, Josephine C

    2014-07-01

    Cardiogenic shock remains a leading cause of mortality despite advances in the treatment of myocardial infarction and advanced heart failure. Medical therapy can be inadequate, and patients may need mechanical circulatory support (MCS). The proper application of MCS requires knowledge of the underlying cause of acute heart failure, familiarity with the circulatory support devices, and the potential benefits and limitations of device therapy. This article describes the most commonly used temporary ventricular assist devices and their use in the various causes of cardiogenic shock.

  3. Electrochromic device

    SciTech Connect

    Schwendemanm, Irina G; Polcyn, Adam D; Finley, James J; Boykin, Cheri M; Knowles, Julianna M

    2011-03-15

    An electrochromic device includes a first substrate spaced from a second substrate. A first conductive member is formed over at least a portion of the first substrate. A first electrochromic material is formed over at least a portion of the first conductive member. The first electrochromic material includes an organic material. A second conductive member is formed over at least a portion of the second substrate. A second electrochromic material is formed over at least a portion of the second conductive member. The second electrochromic material includes an inorganic material. An ionic liquid is positioned between the first electrochromic material and the second electrochromic material.

  4. Device Connectivity

    PubMed Central

    Walsh, John; Roberts, Ruth; Morris, Richard

    2015-01-01

    Patients with diabetes have to take numerous factors/data into their therapeutic decisions in daily life. Connecting the devices they are using by feeding the data generated into a database/app is supposed to help patients to optimize their glycemic control. As this is not established in practice, the different roadblocks have to be discussed to open the road. That large telecommunication companies are now entering this market might be a big help in pushing this forward. Smartphones offer an ideal platform for connectivity solutions. PMID:25614015

  5. Electrooptical Devices.

    DTIC Science & Technology

    1984-09-30

    Table 1-1 10 II-5 Calculated Ij as a Function of the Cap p-Doping 12 III-1 L-I Characteristics of the Five Mass-Transported BH Lasers with Different...343, a = 5.0 /im, W = 1.5 nmy and b = 2.0 pm 9 vni ELECTROOPTICAL DEVICES I. NEW DEVELOPMENTS IN MASS-TRANSPORTED GalnAsP/InP BURIED...HETEROSTRUCTURE LASERS As a potentially very important class of sources in fiber optical communication and inte- grated optics, GalnAsP/InP buried

  6. Electrospray device

    NASA Technical Reports Server (NTRS)

    Demmons, Nathaniel (Inventor); Martin, Roy (Inventor); Hruby, Vladimir (Inventor); Roy, Thomas (Inventor); Spence, Douglas (Inventor); Ehrbar, Eric (Inventor); Zwahlen, Jurg (Inventor)

    2011-01-01

    An electrospray device includes an electrospray emitter adapted to receive electrospray fluid; an extractor plate spaced from the electrospray emitter and having at least one aperture; and a power supply for applying a first voltage between the extractor plate and emitter for generating at least one Taylor cone emission through the aperture to create an electrospray plume from the electrospray fluid, the extractor plate as well as accelerator and shaping plates may include a porous, conductive medium for transporting and storing excess, accumulated electrospray fluid away from the aperture.

  7. Diversionary device

    DOEpatents

    Grubelich, Mark C.

    2001-01-01

    A diversionary device has a housing having at least one opening and containing a non-explosive propellant and a quantity of fine powder packed within the housing, with the powder being located between the propellant and the opening. When the propellant is activated, it has sufficient energy to propel the powder through the opening to produce a cloud of powder outside the housing. An igniter is also provided for igniting the cloud of powder to create a diversionary flash and bang, but at a low enough pressure to avoid injuring nearby people.

  8. OLED devices

    SciTech Connect

    Sapochak, Linda Susan; Burrows, Paul Edward; Bimalchandra, Asanga

    2011-02-22

    An OLED device having an emission layer formed of an ambipolar phosphine oxide host material and a dopant, a hole transport layer in electrical communication with an anode, an electron transport layer in communication with a cathode, wherein the HOMO energy of the hole transport layer is substantially the same as the HOMO energy of the ambipolar host in the emission layer, and the LUMO energy of the electron transport layer is substantially the same as the LUMO energy of the ambipolar host in the emission layer.

  9. Cooling device

    SciTech Connect

    Teske, L.

    1984-02-21

    A cooling device is claimed for coal dust comprising a housing, a motor-driven conveyor system therein to transport the coal dust over coolable trays in the housing and conveyor-wheel arms of spiral curvature for moving the coal dust from one or more inlets to one or more outlets via a series of communicating passages in the trays over which the conveyor-wheel arms pass under actuation of a hydraulic motor mounted above the housing and driving a vertical shaft, to which the conveyor-wheel arms are attached, extending centrally downwardly through the housing.

  10. Electroexplosive device

    NASA Technical Reports Server (NTRS)

    Menichelli, V. J. (Inventor)

    1978-01-01

    An electroexplosive device is presented which employs a header having contact pins hermetically sealed with glass passing through from a connector end of the header to a cavity filled with a shunt layer of a new nonlinear resistive composition and a heat-sink layer of a new dielectric composition having good thermal conductivity and capacity. The nonlinear resistive layer and the heat-sink layer are prepared from materials by mixing with a low temperature polymerizing resin. The resin is dissolved in a suitable solvent and later evaporated. The resultant solid composite is ground into a powder, press formed into the header and cured (polymerized) at about 250 to 300 F.

  11. Biocompatibility of implantable biomedical devices

    NASA Astrophysics Data System (ADS)

    Lyu, Suping

    2008-03-01

    Biomedical devices have been broadly used to treat human disease, especially chronic diseases where pharmaceuticals are less effective. Heart valve and artificial joint are examples. Biomedical devices perform by delivering therapies such as electric stimulations, mechanical supports and biological actions. While the uses of biomedical devices are highly successful they can trigger adverse biological reactions as well. The property that medical devices perform with intended functions but not causing unacceptable adverse effects was called biocompatibility in the early time. As our understanding of biomaterial-biological interactions getting broader, biocompatibility has more meanings. In this talk, I will present some adverse biological reactions observed with implantable biomedical devices. Among them are surface fouling of implantable sensors, calcification with vascular devices, restenosis with stents, foreign particle migration and mechanical fractures of devices due to inflammation reactions. While these effects are repeatable, there are very few quantitative data and theories to define them. The purpose of this presentation is to introduce this biocompatibility concept to biophysicists to stimulate research interests at different angles. An open question is how to quantitatively understand the biocompatibility that, like many other biological processes, has not been quantified experimentally.

  12. Striding Towards Better Physical Therapy

    NASA Technical Reports Server (NTRS)

    2003-01-01

    This paper presents a discussion on a new rehabilitative device that promises to improve physical therapy for patients working to regain the ability to walk after facing traumatic injuries or a degenerative illness. Produced by Enduro Medical Technology, of East Hartford, Connecticut, the Secure Ambulation Module (S.A.M.) creates a stable and secure environment for patients as they stand during ambulation therapy.

  13. CLOSURE DEVICE

    DOEpatents

    Linzell, S.M.; Dorcy, D.J.

    1958-08-26

    A quick opening type of stuffing box employing two banks of rotatable shoes, each of which has a caraming action that forces a neoprene sealing surface against a pipe or rod where it passes through a wall is presented. A ring having a handle or wrench attached is placed eccentric to and between the two banks of shoes. Head bolts from the shoes fit into slots in this ring, which are so arranged that when the ring is rotated a quarter turn in one direction the shoes are thrust inwardly to cramp the neopnrene about the pipe, malting a tight seal. Moving the ring in the reverse direction moves the shoes outwardly and frees the pipe which then may be readily removed from the stuffing box. This device has particular application as a closure for the end of a coolant tube of a neutronic reactor.

  14. Optoelectronic device

    DOEpatents

    Bonekamp, Jeffrey E.; Boven, Michelle L.; Gaston, Ryan S.

    2014-09-09

    The invention is an optoelectronic device comprising an active portion which converts light to electricity or converts electricity to light, the active portion having a front side for the transmittal of the light and a back side opposite from the front side, at least two electrical leads to the active portion to convey electricity to or from the active portion, an enclosure surrounding the active portion and through which the at least two electrical leads pass wherein the hermetically sealed enclosure comprises at the front side of the active portion a barrier material which allows for transmittal of light, one or more getter materials disposed so as to not impede the transmission of light to or from the active portion, and a contiguous gap pathway to the getter material which pathway is disposed between the active portion and the barrier material.

  15. PLASMA DEVICE

    DOEpatents

    Baker, W.R.

    1961-08-22

    A device is described for establishing and maintaining a high-energy, rotational plasma for use as a fast discharge capacitor. A disc-shaped, current- conducting plasma is formed in an axinl magnetic field and a crossed electric field, thereby creating rotational kinetic enengy in the plasma. Such energy stored in the rotation of the plasma disc is substantial and is convertible tc electrical energy by generator action in an output line electrically coupled to the plasma volume. Means are then provided for discharging the electrical energy into an external circuit coupled to the output line to produce a very large pulse having an extremely rapid rise time in the waveform thereof. (AE C)

  16. Electrophoresis device

    NASA Technical Reports Server (NTRS)

    Rhodes, P. H.; Snyder, R. S. (Inventor)

    1982-01-01

    A device for separating cellular particles of a sample substance into fractionated streams of different cellular species includes a casing having a distribution chamber, a separation chamber, and a collection chamber. The electrode chambers are separated from the separation chamber interior by means of passages such that flow variations and membrane variations around the slotted portion of the electrode chamber do not enduce flow perturbations into the laminar buffer curtain flowing in the separation chamber. The cellular particles of the sample are separated under the influence of the electrical field and the separation chamber into streams of different cellular species. The streams of separated cells enter a partition array in the collection chamber where they are fractionated and collected.

  17. Are ventricular assist devices underutilized?

    PubMed

    Boyle, Andrew J

    2010-07-01

    A dramatic shift in the durability and reliability of ventricular assist device (VAD) therapy is taking hold due to the newer generations of continuous flow VADs that are either in clinical trials or under consideration by the Food and Drug Administration (FDA) for commercial approval. To expand the pool of potential mechanical circulatory support (MCS) patients, device reliability will need to prove to be greatly enhanced over previous generations of VADs and functional capacity and quality of life will need to improve substantially over baseline. Improved patient selection should have the simultaneously beneficial effects of improving outcomes while expanding the MCS patient population. The critical factors determining the likelihood of expansion of the MCS field include, but are not limited to, improvements in technology and its reliability, training and education of all advanced heart failure caregivers, improving availability of MCS geographically, and a shift in patient selection to a population more likely to benefit from MCS therapy.

  18. Integrated device architectures for electrochromic devices

    DOEpatents

    Frey, Jonathan Mack; Berland, Brian Spencer

    2015-04-21

    This disclosure describes systems and methods for creating monolithically integrated electrochromic devices which may be a flexible electrochromic device. Monolithic integration of thin film electrochromic devices may involve the electrical interconnection of multiple individual electrochromic devices through the creation of specific structures such as conductive pathway or insulating isolation trenches.

  19. Laser device

    DOEpatents

    Scott, Jill R.; Tremblay, Paul L.

    2007-07-10

    A laser device includes a target position, an optical component separated a distance J from the target position, and a laser energy source separated a distance H from the optical component, distance H being greater than distance J. A laser source manipulation mechanism exhibits a mechanical resolution of positioning the laser source. The mechanical resolution is less than a spatial resolution of laser energy at the target position as directed through the optical component. A vertical and a lateral index that intersect at an origin can be defined for the optical component. The manipulation mechanism can auto align laser aim through the origin during laser source motion. The laser source manipulation mechanism can include a mechanical index. The mechanical index can include a pivot point for laser source lateral motion and a reference point for laser source vertical motion. The target position can be located within an adverse environment including at least one of a high magnetic field, a vacuum system, a high pressure system, and a hazardous zone. The laser source and an electro-mechanical part of the manipulation mechanism can be located outside the adverse environment. The manipulation mechanism can include a Peaucellier linkage.

