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Sample records for resynchronization therapy devices

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

    PubMed

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

    2011-06-01

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

  2. Cardiac resynchronization therapy: a practical guide for device optimization, part I.

    PubMed

    Trupp, Robin J

    2006-01-01

    This is the first part of a two-part series on strategies for optimizing the delivery of cardiac resynchronization therapy (CRT), focusing on device-related aspects. There is overwhelming evidence from prospective randomized controlled trials providing consistent and concordant support for CRT in patients with symptomatic heart failure and ventricular dyssynchrony. CRT has consistently improved quality of life, cardiac structure and function, and survival in the majority of patients enrolled in these trials. No longer a consideration for select individuals with heart failure, the 2005 American College of Cardiology/American Heart Association Guidelines for Managing Adults with Chronic Heart Failure now consider CRT a class IA recommendation for stage C patients (QRS duration > or = 120 milliseconds, left ventricular ejection fraction < or = 35%) who remain symptomatic despite optimal medical therapy. However, not everyone experiences clinical improvement from CRT. This article discusses measures that should be considered to ensure proper functioning of a CRT device. A subsequent article will present strategies to optimize patients' responses to CRT.

  3. 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

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

    PubMed Central

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

    2016-01-01

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

  5. 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

  6. [Biomarkers of inflammation in patients with chronic heart failure and implanted devices for cardiac resynchronization therapy].

    PubMed

    Kuznetsov, V A; Soldatova, A M; Enina, T N; Shebeko, P V; Rychkov, A Iu; Mel'nikov, N N; Zateĭshchikov, D A

    2012-01-01

    The aim of the study was to assess the relationship between N-terminal pro-brain natriuretic peptide (NT-proBNP) and inflammatory markers in patients with congestive heart failure (CHF) treated with cardiac resynchronization therapy (CRT). 97 patients (age 54.9+/-9.9 years; 87% men) with implanted CRT devices (median period after implantation 19.9+/-19.3 months) were enrolled. According to NT-proBNP level patients were divided into tertiles: first (n=36) - less than 848 pg/ml, second (n=29) - from 848 to 2936 pg/ml, and third (n=32) - more than 2936 pg/ml. We didnt find a relationship between inflammatory mediators, NT-probNP level and time after implantation. In the total group NT-proBNP significantly correlated with structural and functional parameters of the heart. In the first group in comparison with the third group levels of IL-6 were lower (pI-III=0.019) and levels of IL-l - higher (pI-III=0.006). IL-10, CRP, TNF- did not differ between groups. In the first group IL-l straightly correlated with IL-6, TNF- , IL-10 and left ventricular ejection fraction (LVEF), in the third group IL-6 straightly correlated with CRP, while correlation of IL-l with LVEF became negative. We suppose that in patients with mild HF IL-l can play an adaptive role. High levels of IL-6, CRP probably can be used as markers of CHF progression in patients treated with CRT. PMID:23098397

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

    PubMed

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

    2010-09-01

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

  8. 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

  9. Imaging techniques in cardiac resynchronization therapy

    PubMed Central

    Sá, Maria Isabel; de Roos, Albert; Westenberg, Jos J. M.

    2007-01-01

    Cardiac resynchronization therapy is a high cost therapeutic option with proven efficacy on improving symptoms of ventricular failure and for reducing both hospitalization and mortality. However, a significant number of patients do not respond to cardiac resynchronization therapy that is due to various reasons. Identification of the optimal pacing site is crucial to obtain the best therapeutic result that necessitates careful patient selection. Currently, using echocardiography for mechanical dyssynchrony assessment performs patient selection. Multi-Detector-Row Computed Tomography (MDCT) and Magnetic Resonance Imaging (MRI) are new imaging techniques that may assist the cardiologist in patient selection. These new imaging techniques have the potential to improve the success rate of cardiac resynchronization therapy, due to pre-interventional evaluation of the venous coronary anatomy, to evaluation of the presence of scar tissue, and to improved evaluation of mechanical dyssynchrony. In conclusion, clinical issues associated with heart failure in potential candidates for cardiac resynchronization therapy, and the information regarding this therapy that can be provided by the imaging techniques echocardiography, MDCT, and MRI, are reviewed. PMID:17503216

  10. Reversible left bundle branch block should be mentioned in cardiac resynchronization therapy; A clinical case report

    PubMed Central

    Vasheghani-Farahani, Ali; Tajdini, Masih; Mohsenizadeh, Seyed Abolfazl; Hosseini, Seyed Mohammad Reza

    2016-01-01

    BACKGROUND Cardiac resynchronization therapy (CRT) is a medical device to help cardiac synchronized contractility by electrical impulses. Improvement of symptoms and left ventricular systolic function, reducing hospital admissions and mortality in patients with moderate to severe heart failure are the main benefits of administration of cardiac resynchronization therapy. CASE REPORT In this article, we describe a case of heart failure and left bundle branch block (LBBB) who was candidate for cardiac resynchronization therapy; but after managing hyperkalemia, left bundle branch block resolved, ejection fraction increased and cardiac resynchronization therapy implantation was canceled. CONCLUSION Exclusion of treatable causes is the first important step before any interventions. Now there is an important question; is cardiac resynchronization therapy effective in patients with heart failure and transient or intermittent left bundle branch block? PMID:27752273

  11. Recent advances in the optimization of cardiac resynchronization therapy.

    PubMed

    Chandraprakasam, Satish; Mentzer, Gina G

    2015-02-01

    Heart failure (HF) continues to grow and affect more than five million people in the USA. One of the leading device therapies in HF is cardiac resynchronization therapy (CRT) which has been studied for over 20 years. Recent advancements in lead placement, lead technology, patient selection, and CRT optimization by electrical maneuvers and imaging modalities have improved outcomes in morbidity, hospitalization reductions and mortalities in those who have responded CRT therapy. This review article is intended to discuss the mechanisms and benefits of CRT, clinical trials, and guidelines for CRT along with a focus on recent updates from the past 3 to 5 years and glimpse into future directions. PMID:25315038

  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. Effect of Smaller Left Ventricular Capture Threshold Safety Margins to Improve Device Longevity in Recipients of Cardiac Resynchronization-Defibrillation Therapy

    PubMed Central

    Steinhaus, Daniel A.; Waks, Jonathan W.; Collins, Robert; Kleckner, Karen; Kramer, Daniel B.; Zimetbaum, Peter J.

