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Sample records for resynchronization therapy devices

  1. Cardiac resynchronization therapy: optimizing the device, optimizing the patient.

    PubMed

    Trupp, Robin J

    2004-01-01

    Heart failure is a major health problem in the United States, associated with high morbidity, mortality, and economic burden. Despite recent advances in pharmacological treatments to attenuate disease progression, medications become relatively ineffective, resulting in worsening congestive symptoms and increased exercise intolerance. Cardiac resynchronization therapy provides a new adjunct for heart failure patients who remain symptomatic despite optimized medical therapies. This article discusses cardiac resynchronization therapy and measures that should be considered to ensure proper functioning of the device and improved quality of life for patients. PMID:15326978

  2. Cardiac resynchronization therapy pacemaker: critical appraisal of the adaptive CRT-P device

    PubMed Central

    Daoud, Georges E; Houmsse, Mahmoud

    2016-01-01

    Cardiac resynchronization therapy (CRT) is an effective and well-established therapy for patients suffering with heart failure, left ventricular (LV) systolic dysfunction (ejection fraction ≤35%), and electrical dyssynchrony, demonstrated by a surface QRS duration of ≥120 ms. Patients undergoing treatment with CRT have shown significant improvement in functional class, quality of life, LV ejection fraction, exercise capacity, hemodynamics, and reverse remodeling of LV, and ultimately, morbidity and mortality. However, 30%–40% of patients who receive a CRT device may not show improvement, and they are termed as non responders. The nonresponders have a poor prognosis; several methods have been developed to try to enhance response to CRT. Echocardiography-guided optimization of CRT has not resulted in significant clinical benefit, since it is done at rest with the patient in supine position. An ideal optimization strategy would provide continuous monitoring and adjustment of device pacing to provide maximal cardiac resynchronization, under a multitude of physiologic states. Intrinsic activation of the right ventricle (RV) with paced activation of the RV, even in the setting of biventricular (BiV) pacing, may result in an adverse effect on cardiac performance. With this physiology, the use of LV-only pacing may be preferred and may enhance CRT. Adaptive CRT is a novel device-based algorithm that was designed to achieve patient-specific adjustment in CRT so as to provide appropriate BiV pacing or LV-only pacing. This article will review the goals of CRT optimization, and implementation and outcomes associated with adaptive CRT. PMID:26848278

  3. Mitral Annuloplasty Using a Cardiac Resynchronization Device

    PubMed Central

    Manzoor Ali, Andrabi Syed; Iqbal, Khurshid; Trambu, Nisar Ahmed

    2010-01-01

    Percutaneous Transvenous Mitral Annuloplasty for mitral regurgitation is in early stages of development and involves a complex intervention which can not be done in patients with left ventricular leads. Since functional mitral regurgitation is common in low ejection fraction states, we propose a device which can serve for annuloplasty in addition to cardiac resynchronization therapy and simplifying the intervention. PMID:20680109

  4. Effect of Continued Cardiac Resynchronization Therapy on Ventricular Arrhythmias After Left Ventricular Assist Device Implantation.

    PubMed

    Schleifer, John William; Mookadam, Farouk; Kransdorf, Evan P; Nanda, Udai; Adams, Jonathon C; Cha, Stephen; Pajaro, Octavio E; Steidley, David Eric; Scott, Robert L; Carvajal, Tomas; Saadiq, Rayya A; Srivathsan, Komandoor

    2016-08-15

    Cardiac resynchronization therapy (CRT) reduces ventricular arrhythmia (VA) burden in some patients with heart failure, but its effect after left ventricular assist device (LVAD) implantation is unknown. We compared VA burden in patients with CRT devices in situ who underwent LVAD implantation and continued CRT (n = 39) to those who had CRT turned off before discharge (n = 26). Implantable cardioverter-defibrillator (ICD) shocks were significantly reduced in patients with continued CRT (1.5 ± 2.7 shocks per patient vs 5.5 ± 9.3 with CRT off, p = 0.014). There was a nonsignificant reduction in cumulative VA episodes per patient with CRT continued at discharge (42 ± 105 VA per patient vs 82 ± 198 with CRT off, p = 0.29). On-treatment analysis by whether CRT was on or off identified a significantly lower burden of VA (17 ± 1 per patient-year CRT on vs 37 ± 1 per patient-year CRT off, p <0.0001) and ICD shocks (1.2 ± 0.3 per patient-year CRT on vs 1.7 ± 0.3 per patient-year CRT off, p = 0.018). In conclusion, continued CRT is associated with significantly reduced ICD shocks and VA burden after LVAD implantation. PMID:27328958

  5. 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

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

    PubMed

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

    2016-01-01

    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, replacement of the CRT device may be complicated by bacterial endocarditis. As noted from this case report, sudden elevation of the pacing lead threshold should prompt thorough and immediate investigation to unravel its causes, not only the electrical characteristics but also the anatomical features. PMID:27435910

  7. Replacement of implantable cardioverter defibrillators and cardiac resynchronization therapy devices: results of the European Heart Rhythm Association survey.

    PubMed

    Tilz, Roland; Boveda, Serge; Deharo, Jean-Claude; Dobreanu, Dan; Haugaa, Kristina H; Dagres, Nikolaos

    2016-06-01

    The aim of this EP Wire was to assess the management, indications, and techniques for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) device replacement in Europe. A total of 24 centres in 14 European countries completed the questionnaire. All centres were members of the European Heart Rhythm Association Electrophysiology Research Network. Replacement procedures were performed by electrophysiologists in 52% of the centres, by cardiologists in 33%, and both in the remaining centres. In the majority of centres, the procedures were performed during a short hospitalization (<2 days; 61.2%), or on an outpatient basis (28%). The overwhelming majority of centres reported that they replaced ICDs at the end of battery life. Only in a small subset (<10%) of patients with ICD for primary prevention and without ventricular tachycardia (VT) since implantation, ICD was not replaced. In inherited primary arrhythmia syndromes, 80% of the centres always replaced the ICD at the end of battery life. After VT ablation, only few centres (9%) explanted or downgraded the device that was previously implanted for secondary prevention, but only in those patients without new VT episodes. Patient's life expectancy <1 year was the most commonly reported reason (61%) to downgrade from a CRT-D to a CRT-P device. While warfarin therapy was continued in 47% of the centres, non-vitamin K oral anticoagulants were discontinued without bridging 24 h prior to replacement procedures in 60%. Finally, in 65% of the centres, VT induction and shock testing during ICD and CRT-D replacement were performed only in the case of leads with a warning or with borderline measurements. This survey provides a snapshot of the perioperative management, indications, and techniques of ICD and CRT device replacement in Europe. It demonstrates some variations between participating centres, probably related to local policies and to the heterogeneity of the ICD population. PMID

  8. Recent advances in cardiac resynchronization therapy.

    PubMed

    Steffel, Jan; Holzmeister, Johannes; Abraham, William T

    2011-03-01

    Cardiac resynchronization therapy (CRT) is an integral component of modern heart failure therapy for patients with severe symptoms (New York Heart Association [NYHA] class III or IV), a reduced ejection fraction (≤ 35%), and a wide QRS complex (> 120 ms). Results from recent trials have provided ample evidence that CRT may also reduce morbidity and mortality in patients with mildly symptomatic heart failure (NYHA class II). As a result, the 2010 European guidelines now recommend CRT for this patient population (level of evidence I, class A). This review summarizes and critically evaluates the landmark Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE), Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT), and Resynchronization/Defibrillation for Ambulatory Heart Failure Trial (RAFT) studies, which comprise the suite of randomized controlled trials available today on this matter. Furthermore, we discuss the rationale and available evidence for other emerging indications for CRT, including its use in patients with a mildly reduced left ventricular ejection fraction (> 35%), in those with a narrow QRS complex (≤ 130 ms), or in patients with concomitant bradyarrhythmic pacemaker indications. PMID:21474889

  9. Cardiac resynchronization therapy for the treatment of heart failure.

    PubMed

    Nayar, Vikrant; Pugh, Peter J

    2010-02-01

    Heart failure is posing an increasing burden on healthcare systems around the world, a consequence of increased survival from acute coronary syndromes and life-prolonging medications. Cardiac resynchronization therapy has become a ratified and established therapy for heart failure to reduce both the morbidity and mortality of the condition. Its prophylactic role in patients who have minimal symptoms to delay future deterioration is a novel development. The indications for this therapy continue to evolve, mainly as a result of company-sponsored multicenter trial data aimed at broadening its usage. Uncertainty remains on how to accurately identify individuals who will respond to resynchronization therapy and how best to manage patients following device implant. PMID:20136609

  10. Device therapy in advanced heart failure: what to put in and what to turn off: remote telemonitoring and implantable hemodynamic devices for advanced heart failure monitoring in the ambulatory setting and the evolving role of cardiac resynchronization therapy.

    PubMed

    Smith, Sakima A; Abraham, William T

    2011-01-01

    Despite evidence based medical and pharmacologic advances the management of heart failure remains challenging, especially in the ambulatory setting. There is an urgent need to develop strategies to reduce hospitalizations and re-admission rates for heart failure in general. This focused review illustrates the potential role for remote telemonitoring and implantable hemodynamic devices to address this significant issue. We also explore the growth of cardiac resynchronization therapy and how it has evolved into another tool in our armamentarium for hemodynamic monitoring. PMID:21906246

  11. Cardiac Resynchronization Therapy Follow-up: Role of Remote Monitoring.

    PubMed

    Linde, Cecilia; Braunschweig, Frieder

    2015-12-01

    Cardiac resynchronization therapy (CRT) is increasingly used in heart failure treatment and management of these patients imposes significant challenges. Remote monitoring is becoming essential for CRT follow-up and allows close surveillance of device function and patient condition. It is helpful to reduce clinic visits, increase device longevity and provide early detection of device failure. Clinical effects include prevention of appropriate and inappropriate shocks and early detection of arrhythmias, such as atrial fibrillation. For modification of heart failure the addition of monitoring to CRT by means of device-based multiparameters may help to modify disease progression and improve survival. PMID:26596821

  12. Cardiac Resynchronization Therapy: An Overview on Guidelines.

    PubMed

    Boriani, Giuseppe; Nesti, Martina; Ziacchi, Matteo; Padeletti, Luigi

    2015-12-01

    Cardiac resynchronization therapy (CRT) is included in international consensus guidelines as a treatment with proven efficacy in well-selected patients on top of optimal medical therapy. Although all the guidelines strongly recommend CRT for LBBB with QRS duration greater than 150 milliseconds, lower strength of recommendation is reported for QRS duration of 120 to 150 milliseconds, especially if not associated with LBBB. CRT is not recommended for a QRS of less than 120 milliseconds. No indication emerges for guiding the implant based on echocardiographic evaluation of dyssynchrony. Many data indicate that CRT is underused and there is heterogeneity in its implementation. PMID:26596811

  13. Longevity of implantable cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer

    PubMed Central

    Landolina, Maurizio; Curnis, Antonio; Morani, Giovanni; Vado, Antonello; Ammendola, Ernesto; D'onofrio, Antonio; Stabile, Giuseppe; Crosato, Martino; Petracci, Barbara; Ceriotti, Carlo; Bontempi, Luca; Morosato, Martina; Ballari, Gian Paolo; Gasparini, Maurizio

    2015-01-01

    Aims Device replacement at the time of battery depletion of implantable cardioverter-defibrillators (ICDs) may carry a considerable risk of complications and engenders costs for healthcare systems. Therefore, ICD device longevity is extremely important both from a clinical and economic standpoint. Cardiac resynchronization therapy defibrillators (CRT-D) battery longevity is shorter than ICDs. We determined the rate of replacements for battery depletion and we identified possible determinants of early depletion in a series of patients who had undergone implantation of CRT-D devices. Methods and results We retrieved data on 1726 consecutive CRT-D systems implanted from January 2008 to March 2010 in nine centres. Five years after a successful CRT-D implantation procedure, 46% of devices were replaced due to battery depletion. The time to device replacement for battery depletion differed considerably among currently available CRT-D systems from different manufacturers, with rates of batteries still in service at 5 years ranging from 52 to 88% (log-rank test, P < 0.001). Left ventricular lead output and unipolar pacing configuration were independent determinants of early depletion [hazard ratio (HR): 1.96; 95% 95% confidence interval (CI): 1.57–2.46; P < 0.001 and HR: 1.58, 95% CI: 1.25–2.01; P < 0.001, respectively]. The implantation of a recent-generation device (HR: 0.57; 95% CI: 0.45–0.72; P < 0.001), the battery chemistry and the CRT-D manufacturer (HR: 0.64; 95% CI: 0.47–0.89; P = 0.008) were additional factors associated with replacement for battery depletion. Conclusion The device longevity at 5 years was 54%. High left ventricular lead output and unipolar pacing configuration were associated with early battery depletion, while recent-generation CRT-Ds displayed better longevity. Significant differences emerged among currently available CRT-D systems from different manufacturers. PMID:25976906

  14. An appreciation of some timing functions of a cardiac resynchronization device capable of left ventricular sensing.

    PubMed

    Barold, S Serge; Kucher, Andreas

    2016-09-01

    Some systems for cardiac resynchronization therapy (CRT) offer left ventricular sensing. This discussion with an illustrative case demonstrates that timing cycles in these devices may sometimes be difficult to understand because of left ventricular sensing. Programming of the left ventricular upper rate interval is crucial to optimize the resynchronization ability of the system. Interactions with the maximum sensor rate, the right ventricular upper rate interval, the left ventricular T wave protection algorithm, and the minimum ventricular tachycardia detection rate have to be considered. PMID:27605233

  15. Biomarkers in electrophysiology: role in arrhythmias and resynchronization therapy

    PubMed Central

    Bose, Abhishek; Truong, Quynh A.

    2015-01-01

    Circulating biomarkers related to inflammation, neurohormones, myocardial stress, and necrosis have been associated with commonly encountered arrhythmic disorders such as atrial fibrillation (AF) and more malignant processes including ventricular arrhythmias (VA) and sudden cardiac death (SCD). Both direct and indirect biomarkers implicated in the heart failure cascade have potential prognostic value in patients undergoing cardiac resynchronization therapy (CRT). This review will focus on the role of biomarkers in AF, history of SCD, and CRT with an emphasis to improve clinical risk assessment for arrhythmias and patient selection for device therapy. Notably, information obtained from biomarkers may supplement traditional diagnostic and imaging techniques, thus providing an additional benefit in the management of patients. PMID:25715916

  16. Lead positioning for cardiac resynchronization therapy: techniques and priorities.

    PubMed

    Morgan, John M; Delgado, Victoria

    2009-11-01

    Although cardiac resynchronization therapy (CRT) has demonstrated to be an effective treatment for heart failure patients, up to 30-40% of the patients do not show a favourable response. Implantation of the left ventricular (LV) pacing lead is one of the determinants of CRT response. This procedure includes several challenging technical issues and strongly depends on the highly variable anatomy of the coronary sinus and tributaries. In addition, the final position of the LV pacing lead may target the latest activated areas of the left ventricle in order to obtain effective resynchronization. Furthermore, the presence of transmural myocardial scar at the region targeted by the LV lead may also determine the response to CRT. This review discusses all the issues related to LV lead implantation and the role of multimodality imaging to anticipate the implantation strategy. Finally, alternative LV pacing sites and their effect on clinical outcome and LV performance will be discussed. PMID:19861387

  17. Cardiac Resynchronization Therapy in CKD: A Systematic Review

    PubMed Central

    Garg, Neha; Thomas, George; Jackson, Gregory; Rickard, John; Nally, Joseph V.; Tang, W.H. Wilson

    2013-01-01

    Summary Background Cardiac resynchronization therapy (CRT) confers morbidity and mortality benefits to selected patients with heart failure. This systematic review examined effects of CRT in CKD patients (estimated GFR [eGFR] <60 ml/min per 1.73 m2). Design, setting, participants, & measurements MEDLINE and Scopus (from 1990 to December 2012) and conference proceedings abstracts were searched for relevant observational studies and randomized controlled trials (RCTs). Studies comparing the following outcomes were included: (1) CKD patients with and without CRT and (2) CKD patients with CRT to non-CKD patients with CRT. Mortality, eGFR, and left ventricular ejection fraction data were extracted and pooled when appropriate using a random-effects model. Results Eighteen studies (14 observational studies and 4 RCTs) were included. There was a modest improvement in eGFR with CRT among CKD patients (mean difference 2.30 ml/min per 1.73m2; 95% confidence interval, 0.33 to 4.27). Similarly, there was a significant improvement in left ventricular ejection with CRT in CKD patients (mean difference 6.24%; 95% confidence interval, 3.46 to 9.07). Subgroup analysis of three RCTs reported lower rates of death or hospitalization for heart failure with CRT (versus other therapy) in the CKD population. Survival outcomes of CKD patients (compared with the non-CKD population) with CRT differed among observational studies and RCTs. Conclusions CRT improves left ventricular and renal function in the CKD population with heart failure. Given the increasing use of cardiac devices, further studies examining the effects of CRT on mortality in CKD patients, particularly those with advanced kidney disease, are warranted. PMID:23660183

  18. Why We Have to Use Cardiac Resynchronization Therapy-Pacemaker More.

    PubMed

    Daubert, Jean-Claude; Martins, Raphaël; Leclercq, Christophe

    2015-12-01

    Both cardiac resynchronization therapy with a pacemaker (CRT-P) and with a biventricular implantable cardioverter-defibrillator (CRT-D) are electrical treatment modalities validated for the management of chronic heart failure. There is no strong scientific evidence that a CRT-D must be offered to all candidates. Common sense should limit the prescription of these costly and complicated devices. The choice of CRT-P is currently acceptable. A direction to explore could be to downgrade from CRT-D to CRT-P at the time of battery depletion in patients with large reverse remodeling and no ventricular tachycardia and ventricular fibrillation detected. PMID:26596813

  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. Multisite Pacing for Cardiac Resynchronization Therapy: Promise and Pitfalls.

    PubMed

    Antoniadis, Antonios P; Behar, Jonathan M; Claridge, Simon; Jackson, Tom; Sohal, Manav; Rinaldi, Christopher Aldo

    2016-07-01

    Cardiac resynchronization therapy (CRT) reduces the morbidity and mortality of patients with symptomatic heart failure and intraventricular conduction delay. However, its clinical outcomes are non-uniform and up to one third of treated patients are subsequently classified as non-responders. Multisite pacing (MSP), i.e. stimulating the myocardium from multiple locations, has emerged as a potential therapeutic option in patients requiring CRT. The rationale for MSP is based on the hypothesis that increasing the pacing locations in the left ventricle results in a more physiologic and coordinated myocardial systole. MSP can be achieved by additional leads in the right or left ventricle but this can lead to high battery drain and more frequent generator replacements. Multipolar left ventricular leads can deliver pacing at multiple sites, and therefore, a single lead can be used for MSP. However, the optimal programming settings and the outcomes of this approach remain yet to be determined. PMID:27216844

  1. Thoracoscopic left ventricular lead implantation in cardiac resynchronization therapy.

    PubMed

    Jeong, Dong Seop; Park, Pyo Won; Lee, Young Tak; Park, Seung-Jung; Kim, June Soo; On, Young Keun

    2012-12-01

    Cardiac resynchronization therapy is known to reduce morbidity and mortality in patients with advanced heart failure as a result of dyssynchrony and systolic dysfunction of the left ventricle. Placement of the left ventricular (LV) lead via the coronary sinus can be difficult. When LV lead implantation is difficult, a video-assisted epicardial approach can be a good alternative. Although there are several reports of video-assisted epicardial LV lead implantation, mini-thoracotomy and lead implantation under direct vision have been used in most series. A 49-yr-old woman with dilated cardiomyopathy underwent the video-assisted epicardial LV lead implantation because percutaneous transvenous approach was difficult due to small cardiac veins. The patient was discharged without problems and showed improved cardiac function at the 3 follow-up months. We report the first successful total thoracoscopic LV lead implantation (without mini-thoracotomy) in Korea. PMID:23255865

  2. Cardiac resynchronization therapy: prospect for long-lasting heart failure remission.

    PubMed

    Sun, Shinning; Joglar, Jose A

    2011-08-01

    Heart failure (HF) remains an important heath care problem in the United States. With the aging of the US population, this trend is expected to continue. However, patients have also benefited from advances in pharmacologic and device-based therapies such as angiotensin-converting enzyme inhibitors, β-blockers, aldosterone blockers, and implantable cardioverter-defibrillators. More recently, cardiac resynchronization therapy (CRT) has become another important therapeutic option for treating heart failure due to systolic dysfunction. In this article, we review the physiologic basis for CRT, the clinical trials that support its efficacy, and the current indications for its use. We also examine key clinical questions regarding CRT still under research, including predictors of response. Finally, we look at the future of CRT and how its indications can be expanded to benefit more patients in the future. PMID:21441824

  3. Toward Sex-Specific Guidelines for Cardiac Resynchronization Therapy?

    PubMed

    Zusterzeel, Robbert; Selzman, Kimberly A; Sanders, William E; O'Callaghan, Kathryn M; Caños, Daniel A; Vernooy, Kevin; Prinzen, Frits W; Gorgels, Anton P M; Strauss, David G

    2016-02-01

    An important treatment for patients with heart failure is cardiac resynchronization therapy (CRT). Even though only 20% of women were included in clinical trials for CRT, a benefit has been shown in recent studies for subgroups of women compared to their male counterparts. Given this low inclusion rate of women in clinical studies, professional society guideline-based CRT recommendations, such as those by the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Rhythm Society (HRS), may not truly represent the best treatment for women, especially since most of the reports that showed this greater benefit in women were published after the latest guidelines. Despite having research and multiple publications regarding sex-specific heart failure outcomes and response to CRT, the ACCF/AHA/HRS guidelines have not yet been updated to account for the recent information regarding the differences in benefit for women and men with similar patient characteristics. This review discusses the physiology behind CRT, sex-specific characteristics of heart failure, and cardiac electrophysiology and summarizes the current sex-specific literature to encourage consideration of CRT guidelines for women and men separately. PMID:26659647

  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. The new criterion for cardiac resynchronization therapy treatment assessed by two channels impedance cardiography

    NASA Astrophysics Data System (ADS)

    Peczalski, K.; Palko, T.; Wojciechowski, D.; Dunajski, Z.; Kowalewski, M.

    2013-04-01

    The cardiac resynchronization therapy is an effective treatment for systolic failure patients. Independent electrical stimulation of left and right ventricle corrects mechanical ventricular dyssynchrony. About 30-40% treated patients do not respond to therapy. In order to improve clinical outcome authors propose the two channels impedance cardiography for assessment of ventricular dyssynchrony. The proposed method is intended for validation of patients diagnosis and optimization of pacemaker settings for cardiac resynchronization therapy. The preliminary study has showed that bichannel impedance cardiography is a promising tool for assessment of ventricular dyssynchrony.

  6. 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

  7. "Hyper-response" evaluated by 3D echocardiography after cardiac resynchronization therapy.

    PubMed

    Hotta, Viviane Tiemi; Vieira, Marcelo Luiz Campos; Rassi, Daniela do Carmo; Nishioka, Silvana Angelina D'orio; Martinelli Filho, Martino; Mathias, Wilson

    2011-06-01

    Cardiac resynchronization therapy consists of a promising treatment for patients with severe heart failure, but about 30% of patients do not exhibit clinical improvement with this procedure. However, approximately 10% of patients undergoing this therapy may have hyperresponsiveness, and three-dimensional echocardiography can provide an interesting option for the selection and evaluation of such patients. PMID:21789343

  8. Profile of St. Jude Medical's Allure Quadra quadripolar pacemaker system for cardiac resynchronization therapy.

    PubMed

    Corbisiero, Raffaele; Muller, David

    2015-01-01

    Congestive heart failure is a major public health epidemic and economic burden in the USA and worldwide. Cardiac resynchronization therapy is an effective therapy for treating congestive heart failure in conjunction with pharmacologic therapy. The average congestive heart failure admission costs approximately US$ 8 billion annually. Current cardiac resynchronization therapy pacemaker systems from various manufacturers deliver therapy-utilizing bipolar leads including the left ventricle, with electrode spacing ranging from 8 to 22 mm. The Quartet LV™ lead model 1458Q (St. Jude Medical Sylmar, CA) is a quadripolar lead with a 4.0 Fr. tip electrode and three 4.7 Fr. ring electrodes located 20, 30 and 47 mm from the tip. The Quartet lead and Allure Quadra TM allows 14 pacing configurations, providing benefits, including reductions in phrenic nerve stimulation, reduced pacing thresholds, improved battery longevity and potential reductions, in non-responders to cardiac resynchronization therapy. In addition, there is cost benefit data from utilizing quadripolar technology compared with traditional bipolar cardiac resynchronization therapy. PMID:25418543

  9. Cardiac resynchronization therapy in a young patient with Duchenne muscular dystrophy

    PubMed Central

    Kono, Tamami; Ogimoto, Akiyoshi; Nishimura, Kazuhisa; Yorozuya, Toshihiro; Okura, Takafumi; Higaki, Jitsuo

    2015-01-01

    A 32-year-old man with Duchenne muscular dystrophy (DMD) was admitted to the hospital because of worsening dyspnea and general fatigue. He had received medication therapy for cardiomyopathy with heart failure and home mechanical ventilation for respiratory failure. An electrocardiogram on admission showed intermittent third-degree atrioventricular block. Echocardiography showed global mild left ventricular systolic dysfunction with dyssynchrony (ejection fraction: 45%). He underwent implantation of a cardiac resynchronization therapy–defibrillator. His B-type natriuretic peptide level was improved after cardiac resynchronization therapy–defibrillator implantation, and he remains asymptomatic. The incidence of cardiomyopathy increases with age. By adulthood, 100% of patients have cardiac involvement. PMID:26346252

  10. Device therapies: new indications and future directions.

    PubMed

    Kumar, Prabhat; Schwartz, Jennifer D

    2015-01-01

    Implantable cardioverter-defibrillator (ICDs), cardiac resynchronization (CRT) and combination (CRT-D) therapy have become an integral part of the management of patients with heart failure with reduced ejection fraction (HFrEF). ICDs treat ventricular arrhythmia and CRTs improve left ventricular systolic function by resynchronizing ventricular contraction. Device therapies (ICD, CRT-D), have been shown to reduce all-cause mortality, including sudden cardiac death. Hospitalizations are reduced with CRT and CRT-D therapy. Major device related complications include device infection, inappropriate shocks, lead malfunction and complications related to extraction of devices. Improvements in device design and implantation have included progressive miniaturization and increasing battery life of the device, optimization of response to CRT, and minimizing inappropriate device therapy. Additionally, better definition of the population with the greatest benefit is an area of active research. PMID:25391852

  11. Changes in pulse pressure variability during cardiac resynchronization therapy in mechanically ventilated patients

    PubMed Central

    Keyl, Cornelius; Stockinger, Jochem; Laule, Sven; Staier, Klaus; Schiebeling-Römer, Jochen; Wiesenack, Christoph

    2007-01-01

    Introduction The respiratory variation in pulse pressure (PP) has been established as a dynamic variable of cardiac preload which indicates fluid responsiveness in mechanically ventilated patients. The impact of acute changes in cardiac performance on respiratory fluctuations in PP has not been evaluated until now. We used cardiac resynchronization therapy as a model to assess the acute effects of changes in left ventricular performance on respiratory PP variability without the need of pharmacological intervention. Methods In 19 patients undergoing the implantation of a biventricular pacing/defibrillator device under general anesthesia, dynamic blood pressure regulation was assessed during right ventricular and biventricular pacing in the frequency domain (power spectral analysis) and in the time domain (PP variation: difference between the maximal and minimal PP values, normalized by the mean value). Results PP increased slightly during biventricular pacing but without statistical significance (right ventricular pacing, 33 ± 10 mm Hg; biventricular pacing, 35 ± 11 mm Hg). Respiratory PP fluctuations increased significantly (logarithmically transformed PP variability -1.27 ± 1.74 ln mm Hg2 versus -0.66 ± 1.48 ln mm Hg2; p < 0.01); the geometric mean of respiratory PP variability increased 1.8-fold during cardiac resynchronization. PP variation, assessed in the time domain and expressed as a percentage, showed comparable changes, increasing from 5.3% (3.1%; 12.3%) during right ventricular pacing to 6.9% (4.7%; 16.4%) during biventricular pacing (median [25th percentile; 75th percentile]; p < 0.01). Conclusion Changes in cardiac performance have a significant impact on respiratory hemodynamic fluctuations in ventilated patients. This influence should be taken into consideration when interpreting PP variation. PMID:17445270

  12. Dyssynchrony by speckle-tracking echocardiography and response to cardiac resynchronization therapy: results of the Speckle Tracking and Resynchronization (STAR) study

    PubMed Central

    Tanaka, Hidekazu; Nesser, Hans-Joachim; Buck, Thomas; Oyenuga, Olusegun; Jánosi, Rolf Alexander; Winter, Siegmund; Saba, Samir; Gorcsan, John

    2010-01-01

    Aims The Speckle Tracking and Resynchronization (STAR) study used a prospective multi-centre design to test the hypothesis that speckle-tracking echocardiography can predict response to cardiac resynchronization therapy (CRT). Methods and results We studied 132 consecutive CRT patients with class III and IV heart failure, ejection fraction (EF) ≤35%, and QRS ≥120 ms from three international centres. Baseline dyssynchrony was evaluated by four speckle tracking strain methods; radial, circumferential, transverse, and longitudinal (≥130 ms opposing wall delay for each). Pre-specified outcome variables were EF response and three serious long-term events: death, transplant, or left ventricular assist device. Of 120 patients (91%) with baseline dyssynchrony data, both short-axis radial strain and transverse strain from apical views were associated with favourable EF response 7 ± 4 months and long-term outcome over 3.5 years (P < 0.01). Radial strain had the highest sensitivity at 86% for predicting EF response with a specificity of 67%. Serious long-term unfavourable events occurred in 20 patients after CRT, and happened three times more frequently in those who lacked baseline radial or transverse dyssynchrony than in patients with dyssynchrony (P < 0.01). Patients who lacked both radial and transverse dyssynchrony had unfavourable clinical events occur in 53%, in contrast to events occurring in 12% if baseline dyssynchrony was present (P < 0.01). Circumferential and longitudinal strains predicted response when dyssynchrony was detected, but failed to identify dyssynchrony in one-third of patients who responded to CRT. Conclusion Dyssynchrony by speckle-tracking echocardiography using radial and transverse strains is associated with EF response and long-term outcome following CRT. PMID:20530502

  13. 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. PMID:26099323

  14. 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.

  15. 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

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

    PubMed

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

    2016-08-01

    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

  17. First clinical evaluation of an atrial haemodynamic sensor lead for automatic optimization of cardiac resynchronization therapy

    PubMed Central

    Duncker, David; Delnoy, Peter Paul; Nägele, Herbert; Mansourati, Jacques; Mont, Lluís; Anselme, Frédéric; Stengel, Petra; Anselmi, Francesca; Oswald, Hanno; Leclercq, Christophe

    2016-01-01

    Aims One option to improve cardiac resynchronization therapy (CRT) responder rates lies in the optimization of pacing intervals. A haemodynamic sensor embedded in the SonRtip atrial lead measures cardiac contractility and provides a systematic automatic atrioventricular and interventricular delays optimization. This multi-centre study evaluated the safety and performance of the lead, up to 1 year. Methods and results A total of 99 patients were implanted with the system composed of the lead and a CRT-Defibrillator device. Patients were followed at 1, 3, 6, and 12 months post-implant. The primary safety objective was to demonstrate that the atrial lead complication free rate was superior to 90% at 3-months follow-up visit. A lead handling questionnaire was filled by implanting investigators. Lead electrical performances and the performance of the system to compute AV and VV delays were evaluated at each study visit over 1 year. The complication free rate at 3 months post-implant was 99.0% [95%CI 94.5–100.0%], P < 0.001. Electrical performances of the lead were adequate whatever the atrial lead position and remained stable over the study period. The optimization algorithm was able to compute AV and VV delays in 97% of patients, during >75% of the weeks. Conclusion The atrial lead is safe to implant and shows stable electrical performance over time. It therefore offers a promising tool for automatic CRT optimization to further improve responder rates to CRT. PMID:25976907

  18. 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. PMID:22521929

  19. 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

  20. 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

  1. Techniques for identification of left ventricular asynchrony for cardiac resynchronization therapy in heart failure

    PubMed Central

    Schuster, Peter; Faerestrand, Svein

    2005-01-01

    The most recent treatment option of medically refractory heart failure includes cardiac resynchronization therapy (CRT) by biventricular pacing in selected patients in NYHA functional class III or IV heart failure. The widely used marker to indicate left ventricular (LV) asynchrony has been the surface ECG, but seems not to be a sufficient marker of the mechanical events within the LV and prediction of clinical response. This review presents an overview of techniques for identification of left ventricular intra- and interventricular asynchrony. Both manuscripts for electrical and mechanical asynchrony are reviewed, partly predicting response to CRT. In summary there is still no gold standard for assessment of LV asynchrony for CRT, but both traditional and new echocardiographic methods have shown asynchronous LV contraction in heart failure patients, and resynchronized LV contraction during CRT and should be implemented as additional methods for selecting patients to CRT. PMID:16943866

  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. The Relationship of Echocardiographic Dyssynchrony to Long-Term Survival Following Cardiac Resynchronization Therapy

    PubMed Central

    Gorcsan, John; Oyenuga, Olusegun; Habib, Phillip J.; Tanaka, Hidekazu; Adelstein, Evan C.; Hara, Hideyuki; McNamara, Dennis M.; Saba, Samir

    2010-01-01

    Background The ability of echocardiographic dyssynchrony to predict response to cardiac resynchronization therapy (CRT) has been unclear. Methods and Results A prospective, longitudinal study was designed with pre-defined dyssynchrony indices and outcome variables to test the hypothesis that baseline dyssynchrony is associated with long term survival following CRT. We studied 229 consecutive Class III–IV heart failure patients, with ejection fraction (EF) ≤35%, and QRS duration ≥120ms for CRT. Dyssynchrony before CRT was defined as: tissue Doppler velocity opposing wall delay ≥ 65 ms, 12-site standard deviation (Yu Index) ≥32ms; speckle tracking radial strain anteroseptal to posterior wall delay ≥130ms; or pulsed Doppler interventricular mechanical delay (IVMD) ≥ 40 ms. Outcome was defined as freedom from death, heart transplant or left ventricular assist device (LVAD). Of 210 patients (89%) with dyssynchrony data available, there were 62 events: 47 deaths, 9 transplants, and 6 LVADs over 4 years. Event-free survival was associated with: Yu Index (p=0.003), speckle tracking radial strain (p=0.003), and IVMD (p=0.019). When adjusted for confounding baseline variables of ischemic etiology and QRS duration, Yu Index and radial strain dyssynchrony remained independently associated with outcome (p<0.05). Lack of radial dyssynchrony was particularly associated with unfavorable outcome in those with QRS duration 120–150 ms (p=0.002). Conclusions The absence of echocardiographic dyssynchrony was associated with significantly less favorable event-free survival following CRT. Patients with narrower QRS duration who lacked dyssynchrony had the least favorable long term outcome. These observations support the relationship of dyssynchrony to CRT response. PMID:20975000

  4. LV Dyssynchrony Is Helpful in Predicting Ventricular Arrhythmia in Ischemic Cardiomyopathy After Cardiac Resynchronization Therapy

    PubMed Central

    Tsai, Shih-Chuan; Chang, Yu-Cheng; Chiang, Kuo-Feng; Lin, Wan-Yu; Huang, Jin-Long; Hung, Guang-Uei; Kao, Chia-Hung; Chen, Ji

    2016-01-01

    Abstract For patients with coronary artery disease, larger scar burdens are associated with higher risk of ventricular arrhythmia. Left ventricular (LV) dyssynchrony is associated with increased risk of sudden cardiac death in patients with heart failure. The purpose of this study was to assess the values of LV dyssynchrony and myocardial scar assessed by myocardial perfusion SPECT (MPS) in predicting the development of ventricular arrhythmia in ischemic cardiomyopathy. Twenty-two patients (16 males, mean age: 66 ± 13) with irreversible ischemic cardiomyopathy received cardiac resynchronization therapy (CRT) for at least 12 months were enrolled for MPS. Quantitative parameters, including LV dyssynchrony with phase standard deviation (phase SD) and bandwidth, left ventricular ejection fraction (LVEF), and scar (% of total areas), were generated by Emory Cardiac Toolbox. Ventricular tachycardia (VT) and ventricular fibrillation (VF) recorded in the CRT device during follow-up were used as the reference standard of diagnosing ventricular arrhythmia. Stepwise logistic regression analysis was performed for determining the independent predictors of VT/VF and receiver operating characteristic (ROC) curve analysis was used for generating the optimal cut-off values for predicting VT/VF. Nine (41%) of the 22 patients developed VT/VF during the follow-up periods. Patients with VT/VF had significantly lower LVEF, larger scar, larger phase SD, and larger bandwidth (all P < 0.05). Logistic regression analysis showed LVEF and bandwidth were independent predictors of VT/VF. ROC curve analysis showed the areas under the curves were 0.71 and 0.83 for LVEF and bandwidth, respectively. The optimal cut-off values were <36% and > 139° for LVEF and bandwidth, respectively. The sensitivity, specificity, positive predictive value, and negative predictive value were 100%, 39%, 53%, and 100%, respectively, for LVEF; and were 78%, 92%, 88%, and 86%, respectively, for bandwidth. LV

  5. 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

  6. 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

  7. Knowledge expectations, self-care, and health complaints of heart failure patients scheduled for cardiac resynchronization therapy implantation

    PubMed Central

    Ingadottir, Brynja; Thylén, Ingela; Jaarsma, Tiny

    2015-01-01

    Purpose To describe what knowledge heart failure patients expect to acquire in relation to their upcoming cardiac resynchronization therapy (CRT) device implantation, to describe their self-care and health complaints, and to explore the relationship between knowledge expectations and self-care, health complaints, and background factors. Patients and methods Cross-sectional multicenter study with 104 patients scheduled for a first-time, elective CRT implantation in Swedish and Icelandic hospitals. Data were collected with the Knowledge Expectations of hospital patient Scale, European Heart Failure Self-care Behavior Scale, and Adjusted Postoperative Recovery Profile. Results Patients expected most knowledge related to their disease and its treatment (median 4.0, interquartile range 0.13) and least on social issues (median 3.5, interquartile range 0.83). Their self-care was average (standardized mean 51.0±19.6) before the procedure. Patients had on average 8.2 (±4.7) health complaints and rated fatigue and sexual problems as the most severe. Age was independently associated with knowledge expectations (Expβ 0.049, P=0.033). Conclusion Heart failure patients waiting for a CRT device implantation have high expectations for multiple aspects of knowledge, including self-care issues, before their procedure. These expectations are similar to those of other surgical patients and they increase with age. PMID:26170641

  8. Pre-implant right ventricular function might be an important predictor of the response to cardiac resynchronization therapy

    PubMed Central

    2011-01-01

    Objective Cardiac resynchronization therapy is proven efficacious in patients with heart failure (HF). Presence of biventricular HF is associated with a worse prognosis than having only left ventricular (LV) HF and pacing might deteriorate heart function. The aim of the study was to assess a possible significance of right ventricular (RV) pre-implant systolic function to predict response to CRT. Design We studied 22 HF-patients aged 72 ± 11 years, QRS-duration 155 ± 20 ms and with an LV ejection fraction (EF) of 26 ± 6% before and four weeks after receiving a CRT-device. Results There were no changes in LV diameters or end systolic volume (ESV) during the study. However, end diastolic volume (EDV) decreased from 226 ± 71 to 211 ± 64 ml (p = 0.02) and systolic maximal velocities (SMV) increased from 2.2 ± 0.4 to 2.6 ± 0.9 cm/s (p = 0.04). Pre-implant RV-SMV (6.2 ± 2.6 cm/s) predicted postoperative increase in LV contractility, p = 0.032. Conclusions Pre-implant decreased RV systolic function might be an important way to predict a poor response to CRT implicating that other treatments should be considered. Furthermore we found that 3D- echocardiography and Tissue Doppler Imaging were feasible to detect short-term changes in LV function. PMID:22029550

  9. 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

  10. Non-responders to cardiac resynchronization therapy: the magnitude of the problem and the issues.

    PubMed

    Auricchio, Angelo; Prinzen, Frits W

    2011-01-01

    A variable proportion of cardiac resynchronization therapy (CRT) patients do not benefit from treatment (termed `non-responders'). The problem of non-response to CRT might become increasingly important, because it is anticipated that larger groups of heart failure patients are indicated to the therapy. This article will discuss the definition of response to CRT, the parameters related to response to CRT, and finally whether response to CRT might be predicted. The effort to improve patient selection in order to maximize human and financial resource utilization has fallen short so far. It is, however, conceivable that rather than the identification of a `universally' applicable cut-off value, risk strata-in which inclusion of method for determination of left ventricular volumes, etiology, QRS duration and morphology, etc-might better serve the goal of defining non-responders. Potentially simple clinical scores might help in refining outcome and by doing so, allow to more precisely measure response to CRT in daily practice in the individual patient at the time of CRT implantation. Although sophisticated cardiac imaging modalities have been intensively utilized for improving patient outcome, it seems that many mechanical dyssynchrony measures suffer from technical limitations and from difficult interpretation of the complex signals, which lack reproducibility outside highly specialized laboratories. PMID:21325727

  11. The relationship between ventricular electrical delay and left ventricular remodelling with cardiac resynchronization therapy

    PubMed Central

    Gold, Michael R.; Birgersdotter-Green, Ulrika; Singh, Jagmeet P.; Ellenbogen, Kenneth A.; Yu, Yinghong; Meyer, Timothy E.; Seth, Milan; Tchou, Patrick J.