  20. Laser device

    DOEpatents

    Scott, Jill R.; Tremblay, Paul L.

    2004-11-23

    A laser device includes a target position, an optical component separated a distance J from the target position, and a laser energy source separated a distance H from the optical component, distance H being greater than distance J. A laser source manipulation mechanism exhibits a mechanical resolution of positioning the laser source. The mechanical resolution is less than a spatial resolution of laser energy at the target position as directed through the optical component. A vertical and a lateral index that intersect at an origin can be defined for the optical component. The manipulation mechanism can auto align laser aim through the origin during laser source motion. The laser source manipulation mechanism can include a mechanical index. The mechanical index can include a pivot point for laser source lateral motion and a reference point for laser source vertical motion. The target position can be located within an adverse environment including at least one of a high magnetic field, a vacuum system, a high pressure system, and a hazardous zone. The laser source and an electro-mechanical part of the manipulation mechanism can be located outside the adverse environment. The manipulation mechanism can include a Peaucellier linkage.

  1. Family Therapy

    MedlinePlus

    Tests and Procedures Family therapy By Mayo Clinic Staff Family therapy is a type of psychological counseling (psychotherapy) that helps family members improve communication and resolve conflicts. Family therapy is usually provided ...

  2. Radiation Therapy

    MedlinePlus

    ... Loss Surgery? A Week of Healthy Breakfasts Shyness Radiation Therapy KidsHealth > For Teens > Radiation Therapy A A ... how to cope with side effects. What Is Radiation Therapy? Cancer is a disease that causes cells ...

  3. [Compression therapy in leg ulcers].

    PubMed

    Dissemond, J; Protz, K; Reich-Schupke, S; Stücker, M; Kröger, K

    2016-04-01

    Compression therapy is well-tried treatment with only few side effects for most patients with leg ulcers and/or edema. Despite the very long tradition in German-speaking countries and good evidence for compression therapy in different indications, recent scientific findings indicate that the current situation in Germany is unsatisfactory. Today, compression therapy can be performed with very different materials and systems. In addition to the traditional bandaging with Unna Boot, short-stretch, long-stretch, or multicomponent bandage systems, medical compression ulcer stockings are available. Other very effective but far less common alternatives are velcro wrap systems. When planning compression therapy, it is also important to consider donning devices with the patient. In addition to compression therapy, intermittent pneumatic compression therapy can be used. Through these various treatment options, it is now possible to develop an individually accepted, geared to the needs of the patients, and functional therapy strategy for nearly all patients with leg ulcers.

  4. Medical devices: US medical device regulation.

    PubMed

    Jarow, Jonathan P; Baxley, John H

    2015-03-01

    Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. It does not regulate the practice of medicine. Devices are classified based on complexity and level of risk, and "pre-1976" devices were allowed to remain on the market after being classified without FDA review. Post-1976 devices of lower complexity and risk that are substantially equivalent to a marketed "predicate" device may be cleared through the 510(k) premarket notification process. Clinical data are typically not needed for 510(k) clearance. In contrast, higher-risk devices typically require premarket approval. Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation.

  5. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  6. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  7. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  8. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  9. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  10. Thermoelectric device for treatment of radiculitis and spinal massage

    NASA Astrophysics Data System (ADS)

    Anatychuk, L. I.; Kobylyansky, R. R.

    2012-06-01

    Results of development of a thermoelectric device that enables controlled cyclic temperature impact on the damaged area of human organism are presented. Unlike the existing medical devices employing direct supply current for thermoelectric module, the present device controls supply current according to time dependence of temperature change assigned by doctor. It is established that such a device is an efficient means of therapy at herniation of intervertebral disks with marked radiculitis and tunicary syndromes, at meningitis, other spinal diseases and back traumas.

  11. Toward biomaterial-based implantable photonic devices

    NASA Astrophysics Data System (ADS)

    Humar, Matjaž; Kwok, Sheldon J. J.; Choi, Myunghwan; Yetisen, Ali K.; Cho, Sangyeon; Yun, Seok-Hyun

    2017-03-01

    Optical technologies are essential for the rapid and efficient delivery of health care to patients. Efforts have begun to implement these technologies in miniature devices that are implantable in patients for continuous or chronic uses. In this review, we discuss guidelines for biomaterials suitable for use in vivo. Basic optical functions such as focusing, reflection, and diffraction have been realized with biopolymers. Biocompatible optical fibers can deliver sensing or therapeutic-inducing light into tissues and enable optical communications with implanted photonic devices. Wirelessly powered, light-emitting diodes (LEDs) and miniature lasers made of biocompatible materials may offer new approaches in optical sensing and therapy. Advances in biotechnologies, such as optogenetics, enable more sophisticated photonic devices with a high level of integration with neurological or physiological circuits. With further innovations and translational development, implantable photonic devices offer a pathway to improve health monitoring, diagnostics, and light-activated therapies.

  12. The oxygen therapy.

    PubMed

    Corsonello, A; Pedone, C; Scarlata, S; Zito, A; Laino, I; Antonelli-Incalzi, R

    2013-01-01

    Oxygen (O(2)) is a vital element. Shortage of O(2) results in deranged metabolism and important changes in vascular tone with opposite effects on the systemic and pulmonary circulation. During hypoxemia, oxidative stress exposes the organism to a sort of accelerated senescence as well as to several acute untoward effects. Thus, hypoxemia should be promptly recognized and treated, hopefully by measures tailored to the pathophysiological mechanisms underlying hypoxemia. However, O(2) therapy remains the most common therapy of hypoxemia, but it must be carefully tailored to relieve hypoxemia without provoking hyperoxia or hypercarbia. Then, the individual response to O(2) as well as changing needs of O(2) during sleep or exercise must be evaluated to provide the best O(2) therapy. Hyperoxia, the effect of overcorrection of hypoxia, can dramatically impact the health status and threaten the survival of the newborn and, through different mechanisms and effects, the adult. A thorough knowledge of the pathophysiological bases of hypoxemia and O(2) storage and delivery devices is then mandatory to administer O(2) therapy guaranteeing for optimal correction of hypoxemia and minimizing the risk of hyperoxia. Consistent with this aim also is a careful scrutiny of instruments and procedures for monitoring the individual response to O(2) over time. Thus, at variance from classical pharmacological therapy, performing O(2) therapy requires a vast array of clinical and technical competences. The optimal integration of these competences is needed to optimize O(2) therapy on individual bases.

  13. Connector device for building integrated photovoltaic device

    DOEpatents

    Keenihan, James R.; Langmaid, Joe A.; Eurich, Gerald K.; Lesniak, Michael J.; Mazor, Michael H.; Cleerman, Robert J.; Gaston, Ryan S.

    2015-11-10

    The present invention is premised upon a connector device and method that can more easily electrically connect a plurality of PV devices or photovoltaic system components and/or locate these devices/components upon a building structure. It also may optionally provide some additional sub-components (e.g. at least one bypass diode and/or an indicator means) and may enhance the serviceability of the device.

  14. Connector device for building integrated photovoltaic device

    DOEpatents

    Keenihan, James R.; Langmaid, Joseph A.; Eurich, Gerald K.; Lesniak, Michael J.; Mazor, Michael H.; Cleereman, Robert J.; Gaston, Ryan S.

    2014-06-03

    The present invention is premised upon a connector device and method that can more easily electrically connect a plurality of PV devices or photovoltaic system components and/or locate these devices/components upon a building structure. It also may optionally provide some additional sub-components (e.g. at least one bypass diode and/or an indicator means) and may enhance the serviceability of the device.

  15. Reuse of pacemakers, defibrillators and cardiac resynchronisation devices

    PubMed Central

    Sakthivel, R; Satheesh, Santhosh; Ananthakrishna Pillai, Ajith; Sagnol, Pascal; Jouven, Xavier; Dodinot, Bernard; Balachander, Jayaraman

    2017-01-01

    Objective Access to pacemakers remains poor among many patients in low/middle-income countries. Reuse of explanted pacemakers is a possible solution, but is still not widespread because of concerns regarding outcomes, especially infection. Our objective was to study early outcomes with implants using reused devices and compare them with those with implants using new devices. Methods We studied all patients who underwent implantation of a new or reused pacemaker, cardiac resynchronisation therapy (CRT) device or implantable cardioverter defibrillator (ICD) in the last 5 years at a single institution. We analysed outcomes related to infection, device malfunction and device-related death within 6 months after initial implantation. Results During the study period, 887 patients underwent device implant, including 127 CRT devices or ICDs. Of these, 260 devices (29.3%) were reused and the others were new. At 6 months, there were three device-related infections in implants using a new device. There were no infections among patients receiving a reused device. There were no device malfunctions or device-related deaths in either group. Conclusions We found no difference in rate of infection or device malfunction among patients getting a reused device as compared with those with a new device. This study reinforces the safety of reusing devices for implant including CRT and ICDs. PMID:28176981

  16. Virtual reality exposure therapy.

    PubMed

    Rothbaum, B O; Hodges, L; Kooper, R

    1997-01-01

    It has been proposed that virtual reality (VR) exposure may be an alternative to standard in vivo exposure. Virtual reality integrates real-time computer graphics, body tracking devices, visual displays, and other sensory input devices to immerse a participant in a computer-generated virtual environment. Virtual reality exposure is potentially an efficient and cost-effective treatment of anxiety disorders. VR exposure therapy reduced the fear of heights in the first controlled study of virtual reality in treatment of a psychiatric disorder. A case study supported the efficacy of VR exposure therapy for the fear of flying. The potential for virtual reality exposure treatment for these and other disorders is explored, and therapeutic issues surrounding the delivery of VR exposure are discussed.

  17. Medical Device Safety

    MedlinePlus

    A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range ... may need one in a hospital. To use medical devices safely Know how your device works. Keep instructions ...

  18. CONTROL LIMITER DEVICE

    DOEpatents

    DeShong, J.A.

    1960-03-01

    A control-limiting device for monltoring a control system is described. The system comprises a conditionsensing device, a condition-varying device exerting a control over the condition, and a control means to actuate the condition-varying device. A control-limiting device integrates the total movement or other change of the condition-varying device over any interval of time during a continuum of overlapping periods of time, and if the tothl movement or change of the condition-varying device exceeds a preset value, the control- limiting device will switch the control of the operated apparatus from automatic to manual control.

  19. Radial Shock Wave Devices Generate Cavitation

    PubMed Central

    Császár, Nikolaus B. M.; Angstman, Nicholas B.; Milz, Stefan; Sprecher, Christoph M.; Kobel, Philippe; Farhat, Mohamed; Furia, John P.; Schmitz, Christoph

    2015-01-01

    Background Conflicting reports in the literature have raised the question whether radial extracorporeal shock wave therapy (rESWT) devices and vibrating massage devices have similar energy signatures and, hence, cause similar bioeffects in treated tissues. Methods and Findings We used laser fiber optic probe hydrophone (FOPH) measurements, high-speed imaging and x-ray film analysis to compare fundamental elements of the energy signatures of two rESWT devices (Swiss DolorClast; Electro Medical Systems, Nyon, Switzerland; D-Actor 200; Storz Medical, Tägerwillen, Switzerland) and a vibrating massage device (Vibracare; G5/General Physiotherapy, Inc., Earth City, MO, USA). To assert potential bioeffects of these treatment modalities we investigated the influence of rESWT and vibrating massage devices on locomotion ability of Caenorhabditis elegans (C. elegans) worms. Results FOPH measurements demonstrated that both rESWT devices generated acoustic waves with comparable pressure and energy flux density. Furthermore, both rESWT devices generated cavitation as evidenced by high-speed imaging and caused mechanical damage on the surface of x-ray film. The vibrating massage device did not show any of these characteristics. Moreover, locomotion ability of C. elegans was statistically significantly impaired after exposure to radial extracorporeal shock waves but was unaffected after exposure of worms to the vibrating massage device. Conclusions The results of the present study indicate that both energy signature and bioeffects of rESWT devices are fundamentally different from those of vibrating massage devices. Clinical Relevance Prior ESWT studies have shown that tissues treated with sufficient quantities of acoustic sound waves undergo cavitation build-up, mechanotransduction, and ultimately, a biological alteration that “kick-starts” the healing response. Due to their different treatment indications and contra-indications rESWT devices cannot be equated to vibrating

  20. Biofilms in device-related infections.

    PubMed

    Khardori, N; Yassien, M

    1995-09-01

    The use of various medical devices including indwelling vascular catheters, cardiac pacemakers, prosthetic heart valves, chronic ambulatory peritoneal dialysis catheters and prosthetic joints has greatly facilitated the management of serious medical and surgical illness. However, the successful development of synthetic materials and introduction of these artificial devices into various body systems has been accompanied by the ability of microorganism to adhere to these devices in the environment of biofilms that protect them from the activity of antimicrobial agents and from host defense mechanisms. A number of host, biomaterial and microbial factors are unique to the initiation, persistence and treatment failures of device-related infections. Intravascular catheters are the most common devices used in clinical practice and interactions associated with these devices are the leading cause of nosocomial bacteremias. The infections associated with these devices include insertion site infection, septic thrombophlebitis, septicemia, endocarditis and metastatic abscesses. Other important device-related infections include infections of vascular prostheses, intracardiac prostheses, total artificial hearts, indwelling urinary catheters, orthopedic prostheses, endotracheal tubes and extended wear lenses. The diagnosis and management of biofilm-associated infections remain difficult but critical issues. Appropriate antimicrobial therapy is often not effective in eradicating these infections and the removal of the device becomes necessary. Several improved diagnostic and therapeutic modalities have been reported in recent experimental studies. The clinical usefulness of these strategies remains to be determined.