    2015-01-01

    Device longevity in cardiac resynchronization therapy (CRT) is affected by the pacing capture threshold (PCT) and programmed pacing amplitude of the left ventricular (LV) pacing lead. The aims of this study were to evaluate the stability of LV pacing thresholds in a nationwide sample of CRT defibrillator recipients and to determine potential longevity improvements associated with a decrease in the LV safety margin while maintaining effective delivery of CRT. CRT defibrillator patients in the Medtronic CareLink database were eligible for inclusion. LV PCT stability was evaluated using ≥2 measurements over a 14-day period. Separately, a random sample of 7,250 patients with programmed right atrial and right ventricular amplitudes ≤2.5 V, LV thresholds ≤ 2.5 V, and LV pacing ≥90% were evaluated to estimate theoretical battery longevity improvement using LV safety margins of 0.5 and 1.5 V. Threshold stability analysis in 43,256 patients demonstrated LV PCT stability of <0.5 V in 77% of patients and <1 V in 95%. Device longevity analysis showed that the use of a 0.5-V safety margin increased average battery longevity by 0.62 years (95% confidence interval 0.61 to 0.63) compared with a safety margin of 1.5 V. Patients with LV PCTs >1 V had the greatest increases in battery life (mean increase 0.86 years, 95% confidence interval 0.85 to 0.87). In conclusion, nearly all CRT defibrillator patients had LV PCT stability <1.0 V. Decreasing the LV safety margin from 1.5 to 0.5 V provided consistent delivery of CRT for most patients and significantly improved battery longevity. PMID:25933732

  14. 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

  15. 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

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

    PubMed

    Zizek, David; Cvijić, Marta; Zupan, Igor

    2013-06-01

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

  17. [Cardiac resynchronization therapy in non-ischemic cardiomyopathy].

    PubMed

    Weretka, S; Rüb, N; Weig, H J; Laszlo, R; Dörnberger, V; Gawaz, M; Schreieck, J

    2008-01-01

    Cardiac resynchronization therapy is recommended in patients with advanced heart failure (usually NYHA class III or IV) despite optimal pharmacologic therapy, severe systolic dysfunction (eg, left ventricular ejection fraction < 35 percent) and intraventricular conduction delay or echocardiographic indices of dyssynchrony and wide QRS complex (eg, QRS > or = 120 ms). Viral infection is the most common cause of myocarditis and has been implicated in the development of non-ischemic cardiomyopathy. We report on a patient who developed progressive congestive heart failure caused by non-ischemic cardiomyopathy after liver transplantation and reactivation of the underlying hepatitis C. Due to an insufficient response to optimized pharmacological therapy, the patient was successfully treated using cardiac resynchronization therapy.

  18. Electrical storm of monomorphic ventricular tachycardia after a cardiac-resynchronization-therapy-defibrillator upgrade.

    PubMed

    Kantharia, Bharat K; Patel, Jigar A; Nagra, Bipinpreet S; Ledley, Gary S

    2006-08-01

    In patients with significant left ventricular dysfunction and congestive heart failure despite optimal medical therapy, implantation of cardiac resynchronization therapy-defibrillation (CRT-D) devices has been shown to improve symptoms and mortality. In this report, we describe a case of a patient with ischaemic cardiomyopathy who developed incessant ventricular tachycardia (VT) after undergoing an upgrade from an implantable cardioverter defibrillator to a CRT-D device. The patient required multiple anti-arrhythmic agents, removal of the coronary sinus lead, and radiofrequency ablation to control VT. Thus, in rare patients, the CRT devices may potentially cause 'proarrhythmia' with serious consequences.

  19. Relationship of electro-mechanical remodeling to survival rates after cardiac resynchronization therapy.

    PubMed

    Kiani, Jawad; Agarwal, Sunil Kumar; Kamireddy, Swapna; Adelstein, Evan; Saba, Samir

    2013-01-01

    Cardiac resynchronization therapy, when added to optimal medical therapy, increases longevity in symptomatic congestive heart failure patients with left ventricular ejection fractions (LVEF)≤0.35 and QRS durations>120 ms. Cardiac resynchronization therapy is also associated with electrical and mechanical reverse remodeling. We examined whether reverse remodeling predicts increased survival rates in non-trial settings. Recipients of cardiac resynchronization therapy and defibrillators (n=112; 78 men; mean age, 69±11 yr) underwent repeat echocardiography and electrocardiography at least 90 days after device implantation. Forty patients had mechanical responses of at least 0.05 improvement in absolute LVEF; 56 had electrical responses (any narrowing of biventricular-paced QRS duration compared with the electrocardiogram immediately after therapy). During a mean follow-up period of 3.1±1.7 years, 55 patients died. The average death rate per 100 person-years was lower among mechanical responders than nonresponders (9.2% vs 23.9%; P=0.009); the unadjusted hazard ratio was 0.39 (95% confidence interval [CI], 0.19-0.79). In a multivariate model adjusted for age, sex, baseline LVEF, and QRS duration, mechanical responders had 60% better survival than nonresponders (hazard ratio=0.40; 95% CI, 0.21-0.79; P=0.008). No difference in survival was observed in electrical response. In our association of absolute change in LVEF over the observed range with death (using restricted cubic splines), we observed a linear relationship with survival. In patients given cardiac resynchronization therapy, mechanical but not electrical remodeling was associated with better survival rates, suggesting that mechanical remodeling underlies this therapy's mechanism of conferring a survival benefit.

  20. Optogenetics for in vivo cardiac pacing and resynchronization therapies.

    PubMed

    Nussinovitch, Udi; Gepstein, Lior

    2015-07-01

    Abnormalities in the specialized cardiac conduction system may result in slow heart rate or mechanical dyssynchrony. Here we apply optogenetics, widely used to modulate neuronal excitability, for cardiac pacing and resynchronization. We used adeno-associated virus (AAV) 9 to express the Channelrhodopsin-2 (ChR2) transgene at one or more ventricular sites in rats. This allowed optogenetic pacing of the hearts at different beating frequencies with blue-light illumination both in vivo and in isolated perfused hearts. Optical mapping confirmed that the source of the new pacemaker activity was the site of ChR2 transgene delivery. Notably, diffuse illumination of hearts where the ChR2 transgene was delivered to several ventricular sites resulted in electrical synchronization and significant shortening of ventricular activation times. These findings highlight the unique potential of optogenetics for cardiac pacing and resynchronization therapies.