    2011-01-01

    Aims The aim of the present study was to evaluate the relationship between left ventricular (LV) electrical delay, as measured by the QLV interval, and outcomes in a prospectively designed substudy of the SMART-AV Trial. Methods and results This was a multicentre study of patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT) defibrillator implantation. In 426 subjects, QLV was measured as the interval from the onset of the QRS from the surface ECG to the first large peak of the LV electrogram. Left ventricular volumes were measured by echocardiography at baseline and after 6 months of CRT by a blinded core laboratory. Quality of life (QOL) was assessed by a standardized questionnaire. When separated by quartiles based on QLV duration, reverse remodelling response rates (>15% reduction in LV end systolic volume) increased progressively from 38.7 to 68.4% and QOL response rate (>10 points reduction) increased from 50 to 72%. Patients in the highest quartile of QLV had a 3.21-fold increase (1.58–6.50, P = 0.001) in their odds of a reverse remodelling response after correcting for QRS duration, bundle branch block type, and clinical characteristics by multivariate logistic regression analysis. Conclusion Electrical dyssynchrony, as measured by QLV, was strongly and independently associated with reverse remodelling and QOL with CRT. Acute measurements of QLV may be useful to guide LV lead placement. PMID:21875862

  12. 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. PMID:27025953

  13. Tracing the European course of cardiac resynchronization therapy from 2006 to 2008.

    PubMed

    Merkely, Bela; Roka, Attila; Kutyifa, Valentina; Boersma, Lucas; Leenhardt, Antoine; Lubinski, Andrzej; Oto, Ali; Proclemer, Alessandro; Brugada, Josep; Vardas, Panos E; Wolpert, Christian

    2010-05-01

    Cardiac resynchronization therapy (CRT) is a highly efficient treatment modality for patients with severe congestive heart failure and intraventricular dyssynchrony. However, the high individual cost and technical complexity of the implantation may limit its widespread utilization. The European Heart Rhythm Association (EHRA) launched a project to assess treatment of arrhythmias in all European Society of Cardiology member countries in order to have a platform for a progressive harmonization of arrhythmia treatment. As a result, two EHRA White Books have been published in 2008 and 2009 based on governmental, insurance, and professional society data. Our aim was to analyse the local differences in the utilization of CRT, based on these surveys. A total of 41 countries provided enough data to analyse years 2006-2008. Significant differences were found in the overall number of implantations and the growth rate between 2006 and 2008. Other contributing factors include local reimbursement of CRT, the existence of national guidelines, and a high number of conventional implantable cardioverter-defibrillator implantations, while GDP or healthcare spending has less effect. Focusing on improving these factors may increase the availability of CRT in countries where it is currently underutilized. PMID:20200017

  14. Safety and Cost-Effectiveness of Same-Day Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillator Implantation.

    PubMed

    Atherton, Gavin; McAloon, Christopher James; Chohan, Bhaveek; Heining, Dominic; Anderson, Benjamin; Barker, Jethro; Randeva, Harpal; Osman, Faizel

    2016-05-01

    Cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD) implantation improve morbidity and mortality in selected patients. Many centers still admit patients overnight. We evaluated the safety, feasibility, and cost savings of same-day CRT/ICD device implantation by performing a retrospective study of all consecutive elective CRT/ICD implants at a tertiary center from January 2009 to April 2013. All emergency and/or inpatient cases were excluded. Data were collected on baseline demographics, implantation indication, procedure details, complications (categorized as immediate [≤24 hours], short term [24 hours to 6 weeks], medium term [6 weeks to 4 months], and long term [>4 months]), and mortality (30 day and 1 year). Comparisons were made between those having planned same-day versus overnight stay procedures. A cost analysis was performed to evaluate cost savings of the same-day policy. A total of 491 devices were implanted during this period: 267 were elective (54 planned overnight, 213 planned same-day) of which 229 were CRT pacemakers or CRT defibrillators and 38 ICDs. There were 26 total overall complications (9.7%) with no significant differences between planned same-day versus planned overnight stay cohorts (9.4% vs 11.1%, p = 0.8) and specifically no differences in immediate, short-, medium-, and long-term complications at follow-up. The 30-day and 1-year mortality rates did not differ between the two groups. An overnight stay at our hospital costs $450 (£300); our cost saving during this period was $91,800 (£61,200). Same-day CRT/ICD implantation is safe, feasible, and associated with significant cost savings. It provides significant advantages for patients and health care providers, especially given the current financial climate. PMID:26993428

  15. Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study

    PubMed Central

    Sack, Stefan; Wende, Christian Michael; Nägele, Herbert; Katz, Amos; Bauer, Wolfgang Rudolf; Barr, Craig Scott; Malinowski, Klaus; Schwacke, Harald; Leyva, Francisco; Proff, Jochen; Berdyshev, Sergey; Paul, Vincent

    2011-01-01

    Aim To investigate whether diagnostic data from implanted cardiac resynchronization therapy defibrillators (CRT-Ds) retrieved automatically at 24 h intervals via a Home Monitoring function can enable dynamic prediction of cardiovascular hospitalization and death. Methods and results Three hundred and seventy-seven heart failure patients received CRT-Ds with Home Monitoring option. Data on all deaths and hospitalizations due to cardiovascular reasons and Home Monitoring data were collected prospectively during 1-year follow-up to develop a predictive algorithm with a predefined specificity of 99.5%. Seven parameters were included in the algorithm: mean heart rate over 24 h, heart rate at rest, patient activity, frequency of ventricular extrasystoles, atrial–atrial intervals (heart rate variability), right ventricular pacing impedance, and painless shock impedance. The algorithm was developed using a 25-day monitoring window ending 3 days before hospitalization or death. While the retrospective sensitivities of the individual parameters ranged from 23.6 to 50.0%, the combination of all parameters was 65.4% sensitive in detecting cardiovascular hospitalizations and deaths with 99.5% specificity (corresponding to 1.83 false-positive detections per patient-year of follow-up). The estimated relative risk of an event was 7.15-fold higher after a positive predictor finding than after a negative predictor finding. Conclusion We developed an automated algorithm for dynamic prediction of cardiovascular events in patients treated with CRT-D devices capable of daily transmission of their diagnostic data via Home Monitoring. This tool may increase patients’ quality of life and reduce morbidity, mortality, and health economic burden, it now warrants prospective studies. ClinicalTrials.gov  NCT00376116. PMID:21852311

  16. 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

  17. Usefulness of the Sum Absolute QRST Integral to Predict Outcomes in Patients Receiving Cardiac Resynchronization Therapy.

    PubMed

    Jacobsson, Jonatan; Borgquist, Rasmus; Reitan, Christian; Ghafoori, Elyar; Chatterjee, Neal A; Kabir, Muammar; Platonov, Pyotr G; Carlson, Jonas; Singh, Jagmeet P; Tereshchenko, Larisa G

    2016-08-01

    Cardiac resynchronization therapy (CRT) reduces mortality and morbidity in selected patients with heart failure (HF), but up to 1/3 of patients are nonresponders. Sum absolute QRST integral (SAI QRST) recently showed association with mechanical response on CRT. However, it is unknown whether SAI QRST is associated with all-cause mortality and HF hospitalizations in patients undergoing CRT. The study population included 496 patients undergoing CRT (mean age 69 ± 10 years, 84% men, 65% left bundle branch block [LBBB], left ventricular ejection fraction 23 ± 6%, 63% ischemic cardiomyopathy). Preimplant digital 12-lead electrocardiogram was transformed into orthogonal XYZ electrocardiogram. SAI QRST was measured as an arithmetic sum of areas under the QRST curve on XYZ leads and was dichotomized based on the median value (302 mV ms). All-cause mortality served as the primary end point. A composite of 2-year all-cause mortality, heart transplant, and HF hospitalization was a secondary end point. Cox regression models were adjusted for known predictors of CRT response. Patients with preimplant low mean SAI QRST had an increased risk of both the primary (hazard ratio [HR] 1.8, 95% CI 1.01 to 3.2) and secondary (HR 1.6, 95% CI 1.1 to 2.2) end points after multivariate adjustment. SAI QRST was associated with secondary outcome in subgroups of patients with LBBB (HR 2.1, 95% CI 1.5 to 3.0) and with non-LBBB (HR 1.7, 95% CI 1.0 to 2.6). In patients undergoing CRT, preimplant SAI QRST <302 mV ms was associated with an increased risk of all-cause mortality and HF hospitalization. After validation in another prospective cohort, SAI QRST may help to refine selection of CRT recipients. PMID:27265674

  18. Effect of cardiac resynchronization therapy on pulmonary function in patients with heart failure.

    PubMed

    Cundrle, Ivan; Johnson, Bruce D; Somers, Virend K; Scott, Christopher G; Rea, Robert F; Olson, Lyle J

    2013-09-15

    Pulmonary congestion due to heart failure causes abnormal lung function. Cardiac resynchronization therapy (CRT) is a proven effective treatment for heart failure. The aim of this study was to test the hypothesis that CRT promotes increased lung volumes, bronchial conductance, and gas diffusion. Forty-four consecutive patients with heart failure were prospectively investigated before and after CRT. Spirometry, gas diffusion (diffusing capacity for carbon monoxide), cardiopulmonary exercise testing, New York Heart Association class, brain natriuretic peptide, the left ventricular ejection fraction, left atrial volume, and right ventricular systolic pressure were assessed before and 4 to 6 months after CRT. Pre- and post-CRT measures were compared using either paired Student's t tests or Wilcoxon's matched-pair test; p values <0.05 were considered significant. Improved New York Heart Association class, left ventricular ejection fraction, left atrial volume, right ventricular systolic pressure, and brain natriuretic peptide were observed after CRT (p <0.05 for all). Spirometry after CRT demonstrated increased percentage predicted total lung capacity (90 ± 17% vs 96 ± 15%, p <0.01) and percentage predicted forced vital capacity (80 ± 19% vs 90 ± 19%, p <0.01). Increased percentage predicted total lung capacity was significantly correlated with increased peak exercise end-tidal carbon dioxide (r = 0.43, p = 0.05). Increased percentage predicted forced vital capacity was significantly correlated with decreased right ventricular systolic pressure (r = -0.30, p = 0.05), body mass index (r = -0.35, p = 0.02) and creatinine (r = -0.49, p = 0.02), consistent with an association of improved bronchial conductance and decreased congestion. Diffusing capacity for carbon monoxide did not significantly change. In conclusion, increased lung volumes and bronchial conductance due to decreased pulmonary congestion and increased intrathoracic space contribute to an improved

  19. Inflammatory activation following interruption of long-term cardiac resynchronization therapy.

    PubMed

    Rubaj, Andrzej; Ruciński, Piotr; Oleszczak, Krzysztof; Trojnar, Michał K; Wójcik, Maciej; Wysokiński, Andrzej; Kutarski, Andrzej

    2013-09-01

    Previous observations suggest that cardiac resynchronization therapy (CRT) may exert an anti-inflammatory effect. The objective of this study was to evaluate the effect of temporary interruption of long-term CRT on plasma concentrations of proinflammatory cytokines and brain natriuretic peptide (BNP). The study group consisted of 54 patients (32 male and 22 female, mean age 64 years) with chronic heart failure (HF) treated with CRT. BNP, high-sensitivity C-reactive protein (hs-CRP), interleukin 6 (IL-6), and neopterin were measured three times: after 26-28 weeks of continuous CRT (CRT-on), 48 h after its cessation (CRT-off), and 48 h after switching the CRT-on again. CRT interruption resulted in a significant worsening of left ventricular systolic function: reduction of cardiac output (CO), dP/dt, and left ventricular ejection fraction (LVEF), as well as deterioration of mitral regurgitation in the CRT responder group. A significant increase in serum concentrations of hs-CRP, neopterin, IL-6, and BNP was noted in this subpopulation. In CRT nonresponders, no significant changes were observed. In responders the changes in serum concentrations of hs-CRP, IL-6, neopterin, and BNP, following CRT interruption, significantly correlated with the respective changes in thoracic fluid content (TFC) and inversely correlated with LVEF changes. Even short (48 h) interruption of long-term CRT led to a significant increase of proinflammatory cytokines and BNP concentrations in responders. The changes in hs-CRP, IL-6, neopterin, and BNP concentrations correlated with the change in TFC-marker of pulmonary congestion and inversely correlated with the change in LVEF. PMID:23242167

  20. Mid-Term Outcomes in Patients Implanted with Cardiac Resynchronization Therapy

    PubMed Central

    Lee, Sung Ho; Park, Seung-Jung; Kim, June Soo; Shin, Dae-Hee; Cho, Dae Kyoung

    2014-01-01

    We applied cardiac resynchronization therapy (CRT) for desynchronized heart failure patients. We evaluated clinical outcomes including morbidity, mortality, and echocardiographic parameters in 47 patients with implanted CRT in Korea from October 2005 to May 2013. The combined outcomes of hospitalization from heart failure, heart transplantation and death were the primary end point. Median follow-up period was 17.5 months. The primary outcomes listed above occurred in 10 (21.3%) patients. Two patients (4.3%) died after CRT and 8 (17%) patients were hospitalized for recurrent heart failure. Among patients hospitalized for heart failure, 2 (4.3%) patients underwent heart transplantation. The overall free rate of heart failure requiring hospitalization was 90.1% (95% CI, 0.81-0.99) over one year and 69.4% (95% CI, 0.47-0.91) over 3 yr. We observed improvement of the New York Heart Association classification (3.1±0.5 to 1.7±0.4), decreases in QRS duration (169.1 to 146.9 ms), decreases in left ventricular (LV) end-diastolic (255.0 to 220.1 mL) and end-systolic (194.4 to 159.4 mL) volume and increases in LV ejection fraction (22.5% to 31.1%) at 6 months after CRT. CRT improved symptoms and echocardiographic parameters in a relatively short period, resulting in low mortality and a decrease in hospitalization due to heart failure. PMID:25469065

  1. Roles and indications for use of implantable defibrillator and resynchronization therapy in the prevention of sudden cardiac death in heart failure.

    PubMed

    Biton, Yitschak; Baman, Jayson R; Polonsky, Bronislava

    2016-07-01

    Implantable devices are indicated in the primary and secondary prevention of potentially life-threatening ventricular tachyarrhythmias in patients with heart failure. Early studies, including the landmark MADIT trials, showed that implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices can play a significant role in aborting and preventing ventricular arrhythmias, respectively, that can cause sudden cardiac death. To this day, there have been a number of randomized controlled trials, with respective substudy analyses, that have attempted to better understand the indications for these interventions in patient care. Here, we summarize the major results of these studies, and we discuss the role of ICD therapy for both ischemic and non-ischemic cardiomyopathy, emerging evidence in support of wearable defibrillators, and the impact of modified ICD programming strategies on patient outcomes. Regarding CRT therapy, the phenomenon of ventricular reverse remodeling is an important prognostic indicator in preventing future ventricular tachyarrhythmia episodes. In summation, we provide an overview of the possible selection criteria that can be used in identifying appropriate patients for ICD and/or CRT therapy, as supported by the data. PMID:26910804

  2. Real-time stroke volume measurements for the optimization of cardiac resynchronization therapy parameters

    PubMed Central

    Dizon, José M.; Quinn, T. Alexander; Cabreriza, Santos E.; Wang, Daniel; Spotnitz, Henry M.; Hickey, Kathleen; Garan, Hasan

    2010-01-01

    Aims We investigated the utility of real-time stroke volume (SV) monitoring via the arterial pulse power technique to optimize cardiac resynchronization therapy (CRT) parameters at implant and prospectively evaluated the clinical and echocardiographic results. Methods and results Fifteen patients with ischaemic or non-ischaemic dilated cardiomyopathy, sinus rhythm, Class III congestive heart failure, and QRS >150 ms underwent baseline 2D echocardiogram (echo), 6 min walk distance, and quality of life (QOL) questionnaire  within 1 week of implant. Following implant, 0.3 mmol lithium chloride was injected to calibrate SV via dilution curve. Atrioventricular (AV) delay (90, 120, 200 ms, baseline: atrial pacing only) and V-V delay (−80 to 80 ms in 20 ms increments) were varied every 60 s. The radial artery pulse power autocorrelation method (PulseCO algorithm, LiDCO, Ltd.) was used to monitor SV on a beat-to-beat basis (LiDCO, Ltd.). Optimal parameters were programmed and echo, 6 min walk, and QOL were repeated at 6–8 weeks post-implant. Nine patients had >5% increase in SV after optimization (Group A). Six patients had <5% improvement in SV (Group B). Compared with Group B, Group A had significant improvements in left ventricular ejection fraction (LVEF) (11.0 ± 8.5 vs. 0.8 ± 2.0%) and decrease in left ventricular end-diastolic dimension (LVEDD) (−0.6 ± 0.4 vs. −0.2 ± 0.2 cm) and 6 min walk (346 ± 226 vs. 32 ±271 ft, P ≤ 0.05). Group A patients also tended to have greater improvement in the septal-to-posterior wall motion delay on M-mode echo (P = 0.07). Conclusion Real-time SV measurements can be used to optimize CRT at the time of implant. Improvement in SV correlates with improvement in LVEF, LVEDD, and 6 min walk, and improvement in echocardiographic dyssynchrony. PMID:20525728

  3. The ratio of the neutrophil leucocytes to the lymphocytes predicts the outcome after cardiac resynchronization therapy

    PubMed Central

    Boros, András Mihály; Széplaki, Gábor; Perge, Péter; Jenei, Zsigmond; Bagyura, Zsolt; Zima, Endre; Molnár, Levente; Apor, Astrid; Becker, Dávid; Gellér, László; Prohászka, Zoltán; Merkely, Béla

    2016-01-01

    Aims The low lymphocyte counts and high neutrophil leucocyte fractions have been associated with poor prognosis in chronic heart failure. We hypothesized that the baseline ratio of the neutrophil leucocytes to the lymphocytes (NL ratio) would predict the outcome of chronic heart failure patients undergoing cardiac resynchronization therapy (CRT). Methods and results The qualitative blood counts and the serum levels of N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) of 122 chronic heart failure patients and 122 healthy controls were analysed prospectively in this observational study. The 2-year mortality was considered as primary endpoint and the 6-month reverse remodelling (≥15% decrease in the end-systolic volume) as secondary endpoint. Multivariable regression analyses were applied and net reclassification improvement (NRI) and integrated discrimination improvement (IDI) were calculated. The NL ratio was elevated in chronic heart failure patients when compared with the healthy controls [2.93 (2.12–4.05) vs. 2.21 (1.64–2.81), P < 0.0001]. The baseline NL ratio exceeding 2.95 predicted the lack of the 6-month reverse remodelling [n = 63, odds ratio = 0.38 (0.17–0.85), P = 0.01; NRI = 0.49 (0.14–0.83), P = 0.005; IDI = 0.04 (0.00–0.07), P = 0.02] and the 2-year mortality [n = 29, hazard ratio = 2.44 (1.04–5.71), P = 0.03; NRI = 0.63 (0.24–1.01), P = 0.001; IDI = 0.04 (0.00–0.08), P = 0.02] independently of the NT-proBNP levels or other factors. Conclusion The NL ratio is elevated in chronic heart failure and predicts outcome after CRT. According to the reclassification analysis, 4% of the patients would have been better categorized in the prediction models by combining the NT-proBNP with the NL ratio. Thus, a single blood count measurement could facilitate the optimal patient selection for the CRT. PMID:25972301

  4. Utility of three-dimensional echocardiography in assessing and predicting response to cardiac resynchronization therapy

    PubMed Central

    Lau, Ching; Abdel-Qadir, Husam M; Lashevsky, Ilan; Hansen, Mark; Crystal, Eugene; Joyner, Campbell

    2010-01-01

    BACKGROUND Cardiac resynchronization therapy (CRT) can be a valuable treatment for heart failure. However, there are high nonresponse rates using current CRT inclusion criteria. OBJECTIVE To assess the value of three-dimensional echocardiography (3DE) in predicting response to CRT. METHODS Functional assessments and 3DE were performed in heart failure patients pre-CRT, 24 h post-CRT and six to 12 months after CRT. The dyssynchrony index (DI) was calculated as the SD of the time to minimum volume in 16 left ventricle segments corrected by heart rate. Response to CRT was defined as functional improvement (alive at late follow-up with improvement by one New York Heart Association class) and a decrease in left ventricular end-systolic volume by 15% or greater at six to 12 months follow-up. RESULTS A total of 53 patients were enrolled. Average 3DE acquisition time was less than 5 min. Seventy-two per cent of patients showed functional improvement, while 43% showed functional and echocardiographic evidence of response. Baseline DI and the decrease in DI at 24 h were both correlated with reverse remodelling. Responders had higher baseline DI values compared with nonresponders (mean 16.8 versus 7.1, P<0.001), and showed a greater decrease in DI values at 24 h (mean decrease 7.9 versus 0.7, P<0.001). All responders had baseline DI values of greater than 10 (negative predictive value of 100%). A decrease in the DI value by more than 5 at 24 h in patients with a baseline DI of greater than 10 identified responders with a positive predictive value of 83%. CONCLUSIONS 3DE may be valuable in predicting response to CRT. A baseline DI cut-off of greater than 10 in our patients excluded reverse remodelling to CRT. In addition, the decrease in DI at 24 h had a high positive predictive value for long-term response to CRT. PMID:21076720

  5. Normalization of left ventricular function following cardiac resynchronization therapy: left bundle branch block as a potential etiology of dilated cardiomyopathy.

    PubMed

    Fujii, Banyo; Takami, Mistuaki

    2008-06-01

    Patients with chronic heart failure (HF) not infrequently present conduction disturbances, which are most commonly exhibited as a left bundle branch block (LBBB). LBBB is associated with intraventricular conduction delay, paradoxical septal motion, and hemodynamic deterioration, indicating an impairment of left ventricular (LV) function. However, there is controversy as to whether dilated cardiomyopathy leading to HF could develop just as a result of conduction disturbances without apparent pre-existing heart disease. We report here 2 cases of patients with non-ischemic dilated cardiomyopathy and LBBB who had complete reversal of their LV dysfunction and enlargement after cardiac resynchronization therapy, which corrects the LV activation sequence. These cases might support the idea that conduction disturbances themselves can be a principal etiology in the development of dilated cardiomyopathy. PMID:18503236

  6. Plasma tissue inhibitor of matrix metalloproteinase-1 (TIMP-1): an independent predictor of poor response to cardiac resynchronization therapy

    PubMed Central

    Tolosana, Jose María; Mont, Lluís; Sitges, Marta; Berruezo, Antonio; Delgado, Victoria; Vidal, Bàrbara; Tamborero, David; Morales, Manel; Batlle, Montserrat; Roig, Eulalia; Castel, M. Angeles; Pérez-Villa, Félix; Godoy, Miguel; Brugada, Josep

    2010-01-01

    Aims Matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPs) play a role in left ventricular structural remodelling. The aim of our study was to analyse MMP-2 and TIMP-1 levels as predictors of poor response to cardiac resynchronization therapy (CRT). Methods and results A cohort of 42 CRT patients from our centre was prospectively evaluated at baseline and after 12-month follow-up. MMP-2 and TIMP-1 assays were performed prior to CRT implant. Cardiac resynchronization therapy responders were defined as patients who survived, were not transplanted, and increased their basal 6 min walking distance test (6MWDT) by ≥10% or improved their NYHA functional class. Overall, 25 patients (60%) were classed as responders. At 12-month follow-up, six patients (14.2%) had died and one (2.4%) patient had been transplanted. Compared with responders, non-responders had higher levels of TIMP-1 (277 ± 59 vs. 216 ± 46 ng/mL, P = 0.001), MMP-2 (325 ± 115 vs. 258 ± 56 ng/mL, P = 0.02), and creatinine (1.76 ± 0.8 vs. 1.25 ± 0.3 mg/dL, P = 0.01). In a multivariate analysis, TIMP-1 was the only independent predictor of non-response to CRT [OR 0.97, 95% (CI 0.96–0.99) P = 0.005]. TIMP-1≥248 ng/mL predicted non-response with 71% sensitivity and 72% specificity. Conclusion TIMP-1 is an independent predictor of non-response in patients treated with CRT. PMID:20360066

  7. Echocardiography for cardiac resynchronization therapy: recommendations for performance and reporting--a report from the American Society of Echocardiography Dyssynchrony Writing Group endorsed by the Heart Rhythm Society.

    PubMed

    Gorcsan, John; Abraham, Theodore; Agler, Deborah A; Bax, Jeroen J; Derumeaux, Genevieve; Grimm, Richard A; Martin, Randy; Steinberg, Jonathan S; Sutton, Martin St John; Yu, Cheuk-Man

    2008-03-01

    Echocardiography plays an evolving and important role in the care of heart failure patients treated with biventricular pacing, or cardiac resynchronization therapy (CRT). Numerous recent published reports have utilized echocardiographic techniques to potentially aide in patient selection for CRT prior to implantation and to optimized device settings afterwards. However, no ideal approach has yet been found. This consensus report evaluates the contemporary applications of echocardiography for CRT including relative strengths and technical limitations of several techniques and proposes guidelines regarding current and possible future clinical applications. Principal methods advised to qualify abnormalities in regional ventricular activation, known as dyssynchrony, include longitudinal velocities by color-coded tissue Doppler and the difference in left ventricular to right ventricular ejection using routine pulsed Doppler, or interventricular mechanical delay. Supplemental measures of radial dynamics which may be of additive value include septal-to-posterior wall delay using M-mode in patients with non-ischemic disease with technically high quality data, or using speckle tracking radial strain. A simplified post-CRT screening for atrioventricular optimization using Doppler mitral inflow velocities is also proposed. Since this is rapidly changing field with new information being added frequently, future modification and refinements in approach are anticipated to continue. PMID:18314047

  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. PMID:26973218

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

    PubMed

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

    2015-04-01

    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 [Formula: see text] and for LV endocardium were [Formula: see text]. 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 [Formula: see text]. This was found to be clinically acceptable. PMID:26158110

  11. Prognostic significance of beta-blocker up-titration in conjunction with cardiac resynchronization therapy in heart failure management.

    PubMed

    Nabeta, Takeru; Inomata, Takayuki; Iida, Yuichiro; Ikeda, Yuki; Iwamoto-Ishida, Miwa; Ishii, Shunsuke; Naruke, Takashi; Mizutani, Tomohiro; Shinagawa, Hisahito; Koitabashi, Toshimi; Takeuchi, Ichiro; Ako, Junya

    2016-07-01

    Clinical practice guidelines emphasize that optimal pharmacotherapy, including beta-blockers (BB), is a prerequisite before receiving cardiac resynchronization therapy (CRT) in eligible patients with heart failure (HF). However, the optimal dose of BB before CRT implantation cannot be tolerated in a number of patients. Sixty-three consecutive patients who underwent CRT in 2006-2013 were retrospectively investigated. Before receiving CRT, BB could not be introduced in 20 patients (32 %); the daily carvedilol-equivalent dose in other 43 patients was 5.6 ± 7.0 mg because of significant HF and bradycardia. After receiving CRT, BB could be introduced in almost all patients (n = 61, 97 %), and the daily BB dose increased from 5.6 ± 7.0 to 13.2 ± 7.8 mg (P < 0.001). Multivariate analysis indicated that the change of BB dose after CRT was independently associated with improved left ventricular end-systolic volume (LVESV) [β = -0.36; 95 % confidence interval (CI) -2.13 to -0.45; P < 0.01] after 6-months follow-up. Furthermore, Cox proportional hazard analysis also showed that the change in the BB dose (hazard ratio, 0.92; 95 % CI, 0.87-0.98; P < 0.01) as well as the New York Heart Association functional classification was an independent predictor of cardiac events. After initiating CRT, BB therapy can be introduced and up-titrated in intolerant HF patients. The up-titrated dose of BB after CRT was an independent predictor for the improvement of LVESV and HF prognosis. PMID:26253941

  12. Tracking preference as unusual trigger of pacemaker-mediated tachycardia in a resynchronization device.

    PubMed

    Crea, Pasquale; Picciolo, Giuseppe; Luzza, Francesco

    2016-01-01

    A 59-year-old woman with a history of congestive heart failure, who previously received a biventricular cardioverter-defibrillator was admitted with dyspnea and peripheral edema. She was noted on telemetry to have multiple self-terminated episodes of rapid ventricular pacing, consistent with pacemaker-mediated tachycardia. All episodes started after three consecutive ventricular extrasystoles. "Tracking preference" algorithm, designed to maintain atrial-tracked biventricular pacing in CRT devices, resulted turned on. It affected minimum PVARP and resulted the trigger for pacemaker mediated tachycardia. PMID:26976512

  13. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure

    PubMed Central

    Cleland, John G.; Abraham, William T.; Linde, Cecilia; Gold, Michael R.; Young, James B.; Claude Daubert, J.; Sherfesee, Lou; Wells, George A.; Tang, Anthony S.L.

    2013-01-01

    Aims Cardiac resynchronization therapy (CRT) with or without a defibrillator reduces morbidity and mortality in selected patients with heart failure (HF) but response can be variable. We sought to identify pre-implantation variables that predict the response to CRT in a meta-analysis using individual patient-data. Methods and results An individual patient meta-analysis of five randomized trials, funded by Medtronic, comparing CRT either with no active device or with a defibrillator was conducted, including the following baseline variables: age, sex, New York Heart Association class, aetiology, QRS morphology, QRS duration, left ventricular ejection fraction (LVEF), and systolic blood pressure. Outcomes were all-cause mortality and first hospitalization for HF or death. Of 3782 patients in sinus rhythm, median (inter-quartile range) age was 66 (58–73) years, QRS duration was 160 (146–176) ms, LVEF was 24 (20–28)%, and 78% had left bundle branch block. A multivariable model suggested that only QRS duration predicted the magnitude of the effect of CRT on outcomes. Further analysis produced estimated hazard ratios for the effect of CRT on all-cause mortality and on the composite of first hospitalization for HF or death that suggested increasing benefit with increasing QRS duration, the 95% confidence bounds excluding 1.0 at ∼140 ms for each endpoint, suggesting a high probability of substantial benefit from CRT when QRS duration exceeds this value. Conclusion QRS duration is a powerful predictor of the effects of CRT on morbidity and mortality in patients with symptomatic HF and left ventricular systolic dysfunction who are in sinus rhythm. QRS morphology did not provide additional information about clinical response. ClinicalTrials.gov numbers NCT00170300, NCT00271154, NCT00251251. PMID:23900696

  14. Coronary Sinus Biomarker Sampling Compared to Peripheral Venous Blood for Predicting Outcomes In Patients with Severe Heart Failure Undergoing Cardiac Resynchronization Therapy: The BIOCRT Study

    PubMed Central

    Truong, Quynh A.; Januzzi, James L.; Szymonifka, Jackie; Thai, Wai-ee; Wai, Bryan; Lavender, Zachary; Sharma, Umesh; Sandoval, Ryan M.; Grunau, Zachary S.; Basnet, Sandeep; Babatunde, Adefolakemi; Ajijola, Olujimi A.; Min, James K.; Singh, Jagmeet P.

    2014-01-01

    Background A significant minority of patients receiving cardiac resynchronization therapy (CRT) remain non-responsive to this intervention. Objective To determine whether coronary sinus (CS) or baseline peripheral venous (PV) levels of established and emerging heart failure (HF) biomarkers are predictive of CRT outcomes. Methods In 73 patients (age 68±12; 83% male; ejection fraction 27 7%) with CS and PV blood drawn simultaneously at the time of CRT implantation, we measured amino-terminal pro-B type natriuretic peptide (NT-proBNP), galectin-3 (gal-3), and soluble (s)ST2 levels. NT-proBNP concentrations>2000 pg/mL, gal-3>25.9 ng/mL, and sST2>35 ng/mL were considered positive, based on established PV cutpoints for identifying “high risk” individuals with HF. CRT response was adjudicated by HF Clinical Composite Score. Major adverse cardiovascular event (MACE) was defined as the composite endpoint of death, cardiac transplant, left ventricular assist device, and HF hospitalization at 2 years. Results NT-proBNP concentrations were 20% higher in the CS than periphery, while gal-3 and sST2 were 10% higher in periphery than CS (all p<0.001). There were 45% CRT non-responders at 6 months and 22% MACE. Triple positive CS values yielded the highest specificity of 95% for predicting CRT non-response. Consistently, CS strategies identified patients at higher risk for developing MACE, with over 11-fold adjusted increase for triple positive CS patients compared to triple negative patients (all p≤0.04). PV strategies were not predictive of MACE. Conclusions Our findings suggest that coronary sinus sampling of HF biomarkers may be better than peripheral venous blood levels for predicting CRT outcomes. Larger studies are needed to confirm our findings. PMID:25014756

  15. Combined score using clinical, electrocardiographic, and echocardiographic parameters to predict left ventricular remodeling in patients having had cardiac resynchronization therapy six months earlier.

    PubMed

    Brunet-Bernard, Anne; Maréchaux, Sylvestre; Fauchier, Laurent; Guiot, Aurélie; Fournet, Maxime; Reynaud, Amélie; Schnell, Frédéric; Leclercq, Christophe; Mabo, Philippe; Donal, Erwan

    2014-06-15

    The aim of this study was to evaluate whether a scoring system integrating clinical, electrocardiographic, and echocardiographic measurements can predict left ventricular reverse remodeling after cardiac resynchronization therapy (CRT). The derivation cohort consisted of 162 patients with heart failure implanted with a CRT device. Baseline clinical, electrocardiographic, and echocardiographic characteristics were entered into univariate and multivariate models to predict reverse remodeling as defined by a ≥15% reduction in left ventricular end-systolic volume at 6 months (60%). Combinations of predictors were then tested under different scoring systems. A new 7-point CRT response score termed L2ANDS2: Left bundle branch block (2 points), Age >70 years, Nonischemic origin, left ventricular end-diastolic Diameter <40 mm/m(2), and Septal flash (2 points) was calculated for these patients. This score was then validated against a validation cohort of 45 patients from another academic center. A highly significant incremental predictive value was noted when septal flash was added to an initial 4-factor model including left bundle branch block (difference between area under the curve C statistics = 0.125, p <0.001). The predictive accuracy using the L2ANDS2 score was then 0.79 for the C statistic. Application of the new score to the validation cohort (71% of responders) gave a similar C statistic (0.75). A score >5 had a high positive likelihood ratio (+LR = 5.64), whereas a score <2 had a high negative likelihood ratio (-LR = 0.19). In conclusion, this L2ANDS2 score provides an easy-to-use tool for the clinician to assess the pretest probability of a patient being a CRT responder. PMID:24793667

  16. Effect of Cardiac Resynchronization Therapy on Left Atrial Size and Function as Expressed by Speckle Tracking 2-Dimensional Strain.

    PubMed

    Valzania, Cinzia; Gadler, Fredrik; Boriani, Giuseppe; Rapezzi, Claudio; Eriksson, Maria J

    2016-07-15

    Changes in left atrial (LA) strain in patients treated with cardiac resynchronization therapy (CRT) remain not entirely explored. We prospectively evaluated long-term changes in LA size and function and their relation with left ventricular (LV) reverse remodeling and noninvasive hemodynamic variables in patients treated with CRT by 2-dimensional speckle tracking echocardiography. Thirty patients (62 ± 11 years, 63% men) underwent 2-dimensional speckle tracking echocardiography before implant and after 12 months. LA area, global and regional LA strains, LV ejection fraction (LVEF) and longitudinal strain, mitral regurgitation (MR), and diastolic variables were evaluated. At 12 months, CRT responders (60%) exhibited an increase in LA strain (11.4 ± 6.5% vs 16.5 ± 7.9%, p <0.001) and a reduction in LA area (p = 0.002), which were associated with an improvement in MR, E/E' ratio, LVEF, and LV longitudinal strain. In nonresponders, a worsening in LA strain (11.4 ± 6.8% vs 8.7 ± 4.6%, p = 0.017) and LA area (p = 0.002) occurred in parallel with an increase in E/E', whereas LVEF and LV longitudinal strain were unchanged. In conclusion, over long-term follow-up, LA size and strain improved in CRT responders, while worsening in nonresponders. Changes in LV function, filling pressures, and MR seem to be related to LA reverse remodeling, giving a feedback loop. PMID:27241837

  17. QRS pattern and improvement in right and left ventricular function after cardiac resynchronization therapy: a radionuclide study

    PubMed Central

    2012-01-01

    Background Predicting response to cardiac resynchronization therapy (CRT) remains a challenge. We evaluated the role of baseline QRS pattern to predict response in terms of improvement in biventricular ejection fraction (EF). Methods Consecutive patients (pts) undergoing CRT implantation underwent radionuclide angiography at baseline and at mid-term follow-up. The relationship between baseline QRS pattern and mechanical dyssynchrony using phase analysis was evaluated. Changes in left and right ventricular EF (LVEF and RVEF) were analyzed with regard to baseline QRS pattern. Results We enrolled 56 pts, 32 with left bundle branch block (LBBB), 4 with right bundle branch block (RBBB) and 20 with non-specific intraventricular conduction disturbance (IVCD). A total of 48 pts completed follow-up. LBBB pts had significantly greater improvement in LVEF compared to RBBB or non-specific IVCD pts (+9.6 ± 10.9% vs. +2.6 ± 7.6%, p = 0.003). Response (defined as ≥ 5% increase in LVEF) was observed in 68% of LBBB vs. 24% of non-specific IVCD pts (p = 0.006). None of the RBBB pts were responders. RVEF was significantly improved in LBBB (+5.0 ± 9.0%, p = 0.007), but not in non-specific IVCD and RBBB pts (+0.4 ± 5.8%, p = 0.76). At multivariate analysis, LBBB was the only predictor of LVEF response (OR, 7.45; 95% CI 1.80-30.94; p = 0.006), but not QRS duration or extent of mechanical dyssynchrony. Conclusions Presence of a LBBB is a marker of a positive response to CRT in terms of biventricular improvement. Pts with non-LBBB pattern show significantly less benefit from CRT than those with LBBB. PMID:22494365

  18. Effect of QRS Narrowing After Cardiac Resynchronization Therapy on Functional Mitral Regurgitation in Patients With Systolic Heart Failure.

    PubMed

    Karaca, Oguz; Omaygenc, Mehmet Onur; Cakal, Beytullah; Cakal, Sinem Deniz; Gunes, Haci Murat; Barutcu, Irfan; Boztosun, Bilal; Kilicaslan, Fethi

    2016-02-01

    The determinants of improvement in functional mitral regurgitation (FMR) after cardiac resynchronization therapy (CRT) remain unclear. We evaluated the predictors of FMR improvement and hypothesized that CRT-induced change in QRS duration (ΔQRS) might have an impact on FMR response after CRT. One hundred ten CRT recipients were enrolled. CRT response (≥ 15 reduction in left ventricular end-systolic volume) and FMR response (absolute reduction in FMR volume) were assessed with echocardiography before and 6 months after CRT. The study end points included all-cause death or hospitalization assessed in 12 ± 3 months (range 1 to 18). A total of 71 patients (65%) responded to CRT at 6 months. FMR response was observed in 49 (69%) of the CRT responders and 8 (20%) of the CRT nonresponders (p <0.001). Although the baseline QRS durations were similar, the paced QRS durations were shorter (p = 0.012) and the ΔQRS values were greater (p = 0.003) in FMR responders compared with FMR nonresponders. There was a linear correlation between ΔQRS and change in regurgitant volume (r = 0.49, p <0.001). At multivariate analysis, baseline tenting area (p = 0.012) and ΔQRS (p = 0.028) independently predicted FMR response. A ΔQRS ≥ 20 ms was related to CRT response, FMR improvement, and lower rates of death or hospitalization during follow-up (p values <0.05). In conclusion, QRS narrowing after CRT independently predicts FMR response. A ΔQRS ≥ 20 ms after CRT is associated with a favorable outcome in all clinical end points. PMID:26721652

  19. Meta-Analysis of the Relation of Baseline Right Ventricular Function to Response to Cardiac Resynchronization Therapy.