  1. Radiation therapy

    MedlinePlus

    ... Intensity-modulated radiotherapy (IMRT) Image-guided radiotherapy (IGRT) Proton therapy is another kind of radiation used to ... than using x-rays to destroy cancer cells, proton therapy uses a beam of special particles called ...

  2. Alternative Therapies

    MedlinePlus

    ... Late Effects of Poliomyelitis for Physicians and Survivors © Alternative Therapies Alternative therapies, also called complementary, can support ... of motion, pain, and fatigue are often reported. Energy work includes acupuncture and acupressure, traditional Chinese medicine ...

  3. Evolution of penile prosthetic devices

    PubMed Central

    Burnett, Arthur L.

    2015-01-01

    Penile implant usage dates to the 16th century yet penile implants to treat erectile dysfunction did not occur until nearly four centuries later. The modern era of penile implants has progressed rapidly over the past 50 years as physicians' knowledge of effective materials for penile prostheses and surgical techniques has improved. Herein, we describe the history of penile prosthetics and the constant quest to improve the technology. Elements of the design from the first inflatable penile prosthesis by Scott and colleagues and the Small-Carrion malleable penile prosthesis are still found in present iterations of these devices. While there have been significant improvements in penile prosthesis design, the promise of an ideal prosthetic device remains elusive. As other erectile dysfunction therapies emerge, penile prostheses will have to continue to demonstrate a competitive advantage. A particular strength of penile prostheses is their efficacy regardless of etiology, thus allowing treatment of even the most refractory cases. PMID:25763121

  4. Implantable CMOS Biomedical Devices

    PubMed Central

    Ohta, Jun; Tokuda, Takashi; Sasagawa, Kiyotaka; Noda, Toshihiko

    2009-01-01

    The results of recent research on our implantable CMOS biomedical devices are reviewed. Topics include retinal prosthesis devices and deep-brain implantation devices for small animals. Fundamental device structures and characteristics as well as in vivo experiments are presented. PMID:22291554

  5. Play Therapy

    PubMed Central

    Kool, Ritesh

    2010-01-01

    Play therapy represents a unique form of treatment that is not only geared toward young children, but is translated into a language children can comprehend and utilize—the language of play. For the referring provider or practitioner, questions may remain regarding the nature, course, and efficacy of play therapy. This article reviews the theoretical underpinnings of play therapy, some practical considerations, and finally a summary of the current state of research in regard to play therapy. The authors present the practicing psychiatrist with a road map for referring a patient to play therapy or initiating it in appropriate cases. PMID:21103141

  6. What Is Music Therapy?

    MedlinePlus

    American Music Therapy Association Home Contact News Help/FAQ Members Only Login About Music Therapy & AMTA What is Music Therapy? Definition and ... is Music Therapy? Print Email Share What is Music Therapy What is Music Therapy? Music Therapy is ...

  7. Psychosexual therapy.

    PubMed

    Gregory, P

    Sexual problems are more likely to originate from psychological or relationship difficulties rather than 'mechanical failure'. Here Peter Gregory reveals the often closed world of psychosexual therapy.

  8. Electroconvulsive therapy

    MedlinePlus

    Shock treatment; Shock therapy; ECT; Depression - ECT; Bipolar - ECT ... ECT is a highly effective treatment for depression, most commonly ... who: Are having delusions or other psychotic symptoms with ...

  9. Implantable ventricular assist device exchange with focused intravascular deairing techniques.

    PubMed

    Woo, Y Joseph; Acker, Michael A

    2011-01-01

    As ventricular assist devices are increasingly adopted and widely implemented as a highly effective therapy for end-stage heart disease, extended utilization periods for destination therapy or bridge-to-transplantation have created the possibility of device failure, infection, or thrombosis, requiring challenging implant exchanges. A major problem in these operations is the risk of air embolization, particularly in a nonsternotomy approach that precludes access to the outflow aortic graft and to the ascending aorta. We report a minimally invasive, nonsternotomy HeartMate II implantable left ventricular assist device (LVAD) exchange, using peripheral cardiopulmonary support and a novel approach to continuous intravascular ascending aortic air removal.

  10. Liquid Crystal Devices.

    ERIC Educational Resources Information Center

    Bradshaw, Madeline J.

    1983-01-01

    The nature of liquid crystals and several important liquid crystal devices are described. Ideas for practical experiments to illustrate the properties of liquid crystals and their operation in devices are also described. (Author/JN)

  11. Sealed container sampling device

    NASA Technical Reports Server (NTRS)

    Hennigan, T. J.

    1969-01-01

    Sampling device, by means of a tapered needle, pierces a sealed container while maintaining the seal and either evacuates or pressurizes the container. This device has many applications in the chemical, preservative and battery-manufacturing industries.

  12. Pulse flux measuring device

    DOEpatents

    Riggan, William C.

    1985-01-01

    A device for measuring particle flux comprises first and second photodiode detectors for receiving flux from a source and first and second outputs for producing first and second signals representing the flux incident to the detectors. The device is capable of reducing the first output signal by a portion of the second output signal, thereby enhancing the accuracy of the device. Devices in accordance with the invention may measure distinct components of flux from a single source or fluxes from several sources.

  13. GAS DISCHARGE DEVICES

    DOEpatents

    Arrol, W.J.; Jefferson, S.

    1957-08-27

    The construction of gas discharge devices where the object is to provide a gas discharge device having a high dark current and stabilized striking voltage is described. The inventors have discovered that the introduction of tritium gas into a discharge device with a subsequent electrical discharge in the device will deposit tritium on the inside of the chamber. The tritium acts to emit beta rays amd is an effective and non-hazardous way of improving the abovementioned discharge tube characteristics

  14. Devices for continence.

    PubMed

    Smith, D A

    1994-09-01

    Ameliorating the acute and chronic forms of incontinence is usually possible. When the functional status of the patient prohibits toileting, then devices are often necessary. The practicing nurse must make decisions on what devices are appropriate and how to teach clients to use them. Often, knowing the device exists is a start in the nurse's ability to eliminate functional incontinence. This article focuses on devices that collect urine, inhibit incontinence, and aid staff and clients to use the toilet.

  15. Organic photosensitive devices

    DOEpatents

    Rand, Barry P; Forrest, Stephen R

    2013-11-26

    The present invention generally relates to organic photosensitive optoelectronic devices. More specifically, it is directed to organic photosensitive optoelectronic devices having a photoactive organic region containing encapsulated nanoparticles that exhibit plasmon resonances. An enhancement of the incident optical field is achieved via surface plasmon polariton resonances. This enhancement increases the absorption of incident light, leading to a more efficient device.

  16. Articulating feedstock delivery device

    SciTech Connect

    Jordan, Kevin

    2013-11-05

    A fully articulable feedstock delivery device that is designed to operate at pressure and temperature extremes. The device incorporates an articulating ball assembly which allows for more accurate delivery of the feedstock to a target location. The device is suitable for a variety of applications including, but not limited to, delivery of feedstock to a high-pressure reaction chamber or process zone.

  17. Photovoltaic device and method

    DOEpatents

    Cleereman, Robert J; Lesniak, Michael J; Keenihan, James R; Langmaid, Joe A; Gaston, Ryan; Eurich, Gerald K; Boven, Michelle L

    2015-01-27

    The present invention is premised upon an improved photovoltaic device ("PVD") and method of use, more particularly to an improved photovoltaic device with an integral locator and electrical terminal mechanism for transferring current to or from the improved photovoltaic device and the use as a system.

  18. Amorphous silicon photovoltaic devices

    DOEpatents

    Carlson, David E.; Lin, Guang H.; Ganguly, Gautam

    2004-08-31

    This invention is a photovoltaic device comprising an intrinsic or i-layer of amorphous silicon and where the photovoltaic device is more efficient at converting light energy to electric energy at high operating temperatures than at low operating temperatures. The photovoltaic devices of this invention are suitable for use in high temperature operating environments.

  19. Photovoltaic device and method

    DOEpatents

    Cleereman, Robert; Lesniak, Michael J.; Keenihan, James R.; Langmaid, Joe A.; Gaston, Ryan; Eurich, Gerald K.; Boven, Michelle L.

    2015-11-24

    The present invention is premised upon an improved photovoltaic device ("PVD") and method of use, more particularly to an improved photovoltaic device with an integral locator and electrical terminal mechanism for transferring current to or from the improved photovoltaic device and the use as a system.

  20. 21 CFR 890.5170 - Powered flotation therapy bed.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered flotation therapy bed. 890.5170 Section 890.5170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  1. 21 CFR 890.5170 - Powered flotation therapy bed.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered flotation therapy bed. 890.5170 Section 890.5170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  2. 21 CFR 890.5170 - Powered flotation therapy bed.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered flotation therapy bed. 890.5170 Section 890.5170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  3. 21 CFR 890.5170 - Powered flotation therapy bed.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered flotation therapy bed. 890.5170 Section 890.5170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  4. 21 CFR 890.5170 - Powered flotation therapy bed.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered flotation therapy bed. 890.5170 Section 890.5170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices §...

  5. Sweat Therapy.

    ERIC Educational Resources Information Center

    Colmant, Stephen A.; Merta, Rod J.

    2000-01-01

    A study combined group sweating and group counseling. Four adolescent boys with disruptive behavior disorders participated in 12 sweat therapy sessions. They reported the sessions useful for sharing personal concerns and receiving assistance with problem solving. Three boys showed improvement in self-esteem. Advantages of sweat therapy over other…

  6. Intravenous Therapy.

    ERIC Educational Resources Information Center

    Galliart, Barbara

    Intended for teaching licensed practical nurses, this curriculum guide provides information related to the equipment and skills required for nursing care of patients needing intravenous (IV) therapy. It also explains the roles and responsibilities of the licensed practical nurse with regard to intravenous therapy. Each of the 15 instructional…

  7. Proton Therapy

    MedlinePlus

    ... Liver Breast Esophagus Rectum Skull base sarcomas Pediatric brain tumors Head and neck - see the Head and Neck Cancer page Eye ... Intensity-Modulated Radiation Therapy (IMRT) Brain Tumor Treatment Brain Tumors Prostate Cancer Lung Cancer ... related to Proton Therapy Videos related ...

  8. Poetry Therapy.

    ERIC Educational Resources Information Center

    Evans, Ronald V.

    Poetry therapy is the method of therapy based on the principle that a poem is a special medium for expressing emotions and that this expression can have psychotherapeutic value. A survey taken in 1973 showed there were over 400 therapists treating 3,500 drug addicts, alcoholics, and mental retardates around the country. Poetry therapists…

  9. Active cleaning technique device

    NASA Technical Reports Server (NTRS)

    Shannon, R. L.; Gillette, R. B.