  1. A review of multisite pacing to achieve cardiac resynchronization therapy.

    PubMed

    Rinaldi, Christopher Aldo; Burri, Haran; Thibault, Bernard; Curnis, Antonio; Rao, Archana; Gras, Daniel; Sperzel, Johannes; Singh, Jagmeet P; Biffi, Mauro; Bordachar, Pierre; Leclercq, Christophe

    2015-01-01

    Non-response to cardiac resynchronization therapy remains a significant problem in up to 30% of patients. Multisite stimulation has emerged as a way of potentially overcoming non-response. This may be achieved by the use of multiple leads placed within the coronary sinus and its tributaries (dual-vein pacing) or more recently by the use of multipolar (quadripolar) left ventricular pacing leads which can deliver pacing stimuli at multiple sites within the same vein. This review covers the role of multisite pacing including the interaction with the underlying pathophysiology, the current and planned studies, and the potential pitfalls of this technology. PMID:25214507

  2. 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

  3. 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

  4. 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

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

    PubMed

    Abraham, William T

    2013-06-01

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

  6. 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.

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

    PubMed

    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

  8. 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.

  9. "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

  10. 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

  11. Device Therapies: New Indications and Future Directions

    PubMed Central

    Kumar, Prabhat; Schwartz, Jennifer D

    2015-01-01

    Implantable cardioverter-defibrillator (ICDs), cardiac resynchronization (CRT) and combination (CRT-D) therapy have be-come 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. De-vice therapies (ICD, CRT-D), have been shown to reduce all-cause mortality, including sudden cardiac death. Hospitaliza-tions 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

  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. 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.

  14. 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.

  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. Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators

    PubMed Central

    Murgatroyd, Francis D.; Helmling, Erhard; Lemke, Bernd; Eber, Bernd; Mewis, Christian; van der Meer-Hensgens, Judith; Chang, Yanping; Khalameizer, Vladimir; Katz, Amos

    2010-01-01

    Aims The Secura™ ICD and Consulta™ CRT-D are the first defibrillators to have automatic right atrial (RA), right ventricular (RV), and left ventricular (LV) capture management (CM). Complete CM was evaluated in an implantable cardioverter defibrillator (ICD) population. Methods and results Two prospective clinical studies were conducted in 28 centres in Europe and Israel. Automatic CM data were compared with manual threshold measurements, the CM applicability was determined, and adjustments to pacing outputs were analysed. In total, 160 patients [age 64.6 ± 10.4 years, 77% male, 80 ICD and 80 cardiac resynchronization therapy defibrillator (CRT-D)] were included. The differences between automatic and manual measurements were ≤0.25 V in 97% (RA CM) and 96% (RV CM) and were all within the safety margin. Fully automatic CM measurements were available within 1 week prior to the 3-month visit in 90% (RA), 99% (RV), and 97% (LV) of the patients. Results indicated increased output (threshold >2.5 V) due to raised RA threshold in seven (4.4%), high RV threshold in nine (5.6%), and high LV threshold in three patients (3.8%). All high threshold detections and all automatic modulations of pacing output were adjudicated appropriate. Conclusion Complete CM adjusts pacing output appropriately, permitting a reduction in office visits while it may maximize device longevity. The study was registered at ClinicalTrials.gov identifiers: NCT00526227 and NCT00526162. PMID:20231152

  18. 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

  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. 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

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

    PubMed

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

    2015-05-01

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

  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. A Study of Mechanical Optimization Strategy for Cardiac Resynchronization Therapy Based on an Electromechanical Model

    PubMed Central

    Dou, Jianhong; Xia, Ling; Deng, Dongdong; Zang, Yunliang; Shou, Guofa; Bustos, Cesar; Tu, Weifeng; Liu, Feng; Crozier, Stuart

    2012-01-01

    An optimal electrode position and interventricular (VV) delay in cardiac resynchronization therapy (CRT) improves its success. However, the precise quantification of cardiac dyssynchrony and magnitude of resynchronization achieved by biventricular (BiV) pacing therapy with mechanical optimization strategies based on computational models remain scant. The maximum circumferential uniformity ratio estimate (CURE) was used here as mechanical optimization index, which was automatically computed for 6 different electrode positions based on a three-dimensional electromechanical canine model of heart failure (HF) caused by complete left bundle branch block (CLBBB). VV delay timing was adjusted accordingly. The heart excitation propagation was simulated with a monodomain model. The quantification of mechanical intra- and interventricular asynchrony was then investigated with eight-node isoparametric element method. The results showed that (i) the optimal pacing location from maximal CURE of 0.8516 was found at the left ventricle (LV) lateral wall near the equator site with a VV delay of 60 ms, in accordance with current clinical studies, (ii) compared with electrical optimization strategy of ERMS, the LV synchronous contraction and the hemodynamics improved more with mechanical optimization strategy. Therefore, measures of mechanical dyssynchrony improve the sensitivity and specificity of predicting responders more. The model was subject to validation in future clinical studies. PMID:23118802

  5. Multi-modal data fusion for Cardiac Resynchronization Therapy planning and assistance.

    PubMed

    Bruge, Sophie; Simon, Antoine; Lederlin, Mathieu; Betancur, Julian; Hernandez, Alfredo; Donal, Erwan; Leclercq, Christophe; Garreau, Mireille

    2015-08-01

    Cardiac Resynchronization Therapy (CRT) has been validated as an efficient treatment for selected patients suffering from heart failure with cardiac dyssynchrony. In case of bi-ventricular stimulation, the response to the therapy may be improved by an optimal choice of the left ventricle (LV) pacing sites. The characterization of LV properties to select the best candidate sites and to precise their access modes would be useful for the clinician in pre- and per-operative stages. For that purpose, we propose a new pre-operative analysis solution integrating previously developed multi-modal data registration methods and a new segmentation process of their coronary venous access. Moreover, a novel visualization interface is proposed to help the clinician to visualize the most relevant pacing sites and their access during the implantation in the operating room. This work is illustrated on real CRT data patients. PMID:26736775