    PubMed

    Sharma, Abhishek; Bax, Jerome J; Vallakati, Ajay; Goel, Sunny; Lavie, Carl J; Kassotis, John; Mukherjee, Debabrata; Einstein, Andrew; Warrier, Nikhil; Lazar, Jason M

    2016-04-15

    Right ventricular (RV) dysfunction has been associated with adverse clinical outcomes in patients with heart failure (HF). Cardiac resynchronization therapy (CRT) improves left ventricular (LV) size and function in patients with markedly abnormal electrocardiogram QRS duration. However, relation of baseline RV function with response to CRT has not been well described. In this study, we aim to investigate the relation of baseline RV function with response to CRT as assessed by change in LV ejection fraction (EF). A systematic search of studies published from 1966 to May 31, 2015 was conducted using PubMed, CINAHL, Cochrane CENTRAL, and the Web of Science databases. Studies were included if they have reported (1) parameters of baseline RV function (tricuspid annular plane systolic excursion [TAPSE] or RVEF or RV basal strain or RV fractional area change [FAC]) and (2) LVEF before and after CRT. Random-effects metaregression was used to evaluate the effect of baseline RV function parameters and change in LVEF. Sixteen studies (n = 1,764) were selected for final analysis. Random-effects metaregression analysis showed no significant association between the magnitude of the difference in EF before and after CRT with baseline TAPSE (β = 0.005, p = 0.989); baseline RVEF (β = 0.270, p = 0.493); baseline RVFAC (β = -0.367, p = 0.06); baseline basal strain (β = -0.342, p = 0.462) after a mean follow-up period of 10.5 months. In conclusion, baseline RV function as assessed by TAPSE, FAC, basal strain, or RVEF does not determine response to CRT as assessed by change in LVEF. PMID:26879068

  20. Wasted septal work in left ventricular dyssynchrony: a novel principle to predict response to cardiac resynchronization therapy

    PubMed Central

    Vecera, J.; Penicka, M.; Eriksen, M.; Russell, K.; Bartunek, J.; Vanderheyden, M.; Smiseth, O.A.

    2016-01-01

    Aims Cardiac resynchronization therapy (CRT) in heart failure is limited by many non-responders. This study explores whether degree of wasted left ventricular (LV) work identifies CRT responders. Methods and results Twenty-one patients who received CRT according to guidelines were studied before and after 8 ± 3 months. By definition, segments that shorten in systole perform positive work, whereas segments that lengthen do negative work. Work was calculated from non-invasive LV pressure and strain by speckle tracking echocardiography. For each myocardial segment and for the entire LV, wasted work was calculated as negative work in percentage of positive work. LV wall motion score index (WMSI) was assessed by echocardiography. Response to CRT was defined as ≥15% reduction in end-systolic volume (ESV). Responder rate to CRT was 71%. In responders, wasted work for septum was 117 ± 102%, indicating more negative than positive work, and decreased to 14 ± 12% with CRT (P < 0.01). In the LV free wall, wasted work was 19 ± 16% and showed no significant change. Global LV wasted work decreased from 39 ± 21 to 17 ± 7% with CRT (P < 0.01). In non-responders, there were no significant changes. In multiple linear regression analysis, septal wasted work and WMSI were the only significant predictors of ESV reduction (β = 0.14, P = 0.01; β = 1.25, P = 0.03). Septal wasted work together with WMSI showed an area under the curve of 0.86 (95% confidence interval 0.71–1.0) for CRT response prediction. Conclusion Wasted work in the septum together with WMSI was a strong predictor of response to CRT. This novel principle should be studied in future larger studies. PMID:26921169

  1. Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-Ischemic Heart Failure Patients: A Randomized Crossover Pilot Trial

    PubMed Central

    Ghotbi, Adam Ali; Sander, Mikael; Køber, Lars; Philbert, Berit Th.; Gustafsson, Finn; Hagemann, Christoffer; Kjær, Andreas; Jacobsen, Peter K.

    2015-01-01

    Background The optimal pacing rate during cardiac resynchronization therapy (CRT) is unknown. Therefore, we investigated the impact of changing basal pacing frequencies on autonomic nerve function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL). Methods Twelve CRT patients with non-ischemic heart failure (NYHA class II–III) were enrolled in a randomized, double-blind, crossover trial, in which the basal pacing rate was set at DDD-60 and DDD-80 for 3 months (DDD-R for 2 patients). At baseline, 3 months and 6 months, we assessed sympathetic nerve activity by microneurography (MSNA), peak oxygen consumption (pVO2), N-terminal pro-brain natriuretic peptide (p-NT-proBNP), echocardiography and QoL. Results DDD-80 pacing for 3 months increased the mean heart rate from 77.3 to 86.1 (p = 0.001) and reduced sympathetic activity compared to DDD-60 (51±14 bursts/100 cardiac cycles vs. 64±14 bursts/100 cardiac cycles, p<0.05). The mean pVO2 increased non-significantly from 15.6±6 mL/min/kg during DDD-60 to 16.7±6 mL/min/kg during DDD-80, and p-NT-proBNP remained unchanged. The QoL score indicated that DDD-60 was better tolerated. Conclusion In CRT patients with non-ischemic heart failure, 3 months of DDD-80 pacing decreased sympathetic outflow (burst incidence only) compared to DDD-60 pacing. However, Qol scores were better during the lower pacing rate. Further and larger scale investigations are indicated. Trial Registration ClinicalTrials.gov NCT02258061 PMID:26382243

  2. The effect of reverse remodeling on long-term survival in mildly symptomatic patients with heart failure receiving cardiac resynchronization therapy: Results of the REVERSE study

    PubMed Central

    Gold, Michael R.; Daubert, Claude; Abraham, William T.; Ghio, Stefano; Sutton, Martin St. John; Hudnall, John Harrison; Cerkvenik, Jeffrey; Linde, Cecilia

    2015-01-01

    BACKGROUND Cardiac resynchronization therapy (CRT) reduces mortality, improves functional status, and induces reverse left ventricular remodeling in selected populations with heart failure (HF). The magnitude of reverse remodeling predicts survival with many HF medical therapies. However, there are few studies assessing the effect of remodeling on long-term survival with CRT. OBJECTIVE The purpose of this study was to assess the effect of CRT-induced reverse remodeling on long-term survival in patients with mildly symptomatic heart failure. METHODS The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction trial was a multicenter, double-blind, randomized trial of CRT in patients with mild HF. Long-term follow-up of 5 years was preplanned. The present analysis was restricted to the 353 patients who were randomized to the CRT ON group with paired echocardiographic studies at baseline and 6 months post-implantation. The left ventricular end-systolic volume index (LVESVi) was measured in the core laboratory and was an independently powered end point of the REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction trial. RESULTS A 68% reduction in mortality was observed in patients with ≥15% decrease in LVESVi compared to the rest of the patients (P = .0004). Multivariable analysis showed that the change in LVESVi was a strong independent predictor (P = .0002), with a 14% reduction in mortality for every 10% decrease in LVESVi. Other remodeling parameters such as left ventricular enddiastolic volume index and ejection fraction had a similar association with mortality. CONCLUSION The change in left ventricular end-systolic volume after 6 months of CRT is a strong independent predictor of long-term survival in mild HF. PMID:25460860

  3. Bundle-Branch Block Morphology and Other Predictors of Outcome After Cardiac Resynchronization Therapy in Medicare Patients

    PubMed Central

    Bilchick, Kenneth C.; Kamath, Sandeep; DiMarco, John P.; Stukenborg, George J.

    2013-01-01

    Background Clinical trials of cardiac resynchronization therapy (CRT) have enrolled a select group of patients, with few patients in subgroups such as right bundle-branch block (RBBB). Analysis of population-based outcomes provides a method to identify real-world predictors of CRT outcomes. Methods and Results Medicare Implantable Cardioverter-Defibrillator Registry (2005 to 2006) data were merged with patient outcomes data. Cox proportional-hazards models assessed death and death/heart failure hospitalization outcomes in patients with CRT and an implantable cardioverter-defibrillator (CRT-D). The 14 946 registry patients with CRT-D (median follow-up, 40 months) had 1-year, 3-year, and overall mortality rates of 12%, 32%, and 37%, respectively. New York Heart Association class IV heart failure status (1-year hazard ratio [HR], 2.23; 3-year HR, 1.98; P<0.001) and age ≥80 years (1-year HR, 1.74; 3-year HR, 1.75; P<0.001) were associated with increased mortality both early and late after CRT-D. RBBB (1-year HR, 1.44; 3-year HR, 1.37; P<0.001) and ischemic cardiomyopathy (1-year HR, 1.39; 3-year HR, 1.44; P<0.001) were the next strongest adjusted predictors of both early and late mortality. RBBB and ischemic cardiomyopathy together had twice the adjusted hazard for death (HR, 1.99; P<0.001) as left BBB and nonischemic cardiomyopathy. QRS duration of at least 150 ms predicted more favorable outcomes in left BBB but had no impact in RBBB. A secondary analysis showed lower hazards for CRT-D compared with standard implantable cardioverter-defibrillators in left BBB compared with RBBB. Conclusions In Medicare patients, RBBB, ischemic cardiomyopathy, New York Heart Association class IV status, and advanced age were powerful adjusted predictors of poor outcome after CRT-D. Real-world mortality rates 3 to 4 years after CRT-D appear higher than previously recognized. PMID:21041691

  4. Role of Right Ventricular Global Longitudinal Strain in Predicting Early and Long-Term Mortality in Cardiac Resynchronization Therapy Patients

    PubMed Central

    Nagy, Vivien Klaudia; Széplaki, Gábor; Apor, Astrid; Kutyifa, Valentina; Kovács, Attila; Kosztin, Annamária; Becker, Dávid; Boros, András Mihály; Gellér, László; Merkely, Béla

    2015-01-01

    Background Right ventricular (RV) dysfunction has been associated with poor prognosis in chronic heart failure (HF). However, less data is available about the role of RV dysfunction in patients with cardiac resynchronization therapy (CRT). We aimed to investigate if RV dysfunction would predict outcome in CRT. Design We enrolled prospectively ninety-three consecutive HF patients in this single center observational study. All patients underwent clinical evaluation and echocardiography before CRT and 6 months after implantation. We assessed RV geometry and function by using speckle tracking imaging and calculated strain parameters. We performed multivariable Cox regression models to test mortality at 6 months and at 24 months. Results RV dysfunction, characterized by decreased RVGLS (RV global longitudinal strain) [10.2 (7.0–12.8) vs. 19.5 (15.0–23.9) %, p<0.0001] and RVFWS (RV free wall strain) [15.6 (10.0–19.3) vs. 17.4 (10.5–22.2) %, p = 0.04], improved 6 months after CRT implantation. Increasing baseline RVGLS and RVFWS predicted survival independent of other parameters at 6 months [hazard ratio (HR) = 0.37 (0.15–0.90), p = 0.02 and HR = 0.42 (0.19–0.89), p = 0.02; per 1 standard deviation increase, respectively]. RVGLS proved to be a significant independent predictor of mortality at 24 months [HR = 0.53 (0.32–0.86), p = 0.01], and RVFWS showed a strong tendency [HR = 0.64 (0.40–1.00), p = 0.05]. The 24-month survival was significantly impaired in patients with RVGLS below 10.04% before CRT implantation [area under the curve = 0.72 (0.60–0.84), p = 0.002, log-rank p = 0.0008; HR = 5.23 (1.76–15.48), p = 0.003]. Conclusions Our findings indicate that baseline RV dysfunction is associated with poor short-term and long-term prognosis after CRT implantation. PMID:26700308

  5. Cardiac Resynchronization Therapy (CRT)

    MedlinePlus

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  6. Impact of septal flash and left ventricle contractile reserve on positive remodeling during 1 year cardiac resynchronization therapy: the multicenter ViaCRT study

    PubMed Central

    Gąsior, Zbigniew; Płońska-Gościniak, Edyta; Wita, Krystian; Mizia-Stec, Katarzyna; Szwed, Hanna; Kasprzak, Jarosław; Tomaszewski, Andrzej; Sinkiewicz, Władysław; Wojciechowska, Celina

    2016-01-01

    Introduction Cardiac resynchronization therapy (CRT) has been shown to improve outcomes in patients with systolic heart failure (HFREF). However, the relatively high non-responder rate results in a need for more precise qualification for CRT. The ViaCRT study was designed to determine the role of contractile reserve and dyssynchrony parameters in predicting CRT response. The purpose of this analysis was to determine the effect of baseline septal flash and contractile reserve (CR) on clinical and echocardiographic parameters of response to CRT in 12-month follow-up. Material and methods One hundred thirty-three guideline-selected CRT candidates (both ischemic and non-ischemic heart failure with reduced ejection fraction) were enrolled in the study. Baseline study population characteristics were: left ventricle ejection fraction (LVEF) 25 ±6%, QRS 165 ±25 ms, NYHA class III (90%) and IV (10%). Results In subjects with septal flash (SF) registered before CRT implantation improvement in LVEF (14 ±2% vs. 8 ±1%, p < 0.05) and left ventricle (LV) systolic (63 ±10 ml vs. 36 ±6 ml, p < 0.05) and diastolic (46 ±10 ml vs. 32 ±7, p < 0.05) volumes was more pronounced than in patients without SF. In patients with CR (defined as LVEF increase by 20% or 4 viable segments) improvement in echo parameters was not significantly different then in the CR– group. Neither SF nor CR was associated with improvement in NYHA class. Subgroup analysis revealed that only in non-ischemic HF patients is presence of septal flash associated with LV function improvement after CRT. Conclusions In non-ischemic HF patients septal flash is a helpful parameter in prediction of LV remodeling after 12 months of resynchronization therapy. PMID:27186179

  7. Devices as destination therapy.

    PubMed

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

    2003-02-01

    The use of circulatory support as destination therapy has been a goal for the treatment of endstage heart failure for several decades. Current investigations are evaluating several circulatory pumps with that particular objective. With continued modification of design, the current and future pumps will become more reliable and provide improved quality of life to patients in need of mechanical circulatory assistance. The new pumps on the horizon specifically address reliability, size, and cost, and are based on the centrifugal system. These devices use the Maglev (Magnetic Levitation) concept that allows for frictionless pumping, low thrombogenicity, minimal noise, and increased durability. Further research with this goal in mind and support from the federal government will be the key to the future use of circulatory assistance as destination therapy for heart failure patients. In addition, the cost-effectiveness of these devices will need to be maintained as the technology improves, as in any new technology that confronts a more intuitive option like the native heart. PMID:12790046

  8. Current Status of Left Ventricular Assist Device Therapy.

    PubMed

    Sajgalik, Pavol; Grupper, Avishay; Edwards, Brook S; Kushwaha, Sudhir S; Stulak, John M; Joyce, David L; Joyce, Lyle D; Daly, Richard C; Kara, Tomas; Schirger, John A

    2016-07-01

    Congestive heart failure (HF) remains a serious burden in the Western World. Despite advances in pharmacotherapy and resynchronization, many patients have progression to end-stage HF. These patients may be candidates for heart transplant or left ventricular assist device (LVAD) therapy. Heart transplants are limited by organ shortages and in some cases by patient comorbidities; therefore, LVAD therapy is emerging as a strategy of bridge to transplant or as a destination therapy in patients ineligible for transplant. Patients initially ineligible for a transplant may, in certain cases, become eligible for transplant after physiologic improvement with LVAD therapy, and a small number of patients with an LVAD may have sufficient recovery of myocardial function to allow device explantation. This clinically oriented review will describe (1) the most frequently used pump types and aspects of the continuous-flow physiology and (2) the clinical indications for and the shift toward the use of LVADs in less sick patients with HF. Additionally, we review complications of LVAD therapy and project future directions in this field. We referred to the Interagency Registry for Mechanically Assisted Circulatory Support, landmark trials, and results from recently published studies as major sources in obtaining recent outcomes, and we searched for related published literature via PubMed. This review focuses primarily on clinical practice for primary care physicians and non-HF cardiologists in the United States. PMID:27378038

  9. Inappropriate Shock Delivered By Implantable Cardioverter Defibrillator - Cardiac Resynchronization Therapy (ICD-CRT) Due To Myopotential Oversensing

    PubMed Central

    Barakpour, Hamid; Emkanjoo, Zahra; Alizadeh, Abolfath; Sadr-Ameli, Mohammad Ali

    2009-01-01

    The clinical efficacy of ICD-CRT therapy depends on accurate sensing of intracardiac signals and sensing algorithms. We report the occurrence of sensing abnormality in a patient with ICD-CRT. In this patient, oversensing of myopotentials during strenuous muscular activity resulted in an inappropriate ICD-CRT discharge. Although modern ICDs are highly effective in detecting and terminating malignant tachyarrhythmias, their detection specificity must be improved. It is possible to find the mechanism of arrhythmia by EGM. Simple device reprogramming make it possible to avoid the oversensing of myopotentials. PMID:19165363

  10. Usefulness of the 12-lead electrocardiogram in the follow-up of patients with cardiac resynchronization devices. Part II.

    PubMed

    Barold, S Serge; Herweg, Bengt

    2011-01-01

    The interval from the pacemaker stimulus to the onset of the earliest paced QRS complex (latency) may be prolonged during left ventricular (LV) pacing. Marked latency is more common with LV than right ventricular (RV) pacing because of indirect stimulation through a coronary vein and higher incidence of LV pathology including scars. During simultaneous biventricular (BiV) pacing a prolonged latency interval may give rise to an ECG dominated by the pattern of RV pacing with a left bundle branch block configuration and commonly a QS complex in lead V1. With marked latency programming the V-V interval (LV before RV) often restore the dominant R wave in lead V1 representing the visible contribution of the LV to overall myocardial depolarization. When faced with a negative QRS complex in lead V1 during simultaneous BiV pacing especially in setting of a relatively short PR interval, the most likely diagnosis is ventricular fusion with the intrinsic rhythm. Fusion may cause misinterpretation of the ECG because narrowing of the paced QRS complex simulates appropriate BiV capture. The diagnosis of fusion depends on temporary reprogramming a very short atrio-ventricular delay or an asynchronous BiV pacing mode. Sequential programming of various interventricular (V-V) delays may bring out a diagnostic dominant QRS complex in lead V1 that was previously negative with simultaneous LV and RV apical pacing even in the absence of an obvious latency problem. The emergence of a dominant R wave by V-V programming strongly indicates that the LV lead captures the LV from the posterior or the posterolateral coronary vein and therefore rules out pacing from the middle or anterior coronary vein. In some cardiac resynchronization systems LV pacing is achieved with the tip electrode of the LV lead as the cathode and the proximal electrode of the bipolar RV as the anode. This arrangement creates a common anode for both RV and LV pacing. RV anodal capture can occur at a high LV output during

  11. Improved clinical course of autologous skeletal myoblast sheet (TCD-51073) transplantation when compared to a propensity score-matched cardiac resynchronization therapy population.

    PubMed

    Imamura, Teruhiko; Kinugawa, Koichiro; Sakata, Yasushi; Miyagawa, Shigeru; Sawa, Yoshiki; Yamazaki, Kenji; Ono, Minoru

    2016-03-01

    We recently reported a multi-center, single-arm, phase II study that evaluated the efficacy and safety of autologous skeletal myoblast sheet (TCD-51073) transplantation. The advantage of this procedure over a control group has not yet been analyzed. Seven patients with advanced heart failure due to ischemic etiology (TCD-51073 group, New York Heart Association (NYHA) class III; left ventricular ejection fraction (LVEF) <35 %) refractory to optimal medical and coronary revascularization therapy, received TCD-51073 at 3 study centers between 2012 and 2013 with a 2-year follow-up period. As previously reported, 112 patients received cardiac resynchronization therapy (CRT) with follow-up at the University of Tokyo Hospital between 2007 and 2014. Of them, 21 patients were selected for the control group by propensity score matching. No significant difference in baseline variables between the groups was observed. LVEF and NYHA class improved significantly in the TCD-51073 group during the 6-month study period (p < 0.05). During the 2-year follow-up, 7 patients (33 %) in the CRT group and no patient in the TCD-51073 group died due to cardiac disease or received VAD implantation (p = 0.128 by the log-rank test). In conclusion, transplantation of TCD-51073 is clinically advantageous in facilitating LV reverse remodeling, improving HF symptoms, and preventing cardiac death in patients with ischemic etiology when compared to background-matched patients receiving CRT. PMID:26267666

  12. 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.

  13. Cardiac resynchronization therapy and AV optimization increase myocardial oxygen consumption, but increase cardiac function more than proportionally☆

    PubMed Central

    Kyriacou, Andreas; Pabari, Punam A.; Mayet, Jamil; Peters, Nicholas S.; Davies, D. Wyn; Lim, P. Boon; Lefroy, David; Hughes, Alun D.; Kanagaratnam, Prapa; Francis, Darrel P.; I.Whinnett, Zachary

    2014-01-01

    Background The mechanoenergetic effects of atrioventricular delay optimization during biventricular pacing (“cardiac resynchronization therapy”, CRT) are unknown. Methods Eleven patients with heart failure and left bundle branch block (LBBB) underwent invasive measurements of left ventricular (LV) developed pressure, aortic flow velocity-time-integral (VTI) and myocardial oxygen consumption (MVO2) at 4 pacing states: biventricular pacing (with VV 0 ms) at AVD 40 ms (AV-40), AVD 120 ms (AV-120, a common nominal AV delay), at their pre-identified individualised haemodynamic optimum (AV-Opt); and intrinsic conduction (LBBB). Results AV-120, relative to LBBB, increased LV developed pressure by a mean of 11(SEM 2)%, p = 0.001, and aortic VTI by 11(SEM 3)%, p = 0.002, but also increased MVO2 by 11(SEM 5)%, p = 0.04. AV-Opt further increased LV developed pressure by a mean of 2(SEM 1)%, p = 0.035 and aortic VTI by 4(SEM 1)%, p = 0.017. MVO2 trended further up by 7(SEM 5)%, p = 0.22. Mechanoenergetics at AV-40 were no different from LBBB. The 4 states lay on a straight line for Δexternal work (ΔLV developed pressure × Δaortic VTI) against ΔMVO2, with slope 1.80, significantly > 1 (p = 0.02). Conclusions Biventricular pacing and atrioventricular delay optimization increased external cardiac work done but also myocardial oxygen consumption. Nevertheless, the increase in cardiac work was ~ 80% greater than the increase in oxygen consumption, signifying an improvement in cardiac mechanoenergetics. Finally, the incremental effect of optimization on external work was approximately one-third beyond that of nominal AV pacing, along the same favourable efficiency trajectory, suggesting that AV delay dominates the biventricular pacing effect — which may therefore not be mainly “resynchronization”. PMID:24332598

  14. Cost–consequence analysis of daily continuous remote monitoring of implantable cardiac defibrillator and resynchronization devices in the UK

    PubMed Central

    Burri, Haran; Sticherling, Christian; Wright, David; Makino, Koji; Smala, Antje; Tilden, Dominic

    2013-01-01

    Aims The need for ongoing and lifelong follow-up (FU) of patients with cardiac implantable electric devices (CIED) requires significant resources. Remote CIED management has been established as a safe alternative to conventional periodical in-office FU (CFU). An economic model compares the long-term cost and consequences of using daily Home Monitoring® (HM) instead of CFU. Methods and results A cost–consequence evaluation comparing HM vs. CFU was performed using a Markov cohort model and data relating to events and costs identified via a systematic review of the literature. The model is conservative, without assuming a reduction of cardiovascular events by HM such as decompensated heart failure or mortality, or considering cost savings such as for transportation. Also cost savings due to an improved timing of elective device replacement, and fewer FU visits needed in patients near device replacement are not considered. Over 10 years, HM is predicted to be cost neutral at about GBP 11 500 per patient in either treatment arm, with all costs for the initial investment into HM and fees for ongoing remote monitoring included. Fewer inappropriate shocks (−51%) reduce the need for replacing devices for battery exhaustion (−7%); the number of FU visits is predicted to be halved by HM. Conclusion From a UK National Health Service perspective, HM is cost neutral over 10 years. This is mainly accomplished by reducing the number of battery charges and inappropriate shocks, resulting in fewer device replacements, and by reducing the number of in-clinic FU visits. PMID:23599169

  15. The role of electrocardiography in the elaboration of a new paradigm in cardiac resynchronization therapy for patients with nonspecific intraventricular conduction disturbance

    PubMed Central

    Vereckei, András; Katona, Gábor; Szelényi, Zsuzsanna; Szénási, Gábor; Kozman, Bálint; Karádi, István

    2016-01-01

    Cardiac resynchronization therapy (CRT) is associated with a favorable outcome only in patients with left bundle branch block (LBBB) pattern and in patients with a QRS duration > 150 ms, in patients with non-LBBB pattern with a QRS duration of 120–150 ms usually is not beneficial. After adjusting for QRS duration, QRS morphology was no longer a determinant of the clinical response to CRT. In contrast to the mainstream view, we hypothesized that the unfavorable CRT outcome in patients with non-LBBB and a QRS duration of 120–150 ms is not due to the QRS morphology itself, but to less dyssynchrony and unfavorable patient characteristics in this subgroup, such as more ischemic etiology and greater prevalence of male patients compared with patients with LBBB pattern. Further, the current CRT technique is devised to eliminate the dyssynchrony present in patients with LBBB pattern and inappropriate to eliminate the dyssynchrony in patients with non-LBBB pattern. We also hypothesized that electrocardiography may also provide information about the presence of interventricular and left intraventricular dyssynchrony and the approximate location of the latest activated left ventricular (LV) region. To this end, we devised new ECG criteria to estimate interventricular and LV intraventricular dyssynchrony and the approximate location of the latest activated LV region. Our preliminary data demonstrated that the latest activated LV region in patients with nonspecific intraventricular conduction disturbance (NICD) pattern might be at a remote site from that present in patients with LBBB pattern, which might necessitate the invention of a novel CRT technique for patients with NICD pattern. The application of the new interventricular and LV intraventricular dyssynchrony ECG criteria and a potential novel CRT technique might decrease the currently high nonresponder rate in patients with NICD pattern. PMID:27168736

  16. 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

  17. The role of electrocardiography in the elaboration of a new paradigm in cardiac resynchronization therapy for patients with nonspecific intraventricular conduction disturbance.

    PubMed

    Vereckei, András; Katona, Gábor; Szelényi, Zsuzsanna; Szénási, Gábor; Kozman, Bálint; Karádi, István

    2016-02-01

    Cardiac resynchronization therapy (CRT) is associated with a favorable outcome only in patients with left bundle branch block (LBBB) pattern and in patients with a QRS duration > 150 ms, in patients with non-LBBB pattern with a QRS duration of 120-150 ms usually is not beneficial. After adjusting for QRS duration, QRS morphology was no longer a determinant of the clinical response to CRT. In contrast to the mainstream view, we hypothesized that the unfavorable CRT outcome in patients with non-LBBB and a QRS duration of 120-150 ms is not due to the QRS morphology itself, but to less dyssynchrony and unfavorable patient characteristics in this subgroup, such as more ischemic etiology and greater prevalence of male patients compared with patients with LBBB pattern. Further, the current CRT technique is devised to eliminate the dyssynchrony present in patients with LBBB pattern and inappropriate to eliminate the dyssynchrony in patients with non-LBBB pattern. We also hypothesized that electrocardiography may also provide information about the presence of interventricular and left intraventricular dyssynchrony and the approximate location of the latest activated left ventricular (LV) region. To this end, we devised new ECG criteria to estimate interventricular and LV intraventricular dyssynchrony and the approximate location of the latest activated LV region. Our preliminary data demonstrated that the latest activated LV region in patients with nonspecific intraventricular conduction disturbance (NICD) pattern might be at a remote site from that present in patients with LBBB pattern, which might necessitate the invention of a novel CRT technique for patients with NICD pattern. The application of the new interventricular and LV intraventricular dyssynchrony ECG criteria and a potential novel CRT technique might decrease the currently high nonresponder rate in patients with NICD pattern. PMID:27168736

  18. Effect of cardiac resynchronization therapy with implantable cardioverter defibrillator versus cardiac resynchronization therapy with pacemaker on mortality in heart failure patients: results of a high-volume, single-centre experience

    PubMed Central

    Kutyifa, Valentina; Geller, Laszlo; Bogyi, Peter; Zima, Endre; Aktas, Mehmet K; Ozcan, Emin Evren; Becker, David; Nagy, Vivien Klaudia; Kosztin, Annamaria; Szilagyi, Szabolcs; Merkely, Bela

    2014-01-01

    Aims There are limited and contradictory data on the effects of CRT with implantable cardioverter defibrillator (CRT-D) on mortality as compared with CRT with pacemaker (CRT-P). Methods and results We evaluated the long-term outcome of patients implanted with a CRT-D or CRT-P device in our high-volume single-centre experience. Data on all-cause mortality were derived from clinic visits and the Hungarian National Healthcare Fund Death Registry. Kaplan–Meier survival analyses and multivariate Cox regression models were used to evaluate all-cause mortality in patients with CRT-D vs. CRT-P, stratified by the aetiology of cardiomyopathy. From 2000 to 2011, 1122 CRT devices, 693 CRT-P (LVEF 28.2 ± 7.4%) and 429 CRT-D (LVEF 27.6 ± 6.4%), were implanted at our centre. During the median follow-up of 28 months, 379 patients died from any cause, 250 patients (36%) with an implanted CRT-P and 129 patients (30%) with an implanted CRT-D. There was no evidence of mortality benefit in patients implanted with a CRT-D compared with a CRT-P in the total cohort [hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.73–1.32, P = 0.884]. In patients with ischaemic cardiomyopathy, CRT-D treatment was associated with a significant 30% risk reduction in all-cause mortality compared with an implanted CRT-P (HR 0.70, 95% CI 0.51–0.97, P = 0.03). In non-ischaemic patients, there was no mortality benefit of CRT-D over CRT-P (HR 0.98, 95% CI 0.73–1.32, P = 0.894, interaction P-value = 0.15). Conclusions In heart failure patients with ischaemic cardiomyopathy, CRT-D was associated with a mortality benefit compared with CRT-P, but no benefit of CRT-D over CRT-P in mortality was observed in non-ischaemic cardiomyopathy. PMID:25379962

  19. 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

  20. Transvenous Access to the Pericardial Space: A Novel Approach to Epicardial Lead Implantation for Cardiac Resynchronization Therapy

    PubMed Central

    MICKELSEN, STEVEN R.; ASHIKAGA, HIROSHI; DESILVA, RANIL; RAVAL, AMISH N.; MCVEIGH, ELLIOT; KUSUMOTO, FRED

    2007-01-01

    Background: Percutaneous access to the pericardial space (PS) may be useful for a number of therapeutic modalities including implantation of epicardial pacing leads. We have developed a catheter-based transvenous method to access the PS for implanting chronic medical devices. Methods: In eight pigs, a transseptal Mullins sheath and Brockenbrough needle were introduced into the right atrium (RA) from the jugular vein under fluoroscopic guidance. The PS was entered through a controlled puncture of the terminal anterior superior vena cava (SVC) (n = 7) or right atrial appendage (n = 1). A guidewire was advanced through the transseptal sheath, which was then removed leaving the wire in PS. The guidewire was used to direct both passive and active fixation pacing leads into the PS. Pacing was attempted and lead position was confirmed by cine fluoroscopy. Animals were sacrificed acutely and at 2 and 6 weeks. Results: All animals survived the procedure. Pericardial effusion (PE) during the procedure was hemodynamically significant in four of the eight animals. At necropsy, lead exit sites appeared to heal without complication at 2 and 6 weeks. Volume of pericardial fluid was 10.8 ± 6.2 mL and appeared normal in four of the six chronic animals. Moderate fibrinous deposition was observed in two animals, which had exhibited significant over-procedural PE. Conclusions: Access to the PS via a transvenous approach is feasible. Pacing leads can be negotiated into this region. The puncture site heals with the lead in place. Further development should focus on eliminating PE and performing this technique in appropriate heart failure models. PMID:16221257

  1. Device-based Therapy for Hypertension.

    PubMed

    Ng, Fu L; Saxena, Manish; Mahfoud, Felix; Pathak, Atul; Lobo, Melvin D

    2016-08-01

    Hypertension continues to be a major contributor to global morbidity and mortality, fuelled by an abundance of patients with uncontrolled blood pressure despite the multitude of pharmacological options available. This may occur as a consequence of true resistant hypertension, through an inability to tolerate current pharmacological therapies, or non-adherence to antihypertensive medication. In recent years, there has been a rapid expansion of device-based therapies proposed as novel non-pharmacological approaches to treating resistant hypertension. In this review, we discuss seven novel devices-renal nerve denervation, baroreflex activation therapy, carotid body ablation, central iliac arteriovenous anastomosis, deep brain stimulation, median nerve stimulation, and vagal nerve stimulation. We highlight how the devices differ, the varying degrees of evidence available to date and upcoming trials. This review also considers the possible factors that may enable appropriate device selection for different hypertension phenotypes. PMID:27370788

  2. 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.

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. Cardiac Resynchronization Therapy Delivered Via a Multipolar Left Ventricular Lead is Associated with Reduced Mortality and Elimination of Phrenic Nerve Stimulation: Long‐Term Follow‐Up from a Multicenter Registry

    PubMed Central

    BEHAR, JONATHAN M.; BOSTOCK, JULIAN; ZHU LI, ADRIAN PO; CHIN, HUI MEN SELINA; JUBB, STEPHEN; LENT, EDWARD; GAMBLE, JAMES; FOLEY, PAUL W.X.; BETTS, TIM R.; RINALDI, CHRISTOPHER ALDO

    2015-01-01

    Lower Mortality and Eliminated PNS Associated with Quadripolar Leads Introduction Cardiac resynchronization therapy (CRT) using quadripolar left ventricular (LV) leads provides more pacing vectors compared to bipolar leads. This may avoid phrenic nerve stimulation (PNS) and allow optimal lead placement to maximize biventricular pacing. However, a long‐term improvement in patient outcome has yet to be demonstrated. Methods A total of 721 consecutive patients with conventional CRTD criteria implanted with quadripolar (n = 357) or bipolar (n = 364) LV leads were enrolled into a registry at 3 UK centers. Lead performance and mortality was analyzed over a 5‐year period. Results Patients receiving a quadripolar lead were of similar age and sex to those receiving a bipolar lead, although a lower proportion had ischemic heart disease (62.6% vs. 54.1%, P = 0.02). Both groups had similar rates of procedural success, although lead threshold, impedance, and procedural radiation dose were significantly lower in those receiving a quadripolar lead. PNS was more common in those with quadripolar leads (16.0% vs. 11.6%, P = 0.08), but was eliminated by switching pacing vector in all cases compared with 60% in the bipolar group (P < 0.001). Furthermore, LV lead displacement (1.7% vs. 4.6%, P = 0.03) and repositioning (2.0% vs. 5.2%, P = 0.03) occurred significantly less often in those with a quadripolar lead. All‐cause mortality was also significantly lower in the quadripolar compared to bipolar lead group in univariate and multivariate analysis (13.2% vs. 22.5%, P < 0.001). Conclusions In a large, multicenter experience, the use of quadripolar LV leads for CRT was associated with elimination of PNS and lower overall mortality. This has important implications for LV pacing lead choice. PMID:25631303

  8. Sex Differences in Device Therapy for Heart Failure: Utilization, Outcomes, and Adverse Events

    PubMed Central

    Herz, Naomi D.; Engeda, Joseph; Zusterzeel, Robbert; Sanders, William E.; O'Callaghan, Kathryn M.; Strauss, David G.; Jacobs, Samantha B.; Selzman, Kimberly A.; Piña, Ileana L.

    2015-01-01

    Abstract Background: Multiple studies of heart failure patients demonstrated significant improvement in exercise capacity, quality of life, cardiac left ventricular function, and survival from cardiac resynchronization therapy (CRT), but the underenrollment of women in these studies is notable. Etiological and pathophysiological differences may result in different outcomes in response to this treatment by sex. The observed disproportionate representation of women suggests that many women with heart failure either do not meet current clinical criteria to receive CRT in trials or are not properly recruited and maintained in these studies. Methods: We performed a systematic literature review through May 2014 of clinical trials and registries of CRT use that stratified outcomes by sex or reported percent women included. One-hundred eighty-three studies contained sex-specific information. Results: Ninety percent of the studies evaluated included ≤35% women. Fifty-six articles included effectiveness data that reported response with regard to specific outcome parameters. When compared with men, women exhibited more dramatic improvement in specific parameters. In the studies reporting hazard ratios for hospitalization or death, women generally had greater benefit from CRT. Conclusions: Our review confirms women are markedly underrepresented in CRT trials, and when a CRT device is implanted, women have a therapeutic response that is equivalent to or better than in men, while there is no difference in adverse events reported by sex. PMID:25793483

  9. Arrhythmia management after device removal.

    PubMed

    Nishii, Nobuhiro

    2016-08-01

    Arrhythmic management is needed after removal of cardiac implantable electronic devices (CIEDs). Patients completely dependent on CIEDs need temporary device back-up until new CIEDs are implanted. Various methods are available for device back-up, and the appropriate management varies among patients. The duration from CIED removal to implantation of a new CIED also differs among patients. Temporary pacing is needed for patients with bradycardia, a wearable cardioverter defibrillator (WCD) or catheter ablation is needed for patients with tachyarrhythmia, and sequential pacing is needed for patients dependent on cardiac resynchronization therapy. The present review focuses on arrhythmic management after CIED removal. PMID:27588151

  10. Balloon Devices for Atrial Fibrillation Therapy

    PubMed Central

    Metzner, Andreas; Lin, Tina; Ouyang, Feifan; Kuck, Karl-Heinz

    2015-01-01

    Ablation of atrial fibrillation (AF) is an established treatment option for symptomatic patients refractory to antiarrhythmic medication. In patients with paroxysmal AF, ablation can be offered as first-line therapy when performed in an experienced centre. The accepted cornerstone for all ablation strategies is isolation of the pulmonary veins. However, it is still challenging to achieve contiguous, transmural, permanent lesions using radio-frequency current (RFC) based catheters in conjunction with a three-dimensional mapping system and the learning curve remains long. These limitations have kindled interest in developing and evaluating novel catheter designs that incorporate alternative energy sources. Novel catheters include balloon-based ablation systems, incorporating different energy modalities such as laser (Heartlight™, CardioFocus, Marlborough, MA, US), RFC (Hot Balloon Catheter, Hayama Arrhythmia Institute, Kanagawa, Japan) and cryo-energy (ArcticFront, Medtronic, Inc., Minneapolis, MN, US). While the cryoballoon (CB) and the radiofrequency hot balloon (RHB) are single-shot devices, the endoscopic ablation system (EAS) allows for point-by-point ablation. The CB and EAS are well established as safe, time-efficient and effective ablation tools. Initial studies using the RHB could also demonstrate promising results. However, more data are required. PMID:26835102

  11. Balloon Devices for Atrial Fibrillation Therapy.

    PubMed

    Metzner, Andreas; Wissner, Erik; Lin, Tina; Ouyang, Feifan; Kuck, Karl-Heinz

    2015-05-01

    Ablation of atrial fibrillation (AF) is an established treatment option for symptomatic patients refractory to antiarrhythmic medication. In patients with paroxysmal AF, ablation can be offered as first-line therapy when performed in an experienced centre. The accepted cornerstone for all ablation strategies is isolation of the pulmonary veins. However, it is still challenging to achieve contiguous, transmural, permanent lesions using radio-frequency current (RFC) based catheters in conjunction with a three-dimensional mapping system and the learning curve remains long. These limitations have kindled interest in developing and evaluating novel catheter designs that incorporate alternative energy sources. Novel catheters include balloon-based ablation systems, incorporating different energy modalities such as laser (Heartlight(™), CardioFocus, Marlborough, MA, US), RFC (Hot Balloon Catheter, Hayama Arrhythmia Institute, Kanagawa, Japan) and cryo-energy (ArcticFront, Medtronic, Inc., Minneapolis, MN, US). While the cryoballoon (CB) and the radiofrequency hot balloon (RHB) are single-shot devices, the endoscopic ablation system (EAS) allows for point-by-point ablation. The CB and EAS are well established as safe, time-efficient and effective ablation tools. Initial studies using the RHB could also demonstrate promising results. However, more data are required. PMID:26835102

  12. 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.