    1973-01-01

    The objective of this program was to develop a laboratory demonstration model of an active cleaning technique (ACT) device. The principle of this device is based primarily on the technique for removing contaminants from optical surfaces. This active cleaning technique involves exposing contaminated surfaces to a plasma containing atomic oxygen or combinations of other reactive gases. The ACT device laboratory demonstration model incorporates, in addition to plasma cleaning, the means to operate the device as an ion source for sputtering experiments. The overall ACT device includes a plasma generation tube, an ion accelerator, a gas supply system, a RF power supply and a high voltage dc power supply.

  10. Biomechanics of Interspinous Devices

    PubMed Central

    Parchi, Paolo D.; Evangelisti, Gisberto; Vertuccio, Antonella; Piolanti, Nicola; Andreani, Lorenzo; Cervi, Valentina; Giannetti, Christian; Calvosa, Giuseppe; Lisanti, Michele

    2014-01-01

    A number of interspinous devices (ISD) have been introduced in the lumbar spine implant market. Unfortunately, the use of these devices often is not associated with real comprehension of their biomechanical role. The aim of this paper is to review the biomechanical studies about interspinous devices available in the literature to allow the reader a better comprehension of the effects of these devices on the treated segment and on the adjacent segments of the spine. For this reason, our analysis will be limited to the interspinous devices that have biomechanical studies published in the literature. PMID:25114923

  11. Portable data collection device

    DOEpatents

    French, Patrick D.

    1996-01-01

    The present invention provides a portable data collection device that has a variety of sensors that are interchangeable with a variety of input ports in the device. The various sensors include a data identification feature that provides information to the device regarding the type of physical data produced by each sensor and therefore the type of sensor itself. The data identification feature enables the device to locate the input port where the sensor is connected and self adjust when a sensor is removed or replaced. The device is able to collect physical data, whether or not a function of a time.

  12. Portable data collection device

    DOEpatents

    French, P.D.

    1996-06-11

    The present invention provides a portable data collection device that has a variety of sensors that are interchangeable with a variety of input ports in the device. The various sensors include a data identification feature that provides information to the device regarding the type of physical data produced by each sensor and therefore the type of sensor itself. The data identification feature enables the device to locate the input port where the sensor is connected and self adjust when a sensor is removed or replaced. The device is able to collect physical data, whether or not a function of a time. 7 figs.

  13. Unitary lens semiconductor device

    DOEpatents

    Lear, K.L.

    1997-05-27

    A unitary lens semiconductor device and method are disclosed. The unitary lens semiconductor device is provided with at least one semiconductor layer having a composition varying in the growth direction for unitarily forming one or more lenses in the semiconductor layer. Unitary lens semiconductor devices may be formed as light-processing devices such as microlenses, and as light-active devices such as light-emitting diodes, photodetectors, resonant-cavity light-emitting diodes, vertical-cavity surface-emitting lasers, and resonant cavity photodetectors. 9 figs.

  14. Unitary lens semiconductor device

    DOEpatents

    Lear, Kevin L.

    1997-01-01

    A unitary lens semiconductor device and method. The unitary lens semiconductor device is provided with at least one semiconductor layer having a composition varying in the growth direction for unitarily forming one or more lenses in the semiconductor layer. Unitary lens semiconductor devices may be formed as light-processing devices such as microlenses, and as light-active devices such as light-emitting diodes, photodetectors, resonant-cavity light-emitting diodes, vertical-cavity surface-emitting lasers, and resonant cavity photodetectors.

  15. [Inhaled therapy in asthma].

    PubMed

    Plaza Moral, Vicente; Giner Donaire, Jordi

    2016-04-01

    Because of its advantages, inhaled administration of aerosolized drugs is the administration route of choice for the treatment of asthma and COPD. Numerous technological advances in the devices used in inhaled therapy in recent decades have boosted the appearance of multiple inhalers and aerosolized drugs. However, this variety also requires that the prescribing physician is aware of their characteristics. The main objective of the present review is to summarize the current state of knowledge on inhalers and inhaled drugs commonly used in the treatment of asthma. The review ranges from theoretical aspects (fundamentals and available devices and drugs) to practical and relevant aspects for asthma care in the clinical setting (therapeutic strategies, education, and adherence to inhalers).

  16. 21 CFR 880.5150 - Nonpowered flotation therapy mattress.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonpowered flotation therapy mattress. 880.5150... Therapeutic Devices § 880.5150 Nonpowered flotation therapy mattress. (a) Identification. A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or...

  17. 21 CFR 880.5150 - Nonpowered flotation therapy mattress.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nonpowered flotation therapy mattress. 880.5150... Therapeutic Devices § 880.5150 Nonpowered flotation therapy mattress. (a) Identification. A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or...

  18. Electrochromic display device

    NASA Astrophysics Data System (ADS)

    Nicholson, M. M.

    1984-07-01

    This invention relates to electrochromic devices. In one aspect it relates to electrically controllable display devices. In another aspect it relates to electrically tunable optical or light filters. In yet another aspect it relates to a chemical sensor device which employs a color changing film. There are many uses for electrically controllable display devices. A number of such devices have been in commercial use for some time. These display devices include liquid crystal displays, light emitting diode displays, plasma displays, and the like. Light emitting diode displays and plasma display panels both suffer from the fact that they are active. Light emissive devices which require substantial power for their operation, In addition, it is difficult to fabricate light emitting diode displays in a manner which renders them easily distinguishable under bright ambient illumination. Liquid crystal displays suffer from the disadvantage that they are operative only over a limited temperature range and have substantially no memory within the liquid crystal material.

  19. Custom Knee Device for Knee Contractures After Internal Femoral Lengthening.

    PubMed

    Bhave, Anil; Shabtai, Lior; Ong, Peck-Hoon; Standard, Shawn C; Paley, Dror; Herzenberg, John E

    2015-07-01

    The development of knee flexion contractures is among the most common problems and complications associated with lengthening the femur with an internal device or external fixator. Conservative treatment strategies include physical therapy, serial casting, and low-load prolonged stretching with commercially available splinting systems. The authors developed an individually molded, low-cost custom knee device with polyester synthetic conformable casting material to treat knee flexion contractures. The goal of this study was to evaluate the results of treatment with a custom knee device and specialized physical therapy in patients who had knee flexion contracture during femoral lengthening with an intramedullary lengthening femoral nail. This retrospective study included 23 patients (27 limbs) who underwent femoral lengthening with an internal device for the treatment of limb length discrepancy. All patients had a knee flexion contracture raging from 10° to 90° during the lengthening process and were treated with a custom knee device and specialized physical therapy. The average flexion contracture before treatment was 36°. The mean amount of lengthening was 5.4 cm. After an average of 3.8 weeks of use of the custom knee device, only 2 of 27 limbs (7.5%) had not achieved complete resolution of the flexion contracture. The average final extension was 1.4°. Only 7 of 27 limbs (26%) required additional soft tissue release. The custom knee device is an inexpensive and effective method for treating knee flexion contracture after lengthening with an internal device.

  20. Device Thrombogenicity Emulation: A Novel Method for Optimizing Mechanical Circulatory Support Device Thromboresistance

    PubMed Central

    Girdhar, Gaurav; Xenos, Michalis; Alemu, Yared; Chiu, Wei-Che; Lynch, Bryan E.; Jesty, Jolyon; Einav, Shmuel; Slepian, Marvin J.; Bluestein, Danny

    2012-01-01

    Mechanical circulatory support (MCS) devices provide both short and long term hemodynamic support for advanced heart failure patients. Unfortunately these devices remain plagued by thromboembolic complications associated with chronic platelet activation – mandating complex, lifelong anticoagulation therapy. To address the unmet need for enhancing the thromboresistance of these devices to extend their long term use, we developed a universal predictive methodology entitled Device Thrombogenicity Emulation (DTE) that facilitates optimizing the thrombogenic performance of any MCS device – ideally to a level that may obviate the need for mandatory anticoagulation. DTE combines in silico numerical simulations with in vitro measurements by correlating device hemodynamics with platelet activity coagulation markers – before and after iterative design modifications aimed at achieving optimized thrombogenic performance. DTE proof-of-concept is demonstrated by comparing two rotary Left Ventricular Assist Devices (LVADs) (DeBakey vs HeartAssist 5, Micromed Houston, TX), the latter a version of the former following optimization of geometrical features implicated in device thrombogenicity. Cumulative stresses that may drive platelets beyond their activation threshold were calculated along multiple flow trajectories and collapsed into probability density functions (PDFs) representing the device ‘thrombogenic footprint’, indicating significantly reduced thrombogenicity for the optimized design. Platelet activity measurements performed in the actual pump prototypes operating under clinical conditions in circulation flow loops – before and after the optimization with the DTE methodology, show an order of magnitude lower platelet activity rate for the optimized device. The robust capability of this predictive technology – demonstrated here for attaining safe and cost-effective pre-clinical MCS thrombo-optimization – indicates its potential for reducing device

  1. The debate on continuous home oxygen therapy.

    PubMed

    Díaz Lobato, Salvador; García González, José Luis; Mayoralas Alises, Sagrario

    2015-01-01

    Two studies published in the early 80s, namely the Nocturnal Oxygen Therapy Trial (NOTT) and the Medical Research Council Trial (MRC), laid the foundations for modern home oxygen therapy. Since then, little progress has been made in terms of therapeutic indications, and several prescription-associated problems have come to light. Advances in technology have gone hand in hand with growing disregard for the recommendations in clinical guidelines on oxygen therapy. The introduction of liquid oxygen brought with it a number of technical problems, clinical problems related to selecting candidate patients for portable delivery devices, and economic problems associated with the rising cost of the therapy. Continuous home oxygen therapy has been further complicated by the recent introduction of portable oxygen concentrators and the development in quick succession of a range of delivery devices with different levels of efficiency and performance. Modern oxygen therapy demands that clinicians evaluate the level of mobility of their patients and the mobility permitted by available oxygen sources, correctly match patients with the most appropriate oxygen source and adjust the therapy accordingly. The future of continuous home oxygen therapy lies in developing the ideal delivery device, improving the regulations systems and information channels, raise patient awareness and drive research.

  2. Antiparasitic Therapy

    PubMed Central

    Kappagoda, Shanthi; Singh, Upinder; Blackburn, Brian G.

    2011-01-01

    Parasitic diseases affect more than 2 billion people globally and cause substantial morbidity and mortality, particularly among the world's poorest people. This overview focuses on the treatment of the major protozoan and helminth infections in humans. Recent developments in antiparasitic therapy include the expansion of artemisinin-based therapies for malaria, new drugs for soil-transmitted helminths and intestinal protozoa, expansion of the indications for antiparasitic drug treatment in patients with Chagas disease, and the use of combination therapy for leishmaniasis and human African trypanosomiasis. PMID:21628620

  3. A suspicious reason for Raynaud's phenomenon: Intrauterine device.

    PubMed

    Diken, Adem I; Yalçınkaya, Adnan; Aksoy, Eray; Yılmaz, Seyhan; Çağlı, Kerim

    2015-06-01

    Primary Raynaud's phenomenon may be insistent in patients under medical therapy, and intrauterine devices may be an unnoticed reason in these patients. Fluctuations in female sex hormone status were reported to be associated with the emergence of primary Raynaud's phenomenon symptoms. The use of intrauterine devices was not reported to be associated with Raynaud's phenomenon previously. Intrauterine device may stimulate vascular hyperactivity regarding hormonal or unknown mechanisms that result in Raynaud's phenomenon. We present a postmenopausal patient who complained of primary Raynaud's phenomenon symptoms and had recovery after the removal of her copper intrauterine device.

  4. Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery

    PubMed Central

    Tom, James

    2016-01-01

    The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias. PMID:27269668

  5. Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery.

    PubMed

    Tom, James

    2016-01-01

    The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias.