  6. 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

  7. Role of cardiac dyssynchrony and resynchronization therapy in functional mitral regurgitation.

    PubMed

    Spartera, Marco; Galderisi, Maurizio; Mele, Donato; Cameli, Matteo; D'Andrea, Antonello; Rossi, Andrea; Mondillo, Sergio; Novo, Giuseppina; Esposito, Roberta; D'Ascenzi, Flavio; Montisci, Roberta; Gallina, Sabina; Margonato, Alberto; Agricola, Eustachio

    2016-05-01

    Functional mitral regurgitation (FMR) is a common complication of left ventricle (LV) dysfunction and remodelling. Recently, it has been recognized as an independent prognostic factor in both ischaemic and non-ischaemic LV dysfunctions. In this review article, we discuss the mechanisms through which cardiac dyssynchrony is involved in FMR pathophysiologic cascade and how cardiac resynchronization therapy (CRT) can have therapeutic effects on FMR by reverting specific dyssynchrony pathways. We analyse recent clinical trials focusing on CRT impact on FMR in 'real-world' patients, the limits and future perspectives that could eventually generate new predictors of CRT response in terms of FMR reduction. Finally, we propose a practical diagnostic and therapeutic strategy for the management of symptomatic patients with severe LV dysfunction and concomitant 'prognostic' FMR.

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

    NASA Astrophysics Data System (ADS)

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

    2013-11-01

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

  9. 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

  10. Transvenous cardiac resynchronization therapy in complex congenital heart diseases: dextrocardia with transposition of the great arteries after Mustard operation.

    PubMed

    Zartner, Peter A; Wiebe, Walter; Volkmer, Marius; Thomas, Daniel; Schneider, Martin

    2009-04-01

    Cardiac resynchronization therapy revealed first promising results in patients with a congenital heart disease and a systemic right ventricle. Contrast-enhanced magnetic resonance imaging showed accessibility of the coronary sinus in an 18-year-old male patient with mirror dextrocardia, d-transposition of the great arteries and ventricular septal defect (VSD) after Mustard operation and VSD patch closure. In literatures, transvenous lead placement is discussed in this anatomical setting, with opposed position of the ventricular leads and reliable lead characteristics.

  11. Analysis of endocardial acceleration during intraoperative optimization of cardiac resynchronization therapy

    PubMed Central

    Hernandez, Alfredo I.; Ziglio, Filippo; Amblard, Amel; Senhadji, Lotfi; Leclercq, Christophe

    2013-01-01

    Cardiac resynchronization therapy (CRT) is the therapy of choice for selected patients suffering from drug-refractory congestive heart failure and presenting an interventricular desynchronization. CRT is delivered by an implantable biventricular pacemaker, which stimulates the right atrium and both ventricles at specific timings. The optimization and personalization of this therapy requires to quantify both the electrical and the mechanical cardiac functions during the intraoperative and postoperative phases. The objective of this paper is to evaluate the feasibility of the calculation of features extracted from endocardial acceleration (EA) signals and the potential utility of these features for the intraoperative optimization of CRT. Endocardial intraoperative data from one patient are analyzed for 33 different pacing configurations, including changes in the atrio-ventricular and inter-ventricular delays and different ventricular stimulation sites. The main EA features are extracted for each pacing configuration and analyzed so as to estimate the intra-configuration and inter-configuration variability. Results show the feasibility of the proposed approach and suggest the potential utility of EA for intraoperative monitoring of the cardiac function and defining optimal, adaptive pacing configurations. PMID:24111356

  12. 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

  13. 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

  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. A case of premature ventricular contractions, ventricular tachycardia, and arrhythmic storm induced by right ventricular pacing during cardiac resynchronization therapy: Electrophysiological mechanism and catheter ablation

    PubMed Central

    Pedretti, Stefano; Vargiu, Sara; Paolucci, Marco; Lunati, Maurizio

    2015-01-01

    A 77-year-old man with ischemic cardiomyopathy and a cardiac resynchronization therapy-defibrillator (CRT-D) device came to our attention due to incessant ventricular tachycardia and multiple implantable cardioverter defibrillator (ICD) shocks. An electrocardiogram showed non-sustained monomorphic ventricular tachycardias (NSVTs) constantly occurring after each biventricular stimulation. During an electrophysiological study, NSVTs reproducibly recurred only after right ventricular (RV) pacing; LV pacing did not induce any NSVTs. The activation map was consistent with a localized reentry at the interventricular septum, and a double exit; at the LV exit site, a single radiofrequency energy application immediately interrupted the occurrence of the NSVTs. Current evidence supports LV pacing to be pro-arrhythmogenic in few CRT patients. This unusual case shows that RV pacing during CRT could produce frequent ventricular arrhythmias and arrhythmic storm. Catheter ablation can be considered an effective therapeutic option, especially when CRT maintenance is highly advisable. PMID:26702324

  17. Cardiac Resynchronization Therapy Induces Adaptive Metabolic Transitions in the Metabolomic Profile of Heart Failure

    PubMed Central

    Nemutlu, Emirhan; Zhang, Song; Xu, Yi-Zhou; Terzic, Andre; Zhong, Li; Dzeja, Petras D.; Cha, Yong-Mei

    2015-01-01

    Background Heart failure (HF) is associated with ventricular dyssynchrony and energetic inefficiency, which can be alleviated by cardiac resynchronization therapy (CRT). The aim of this study was to determine the metabolomic signature in HF and its prognostic value for the response to CRT. Methods This prospective study consisted of 24 patients undergoing CRT for advanced HF and 10 control patients who underwent catheter ablation for supraventricular arrhythmia but not CRT. Blood samples were collected before and 3 months after CRT. Metabolomic profiling of plasma samples was performed using gas chromatography–mass spectrometry and nuclear magnetic resonance. Results The plasma metabolomic profile was altered in the HF patients, with a distinct panel of metabolites, including Krebs cycle and lipid, amino acid, and nucleotide metabolism. CRT improved the metabolic profile. The succinate/glutamate ratio, an index of Krebs cycle activity, improved from 0.58±0.13 to 2.84±0.60 (P<.05). The glucose/palmitate ratio, an indicator of the balance between glycolytic and fatty acid metabolism, increased from 0.96±0.05 to 1.54±0.09 (P<.01). Compared with the nonresponders to CRT, the responders had a distinct baseline plasma metabolomic profile, including higher isoleucine, phenylalanine, leucine, glucose, and valine levels and lower glutamate levels at baseline (P<.05). Conclusion CRT improves plasma metabolomic profile of HF patients indicating harmonization of myocardial energy substrate metabolism. CRT responders may have a favorable metabolic profile as a potential biomarker for predicting CRT outcome. PMID:25911126