  13. 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. PMID:27180326

  14. Inhaled therapy in cystic fibrosis: agents, devices and regimens

    PubMed Central

    Parrott, Helen

    2015-01-01

    Key points There have been significant advances in both inhalation medicines and delivery devices with “intelligent nebulisers” and “dry-powder inhalers” becoming commonplace in CF care. Inhaled medicines generate high levels of a drug within the airways with limited systemic effects, offering safe and convenient antibiotic and mucolytic therapy for individuals with CF. Variations in adherence are not unique to CF; however, treatment burden is high and therefore fast inhaled drug delivery devices may assist individuals in completing the prescribed treatment regimes. Prescribers of inhaled medicines have a responsibility to consider, in addition to efficacy, the appropriated drug/device combination for each individual in order to promote adherence and achieve the desired clinical benefit. Summary The recognised mainstay daily treatments for cystic fibrosis (CF) focus on inhaled and oral medications, airway clearance and optimised nutrition. This review discusses recent advances in inhaled therapies for the management of CF, including devices such as intelligent nebulisers, drug formulations and supporting evidence for inhaled antibiotics (for the management of chronic Pseudomonas aeruginosa) and muco-active drugs. We include practical advice for clinicians regarding the optimisation of inhalation technique and education. The influence of adherence on the use of inhaled therapies in CF is also reviewed. Educational aims To inform readers about the history and progression of inhaled therapies for people with CF with reference to the literature supporting current practice. To highlight the factors that may impact the success of inhaled therapies, including those which are device specific such as drug deposition and those which influence adherence. PMID:26306111

  15. The year in cardiology 2014: arrhythmias and device therapy.

    PubMed

    Heidbuchel, Hein; Hindricks, Gerhard

    2015-02-01

    This review looks back at important and clinically relevant new developments in the fields of invasive electrophysiology and device therapy in 2014. Many findings do not only apply to pure electrophysiologists, but also to every clinical cardiologist’s practice. The authors have extracted the key findings of studies with potential guideline impact and put those into a clinical perspective. Looking back at the achievements of 2014 may instil enthusiasm for further scientific endeavours in the years to come! PMID:25559132

  16. Negative pressure wound therapy limits downgrowth in percutaneous devices.

    PubMed

    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

  17. 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

  18. 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

  19. 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

  20. Home Monitoring for Cardiovascular Implantable Electronic Devices: Benefits to Patients and to Their Follow-up Clinic.

    PubMed

    Leahy, Robin A; Davenport, Elizabeth E

    2015-01-01

    Recent technological advances in the management of patients with cardiovascular implantable electronic devices (CIEDs) have expanded clinicians' ability to remotely monitor patients with CIEDs. Remote monitoring, in addition to periodic in-person device evaluation, provides many advantages to patients and clinicians. Aside from the therapeutic and diagnostic benefits of pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, and implantable loop recorders, improvement in clinical outcomes, clinical efficiencies, and patient experience can be realized with the adoption of remote CIED monitoring. These advantages create significant value to both patients and CIED follow-up centers. PMID:26484995

  1. Resynchronization in neuronal network divided by femtosecond laser processing.

    PubMed

    Hosokawa, Chie; Kudoh, Suguru N; Kiyohara, Ai; Taguchi, Takahisa

    2008-05-01

    We demonstrated scission of a living neuronal network on multielectrode arrays (MEAs) using a focused femtosecond laser and evaluated the resynchronization of spontaneous electrical activity within the network. By an irradiation of femtosecond laser into hippocampal neurons cultured on a multielectrode array dish, neurites were cut at the focal point. After the irradiation, synchronization of neuronal activity within the network drastically decreased over the divided area, indicating diminished functional connections between neurons. Cross-correlation analysis revealed that spontaneous activity between the divided areas gradually resynchronized within 10 days. These findings indicate that hippocampal neurons have the potential to regenerate functional connections and to reconstruct a network by self-assembly. PMID:18418255

  2. 75 FR 7282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

    ... approval application (PMA) for the Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) sponsored by... recommendations and vote on a PMA for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI...

  3. Exercise Rehabilitation for Chronic Heart Failure Patients with Cardiac Device Implants

    PubMed Central

    Haennel, Robert G.

    2012-01-01

    In the past decade a significant development in the management and rehabilitation of people with chronic heart failure (CHF) has been the utilization of cardiac devices. The use of biventricular pacemakers, referred to as Cardiac Resynchronization Therapy (CRT) can yield improvements in functional abilities for a select group of CHF patients and the inclusion of implantable cardiac defibrillators (ICDs) may reduce the risk of sudden death. This review provides physical therapists with a basic understanding of how to prescribe exercise for people with CHF who have these device implants. PMID:22993499

  4. Device Cleaning and Infection Control in Aerosol Therapy.

    PubMed

    O'Malley, Catherine A

    2015-06-01

    Aerosol delivery equipment used to administer inhaled medications includes the nebulizer, positive expiratory pressure devices added to the nebulizer, and valved holding chambers (spacers). These devices are semi-critical medical devices, and as such, infection prevention and control (IPC) guidelines recommend that they be cleaned, disinfected, rinsed with sterile water, and air-dried. There is confusion surrounding the care of aerosol devices because of inconsistencies in the various published IPC guidelines, lack of a standard of practice among institutions and respiratory therapists (RTs), and manufacturer's instructions for use of these devices are not always compatible with guidelines or practice. Challenges lie in awareness of IPC guidelines and establishing a standard for the care of aerosol delivery devices among all stakeholders/manufacturers, governments, vendors, and users. The latest IPC guideline from the Cystic Fibrosis Foundation, reviewed and endorsed by the Society for Healthcare Epidemiology of America and the Association for Professionals in Infection Control, has a recommendation for disposable nebulizers and a recommendation for reusable nebulizers. Reusable nebulizers should be cleaned, disinfected, rinsed with sterile water (if using a cold disinfectant), and air-dried between uses. The mouthpiece/mask of disposable nebulizers should be wiped with an alcohol pad, the residual volume should be rinsed out with sterile water after use, and the nebulizer should be replaced every 24 h. The RT plays a significant and responsible role in providing and teaching aerosol therapy to patients. The RT and all stakeholders need to work together to provide a standard of care for the safe use of aerosol delivery devices. PMID:26070583

  5. Management of antithrombotic therapy during cardiac implantable device surgery.

    PubMed

    AlTurki, Ahmed; Proietti, Riccardo; Birnie, David H; Essebag, Vidal

    2016-06-01

    Anticoagulants are commonly used drugs that are frequently encountered during device placement. Deciding when to halt or continue the use of anticoagulants is a balance between the risks of thromboembolism versus bleeding. Patients taking warfarin with a high risk of thromboembolism should continue to take their warfarin without interruption during device placement while ensuring their international normalized ratio remains below 3. For patients who are taking warfarin and have low risk of thromboembolism, either interrupted or continued warfarin may be used, with no evidence to clearly support either strategy. There is little evidence to support continuing direct acting oral anticoagulants (DOACs) for device implantation. The timing of halting these medications depends largely on renal function. If bleeding occurs, warfarin׳s anticoagulation effect is reversible with vitamin K and activated prothrombin complex concentrate. There are no DOAC reversal agents currently available, but some are under development. Regarding antiplatelet agents, aspirin alone can be safely continued while clopidogrel alone may also be continued, but with a slightly higher bleeding risk. Dual antiplatelet therapy for bare-metal stent/drug-eluting stent implanted within 4 weeks/6 months, respectively, should be continued due to high risk of stent thrombosis; however, if they are implanted after this period, then clopidogrel can be halted 5 days before the procedure and resumed soon after, while aspirin is continued. If the patient is taking both aspirin and warfarin, aspirin should be halted 5 days prior to the procedure, while warfarin is continued. PMID:27354859

  6. [Electronic portal image device dosimetry for volumetric modulated arc therapy].

    PubMed

    Tatsumi, Daisaku; Nakada, Ryosei; Ienaga, Akinori; Yomoda, Akane; Inoue, Makoto; Ichida, Takao; Hosono, Masako

    2013-01-01

    Recently electronic portal image devices (EPIDs) have been widely used for quality assurance and dose verification. However there are no reports describing EPID dosimetry for Elekta volumetric modulated arc therapy (VMAT). We have investigated EPID dosimetry during VMAT delivery using a commercial software EPIDose with an Elekta Synergy linac. Dose rate dependence and the linac system sag during gantry rotation were measured. Gamma indices were calculated between measured doses using an EPID and calculation made by a treatment planning system for prostate VMAT test plans. The results were also compared to gamma indices using films and a two-dimensional detector array, MapCHECK2. The pass rates of the gamma analysis with a criterion of 3% and 2 mm for the three methods were over 96% with good consistency. Our results have showed that EPID dosimetry is feasible for Elekta VMAT. PMID:23358333

  7. Ventricular Assist Devices as Destination Therapy: Psychosocial and Ethical Implications

    PubMed Central

    Grogan, Sherry; Kostick, Kristin; Delgado, Estevan; Bruce, Courtenay R.

    2015-01-01

    One of the candidate evaluation challenges is determining when and how psychosocial domains influence short- and long-term destination therapy ventricular assist device (DT-VAD) outcomes. There are very few DT-VAD studies and no validated instruments to identify psychosocial risk factors. General practice is to borrow from the transplant literature, which may not be applicable to this unique device application. We question the relevance of using transplant psychosocial evaluation for patients who are candidates for DT-VAD only, particularly because these patients require a certain level of cognitive, psychological, and behavioral functioning to ensure proper long-term self-care with the VAD. We may be missing important psychological characteristics in our pre-evaluations by “borrowing” from the transplant literature, thereby underplaying significant factors that are especially relevant for DT-VAD candidates. Conversely, we may be screening out candidates who may benefit greatly from DT-VAD by using transplant criteria as part of the screening process. We use a case study to illustrate some of the challenges of weighing psychosocial risk factors in the DT-VAD population and to emphasize the need for developing distinct psychosocial assessment criteria for DT-VAD patients. PMID:25793023

  8. Considerations in Patients With Cardiac Implantable Electronic Devices at End of Life.

    PubMed

    Gura, Melanie T

    2015-01-01

    Since the introduction of implantable cardiac pacemakers in 1958 and implantable cardioverter-defibrillators in 1980, these devices have been proven to save and prolong lives. Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy are deemed life-sustaining therapies. Despite these life-saving technologies, all patients ultimately will reach the end of their lives from either their heart disease or development of a terminal illness. Clinicians may be faced with patient and family requests to withdraw these life-sustaining therapies. The purpose of this article is to educate clinicians about the legal and ethical principles that underlie withdrawal of life-sustaining therapies such as device deactivation and to highlight the importance of proactive communication with patients and families in these situations. PMID:26484996

  9. The case for over-the-counter shortwave therapy: safe and effective devices for pain management.

    PubMed

    Rawe, Ian M

    2014-01-01

    Pulsed shortwave diathermy, an electromagnetic therapy, has been in clinical use for acute and chronic musculoskeletal pain for many decades. Innovation, miniaturization and advances in technology have allowed for the development of a new generation of shortwave devices that deliver a localized, low fixed dose of shortwave therapy. Clinical research has shown that these novel shortwave devices can be used safely in order to reduce acute and chronic pain, as well as the need for pain medications. Their ease of use and safety profile make low-dose shortwave devices an attractive alternative, or adjunct therapy, to pharmacological-based pain therapies. PMID:24641342

  10. Technical and Practical Considerations for Device Selection in Locoregional Ablative Therapy

    PubMed Central

    Zivin, Sean P.; Gaba, Ron C.

    2014-01-01

    Percutaneous ablation therapy is an essential component of contemporary interventional oncologic therapy of primary and secondary malignancies. The growing armamentarium of available ablation technologies calls for thorough understanding of the different ablation modalities to optimize device selection in individual clinical settings. The goal of the current article is to provide direction on ablative device selection by reviewing device mechanisms of action, advantages and disadvantages, and practical considerations in real-life case scenarios. PMID:25053866

  11. 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

  12. 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.

  13. Ventricular Assist Devices (VAD) Therapy: New Technology, New Hope?

    PubMed Central

    Rodriguez, Limael E.; Suarez, Erik E.; Loebe, Matthias; Bruckner, Brian A.

    2013-01-01

    Ventricular assist devices are commonly utilized in the treatment of end-stage heart failure. Advances in continuous flow technology have improved efficiency, size, implantability, extended support, and overall patient outcomes. This has led to an expanded role of left ventricular assist device (LVAD) clinical use and applications. This review describes the advances and current state of LVAD devices and provides a future outlook for this technology. PMID:23519193

  14. [At-home-therapeutic space. Development of a device intended for family therapy at home].

    PubMed

    Segura, José Adolfo

    2003-01-01

    Inspired by his ethnographic experience with the Mapuche, a native community in the South of Chile and his reflection on family therapy and the literature pertaining to ethnopsychiatry, the author proposes the elaboration of an at-home-therapeutic space (HTS), a specific device for family therapy in the homes of patients. The author describes the various steps of his approach and his first-hand experience of the device. PMID:15368013

  15. Effectiveness of device-based therapy for conservative management of low back pain

    PubMed Central

    Anandani, Garima; Shetty, Gautam M; Bafna, Suraj; Narula, Neha; Gandhi, Aabha

    2015-01-01

    [Purpose] Device based therapy for low back pain (LBP) involves quantitative assessment of muscle strength, resistance and lumbar motion and tailoring the rehabilitation protocol based on this objective assessment. The purpose of this study was to determine the effectiveness of device based therapy for LBP. [Subjects and Methods] In this retrospective study, clinical data of 235 patients who underwent device-based physiotherapy for low back pain was reviewed. Pre and post-treatment outcome measures for pain (visual analogue scale or VAS score), disability (Oswestry disability index) and functional ability were compared to determine effectiveness of device-based physiotherapy at the end of 6 weeks of treatment. [Results] All outcome measures including VAS Score and mean Oswestry Disability Score showed significant improvement at the end of 6 weeks of device-based physical therapy. Before treatment, 73% of patients had moderate to severe disability which reduced to 28% after treatment. [Conclusion] Device-based therapy is effective in relieving pain, improving function and reducing disability in patients with low back pain in the short term. Device-based therapy may help to objectively evaluate the function of the spine and paraspinal muscles and help the therapist tailor treatment accordingly. PMID:26311940

  16. Left ventricular assist devices in patients with end-stage heart failure: suggestion of an alternative treatment based on clinically well-known concepts.

    PubMed

    Fantidis, Panayotis; Sánchez, Eladio; Tarhini, Ibrahim; Khan, Ijaz; Pineda, Tomas; Corrales, Juan Antonio; González, José Ramón

    2014-11-01

    Encouraging results were obtained by using left ventricular assist devices (LVADs) in patients with end-stage heart failure (HF) that exhibits extremely high mortality and who were not candidates for heart transplantation. By using this so-called destination therapy (DT), a substantial percentage of these patients achieved sufficient improvement in cardiac function to permit the explantation of the device. The combination of mechanical and pharmacological therapy increased the frequency and durability of myocardial recovery as compared with other therapeutic approaches. Although cardiac transplantation, LVADs, and cardiac resynchronization therapy have provided a major advance in DT, their limitations stimulate the search for alternative therapies. We discuss the limitations of these 3 treatment options for end-stage HF. Also, we propose and discuss the possible advantages of a new intracorporeal procedure that works continuously as intraaortic balloon counterpulsation without an extracorporeal or intracorporeal computer-controlled mechanism. PMID:24482491

  17. Development of a device for photodynamic therapy of oral cavity mucous

    NASA Astrophysics Data System (ADS)

    Ovchinnikov, Ilya S.; Tuchin, Valery V.; Ulyanov, Sergey S.

    1999-03-01

    The device, offered for reviewing, was designed and developed for photodynamic therapy of oral cavity mucous diseases and for laboratory experiments on the red light influence on the bacterial colonies in presence of a dye. The device has rather simple construction, it is cheap but convenience in use.

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

    PubMed Central

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

    2014-01-01

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

  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. Clinical Effectiveness of CRT and ICD Therapy in Heart Failure Patients by Racial/Ethnic Classification

    PubMed Central

    Ziaeian, Boback; Zhang, Yan; Albert, Nancy M.; Curtis, Anne B.; Gheorghiade, Mihai; Heywood, J. Thomas; Mehra, Mandeep R.; O'Connor, Christopher M.; Reynolds, Dwight; Walsh, Mary Norine; Yancy, Clyde W.; Fonarow, Gregg C.

    2015-01-01

    BACKGROUND Clinical trials have demonstrated benefit for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) therapies in patients with heart failure with reduced ejection fraction (HFrEF); yet, questions have been raised with regard to the benefit of device therapy for minorities. OBJECTIVES The purpose of this study was to determine the clinical effectiveness of CRT and ICD therapies as a function of race/ethnicity in outpatients with HFrEF (ejection fraction ≤35%). METHODS Data from IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) were analyzed by device status and race/ethnicity among guideline-eligible patients for mortality at 24 months. Multivariate Generalized Estimating Equations analyses were conducted, adjusting for patient and practice characteristics. RESULTS The ICD/cardiac resynchronization defibrillator (CRT-D)–eligible cohort (n = 7,748) included 3,391 (44%) non-Hispanic white, 719 (9%) non-Hispanic black, and 3,638 (47%) other racial/ethnic minorities or race-not-documented patients. The cardiac resynchronization pacemaker (CRT-P)/CRT-D–eligible cohort (n = 1,188) included 596 (50%) non-Hispanic white, 99 (8%) non-Hispanic black, and 493 (41%) other/not-documented patients. There was clinical benefit associated with ICD/CRT-D therapy (adjusted odds ratio: 0.64, 95% confidence interval: 0.52 to 0.79, p = 0.0002 for 24-month mortality), which was of similar proportion in white, black, and other minority/not-documented patients (device–race/ethnicity interaction p = 0.7861). For CRT-P/CRT-D therapy, there were also associated mortality benefits (adjusted odds ratio: 0.55, 95% confidence interval: 0.33 to 0.91, p = 0.0222), and the device–race/ethnicity interaction was not significant (p = 0.5413). CONCLUSIONS The use of guideline-directed CRT and ICD therapy was associated with reduced 24-month mortality without significant interaction by racial

  1. Are Electronic Cardiac Devices Still Evolving?

    PubMed Central

    Mabo, P.

    2014-01-01

    Summary Objectives The goal of this paper is to review some important issues occurring during the past year in Implantable devices. Methods First cardiac implantable device was proposed to maintain an adequate heart rate, either because the heart’s natural pacemaker is not fast enough, or there is a block in the heart’s electrical conduction system. During the last forty years, pacemakers have evolved considerably and become programmable and allow to configure specific patient optimum pacing modes. Various technological aspects (electrodes, connectors, algorithms diagnosis, therapies, …) have been progressed and cardiac implants address several clinical applications: management of arrhythmias, cardioversion / defibrillation and cardiac resynchronization therapy. Results Observed progress was the miniaturization of device, increased longevity, coupled with efficient pacing functions, multisite pacing modes, leadless pacing and also a better recognition of supraventricular or ventricular tachycardia’s in order to deliver appropriate therapy. Subcutaneous implant, new modes of stimulation (leadless implant or ultrasound lead), quadripolar lead and new sensor or new algorithm for the hemodynamic management are introduced and briefly described. Each times, the main result occurring during the two past years are underlined and repositioned from the history, remaining limitations are also addressed. Conclusion Some important technological improvements were described. Nevertheless, news trends for the future are also considered in a specific session such as the remote follow-up of the patient or the treatment of heart failure by neuromodulation. PMID:25123732

  2. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION... 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...

  3. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION... 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION... 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. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION... 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...

  6. How are arrhythmias detected by implanted cardiac devices managed in Europe? Results of the European Heart Rhythm Association Survey.

    PubMed

    Todd, Derick; Hernandez-Madrid, Antonio; Proclemer, Alessandro; Bongiorni, Maria Grazia; Estner, Heidi; Blomström-Lundqvist, Carina

    2015-09-01

    The management of arrhythmias detected by implantable cardiac devices can be challenging. There are no formal international guidelines to inform decision-making. The purpose of this European Heart Rhythm Association (EHRA) survey was to assess the management of various clinical scenarios among members of the EHRA electrophysiology research network. There were 49 responses to the questionnaire. The survey responses were mainly (81%) from medium-high volume device implanting centres, performing more than 200 total device implants per year. Clinical scenarios were described focusing on four key areas: the implantation of pacemakers for bradyarrhythmia detected on an implantable loop recorder (ILR), the management of patients with ventricular arrhythmia detected by an ILR or pacemaker, the management of atrial fibrillation in patients with pacemakers and cardiac resynchronization therapy devices and the management of ventricular tachycardia in patients with implantable cardioverter-defibrillators. PMID:26443791

  7. 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

  8. Assistive acting movement therapy devices with pneumatic rotary-type soft actuators.

    PubMed

    Wilkening, André; Baiden, David; Ivlev, Oleg

    2012-12-01

    Inherent compliance and assistive behavior are assumed to be essential properties for safe human-robot interaction. Rehabilitation robots demand the highest standards in this respect because the machine interacts directly with weak persons who are often sensitive to pain. Using novel soft fluidic actuators with rotary elastic chambers (REC actuators), compact, lightweight, and cost-effective therapeutic devices can be developed. This article describes modular design and control strategies for new assistive acting robotic devices for upper and lower extremities. Due to the inherent compliance and natural back-drivability of pneumatic REC actuators, these movement therapy devices provide gentle treatment, whereby the interaction forces between humans and the therapy device are estimated without the use of expensive force/torque sensors. An active model-based gravity compensation based on separated models of the robot and of the individual patient's extremity provides the basis for effective assistive control. The utilization of pneumatic actuators demands a special safety concept, which is merged with control algorithms to provide a sufficient level of safeness and to catch any possible system errors and/or emergency situations. A self-explanatory user interface allows for easy, intuitive handling. Prototypes are very comfortable for use due to several control routines that work in the background. Assistive devices have been tested extensively with several healthy persons; the knee/hip movement therapy device is now under clinical trials at the Clinic for Orthopaedics and Trauma Surgery at the Klinikum Stuttgart. PMID:23241570

  9. 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.

  10. Evaluation of advanced cooling therapy's esophageal cooling device for core temperature control.

    PubMed

    Naiman, Melissa; Shanley, Patrick; Garrett, Frank; Kulstad, Erik

    2016-05-01

    Managing core temperature is critical to patient outcomes in a wide range of clinical scenarios. Previous devices designed to perform temperature management required a trade-off between invasiveness and temperature modulation efficiency. The Esophageal Cooling Device, made by Advanced Cooling Therapy (Chicago, IL), was developed to optimize warming and cooling efficiency through an easy and low risk procedure that leverages heat transfer through convection and conduction. Clinical data from cardiac arrest, fever, and critical burn patients indicate that the Esophageal Cooling Device performs very well both in terms of temperature modulation (cooling rates of approximately 1.3°C/hour, warming of up to 0.5°C/hour) and maintaining temperature stability (variation around goal temperature ± 0.3°C). Physicians have reported that device performance is comparable to the performance of intravascular temperature management techniques and superior to the performance of surface devices, while avoiding the downsides associated with both. PMID:27043177

  11. Impact of cardiac magnetic resonance imaging on cardiac device and surgical therapy: a prospective study.

    PubMed

    Taylor, Andrew J; Ellims, Andris; Lew, Philip J K; Murphy, Bridie; Pally, Suzana; Younie, Sandra

    2013-04-01

    Cardiac magnetic resonance (CMR) imaging may allow more appropriate selection of patients for cardiac device implantation and/or cardiac surgery. In this prospective observational study we evaluated the impact of CMR imaging on cardiac device and surgical therapy. All CMR examinations performed in a single centre over a 2 year period were prospectively recorded in a dedicated database under 4 clinical pathways [cardiomyopathy, viability, tumour/mass and arrythmogenic right ventricular cardiomyopathy (ARVC)]. Baseline data entered included planned cardiac device implantation and/or cardiac surgical intervention. Patients were contacted 6 months following CMR to evaluate the impact of CMR on planned therapy. Cost savings due to CMR were calculated as the number of surgical or device procedures averted following CMR scanning multiplied by their respective cost weights. Of 732 CMR examinations performed, the clinical pathway was cardiomyopathy in 488 (67 %), ARVC in 118 (16 %), viability in 92 (12 %) and tumour/mass in 34 (5 %). Six month follow-up was available in 666/732 patients. Following CMR, 56/150 (37 %) of patients with an initial plan for device implantation or cardiac surgery, did not undergo the planned intervention (P < 0.001, one-sample exact binomial test). Of 516 patients without an initial device or surgical plan, 33 (6 %) CMR resulted in device implantation or cardiac surgery (P < 0.001, Chi squared). Overall, the estimated saving due to CMR-guided management changes was AUD$737,270. CMR has a significant impact on patient management and offers potential cost savings with respect to selection of device and surgical therapy for cardiac disease. PMID:23592405

  12. 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

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

    PubMed

    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 because of lack of safer alternatives. Complications occur using adult CRRT devices in children because of 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 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

  14. Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE® device therapy: a case series

    PubMed Central

    2010-01-01

    Introduction Approximately 15% (more than 2 million individuals, based on these estimates) of all people with diabetes will develop a lower-extremity ulcer during the course of the disease. Ultimately, between 14% and 20% of patients with lower-extremity diabetic ulcers will require amputation of the affected limb. Analysis of the 1995 Medicare claims revealed that lower-extremity ulcer care accounted for $1.45 billion in Medicare costs. Therapies that promote rapid and complete healing and reduce the need for expensive surgical procedures would impact these costs substantially. One such example is the electrotherapeutic modality utilizing the H-Wave® device therapy and program. It has been recently shown in acute animal experiments that the H-Wave® device stimulation induces a nitric oxide-dependent increase in microcirculation of the rat Cremaster skeletal muscle. Moreover, chronic H-wave® device stimulation of rat hind limbs not only increases blood flow but induces measured angiogenesis. Coupling these findings strongly suggests that H-Wave® device stimulation promotes rapid and complete healing without need of expensive surgical procedures. Case presentation We decided to do a preliminary evaluation of the H-Wave® device therapy and program in three seriously afflicted diabetic patients. Patient 1 had chronic venous stasis for 6 years. Patient 2 had chronic recurrent leg ulcerations. Patient 3 had a chronic venous stasis ulcer for 2 years. All were dispensed a home H-Wave® unit. Patient 1 had no other treatment, patient 2 had H-Wave® therapy along with traditional compressive therapy, and patient 3 had no other therapy. For patient 1, following treatment the ulcer completely healed with the H-Wave® device and program after 3 months. For patient 2, by one month complete ulcer closure occurred. Patient 3 had a completely healed ulcer after 9 months. Conclusions While most diabetic ulcers can be treated successfully on an outpatient basis, a significant

  15. 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

  16. 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

    2014-12-01

    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

  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. PMID:25453936

  18. An implantable active-targeting micelle-in-nanofiber device for efficient and safe cancer therapy.

    PubMed

    Yang, Guang; Wang, Jie; Wang, Yi; Li, Long; Guo, Xing; Zhou, Shaobing

    2015-02-24

    Nanocarriers have attracted broad attention in cancer therapy because of their ability to carry drugs preferentially into cancer tissue, but their application is still limited due to the systemic toxicity and low delivery efficacy of intravenously delivered chemotherapeutics. In this study, we develop a localized drug delivery device with combination of an active-targeting micellar system and implantable polymeric nanofibers. This device is achieved first by the formation of hydrophobic doxorubicin (Dox)-encapsulated active-targeting micelles assembled from a folate-conjugated PCL-PEG copolymer. Then, fabrication of the core-shell polymeric nanofibers is achieved with coaxial electrospinning in which the core region consists of a mixture of poly(vinyl alcohol) and the micelles and the outer shell layer consists of cross-linked gelatin. In contrast to the systematic administration of therapeutics via repeatedly intravenous injections of micelles, this implantable device has these capacities of greatly reducing the drug dose, the frequency of administration and side effect of chemotherapeutic agents while maintaining highly therapeutic efficacy against artificial solid tumors. This micelle-based nanofiber device can be developed toward the next generation of nanomedicine for efficient and safe cancer therapy. PMID:25602381

  19. 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

  20. 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.

  1. 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

  2. Transcatheter valve therapy registry is a model for medical device innovation and surveillance.

    PubMed

    Carroll, John D; Shuren, Jeff; Jensen, Tamara Syrek; Hernandez, John; Holmes, David; Marinac-Dabic, Danica; Edwards, Fred H; Zuckerman, Bram D; Wood, Larry L; Kuntz, Richard E; Mack, Michael J

    2015-02-01

    Heart valve diseases are increasingly prevalent, especially in people older than age seventy. Many of these elderly people have other comorbid conditions, making them poor candidates for surgical treatment of heart valve diseases. Since 2011 such patients have been eligible to receive new nonsurgical heart valve treatments approved by the Food and Drug Administration (FDA) and covered by Medicare. This article examines the Transcatheter Valve Therapy Registry, which captures clinical information on all US patients undergoing new nonsurgical heart valve treatments. The registry has patient-level data from more than 27,000 patients treated with the novel devices. Patient- and procedure-related data are gathered from hospitals, patient-reported outcomes are assessed pre- and postprocedure, and longer-term data on mortality and repeat hospitalization are provided by linking the registry's data to Medicare patient data. The registry is a model of collaboration among professional societies, the FDA, the Centers for Medicare and Medicaid Services, hospitals, patients, and the medical device industry. It has been used to support Medicare coverage decisions, expand device indications, provide comprehensive device surveillance, and establish national quality benchmarks. Beyond having it serve as a collaborative model, future goals for the registry include shortening the FDA-approval timeline for devices, providing data for decision-making tools for patients, and public reporting of hospital performance. PMID:25646114

  3. Illumination devices for uniform delivery of light to the oral cavity for photodynamic therapy

    NASA Astrophysics Data System (ADS)

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

    2011-10-01

    To date, the lack of light delivery mechanisms to the oral cavity remains a barrier to the treatment of oral cancer with photodynamic therapy (PDT). The greatest impediment to medical practitioners is the current need to shield the normal tissues of the oral cavity, a costly and time-consuming procedure. In this research, we present the design of illumination devices to deliver light to the oral cavity for PDT, which will facilitate administration of PDT in the clinic. The goal for such an illumination device, as indicated by our clinical collaborators at Roswell Park Cancer Institute in Buffalo, NY, is to limit exposure of healthy tissue and produce an average irradiance of 100 mW/cm2 over the treatment field, with spatial non-uniformities below 10%. Furthermore, the size of the device must be compact to allow use in the oral cavity. Our research led to the design and fabrication of two devices producing spatial non-uniformities below 6% over a treatment area of 0.25 cm2 by design. One device consisted of an appropriately-sized reflector, inspired by solar concentrators, illuminated by a cylindrical diffusing fiber optimally located within the reflector; another was a solid lightpipe with a combination of optimized tapered and straight components.

  4. 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.

  5. Cost comparison of heart transplant vs. left ventricular assist device therapy at one year.

    PubMed

    Marasco, Silvana F; Summerhayes, Robyn; Quayle, Margaret; McGiffin, David; Luthe, Marco

    2016-05-01

    With the worldwide shortage of donor organs, use of ventricular assist device (VAD) therapy is rapidly increasing in both the bridge to transplant and destination therapy settings. However, the high cost of VADs and VAD care is a cause for concern for policy makers who have relied on the limited supply of donor hearts to naturally cap health expenditure on heart transplantation (HTx). We sought to compare costs of the first 12 months of care of VADs vs. HTx. Single center retrospective study utilizing real generated costs over a three yr span from 2010-2012. Only patients with 12 months of costing data were included. Costs of 28 HTx patients and 24 VAD patients were analyzed. Index admission costs were more than double in the VAD group compared to the HTx group and this was driven by the procurement costs and length of stay which increased almost all aspects of in hospital care costs. Subsequent costs were six times higher in the HTx group and this was driven largely by pharmaceuticals. VAD therapy remains a very expensive treatment option for end stage heart failure patients. Device prices need to reduce substantially to make this a more widely applicable and cost effective treatment option. PMID:26913688

  6. 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. PMID:26202221

  7. 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.

  8. 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.

  9. Targeted Prostate Thermal Therapy with Catheter-Based Ultrasound Devices and MR Thermal Monitoring

    NASA Astrophysics Data System (ADS)

    Diederich, Chris; Ross, Anthony; Kinsey, Adam; Nau, Will H.; Rieke, Viola; Butts Pauly, Kim; Sommer, Graham

    2006-05-01

    Catheter-based ultrasound devices have significant advantages for thermal therapy procedures, including potential for precise spatial and dynamic control of heating patterns to conform to targeted volumes. Interstitial and transurethral ultrasound applicators, with associated treatment strategies, were developed for thermal ablation of prostate combined with MR thermal monitoring. Four types of multielement transurethral applicators were devised, each with different levels of selectivity and intended therapeutic goals: sectored tubular transducer devices with fixed directional heating patterns; planar and lightly focused curvilinear devices with narrow heating patterns; and multi-sectored tubular devices capable of dynamic angular control without applicator movement. These devices are integrated with a 4 mm delivery catheter, incorporate an inflatable cooling balloon (10 mm OD) for positioning within the prostate and capable of rotation via an MR-compatible motor. Similarly, interstitial devices (2.4 mm OD) have been developed for percutaneous implantation with fixed directional heating patterns (e.g., 180 deg.). In vivo experiments in canine prostate (n=15) under MR temperature imaging were used to evaluate the heating technology and develop treatment strategies. MR thermal imaging in a 0.5 T interventional MRI was used to monitor temperature contours and thermal dose in multiple slices through the target volume. Sectored transurethral devices produce directional coagulation zones, extending 15-20 mm radial distance to the outer prostate capsule. The curvilinear applicator produces distinct 2-3 mm wide lesions, and with sequential rotation and modulated dwell time can precisely conform thermal ablation to selected areas or the entire prostate gland. 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. Interstitial implants with

  10. Combination therapy in clinical and cosmetic dermatology: the marriage of device and drug.

    PubMed

    Nestor, Mark Steven

    2004-01-01

    The first generations of lasers used in clinical and cosmetic dermatology achieved their effects by means of epidermal and dermal ablation. While effective in removing some of the stigmata of photodamage including pigmentary changes and rhytides, vascular abnormalities associated with such conditions as melasma and rosacea, were not sufficiently effective. The new generation of laser and non-laser light devices (eg, intense pulsed light or IPL) offer excellent results in the management of clinical and cosmetic conditions, including significant changes in improvement in vascular conditions such as rosacea and actinic damage and stimulating dermal collagen production, without significant injury to the epidermis. The combination of light therapies and topical agents adds to the efficacy of these procedures, particularly in post-procedural maintenance. Light-based therapies have been an important addition to the anti-acne armamentarium as they are effective and do not add to the increasing bacterial resistance problem. PMID:15552594

  11. Biological therapies for cardiac arrhythmias: can genes and cells replace drugs and devices?

    PubMed

    Cho, Hee Cheol; Marbán, Eduardo

    2010-03-01

    Cardiac rhythm disorders reflect failures of impulse generation and/or conduction. With the exception of ablation methods that yield selective endocardial destruction, present therapies are nonspecific and/or palliative. Progress in understanding the underlying biology opens up prospects for new alternatives. This article reviews the present state of the art in gene- and cell-based therapies to correct cardiac rhythm disturbances. We begin with the rationale for such approaches, briefly discuss efforts to address aspects of tachyarrhythmia, and review advances in creating a biological pacemaker to cure bradyarrhythmia. Insights gained bring the field closer to a paradigm shift away from devices and drugs, and toward biologics, in the treatment of rhythm disorders. PMID:20203316

  12. 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.

  13. 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. PMID:26886464

  14. Negative pressure wound therapy and external fixation device: a simple way to seal the dressing.

    PubMed

    Bulla, Antonio; Farace, Francesco; Uzel, André-Pierre; Casoli, Vincent

    2014-07-01

    Negative pressure therapy is widely applied to treat lower limb trauma. However, sealing a negative pressure dressing in the presence of an external fixation device may be difficult and time consuming. Therefore, screws, pins, wires, etc, may preclude the vacuum, preventing the plastic drape to perfectly adhere to the foam. To maintain the vacuum, we tried to prevent air leaking around the screws putting bone wax at the junction between the pins and the plastic drape. This solution, in our hands, avoids air leakage and helps maintain vacuum in a fast and inexpensive way. PMID:24296597

  15. 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

  16. Malfunctions of implantable cardiac devices in patients receiving proton beam therapy: incidence and predictors

    PubMed Central

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

    2014-01-01

    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 From March 2009 through July 2012, 42 patients with implanted cardiac implantable electronic devices (CIEDs) (28 pacemakers and 14 cardioverter-defillibrators) 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(RBE) [range 46.8–87.5 Gy(RBE)], 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 five patients (2 pacemakers and 3 defibrillators). Five of these malfunctions were CIED resets, and one patient with a defibrillator (in a patient with a liver tumor) had an elective replacement indicator (ERI) 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 ERI 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 thoracic PBT be followed closely. PMID

  17. Cardiac pacing device therapy for atrial dysrhythmias: how does it work?

    PubMed

    Irwin, Marleen E

    2004-01-01

    Atrial fibrillation (AF) is the most common dysrhythmia in North America. Paroxysmal or persistent AF affects an estimated 2.8 million individuals, causes significant morbidity, and is associated with 1 billion dollars in healthcare costs each year in the United States. An aging population, the prevalence of hypertension, and the emergence of heart failure as the final common pathway of heart disease finds us in an age where the incidence of AF is ever increasing and the management challenges are indeed an expanding clinical problem. Although guidelines for selection of the appropriate pacing mode have been published, device therapy for the control of AF and paroxysmal AF is an emerging clinical management strategy. In 2001 The American College of Cardiology (ACC)/American Heart Association (AHA) published a document to revise the 1998 guidelines for device therapy, and even now these guidelines require elucidation and inclusion for the use of cardiac pacing device therapy for the control of atrial dysrhythmia. Choosing a complex system, in particular for the patient with persistent and symptomatic atrial dysrhythmia, is a most intricate challenge for the healthcare professional and the healthcare system. Rate dependent effects on refractoriness, reduction of ectopy, remodeling of the substrate, and prevention of pauses have been described as the potential mechanisms responsible for the rhythmic control effect attributed to atrial pacing. However, while permanent cardiac pacing is required for patients with symptomatic bradycardia with atrioventricular block and AF, the concept of pacing for the primary prevention of AF is novel. Pacing algorithms, single site, biatrial, and dual-site atrial pacing and site-specific pacing have all been studied as substrate modulators to prevent recurrent atrial dysrhythmia.A dilemma exists surrounding the primary approach for the control of symptomatic AF with rapid ventricular response. The question remains: should it be to

  18. Left ventricular assist device: a bridge to transplant or destination therapy?

    PubMed

    Patel, Swati; Nicholson, Louise; Cassidy, Christopher J; Wong, Kenneth Y-K

    2016-05-01

    Heart failure is a major problem worldwide; it is the leading cause of hospitalisation and is posing a huge financial burden. Advances in healthcare have contributed to increased life expectancy, with a resultant increase in the number of patients with chronic heart failure. For many patients who are still severely symptomatic despite optimal medical therapy and cardiac resynchronisation therapy, cardiac transplantation would be the preferred treatment option. However, hopes are cut short with a limited donor pool of hearts for the increasing number of patients requiring cardiac transplantation. One uprising method to fill this treatment void for patients with advanced end-stage heart failure (ESHF) is the Left Ventricular Assist Device (LVAD). Although traditionally used as a bridge to transplantation, owing to limitation of suitable donors, evidence suggests increasing potential for the use of LVAD as destination therapy (DT), that is, lifelong permanent support. Exploration of DT is a promising avenue to many patients suffering with ESHF who may never be fortunate enough to receive a heart transplant, but not without reservations of its efficacy, safety, effects on quality-adjusted life years and cost-effectiveness, especially in comparison to heart transplantation. PMID:26969730

  19. Anesthetic management for implantation of a treatment device: the Rheos Baroreflex Hypertensive Therapy System.

    PubMed

    Thai, Nina N

    2012-02-01

    Resistant hypertension is a prevalent dilemma. Despite all available antihypertensive medications and multiple strategies such as healthier diets and exercise programs, many patients are still unable to maintain or reach a therapeutic goal for systolic blood pressure. Because of this major health concern, CVRx, Inc has developed a treatment involving baroreflex activation therapy (Rheos Baroreflex Hypertension Therapy System) to treat patients with uncontrolled high blood pressure. The surgical implantation of this system is similar to a carotid endarterectomy procedure; however, the anesthetic management for this procedure is unique and challenging. This case report describes a 45-year-old African American woman with a history of hypertension who was receiving multiple antihypertensive medications and, thus, was a qualified candidate for implantation of this device. The goal of anesthetic management during implantation of this hypertension therapy system is to preserve the carotid sinus baroreceptor sensitivity by avoiding administering anesthetic agents that inhibit the baroreceptor reflex during electrode placement and the testing period. Because of the restriction of some of the anesthetic agents that an anesthesia provider can use, this procedure poses major challenges to the anesthesia provider in planning for anesthesia care and managing risks to the patient. PMID:22474800

  20. Device-Based Therapy for Drug-Resistant Hypertension: An Update.

    PubMed

    Li, Ping; Nader, Mark; Arunagiri, Kousalya; Papademetriou, Vasilios

    2016-08-01

    Drug-resistant hypertension (RH) remains a significant and common cardiovascular risk despite the availability of multiple potent antihypertensive medications. Uncontrolled resistant hypertension contributes substantially to excessive cardiovascular and renal morbidity and mortality. Clinical and experimental evidence suggest that sympathetic nervous system over-activity is the main culprit for the development and maintenance of drug-resistant hypertension. Both medical and interventional strategies, targeting the sympathetic over-activation, have been designed in patients with hypertension over the past few decades. Minimally invasive, catheter-based, renal sympathetic denervation (RDN) and carotid baroreceptor activation therapy (BAT) have been extensively evaluated in patients with RH in clinical trials. Current trial outcomes, though at times impressive, have been mostly uncontrolled trials in need of validation. Device-based therapy for drug-resistant hypertension has the potential to provide alternative treatment options to certain groups of patients who are refractory or intolerant to current antihypertensive medications. However, more research is needed to prove its efficacy in both animal models and in humans. In this article, we will review the evidence from recent renal denervation, carotid baroreceptor stimulation therapy, and newly emerged central arteriovenous anastomosis trials to pinpoint the weak links, and speculate on potential alternative approaches. PMID:27402013

  1. Design of illumination devices for delivery of photodynamic therapy in the oral cavity

    NASA Astrophysics Data System (ADS)

    Canavesi, Cristina; Fournier, Florian; Foster, Thomas H.; Rolland, Jannick P.