  6. Lead or be led: an update on leadless cardiac devices for general physicians.

    PubMed

    Wiles, Benedict M; Roberts, Paul R

    2017-02-01

    Implantable cardiac devices have an increasingly important role. Pacemakers remain the only effective treatment for symptomatic bradycardia; cardiac resynchronisation therapy is a proven treatment for heart failure; and implantable cardioverter defibrillators (ICD) are superior to medical therapy in prevention of sudden cardiac death. Our ageing population has led to a rising number of device implants. Physicians in all specialties increasingly encounter patients with cardiac devices and require an understanding of their capabilities and functions. The rising prevalence of implantable devices has been matched by a parallel expanse in device technology. Leadless devices have become a reality and represent the future of device therapy. The absence of a transvenous lead offers a significant clinical advantage because of many well established issues related to lead complications. The leadless pacemaker and subcutaneous ICD are significant new products that are currently not well recognised or understood by general physicians.

  7. Cardiac CT Angiography in Congestive Heart Failure.

    PubMed

    Levine, Avi; Hecht, Harvey S

    2015-06-01

    Cardiac CT angiography has become an important tool for the diagnosis and treatment of congestive heart failure. Differentiation of ischemic from nonischemic cardiomyopathy; evaluation of myocardial perfusion; characterization of hypertrophic cardiomyopathy, left ventricular noncompaction, and arrhythmogenic right ventricular dysplasia; and delineation of congenital heart defects and valvular abnormalities are the primary diagnostic applications. Therapeutic use includes visualization of the coronary venous anatomy for optimal implementation of cardiac resynchronization therapy and evaluation of left ventricular assist devices and transplant vasculopathy.

  8. Update on arrhythmias and cardiac pacing 2013.

    PubMed

    Almendral, Jesús; Pombo, Marta; Martínez-Alday, Jesús; González-Rebollo, José M; Rodríguez-Font, Enrique; Martínez-Ferrer, José; Castellanos, Eduardo; García-Fernández, F Javier; Ruiz-Mateas, Francisco

    2014-04-01

    This report discusses a selection of the most relevant articles on cardiac arrhythmias and pacing published in 2013. The first section discusses arrhythmias, classified as regular paroxysmal supraventricular tachyarrhythmias, atrial fibrillation, and ventricular arrhythmias, together with their treatment by means of an implantable cardioverter defibrillator. The next section reviews cardiac pacing, subdivided into resynchronization therapy, remote monitoring of implantable devices, and pacemakers. The final section discusses syncope.

  9. Laser therapy

    MedlinePlus

    ... of preoperative and operative surgery: surgical devices and energy sources. In: Townsend CM, Beauchamp RD, Evers BM, Mattox KL, eds. Sabiston Textbook of Surgery . 19th ed. Philadelphia, ... technologies: principles and skin interactions. In: Bolognia JL, ...

  10. Stretchable Organic Semiconductor Devices.

    PubMed

    Qian, Yan; Zhang, Xinwen; Xie, Linghai; Qi, Dianpeng; Chandran, Bevita K; Chen, Xiaodong; Huang, Wei

    2016-11-01

    Stretchable electronics are essential for the development of intensely packed collapsible and portable electronics, wearable electronics, epidermal and bioimplanted electronics, 3D surface compliable devices, bionics, prosthesis, and robotics. However, most stretchable devices are currently based on inorganic electronics, whose high cost of fabrication and limited processing area make it difficult to produce inexpensive, large-area devices. Therefore, organic stretchable electronics are highly attractive due to many advantages over their inorganic counterparts, such as their light weight, flexibility, low cost and large-area solution-processing, the reproducible semiconductor resources, and the easy tuning of their properties via molecular tailoring. Among them, stretchable organic semiconductor devices have become a hot and fast-growing research field, in which great advances have been made in recent years. These fantastic advances are summarized here, focusing on stretchable organic field-effect transistors, light-emitting devices, solar cells, and memory devices.

  11. Electrical signature analysis to quantify human and animal performance on fitness and therapy equipment such as a treadmill

    DOEpatents

    Cox, Daryl F.; Hochanadel, Charles D.; Haynes, Howard D.

    2010-05-18

    The invention is a human and animal performance data acquisition, analysis, and diagnostic system for fitness and therapy devices having an interface box removably disposed on incoming power wiring to a fitness and therapy device, at least one current transducer removably disposed on said interface box for sensing current signals to said fitness and therapy device, and a means for analyzing, displaying, and reporting said current signals to determine human and animal performance on said device using measurable parameters.

  12. Proton Therapy

    MedlinePlus

    ... for e-updates Please leave this field empty Proton Therapy SHARE Home > Treatment and Care > Treatments Listen ... a nucleus, which holds two types of particles—protons and neutrons. The nucleus is surrounded by electrons. ...

  13. Play Therapy

    PubMed Central

    Lawver, Timothy; Blankenship, Kelly

    2008-01-01

    Play therapy is a treatment modality in which the therapist engages in play with the child. Its use has been documented in a variety of settings and with a variety of diagnoses. Treating within the context of play brings the therapist and the therapy to the level of the child. By way of an introduction to this approach, a case is presented of a six-year-old boy with oppositional defiant disorder. The presentation focuses on the events and interactions of a typical session with an established patient. The primary issues of the session are aggression, self worth, and self efficacy. These themes manifest themselves through the content of the child’s play and narration of his actions. The therapist then reflects these back to the child while gently encouraging the child toward more positive play. Though the example is one of nondirective play therapy, a wide range of variation exists under the heading of play therapy. PMID:19724720

  14. Proton Therapy

    MedlinePlus

    ... effects of the treatment. top of page What equipment is used? Proton beam therapy uses special machines, ... tumor cells. top of page Who operates the equipment? With backgrounds in mechanical, electrical, software, hardware and ...

  15. Hand Therapy

    MedlinePlus

    ... Guide Journal of Hand Surgery (JHS) Home Anatomy Hand Therapy Email to a friend * required fields From * ... ensure a healthy style of work. Find a Hand Therapist Search for a hand therapist in your ...

  16. Oxygen Therapy

    MedlinePlus

    Oxygen therapy is a treatment that provides you with extra oxygen. Oxygen is a gas that your body needs to function. Normally, your lungs absorb oxygen from the air you breathe. But some conditions ...

  17. Barrier breaching device

    DOEpatents

    Honodel, C.A.

    1983-06-01

    A barrier breaching device that is designed primarily for opening holes in interior walls of buildings uses detonating fuse for explosive force. The fuse acts as the ribs or spokes of an umbrella-like device that may be opened up to form a cone. The cone is placed against the wall so that detonating fuse that rings the base of the device and which is ignited by the spoke-like fuses serves to cut a circular hole in the wall.

  18. Sensor sentinel computing device

    DOEpatents

    Damico, Joseph P.

    2016-08-02

    Technologies pertaining to authenticating data output by sensors in an industrial environment are described herein. A sensor sentinel computing device receives time-series data from a sensor by way of a wireline connection. The sensor sentinel computing device generates a validation signal that is a function of the time-series signal. The sensor sentinel computing device then transmits the validation signal to a programmable logic controller in the industrial environment.

  19. Radionuclide Therapy

    NASA Astrophysics Data System (ADS)

    Zalutsky, M. R.

    Radionuclide therapy utilizes unsealed sources of radionuclides as a treatment for cancer or other pathological conditions such as rheumatoid arthritis. Radionuclides that decay by the emission of β and α particles, as well as those that emit Auger electrons, have been used for this purpose. In this chapter, radiochemical aspects of radionuclide therapy, including criteria for radionuclide selection, radionuclide production, radiolabeling chemistry, and radiation dosimetry are discussed.

  20. Left Atrial Appendage Closure Devices

    PubMed Central

    Romero, Jorge; Perez, Irving E; Krumerman, Andrew; Garcia, Mario J; Lucariello, Richard J

    2014-01-01

    Atrial fibrillation (AF) increases the risk for thromboembolic stroke five-fold. The left atrial appendage (LAA) has been shown to be the main source of thrombus formation in the majority of strokes associated with AF. Oral anticoagulation with warfarin and novel anticoagulants remains the standard of care; however, it has several limitations, including bleeding and poor compliance. Occlusion of the LAA has been shown to be an alternative therapeutic approach to drug therapy. The purpose of this article is to review the different techniques and devices that have emerged for the purpose of occluding this structure, with a particular emphasis on the efficacy and safety studies published to date in the medical literature. PMID:24963274

  1. Surgical considerations for the explantation of the Parachute left ventricular partitioning device and the implantation of the HeartMate II left ventricular assist device

    PubMed Central

    Bansal, Shelley; Rosas, Paola C.; Mazzaferri, Ernest L.; Sai-Sudhakar, Chittoor B.

    2016-01-01

    Chronic heart failure is the leading cause of death in the world. With newer therapies, the burden of this disease has decreased; however, a significant number of patients remain refractive to existing therapies. Myocardial infarction often leads to ventricular remodeling and eventually contributes to heart failure. The Parachute™ (Cardiokinetix, Menlo Park, CA) is the first device designed for percutaneous ventricular restoration therapy, which reduces left ventricular volume and minimizes the risk of open surgical procedures. For the first time, we report a case of explantation of the Parachute ventricular partitioning device and transition to a HeartMate II™ left ventricular assist device and the surgical considerations for a successful outcome. PMID:27034560

  2. [New Medical Device Evaluation].

    PubMed

    Ikeda, Koji

    2016-01-01

    In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and our experience in the international collaboration process for medical devices. In Japan, most innovative medical therapeutic devices were previously developed and exported by foreign-based companies. Due to this device lag, Japanese had minimal opportunities for receiving treatment with innovative medical devices. To address this issue, the Japanese government has actively accepted foreign clinical trial results and promoted global clinical trials in projects such as HBD. HBD is a project with stakeholders from academia, regulatory authorities, and industry in the US and Japan to promote global clinical trials and reduce device lags. When the project started, medical device clinical trials were not actively conducted in Japan at not just hospitals but also at medical device companies. We started to identify issues under the concept of HBD. After 10 years, we have now become key members in global clinical trials and able to obtain approvals without delay. Recently, HBD has started promoting international convergence. Physicians and regulatory authorities play central roles in compiling guidelines for the clinical evaluation of medical device development, which will be a more active field in the near future. The guidelines compiled will be confirmed with members of academia and regulatory authorities in the United Sates.

  3. New unorthodox semiconductor devices

    NASA Astrophysics Data System (ADS)

    Board, K.

    1985-12-01

    A range of new semiconductor devices, including a number of structures which rely entirely upon new phenomena, are discussed. Unipolar two-terminal devices, including impurity-controlled barriers and graded composition barriers, are considered, as are new transistor structures, including the hot-electron camel transistor, the planar-doped barrier transistor, the thermionic emission transistor, and the permeable base transistor. Regenerative switching devices are addressed, including the metal-tunnel insulator-semiconductor switch, the polysilicon switch, MIS, and MISIM switching structures, and the triangular-barrier switch. Heterostructure devices are covered, including the heterojunction bipolar transistor, the selectively doped heterojunction transistor, heterojunction lasers, and quantum-well structures.

  4. Interconnected semiconductor devices

    DOEpatents

    Grimmer, Derrick P.; Paulson, Kenneth R.; Gilbert, James R.

    1990-10-23

    Semiconductor layer and conductive layer formed on a flexible substrate, divided into individual devices and interconnected with one another in series by interconnection layers and penetrating terminals.

  5. High efficiency photovoltaic device

    DOEpatents

    Guha, Subhendu; Yang, Chi C.; Xu, Xi Xiang

    1999-11-02

    An N-I-P type photovoltaic device includes a multi-layered body of N-doped semiconductor material which has an amorphous, N doped layer in contact with the amorphous body of intrinsic semiconductor material, and a microcrystalline, N doped layer overlying the amorphous, N doped material. A tandem device comprising stacked N-I-P cells may further include a second amorphous, N doped layer interposed between the microcrystalline, N doped layer and a microcrystalline P doped layer. Photovoltaic devices thus configured manifest improved performance, particularly when configured as tandem devices.