  18. Serum phosphate levels reflect responses to cardiac resynchronization therapy in chronic heart failure patients

    PubMed Central

    Kamiyama, Yoshiyuki; Suzuki, Hitoshi; Yamada, Shinya; Kaneshiro, Takashi; Takeishi, Yasuchika

    2014-01-01

    Background Recent studies have shown that high levels of serum phosphate are associated with adverse cardiovascular events. However, little is known about the relation between phosphate levels and improvement of cardiac function in chronic heart failure (CHF) patients who underwent cardiac resynchronization therapy (CRT). The purpose of this study was to examine whether serum phosphate levels were able to predict responders to CRT and adverse cardiac events. Methods The study population consisted of 30 CHF patients (24 males, mean age 65.7±8.5 years) who received CRT with defibrillator (CRT-D) implantation. Levels of serum phosphate were measured before, and 6 months after, CRT-D implantation. Left ventricular end-diastolic volume and end-systolic volume were assessed simultaneously by echocardiography. In addition, the rate of re-hospitalization due to worsening of heart failure was investigated. All patients were divided into 2 groups: responders (Group-R, n=18) and non-responders (Group-NR, n=12) to CRT-D. Responders were defined as patients who showed >15% reduction in left ventricular end-systolic volume. We compared these parameters between the 2 groups. Results Serum phosphate levels were significantly lower in Group-R than in Group-NR (3.3±0.2 vs. 3.7±0.4 mg/dL, p=0.01). The rate of re-hospitalization was lower in Group-R than in Group-NR (0% vs. 33%, p=0.018). Multivariate analysis showed that serum phosphate levels had a predictive power to determine responders to CRT (odds ratio 0.008, 95% confidence interval 0.000–0.348, p=0.015). Conclusions These results suggest that serum phosphate levels might predict both responders to CRT, and adverse cardiac events, in CHF patients with CRT-D. PMID:26336522

  19. Volumetric Response beyond Six Months of Cardiac Resynchronization Therapy and Clinical Outcome

    PubMed Central

    van ’t Sant, Jetske; Fiolet, Aernoud T. L.; ter Horst, Iris A. H.; Cramer, Maarten J.; Mastenbroek, Mirjam H.; van Everdingen, Wouter M.; Mast, Thomas P.; Doevendans, Pieter A.

    2015-01-01

    Aims Response to cardiac resynchronization therapy (CRT) is often assessed six months after implantation. Our objective was to assess the number of patients changing from responder to non-responder between six and 14 months, so-called late non-responders, and compare them to patients who were responder both at six and 14 months, so-called stable responders. Furthermore, we assessed predictive values of six and 14-month response concerning clinical outcome. Methods 105 patients eligible for CRT were enrolled. Clinical, laboratory, ECG, and echocardiographic parameters and patient-reported health status (Kansas City Cardiomyopathy Questionnaire [KCCQ]) were assessed before, and six and 14 months after implantation. Response was defined as ≥15% LVESV decrease as compared to baseline. Major adverse cardiac events (MACE) were registered until 24 months after implantation. Predictive values of six and 14-month response for MACE were examined. Results In total, 75 (71%) patients were six-month responders of which 12 (16%) patients became late non-responder. At baseline, late non-responders more often had ischemic cardiomyopathy and atrial fibrillation, higher BNP and less dyssynchrony compared to stable responders. At six months, late non-responders showed significantly less LVESV decrease, and higher creatinine levels. Mean KCCQ scores of late non-responders were lower than those of stable responders at every time point, with the difference being significant at 14 months. The 14 months response was a better predictor of MACE than six months response. Conclusions The assessment of treatment outcomes after six months of CRT could be premature and response rates beyond might better correlate to long-term clinical outcome. PMID:25933068

  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. 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

  2. LV Dyssynchrony Is Helpful in Predicting Ventricular Arrhythmia in Ischemic Cardiomyopathy After Cardiac Resynchronization Therapy: A Preliminary Study.

    PubMed

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

    2016-02-01

    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

  3. Detection of atrial high-rate events by continuous Home Monitoring: clinical significance in the heart failure–cardiac resynchronization therapy population

    PubMed Central

    Shanmugam, Nesan; Boerdlein, Annegret; Proff, Jochen; Ong, Peter; Valencia, Oswaldo; Maier, Sebastian K.G.; Bauer, Wolfgang R.; Paul, Vince; Sack, Stefan

    2012-01-01

    Aims Uncertainty exists over the importance of device-detected short-duration atrial arrhythmias. Continuous atrial diagnostics, through home monitoring (HM) technology (BIOTRONIK, Berlin, Germany), provides a unique opportunity to assess frequency and quantity of atrial fibrillation (AF) episodes defined as atrial high-rate events (AHRE). Methods and results Prospective data from 560 heart failure (HF) patients (age 67 ± 10 years, median ejection fraction 27%) patients with a cardiac resynchronization therapy (CRT) device capable of HM from two multi-centre studies were analysed. Atrial high-rate events burden was defined as the duration of mode switch in a 24-h period with atrial rates of >180 beats for at least 1% or total of 14 min per day. The primary endpoint was incidence of a thromboembolic (TE) event. Secondary endpoints were cardiovascular death, hospitalization because of AF, or worsening HF. Over a median 370-day follow-up AHRE occurred in 40% of patients with 11 (2%) patients developing TE complications and mortality rate of 4.3% (24 deaths, 16 with cardiovascular aetiology). Compared with patients without detected AHRE, patients with detected AHRE>3.8 h over a day were nine times more likely to develop TE complications (P= 0.006). The majority of patients (73%) did not show a temporal association with the detected atrial episode and their adverse event, with a mean interval of 46.7 ± 71.9 days (range 0–194) before the TE complication. Conclusion In a high-risk cohort of HF patients, device-detected atrial arrhythmias are associated with an increased incidence of TE events. A cut-off point of 3.8 h over 24 h was associated with significant increase in the event rate. Routine assessment of AHRE should be considered with other data when assessing stroke risk and considering anti-coagulation initiation and should also prompt the optimization of cardioprotective HF therapy in CRT patients. PMID:21933802