    2010-08-01

    We present three designs for delivery of light in the oral cavity for photodynamic therapy (PDT) under the requirements of average irradiance of 50 mW/cm2 and spatial non-uniformities well under 10% over a square area of 25 mm2. The main goal is to design a device that avoids having to shield the oral cavity prior to irradiation for PDT. Illumination theory is instrumental in identifying an effective geometry for the device. The designs proposed build upon the technology that is already available for PDT and use illumination theory concepts to maximize the efficiency of the light delivery. One design combines a cylindrical diffusing fiber with a reflector derived from the edge-ray theorem while a second consists of a fiber illuminator coupled to a lightpipe device. Both designs are successful in delivering the light reducing the need of shielding and in providing the desired irradiance and uniformity. The two approaches performed comparably and provided a higher irradiance than needed, thus inspiring the design of a third, simpler design based on an off-axis cylinder reflector.

  2. 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

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

    PubMed Central

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

    2016-01-01

    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. PMID:27470015

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

    PubMed

    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. PMID:26999482

  5. 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.

  6. Critical appraisal of cardiac implantable electronic devices: complications and management

    PubMed Central

    Padeletti, Luigi; Mascioli, Giosuè; Perini, Alessandro Paoletti; Grifoni, Gino; Perrotta, Laura; Marchese, Procolo; Bontempi, Luca; Curnis, Antonio

    2011-01-01

    Population aging and broader indications for the implant of cardiac implantable electronic devices (CIEDs) are the main reasons for the continuous increase in the use of pacemakers (PMs), implantable cardioverter-defibrillators (ICDs) and devices for cardiac resynchronization therapy (CRT-P, CRT-D). The growing burden of comorbidities in CIED patients, the greater complexity of the devices, and the increased duration of procedures have led to an augmented risk of infections, which is out of proportion to the increase in implantation rate. CIED infections are an ominous condition, which often implies the necessity of hospitalization and carries an augmented risk of in-hospital death. Their clinical presentation may be either at pocket or at endocardial level, but they can also manifest themselves with lone bacteremia. The management of these infections requires the complete removal of the device and subsequent, specific, antibiotic therapy. CIED failures are monitored by competent public authorities, that require physicians to alert them to any failures, and that suggest the opportune strategies for their management. Although the replacement of all potentially affected devices is often suggested, common practice indicates the replacement of only a minority of devices, as close follow-up of the patients involved may be a safer strategy. Implantation of a PM or an ICD may cause problems in the patients’ psychosocial adaptation and quality of life, and may contribute to the development of affective disorders. Clinicians are usually unaware of the psychosocial impact of implanted PMs and ICDs. The main difference between PM and ICD patients is the latter’s dramatic experience of receiving a shock. Technological improvements and new clinical evidences may help reduce the total burden of shocks. A specific supporting team, providing psychosocial help, may contribute to improving patient quality of life. PMID:22915942

  7. Simple Myofunctional Therapy Using Ready-made 
Mouthpiece Device before and after Orthodontic Treatment.

    PubMed

    Fukumoto, Aoi; Otsuka, Takero; Kawata, Toshitsugu

    2016-01-01

    The present report describes myofunctional therapy using a ready-made training device, the T4A, in patients with permanent dentition and its effect on the prevention of relapse. The buccinator mechanism maintains the inner pressure of the tongue muscle equivalent to the outer pressure of the perioral soft tissues, such as the orbicular muscles, including the cephalopharyngeus and buccinator muscles. Training is performed so that patients learn to place their tongue and lips in the appropriate resting positions. The shape of the T4A and tongue guard supports the tongue from the bottom, allowing formation of the correct resting tongue position. However, the use of T4A for a long period of time may cause the teeth movement; therefore, caution is required. Use of the T4A is effective for the correction of oral habits, myofunctional therapy and for teaching the correct resting tongue position during the daytime and for the correction of oral habits, teaching correct resting tongue position during sleep. PMID:27622220

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

    PubMed

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

    2015-10-01

    Negative pressure wound therapy (NPWT) provides proven wound healing benefits and is often a desirable wound treatment methodology. Unfortunately, NPWT devices are not widely available in low-resource settings. To overcome the 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 in this article. 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 an sNPWT system is that it must be airtight. The details of the design iterations, which are 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 periwound 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 low-resource settings. Since the completion of the clinical testing, the design has been further evolved, and the developers are working with contract manufacturers to produce the final design and preparing for regulatory approval applications. PMID:26356213

  9. 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.

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

    PubMed

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

    2013-08-01

    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

  11. 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

  12. Update on Renal Replacement Therapy: Implantable Artificial Devices and Bioengineered Organs.

    PubMed

    Attanasio, Chiara; Latancia, Marcela T; Otterbein, Leo E; Netti, Paolo A

    2016-08-01

    Recent advances in the fields of artificial organs and regenerative medicine are now joining forces in the areas of organ transplantation and bioengineering to solve continued challenges for patients with end-stage renal disease. The waiting lists for those needing a transplant continue to exceed demand. Dialysis, while effective, brings different challenges, including quality of life and susceptibility to infection. Unfortunately, the majority of research outputs are far from delivering satisfactory solutions. Current efforts are focused on providing a self-standing device able to recapitulate kidney function. In this review, we focus on two remarkable innovations that may offer significant clinical impact in the field of renal replacement therapy: the implantable artificial renal assist device (RAD) and the transplantable bioengineered kidney. The artificial RAD strategy utilizes micromachining techniques to fabricate a biohybrid system able to mimic renal morphology and function. The current trend in kidney bioengineering exploits the structure of the native organ to produce a kidney that is ready to be transplanted. Although these two systems stem from different technological approaches, they are both designed to be implantable, long lasting, and free standing to allow patients with kidney failure to be autonomous. However, for both of them, there are relevant issues that must be addressed before translation into clinical use and these are discussed in this review. PMID:26905099

  13. 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

    2016-01-01

    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. PMID:26894331

  14. Management of cardiac device infections: A retrospective survey of a non-surgical approach combining antibiotic therapy with transvenous removal.

    PubMed

    Tascini, C; Bongiorni, M G; Gemignani, G; Soldati, E; Leonildi, A; Arena, G; Doria, R; Giannola, G; La Pira, F; Tagliaferri, E; Caravelli, P; Dell'Anna, R; Menichetti, F

    2006-04-01

    Pacemakers (PMs) and implantable cardioverter defibrillators (ICDs) have become life-saving therapeutic tools for patients with cardiac arrhythmia. Complications include thrombosis, embolism and infections at a highly variable rate. Surgical removal of the infected device has been perceived as the only way to guarantee a successful outcome and to reduce the high risk of mortality. Recently, a transvenous extraction method has been developed to remove infected intracardiac leads without sternotomy. This survey was designed to evaluate the outcome of an approach combining antibiotic therapy with non-surgical transvenous complete removal for the management of cardiac device infections (CDIs). We reviewed case-histories of 121 patients (105 with PM and 16 with ICD infections). The aim of our retrospective survey was to ascertain that a non-invasive transvenous complete removal of the infected devices is safe and effective when associated with appropriate antibiotic therapy starting 10 days before the procedure and extending to at least three weeks after. The infected devices were successfully removed in all patients with a non-surgical transvenous technique. The infections were most frequently caused by coagulase-negative staphylococci (70%), Staphylococcus aureus (14%), and Gram-negative rods (12%). Polymicrobial infections were documented in 19 patients and represent 16% of all device-related infections. The removal of the devices was done during antibiotic therapy, administered for a median of 26 days (range 23 to 45 days). Neither fatalities nor relapse of infections were recorded in the patient population during the one-year follow-up visits. According to our experience, CDIs can be treated with antibiotic therapy and non-surgical removal of the entire infected device, thus allowing a successful reimplantation. This procedure prevents recurrent infections and operative mortality. PMID:16736884

  15. Cardiac or Other Implantable Electronic Devices and Sleep-disordered Breathing – Implications for Diagnosis and Therapy

    PubMed Central

    Bitter, Thomas; Gutleben, Klaus-Jürgen; Horstkotte, Dieter; Oldenburg, Olaf

    2014-01-01

    Sleep-disordered breathing (SDB) is of growing interest in cardiology because SDB is a highly prevalent comorbidity in patients with a variety of cardiovascular diseases. The prevalence of SDB is particularly high in patients with cardiac dysrhythmias and/or heart failure. In this setting, many patients now have implantable cardiac devices, such as pacemakers, implantable cardioverter-defibrillators or implanted cardiac resynchronisation therapy devices (CRT). Treatment of SDB using implantable cardiac devices has been studied previously, with atrial pacing and CRT being shown not to bring about satisfactory results in SDB care. The latest generations of these devices have the capacity to determine transthoracic impedance, to detect and quantify breathing efforts and to identify SDB. The capability of implantable cardiac devices to detect SDB is of potential importance for patients with cardiovascular disease, allowing screening for SDB, monitoring of the course of SDB in relation to cardiac status, and documenting of the effects of treatment. PMID:26835077

  16. Plasma exchange therapy for a severe relapse of Devic's disease in a pregnant woman: A case report and concise review.

    PubMed

    Rubio Tabares, Jonathan; Amaya Gonzalez, Pablo Felipe

    2016-09-01

    Neuromyelitis optica (NMO) or Devic's disease is an autoimmune inflammatory demyelinating condition affecting the central nervous system (CNS). It was initially believed to be a variant of multiple sclerosis (MS). However, the discovery of NMO-IgG anti-AQP4 antibodies marked an objective distinction between these conditions. Treatment of acute attacks is generally based on pulsed steroids, followed by long-term immunosuppression with azathioprine, oral steroids, and rituximab as first-line therapies. Plasma exchange therapy is indicated for steroid-resistant relapses. We describe a case report of a pregnant woman with a severe relapse of Devic's disease, initially misdiagnosed as MS, unresponsive to pulsed steroids, and who underwent plasma exchange therapy safely, with excellent clinical response and with no adverse outcome for the fetus. PMID:27428489

  17. Efficacy of cardiac resynchronization with defibrillator insertion in patients undergone coronary artery bypass graft: A cohort study of cardiac function

    PubMed Central

    Karbasi-Afshar, Reza; Ramezani-Binabaj, Mahdi; Rezaee-Zavareh, Mohammad Saeid; Saburi, Amin; Ajudani, Reza

    2015-01-01

    Introduction: Cardiac resynchronization therapy (CRT) is a proven therapeutic method in selected patients with heart failure and systolic dysfunction which increases left ventricular function and patient survival. We designed a study that included patients undergoing coronary artery bypass graft (CABG), with and without CRT-defibrillator (CRT-D) inserting and then measured its effects on these two groups. Patients and Methods: Between 2010 and 2013, we conducted a prospective cohort study on 100 coronary artery disease patients where candidate for CABG. Then based on the receiving CRT-D, the patients were categorized in two groups; Group 1 (n = 48, with CRT-D insertion before CABG) and Group 2 (n = 52 without receiving CRT-D). Thereafter both of these groups were followed-up at 1–3 months after CABG for mortality, hospitalization, atrial fibrillation (AF), echocardiographic assessment, and New York Heart Association (NYHA) class level. Results: The mean age of participants in Group 1 (48 male) and in Group 2 (52 male) was 58 ± 13 and 57 ± 12 respectively. Difference between Groups 1 and 2 in cases of mean left ventricular ejection fraction (LVEF) changes and NYHA class level was significant (P > 0.05). Hospitalization (P = 0.008), mortality rate (P = 0.007), and AF were significantly different between these two groups. Conclusions: The results showed that the increase in LVEF and patient's improvement according to NYHA-class was significant in the first group, and readmission, mortality rate and AF was increased significantly in the second group. PMID:25566709

  18. Infection control in implantation of cardiac implantable electronic devices: current evidence, controversial points, and unresolved issues.

    PubMed

    Korantzopoulos, Panagiotis; Sideris, Skevos; Dilaveris, Polychronis; Gatzoulis, Konstantinos; Goudevenos, John A

    2016-04-01

    A significant increase in the implantation of cardiac implantable electronic devices (CIEDs) is evident over the past years, while there is evidence for a disproportionate increase in CIED-related infections. The cumulative probability of device infection seems to be higher in implantable cardioverter defibrillator and in cardiac resynchronization therapy patients compared with permanent pacemaker patients. Given that more than a half of CIED infections are possibly related to the operative procedure, there is a need for effective periprocedural infection control. However, many of the current recommendations are empirical and not evidence-based, while questions, unresolved issues, and conflicting evidence arise. The perioperative systemic use of antibiotics confers significant benefit in prevention of CIED infections. However, there are no conclusive data regarding the specific value of each agent in different clinical settings, the value of post-operative antibiotic treatment as well as the optimal duration of therapy. The merit of local pocket irrigation with antibiotic and/or antiseptic agents remains unproved. Of note, recent evidence indicates that the application of antibacterial envelopes into the device pocket markedly decreases the infection risk. In addition, limited reports on strict integrated infection control protocols show a dramatic reduction in infection rates in this setting and therefore deserve further attention. Finally, the relative impact of particular factors on the infection risk, including the type of the CIED, patients' individual characteristics and comorbidities, should be further examined since it may facilitate the development of tailored prophylactic interventions for each patient. PMID:26516219

  19. 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.

  20. Stroke in atrial fibrillation: update on pathophysiology, new antithrombotic therapies, and evolution of procedures and devices.

    PubMed

    Savelieva, Irina; Bajpai, Abhay; Camm, A John

    2007-01-01

    Atrial fibrillation (AF) is said to be an epidemic, affecting 1%-1.5% of the population in the developed world. The clinical significance of AF lies predominantly in a 5-fold increased risk of stroke. Strokes associated with AF are usually more severe and confer increased risk of morbidity, mortality, and poor functional outcome. Despite the advent of promising experimental therapies for selected patients with acute stroke, pharmacological primary prevention remains the best approach to reducing the burden of stroke. New antithrombotic drugs include both parenteral agents (e.g. a long-acting factor Xa inhibitor idraparinux) and oral anticoagulants, such as oral factor Xa inhibitors and direct oral thrombin inhibitors (ximelagatran, dabigatran). Ximelagatran had shown significant potential as a possible replacement to warfarin therapy, but has been withdrawn because of potential liver toxicity. Its congener dabigatran appears to have a better safety profile and has recently entered a phase III randomized clinical trial in AF. Oral factor Xa inhibitors (rivaroxaban, apixaban, YM150) inhibit factor Xa directly, without antithrombin III mediation, and may prove to be more potent and safe. Selective inhibitors of specific coagulation factors involved in the initiation and propagation of the coagulation cascade (factor IXa, factor VIIa, circulating tissue factor) are at an early stage of development. Additional new agents with hypothetical, although not yet proven, anticoagulation benefits include nematode anticoagulant peptide (NAPc2), protein C derivatives, and soluble thrombomodulin. A battery of novel mechanical approaches for the prevention of cardioembolic stroke has recently been evaluated, including various models of percutaneous left atrial appendage occluders which block the connection between the left atrium and the left atrial appendage, minimally invasive surgical isolation of the left atrial appendage, and implantation of the carotid filtering devices which

  1. Multi-Targeted Antithrombotic Therapy for Total Artificial Heart Device Patients.

    PubMed

    Ramirez, Angeleah; Riley, Jeffrey B; Joyce, Lyle D

    2016-03-01

    To prevent thrombotic or bleeding events in patients receiving a total artificial heart (TAH), agents have been used to avoid adverse events. The purpose of this article is to outline the adoption and results of a multi-targeted antithrombotic clinical procedure guideline (CPG) for TAH patients. Based on literature review of TAH anticoagulation and multiple case series, a CPG was designed to prescribe the use of multiple pharmacological agents. Total blood loss, Thromboelastograph(®) (TEG), and platelet light-transmission aggregometry (LTA) measurements were conducted on 13 TAH patients during the first 2 weeks of support in our institution. Target values and actual medians for postimplant days 1, 3, 7, and 14 were calculated for kaolinheparinase TEG, kaolin TEG, LTA, and estimated blood loss. Protocol guidelines were followed and anticoagulation management reduced bleeding and prevented thrombus formation as well as thromboembolic events in TAH patients postimplantation. The patients in this study were susceptible to a variety of possible complications such as mechanical device issues, thrombotic events, infection, and bleeding. Among them all it was clear that patients were at most risk for bleeding, particularly on postoperative days 1 through 3. However, bleeding was reduced into postoperative days 3 and 7, indicating that acceptable hemostasis was achieved with the anticoagulation protocol. The multidisciplinary, multi-targeted anticoagulation clinical procedure guideline was successful to maintain adequate antithrombotic therapy for TAH patients. PMID:27134306

  2. Case study of radiation therapy treatment of a patient with a cardiac ventricular assist device.

    PubMed

    Lasher, Donette E; Wojcicka, Jadwiga B; Malcom, Ronald; Shears, Lawrence L

    2008-01-01

    A patient with a cardiac ventricular assist device (VAD) with computer-controlled driver presented to our department for radiation therapy. The treatment plan was 4500 cGy to the rectum over 25 fractions with 15MV photon beams. All beams avoided the pump and leads. The response to electromagnetic interference (EMI) was evaluated by observing a duplicate driver in the treatment configuration as the patient's fields were delivered to a solid water equivalent phantom. Pretreatment dose assessment included calculations with Pinnacle treatment planning system, AAPM TG36 data analysis, and MOSFET measurements on the surface of the driver during the phantom irradiation. During the first patient treatment, MOSFETs were placed on the pump and leads, approximately 1cm from the left lateral treatment portal. No additional shielding was applied to the VAD. EMI was absent and the VAD operated normally during the pretreatment test and throughout the treatment course. Radiation to the driver was too low to be detected by the MOSFETS. Cumulative dose estimates to the pump were 425 cGy to 0.1cc (DVH), 368 cGy (TG36), and 158.5 cGy (MOSFET). MOSFET readings to the leads were 70.5 cGy. External beam radiation treatment was safely delivered to a VAD dependent patient. The VAD exhibited no adverse response to EMI and doses up to 425 cGy. Our results are based on one case and further study is encouraged. PMID:19020490

  3. Development and Clinical Application of a Precise Temperature-Control Device as an Alternate for Conventional Moxibustion Therapy

    PubMed Central

    Takayama, Shin; Takashima, Shigeru; Okajima, Junnosuke; Watanabe, Masashi; Kamiya, Tetsuharu; Seki, Takashi; Yamasaki, Miyako; Yaegashi, Nobuo; Yambe, Tomoyuki; Maruyama, Shigenao

    2012-01-01

    Moxibustion therapy has been used in East Asian medicine for more than a thousand years. However, there are some problems associated with this therapy in clinical practice. These problems include lack of control over the treatment temperature, emission of smoke, and uneven temperature distribution over the treatment region. In order to resolve these problems, we developed a precise temperature-control device for use as an alternate for conventional moxibustion therapy. In this paper, we describe the treatment of a single patient with paralytic ileus that was treated with moxibustion. We also describe an evaluation of temperature distribution on the skin surface after moxibustion therapy, the development of a heat-transfer control device (HTCD), an evaluation of the HTCD, and the clinical effects of treatment using the HTCD. The HTCD we developed can heat the skin of the treatment region uniformly, and its effect may be equivalent to conventional moxibustion, without the emission of smoke and smell. This device can be used to treat ileus, abdominal pain, and coldness of abdomen in place of conventional moxibustion in modern hospitals. PMID:22754583

  4. Déjà vu: Ralstonia mannitolilytica infection associated with a humidifying respiratory therapy device, Israel, June to July 2011.

    PubMed

    Block, C; Ergaz-Shaltiel, Z; Valinsky, L; Temper, V; Hidalgo-Grass, C; Minster, N; Weissman, C; Benenson, S; Jaffe, J; Moses, A E; Bar-Oz, B

    2013-01-01

    Following a bloodstream infection in June 2011 with Ralstonia mannitolilytica in a premature infant treated with a humidifying respiratory therapy device, an investigation was initiated at the Hadassah Medical Centres in Jerusalem. The device delivers a warmed and humidified mixture of air and oxygen to patients by nasal cannula. The investigation revealed colonisation with R. mannitolilytica of two of 15 patients and contamination of components of five of six devices deployed in the premature units of the Hadassah hospitals. Ten isolates from the investigation were highly related and indistinguishable from isolates described in an outbreak in 2005 in the United States (US). Measures successful in containing the US outbreak were not included in user instructions provided to our hospitals by the distributor of the device. PMID:23725776

  5. 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.

  6. [Remote monitoring for follow-up of patients with implantable cardiac devices].

    PubMed

    Oliveira, Mário; Silva Cunha, Pedro; da Silva, Nogueira

    2013-03-01

    With a widening of indications for cardiac devices, especially in view of the clinical benefits of implantable cardioverter-defibrillators and cardiac resynchronization therapy, the number of patients with such devices is growing steadily. However, the resources required, and the need for long-term regular interrogation in dedicated clinics, represent a significant burden for already overstretched electrophysiology teams and hospital services. Remote telemonitoring is increasingly used for such follow-up, as it is a safe and effective alternative to conventional follow-up programs in outpatient clinics. This technology has been shown to be technically reliable, enabling early identification of device malfunction, arrhythmic events and heart failure decompensation, while reducing the risk of under-reporting, the number of outpatient clinic visits and hospitalizations due to cardiac events, and healthcare costs. Further studies are needed to determine how best to implement this new technology in a cost-effective manner, and what new legislation governing the use of remote monitoring in clinical practice may be required. In this article, we describe current systems, review the technical and clinical evidence in the literature regarding remote monitoring of implantable cardiac devices, and expand on outstanding questions. PMID:23415739

  7. 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. PMID:26470404

  8. Prostate thermal therapy with catheter-based ultrasound devices and MR thermal monitoring

    NASA Astrophysics Data System (ADS)

    Diederich, Chris J.; Nau, Will H.; Kinsey, Adam; Ross, Tony; Wootton, Jeff; Juang, Titania; Butts-Pauly, Kim; Ricke, Viola; Liu, Erin H.; Chen, Jing; Bouley, Donna M.; Van den Bosch, Maurice; Sommer, Graham

    2007-02-01

    Four types of transurethral applicators were devised for thermal ablation of prostate combined with MR thermal monitoring: sectored tubular transducer devices with directional heating patterns; planar and curvilinear devices with narrow heating patterns; and multi-sectored tubular devices capable of dynamic angular control without applicator movement. These devices are integrated with a 4 mm delivery catheter, incorporate an inflatable cooling balloon (10 mm OD) for positioning within the prostate and capable of rotation via an MR-compatible motor. 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 the heating technology and develop treatment control strategies. MR thermal imaging in a 0.5 T interventional MRI was used to monitor temperature and thermal dose in multiple slices through the target volume. Sectored tubular, planar, and curvilinear transurethral devices produce directional coagulation zones, extending 15-20 mm radial distance to the outer prostate capsule. Sequential rotation and modulated dwell time can conform thermal ablation to selected regions. 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. Interstitial implants with directional devices can be used to effectively ablate the posterior peripheral zone of the gland while protecting the rectum. The MR derived 52 °C and lethal thermal dose contours (t 43=240 min) allowed for real-time control of the applicators and effectively defined the extent of thermal damage. Catheter-based ultrasound devices, combined with MR thermal monitoring, can produce relatively fast and precise thermal ablation of prostate, with potential for treatment of cancer or BPH.

  9. Current state-of-the-art of device therapy for advanced heart failure

    PubMed Central

    Lee, Lawrence S.; Shekar, Prem S.

    2014-01-01

    Heart failure remains one of the most common causes of morbidity and mortality worldwide. The advent of mechanical circulatory support devices has allowed significant improvements in patient survival and quality of life for those with advanced or end-stage heart failure. We provide a general overview of past and current mechanical circulatory support devices encompassing options for both short- and long-term ventricular support. PMID:25559828

  10. Hydrophilic MoSe2 Nanosheets as Effective Photothermal Therapy Agents and Their Application in Smart Devices.

    PubMed

    Lei, Zhouyue; Zhu, Wencheng; Xu, Shengjie; Ding, Jian; Wan, Jiaxun; Wu, Peiyi

    2016-08-17

    A facile poly(vinylpyrrolidone) (PVP)-assisted exfoliation method is utilized to simultaneously exfoliate and noncovalently modify MoSe2 nanosheets. The resultant hydrophilic nanosheets are shown to be promising candidates for biocompatible photothermal therapy (PTT) agents, and they could also be encapsulated into a hydrogel matrix for some intelligent devices. This work not only provides novel insights into exfoliation and modification of transition metal dichalcogenide (TMD) nanosheets but also might spark more research into engineering multifunctional TMD-related nanocomposites, which is in favor of further exploiting the attractive properties of these emerging layered two-dimensional (2D) nanomaterials. PMID:27467718

  11. New therapy, new challenges: The effects of long-term continuous flow left ventricular assist device on inflammation.

    PubMed

    Grosman-Rimon, Liza; Billia, Filio; Fuks, Avi; Jacobs, Ira; A McDonald, Michael; Cherney, David Z; Rao, Vivek

    2016-07-15

    Surgically implanted continuous flow left ventricular assist devices (CF-LVADs) are currently used in patients with end-stage heart failure (HF). However, CF-LVAD therapy introduces a new set of complications and adverse events in these patients. Major adverse events with the CF-LVAD include right heart failure, vascular dysfunction, stroke, hepatic failure, and multi-organ failure, complications that may have inflammation as a common etiology. Our aim was to review the current evidence showing a relationship between these adverse events and elevated levels of inflammatory biomarkers in CF-LVAD recipients. PMID:27131263

  12. Ventricular assist devices as a bridge to cardiac transplantation. A prelude to destination therapy.

    PubMed Central

    Holman, W L; Bourge, R C; Spruell, R D; Murrah, C P; McGiffin, D C; Kirklin, J K

    1997-01-01

    OBJECTIVE AND BACKGROUND: Ventricular assist devices (VADs) have been used for temporary circulatory support pending transplantation or recovery of the native heart. Outcome in 38 patients treated at the authors' institution with VADs pending transplantation was analyzed to provide information relevant to the future use of VADs as permanent implants. METHODS: Thoratec (Thoratec Laboratories, Pleasanton, CA) or HeartMate (Thermo Cardiosystems, Woburn, MA) VADs were used in all cases. Patients were considered for VAD placement if they were candidates for cardiac transplantation and fulfilled the criteria for the Food and Drug Administration investigational Device Exemption trials. The following adverse events were included in the analysis; death during VAD support, device malfunction, bleeding, neurologic events, support-related events that preclude transplantation, and device-related infections. Patient survival and complication rates were quantified using the Kaplan-Meier method, competing risk analysis, and hazard functions. RESULTS: Nineteen patients had transplantation. Three patients had VAD removal after cardiac recovery and 16 died without transplantation. The duration of VAD support ranged from 0 to 279 days. The hazard function for death during VAD support had an early phase that lasted for 2 weeks after VAD placement, and early death was related to the preimplant condition of the patient. Device-related infections were noted in 11 patients. Seven of these patients had transplantation after clearing the infection, whereas four died without transplantation. Neurologic events occurred in seven patients. There were no device malfunctions that led to patient death. CONCLUSIONS: The absence of fatal device malfunctions suggests that longer term support with current VAD designs is feasible. Appropriate patient selection, infection control, and avoidance of thromboembolic neurologic complications will be crucial to the success of permanent VAD use. PMID:9230810

  13. Novel Approach to Simulate Sleep Apnea Patients for Evaluating Positive Pressure Therapy Devices.

    PubMed

    Isetta, Valentina; Montserrat, Josep M; Santano, Raquel; Wimms, Alison J; Ramanan, Dinesh; Woehrle, Holger; Navajas, Daniel; Farré, Ramon

    2016-01-01

    Bench testing is a useful method to characterize the response of different automatic positive airway pressure (APAP) devices under well-controlled conditions. However, previous models did not consider the diversity of obstructive sleep apnea (OSA) patients' characteristics and phenotypes. The objective of this proof-of-concept study was to design a new bench test for realistically simulating an OSA patient's night, and to implement a one-night example of a typical female phenotype for comparing responses to several currently-available APAP devices. We developed a novel approach aimed at replicating a typical night of sleep which includes different disturbed breathing events, disease severities, sleep/wake phases, body postures and respiratory artefacts. The simulated female OSA patient example that we implemented included periods of wake, light sleep and deep sleep with positional changes and was connected to ten different APAP devices. Flow and pressure readings were recorded; each device was tested twice. The new approach for simulating female OSA patients effectively combined a wide variety of disturbed breathing patterns to mimic the response of a predefined patient type. There were marked differences in response between devices; only three were able to overcome flow limitation to normalize breathing, and only five devices were associated with a residual apnea-hypopnea index of <5/h. In conclusion, bench tests can be designed to simulate specific patient characteristics, and typical stages of sleep, body position, and wake. Each APAP device behaved differently when exposed to this controlled model of a female OSA patient, and should lead to further understanding of OSA treatment. PMID:26978077

  14. Novel Approach to Simulate Sleep Apnea Patients for Evaluating Positive Pressure Therapy Devices

    PubMed Central

    Isetta, Valentina; Montserrat, Josep M.; Santano, Raquel; Wimms, Alison J.; Ramanan, Dinesh; Woehrle, Holger; Navajas, Daniel; Farré, Ramon

    2016-01-01

    Bench testing is a useful method to characterize the response of different automatic positive airway pressure (APAP) devices under well-controlled conditions. However, previous models did not consider the diversity of obstructive sleep apnea (OSA) patients’ characteristics and phenotypes. The objective of this proof-of-concept study was to design a new bench test for realistically simulating an OSA patient’s night, and to implement a one-night example of a typical female phenotype for comparing responses to several currently-available APAP devices. We developed a novel approach aimed at replicating a typical night of sleep which includes different disturbed breathing events, disease severities, sleep/wake phases, body postures and respiratory artefacts. The simulated female OSA patient example that we implemented included periods of wake, light sleep and deep sleep with positional changes and was connected to ten different APAP devices. Flow and pressure readings were recorded; each device was tested twice. The new approach for simulating female OSA patients effectively combined a wide variety of disturbed breathing patterns to mimic the response of a predefined patient type. There were marked differences in response between devices; only three were able to overcome flow limitation to normalize breathing, and only five devices were associated with a residual apnea-hypopnea index of <5/h. In conclusion, bench tests can be designed to simulate specific patient characteristics, and typical stages of sleep, body position, and wake. Each APAP device behaved differently when exposed to this controlled model of a female OSA patient, and should lead to further understanding of OSA treatment. PMID:26978077

  15. Changes in functional connectivity correlate with behavioral gains in stroke patients after therapy using a brain-computer interface device.

    PubMed

    Young, Brittany Mei; Nigogosyan, Zack; Remsik, Alexander; Walton, Léo M; Song, Jie; Nair, Veena A; Grogan, Scott W; Tyler, Mitchell E; Edwards, Dorothy Farrar; Caldera, Kristin; Sattin, Justin A; Williams, Justin C; Prabhakaran, Vivek

    2014-01-01

    Brain-computer interface (BCI) technology is being incorporated into new stroke rehabilitation devices, but little is known about brain changes associated with its use. We collected anatomical and functional MRI of nine stroke patients with persistent upper extremity motor impairment before, during, and after therapy using a BCI system. Subjects were asked to perform finger tapping of the impaired hand during fMRI. Action Research Arm Test (ARAT), 9-Hole Peg Test (9-HPT), and Stroke Impact Scale (SIS) domains of Hand Function (HF) and Activities of Daily Living (ADL) were also assessed. Group-level analyses examined changes in whole-brain task-based functional connectivity (FC) to seed regions in the motor network observed during and after BCI therapy. Whole-brain FC analyses seeded in each thalamus showed FC increases from baseline at mid-therapy and post-therapy (p < 0.05). Changes in FC between seeds at both the network and the connection levels were examined for correlations with changes in behavioral measures. Average motor network FC was increased post-therapy, and changes in average network FC correlated (p < 0.05) with changes in performance on ARAT (R (2) = 0.21), 9-HPT (R (2) = 0.41), SIS HF (R (2) = 0.27), and SIS ADL (R (2) = 0.40). Multiple individual connections within the motor network were found to correlate in change from baseline with changes in behavioral measures. Many of these connections involved the thalamus, with change in each of four behavioral measures significantly correlating with change from baseline FC of at least one thalamic connection. These preliminary results show changes in FC that occur with the administration of rehabilitative therapy using a BCI system. The correlations noted between changes in FC measures and changes in behavioral outcomes indicate that both adaptive and maladaptive changes in FC may develop with this therapy and also suggest a brain-behavior relationship that may be stimulated by the neuromodulatory

  16. Changes in functional connectivity correlate with behavioral gains in stroke patients after therapy using a brain-computer interface device

    PubMed Central

    Young, Brittany Mei; Nigogosyan, Zack; Remsik, Alexander; Walton, Léo M.; Song, Jie; Nair, Veena A.; Grogan, Scott W.; Tyler, Mitchell E.; Edwards, Dorothy Farrar; Caldera, Kristin; Sattin, Justin A.; Williams, Justin C.; Prabhakaran, Vivek

    2014-01-01

    Brain-computer interface (BCI) technology is being incorporated into new stroke rehabilitation devices, but little is known about brain changes associated with its use. We collected anatomical and functional MRI of nine stroke patients with persistent upper extremity motor impairment before, during, and after therapy using a BCI system. Subjects were asked to perform finger tapping of the impaired hand during fMRI. Action Research Arm Test (ARAT), 9-Hole Peg Test (9-HPT), and Stroke Impact Scale (SIS) domains of Hand Function (HF) and Activities of Daily Living (ADL) were also assessed. Group-level analyses examined changes in whole-brain task-based functional connectivity (FC) to seed regions in the motor network observed during and after BCI therapy. Whole-brain FC analyses seeded in each thalamus showed FC increases from baseline at mid-therapy and post-therapy (p < 0.05). Changes in FC between seeds at both the network and the connection levels were examined for correlations with changes in behavioral measures. Average motor network FC was increased post-therapy, and changes in average network FC correlated (p < 0.05) with changes in performance on ARAT (R2 = 0.21), 9-HPT (R2 = 0.41), SIS HF (R2 = 0.27), and SIS ADL (R2 = 0.40). Multiple individual connections within the motor network were found to correlate in change from baseline with changes in behavioral measures. Many of these connections involved the thalamus, with change in each of four behavioral measures significantly correlating with change from baseline FC of at least one thalamic connection. These preliminary results show changes in FC that occur with the administration of rehabilitative therapy using a BCI system. The correlations noted between changes in FC measures and changes in behavioral outcomes indicate that both adaptive and maladaptive changes in FC may develop with this therapy and also suggest a brain-behavior relationship that may be stimulated by the neuromodulatory component of BCI

  17. Patient-Specific Flexible and Stretchable Devices for Cardiac Diagnostics and Therapy

    PubMed Central

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

    2014-01-01

    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. PMID:25106701

  18. 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.

  19. Monitoring Therapy Adherence of Tuberculosis Patients by using Video-Enabled Electronic Devices

    PubMed Central

    Story, Alistair; Garfein, Richard S.; Hayward, Andrew; Rusovich, Valiantsin; Dadu, Andrei; Soltan, Viorel; Oprunenco, Alexandru; Collins, Kelly; Sarin, Rohit; Quraishi, Subhi; Sharma, Mukta; Migliori, Giovanni Battista; Varadarajan, Maithili

    2016-01-01

    A recent innovation to help patients adhere to daily tuberculosis (TB) treatment over many months is video (or virtually) observed therapy (VOT). VOT is becoming increasingly feasible as mobile telephone applications and tablet computers become more widely available. Studies of the effectiveness of VOT in improving TB patient outcomes are being conducted. PMID:26891363

  20. Monitoring Therapy Compliance of Tuberculosis Patients by using Video-Enabled Electronic Devices.

    PubMed

    Story, Alistair; Garfein, Richard S; Hayward, Andrew; Rusovich, Valiantsin; Dadu, Andrei; Soltan, Viorel; Oprunenco, Alexandru; Collins, Kelly; Sarin, Rohit; Quraishi, Subhi; Sharma, Mukta; Migliori, Giovanni Battista; Varadarajan, Maithili; Falzon, Dennis

    2016-03-01

    A recent innovation to help patients adhere to daily tuberculosis (TB) treatment over many months is video (or virtually) observed therapy (VOT). VOT is becoming increasingly feasible as mobile telephone applications and tablet computers become more widely available. Studies of the effectiveness of VOT in improving TB patient outcomes are being conducted. PMID:26891363

  1. Implantable Cardioverter-Defibrillator Shock after Stenting Across the Device Leads.

    PubMed

    Mehra, Sanjay; Chelu, Mihail Gabriel

    2016-02-01

    A 45-year-old man with nonischemic cardiomyopathy and end-stage renal disease had lived uneventfully with a cardiac resynchronization therapy defibrillator (CRT-D) for 5 years. Less than a month before presenting at our institution, he had undergone stenting of his partially occluded subclavian vein, to relieve stenosis of the ipsilateral arteriovenous fistula that was used for his hemodialysis. The CRT-D subsequently discharged. Device interrogation revealed that electrical noise originating from leads damaged by the stent had caused the inappropriate shock and intermittent electrical discharges thereafter. The patient was highly traumatized by these events and insisted upon device removal, which deprived him of a potentially life-saving intervention. He later had a cardiac arrest that resulted in sustained profound hypoxic ischemic encephalopathy with minimal neurologic recovery: his family placed him in a long-term care facility on ventilator support, with a tracheostomy and feeding tube. This situation might have been avoided through collaboration between the interventional radiologist and the electrophysiologist. To our knowledge, this is the first report of a patient with nonischemic cardiomyopathy and end-stage renal disease who presented with inappropriate defibrillator discharge caused by lead damage secondary to stenting across the leads. PMID:27047295

  2. 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

  3. [Innovative therapies for the treatment of refractory angina: the Reducer, a percutaneous device to narrow the coronary sinus].