  6. Antiviral Therapy

    PubMed Central

    Stalder, Hans

    1977-01-01

    The current status of antiviral therapy is reviewed, including discussion of older approaches together with more recently developed chemotherapy. Following the introduction dealing with pathophysiological aspects of virus disease, the different approaches to antiviral therapy are presented. The reasons for the slow progress in antiviral therapy are discussed. These include: 1. the necessity of intracellular penetration of drugs acting on viral replication; 2. the severe toxicity of most antiviral drugs; 3. the narrow antiviral spectrum of most of these agents; 4. the difficulty of making a rapid etiological diagnosis in view of the necessity of starting (specific?) treatment early in the course of the disease; 5. the difficult evaluation of beneficial as compared with deleterious effects of antiviral therapy. After a detailed review of clinically tested substances, including immunoglobulins, synthetic antiviral drugs (amantadine, nucleoside analogs, thiosemicarbazones and photodynamic dyes) and interferon, a guide concerning indications and application of specific antiviral therapy is presented. Although at present there are few indications, clinicians should be aware of the (present and future) possibilities of antiviral therapy. PMID:341538

  7. Proton beam therapy control system

    DOEpatents

    Baumann, Michael A; Beloussov, Alexandre V; Bakir, Julide; Armon, Deganit; Olsen, Howard B; Salem, Dana

    2013-12-03

    A tiered communications architecture for managing network traffic in a distributed system. Communication between client or control computers and a plurality of hardware devices is administered by agent and monitor devices whose activities are coordinated to reduce the number of open channels or sockets. The communications architecture also improves the transparency and scalability of the distributed system by reducing network mapping dependence. The architecture is desirably implemented in a proton beam therapy system to provide flexible security policies which improve patent safety and facilitate system maintenance and development.

  8. Proton beam therapy control system

    DOEpatents

    Baumann, Michael A.; Beloussov, Alexandre V.; Bakir, Julide; Armon, Deganit; Olsen, Howard B.; Salem, Dana

    2008-07-08

    A tiered communications architecture for managing network traffic in a distributed system. Communication between client or control computers and a plurality of hardware devices is administered by agent and monitor devices whose activities are coordinated to reduce the number of open channels or sockets. The communications architecture also improves the transparency and scalability of the distributed system by reducing network mapping dependence. The architecture is desirably implemented in a proton beam therapy system to provide flexible security policies which improve patent safety and facilitate system maintenance and development.

  9. Proton beam therapy control system

    DOEpatents

    Baumann, Michael A; Beloussov, Alexandre V; Bakir, Julide; Armon, Deganit; Olsen, Howard B; Salem, Dana

    2013-06-25

    A tiered communications architecture for managing network traffic in a distributed system. Communication between client or control computers and a plurality of hardware devices is administered by agent and monitor devices whose activities are coordinated to reduce the number of open channels or sockets. The communications architecture also improves the transparency and scalability of the distributed system by reducing network mapping dependence. The architecture is desirably implemented in a proton beam therapy system to provide flexible security policies which improve patent safety and facilitate system maintenance and development.

  10. Proton beam therapy control system

    DOEpatents

    Baumann, Michael A.; Beloussov, Alexandre V.; Bakir, Julide; Armon, Deganit; Olsen, Howard B.; Salem, Dana

    2010-09-21

    A tiered communications architecture for managing network traffic in a distributed system. Communication between client or control computers and a plurality of hardware devices is administered by agent and monitor devices whose activities are coordinated to reduce the number of open channels or sockets. The communications architecture also improves the transparency and scalability of the distributed system by reducing network mapping dependence. The architecture is desirably implemented in a proton beam therapy system to provide flexible security policies which improve patent safety and facilitate system maintenance and development.

  11. Robot-assisted Therapy in Stroke Rehabilitation.

    PubMed

    Chang, Won Hyuk; Kim, Yun-Hee

    2013-09-01

    Research into rehabilitation robotics has grown rapidly and the number of therapeutic rehabilitation robots has expanded dramatically during the last two decades. Robotic rehabilitation therapy can deliver high-dosage and high-intensity training, making it useful for patients with motor disorders caused by stroke or spinal cord disease. Robotic devices used for motor rehabilitation include end-effector and exoskeleton types; herein, we review the clinical use of both types. One application of robot-assisted therapy is improvement of gait function in patients with stroke. Both end-effector and the exoskeleton devices have proven to be effective complements to conventional physiotherapy in patients with subacute stroke, but there is no clear evidence that robotic gait training is superior to conventional physiotherapy in patients with chronic stroke or when delivered alone. In another application, upper limb motor function training in patients recovering from stroke, robot-assisted therapy was comparable or superior to conventional therapy in patients with subacute stroke. With end-effector devices, the intensity of therapy was the most important determinant of upper limb motor recovery. However, there is insufficient evidence for the use of exoskeleton devices for upper limb motor function in patients with stroke. For rehabilitation of hand motor function, either end-effector and exoskeleton devices showed similar or additive effects relative to conventional therapy in patients with chronic stroke. The present evidence supports the use of robot-assisted therapy for improving motor function in stroke patients as an additional therapeutic intervention in combination with the conventional rehabilitation therapies. Nevertheless, there will be substantial opportunities for technical development in near future.

  12. Upscaling cardiac assist devices in decompensated heart failure: Choice of device and its timing.

    PubMed

    Mishra, Sundeep

    2016-04-01

    Advanced heart failure is a heterogeneous condition unified by a very high mortality unless right treatment is instituted at the right time. The first step is understanding the mechanism leading to instability: hemodynamic or ischemic. Right kind of therapy; drugs (ionotropic) or IABP or other cardiac assist devices should be chosen according to mechanism of insult as well as degree of insult. Drugs such as ionotropes are effective only in very early course but if the decompensation has progressed beyond a certain point device such as IABP may be effective but again only early in the course when CPO? 0.6. Beyond a certain point, even IABP may not be effective: here only Impella (2.5, CP or 5) or Tandem Heart may be effective. However, beyond a certain point CPO<0.53, even these devices may not be effective. Thus crux of the matter is choice of a right device/drug and timing of its institution.

  13. Cotton-based Diagnostic Devices

    PubMed Central

    Lin, Shang-Chi; Hsu, Min-Yen; Kuan, Chen-Meng; Wang, Hsi-Kai; Chang, Chia-Ling; Tseng, Fan-Gang; Cheng, Chao-Min

    2014-01-01

    A good diagnostic procedure avoids wasting medical resources, is easy to use, resists contamination, and provides accurate information quickly to allow for rapid follow-up therapies. We developed a novel diagnostic procedure using a “cotton-based diagnostic device” capable of real-time detection, i.e., in vitro diagnostics (IVD), which avoids reagent contamination problems common to existing biomedical devices and achieves the abovementioned goals of economy, efficiency, ease of use, and speed. Our research reinforces the advantages of an easy-to-use, highly accurate diagnostic device created from an inexpensive and readily available U.S. FDA-approved material (i.e., cotton as flow channel and chromatography paper as reaction zone) that adopts a standard calibration curve method in a buffer system (i.e., nitrite, BSA, urobilinogen and uric acid assays) to accurately obtain semi-quantitative information and limit the cross-contamination common to multiple-use tools. Our system, which specifically targets urinalysis diagnostics and employs a multiple biomarker approach, requires no electricity, no professional training, and is exceptionally portable for use in remote or home settings. This could be particularly useful in less industrialized areas. PMID:25393975

  14. Advanced resistive exercise device

    NASA Technical Reports Server (NTRS)

    Raboin, Jasen L. (Inventor); Niebuhr, Jason (Inventor); Cruz, Santana F. (Inventor); Lamoreaux, Christopher D. (Inventor)

    2008-01-01

    The present invention relates to an exercise device, which includes a vacuum cylinder and a flywheel. The flywheel provides an inertial component to the load, which is particularly well suited for use in space as it simulates exercising under normal gravity conditions. Also, the present invention relates to an exercise device, which has a vacuum cylinder and a load adjusting armbase assembly.

  15. Emergency descent device

    NASA Technical Reports Server (NTRS)

    Belew, R. R.

    1974-01-01

    Device includes cable wound on reel; special assembly enclosed in fluid medium controls unwinding speed of cable during descent. Device is compact and reliable. It can be rewound quickly because reel disengages from latches when it is turned in opposite direction.

  16. Assistive Listening Devices

    ERIC Educational Resources Information Center

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

    1997-01-01

    For most hard of hearing students, and for some who are deaf, hearing aids and related sound amplification devices are of great benefit in their communication and learning. Technology has more recently produced an additional array of electronic devices which benefit many hard of hearing students. This report will deal primarily with the relatively…

  17. Devices and Educational Change

    ERIC Educational Resources Information Center

    Nespor, Jan

    2011-01-01

    This paper uses Actor Network Theory to examine two cases of device-mediated educational change, one involving a computer-assisted interactive video module that provided a half-hour of instruction for a university course, the other an assistive communication device that proved a supposedly retarded pre-school child to be intelligent. The paper…

  18. Capillary interconnect device

    DOEpatents

    Renzi, Ronald F

    2013-11-19

    An interconnecting device for connecting a plurality of first fluid-bearing conduits to a corresponding plurality of second fluid-bearing conduits thereby providing fluid communication between the first fluid-bearing conduits and the second fluid-bearing conduits. The device includes a manifold and one or two ferrule plates that are held by compressive axial forces.

  19. Self-actuated device

    DOEpatents

    Hecht, Samuel L.

    1984-01-01

    A self-actuated device, of particular use as a valve or an orifice for nuclear reactor fuel and blanket assemblies, in which a gas produced by a neutron induced nuclear reaction gradually accumulates as a function of neutron fluence. The gas pressure increase occasioned by such accumulation of gas is used to actuate the device.

  20. Microfabricated particle focusing device

    DOEpatents

    Ravula, Surendra K.; Arrington, Christian L.; Sigman, Jennifer K.; Branch, Darren W.; Brener, Igal; Clem, Paul G.; James, Conrad D.; Hill, Martyn; Boltryk, Rosemary June

    2013-04-23

    A microfabricated particle focusing device comprises an acoustic portion to preconcentrate particles over large spatial dimensions into particle streams and a dielectrophoretic portion for finer particle focusing into single-file columns. The device can be used for high throughput assays for which it is necessary to isolate and investigate small bundles of particles and single particles.

  1. Inverted organic photosensitive devices

    DOEpatents

    Forrest, Stephen R.; Bailey-Salzman, Rhonda F.

    2016-12-06

    The present disclosure relates to organic photosensitive optoelectronic devices grown in an inverted manner. An inverted organic photosensitive optoelectronic device of the present disclosure comprises a reflective electrode, an organic donor-acceptor heterojunction over the reflective electrode, and a transparent electrode on top of the donor-acceptor heterojunction.

  2. STORM INLET FILTRATION DEVICE

    EPA Science Inventory

    Five field tests were conducted to evaluate the effectiveness of the Storm and Groundwater Enhancement Systems (SAGES) device for removing contaminants from stormwater. The SAGES device is a three-stage filtering system that could be used as a best management practices (BMP) retr...

  3. Device for removing blackheads

    DOEpatents

    Berkovich, Tamara

    1995-03-07

    A device for removing blackheads from pores in the skin having a elongated handle with a spoon shaped portion mounted on one end thereof, the spoon having multiple small holes piercing therethrough. Also covered is method for using the device to remove blackheads.

  4. Vaginal mechanical contraceptive devices.

    PubMed

    Smith, M; Barwin, B N

    1983-10-01

    The alleged adverse effects of oral contraceptives and intrauterine devices have led to increased consumer and physician demand for vaginal contraceptive devices. The efficacy and the advantages and disadvantages of vaginal sponges, cervical caps and diaphragms are discussed and compared in this article.