  4. 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

  5. Cardiac resynchronization therapy for chronic heart failure: why does it not always work?

    PubMed

    Conti, C Richard

    2006-08-01

    Since coronary angiography and ventriculography are performed in all of these patients with LV dysfunction and symptoms of heart failure, it seems silly to waste the opportunity to study this technique and its value in identifying patients who will respond to CRT, at least in the immediate post-CRT state. The critical factors that may result in a successful long-term positive result of CRT in patients with optimal device programming and optimized medical therapy for heart failure are these: (1) Venous anatomy suitable for electrical stimulation of the LV free wall. (2) Viable myocardium in the septum and the LV free wall. (3) Adequate perfusion of the microcirculation in the distribution where the leads are being placed. PMID:16933572

  6. [Venous thrombosis as a barrier in cardiac resynchronization therapy--case report].

    PubMed

    Murzyn, Joanna; Nessler, Katarzyna; Nessler, Michał; Lelakowski, Jacek

    2009-01-01

    According to results of several international clinical trials, Cardiac Resynchronisation Therapy (CRT) among patients with moderately or severely damaged heart's pumping capacity improves quality of life along with reduction of combined morbidity and hospitalisation measures. The procedure involves placing leads in both ventricles and as all complicated heart catheter procedures can be disturbed in many ways. In order to present possible difficulties occurring during the procedure, we investigate one case of ineffective CRT device implantation. We report a patient with permanent ventricular pacing treated in the Department of Electrocardiology, John Paul II Hospital in Krakow, who was admitted with signs of circulatory decompensation and consequently qualified for CRT. Although the patient was remaining in permanently controlled coumarine therapy, the massive thrombosis made the CRT impossible. In this rare condition following procedures are under consideration: implanting the electrode from the left side and connecting it to the right side located pacemaker (unless there is no thrombosis on this side), microthoracotomy with Hunter electrode epicardial placement to restore the proper heart stimulation. This case report highlights the importance of considering potential difficulties occurring during various electrocardiological procedures in patients with impaired pacemaker function. PMID:20043586

  7. The effectiveness of cardiac resynchronization therapy for patients with New York Heart Association class IV non-ambulatory heart failure

    PubMed Central

    Yamashita, Soichiro; Fukuzawa, Koji; Yoshida, Akihiro; Itoh, Mitsuaki; Imamura, Kimitake; Fujiwara, Ryudo; Suzuki, Atsushi; Nakanishi, Tomoyuki; Matsumoto, Akinori; Kanda, Gaku; Kiuchi, Kunihiko; Shimane, Akira; Okajima, Katsunori; Tanaka, Hidekazu; Hirata, Ken-ichi

    2015-01-01

    Background We reviewed the effectiveness and safety of cardiac resynchronization therapy (CRT) for patients with New York Heart Association (NYHA) class IV non-ambulatory heart failure (NAHF). Methods From 2006 to 2011, 310 patients underwent CRT at Kobe University Hospital and Himeji Cardiovascular Center because of heart failure. Of these, 29 NAHF patients were retrospectively analyzed. The control group comprised 21 age- and ejection fraction-matched patients with NAHF who did not undergo CRT from the ICU database of Kobe University Hospital. The primary endpoint was all-cause death and hospitalization for heart failure. Response was defined as a >15% reduction in left ventricular end-systolic volume (LVESV). Results CRT was performed successfully without serious complications in all patients. Twenty-three patients (79%) were discharged 19±15 days after CRT implantation, while 6 (21%) died during their hospital stay due to progressive heart failure. Compared with the control group, patients in the CRT group showed significant improvements in the primary endpoint (log-rank p=0.04). Six patients (21%) were defined as responders and the Kaplan–Meier curve showed that responders experienced a better outcome than non-responders (log-rank p=0.029). LV dyssynchrony before implantation was significantly related to the occurrence of the primary endpoint (p=0.02). Conclusions CRT can be safely used in patients with NAHF and can improve long-term patient outcomes, especially in treatment responders. PMID:26336563

  8. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring

    PubMed Central

    Da Costa, Antoine; Ricci, Renato Pietro; Quesada, Aurelio; Favale, Stefano; Iacopino, Saverio; Romeo, Francesco; Risi, Arnaldo; Mangoni di S Stefano, Lorenza; Navarro, Xavier; Biffi, Mauro; Santini, Massimo; Burri, Haran

    2013-01-01

    Background Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. Objective The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. Methods In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. Results The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25th-75th percentile, 1-4) days vs 29 (25th-75th percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). Conclusions RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. Trial Registration Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF). PMID:23965236

  9. 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.

  10. 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

  11. Remodeling of the sarcomeric cytoskeleton in cardiac ventricular myocytes during heart failure and after cardiac resynchronization therapy.

    PubMed

    Lichter, Justin G; Carruth, Eric; Mitchell, Chelsea; Barth, Andreas S; Aiba, Takeshi; Kass, David A; Tomaselli, Gordon F; Bridge, John H; Sachse, Frank B

    2014-07-01

    Sarcomeres are the basic contractile units of cardiac myocytes. Recent studies demonstrated remodeling of sarcomeric proteins in several diseases, including genetic defects and heart failure. Here we investigated remodeling of sarcomeric α-actinin in two models of heart failure, synchronous (SHF) and dyssynchronous heart failure (DHF), as well as a model of cardiac resynchronization therapy (CRT). We applied three-dimensional confocal microscopy and quantitative methods of image analysis to study isolated cells from our animal models. 3D Fourier analysis revealed a decrease of the spatial regularity of the α-actinin distribution in both SHF and DHF versus control cells. The spatial regularity of α-actinin in DHF cells was reduced when compared with SHF cells. The spatial regularity of α-actinin was partially restored after CRT. We found longitudinal depositions of α-actinin in SHF, DHF and CRT cells. These depositions spanned adjacent Z-disks and exhibited a lower density of α-actinin than in the Z-disk. Differences in the occurrence of depositions between the SHF, CRT and DHF models versus control were significant. Also, CRT cells exhibited a higher occurrence of depositions versus SHF, but not DHF cells. Other sarcomeric proteins did not accumulate in the depositions to the same extent as α-actinin. We did not find differences in the expression of α-actinin protein and its encoding gene in our animal models. In summary, our studies indicate that HF is associated with two different types of remodeling of α-actinin and only one of those was reversed after CRT. We suggest that these results can guide us to an understanding of remodeling of structures and function associated with sarcomeres.