    PubMed

    Benedetto, Daniela; Abawi, Masieh; Stella, Pieter R; Nijhoff, Freek; Agostoni, Pierfrancesco

    2015-11-01

    Refractory angina is a chronic condition characterized by the presence of disabling symptoms due to severe obstructive coronary artery disease that is not improved by a combination of medical therapy and percutaneous or surgical revascularization. Mortality rates associated with this condition are quite low in clinically stable patients on optimal medical therapy, but rehospitalization rates remain high. This mandates the need for new therapies targeting an improvement of symptoms in this population, taking into account also the potential impact in terms of healthcare and costs. The increase in coronary sinus pressure seems to reduce myocardial ischemia leading to a redistribution of blood flow to the ischemic territories. The coronary sinus Reducer is a percutaneous implantable device, made of a stainless steel hourglass-shaped stent, designed to achieve controlled narrowing of the coronary sinus and to increase its upstream pressure. In various studies, the Reducer was safely implanted percutaneously via the right jugular vein in patients with refractory angina who were not amenable to revascularization and was associated with an improvement in anginal symptoms and ischemia. These results support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization. PMID:26571476

  4. Influence of category-heifers, primiparous and multiparous lactating cows-in a large-scale resynchronization fixed-time artificial insemination program

    PubMed Central

    Marques, Márcio de Oliveira; Morotti, Fábio; da Silva, Camila Bizarro; Júnior, Mario Ribeiro; da Silva, Rubens César Pinto; Baruselli, Pietro Sampaio; Seneda, Marcelo Marcondes

    2015-01-01

    This study was conducted to evaluate the influence of category (heifers, primiparous or multiparous cows) on pregnancy rates in a large scale resynchronization ovulation program. Nelore heifers (n = 903), primiparous lactating cows (n = 338) and multiparous lactating cows (n = 1,223) were synchronized using a conventional protocol of estradiol/P4-based fixed-time artificial insemination (FTAI). Thirty days after ultrasonography, females who failed the first FTAI were resynchronized with the same hormonal protocol prior to a second FTAI. The pregnancy status of each cohort was evaluated by ultrasonography 30 days after each FTAI. The average conception rate after the first FTAI and resynchronization was 80.5%. Heifers had a higher conception rate (85%) than primiparous (76%) or multiparous cows (78%; p = 0.0001). The conception rate after the first FTAI was similar among heifers (57%), primiparous cows (51%) and multiparous cows (56%; p = 0.193). After the second FTAI, heifers exhibited a higher conception rate (66%) than primiparous or multiparous cows (51%; p = 0.0001). These results demonstrate the feasibility of resynchronization in large beef herds for providing consistent pregnancy rates in a short period of time. We also demonstrated that ovulation resynchronization 30 days after FTAI is particularly effective for heifers, providing a conception rate of up to 66%. PMID:25797292

  5. Integrated approach for smart implantable cardioverter defibrillator (ICD) device with real time ECG monitoring: use of flexible sensors for localized arrhythmia sensing and stimulation

    PubMed Central

    Puri, Munish; Chapalamadugu, Kalyan C.; Miranda, Aimon C.; Gelot, Shyam; Moreno, Wilfrido; Adithya, Prashanth C.; Law, Catherine; Tipparaju, Srinivas M.

    2013-01-01

    Arrhythmias are the most common cause of death associated with sudden death and are common in US and worldwide. Cardiac resynchronization therapy (CRT), evolving from pacemakers and development of implantable cardioverter defibrillator (ICD), has been adopted for therapeutic use and demonstrated benefits in patients over the years due to its design and intricate functionality. Recent research has been focused on significant design improvement and efforts are dedicated toward device size reduction, weight and functionality in commercially available ICD's since its invention in the 1960's. Commercially available CRT-D has shown advancement on both clinical and technical side. However, improved focus is required on the device miniaturization, technologically supported and integrated wireless based system for real time heart monitoring electrocardiogram (ECG). In the present report a concise overview for the state-of-the art technology in ICDs and avenues for future development are presented. A unique perspective is also included for ICD device miniaturization and integration of flexible sensing array. Sensor array integration along with its capabilities for identifying localized arrhythmia detection and targeted stimulation for enhancing ICD device capabilities is reviewed. PMID:24167492

  6. 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. PMID:25713012

  7. Improving the Safety and Effectiveness of Medical Device Therapy in Women.

    PubMed

    Zusterzeel, Robbert; O'Callaghan, Kathryn M; Caños, Daniel A; Sanders, William E; Marinac-Dabic, Danica; Strauss, David G

    2016-05-01

    When not enough women are included in many clinical trials, an information gap on medical device safety and effectiveness exists, which can make it difficult to detect sex-specific results. In this article we discuss potential reasons for the underrepresentation of women and the regulatory research conducted by the U.S. Food and Drug Administration (FDA) used in supporting regulatory decisions. We demonstrate that important differences in cardiovascular device performance between women and men exist. Furthermore, concrete steps are outlined on the possible ways these sex-specific results can be detected and how a recent FDA Action Plan and Guidance Document aim at encouraging female participation in clinical trials and the appropriate analysis thereof. PMID:27028582

  8. 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

  9. 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

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

    PubMed

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

    2015-04-01

    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

  11. The effect of constant darkness and circadian resynchronization on the recovery of alcohol hangover.

    PubMed

    Karadayian, Analía G; Lores-Arnaiz, Silvia; Cutrera, Rodolfo A

    2014-07-15

    Alcohol hangover (AH) is a particular state after binge-like drinking. AH begins when ethanol is absent in plasma and is characterized by a cluster of physical and psychological symptoms. Alcohol disrupts circadian patterns of behavioral and physiological parameters; however, the involvement of circadian clock on the recovery of AH was not explored. Our aim was to study the effect of continuous darkness and the possible involvement of the circadian clock in the recovery time of neuromuscular impairment and anxiety related-behavior due to AH. Male Swiss mice were habituated to 12:12 L:D or continuous darkness. Each group was injected i.p. either with saline (control group) or with ethanol (3.8 g/kg BW) (hangover group). Motor performance and anxiety phenotype were evaluated at a basal point (ZT0) and every 2 h up to 20 h after blood alcohol levels were close to zero (hangover onset). A third group was subjected to a phase advance during which a hangover episode was induced and behavioral tests were carried out for each group of treatment and resynchronization day. Constant darkness resulted to be in a faster recovery of both motor and anxiety impairments in AH compared with the recovery pattern observed under normal light-dark conditions. Mice suffering from a phase shift exhibited behavioral disruptions due to both AH and phase advance. Results indicated that a synchronized circadian clock is necessary for an adequate recovery of alcohol hangover symptoms. PMID:24717330

  12. Posterior Segment Drug Delivery Devices: Current and Novel Therapies in Development.

    PubMed

    Bansal, Pooja; Garg, Satpal; Sharma, Yograj; Venkatesh, Pradeep

    2016-04-01

    Ocular drug delivery by conventional routes of administration does not maintain therapeutic drug concentrations in the target tissues for a long duration because of various anatomical and physiological barriers. Treatment of diseases of the posterior segment of the eye requires novel drug delivery systems that can overcome these barriers for efficacious delivery, provide controlled release for the treatment of chronic diseases, and increase patient's and doctor's convenience to reduce the dosing frequency and associated side effects. Thereby, an increasing number of sustained-release drug delivery devices using different mechanisms have been developed. This article discusses various current and future sustained-release drug delivery systems for the posterior segment disorders. PMID:26811883

  13. Anti-prostglandin therapy in prevention of side-effects of intrauterine contraceptive devices.

    PubMed

    Ylikorkala, O; Kauppila, A; Siljander, M

    1978-08-19

    The efficacy of an anti-prostaglandin, tolfenamic acid (T.A.), in the prevention of side-effects after insertion of a copper-T200 intrauterine contraceptive device (I.U.D.) was evaluated in a double-blind trial in 160 women. T.A. relieved pain and reduced bleeding after insertion and during three subsequent menstruations without serious side-effects. A scoring system for the assessment of I.U.D. side-effects showed that the acceptability of I.U.D. was significantly better in women treated with T.A. than in those given placebo. PMID:79760

  14. 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.

  15. 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.

  16. Adding a second prostaglandin F2α treatment to but not reducing the duration of a PRID-Synch protocol increases fertility after resynchronization of ovulation in lactating Holstein cows.

    PubMed

    Santos, V G; Carvalho, P D; Maia, C; Carneiro, B; Valenza, A; Crump, P M; Fricke, P M

    2016-05-01

    Our objective was to evaluate the effect of a second PGF2α treatment and duration of an Ovsynch protocol that included a progesterone-releasing intravaginal device (PRID) on progesterone (P4) concentrations and pregnancies per artificial insemination (P/AI) after resynchronization of ovulation and timed artificial insemination (TAI). Lactating Holstein cows (n=821) were assigned randomly at a nonpregnancy diagnosis (d 0) to 3 resynchronization protocols: (1) GnRH, d 0; PGF2α, d 7; GnRH, d 9.5 (7D1PGF); (2) GnRH, d 0; PGF2α, d 7; PGF2α, d 8; GnRH, d 9.5); (7D2PGF); or (3) GnRH, d 2; PGF2α, d 7; PGF2α, d 8; GnRH, d 9.5 (5D2PGF). All cows received a PRID at the first GnRH treatment of the resynchronization protocol, which was removed at the first PGF2α treatment, and all cows received TAI approximately 16h after the second GnRH treatment. Blood samples were collected from a subgroup of cows at each treatment of the resynchronization protocols. At 32 d after TAI, cows receiving a second PGF2α treatment (7D2PGF + 5D2PGF cows) had more P/AI (42.6 vs. 35.7%) than cows receiving a single PGF2α treatment (7D1PGF cows). For cows treated with a second PGF2α treatment, decreasing the duration of the protocol did not increase P/AI (41.4 vs. 43.8% for 7D2PGF vs. 5D2PGF cows). At 60 d after TAI, P/AI did not differ between cows treated with the 1 PGF2α (7D1PGF cows) or 2 PGF2α (7D2PGF + 5D1PGF cows) treatments (32.5 vs. 37.9%, respectively). In addition, reducing the duration of the protocol did not increase P/AI at 60 d after TAI (37.8 vs. 38.5% for 7D2PGF vs. 5D2PGF cows). Pregnancy loss from 32 to 60 d after TAI was not affected by the number of PGF2α treatments (8.5 vs. 10.6%, for 7D1PGF vs. 7D2PGF + 5D2PGF cows) or the duration of the protocol (9.1 vs. 12.1%, for 7D2PGF vs. 5D2PGF cows). The percentage of cows with incomplete luteal regression at the second GnRH treatment tended to differ among treatments and was lowest for 7D2PGF cows, intermediate for 5D2PGF

  17. 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

  18. 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.

  19. Device-based nonspecific immunomodulation therapy (Celacade), and its potential role in the treatment of chronic heart failure.

    PubMed

    Sporter, Robert J; Kim, Joon-Hyuk; Frishman, William H

    2008-01-01

    Chronic heart failure (CHF) remains a leading cause of mortality and morbidity, despite the use of optimal standard-of-care medical therapies. Although the role of the immune system in the pathogenesis and progression of CHF has been well-appreciated, attempts to modify specific systemic immune mediators have been unsuccessful. Building on the modest successes of more broad-spectrum immune therapies, Celacade therapy was developed, a device that induces apoptosis in an ex vivo blood sample. Upon reinjection into the body, the treated blood sample has been shown to have an anti-inflammatory effect. Celacade has been successful in several animal models of disease where inflammation plays an important pathogenic role. Two phase III clinical trials of Celacade have been undertaken. A trial on the use of Celacade in peripheral arterial disease with intermittent claudication was terminated early due to a lack of clinical effect, and a larger trial of Celacade treatment in CHF (ACCLAIM) was completed in 2006. ACCLAIM did not reach the primary end point for the overall study population; however, the study results demonstrated a reduced risk of death or first cardiovascular hospitalization by 39% in patients with New York Heart Association class II CHF and a 26% reduction in patients with class II, III, and IV disease who had no prior history of myocardial infarction. Celacade has been approved for treatment of CHF in these groups of patients in the European Union, and an FDA-mandated confirmatory study of Celacade for possible approval in the United States is in progress. PMID:18923231

  20. Skin Dose Impact from Vacuum Immobilization Device and Carbon Fiber Couch in Intensity Modulated Radiation Therapy for Prostate Cancer

    SciTech Connect

    Lee, K.-W.; Wu, J.-K.; Jeng, S.-C.; Hsueh Liu Yen-Wan; Cheng, Jason Chia-Hsien

    2009-10-01

    To investigate the unexpected skin dose increase from intensity-modulated radiation therapy (IMRT) on vacuum cushions and carbon-fiber couches and then to modify the dosimetric plan accordingly. Eleven prostate cancer patients undergoing IMRT were treated in prone position with a vacuum cushion. Two under-couch beams scattered the radiation from the vacuum cushion and carbon-fiber couch. The IMRT plans with both devices contoured were compared with the plans not contouring them. The skin doses were measured using thermoluminescent dosimeters (TLDs) placed on the inguinal regions in a single IMRT fraction. Tissue equivalent thickness was transformed for both devices with the relative densities. The TLD-measured skin doses (59.5 {+-} 9.5 cGy and 55.6 {+-} 5.9 cGy at left and right inguinal regions, respectively) were significantly higher than the calculated doses (28.7 {+-} 4.7 cGy; p = 2.2 x 10{sup -5} and 26.2 {+-} 4.3 cGy; p = 1.5 x 10{sup -5}) not contouring the vacuum cushion and carbon-fiber couch. The calculated skin doses with both devices contoured (59.1 {+-} 8.8 cGy and 55.5 {+-} 5.7 cGy) were similar to the TLD-measured doses. In addition, the calculated skin doses using the vacuum cushion and a converted thickness of the simulator couch were no different from the TLD-measured doses. The recalculated doses of rectum and bladder did not change significantly. The dose that covered 95% of target volume was less than the prescribed dose in 4 of 11 patients, and this problem was solved after re-optimization applying the corrected contours. The vacuum cushion and carbon-fiber couch contributed to increased skin doses. The tissue-equivalent-thickness method served as an effective way to correct the dose variations.

  1. 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. PMID:24170423

  2. A stereotactic radiation therapy device for retinoblastoma using a noncircular collimator and intensity filter.

    PubMed

    Cormack, R A; Kooy, H M; Bellerive, M R; Loeffler, J S; Petersen, R A; Tarbell, N J

    1998-08-01

    The proximity of the lens to the retina makes the treatment of retinoblastoma a challenge for external beam radiation therapy. The approximately 1 mm separation between the posterior edge of the lens and the anterior region of the retina causes a trade-off between coverage of the entire retina and excessive dose to the lens. A stereotactic, LINAC based, lens sparing technique for treating retinoblastoma is presented. The technique uses noncoplanar arcs with the lens at isocenter. A special noncircular collimator blocks the lens but it also causes the dose distribution to vary across the retina. A fluence modulation filter is used to reduce the dose inhomogeneity across the target. The resulting dose distribution is roughly hemispheric, providing both anterior coverage of the retina and lens blocking unlike conventional techniques. The method used to develop the collimator and filter assembly is presented. Dosimetry of the assembly was carried out using radiochromic film, and the results were entered in a treatment planning system. The dose distribution as measured in a phantom is provided and compared to calculations. PMID:9725131

  3. Novel technique for avoidance of pressure competition between a negative pressure wound therapy device and chest drains in the management of deep sternal wound infections.

    PubMed

    Davis, James S; Kourliouros, Antonios; Deshpande, Ranjit; Cavale, Naveen

    2015-02-01

    In recent years, the use of negative pressure wound therapy (NPWT) devices has changed the way sternal wound infections are being managed. It is not uncommon for deep sternal wound infections to occur together with mediastinal or even pleural collections requiring underwater seal drainage. In these patients in whom there is a communication between the pleural and mediastinal cavities, the concomitant use of an NPWT device negates the pressure gradient within the pleural and mediastinal drains, allowing suppurative fluid to stagnate. We present a novel technique to address this limitation of NPWT devices in patients with sternal wound infections that communicate with a pleural collection. PMID:25415315

  4. Sympathetic Activation in Chronic Heart Failure: Potential Benefits of Interventional Therapies.

    PubMed

    Lachowska, Kamila; Gruchała, Marcin; Narkiewicz, Krzysztof; Hering, Dagmara

    2016-07-01

    Heart failure (HF) is a major and growing public health problem. This condition is associated with poor prognosis, a high rate of mortality, frequent hospitalization and increasing costs to health care systems. Pharmacological approaches aimed at reducing morbidity and mortality in HF have primarily focused on inhibition of the renin-angiotensin-aldosterone system (RAAS) and the sympathetic nervous system (SNS), both of which have been associated with disease development, progression and adverse cardiovascular (CV) outcomes. The increasing number of hospitalizations for HF decompensation suggests the failure of available treatment options, indicating the necessity for alternative therapeutic approaches. Alongside pharmacological and cardiac resynchronization therapies in selected patients with arrhythmia, recent advancements in the management of HF have been directed at inhibiting relevant neurogenic pathways underlying disease development and progression. Initial evidence regarding the safety and effectiveness of interventional procedures suggests that HF patients may benefit from novel adjunctive therapies. Here we review the critical role of sympathetic activation in HF and the rationale for therapeutic interventions including device-based and interventional approaches aimed at restoring autonomic neural balance in this condition. PMID:27193773

  5. Possibility for the Conjugated Use of Photodynamic Therapy and Electrosurgical Devices.

    PubMed

    Rego Filho, Francisco de Assis Martins Gomes; Caldas, Romualdo Arthur Alencar; Kurachi, Cristina; Bagnato, Vanderlei Salvador; de Araujo, Maria Tereza

    2015-01-01

    Because tissue optics limits the treated volume during anti-tumor Photodynamic Therapy (PDT), its conjugation with prior tissue debulking has been suggested clinically. In this context, the conjugation of radiofrequency ablation and PDT has already been demonstrated. However, the basic principles that enable the success of these protocols have not been discussed. This proof-of-principle study analyzes the possibility of conjugating electrosurgery (ES) and PDT, analyzing different sequences of photosensitizer (PS) administration in an animal model. The animals were distributed over five groups: ES, PS+Light, PS+ES, ES+PS+Light and PS+ES+Light. The PS Photogem was administered systemically. An electrosurgical unit (480 kHz) was used to remove a portion of the liver, leaving a plane surface for PDT illumination (630 nm, 150 J/cm²). Fluorescence was collected during the stages of the experiment to monitor the PS accumulation. After 30 hours, histological processing was performed. The fluorescence spectra revealed strong Photogem emission in both administration sequences (ES+PS; PS+ES), and little PS bleach after ES was observed. The maximum necrosis depth was observed for the PS+ES+Light group-(716 ± 75) μm-higher than its respective control group (160 ± 28) μm, proving successful conjugation. Histological features from ES and PDT on both conjugation sequences were observed. Pre-photosensitized tissue presented decreased ES-related thermal damage. A simple physical hypothesis, based on the Joule effect and the tissue electrical conductivity, was proposed to support these findings. In conclusion, the results successfully demonstrated the possibility of conjugating ES and PDT in a single protocol. PMID:26284935

  6. Heart Failure Therapies for End-Stage Chemotherapy-Induced Cardiomyopathy.

    PubMed

    Mukku, Roy B; Fonarow, Gregg C; Watson, Karol E; Ajijola, Olujimi A; Depasquale, Eugene C; Nsair, Ali; Baas, Arnold S; Deng, Mario C; Yang, Eric H

    2016-06-01

    With ongoing advancements in cancer-related treatments, the number of cancer survivors continues to grow globally, with numbers in the United States predicted to reach 18 million by 2020. As a result, it is expected that a greater number of patients will present with chemotherapy-related side effects. One entity in particular, chemotherapy-related cardiomyopathy (CCMP), is a known cardiotoxic manifestation associated with agents such as anthracyclines, trastuzumab, and tyrosine kinase inhibitors. Although such effects have been described in the medical literature for decades, concrete strategies for screening, prevention, and management of CCMP continue to be elusive owing to limited studies. Late recognition of CCMP is associated with a poorer prognosis, including a lack of clinical response to pharmacologic therapy, and end-stage heart failure. A number of advanced cardiac therapies, including cardiac resynchronization therapy, ventricular assist devices, and orthotopic cardiac transplantation, are available to for end-stage heart failure; however, the role of these therapies in CCMP is unclear. In this review, management of end-stage CCMP with the use of advanced therapies and their respective effectiveness are discussed, as well as clinical characteristics of patients undergoing these treatments. The relative paucity of data in this field highlights the importance and need for larger-scale longitudinal studies and long-term registries tracking the outcomes of cancer survivors who have received cardiotoxic cancer therapy to determine the overall incidence of end-stage CCMP, as well as prognostic factors that will ultimately guide such patients toward receiving appropriate end-stage care. PMID:27109619

  7. 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

  8. Exploring time series retrieved from cardiac implantable devices for optimizing patient follow-up

    PubMed Central

    Guéguin, Marie; Roux, Emmanuel; Hernández, Alfredo I; Porée, Fabienne; Mabo, Philippe; Graindorge, Laurence; Carrault, Guy

    2008-01-01

    Current cardiac implantable devices (ID) are equipped with a set of sensors that can provide useful information to improve patient follow-up and to prevent health deterioration in the postoperative period. In this paper, data obtained from an ID with two such sensors (a transthoracic impedance sensor and an accelerometer) are analyzed in order to evaluate their potential application for the follow-up of patients treated with a cardiac resynchronization therapy (CRT). A methodology combining spatio-temporal fuzzy coding and multiple correspondence analysis (MCA) is applied in order to: i) reduce the dimensionality of the data and provide new synthetic indices based on the “factorial axes” obtained from MCA, ii) interpret these factorial axes in physiological terms and iii) analyze the evolution of the patient’s status by projecting the acquired data into the plane formed by the first two factorial axes named “factorial plane”. In order to classify the different evolution patterns, a new similarity measure is proposed and validated on simulated datasets, and then used to cluster observed data from 41 CRT patients. The obtained clusters are compared with the annotations on each patient’s medical record. Two areas on the factorial plane are identified, one being correlated with a health degradation of patients and the other with a stable clinical state. PMID:18838359

  9. 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

  10. Error concealment and early resynchronization techniques for MPEG-2 video streams damaged by transmission over ATM networks

    NASA Astrophysics Data System (ADS)

    Fernandez, Carlos L.; Basso, Andrea; Hubaux, Jean-Pierre

    1996-03-01

    In this paper we present some error concealment techniques for MPEG-2 video coded and multiplexed streams damaged by ATM cell losses. Decoder early resynchronization limits the effects of transmission errors by decoding some information that is normally discarded from the damaged MPEG-2 video bitstreams. A part of this information cannot be completely decoded due to its differential coding among macroblocks (DC levels, motion vectors). Three different techniques are presented for the case of DC level recovery in Intra pictures. Two of them are predictive techniques, one operating in the frequency domain and the other in the spatial domain. The third technique provides an exact reconstruction of DC values using special data coded into the user data area of the MPEG-2 video bitstream. For not resynchronized areas classical temporal and spatial concealment techniques are used. These techniques have been tested on a simulated environment which includes an implementation of MPEG-2 elementary video coding and decoding and MPEG-2 system standards. The ATM transmission part has been simulated by means of specialized simulation software. Results relative to the presented concealment techniques are included.

  11. Effect of Neurohormonal Blockade Drug Therapy on Outcomes and Left Ventricular Function and Structure After Left Ventricular Assist Device Implantation.

    PubMed

    Grupper, Avishay; Zhao, Yanjun M; Sajgalik, Pavol; Joyce, Lyle D; Park, Soon J; Pereira, Naveen L; Stulak, John M; Burnett, John C; Edwards, Brooks S; Daly, Richard C; Kushwaha, Sudhir S; Schirger, John A

    2016-06-01

    Neurohormonal blockade drug therapy (NHBDT) is the cornerstone therapy in heart failure (HF) management for promoting reverse cardiac remodeling and improving outcomes. It's utility in left ventricular assist device (LVAD) supported patients remains undefined. Sixty-four patients who received continuous flow LVAD at our institution were retrospectively reviewed and divided into 2 groups: no-NHBDT group (n = 33) received LVAD support only and NHBDT group (n = 31) received concurrent NHBDT based on the clinical judgment of the attending physicians. Cardiac remodeling (echocardiographic parameters and biomarkers) and clinical outcome (functional status, HF-related hospital readmissions, and mortality) data were collected. A statistically significant increase in ejection fraction, decrease in LV end-diastolic diameter index and LV mass index, and a sustained reduction in N-terminal pro B-type natriuretic peptide (NTproBNP) were observed in the NHBDT group at 6 months after LVAD implant (p <0.05). NHBDT-treated patients experienced significantly greater improvement in New York Heart Association functional classification and 6-minute-walk distance throughout the study. The combined end point of cardiovascular death or HF hospitalization was significantly reduced in patients receiving NHBDT (p = 0.013) associated primarily with a 12.1% absolute reduction in HF-related hospitalizations (p = 0.046). In conclusion, NHBDT in LVAD-supported patients is associated with a significant reversal in adverse cardiac remodeling and a reduction in morbidity and mortality compared with LVAD support alone. PMID:27079215

  12. 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.

  13. 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.

  14. Medical eligibility, contraceptive choice, and intrauterine device acceptance among HIV-infected women receiving antiretroviral therapy in Lilongwe, Malawi

    PubMed Central

    Haddad, Lisa B.; Feldacker, Caryl; Jamieson, Denise J.; Tweya, Hannock; Cwiak, Carrie; Bryant, Amy G.; Hosseinipour, Mina C.; Chaweza, Thomas; Mlundira, Linly; Kachale, Fanny; Stuart, Gretchen S.; Hoffman, Irving; Phiri, Sam

    2014-01-01

    Objective To determine medical eligibility for contraceptive use, contraceptive preference, and acceptance of a copper intrauterine device (IUD) among a cohort of HIV-infected women receiving antiretroviral therapy (ART). Methods All HIV-infected women who received ART and sought contraceptive services at the Lighthouse clinic, an integrated HIV/ART clinic in Lilongwe, Malawi, between August and December 2010 were invited to participate in a structured interview. Eligibility and preference for the following contraceptive methods were assessed: combined hormonal contraceptives, progestogen-only pills, copper IUD, injectable depot medroxyprogesterone acetate (DMPA), and contraceptive implants. Results The final sample included 281 women; five were pregnant. The remaining 276 women were eligible for at least three contraceptive methods, with 242 (87.7%) eligible for all five methods evaluated. After counseling, 163 (58.0%) selected DMPA and 98 (34.9%) selected an IUD as their preferred contraceptive method. Regardless of their method of choice, 222 (79.0%) women agreed to have an IUD placed on the same day. Conclusion Most methods of contraception are safe for use by HIV-infected women. Approximately 80% of the women were willing to receive an IUD. Efforts must be made to increase education about, and access to, long-acting reversible methods that may be acceptable and appropriate contraceptive options for HIV-infected women. PMID:24890746

  15. 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 Central

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

    2015-01-01

    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

  16. Drug and drug-device therapy in heart failure patients in the post-COMET and SCD-HeFT era.

    PubMed

    Reiffel, James A

    2005-06-01

    Reduced left ventricular ejection fraction and heart failure are the most important risk factors for sudden cardiac death. Recent trials have contributed to the knowledge base of critical therapies for the treatment of left ventricular systolic dysfunction and heart failure as it relates to arrhythmic and sudden cardiac death. Both pharmacologic and device therapies can reduce sudden cardiac death. The trials discussed in this paper have identified the pharmacologic and device interventions that are likely to improve the length and quality of life of the patient with left ventricular dysfunction and reduce the risk of sudden cardiac death. The mortality and anti-arrhythmic effects of angiotensin-converting enzyme inhibitors and beta-blockers have been confirmed in large-scale controlled clinical heart failure trials. Recent trials have evaluated which agents are most effective and which patients will derive the most benefit from device therapy in terms of the reduction in the risk of sudden cardiac death and in the amelioration of heart failure. The recent data from the Carvedilol or Metoprolol European Trial (COMET) and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) are discussed as the latest in the series of landmark studies that have shaped the current approaches to treating patients with heart failure and that have altered the heart failure treatment paradigm. PMID:15965572

  17. Bridge-to-Decision Therapy With a Continuous-Flow External Ventricular Assist Device in Refractory Cardiogenic Shock of Various Causes

    PubMed Central

    Takayama, Hiroo; Soni, Lori; Kalesan, Bindu; Truby, Lauren K.; Ota, Takeyoshi; Cedola, Sophia; Khalpey, Zain; Uriel, Nir; Colombo, Paolo; Mancini, Donna M.; Jorde, Ulrich P.; Naka, Yoshifumi

    2014-01-01

    Background Mortality for refractory cardiogenic shock remains high. In this patient cohort, there have been mixed results in mechanical circulatory support device use as a bridge-to-decision therapy. We evaluated a continuous-flow external ventricular assist device (VAD), CentriMag VAD (Thoratec Corp., Pleasanton, CA), in patients with various causes of refractory cardiogenic shock. Methods and Results This is a retrospective review of adult patients who underwent surgical CentriMag VAD insertion as bridge-to-decision therapy. From January 2007 through June 2012, 143 patients received CentriMag VAD. The cause of refractory cardiogenic shock was failure of medical management in 71 patients, postcardiotomy shock in 37, graft failure post–heart transplantation in 22, and right ventricular failure post–implantable left VAD in 13. Mean age was 52±16 years, and 71% were in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 1. Among 158 device runs, device configuration was BiVAD in 67%, isolated right VAD in 26%, and isolated left VAD in 8%. Median duration of support was 14 days (interquartile range, 8–26). Survival was 69% at 30 days and 49% at 1 year. The next destination after the CentriMag VAD was myocardial recovery in 30%, device exchange to an implantable VAD in 15%, and heart transplantation in 18%. The failure of medical management and the graft failure post–heart transplantation groups had higher 30-day survival compared with the postcardiotomy shock group. Major bleeding events occurred in 33% and cerebrovascular accidents in 14%. There was no CentriMag pump failure or thrombosis. Conclusions Bridge-to-decision therapy with CentriMag VAD is feasible in a variety of refractory cardiogenic shock settings. Patients with postcardiotomy shock have inferior survival. PMID:25027874

  18. 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.

  19. 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

  20. 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.

  1. 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. PMID:25851773

  2. [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

  3. External incontinence devices

    MedlinePlus

    ... of products that are available in your area. URINARY INCONTINENCE DEVICES Urine collection devices are mainly used by ... urinary system References Payne CK. Conservative management of urinary incontinence: Behavioral and pelvic floor therapy, urethral and pelvic ...

  4. A non-randomised, controlled clinical trial of an innovative device for negative pressure wound therapy of pressure ulcers in traumatic paraplegia patients.

    PubMed

    Srivastava, Rajeshwar N; Dwivedi, Mukesh K; Bhagat, Amit K; Raj, Saloni; Agarwal, Rajiv; Chandra, Abhijit

    2016-06-01

    The conventional methods of treatment of pressure ulcers (PUs) by serial debridement and daily dressings require prolonged hospitalisation, associated with considerable morbidity. There is, however, recent evidence to suggest that negative pressure wound therapy (NPWT) accelerates healing. The commercial devices for NPWT are costly, cumbersome, and electricity dependent. We compared PU wound healing in traumatic paraplegia patients by conventional dressing and by an innovative negative pressure device (NPD). In this prospective, non-randomised trial, 48 traumatic paraplegia patients with PUs of stages 3 and 4 were recruited. Patients were divided into two groups: group A (n = 24) received NPWT with our NPD, and group B (n = 24) received conventional methods of dressing. All patients were followed up for 9 weeks. At week 9, all patients on NPD showed a statistically significant improvement in PU healing in terms of slough clearance, granulation tissue formation, wound discharge and culture. A significant reduction in wound size and ulcer depth was observed in NPD as compared with conventional methods at all follow-up time points (P = 0·0001). NPWT by the innovative device heals PUs at a significantly higher rate than conventional treatment. The device is safe, easy to apply and cost-effective. PMID:24894079

  5. The relative role of patient physiology and device optimisation in cardiac resynchronisation therapy: A computational modelling study.

    PubMed

    Crozier, Andrew; Blazevic, Bojan; Lamata, Pablo; Plank, Gernot; Ginks, Matthew; Duckett, Simon; Sohal, Manav; Shetty, Anoop; Rinaldi, Christopher A; Razavi, Reza; Smith, Nicolas P; Niederer, Steven A

    2016-07-01

    Cardiac resynchronisation therapy (CRT) is an established treatment for heart failure, however the effective selection of patients and optimisation of therapy remain controversial. While extensive research is ongoing, it remains unclear whether improvements in patient selection or therapy planning offers a greater opportunity for the improvement of clinical outcomes. This computational study investigates the impact of both physiological conditions that guide patient selection and the optimisation of pacing lead placement on CRT outcomes. A multi-scale biophysical model of cardiac electromechanics was developed and personalised to patient data in three patients. These models were separated into components representing cardiac anatomy, pacing lead location, myocardial conductivity and stiffness, afterload, active contraction and conduction block for each individual, and recombined to generate a cohort of 648 virtual patients. The effect of these components on the change in total activation time of the ventricles (ΔTAT) and acute haemodynamic response (AHR) was analysed. The pacing site location was found to have the largest effect on ΔTAT and AHR. Secondary effects on ΔTAT and AHR were found for functional conduction block and cardiac anatomy. The simulation results highlight a need for a greater emphasis on therapy optimisation in order to achieve the best outcomes for patients. PMID:26546827

  6. 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.

  7. 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. PMID:26996767

  8. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

    PubMed Central

    Rome, Benjamin N.; Kramer, Daniel B.; Kesselheim, Aaron S.

    2014-01-01

    IMPORTANCE The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via “supplements,” which may not require additional clinical testing. OBJECTIVE To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. DESIGN Using the FDA’s PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories overtime. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. RESULTS From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device’s design. Among 180-day supplements approved from 2010

  9. 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

  10. 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

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

    PubMed

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

    2009-02-21

    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

  12. Gaps in Medical and Device Therapy for Patients with Left Ventricular Systolic Dysfunction: The EchoGap Study

    PubMed Central

    Dokainish, Hisham; Jewett, Lauren; Nieuwlaat, Robby; Coulson, Joshua; Demers, Catherine; Lonn, Eva; Healey, Jeff; Haynes, Brian; Connolly, Stuart

    2014-01-01

    Objectives: To assess gaps between guidelines and medicine prescription/dosing and referral for defibrillator therapy in patients with left ventricular systolic dysfunction (LVSD). Methods: Outpatient echocardiography reports at an academic hospital centre were screened and outpatients with LVEF<40% were included. A questionnaire was mailed to the patients’ physician, querying prescription/dosing of ACE-inhibitors (ACEi), angiotensin receptor blockers (ARB) and beta-blockers (BB). Patients with LVEF<30% had additional questions on implantable cardiac defibrillator (ICD) referral. Results: Mean age was 69.6+/-12.2 years and mean LVEF was 29.7+/-6.5%. ACEi and/or ARB prescription rate was 260/309(84.1%) versus 256/308(83.1%) for BB (p=NS for comparison). Of patients on ACEi, 77/183(42.1%) were on target dose, compared to 7/45(15.5%) for ARB and 9/254(3.5%) for BB (p<0.01). Of 171/309 patients (55.3%) with LVEF<30%, 72/171(42.1%) had an ICD and 16/171(9.4%) were referred for one. Conclusion: Prescription rates of evidence-based HF medicines are relatively high in outpatients with LVSD referred for echocardiography at this Canadian academic medical centre; however, the proportion of patients at target doses was modest for ACEi and low for ARB and BB. Approximately half of patients who qualify for ICD by EF alone have one or were referred. Important reasons for patients with LVSD not on evidence-based therapy were identified. PMID:25343000

  13. A software tool to automatically assure and report daily treatment deliveries by a Cobalt-60 radiation therapy device.

    PubMed

    Yang, Deshan; Wooten, H Omar; Green, Olga; Li, Harold H; Liu, Shi; Li, Xiaoling; Rodriguez, Vivian; Mutic, Sasa; Kashani, Rojano

    2016-01-01

    The aims of this study were to develop a method for automatic and immediate verification of treatment delivery after each treatment fraction in order to detect and correct errors, and to develop a comprehensive daily report which includes delivery verification results, daily image-guided radiation therapy (IGRT) review, and information for weekly physics reviews. After systematically analyzing the requirements for treatment delivery verification and understanding the available information from a commercial MRI-guided radiotherapy treatment machine, we designed a procedure to use 1) treatment plan files, 2) delivery log files, and 3) beam output information to verify the accuracy and completeness of each daily treatment delivery. The procedure verifies the correctness of delivered treatment plan parameters including beams, beam segments and, for each segment, the beam-on time and MLC leaf positions. For each beam, composite primary fluence maps are calculated from the MLC leaf positions and segment beam-on time. Error statistics are calculated on the fluence difference maps between the plan and the delivery. A daily treatment delivery report is designed to include all required information for IGRT and weekly physics reviews including the plan and treatment fraction information, daily beam output information, and the treatment delivery verification results. A computer program was developed to implement the proposed procedure of the automatic delivery verification and daily report generation for an MRI guided radiation therapy system. The program was clinically commissioned. Sensitivity was measured with simulated errors. The final version has been integrated into the com-mercial version of the treatment delivery system. The method automatically verifies the EBRT treatment deliveries and generates the daily treatment reports. Already in clinical use for over one year, it is useful to facilitate delivery error detection, and to expedite physician daily IGRT review and

  14. 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. PMID:26839324

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

    PubMed

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

    2015-01-01

    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. PMID:25965295

  16. 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.

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

    PubMed Central

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

    2015-01-01

    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. PMID:25965295

  18. Automated knowledge-based fuzzy models generation for weaning of patients receiving ventricular assist device (VAD) therapy.

    PubMed

    Tsipouras, Markos G; Karvounis, Evaggelos C; Tzallas, Alexandros T; Goletsis, Yorgos; Fotiadis, Dimitrios I; Adamopoulos, Stamatis; Trivella, Maria G

    2012-01-01

    The SensorART project focus on the management of heart failure (HF) patients which are treated with implantable ventricular assist devices (VADs). This work presents the way that crisp models are transformed into fuzzy in the weaning module, which is one of the core modules of the specialist's decision support system (DSS) in SensorART. The weaning module is a DSS that supports the medical expert on the weaning and remove VAD from the patient decision. Weaning module has been developed following a "mixture of experts" philosophy, with the experts being fuzzy knowledge-based models, automatically generated from initial crisp knowledge-based set of rules and criteria for weaning. PMID:23366361

  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. PMID:23448817

  20. Resynchronization of estrus in beef cattle: Ovarian function, estrus and fertility following progestin treatment and treatments to synchronize ovarian follicular development and estrus

    PubMed Central

    Colazo, Marcos G.; Kastelic, John P.; Small, Julie A.; Wilde, Randy E.; Ward, Douglas R.; Mapletoft, Reuben J.

    2007-01-01

    The objective was to optimize rebreeding of nonpregnant, previously inseminated beef cattle. In Experiment 1, 43 cows received a used intravaginal progesterone-releasing insert (IVPRI; Days 0–7) 12.3 d after ovulation and received concurrently no treatment, 100 μg gonadotropin releasing hormone (GnRH), 1 mg estradiol cypionate (ECP), or 150 mg progesterone. Emergence of a new ovarian follicular wave was most synchronous (P < 0.0001) in the GnRH group. In Experiment 2, 675 heifers were given GnRH or no treatment on Day 0, fed melengestrol acetate (MGA; 0.5 mg/head/d) from Days 0–5 (Day 0 = 13–14 d after timed insemination; TAI), given 0.5 mg ECP or nothing on Day 7, and reinseminated 6–12 h after onset of estrus. Estrus was more synchronous (P < 0.05) in heifers given GnRH versus no treatment on Day 0. In Experiment 3, 317 TAI heifers were resynchronized with either MGA or a used IVPRI with or without ECP on Day 7; estrus was more synchronous (P < 0.05) and pregnancy rates were higher (54.1% versus 39.2%, P < 0.05) in heifers given a used IVPRI than those fed MGA. For resynchronization of heifers, pregnancy rates were not significantly improved with GnRH treatment, but were higher with a used IVPRI than with MGA. PMID:17310622

  1. Effect of different gonadorelin (GnRH) products used for the first or resynchronized timed artificial insemination on pregnancy rates in postpartum dairy cows.