  5. Statement on intrauterine devices.

    PubMed

    1981-12-01

    These policy statements and guidelines from the International Planned Parenthood Federation's (IPPF) International Medical Advisory Panel (IMAP) concern IUDs. The following contraindications to IUD use are recognized: 1) pelvic inflaminatory disease, 2) known or suspected pregnancy, 3) history of previous ectopic pregnancy, 4) gynecological bleeding disorders, 5) suspected malignancy of the genital tract, 6) congenital uterine abnormalities or fibroids distorting the cavity, and 7) anemia, blood coagulation, severe cervical stenosis, copper allergy, Wilson's disease, and others. Generalities regarding appropriate IUDs are: 1) non-medicated devices (e.g. Lippes Loop) are studied for women who may not return for regular check-ups, 2) smaller medicated devices usually cause less menstrual blood loss than the non-medicated devices, 3) smaller devices are better for a smaller uterus and larger devices for the larger uterus, and 4) when a smaller device is expelled it is advisable to try a larger one and vice versa. Dalkon Shields should not be used by the IPPF system and all women using them should have the device removed. Correct insertion of IUDs is important and should be done by properly trained personnel. The timing of insertion is best during the menstrual period. Withdrawal of the applicator while leaving the device in place is the recommended insertion technique. Sterilization of IUDs should follow instructions on bulk-packaged IUDs. Complications include perforation, bleeding and pain, infection, and ectopic pregnancy. IUD removal should be done during menstruation. Good clinical management and follow-up care are recommended.

  6. Microwave device investigations

    NASA Technical Reports Server (NTRS)

    Choudhury, K. K. D.; Haddad, G. I.; Kwok, S. P.; Masnari, N. A.; Trew, R. J.

    1972-01-01

    Materials, devices and novel schemes for generation, amplification and detection of microwave and millimeter wave energy are studied. Considered are: (1) Schottky-barrier microwave devices; (2) intermodulation products in IMPATT diode amplifiers; and (3) harmonic generation using Read diode varactors.

  7. Device for cutting protrusions

    DOEpatents

    Bzorgi, Fariborz M.

    2011-07-05

    An apparatus for clipping a protrusion of material is provided. The protrusion may, for example, be a bolt head, a nut, a rivet, a weld bead, or a temporary assembly alignment tab protruding from a substrate surface of assembled components. The apparatus typically includes a cleaver having a cleaving edge and a cutting blade having a cutting edge. Generally, a mounting structure configured to confine the cleaver and the cutting blade and permit a range of relative movement between the cleaving edge and the cutting edge is provided. Also typically included is a power device coupled to the cutting blade. The power device is configured to move the cutting edge toward the cleaving edge. In some embodiments the power device is activated by a momentary switch. A retraction device is also generally provided, where the retraction device is configured to move the cutting edge away from the cleaving edge.

  8. Fluidic nanotubes and devices

    DOEpatents

    Yang, Peidong; He, Rongrui; Goldberger, Joshua; Fan, Rong; Wu, Yiying; Li, Deyu; Majumdar, Arun

    2010-01-10

    Fluidic nanotube devices are described in which a hydrophilic, non-carbon nanotube, has its ends fluidly coupled to reservoirs. Source and drain contacts are connected to opposing ends of the nanotube, or within each reservoir near the opening of the nanotube. The passage of molecular species can be sensed by measuring current flow (source-drain, ionic, or combination). The tube interior can be functionalized by joining binding molecules so that different molecular species can be sensed by detecting current changes. The nanotube may be a semiconductor, wherein a tubular transistor is formed. A gate electrode can be attached between source and drain to control current flow and ionic flow. By way of example an electrophoretic array embodiment is described, integrating MEMs switches. A variety of applications are described, such as: nanopores, nanocapillary devices, nanoelectrophoretic, DNA sequence detectors, immunosensors, thermoelectric devices, photonic devices, nanoscale fluidic bioseparators, imaging devices, and so forth.

  9. Fluidic nanotubes and devices

    DOEpatents

    Yang, Peidong; He, Rongrui; Goldberger, Joshua; Fan, Rong; Wu, Yiying; Li, Deyu; Majumdar, Arun

    2008-04-08

    Fluidic nanotube devices are described in which a hydrophilic, non-carbon nanotube, has its ends fluidly coupled to reservoirs. Source and drain contacts are connected to opposing ends of the nanotube, or within each reservoir near the opening of the nanotube. The passage of molecular species can be sensed by measuring current flow (source-drain, ionic, or combination). The tube interior can be functionalized by joining binding molecules so that different molecular species can be sensed by detecting current changes. The nanotube may be a semiconductor, wherein a tubular transistor is formed. A gate electrode can be attached between source and drain to control current flow and ionic flow. By way of example an electrophoretic array embodiment is described, integrating MEMs switches. A variety of applications are described, such as: nanopores, nanocapillary devices, nanoelectrophoretic, DNA sequence detectors, immunosensors, thermoelectric devices, photonic devices, nanoscale fluidic bioseparators, imaging devices, and so forth.

  10. Planar electrochemical device assembly

    DOEpatents

    Jacobson; Craig P. , Visco; Steven J. , De Jonghe; Lutgard C.

    2010-11-09

    A pre-fabricated electrochemical device having a dense electrolyte disposed between an anode and a cathode preferably deposited as thin films is bonded to a porous electrically conductive support. A second porous electrically conductive support may be bonded to a counter electrode of the electrochemical device. Multiple electrochemical devices may be bonded in parallel to a single porous support, such as a perforated sheet to provide a planar array. Planar arrays may be arranged in a stacked interconnected array. A method of making a supported electrochemical device is disclosed wherein the method includes a step of bonding a pre-fabricated electrochemical device layer to an existing porous metal or porous metal alloy layer.

  11. Planar electrochemical device assembly

    DOEpatents

    Jacobson, Craig P.; Visco, Steven J.; De Jonghe, Lutgard C.

    2007-06-19

    A pre-fabricated electrochemical device having a dense electrolyte disposed between an anode and a cathode preferably deposited as thin films is bonded to a porous electrically conductive support. A second porous electrically conductive support may be bonded to a counter electrode of the electrochemical device. Multiple electrochemical devices may be bonded in parallel to a single porous support, such as a perforated sheet to provide a planar array. Planar arrays may be arranged in a stacked interconnected array. A method of making a supported electrochemical device is disclosed wherein the method includes a step of bonding a pre-fabricated electrochemical device layer to an existing porous metal or porous metal alloy layer.

  12. Heat tube device

    NASA Technical Reports Server (NTRS)

    Khattar, Mukesh K. (Inventor)

    1990-01-01

    The present invention discloses a heat tube device through which a working fluid can be circulated to transfer heat to air in a conventional air conditioning system. The heat tube device is disposable about a conventional cooling coil of the air conditioning system and includes a plurality of substantially U-shaped tubes connected to a support structure. The support structure includes members for allowing the heat tube device to be readily positioned about the cooling coil. An actuatable adjustment device is connected to the U-shaped tubes for allowing, upon actuation thereof, for the heat tubes to be simultaneously rotated relative to the cooling coil for allowing the heat transfer from the heat tube device to air in the air conditioning system to be selectively varied.

  13. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  14. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  15. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  16. Antifungal Lock Therapy

    PubMed Central

    Walraven, Carla J.

    2013-01-01

    The widespread use of intravascular devices, such as central venous and hemodialysis catheters, in the past 2 decades has paralleled the increasing incidence of catheter-related bloodstream infections (CR-BSIs). Candida albicans is the fourth leading cause of hospital-associated BSIs. The propensity of C. albicans to form biofilms on these catheters has made these infections difficult to treat due to multiple factors, including increased resistance to antifungal agents. Thus, curing CR-BSIs caused by Candida species usually requires catheter removal in addition to systemic antifungal therapy. Alternatively, antimicrobial lock therapy has received significant interest and shown promise as a strategy to treat CR-BSIs due to Candida species. The existing in vitro, animal, and patient data for treatment of Candida-related CR-BSIs are reviewed. The most promising antifungal lock therapy (AfLT) strategies include use of amphotericin, ethanol, or echinocandins. Clinical trials are needed to further define the safety and efficacy of AfLT. PMID:23070153

  17. Infusion therapy part one: minimising the risks.

    PubMed

    Gabriel, J

    The role of the nurse in infusion therapy has evolved with advances i in vascular access technology and the variety of infusion devices available. With increasing numbers of patients requiring vascular access for a range of parenteral therapies, nursing staff need to demonstrate an understanding of the range and management of vascular access devices (VADs) and the clinical indications for individual devices. This article, the first of two, provides information on the type of VADs available and emphasises the importance o patient assessment to ensure safe, reliable and high-quality care for individual patients. The second part, to be published next week, examines some of the common complications associated with infusion therapy and identifies preventive measures.

  18. [Testosterone therapy].

    PubMed

    Diemer, T; Hauptmann, A; Wagenlehner, F M E

    2016-04-01

    Hormone replacement therapy with testosterone has become well-established over the course of time. The initial substantial concerns with respect to complications and potential adverse events, particularly in older patients, were proven to be unfounded over time. Testosterone therapy has therefore gradually become a regular treatment modality in urological practice. It has also been shown to represent a valuable tool as supportive treatment for patients with erectile dysfunction and hypogonadism. A variety of testosterone preparations are available for treatment. Recent pharmaceutical developments have greatly improved the practicability and ease of administration for patients. Several guidelines have been developed that provide clearly formulated standards and instructions for indications, contraindications, application, risk factors and monitoring of testosterone therapy. Adverse events affecting the cardiovascular system and especially diseases of the prostate gland are of great importance, thus making the urologist the primary partner in the treatment of patients with testosterone deficiency.

  19. Optical thin film devices

    NASA Astrophysics Data System (ADS)

    Mao, Shuzheng

    1991-11-01

    Thin film devices are applied to almost all modern scientific instruments, and these devices, especially optical thin film devices, play an essential role in the performances of the instruments, therefore, they are attracting more and more attention. Now there are numerous kinds of thin film devices and their applications are very diversified. The 300-page book, 'Thin Film Device and Applications,' by Prof. K. L. Chopra gives some general ideas, and my paper also outlines the designs, fabrication, and applications of some optical thin film devices made in my laboratory. Optical thin film devices have been greatly developed in the recent decades. Prof. A. Thelan has given a number of papers on the theory and techniques, Prof. H. A. Macleod's book, 'Thin Film Optical Filters,' has concisely concluded the important concepts of optical thin film devices, and Prof. J. A. Dobrowobski has proposed many successful designs for optical thin film devices. Recently, fully-automatic plants make it easier to produce thin film devices with various spectrum requirements, and some companies, such as Balzers, Leybold AG, Satis Vacuum AG, etc., have manufactured such kinds of coating plants for research or mass-production, and the successful example is the production of multilayer antireflection coatings with high stability and reproducibility. Therefore, it could be said that the design of optical thin film devices and coating plants is quite mature. However, we cannot expect that every problem has been solved, the R&D work still continues, the competition still continues, and new design concepts, new techniques, and new film materials are continually developed. Meanwhile, the high-price of fully-automatic coating plants makes unpopular, and automatic design of coating stacks is only the technique for optimizing the manual design according to the physical concepts and experience, in addition, not only the optical system, but also working environment should be taken into account when

  20. Study of device malfunctions in patients with implantable ventricular assist devices living at home.

    PubMed

    Kashiwa, Koichi; Nishimura, Takashi; Kubo, Hitoshi; Tamai, Hisayoshi; Baba, Atsushi; Ono, Minoru; Takamoto, Shinichi; Kyo, Shunei

    2010-09-01

    Clinical introduction of implantable ventricular assist devices (VADs) is expected to encourage VAD therapy for severe heart failure patients in Japan. Since even minor device malfunctions can lead to serious outcomes in these patients, it is very important to collect and analyze data on device malfunctions occurring during their use at home. This study was undertaken to collect and analyze such data from 9 patients with implanted VADs (EVAHEART™, 4 patients; Jarvik2000, 3 patients; Duraheart™, 2 patients) living at home, within the framework of a clinical trial carried out at our hospital. During the home stay period of 449 ± 253 days (range 12-801 days, total 4044 days), the total number of device malfunctions was 31 (0.31 events/patient/year). Those with EVAHEART™ were Cool-seal system-related (9 events) and battery-related (6 events) malfunctions. Those with Jarvik2000 were battery-related (7 events), alarm (1 event) and uncertain cause (1 event) malfunctions. Those with Duraheart™ were battery-related (3 events), alarm (3 events) and other component (1 event) malfunctions. Although the incidence was not very high and none of these device malfunctions led to cessation of blood pump operation in this study, it is necessary to establish a communication system for properly obtaining detailed information in the event of serious device malfunctions. Furthermore, establishment of a home-living-patient support system covering extensive areas is urgently needed, since this can facilitate rapid action to deal with serious device malfunctions.