  12. 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

  13. What is the Lowest Value of Left Ventricular Baseline Ejection Fraction that Predicts Response to Cardiac Resynchronization Therapy?

    PubMed Central

    Agir, Aysen Agacdiken; Celikyurt, Umut; Sahin, Tayfun; Yilmaz, Irem; Karauzum, Kurtulus; Bozyel, Serdar; Ural, Dilek; Vural, Ahmet

    2014-01-01

    Background Cardiac resynchronization therapy (CRT) is an effective treatment option for patients with refractory heart failure. However, many patients do not respond to therapy. Although it has been thought that there was no relation between response to CRT and baseline ejection fraction (EF), the response rate of patients with different baseline LVEF to CRT has not been evaluated in severe left ventricular systolic dysfunction. We aimed to investigate any difference in response to CRT between the severe heart failure patients with different baseline LVEF. Material/Methods In this study, 141 consecutive patients (mean age 59±13 years; 89 men) with severe heart failure and complete LBBB were included. Patients were divided into 3 groups according to their baseline LVEF: 5–15%, Group 1; 15–25%, Group 2, and 25–35%, Group 3. NYHA functional class, LVEF, LV volumes, and diameters were assessed at baseline and after 6 months of CRT. A response to CRT was defined as a decrease in LVSVi (left ventricular end-systolic volume index) ≥10% on echocardiography at 6 months. Results After 6 months, a significant increase of EF and a significant decrease of LVESVi and LVEDVi after 6 months of CRT were observed in all groups. Although the magnitude of improvement in EF was biggest in the first group, the percentage of decrease in LVESVi and LVEDVi was similar between the groups. The improvement in NYHA functional class was similar in all EF subgroups. At 6-month follow-up, 100 (71%) patients showed a reduction of >10% in LVESVi (mean reduction: −15.5±26.1 ml/m2) and were therefore classified as responders to CRT. Response rate to CRT was similar in all groups. It was 67%, 75%, and 70% in Group 1, 2, and 3, respectively, at 6-month follow-up (p>0.05). There was no statistically significant relation between the response rate to CRT and baseline LVEF, showing that the CRT has beneficial effects even in patients with very low LVEF. Conclusions It seems there is no lower

  14. MSCT labelling for pre-operative planning in cardiac resynchronization therapy

    PubMed Central

    Rioual, Kristell; Unanua, Edurne; Laguitton, Soizic; Garreau, Mireille; Boulmier, Dominique; Haigron, Pascal; Leclercq, Christophe; Coatrieux, Jean-Louis

    2005-01-01

    The objective of this paper is twofold: (i) to show how Multislice Computed Tomography (MSCT) data sets bring the information required for Cardiac Resynchronisation Therapy (CRT) planning; (ii) to demonstrate the feasibility of 3-D navigation into the veins where Left Ventricular leads have to be placed. The former has been achieved by exploring and labelling the cardiac structures of concern, the latter has been performed by using the concept of virtual navigation with high resolution surface detection and estimation algorithms. PMID:16005608

  15. Magnetic Resonance Imaging Analysis of Dyssynchrony and Myocardial Scar Predicts Function Class Improvement following Cardiac Resynchronization Therapy

    PubMed Central

    Bilchick, Kenneth C.; Dimaano, Veronica; Wu, Katherine C.; Helm, Robert H.; Weiss, Robert G.; Lima, Joao A.; Berger, Ronald D.; Tomaselli, Gordon F.; Bluemke, David A.; Halperin, Henry R.; Abraham, Theodore; Kass, David A.; Lardo, Albert C.

    2009-01-01

    STRUCTURED ABSTRACT Objective We tested a circumferential mechanical dyssynchrony index (circumferential uniformity ratio estimate, or CURE; 0–1, 1=synchrony) derived from magnetic resonance myocardial tagging (MR-MT) for predicting clinical function class improvement following cardiac resynchronization therapy (CRT). Background There remains a significant nonresponse rate to CRT, with recent data questioning the reproducibility of standard echocardiography-based dyssynchrony metrics. MR-MT provides high quality mechanical activation data throughout the heart, and delayed enhancement magnetic resonance imaging (DEMRI) offers precise characterization of myocardial scar and scar distribution. Methods MR-MT was performed in patients with cardiomyopathy, divided into: 1) a CRT-HF cohort (n=20) with mean (SD) LVEF 0.23 (0.057) in order to evaluate the clinical use of MR-MT and DEMRI prior to CRT; and 2) a multimodality cohort (n=27) with mean (SD) LVEF 0.20 (0.066) in order to compare MR-MT and tissue Doppler imaging (TDI) assessments of mechanical dyssynchrony. MR-MT was also performed in 9 healthy control subjects. Results MR-MT showed that control subjects had highly synchronous contraction (mean [SD] CURE 0.96 [0.01]) while TDI septal-lateral delay indicated dyssynchrony in 44% of normal controls. Using a cutoff of <0.75 for CURE based on ROC analysis (AUC 0.889), 56% of patients tested positive for mechanical dyssynchrony, and the MR-MT CURE predicted improved function class in CRT-HF patients with 90% accuracy (PPV 87%; NPV 100%). Adding DEMRI (% total scar<15%) data improved accuracy further to 95% (PPV 93%; NPV 100%). The correlation between CURE and QRSd was modest in all cardiomyopathy subjects (r=0.58, p<0.001), and somewhat less in the CRT-HF group (r=0.40, p=0.08). The multimodality cohort showed a 30% discordance rate between CURE and TDI septal-lateral delay. Conclusions MR-MT assessment of circumferential mechanical dyssynchrony predicts improvement in

  16. Acute and Chronic Changes and Predictive Value of Tpeak-Tend for Ventricular Arrhythmia Risk in Cardiac Resynchronization Therapy Patients