    PubMed

    Poock, S E; Lamberson, W R; Lucy, M C

    2015-09-01

    Different GnRH products are used for timed artificial insemination (AI) in postpartum dairy cows. Previous studies reported greater LH release and increased ovulation percentage for gonadorelin diacetate tetrahydrate compared with gonadorelin hydrochloride but pregnancies per AI (P/AI) were not evaluated. The objective, therefore, was to compare P/AI for cows treated with either gonadorelin hydrochloride or gonadorelin diacetate tetrahydrate before the first timed AI or resynchronized timed AI. Holstein cows (n = 3938) in a confinement dairy in northeast Missouri were assigned to weekly cohorts (n = 22) on the basis of calving date. Cows were treated with "Presynch Ovsynch" (PGF2α, 14 days; PGF2α, 14 days; GnRH, 7 days; PGF2α, 56 hours; GnRH, 16 hours; timed AI) so that the first timed AI was 70 to 76 days postpartum. The PGF2α was Lutalyse (5 mL; 25 mg; Zoetis). The GnRH product was either gonadorelin hydrochloride (2 mL; 100 μg; n = 1945) or gonadorelin diacetate tetrahydrate (2 mL; 100 μg; n = 1993) and alternated weekly for cows assigned to cohorts. There were first timed AI (n = 1790) and resynchronized timed AI (n = 2148) cows within each cohort. The resynchronization began 32 days after timed AI (GnRH, 6 days; ultrasound pregnancy diagnosis, 1 day; and then for nonpregnant cows: PGF2α, 56 hours; GnRH, 16 hours; timed AI). The trial was conducted from January to February 2012 (n = 1203) and July to October 2012 (n = 2735). Cows were fed a total mixed ration, milked thrice daily, and milk tested monthly for volume, somatic cell count (SCC), fat percentage, protein percentage, and milk urea nitrogen. Data were analyzed by fitting the binary response data to a generalized linear mixed model for repeated measures. There was no effect of the GnRH product (treatment) on P/AI (38.4 ± 1.2 vs. 35.7 ± 1.3; gonadorelin diacetate tetrahydrate vs. gonadorelin hydrochloride). Treatment interactions with parity, month of breeding

  2. Comparison of vancomycin and teicoplanin trough serum levels in patients with infected orthopedic devices: new data for old therapies.

    PubMed

    Lemaire, Xavier; Loiez, Caroline; Valette, Michel; Migaud, Henri; Dubreuil, Luc; Yazdanpanah, Yazdan; Senneville, Eric

    2011-06-01

    We compared retrospectively vancomycin and teicoplanin trough serum levels after loading doses and, subsequently, after high daily doses, in 52 patients (26 in each group) who had developed infections after implantation of an orthopedic device. The target trough serum level was > 25 mg/l. Trough levels were significantly higher at 2 days (±1) and 5 days (±1) in patients who received teicoplanin compared with patients who received a continuous perfusion of vancomycin (26.1 vs. 16 mg/l at day 2 ± 1, P = 0.01; 27.8 vs. 19.9 mg/l at day 5 ± 1, P = 0.01). One of the 26 patients taking vancomycin reached the target trough serum level by day 2 (±1), whereas 10 of the 26 patients taking teicoplanin reached the target by that time (P = 0.002). At day 5 (±1), 6/26 patients taking vancomycin reached the target, versus 13/26 patients taking teicoplanin (P = 0.04). However, physicians should remain cautious when administering teicoplanin empirically because of the higher MIC₉₀ values observed for coagulase-negative staphylococci compared with vancomycin. PMID:21053041

  3. A filter device for the prevention of both heparin- and protamine-induced complications associated with extracorporeal therapy.

    PubMed

    Yang, V C; Teng, C L; Kim, J S

    1990-01-01

    When extracorporeal blood circulation (ECBC) is used, systemic heparinization is necessary to prevent clotting of the blood in the extracorporeal circuit. However, the high circulating heparin concentration needed often leads to bleeding complications. To avoid these, protamine, a heparin antagonist, is administered at the conclusion of the ECBC procedure to reverse the anticoagulant activity of heparin. Intravenous administration of protamine can cause hypotension and shock. To date, there has been no real alternative to control the bleeding risks associated with systemic use of heparin and the adverse effects resulting from heparin reversal with protamine. A novel approach that might control both the heparin- and the protamine-induced complications is suggested. It consists of placing a blood-compatible filter device containing immobilized protamine (a protamine filter) at the distal end of the ECBC apparatus. The filter removes heparin after heparin serves its anticoagulant purpose in the extracorporeal circuit and before blood is returned to the patient. The filter also allows for an external protamine treatment. Since protamine toxicity results from the direct contact of protamine with cells of the liver, lungs, and other organ tissues, the use of an external protamine treatment would minimize it. Protamine was covalently immobilized onto a cellulosic hollow fiber bundle obtained from a clinically used hemodialyzer. The bundle was accessed to the vascular system of a dog by femoral artery and vein cannulation. In in-vivo experiments the protamine-bound fiber bundle not only removed heparin from the extracorporeal circuit, but also caused no clinically significant hemodynamic change in the animal.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2261582

  4. Continuous-flow left ventricular assist device therapy in patients with preoperative hepatic failure: are we pushing the limits too far?

    PubMed

    Weymann, Alexander; Patil, Nikhil P; Sabashnikov, Anton; Mohite, Phrashant N; Garcia Saez, Diana; Bireta, Christian; Wahlers, Thorsten; Karck, Matthias; Kallenbach, Klaus; Ruhparwar, Arjang; Fatullayev, Javid; Amrani, Mohamed; De Robertis, Fabio; Bahrami, Toufan; Popov, Aron-Frederik; Simon, Andre R

    2015-04-01

    The purpose of this study was to evaluate the effects and outcome of continuous-flow left ventricular assist device (cf-LVAD) therapy in patients with preoperative acute hepatic failure. The study design was a retrospective review of prospectively collected data. Included were 42 patients who underwent cf-LVAD implantation (64.3% HeartMate II, 35.7% HeartWare) between July 2007 and May 2013 with preoperative hepatic failure defined as elevation of greater than or equal to two liver function parameters above twice the upper normal range. Mean patient age was 35 ± 12.5 years, comprising 23.8% females. Dilated cardiomyopathy was present in 92.9% of patients (left ventricular ejection fraction 17.3 ± 5.9%). Mean support duration was 511 ± 512 days (range: 2-1996 days). Mean preoperative laboratory parameters for blood urea nitrogen, serum creatinine, total bilirubin, and alanine aminotransferase were 9.5 ± 5.4 mg/dL, 110.3 ± 42.8 μmol/L, 51.7 ± 38.3 mmol/L, and 242.1 ± 268.6 U/L, respectively. All parameters decreased significantly 1 month postoperatively. The mean preoperative modified Model for Endstage Liver Disease excluding international normalized ratio score was 16.03 ± 5.57, which improved significantly after cf-LVAD implantation to 10.62 ± 5.66 (P < 0.001) at 7 days and 5.83 ± 4.98 (P < 0.001) at 30 days postoperatively. One-year and 5-year survival was 75.9 and 48.1%, respectively. 21.4% of the patients underwent LVAD explantation for myocardial recovery, 16.7% were successfully transplanted, and 7.1% underwent LVAD exchange for device failure over the follow-up period. Patients with preexisting acute hepatic failure are reasonable candidates for cf-LVAD implantation, with excellent rates of recovery and survival, suggesting that cf-LVAD therapy should not be denied to patients merely on grounds of "preoperative elevated liver enzymes/hepatopathy." PMID:25345547

  5. 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

  6. 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

  7. Interlaboratory and Interstudy Reproducibility of a Novel Lateral-Flow Device and Influence of Antifungal Therapy on Detection of Invasive Pulmonary Aspergillosis

    PubMed Central

    Najvar, Laura K.; Bocanegra, Rosie; Kirkpatrick, William R.; Patterson, Thomas F.; Thornton, Christopher R.

    2013-01-01

    Interest in lateral-flow devices (LFDs) as potential point-of-care assays for the diagnosis of infectious diseases has increased. Our objective was to evaluate the interlaboratory and interstudy reproducibility and the effects of antifungal therapy on an LFD developed for invasive pulmonary aspergillosis (IPA) detection. An established neutropenic guinea pig model of IPA caused by Aspergillus fumigatus was used. At predetermined time points (1 h and 3, 5, and 7 days postinoculation), blood and bronchoalveolar lavage (BAL) fluid were collected from infected and uninfected animals. In a separate experiment, guinea pigs were treated with posaconazole (10 mg/kg of body weight orally [p.o.] twice a day [BID]), voriconazole (10 mg/kg p.o. BID), liposomal amphotericin B (10 mg/kg intraperitoneally [i.p.] once a day [QD]), or caspofungin (2 mg/kg i.p. QD), and samples were collected on days 7 and 11. Each laboratory independently evaluated the IgG monoclonal antibody-based LFD. Galactomannan and (1→3)-β-d-glucan were also measured using commercially available kits. Good interlaboratory agreement was observed with the LFD, as the results for 97% (32/33) of the serum and 78.8% (26/33) of the BAL fluid samples from infected animals were in agreement. Good interstudy agreement was also observed. The serum sensitivity of each surrogate-marker assay was reduced in animals treated with antifungals. In contrast, these markers remained elevated within the BAL fluids of treated animals, which was consistent with the fungal burden and histopathology results. These results demonstrate that the LFD assay is reproducible between different laboratories and studies. However, the sensitivity of this assay and other markers of IPA may be reduced with serum in the presence of antifungal therapy. PMID:23175252

  8. 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

  9. Real time three-dimensional transesophageal echocardiography guided coronary sinus cannulation during CARILLON mitral annuloplasty device therapy for a patient with chronic severe mitral regurgitation.

    PubMed

    Mahmoud, Hani M; Al-Ghamdi, Mohammed A; Ghabashi, Abdullah E

    2015-01-01

    The coronary sinus (CS) has become a clinically important structure especially through its role in providing access for different cardiac procedures such as arrhythmia ablation, biventricular pacing and recently, percutaneous valvular interventions. Fluoroscopy with or without two-dimensional transesophageal echocardiography is the widely used method for guidance. A 78-year-old female patient undergoing percutaneous CARILLON mitral annuloplasty device therapy for chronic severe symptomatic mitral regurgitation. After insertion of the CS catheter through the right internal jugular vein, multiple trials for CS cannulation guided by fluoroscopy and two-dimensional transesophageal echocardiography were unsuccessful. So, real time three-dimensional zoom mode was used. Then, the volume was rotated to have the anatomically oriented enface view of the interatrial septum from the right atrial perspective. The CS ostium was identified adjacent to the eustachian valve. Then the catheter was reintroduced through the superior vena cava into the right atrium then easily navigated to cannulate the CS ostium. The position was confirmed by the fluoroscopically known course of the CS plus the pattern of the invasive pressure wave form. CS cannulation is not always feasible using fluoroscopy and/or two-dimensional Echocardiography guidance. Real time three-dimensional transesophageal echocardiography can be used to guide CS cannulation as it provides an anatomically oriented and informative enface view of the CS ostium. It can help reducing fluoroscopic radiation time. PMID:25231878

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. Left ventricular restoration devices.

    PubMed

    Oliveira, Guilherme H; Al-Kindi, Sadeer G; Bezerra, Hiram G; Costa, Marco A

    2014-04-01

    Left ventricular (LV) remodeling results in continuous cardiac chamber enlargement and contractile dysfunction, perpetuating the syndrome of heart failure. With current exhaustion of the neurohormonal medical paradigm, surgical and device-based therapies have been increasingly investigated as a way to restore LV chamber architecture and function. Left ventricular restoration has been attempted with surgical procedures, such as partial left ventriculectomy, surgical ventricular restoration with or without revascularization, and devices, such as the Acorn CorCap, the Paracor HeartNet, and the Myocor Myosplint. Whereas all these techniques require surgical access, with or without cardiopulmonary bypass, a newer ventricular partitioning device (VPD) called Parachute, can be delivered percutaneously through the aortic valve. Designed to achieve LV restoration from within the ventricle, this VPD partitions the LV by isolating aneurysmal from normal myocardium thereby diminishing the functioning cavity. This review aims to critically appraise the above methods, with particular attention to device-based therapies. PMID:24574107

  19. Cardiac Resynchronization Therapy With and Without Defibrillator in a Commercial Truck Driver with Ischemic Cardiomyopathy and New York Heart Association Class III Heart Failure.

    PubMed

    Jentzer, Jacob C; Jentzer, John H

    2012-06-01

    Commercial drivers warrant tighter restrictions to their driving privileges than private drivers. Patients with cardiac disease who are at risk of consciousness-impairing arrhythmias are not allowed to drive commercially. Patients with left ventricular systolic dysfunction and/or heart failure symptoms are permanently disqualified from commercial driving. A biventricular pacemaker without defibrillator can improve symptoms and mortality in selected patients with heart failure. Biventricular pacing may have antiarrhythmic effects that may reduce the added benefit of a defibrillator. Motor vehicle collisions resulting from arrhythmic events are infrequent. The interests of public safety must outweigh individual liberties when driving safety is in question. PMID:26939814

  20. Dilemma with the route of venous access for hemodialysis catheter insertion in a patient with dilated ischemic cardiomyopathy treated by cardiac resynchronization therapy

    PubMed Central

    Ashokananda, Devanahalli; Chakravarthy, Murali; Gowda, Mohan; Maddirala, Pavani; Sripar, Sanjay

    2016-01-01

    A 68 year old patient requiring urgent dialysis due to raising potassium was referred to our center. He had 3 indwelling catheters in his heart via right subclavian vein. His left subclavian and interngal jugular veins were thrombosed possibly due to earlier indwelling catheters. The dilemma was if right internal jugular venous route could be used for insertion of dialysis catheter. Under fluoroscopic guidance, right internal jugular vein was cannulated with the dialysis catheter without problems. This case is being presented to highlight the need for imaging both by ultrasound and radiography during the procedure. PMID:27397439

  1. Effects of resynchronization programs on pregnancy per artificial insemination, progesterone, and pregnancy-associated glycoproteins in plasma of lactating dairy cows.

    PubMed

    Thompson, I M; Cerri, R L A; Kim, I H; Green, J A; Santos, J E P; Thatcher, W W

    2010-09-01

    Objectives were to develop a timed artificial insemination (TAI) resynchronization program to improve pregnancy per AI and to evaluate responses of circulating progesterone and pregnancy-associated glycoproteins in lactating cows. Cows (n=1,578) were presynchronized with 2 injections of PGF2alpha, given 14 d apart starting on d 45+/-3 postpartum, followed by Ovsynch [2 injections of GnRH 7 d before and 56 h after injection of PGF2alpha, TAI 16 h after second injection (d 0)]. The Resynch-treated cows received an intravaginal progesterone insert from d 18 to 25, GnRH on d 25, and pregnancy diagnosis on d 32, and nonpregnant cows received PGF2alpha., GnRH 56 h later, and TAI 16 h later (d 35). The control cows were diagnosed for pregnancy on d 32 and nonpregnant cows received GnRH, PGF2alpha 39 d after TAI, GnRH 56 h later, and TAI 16 h later (d 42). Pregnancy was reconfirmed on d 60 after AI. Ovarian structures were examined in a subset of cows at the time of GnRH and PGF2alpha injections. Blood samples for analyses of progesterone and pregnancy-associated glycoproteins were collected every 2 d from d 18 to 30 in 100 cows, and collection continued weekly to d 60 for pregnant cows (n=43). Preenrollment pregnancies per AI on d 32 did not differ for cows subsequently treated as Resynch (45.8%, n=814) and control (45.9%, n=764), and pregnancy losses on d 60 were 6.7 and 4.0%, respectively. Resynchronized service pregnancy per AI (36%, n=441; 39.5%, n=412) and pregnancy losses (6.3 and 6.7%) did not differ for Resynch and control treatments, respectively. Days open for pregnant cows after 2 TAI were less for the Resynch treatment than for the control treatment (96.2+/-0.82 vs. 99.5+/-0.83 d). Cows in the Resynch treatment had more large follicles at the time of GnRH. The number of corpora lutea did not differ between treatments at the time of PGF2alpha. Plasma progesterone for pregnant cows was greater for Resynch cows than for control cows (18-60 d; 6.6 vs. 5.3 ng

  2. [Antibradycardia therapy : Indication and implementation].

    PubMed

    Zartner, Peter

    2016-06-01

    Pacemaker therapy (PMT) in grown-up congenital heart disease (GUCH) must meet the demands of a young, dynamic and heterogeneous group of patients. The duration of the therapy has to be planned for several decades and should be accompanied by an invasive procedure at the very least. Most of the patients enter adulthood with their pacemaker (PM) already implanted; for others the indications can be derived from the published guidelines for GUCH and PMT, but need to be adjusted to the individual situation of the patient. Depending on the underlying heart disease the decision on the use of either an epimyocardial or a transvenous PM system has to be made. Both electrodes and PM should correspond to the latest technical developments to optimally adapt to the patients' multiple requirements. In the case of PM system revisions abandoned leads should be removed and vascular stenosis or occlusions cleared to be prepared for later revisions. During any cardiac surgery epimyocardial PM systems should be checked against the patient's needs and expanded or revised accordingly. Epimyocardial resynchronization systems in particular offer more opportunities for compensating for cardiac dysfunction with greater reliability using a second ventricular lead. The PMT is an essential part of the medical treatment for many patients with GUCH and contributes significantly to the well-being and quality of life. Against this background, a competent and consequent follow-up regime requires experienced physicians. An integrated telemetric monitoring system for the PM has proven valuable and supports the early recognition of cardiac arrhythmia. PMID:27221084

  3. 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.

  4. 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...

  5. 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

  6. 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

  7. Use of self-expanding covered stent and negative pressure wound therapy to manage late rectal perforation after injury from an improvised explosive device: a case report.

    PubMed

    Ozer, M Tahir; Coskun, Ali K; Sinan, Huseyin; Saydam, Mehmet; Akay, Emin O; Peker, Subutay; Ogunc, Gokhan; Demirbas, Sezai; Peker, Yusuf

    2014-06-01

    Blast injuries, caused by explosions accompanied by high-pressure waves, produce tissue damage in the acute period, followed in the later period by circulatory disorders due to vascular endothelial damage and related tissue necrosis. Blunt rectal perforation is rare and difficult to diagnose. In the acute period following blast pelvic injuries, the main objectives are to stop bleeding, minimise contamination and preserve the patient's life. The patient in this report had major vascular injuries, severe pelvic injury and, in the later period, rectal perforation because of vascular endothelial damage caused by the blast effect. Our aim was to treat the patient conservatively because of his poor general condition. We placed a self-expanding covered stent (SECS) into the rectum and then applied negative pressure wound therapy (NPWT; V.A.C.® Therapy, KCI) to the pelvic region and perirectal area. At the end of the treatment, the rectal perforation was closed, and the patient was discharged with healing. In this article, we discuss the novel use of an SECS with NPWT and review related literature. PMID:24851734

  8. EHRA Expert Consensus Statement on the management of cardiovascular implantable electronic devices in patients nearing end of life or requesting withdrawal of therapy.

    PubMed

    Padeletti, Luigi; Arnar, David O; Boncinelli, Lorenzo; Brachman, Johannes; Camm, John A; Daubert, Jean Claude; Hassam, Sarah K; Kassam, Sarah; Deliens, Luc; Glikson, Michael; Hayes, David; Israel, Carsten; Lampert, Rachel; Lobban, Trudie; Raatikainen, Pekka; Siegal, Gil; Vardas, Panos; Kirchhof, Paulus; Becker, Rüdiger; Cosio, Francisco; Loh, Peter; Cobbe, Stuart; Grace, Andrew; Morgan, John

    2010-10-01

    The purpose of this Consensus Statement is to focus on implantable cardioverter-defibrillator (ICD) deactivation in patients with irreversible or terminal illness. This statement summarizes the opinions of the Task Force members, convened by the European Heart Rhythm Association (EHRA) and the Heart Rhythm Society (HRS), based on ethical and legal principles, as well as their own clinical, scientific, and technical experience. It is directed to all healthcare professionals who treat patients with implanted ICDs, nearing end of life, in order to improve the patient dying process. This statement is not intended to recommend or promote device deactivation. Rather, the ultimate judgement regarding this procedure must be made by the patient (or in special conditions by his/her legal representative) after careful communication about the deactivation's consequences, respecting his/her autonomy and clarifying that he/she has a legal and ethical right to refuse it. Obviously, the physician asked to deactivate the ICD and the industry representative asked to assist can conscientiously object to and refuse to perform device deactivation. PMID:20675674

  9. Endovascular Treatment of Acute Stroke with Major Vessel Occlusion before Approval of Mechanical Thrombectomy Devices in Japan: Japanese Registry of Neuroendovascular Therapy (JR-NET) and JR-NET 2

    PubMed Central

    HAYAKAWA, Mikito; YAMAGAMI, Hiroshi; SAKAI, Nobuyuki; MATSUMARU, Yuji; YOSHIMURA, Shinichi; TOYODA, Kazunori

    2014-01-01

    The aim of this study was to clarify the general status and historical transition of endovascular therapy (EVT) of acute stroke with major vessel occlusion before approval of mechanical thrombectomy devices in Japan from January 2005 to December 2009. We extracted 1,409 acute ischemic stroke patients receiving EVT (513 women, 69.8 ± 11.8 years) from two nationwide registry studies, the Japanese Registry of Neuroendovascular Therapy (JR-NET) and JR-NET 2. The median baseline National Institutes of Health Stroke Scale (NIHSS) score was 18, and 81.3% of the patients received EVT within 6 hours after symptom onset. The culprit occluded arteries were the internal carotid artery (ICA) in 21.2%, middle cerebral artery (MCA) in 53.0%, and basilar artery (BA) in 20.6%. Intravenous thrombolysis was administered to 6.7% of the patients, and EVT mainly consisted of intra-arterial thrombolysis and percutaneous balloon angioplasty/balloon clot disruption. The final recanalization rate was 82.5%, and the clinical outcome was favorable in 35.8% and fatal in 11.6% at 30 days after onset or at discharge. There was no significant change in neurological severity at baseline throughout the study period, but the onset-to-treatment time became longer and the proportion of ICA or BA occlusion increased annually. Although the final recanalization rate was similar throughout the study period, the incidence of a favorable outcome tended to decreased annually from 41.0% to 29.0%. These results could be considered as baseline data that can be used to validate the beneficial effects of novel EVT devices in Japan. PMID:24292608

  10. Transgenic DNA modules with pre-programmed self-destruction: Universal molecular devices to escape 'genetic litter' in gene and cell therapy.

    PubMed

    Tolmachov, Oleg E

    2015-11-01

    Gene delivery to human somatic cells is a well-established therapeutic strategy to treat a variety of diseases. In addition, gene transfer to human cells is required to generate human induced pluripotent cells and also to eliminate tumorigenic undifferentiated cells in many types of stem-cell derived transplantation material. The expression of transgenes in these medical technologies is often required only in some of the recipient cells and only in specific limited time-windows, with inappropriately located or untimely expressed transgenes presenting a risk of undesired collateral effects. Unfortunately, current gene transfer procedures commonly result in a number of cells in the patient's body containing fragments of transferred genetic material which are either not therapeutically necessary at all, are no longer necessary or are necessary but in some other cells. Such transgenic material in the patient, created as a by-product of the chosen therapeutic procedure, constitutes, in fact, 'genetic litter', that is, persisting potentially-hazardous foreign genetic material which is neither required therapeutically nor explicitly chosen by an informed and free-willing person as an artificial body element. Wider use and more frequent administration of gene and cell therapy in the future are likely to give greater prominence to the issue of misdelivered genetic medicines and of their unwanted remainders accumulating in human bodies. Thus, novel DNA templates, which, on the one hand, are capable of providing transgene expression over broad time-windows, and, on the other hand, do not leave unwanted permanent 'genetic traces', are required. I propose that the problem of 'genetic litter' in patients' bodies can be addressed through the employment of a new type of gene vectors delivering DNA-based transgenic modules with pre-programmed self-destruction. Such vectors could deliver therapeutic DNA cargo and then execute self-liquidation through pre-scheduled activation of co

  11. Gender differences in continuous-flow left ventricular assist device therapy as a bridge to transplantation: a risk-adjusted comparison using a propensity score-matching analysis.

    PubMed

    Weymann, Alexander; Patil, Nikhil Prakash; Sabashnikov, Anton; Mohite, Prashant N; García Sáez, Diana; Amrani, Mohamed; Bahrami, Toufan; De Robertis, Fabio; Wahlers, Thorsten; Banner, Nicholas R; Popov, Aron-Frederik; Simon, André R

    2015-03-01

    The purpose of this study was to evaluate gender differences regarding outcome after continuous-flow left ventricular assist device (cfLVAD) implantation. The study was a retrospective review of prospectively collected data. Included were 24 consecutive female cfLVAD recipients and 24 male recipients (62.5% HeartMate II, 37.5% HeartWare) who received their devices between July 2007 and May 2013. Subjects were matched using propensity score analysis based on age, diagnosis, body surface area, preoperative mechanical circulatory support, heart failure severity score (INTERMACS class), and comorbidities. Female patients were significantly sicker before operation. After propensity score matching, there were no statistically significant differences in demographics or clinical baseline characteristics between male and female LVAD recipients. Also, there was a trend towards a longer postoperative intensive care unit stay in the female group (median 9 days [interquartile range 5-17] versus 15 days [interquartile range 8-33]; P < 0.061) and higher postoperative bilirubin values (median 14 mmol/L [interquartile range 10-17] versus 21 mmol/L [interquartile range 13-30]). However, there were no significant differences between the two groups in terms of outcome (P < 0.569). The overall survival was comparable between the two groups (log rank P < 0.389). Half (50%) of female patients required inotropic support for more than 7 days compared with 21.7% in the male group (P < 0.048). Half (50%) of female recipients required short-term postoperative right ventricular assist device implantation compared with 16.7% in the male group (P < 0.014). In conclusion, cfLVAD implantation as a bridge to transplantation is associated with longer duration of inotropic support and higher requirement for postoperative mechanical right ventricular support in women with similar survival rates. Further studies are required to identify additional demographic and clinical

  12. Left Ventricular Assist Device Implantation After Intracardiac Parachute Device Removal.

    PubMed

    Abu Saleh, Walid K; Al Jabbari, Odeaa; Bruckner, Brian A; Suarez, Erik E; Estep, Jerry D; Loebe, Matthias

    2015-08-01

    Left ventricular assist device implantation is a proven and efficient modality for the treatment of end-stage heart failure. Left ventricular assist device versatility as a bridge to heart transplantation or destination therapy has led to improved patient outcomes with a concomitant rise in its overall use. Other less invasive treatment modalities are being developed to improve heart function and morbidity and mortality for the heart failure population. Percutaneous ventricular restoration is a new investigational therapy that deploys an intracardiac parachute to wall off damaged myocardium in patients with dilated left ventricles and ischemic heart failure. Clinical trials are under way to test the efficacy of percutaneous ventricular restoration using the parachute device. This review describes our encounter with the parachute device, its explantation due to refractory heart failure, and surgical replacement with a left ventricular assist device. PMID:26234850

  13. 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.

  14. Photovoltaic device

    SciTech Connect

    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.

  15. Biomedical materials and devices

    SciTech Connect

    Hanker, J. S. ); Giammara, B. L. )

    1989-01-01

    This conference reports on how biomedical materials and devices are undergoing important changes that require interdisciplinary approaches, innovation expertise, and access to sophisticated preparative and analytical equipment and methodologies. The interaction of materials scientists with biomedical, biotechnological, bioengineering and clinical scientists in the last decade has resulted in major advances in therapy. New therapeutic modalities and bioengineering methods and devices for the continuous removal of toxins or pathologic products present in arthritis, atherosclerosis and malignancy are presented. Novel monitoring and controlled drug delivery systems and discussions of materials such as blood or plasma substitutes, artificial organs, and bone graft substitutes are discussed.

  16. Devices in Heart Failure

    PubMed Central

    Munir, Shahzeb M.; Bogaev, Roberta C.; Sobash, Ed; Shankar, K. J.; Gondi, Sreedevi; Stupin, Igor V.; Robertson, Jillian; Brewer, M. Alan; Casscells, S. Ward; Delgado, Reynolds M.; Ahmed, Amany

    2008-01-01

    Congestive heart failure has long been one of the most serious medical conditions in the United States; in fact, in the United States alone, heart failure accounts for 6.5 million days of hospitalization each year. One important goal of heart-failure therapy is to inhibit the progression of congestive heart failure through pharmacologic and device-based therapies. Therefore, there have been efforts to develop device-based therapies aimed at improving cardiac reserve and optimizing pump function to meet metabolic requirements. The course of congestive heart failure is often worsened by other conditions, including new-onset arrhythmias, ischemia and infarction, valvulopathy, decompensation, end-organ damage, and therapeutic refractoriness, that have an impact on outcomes. The onset of such conditions is sometimes heralded by subtle pathophysiologic changes, and the timely identification of these changes may promote the use of preventive measures. Consequently, device-based methods could in the future have an important role in the timely identification of the subtle pathophysiologic changes associated with congestive heart failure. PMID:18612451

  17. Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices

    PubMed Central

    Pron, G; Ieraci, L; Kaulback, K

    2012-01-01

    Executive Summary Objective The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions. Clinical Need: Condition and Target Population Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD. Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities. Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs. Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however

  18. 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.

  19. 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.

  20. 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.

  1. Endoscopic Devices for Obesity.

    PubMed

    Sampath, Kartik; Dinani, Amreen M; Rothstein, Richard I

    2016-06-01

    The obesity epidemic, recognized by the World Health Organization in 1997, refers to the rising incidence of obesity worldwide. Lifestyle modification and pharmacotherapy are often ineffective long-term solutions; bariatric surgery remains the gold standard for long-term obesity weight loss. Despite the reported benefits, it has been estimated that only 1% of obese patients will undergo surgery. Endoscopic treatment for obesity represents a potential cost-effective, accessible, minimally invasive procedure that can function as a bridge or alternative intervention to bariatric surgery. We review the current endoscopic bariatric devices including space occupying devices, endoscopic gastroplasty, aspiration technology, post-bariatric surgery endoscopic revision, and obesity-related NOTES procedures. Given the diverse devices already FDA approved and in development, we discuss the future directions of endoscopic therapies for obesity. PMID:27115879

  2. 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

  3. 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...

  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. 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.

  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. Gripping device

    NASA Technical Reports Server (NTRS)

    Parma, George F. (Inventor)

    1989-01-01

    This invention relates to a gripping device, and more particularly to one with a large moment carrying capability for handling long workpieces of various diameters and which can be particularly used as an end effector on a robotic arm.

  8. Assistive Devices

    MedlinePlus

    ... center provides information on VA benefits for assistive technology. Medicare − Benefits may include assistive devices, such as ... a Web site that provides information about assistive technology products. Go to the “Products” section to find ...

  9. 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.

  10. Solitaire FR device for treatment of dural sinus thrombosis

    PubMed Central

    Pukenas, Bryan Anthony; Kumar, Monisha; Stiefel, Michael; Smith, Michelle; Hurst, Robert

    2012-01-01

    Dural venous sinus thrombosis is a rare and potentially devastating disease. Several predisposing factors exist, including oral contraceptive therapy and colitis. First-line therapy consists of systemic anticoagulation. If first-line therapies fail, more aggressive endovascular therapies may be performed. We report our initial experience with the Solitaire FR device for treatment of refractory symptomatic dural venous sinus thrombosis. PMID:23257943

  11. Robotic Therapy

    PubMed Central

    Krebs, H. I.; Hogan, N.

    2012-01-01

    The last two decades have seen a remarkable shift in the neuro-rehabilitation paradigm. Neuroscientists and clinicians moved away from the perception that the brain is static and hardwired, to a new dynamic understanding that plasticity is a fundamental property of the adult human brain and might be harnessed to remap or create new neural pathways. Capitalizing on this innovative understanding, we introduced a paradigm shift in the clinical practice in 1989 when we initiated the development of the MIT-Manus robot for neuro-rehabilitation and deployed it in the clinic in 1994 10. Since then, we and others have developed and tested a multitude of robotic devices for stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and Parkinson’s disease. Here we discuss whether robotic therapy has achieved a level of maturity to justify its broad adoption in the clinical realm as a tool for motor recovery. PMID:23080044

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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

  2. 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)

  3. Pediatric ventricular assist devices.

    PubMed

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

    2015-12-01

    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

  4. 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

  5. Analytical Device

    NASA Technical Reports Server (NTRS)

    1983-01-01

    In the mid 60s under contract with NASA, Dr. Benjamin W. Grunbaum was responsible for the development of an automated electrophoresis device that would work in the weightless environment of space. The device was never used in space but was revived during the mid 70s as a technology utilization project aimed at an automated system for use on Earth. The advanced system became known as the Grunbaum System for electrophoresis. It is a versatile, economical assembly for rapid separation of specific blood proteins in very small quantities, permitting their subsequent identification and quantification.

  6. Medical Device Safety

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing ...

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Devices for insulin administration.

    PubMed

    Selam, J L; Charles, M A

    1990-09-01

    There is a significant need for revised, safe, and more effective insulin-delivery methods than subcutaneous injections in the treatment of both type I (insulin-dependent) and type II (non-insulin-dependent) diabetes. The aim of this review is to describe the rationale and methods for better use of injection and infusion devices for intensive insulin therapy and to describe results of animal and human research that will lead to an implantable artificial pancreas. Injection devices, e.g., jet injectors, insulin pens, and access ports, cannot be considered as a major breakthrough in the quest for improved control, although they may improve the patient's comfort. External pumps have benefits over multiple injections and conventional insulin therapy only in specific subgroups of patients, e.g., those with recurrent severe hypoglycemia, but only when used by experienced personnel. The external artificial pancreas (Biostator) is also to be used by experienced personnel for limited clinical and research applications, e.g., surgery of the diabetic patient. The development of an implantable version of the artificial pancreas is linked to progress in the field of reliable long-duration glucose sensors. Finally, programmable implantable insulin pumps, used as an open-loop delivery system, are the most promising alternative to intensive subcutaneous insulin strategies in the short term, although clear evidence of improved safety and efficacy remains to be documented. PMID:2226111

  13. Ventricular assist devices in pediatrics

    PubMed Central

    Fuchs, A; Netz, H

    2001-01-01

    The implantation of a mechanical circulatory device for end-stage ventricular failure is a possible therapeutic approach in adult and pediatric cardiac surgery and cardiology. The aim of this article is to present mechanical circulatory assist devices used in infants and children with special emphasis on extracorporeal membrane oxygenation, Berlin Heart assist device, centrifugal pump and Medos assist device. The success of long-term support with implantable ventricular assist devices in adults and children has led to their increasing use as a bridge to transplantation in patients with otherwise non-treatable left ventricular failure, by transforming a terminal phase heart condition into a treatable cardiopathy. Such therapy allows rehabilitation of patients before elective cardiac transplantation (by removing contraindications to transplantation mainly represented by organ impairment) or acting as a bridge to recovery of the native left ventricular function (depending on underlying cardiac disease). Treatment may also involve permanent device implantation when cardiac transplantation is contraindicated. Indications for the implantation of assisted circulation include all states of cardiac failure that are reversible within a variable period of time or that require heart transplantation. This article will address the current status of ventricular assist devices by examining historical aspects of its development, current technical issues and clinical features of pediatric ventricular assist devices, including indications and contraindications for support. PMID:22368605

  14. Year in Review 2014: Aerosol Delivery Devices.

    PubMed

    Myers, Timothy R

    2015-08-01

    After centuries of discoveries and technological growth, aerosol therapy remains a cornerstone of care in the management of both acute and chronic respiratory conditions. Aerosol therapy embraces the concept that medicine is both an art and a science, where an explicit understanding of the science of aerosol therapy, the nuances of the different delivery devices, and the ability to provide accurate and reliable education to patients become increasingly important. The purpose of this article is to review recent literature regarding aerosol delivery devices in a style that readers of Respiratory Care may use as a key topic resource. PMID:26038596

  15. Intrauterine devices.

    PubMed

    Burkman, R T

    1991-08-01

    Approximately 60 million women use the intrauterine device (IUD) worldwide; however, owing primarily to nonmedical reasons, the IUD is far less popular in the United States. Although the contraceptive mechanism of action is unknown, it appears that spermicidal activity may be important. Overall, the efficacy of the copper devices is quite good, such that the overall lifespan can probably be extended. Possible pelvic infection remains the greatest potential risk, although in properly selected women the risk is quite low. Use of prophylactic antibiotics at the time of insertion may offer additional protection against this risk. Although IUD users may have more nonspecific vaginal inflammation than do other women, the clinical significance is probably limited. Further, users do not appear to have elevated risks for cervical infections. Although menometrorrhagia persists as a potential problem, the mechanism for such bleeding is not well understood. Finally, the retroflexed uterine position does not appear to increase the risk of abnormal outcomes. PMID:1878504

  16. 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.

  17. 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.

  18. 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 Section 892.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy...

  19. 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 Section 892.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy...

  20. 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 Section 892.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy...

  1. 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 Section 892.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5840 Radiation therapy...

  2. 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.

  3. 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

  4. OLED devices

    DOEpatents

    Sapochak, Linda Susan [Arlington, VA; Burrows, Paul Edward [Kennewick, WA; Bimalchandra, Asanga [Richland, WA

    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.

  5. 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.

  6. 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.

  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. 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. PMID:23317164

  9. 75 FR 4407 - The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... System for Epilepsy sponsored by Medtronic, Inc. This device is indicated as adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. For this device, a patient's epilepsy should be characterized by partial-onset seizures (affecting only a part of the brain when...

  10. 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.

  11. 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.

  12. 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)

  13. 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.

  14. Medical Devices in the Treatment of Obesity.

    PubMed

    Chang, Julietta; Brethauer, Stacy

    2016-09-01

    Obesity continues to be a growing epidemic worldwide. Although bariatric surgery remains the most effective and durable treatment of obesity and its comorbidities, there is a need for less invasive yet efficacious weight loss therapies. Currently the Food and Drug Administration has approved two endoscopically placed intragastric balloon devices and a surgically placed vagal blockade device. Another device that holds promise, particularly for the treatment of type 2 diabetes, is the endoscopically placed duodenojejunal bypass sleeve. This article reviews the indications and current data regarding results for these devices. PMID:27519137

  15. Are needle-free injections a useful alternative for growth hormone therapy in children? Safety and pharmacokinetics of growth hormone delivered by a new needle-free injection device compared to a fine gauge needle.

    PubMed

    Dörr, H G; Zabransky, S; Keller, E; Otten, B J; Partsch, C J; Nyman, L; Gillespie, B K; Lester, N R; Wilson, A M; Hyrén, Cecilia; van Kuijck, M A; Schuld, P; Schoenfeld, S L

    2003-03-01

    The clinical safety, use and pharmacokinetics of a new needle-free device for delivery of growth hormone (GH) were compared with those of conventional needle injection devices. In an open-label, randomized, 4-period crossover study, 18 healthy adults received single subcutaneous injections of Genotropin administered by the Genotropin ZipTip needle-free device and by conventional injection. Bioequivalence was established between the devices. In a separate open-label, randomized, multicenter, 2-period crossover study, pediatric patients underwent 2-weeks Genotropin treatment administered by the Genotropin ZipTip and by a fine-gauge needle device (>95% used the Genotropin Pen). In total, 128/133 patients who were treated completed the study. Genotropin ZipTip was well tolerated and >50% of patients found no difference between the devices for all parameters assessed. After study completion, >20% patients preferred to continue using Genotropin ZipTip. Although statistical analyses demonstrated superiority of the Genotropin Pen versus Genotropin ZipTip for bleeding, pain, soreness, and bruising, Genotropin ZipTip was considered to provide a safe and bioequivalent alternative to needle injection. PMID:12705363

  16. 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.

  17. [Topical therapy in erectile dysfunction].

    PubMed

    Floth, A

    2000-01-01

    All forms of pharmacological therapy result in a relaxation of the corporeal smooth muscle. Intracorporeal injection of vasoactive drugs was introduced around 15 years ago and still is the most effective therapy in erectile dysfunction. Resulting in a consistent success rate of 70-80% this form of therapy will find numerous applications, even after the introduction of effective oral agents such as sildenafil. Prostaglandin E1 and--less frequently used--the combination of papaverine and phentolamine are the mainstay of intracorporeal injection therapy. Intraurethral prostaglandin (MUSE) has recently become available and is somewhat less effective than injection therapy. Externally applied drugs (nitroglycerin paste on the penile shaft and minoxidil solution on the glans penis) have not succeeded in the long run. Vacuum erection devices represent a form of physical topical therapy that is very versatile and also effective but rather infrequently applied. PMID:10746290

  18. 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.