  1. Anticoagulant Therapy

    PubMed Central

    Teitel, Jerome M.

    1984-01-01

    Venous thromboembolic diseases are among the most important causes of morbidity and mortality in Canada. Agents which interfere with the coagulation mechanism are highly effective in treating these disorders, but at the potentially high cost of serious hemorrhagic complications. The optimal prevention of both serious outcomes and complications of therapy can be achieved by prophylactic treatment of high risk patients. Heparin and vitamin K antagonists remain the mainstays of antithrombotic therapy. The pharmacology of these agents is reviewed, and a rational approach to their clinical use is presented. PMID:21279098

  2. To ventricular assist devices or not: When is implantation of a ventricular assist device appropriate in advanced ambulatory heart failure?

    PubMed Central

    Cerier, Emily; Lampert, Brent C; Kilic, Arman; McDavid, Asia; Deo, Salil V; Kilic, Ahmet

    2016-01-01

    Advanced heart failure has been traditionally treated via either heart transplantation, continuous inotropes, consideration for hospice and more recently via left ventricular assist devices (LVAD). Heart transplantation has been limited by organ availability and the futility of other options has thrust LVAD therapy into the mainstream of therapy for end stage heart failure. Improvements in technology and survival combined with improvements in the quality of life have made LVADs a viable option for many patients suffering from heart failure. The question of when to implant these devices in those patients with advanced, yet still ambulatory heart failure remains a controversial topic. We discuss the current state of LVAD therapy and the risk vs benefit of these devices in the treatment of heart failure. PMID:28070237

  3. Therapy using implanted organic bioelectronics

    PubMed Central

    Jonsson, Amanda; Song, Zhiyang; Nilsson, David; Meyerson, Björn A.; Simon, Daniel T.; Linderoth, Bengt; Berggren, Magnus

    2015-01-01

    Many drugs provide their therapeutic action only at specific sites in the body, but are administered in ways that cause the drug’s spread throughout the organism. This can lead to serious side effects. Local delivery from an implanted device may avoid these issues, especially if the delivery rate can be tuned according to the need of the patient. We turned to electronically and ionically conducting polymers to design a device that could be implanted and used for local electrically controlled delivery of therapeutics. The conducting polymers in our device allow electronic pulses to be transduced into biological signals, in the form of ionic and molecular fluxes, which provide a way of interfacing biology with electronics. Devices based on conducting polymers and polyelectrolytes have been demonstrated in controlled substance delivery to neural tissue, biosensing, and neural recording and stimulation. While providing proof of principle of bioelectronic integration, such demonstrations have been performed in vitro or in anesthetized animals. Here, we demonstrate the efficacy of an implantable organic electronic delivery device for the treatment of neuropathic pain in an animal model. Devices were implanted onto the spinal cord of rats, and 2 days after implantation, local delivery of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) was initiated. Highly localized delivery resulted in a significant decrease in pain response with low dosage and no observable side effects. This demonstration of organic bioelectronics-based therapy in awake animals illustrates a viable alternative to existing pain treatments, paving the way for future implantable bioelectronic therapeutics. PMID:26601181

  4. Contamination sampling device

    NASA Technical Reports Server (NTRS)

    Delgado, Felix A. (Inventor); Stern, Susan M. (Inventor)

    1998-01-01

    A contamination sample collection device has a wooden dowel with a cotton swab at one end, the cotton being covered by a nylon cloth and the wooden dowel being encapsulated by plastic tubing which is heat shrunk onto the dowel and onto a portion of the cotton swab to secure the cotton in place. Another plastic tube is heat shrunk onto the plastic that encapsulates the dowel and a portion of the nylon cloth to secure the nylon cloth in place. The device may thereafter be covered with aluminum foil protector. The device may be used for obtaining samples of contamination in clean room environments.

  5. Rain sampling device

    DOEpatents

    Nelson, Danny A.; Tomich, Stanley D.; Glover, Donald W.; Allen, Errol V.; Hales, Jeremy M.; Dana, Marshall T.

    1991-01-01

    The present invention constitutes a rain sampling device adapted for independent operation at locations remote from the user which allows rainfall to be sampled in accordance with any schedule desired by the user. The rain sampling device includes a mechanism for directing wet precipitation into a chamber, a chamber for temporarily holding the precipitation during the process of collection, a valve mechanism for controllably releasing samples of said precipitation from said chamber, a means for distributing the samples released from the holding chamber into vessels adapted for permanently retaining these samples, and an electrical mechanism for regulating the operation of the device.

  6. Rain sampling device

    DOEpatents

    Nelson, D.A.; Tomich, S.D.; Glover, D.W.; Allen, E.V.; Hales, J.M.; Dana, M.T.

    1991-05-14

    The present invention constitutes a rain sampling device adapted for independent operation at locations remote from the user which allows rainfall to be sampled in accordance with any schedule desired by the user. The rain sampling device includes a mechanism for directing wet precipitation into a chamber, a chamber for temporarily holding the precipitation during the process of collection, a valve mechanism for controllably releasing samples of the precipitation from the chamber, a means for distributing the samples released from the holding chamber into vessels adapted for permanently retaining these samples, and an electrical mechanism for regulating the operation of the device. 11 figures.

  7. INTERNAL CUTTING DEVICE

    DOEpatents

    Russell, W.H. Jr.

    1959-06-30

    A device is described for removing material from the interior of a hollow workpiece so as to form a true spherical internal surface in a workpiece, or to cut radial slots of an adjustable constant depth in an already established spherical internal surface. This is accomplished by a spring loaded cutting tool adapted to move axially wherein the entire force urging the tool against the workpiece is derived from the spring. Further features of importance involve the provision of a seal between the workpiece and the cutting device and a suction device for carrying away particles of removed material.

  8. Automobile maneuvering device

    SciTech Connect

    Ricciardi, R.

    1987-08-18

    An automobile maneuvering device is described which consists of: a chassis comprising transport wheels for permitting movement of the device along the ground, a drive wheel operably rotatably connected to the chassis, and means for rotating the drive wheel, clamp means operably connected to the chassis and spaced from and opposed to the drive wheel, the chassis including means to move the clamp means to engage one portion of an automobile tire with the drive wheel engaged at another portion of the automobile tire, and means to actuate the rotating means, so that with rotation of the drive wheel the automobile tire is rotated and the automobile and device moved along the ground.

  9. Radiation Therapy

    MedlinePlus

    ... can watch you during the procedure. As you go through radiation treatment, you may feel like you're all ... treatment. Avoid exposing the treated area to the sun during the weeks you're getting radiation therapy. And when the treatment's over, wear sunscreen ...

  10. Dance Therapy.

    ERIC Educational Resources Information Center

    Leventhal, Marcia B.

    1980-01-01

    Dance therapy deals with personal growth via body-mind interaction. A change in movement expression is believed to result in a personality or behavior change. The therapist is trained to become sensitive to movement expression as it relates to the psychological, motor, and cognitive development of the child. (JN)

  11. Gene therapy.

    PubMed

    Williamson, B

    1982-07-29

    Gene therapy is not yet possible, but may become feasible soon, particularly for well understood gene defects. Although treatment of a patient raises no ethical problems once it can be done well, changing the genes of an early embryo is more difficult, controversial and unlikely to be required clinically.

  12. Sex Therapy

    MedlinePlus

    ... effective for individuals of any age, sex or sexual orientation. Sex therapy is usually provided by psychologists, social workers, physicians or licensed therapists who have special training in issues related to sex ... do not have sexual contact with clients, in the office or anywhere ...

  13. Pet Therapy.

    ERIC Educational Resources Information Center

    Kavanagh, Kim

    1994-01-01

    This resource guide presents information on a variety of ways that animals can be used as a therapeutic modality with people having disabilities. Aspects addressed include: pet ownership and selection criteria; dogs (including service dogs, hearing/signal dogs, seeing leader dogs, and social/specialty dogs); horseriding for both therapy and fun;…

  14. Radiation Therapy

    MedlinePlus

    ... them from spreading. About half of all cancer patients receive it. The radiation may be external, from special machines, or internal, from radioactive substances that a doctor places inside your body. The type of radiation therapy you receive depends on many factors, including The ...

  15. Gene Therapy

    MedlinePlus

    ... cells in an effort to treat or stop disease. Genes contain your DNA — the code that controls much of your body's form and function, from making you grow taller to regulating your body systems. Genes that don't work properly can cause disease. Gene therapy replaces a faulty gene or adds ...

  16. Vacuum bell therapy

    PubMed Central

    Sesia, Sergio

    2016-01-01

    Background For specific therapy to correct pectus excavatum (PE), conservative treatment with the vacuum bell (VB) was introduced more than 10 years ago in addition to surgical repair. Preliminary results using the VB were encouraging. We report on our 13-year experience with the VB treatment including the intraoperative use during the Nuss procedure and present some technical innovations. Methods A VB with a patient-activated hand pump is used to create a vacuum at the anterior chest wall. Three different sizes of vacuum bells, as well as a model fitted for young women, exist. The appropriate size is selected according to the individual patient’s age and ventral surface. The device should be used at home for a minimum of 30 minutes (twice a day), and may be used up to a maximum of several hours daily. The intensity of the applied negative pressure can be evaluated with an integrated pressure gauge during follow-up visits. A prototype of an electronic model enables us to measure the correlation between the applied negative pressure and the elevation of the anterior chest wall. Results Since 2003, approx. 450 patients between 2 to 61 years of age started the VB therapy. Age and gender specific differences, depth of PE, symmetry or asymmetry, and concomitant malformations such as scoliosis and/or kyphosis influence the clinical course and success of VB therapy. According to our experience, we see three different groups of patients. Immediate elevation of the sternum was confirmed thoracoscopically during the Nuss procedure in every patient. Conclusions The VB therapy has been established as an alternative therapeutic option in selected patients suffering from PE. The initial results up to now are encouraging, but long-term results comprising more than 15 years are so far lacking, and further evaluation and follow-up studies are necessary. PMID:27747177

  17. Devices for hearing loss

    MedlinePlus

    ... sounds, such as the doorbell or a ringing phone. They can also alert you to things happening ... telephone. Devices called amplifiers make sound louder. Some phones have amplifiers built-in. You can also attach ...

  18. Optical devices: A compilation

    NASA Technical Reports Server (NTRS)

    1976-01-01

    Technological developments in the field of optics devices which have potential utility outside the aerospace community are described. Optical instrumentation, light generation and transmission, and laser techniques are among the topics covered. Patent information is given.

  19. Authenticated sensor interface device

    SciTech Connect

    Coleman, Jody Rustyn; Poland, Richard W.

    2016-10-18

    A system and method for the secure storage and transmission of data is provided. A data aggregate device can be configured to receive secure data from a data source, such as a sensor, and encrypt the secure data using a suitable encryption technique, such as a shared private key technique, a public key encryption technique, a Diffie-Hellman key exchange technique, or other suitable encryption technique. The encrypted secure data can be provided from the data aggregate device to different remote devices over a plurality of segregated or isolated data paths. Each of the isolated data paths can include an optoisolator that is configured to provide one-way transmission of the encrypted secure data from the data aggregate device over the isolated data path. External data can be received through a secure data filter which, by validating the external data, allows for key exchange and other various adjustments from an external source.

  20. Devices for Arrhythmia

    MedlinePlus

    ... Disease Venous Thromboembolism Aortic Aneurysm More Devices for Arrhythmia Updated:Dec 21,2016 In a medical emergency, ... This content was last reviewed September 2016. Printable Arrhythmia Information Sheets What is Arrhythmia? What is Atrial ...