  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. Radiation therapy

    MedlinePlus

    ... this page: //medlineplus.gov/ency/article/001918.htm Radiation therapy To use the sharing features on this page, please enable JavaScript. Radiation therapy uses high-powered x-rays, particles, or ...

  1. 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 ...

  2. Radiation Therapy

    MedlinePlus

    Radiation therapy is a cancer treatment. It uses high doses of radiation to kill cancer cells and stop them ... places inside your body. The type of radiation therapy you receive depends on many factors, including The ...

  3. Radiation Therapy

    MedlinePlus

    ... people who have radiation therapy may feel more tired than usual, not feel hungry, or lose their ... of radiation therapy include: Fatigue. Fatigue, or feeling tired, is the most common side effect of radiation ...

  4. Feminist Therapy.

    ERIC Educational Resources Information Center

    Laidlaw, Toni; Malmo, Cheryl

    1991-01-01

    Traces roots of feminist therapy and its independence from traditional and prevalent theories and therapy practices. Asserts that Freudian theory and humanistic assumptions are sexist and contribute to powerlessness of women. In contrast, feminist therapy is seen as dealing directly with client-counselor relationships, trust, advocacy, and…

  5. 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.

  6. Incremental Reduction in Risk of Death Associated With Use of Guideline-Recommended Therapies in Patients With Heart Failure: A Nested Case-Control Analysis of IMPROVE HF

    PubMed Central

    Fonarow, Gregg C.; Albert, Nancy M.; Curtis, Anne B.; Gheorghiade, Mihai; Liu, Yang; Mehra, Mandeep R.; O'Connor, Christopher M.; Reynolds, Dwight; Walsh, Mary N.; Yancy, Clyde W.

    2012-01-01

    Background Several therapies are guideline-recommended to reduce mortality in patients with heart failure (HF) and reduced left ventricular ejection fraction, but the incremental clinical effectiveness of these therapies has not been well studied. We aimed to evaluate the individual and incremental benefits of guideline-recommended HF therapies associated with 24-month survival. Methods and Results We performed a nested case-control study of HF patients enrolled in IMPROVE HF. Cases were patients who died within 24 months and controls were patients who survived to 24 months, propensity-matched 1:2 for multiple prognostic variables. Logistic regression was performed, and the attributable mortality risk from incomplete application of each evidence-based therapy among eligible patients was calculated. A total of 1376 cases and 2752 matched controls were identified. β-Blocker and cardiac resynchronization therapy were associated with the greatest 24-month survival benefit (adjusted odds ratio for death 0.42, 95% confidence interval (CI), 0.34–0.52; and 0.44, 95% CI, 0.29–0.67, respectively). Angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, implantable cardioverter-defibrillators, anticoagulation for atrial fibrillation, and HF education were also associated with benefit, whereas aldosterone antagonist use was not. Incremental benefits were observed with each successive therapy, plateauing once any 4 to 5 therapies were provided (adjusted odds ratio 0.31, 95% CI, 0.23–0.42 for 5 or more versus 0/1, P<0.0001). Conclusions Individual, with a single exception, and incremental use of guideline-recommended therapies was associated with survival benefit, with a potential plateau at 4 to 5 therapies. These data provide further rationale to implement guideline-recommended HF therapies in the absence of contraindications to patients with HF and reduced left ventricular ejection fraction. (J Am Heart Assoc. 2012;1:16-26.) PMID:23130115

  7. 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.

  8. 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.

  9. Left Ventricular Assist Devices

    PubMed Central

    2004-01-01

    Executive Summary Objective The objective of this health technology policy assessment was to determine the effectiveness and cost-effectiveness of using implantable ventricular assist devices in the treatment of end-stage heart failure. Heart Failure Heart failure is a complex syndrome that impairs the ability of the heart to maintain adequate blood circulation, resulting in multiorgan abnormalities and, eventually, death. In the period of 1994 to 1997, 38,702 individuals in Ontario had a first hospital admission for heart failure. Despite reported improvement in survival, the five-year mortality rate for heart failure is about 50%. For patients with end-stage heart failure that does not respond to medical therapy, surgical treatment or traditional circulatory assist devices, heart transplantation (in appropriate patients) is the only treatment that provides significant patient benefit. Heart Transplant in Ontario With a shortage in the supply of donor hearts, patients are waiting longer for a heart transplant and may die before a donor heart is available. From 1999 to 2003, 55 to 74 people received a heart transplant in Ontario each year. Another 12 to 21 people died while waiting for a suitable donor heart. Of these, 1 to 5 deaths occurred in people under 18 years old. The rate-limiting factor in heart transplant is the supply of donor hearts. Without an increase in available donor hearts, attempts at prolonging the life of some patients on the transplant wait list could have a harmful effect on other patients that are being pushed down the waiting list (knock on effect). LVAD Technology Ventricular assist devices [VADs] have been developed to provide circulatory assistance to patients with end-stage heart failure. These are small pumps that usually assist the damaged left ventricle [LVADs] and may be situated within the body (intracorporeal] or outside the body [extracorporeal). Some of these devices were designed for use in the right ventricle [RVAD] or both

  10. Infrared criminalistic devices

    NASA Astrophysics Data System (ADS)

    Gibin, Igor S.; Savkov, E. V.; Popov, Pavel G.

    1996-12-01

    We are presenting the devices of near-IR spectral range in this report. The devices may be used in criminalistics, in bank business, in restoration works, etc. the action principle of these devices is describing briefly.

  11. 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 ...

  12. Medical Device Safety

    MedlinePlus

    A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...

  13. Device-related infections: a review.

    PubMed

    Vinh, Donald C; Embil, John M

    2005-01-01

    The use of surgically implanted devices has increased as a result of their beneficial effect on quality of life, and in some circumstances, on patient survival rates. They can, however, be associated with a variety of complications, the most dreaded being infection. Device-related infections are important to understand because of the morbidity and mortality associated with them. Frequently, patients are managed with hospitalization, prolonged courses of antibiotics, and surgical interventions, all of which can negatively impact on patients' quality of life. Such care is also associated with increased costs to health care systems. Furthermore, these infections often represent a diagnostic challenge because of the lack of consensus definition of what constitutes an infection and its severity, as well as the paucity of well-designed, large studies addressing optimal methods of investigation and management. An implant-associated infection is defined as a host immune response to one or more microbial pathogens on an indwelling implant. An understanding of the pathogenesis of these infections provides a rationale for management. Development of device-related infections begins with colonization of the foreign material, followed by a complex metamorphosis by the microorganisms with resultant biofilm formation. In this surface-associated form, bacteria have altered phenotypic properties. This change, in conjunction with the physical protective layer provided by the biofilm, renders antimicrobial therapy ineffective when used alone. Because the microorganisms are able to reside on the hardware, they proliferate and cause local damage, such as loosening of implanted devices, wound dehiscence, or disruption of prosthetic valves, as well as systemic manifestations, such as fever or embolic phenomenon. The onset and clinical manifestations of device-related infections vary with the pathogen involved, as well as which component of the device is affected. The time period after

  14. Biventricular mechanical support devices - clinical perspectives.

    PubMed

    Shehab, Sajad; Newton, Phillip J; Allida, Sabine M; Jansz, Paul C; Hayward, Christopher S

    2016-04-01

    Cardiac transplantation remains the optimal treatment for end stage heart failure in selected patients. However, the shortage of donor hearts, rigorous eligibility criteria and long waiting lists have increased the demand for alternative treatment strategies such as mechanical circulatory support. While many patients are adequately supported with left ventricular assist devices, frequently there is right heart failure or involvement of the right ventricle, requiring biventricular support. Pulsatile flow biventricular devices and total artificial hearts approved for temporary biventricular support have limitations including size, high rates of adverse events and restricted mobility which makes them unsuitable for long term support. A number of centres have reported dual continuous flow left ventricular assist devices as a means of supporting the left and right heart. This review will summarise the literature on the outcomes and complications from current biventricular support devices and assess the role of dual continuous flow VAD therapy, and the new continuous flow total heart replacement devices. PMID:26894825

  15. Treatment of Infected Cardiac Implantable Electronic Devices.

    PubMed

    Fakhro, Abdulla; Jalalabadi, Faryan; Brown, Rodger H; Izaddoost, Shayan A

    2016-05-01

    With their rising benefits, cardiac implantable electronic devices (CIEDs) such as pacemakers and left ventricular assist devices (LVADs) have witnessed a sharp rise in use over the past 50 years. As indications for use broaden, so too does their widespread employment with its attendant rise of CIED infections. Such large numbers of infections have inspired various algorithms mandating treatment. Early diagnosis of inciting organisms is crucial to tailoring appropriate antibiotic and or antifungal treatment. In addition, surgical debridement and explant of the device have been a longstanding modality of care. More novel therapies focus on salvage of the device by way of serial washouts and instilling drug-eluting antibiotic impregnated beads into the wound. The wound is then serially debrided until clean and closed. This technique is better suited to patients whose device cannot be removed, patients who are poor candidates for cardiac surgery, or patients who have failed conventional prior treatments. PMID:27152097

  16. 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.

  17. DEVICE THROMBOGENICITY EMULATION: A NOVEL METHODOLOGY FOR OPTIMIZING THE THROMBORESISTANCE OF CARDIOVASCULAR DEVICES

    PubMed Central

    Bluestein, Danny; Einav, Shmuel; Slepian, Marvin J.

    2012-01-01

    Thrombotic complications with mechanical circulatory support (MCS) devices remain a critical limitation to their long-term use. Device-induced shear forces may enhance the thrombotic potential of MCS devices through chronic activation of platelets, with a known dose–time response of the platelets to the accumulated stress experienced while flowing through the device–mandating complex, lifelong anticoagulation therapy. To enhance the thromboresistance of these devices for facilitating their long-term use, a universal predictive methodology entitled Device Thrombogenicity Emulation (DTE) was developed. DTE is aimed at optimizing the thromboresistance of any MCS device. It is designed to test device-mediated thrombogenicity, coupled with virtual design modifications, in an iterative approach. This disruptive technology 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. The design changes are first tested in the numerical domain, and the resultant device conditions are then emulated in a Hemodynamic Shearing Device (HSD) in which platelet activity is measured under device emulated conditions. As such, DTE can be easily incorporated during the device research and development phase – achieving minimization of the device thrombogenicity before prototypes are built and tested thereby reducing the ultimate cost of preclinical and clinical trials. The robust capability of this predictive technology is demonstrated here in various MCS devices. The presented examples indicate the potential of DTE for reducing device thrombogenicity to a level that may obviate or significantly reduce the extent of anticoagulation currently mandated for patients implanted with MCS devices for safe long-term clinical use. PMID:23219278

  18. 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

  19. 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

  20. Evolution of penile prosthetic devices.

    PubMed

    Le, Brian; Burnett, Arthur L

    2015-03-01

    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

  1. Transmyocardial revascularization devices: technology update

    PubMed Central

    Kindzelski, Bogdan A; Zhou, Yifu; Horvath, Keith A

    2015-01-01

    Transmyocardial laser revascularization (TMR) emerged as treatment modality for patients with diffuse coronary artery disease not amendable to percutaneous or surgical revascularization. The procedure entails the creation of laser channels within ischemic myocardium in an effort to better perfuse these areas. Currently, two laser devices are approved by the US Food and Drug Administration for TMR – holmium:yttrium–aluminum–garnet and CO2. The two devices differ in regard to energy outputs, wavelengths, ability to synchronize with the heart cycle, and laser–tissue interactions. These differences have led to studies showing different efficacies between the two laser devices. Over 50,000 procedures have been performed worldwide using TMR. Improvements in angina stages, quality of life, and perfusion of the myocardium have been demonstrated with TMR. Although several mechanisms for these improvements have been suggested, evidence points to new blood vessel formation, or angiogenesis, within the treated myocardium, as the major contributory factor. TMR has been used as sole therapy and in combination with coronary artery bypass grafting. Clinical studies have demonstrated that TMR is both safe and effective in angina relief long term. The objective of this review is to present the two approved laser devices and evidence for the safety and efficacy of TMR, along with future directions with this technology. PMID:25565905

  2. [Radiation therapy and cardiac pacemakers].

    PubMed

    Serafim, P; Fonseca, G; Oliveira, A; Fernandes, T

    1999-05-01

    The number of patients with cardiac pacemakers submitted annually to radiation therapy is increasing. Radiation therapy causes interference in the normal functioning processes, directly by chemical changes in the structure of the device and also by electromagnetic disturbances generated in the process of treatment. The changes in the technology used in the manufacture of cardiac pacemakers after the 70's, with the introduction of complementary metal-oxide semi-conductors (CMOS) in the circuits, drastically increased the chance of dangerous interference in the normal function of cardiac pacemakers occurring when in contact with an ionizing radiation source. The authors briefly describe the mechanisms underlying the radio-induced damage usually observed. A review of the literature on this issue is made and solutions are pointed out to perform safe radiation therapy and minimize the risk of device malfunction. PMID:10418264

  3. 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…

  4. 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…

  5. 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…

  6. Sex Therapy

    ERIC Educational Resources Information Center

    Hogan, Douglas

    1977-01-01

    Notes that no single theory of psychotherapy dominates the field of sex therapy. On one hand, sex therapy is not subject to the rigid dogmas of many areas of psychotherapy. But on the other hand, many techniques are invented at the whim of clinicians with no basis in theory. (Author/AM)

  7. Gene Therapy

    PubMed Central

    Baum, Bruce J

    2014-01-01

    Applications of gene therapy have been evaluated in virtually every oral tissue, and many of these have proved successful at least in animal models. While gene therapy will not be used routinely in the next decade, practitioners of oral medicine should be aware of the potential of this novel type of treatment that doubtless will benefit many patients with oral diseases. PMID:24372817

  8. 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

  9. Patient Education and Adherence to Aerosol Therapy.

    PubMed

    Ari, Arzu

    2015-06-01

    Nonadherence to prescribed medications results in disease instability and poor clinical control, with increases in hospital admissions, emergency room visits, school/work absenteeism, morbidity, and mortality. Poor patient adherence to therapy can be due to lack of cognition, competence, or contrivance. Patients who have not been trained or fail to understand use of drug and device combinations (cognition) often do not have the ability to use an aerosol device correctly (competence). Many patients have the competence to use the device correctly and know why they should use the device in the way they were taught; however, they still contrive to use it in an ineffective and suboptimal manner that reduces its efficiency and effectiveness. Ensuring effective aerosol therapy and optimizing its role in disease management involve not only delivery of aerosolized medications to the lungs, but also understanding why, when, and how to use the medications, competence to use the device, motivation to adhere to therapy, and not contriving to use the device in a way that will prevent effective drug delivery. This paper explains some of the problems with patient education and adherence to aerosol therapy and suggests strategies to evaluate, monitor, and improve patient adherence effectively in primary care. Factors affecting patient adherence to prescribed medications, effective educational interventions, and strategies to promote patient adherence to aerosol therapy are also discussed. PMID:26070585

  10. [Domiciliary oxygen therapy].

    PubMed

    Abdel Kafi, S

    2010-09-01

    In Belgium, oxygen therapy is becoming more and more accessible. When oxygen is needed for short periods or for special indications as palliative care, an agreement between mutual insurance companies and pharmacists allows the practitioner the home installation of gazeous oxygen cylinder or of oxygen concentrator. When long term oxygen therapy (LTOT) is indicated for patients with respiratory insufficiency, the pneumologist must first ask the INAMI the authorization to install one of the following modalities: oxygen concentrator with or without demand oxygen delivery cylinder and liquid oxygen. The goal of LTOT is to increase survival and quality of life. The principal and well accepted indication for LTOT is severe hypoxemia. The beneficial effects of oxygen therapy limited at night or on exertion are controversial. In order to increase patient's autonomy, oxygen can be prescribed for ambulation, respecting prescription's rules. At each step of oxygen therapy implementing (indication, choice of the device and follow-up) the patient under oxygen may benefit from a joint approach between the general practitioner and the chest specialist. PMID:21089403

  11. Fluid sampling device

    NASA Technical Reports Server (NTRS)

    Studenick, D. K. (Inventor)

    1977-01-01

    An inlet leak is described for sampling gases, more specifically, for selectively sampling multiple fluids. This fluid sampling device includes a support frame. A plurality of fluid inlet devices extend through the support frame and each of the fluid inlet devices include a longitudinal aperture. An opening device that is responsive to a control signal selectively opens the aperture to allow fluid passage. A closing device that is responsive to another control signal selectively closes the aperture for terminating further fluid flow.

  12. 21 CFR 880.5150 - Nonpowered flotation therapy mattress.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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...

  13. 21 CFR 880.5150 - Nonpowered flotation therapy mattress.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

  14. [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). PMID:26683076

  15. 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

  16. 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 Section 892.5710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy...

  17. 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 §...

  18. 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 §...

  19. 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 §...

  20. 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 §...

  1. 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 §...

  2. 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 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron...

  3. 21 CFR 892.5750 - Radionuclide radiation therapy system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radionuclide radiation therapy system. 892.5750 Section 892.5750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5750 Radionuclide radiation...

  4. 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 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron...

  5. 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 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron...

  6. 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 Section 892.5300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5300 Medical neutron...

  7. 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 ...

  8. Radiation Therapy

    MedlinePlus

    Radiation therapy is a cancer treatment. It uses high doses of radiation to kill cancer cells and stop them from ... half of all cancer patients receive it. The radiation may be external, from special machines, or internal, ...

  9. Radiation therapy

    MedlinePlus

    Radiation therapy uses high-powered x-rays, particles, or radioactive seeds to kill cancer cells. ... faster than normal cells in the body. Because radiation is most harmful to quickly growing cells, radiation ...

  10. Electroconvulsive therapy

    MedlinePlus

    Electroconvulsive therapy (ECT) uses an electric current to treat depression and some other mental illnesses. ... During ECT, the electric current triggers a seizure in the brain. Doctors believe that the seizure activity may help the brain "rewire" itself, which ...

  11. Electroconvulsive therapy

    MedlinePlus

    ... please enable JavaScript. Electroconvulsive therapy (ECT) uses an electric current to treat depression and some other mental illnesses. Description During ECT, the electric current triggers a seizure in the brain. Doctors believe ...

  12. Proton Therapy

    MedlinePlus

    ... nucleus is surrounded by electrons. In proton therapy, beams of fast-moving protons are used to destroy ... atoms to release proton, neutron, and helium ion beams. In this highly specialized form of radiosurgery , proton ...

  13. Hug Therapy.

    ERIC Educational Resources Information Center

    Johnson, Sally; Franke, Sue

    1997-01-01

    Describes Hug Therapy as used at the Allegheny County Head Start centers in Pennsylvania. Discusses the value of appropriate touch for healthy physical and emotional development. Addresses barriers to therapeutic touching and benefits to children and parents. (KB)

  14. Oxygen Therapy

    MedlinePlus

    ... therapy works, it helps to understand how your respiratory system works. This system is a group of organs and tissues that help you breathe. The respiratory system includes the airways and lungs. The airways carry ...

  15. Proton Therapy

    MedlinePlus

    ... in a much more confined way than conventional photon therapy thus allowing the radiation oncologist to use ... charge. Just as x-rays (also known as photons) are used to treat both benign and malignant ...

  16. 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. PMID:24976235

  17. 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.

  18. Cotton-based diagnostic devices.

    PubMed

    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

  19. 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)

  20. Medical device error.

    PubMed

    Goodman, Gerald R

    2002-12-01

    This article discusses principal concepts for the analysis, classification, and reporting of problems involving medical device technology. We define a medical device in regulatory terminology and define and discuss concepts and terminology used to distinguish the causes and sources of medical device problems. Database classification systems for medical device failure tracking are presented, as are sources of information on medical device failures. The importance of near-accident reporting is discussed to alert users that reported medical device errors are typically limited to those that have caused an injury or death. This can represent only a fraction of the true number of device problems. This article concludes with a summary of the most frequently reported medical device failures by technology type, clinical application, and clinical setting. PMID:12400632

  1. Endoscopic Bariatric Therapies.

    PubMed

    Goyal, Deepinder; Watson, Rabindra R

    2016-06-01

    Obesity and its associated cardio-metabolic comorbidities have emerged as a global pandemic. The efficacy of various hypo-caloric diets and prescription drugs has been poor with respect to sustained weight loss. Recent advancements in endoscopic technology and techniques have opened a new field of minimally invasive endoscopic treatment options for combatting obesity both as a first line and adjunctive therapy. Presently, two endoscopic space-occupying devices in the form of intragastric balloons have received FDA approval for 6-month implantation in patients within a BMI range of 30-40 kg/m(2). Furthermore, full-thickness suturing has led to the development of primary endoscopic sleeve gastroplasty and Roux-en-Y gastric bypass revision as viable endoscopic alternatives to surgical approaches. These techniques have the potential to reduce adverse events, cost, and recovery times. Looking forward, a variety of promising and novel medical devices and endoscopic platforms that target obesity and diabetes are in various phases of development and investigation. The present review aims to discuss the current and forthcoming endoscopic bariatric therapies with emphasis on relevant procedural technique and review of available evidence. PMID:27098813

  2. Pulse detecting device

    DOEpatents

    Riggan, W.C.

    1984-01-01

    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.

  3. 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

  4. Electrical signature analysis to quantify human and animal performance on fitness and therapy equipment such as a treadmill

    SciTech Connect

    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.

  5. Flexible thermal device

    NASA Technical Reports Server (NTRS)

    Wallace, S. D.; Elliott, D. H.

    1972-01-01

    Fabrication of expansion joint, vibration isolator device with sufficient cross sectional area for high thermal conductivity is discussed. Device consists of multiple layers of metal foil which may be designed to meet specific applications. Thermodynamic properties of the device and illustration of construction are provided.

  6. Amorphous silicon photovoltaic devices

    SciTech Connect

    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.

  7. 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.

  8. 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.

  9. Photovoltaic device and method

    SciTech Connect

    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.

  10. Articulating feedstock delivery device

    DOEpatents

    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.

  11. Photodynamic Therapy

    PubMed Central

    Dougherty, Thomas J.; Gomer, Charles J.; Henderson, Barbara W.; Jori, Giulio; Kessel, David; Korbelik, Mladen; Moan, Johan; Peng, Qian

    2015-01-01

    Photodynamic therapy involves administration of a tumor-localizing photosensitizing agent, which may require metabolic synthesis (i.e., a prodrug), followed by activation of the agent by light of a specific wavelength. This therapy results in a sequence of photochemical and photobiologic processes that cause irreversible photodamage to tumor tissues. Results from preclinical and clinical studies conducted worldwide over a 25-year period have established photodynamic therapy as a useful treatment approach for some cancers. Since 1993, regulatory approval for photodynamic therapy involving use of a partially purified, commercially available hematoporphyrin derivative compound (Photofrin®) in patients with early and advanced stage cancer of the lung, digestive tract, and genitourinary tract has been obtained in Canada, The Netherlands, France, Germany, Japan, and the United States. We have attempted to conduct and present a comprehensive review of this rapidly expanding field. Mechanisms of subcellular and tumor localization of photosensitizing agents, as well as of molecular, cellular, and tumor responses associated with photodynamic therapy, are discussed. Technical issues regarding light dosimetry are also considered. PMID:9637138

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 78 FR 20928 - Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... device benefit-risk information to this population Different considerations regarding effects of hormones through life stages (first menstrual period (menarche) to menopause; hormone replacement therapy)...

  17. [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. PMID:27067659

  18. Biomechanics of interspinous devices.

    PubMed

    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

  19. 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

  20. Solid state devices

    NASA Technical Reports Server (NTRS)

    1991-01-01

    The Solid State Device research program is directed toward developing innovative devices for space remote and in-situ sensing, and for data processing. Innovative devices can result from the standard structures in innovative materials such as low and high temperature superconductors, strained layer superlattices, or diamond films. Innovative devices can also result from innovative structures achieved using electron tunneling or nanolithography in standard materials. A final step is to use both innovative structures and innovative materials. A new area of emphasis is the miniaturization of sensors and instruments molded by using the techniques of electronic device fabrication to micromachine silicon into micromechanical and electromechanical sensors and actuators.

  1. 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.

  2. Thermionic deposition devices (survey)

    SciTech Connect

    Saenko, V.A.

    1985-11-01

    Various devices for the deposition of thin films and coatings from a plasma of solid-phase-material vapor are surveyed. The devices operate by vaporization and ionization of the working material in a vacuum. The classification, parameters, designs and development trends of thermionic devices (plasma vaporizers) are examined. Their characteristics and areas of application in modern high-energy plasma technology are described. The relative simplicity of the design and operation of the devices should allow them to be widely used not only in the laboratory but also in industry. The first manufactured units with thermionic devices and some of the properties of the films they produce are described.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Physical Modalities (Devices) in the Management of Acne.

    PubMed

    Nestor, Mark S; Swenson, Nicole; Macri, Angela

    2016-04-01

    Treatment options for acne vulgaris are enhanced by laser and light therapy. Both visible and laser light are effective treatments for acne. Visible light and many lasers target Propionibacterium acnes porphyrins while others act as anti-inflammatory mediators or reduce sebaceous gland activity. Compared with topical and systemic therapies, laser and light therapies have few if any side effects and appear to be safe during pregnancy. If patients prefer at home light treatments, several devices are currently available and have been shown to have efficacy. Ultimately, combining laser and light with topical therapy may well become the mainstay of acne treatment. PMID:27015782

  8. Heart failure therapy and sudden cardiac death prevention.

    PubMed

    Morgan, J M

    2004-12-01

    Primary prophylaxis of sudden cardiac death by implantable defibrillators is an accepted therapeutic strategy because sudden cardiac death is reduced by their use. However, many patients at risk of sudden cardiac death due to left ventricular systolic dysfunction also suffer heart failure symptoms. There is increasing evidence that the morbidity of heart failure can be alleviated by device therapy in which ventricular dysynchrony is improved by biventricular pacing. Both therapies in the same device can reduce both morbidity and mortality. Device therapy is an important new aspect in the field of heart failure management. PMID:15729212

  9. 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 Quotes ... is Music Therapy? Print Email Share What is Music Therapy What is Music Therapy? Music Therapy is the ...

  10. 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

  11. Aerosol Therapy for Obstructive Lung Diseases

    PubMed Central

    2011-01-01

    Inhaled aerosol therapies are the mainstay of treatment of obstructive lung diseases. Aerosol devices deliver drugs rapidly and directly into the airways, allowing high local drug concentrations while limiting systemic toxicity. While numerous clinical trials, literature reviews, and expert panel guidelines inform the choice of inhalational drugs, deciding which aerosol device (ie, metered-dose inhaler, nebulizer, or dry powder inhaler) best suits a given patient and clinical setting can seem arbitrary and confusing. Similar confusion regarding Current Procedural Terminology (CPT) coding for administration of aerosol therapies can lead to lost revenue from underbilling and wasted administrative effort handling denied claims. This article reviews the aerosol devices currently available, discusses their relative merits in various clinical settings, and summarizes appropriate CPT coding for aerosol therapy. PMID:21896522

  12. [Auricle therapy].

    PubMed

    Masip Sales, Mireia

    2005-05-01

    Auricle therapy is the method which diagnoses and treats the human body via the external ear. The author describes its simple application as its principal characteristics and contrasts these with the efficiency of its results. Furthermore, the author provides a wide range of therapeutic possibilities. PMID:15981969

  13. Proton therapy

    MedlinePlus

    ... skin redness in the radiation area, and temporary hair loss. AFTER THE PROCEDURE Following proton therapy, you should be able to resume your normal activities. You will likely see your doctor every 3 to 4 months for a follow-up exam.

  14. Multimodal Therapy.

    ERIC Educational Resources Information Center

    Lazarus, Arnold A.

    The multimodal therapy (MMT) approach provides a framework that facilitates systematic treatment selection in a broad-based, comprehensive and yet highly focused manner. It respects science, and data driven findings, and endeavors to use empirically supported methods when possible. Nevertheless, it recognizes that many issues still fall into the…

  15. 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)

  16. 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

  17. Surgical considerations for the explantation of the Parachute left ventricular partitioning device and the implantation of the HeartMate II left ventricular assist device.

    PubMed

    Ravi, Yazhini; Bansal, Shelley; Rosas, Paola C; Mazzaferri, Ernest L; Sai-Sudhakar, Chittoor B

    2016-04-01

    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

  18. Bellyboard device reduces small bowel displacement

    SciTech Connect

    Bertelrud, K.; Mehta, M.; Shanahan, T.; Utrie, P.; Gehring, M. )

    1991-03-01

    The ability to cure several pelvic malignancies is hampered by the inability to deliver doses greater than 45 to 50 Gy, beyond which radiation enteritis becomes dose-limiting. The design and fabrication of a device that allows exclusion of small bowel from the pelvis during radiation therapy are described in this study. A prospective dose-volume analysis conducted on 30 patients reveals a 66 percent reduction in the volume of small bowel within the radiation portals.

  19. 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. PMID:27269668

  20. DEVICE CONTROLLER, CAMERA CONTROL

    Energy Science and Technology Software Center (ESTSC)

    1998-07-20

    This is a C++ application that is the server for the cameral control system. Devserv drives serial devices, such as cameras and videoswitchers used in a videoconference, upon request from a client such as the camxfgbfbx ccint program. cc Deverv listens on UPD ports for clients to make network contractions. After a client connects and sends a request to control a device (such as to pan,tilt, or zooma camera or do picture-in-picture with a videoswitcher),more » devserv formats the request into an RS232 message appropriate for the device and sends this message over the serial port to which the device is connected. Devserv then reads the reply from the device from the serial port to which the device is connected. Devserv then reads the reply from the device from the serial port and then formats and sends via multicast a status message. In addition, devserv periodically multicasts status or description messages so that all clients connected to the multicast channel know what devices are supported and their ranges of motion and the current position. The software design employs a class hierarchy such that an abstract base class for devices can be subclassed into classes for various device categories(e.g. sonyevid30, cononvco4, panasonicwjmx50, etc.). which are further subclassed into classes for various device categories. The devices currently supported are the Sony evi-D30, Canon, VCC1, Canon VCC3, and Canon VCC4 cameras and the Panasonic WJ-MX50 videoswitcher. However, developers can extend the class hierarchy to support other devices.« less

  1. DEVICE CONTROLLER, CAMERA CONTROL

    SciTech Connect

    Perry, Marcia

    1998-07-20

    This is a C++ application that is the server for the cameral control system. Devserv drives serial devices, such as cameras and videoswitchers used in a videoconference, upon request from a client such as the camxfgbfbx ccint program. cc Deverv listens on UPD ports for clients to make network contractions. After a client connects and sends a request to control a device (such as to pan,tilt, or zooma camera or do picture-in-picture with a videoswitcher), devserv formats the request into an RS232 message appropriate for the device and sends this message over the serial port to which the device is connected. Devserv then reads the reply from the device from the serial port to which the device is connected. Devserv then reads the reply from the device from the serial port and then formats and sends via multicast a status message. In addition, devserv periodically multicasts status or description messages so that all clients connected to the multicast channel know what devices are supported and their ranges of motion and the current position. The software design employs a class hierarchy such that an abstract base class for devices can be subclassed into classes for various device categories(e.g. sonyevid30, cononvco4, panasonicwjmx50, etc.). which are further subclassed into classes for various device categories. The devices currently supported are the Sony evi-D30, Canon, VCC1, Canon VCC3, and Canon VCC4 cameras and the Panasonic WJ-MX50 videoswitcher. However, developers can extend the class hierarchy to support other devices.

  2. Quality assurance devices for dynamic conformal radiotherapy.

    PubMed

    Wong, Victy Y M

    2004-01-01

    Two quality control devices, light-field device and radiation-field device, have been specially designed to facilitate the clinical implementation of conformal dynamic arc treatment (CDAT) and intensity modulated radiation therapy (IMRT). With the devices, the light field as well as the radiation field, projected from the individual beam at any treatment position (i.e. arbitrary gantry angle) can be evaluated. For application, the device was attached at the front end of the couch and was placed at the isocentre of the linear accelerator treatment system (LINAC). The devices are designed to be rotated parallel to the gantry head so that the light field and the radiation field projected from a direct beam can be assessed. The aim of the study is, with the aid of the devices, to evaluate the geometric precision of the beam placement and the dosimetric accuracy performed in CDAT and IMRT. The devices are placed separately from the LINAC during application and provide an independent check on the quality performance of the LINAC in three dimensions. The condition of gantry sag and any mechanical displacement resulting in field shift can be observed and traced during gantry rotation. Mistakes that occurred during the isocentre calibration can lead to significant displacement in the field projection, which would not be revealed with the conventional quality control setting (i.e. gantry 0(o)), was demonstrated with the aid of the devices here. The influence of gravitational acceleration in MLC leaf positioning error, which would consequently lead to inaccurate dose delivery, was investigated. The results of our study show that the existence of gravitational influence is statistically significant, although the magnitude of the dose inaccuracy has been found to be small. PMID:15753929

  3. Anecdotal therapies.

    PubMed

    Millikan, L E

    1999-01-01

    Traditionally, many advances in medicine have been serendipitous. Are serendipitous and anecdotal synonymous? Many of our materia medica today relate to initial probes and anecdotal reports that matured to full investigation and therapeutic indications. The recent situation regarding Skin Cap is one that highlights the downside of this scenario. Several drugs in the US continue usage largely related to anecdotal indications, and anecdotal extension of legend indications is a standard for American Dermatology. The situation with systemic drugs, such as Trental, zinc preparations, imidazoles for extended indications, lysine and melatonin, all will be discussed. Topical preparations such as skin cap, cantharone, Vioform, all also are included in this category. It is important to place this topic in perspective in regards to geographic variation and therapeutic need. Many diseases lacking specific therapy are important targets for anecdotal therapy, and this will foster continued approaches in this area. The growing standardization of medicine and pharmaceutical regulation, threatens the anecdotal approach, but it provides still an important link to the future for some forms of therapy in diseases that are difficult to treat. Traditionally, the anecdote has been the first step in the therapeutic chain. Withering discovery of the benefits of the common fox glove in dropsy, was followed by many other anecdotes arriving via folk-medicine in the New World. This approach of utilizing folk medicine has now reached new heights, with very active searches by major pharmaceutical companies throughout the third world for remedies that may have potential. Couched with this is the history of anecdotal "snake-oil" remedies, that clearly had no benefit to anyone except the huckster marketing same. The excesses in this area of unproven and false therapies, led to the gradual organization of therapeutic trials and the Food and Drug Administration in the US as we know it today. The

  4. 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

  5. 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.

  6. 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.

  7. Barrier breaching device

    DOEpatents

    Honodel, Charles A.

    1985-01-01

    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.

  8. 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. PMID:27040333

  9. 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.

  10. Active multistable twisting device

    NASA Technical Reports Server (NTRS)

    Schultz, Marc R. (Inventor)

    2008-01-01

    Two similarly shaped, such as rectangular, shells are attached to one another such that they form a resulting thin airfoil-like structure. The resulting device has at least two stable equilibrium shapes. The device can be transformed from one shape to another with a snap-through action. One or more actuators can be used to effect the snap-through; i.e., transform the device from one stable shape to another. Power to the actuators is needed only to transform the device from one shape to another.

  11. Benchmarking emerging logic devices

    NASA Astrophysics Data System (ADS)

    Nikonov, Dmitri

    2014-03-01

    As complementary metal-oxide-semiconductor field-effect transistors (CMOS FET) are being scaled to ever smaller sizes by the semiconductor industry, the demand is growing for emerging logic devices to supplement CMOS in various special functions. Research directions and concepts of such devices are overviewed. They include tunneling, graphene based, spintronic devices etc. The methodology to estimate future performance of emerging (beyond CMOS) devices and simple logic circuits based on them is explained. Results of benchmarking are used to identify more promising concepts and to map pathways for improvement of beyond CMOS computing.

  12. Ion trap device

    DOEpatents

    Ibrahim, Yehia M.; Smith, Richard D.

    2016-01-26

    An ion trap device is disclosed. The device includes a series of electrodes that define an ion flow path. A radio frequency (RF) field is applied to the series of electrodes such that each electrode is phase shifted approximately 180 degrees from an adjacent electrode. A DC voltage is superimposed with the RF field to create a DC gradient to drive ions in the direction of the gradient. A second RF field or DC voltage is applied to selectively trap and release the ions from the device. Further, the device may be gridless and utilized at high pressure.

  13. Pyrotechnic device technology

    SciTech Connect

    Wilcox, P.D.

    1989-01-01

    This talk was given at the 14th International Pyrotechnic Seminar on September 21, 1989, in Jersey, United Kingdom, as one of two plenary lectures. It briefly surveys the current technology of pyrotechnic devices and examines trends for the future. The pyrotechnic'' can have several meanings. In this talk, pyrotechnic devices'' are devices in which porous materials undergo reduction-oxidation reactions and produce useful products. The pyrotechnic materials are generally fuel-oxidizer systems without binders, in contrast to primary or secondary explosives or propellants. The word pyrotechnic'' is often used to include explosive, squib, propellant, or other ordnance type devices, especially in the European community. The major need for pyrotechnic devices has always been military and defense; however, as technology advances, the civilian uses of pyrotechnics will continue to grow. If every automobile had a pyrotechnic device to trigger its air or crash bag, that application alone would mean millions of devices per year. Applications in safety, fire fighting, law enforcement, and other commercial applications are likely to increase due to the increased capability of pyrotechnic devices and the integration of such devices in system designs. 2 refs., 56 figs.

  14. 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.

  15. CT of left ventricular assist devices.

    PubMed

    Carr, Carrie M; Jacob, Jaisy; Park, Soon J; Karon, Barry L; Williamson, Eric E; Araoz, Philip A

    2010-03-01

    Left ventricular assist devices (LVADs) have become an increasingly beneficial option for patients with heart failure, especially in light of the insufficient availability of donor hearts. LVADs have been used effectively in end-stage heart failure as a bridge to heart transplantation, as destination therapy for those ineligible for transplantation, or as a bridge to myocardial recovery. Presently, a wide variety of LVADs are being used therapeutically. Four different LVADs have been used at the authors' institution. The records of 42 patients who underwent implantation of 46 total LVADs during a 17-month period were reviewed; in 23 of these patients, computed tomography of the device was performed. Increased use of LVADs necessitates understanding of the normal positioning of a variety of these devices and recognition of potential complications, which include inflow and outflow cannula complications, postoperative hemorrhage, pericardial tamponade, thrombus formation, aortic valve stenosis, aortic valve insufficiency, right-sided heart failure, and infection. PMID:20228327

  16. 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. PMID:27056646

  17. Particle therapy

    SciTech Connect

    Raju, M.R.

    1993-09-01

    Particle therapy has a long history. The experimentation with particles for their therapeutic application got started soon after they were produced in the laboratory. Physicists played a major role in proposing the potential applications in radiotherapy as well as in the development of particle therapy. A brief review of the current status of particle radiotherapy with some historical perspective is presented and specific contributions made by physicists will be pointed out wherever appropriate. The rationale of using particles in cancer treatment is to reduce the treatment volume to the target volume by using precise dose distributions in three dimensions by using particles such as protons and to improve the differential effects on tumors compared to normal tissues by using high-LET radiations such as neutrons. Pions and heavy ions combine the above two characteristics.

  18. Radiation Therapy (For Parents)

    MedlinePlus

    ... 5 Things to Know About Zika & Pregnancy Radiation Therapy KidsHealth > For Parents > Radiation Therapy Print A A ... many questions and concerns about it. About Radiation Therapy In radiation therapy, high-energy radiation from X- ...

  19. Esophagus Cancer: Palliative Therapy

    MedlinePlus

    ... your doctor about cancer of the esophagus? Palliative therapy for cancer of the esophagus Palliative therapy is ... therapy Electrocoagulation Laser ablation Argon plasma coagulation Radiation therapy External-beam radiation can often help relieve some ...

  20. Mechanical Device Traces Parabolas

    NASA Technical Reports Server (NTRS)

    Soper, Terry A.

    1989-01-01

    Mechanical device simplifies generation of parabolas of various focal lengths. Based on fundamental geometrical construction of parabola. Constancy of critical total distance enforced by maintaining cable in tension. Applications of device include design of paraboloidal antennas, approximating catenaries on drawings of powerlines or long-wire antennas, and general tracing of parabolas on drawings.