    PubMed Central

    Xue, Cong; Hua, Wei; Cai, Chi; Ding, Li-Gang; Liu, Zhi-Min; Fan, Xiao-Han; Zhao, Yun-Zi; Zhang, Shu

    2016-01-01

    Background: Prolongation of the Tpeak-Tend (TpTe) interval as a measurement of transmural dispersion of repolarization (TDR) is an independent risk factor for chronic heart failure mortality. However, the cardiac resynchronization therapy's (CRT) effect on TDR is controversial. Therefore, this study aimed to evaluate CRTs acute and chronic effects on repolarization dispersion. Furthermore, we aimed to investigate the relationship between TpTe changes and ventricular arrhythmia. Methods: The study group consisted of 101 patients treated with CRT-defibrillator (CRT-D). According to whether TpTe was shortened, patients were grouped at immediate and 1-year follow-up after CRT, respectively. The echocardiogram index and ventricular arrhythmia were observed and compared in these subgroups. Results: For all patients, TpTe slightly increased immediately after CRT-D implantation, and then decreased at the 1-year follow-up (from 107 ± 23 to 110 ± 21 ms within 24 h, to 94 ± 24 ms at 1-year follow-up, F = 19.366, P < 0.001). No significant difference in the left ventricular reverse remodeling and ventricular tachycardia/ventricular fibrillation (VT/VF) episodes between the TpTe immediately shortened and TpTe immediately nonshortened groups. However, patients in the TpTe at 1-year shorten had a higher rate of the left ventricular (LV) reverse remodeling (65% vs. 44%, χ2 = 4.495, P = 0.038) and less VT/VF episodes (log-rank test, χ2 = 10.207, P = 0.001) compared with TpTe 1-year nonshortened group. TpTe immediately after CRT-D independently predicted VT/VF episodes at 1-year follow-up (hazard ratio [HR], 1.030; P = 0.001). Conclusions: Patients with TpTe shortened at 1-year after CRT had a higher rate of LV reverse remodeling and less VT/VF episodes. The acute changes of TpTe after CRT have minimal value on mechanical reverse remodeling and ventricular arrhythmia. PMID:27625093

  17. 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

  18. 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

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

    PubMed

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

    2015-01-01

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

  20. Cardiac Resynchronization Therapy (CRT)

    MedlinePlus

    ... content was last reviewed on 04/06/2015. Heart Failure Questions to Ask Your Doctor Use these questions ... to heart disease and stroke. Start exploring today ! Heart Failure • Home • About Heart Failure • Causes and Risks for ...

  1. [Cardiac resynchronization through a persistent left superior vena cava].

    PubMed

    Moriña-Vázquez, P; Barba-Pichardo, R; Venegas Gamero, J; Herrera Carranza, M

    2006-12-01

    Cardiac resynchronization therapy is effective in the treatment of patients with severe heart failure and intraventricular dysynchrony. However, we are sometimes faced with the unexpected presence of a persistent left superior vena cava. We report the case of a patient with dilated cardiomyopathy and left ventricular dysynchrony in which we implanted a resynchronization pacemaker exclusively through a persistent left superior vena cava that did not communicate with the right vena cava. PMID:17194405

  2. 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.

  3. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

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

  4. 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

  5. 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

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

    PubMed Central

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

    2016-01-01

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

  7. 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

    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 AND 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

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

    PubMed

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

    2015-05-01

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

  9. 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

  10. 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

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

    PubMed

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

    2016-07-01

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

  12. 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

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

    PubMed

    Manlucu, Jaimie; Tang, Anthony S L

    2014-06-01

    Heart failure continues to be a significant source of morbidity and mortality amongst Canadians. Many patients remain symptomatic despite guideline-directed medical therapy. For drug-refractory patients with dyssynchronous systolic heart failure, cardiac resynchronization therapy (CRT) has reliably reduced heart failure hospitalizations and related deaths. Unfortunately, despite significant advancements in technology and our understanding of its clinical effect, the CRT nonresponder rate remains approximately 30%. Great efforts have been invested into identifying clinical predictors of CRT response. Left bundle branch block conduction delay and wider QRS (> 150 ms) have consistently been associated with clinical response to CRT, earning them the strongest recommendations in the revised guidelines in Canada and across the world. Due in large part to the benefit observed in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) trial, patients with mild heart failure symptoms (New York Heart Association class II) are now also candidates for resynchronization therapy. Patients with atrial fibrillation, non-left bundle branch block conduction patterns, and chronic right ventricular pacing have historically been associated with poor response. However, these populations remain grossly underrepresented in the large trials. In the absence of more data, these patients continue to receive weaker recommendations for CRT in the guidelines. PMID:24882541

  14. Evaluation of global longitudinal strain of left ventricle and regional longitudinal strain in the region of left ventricular leads predicts the response to cardiac resynchronization therapy in patients with ischemic heart failure.

    PubMed

    Ma, Chun-Yan; Liu, Shuang; Yang, Jun; Tang, Li; Zhang, Li-Ming; Li, Nan; Yu, Bo

    2014-09-01

    Myocardium viability in ischemic heart failure (HF) may affect the effect of cardiac resynchronization therapy (CRT). We hypothesized that longitudinal strain of 2D-STE, which reflects myocardium viability, can predict the response to CRT in patients with ischemic HF. 2D-STE was performed in 42 patients with HF, 1 week before and 1 year after CRT. GLS, RLS, and the LV synchrony index (SI), defined as the difference in timing to peak radial strain between LV anterior septal and posterior wall in LV short axis view, were calculated. A decrease in the LV end-systolic volume (LVESV) value of ≥ 15 % 1 year after CRT was defined as response to CRT. Twenty-nine patients responded to CRT (CRT-R group), while 13 patients did not respond and were assigned as CRT-NR group. Pre-CRT RLS and GLS were higher, while SI is lower, in CRT-R patients compared with CRT-NR group (p < 0.001). The ROC curve revealed that RLS of -11.5 % predicted response to CRT with sensitivity of 80.0 % and specificity of 77.9 % (AUC = 0.84, p < 0.001). Further, GLS of -13 % predicted response to CRT with sensitivity of 73.0 % and specificity of 73.4 % (AUC = 0.79, p < 0.001). In conclusion, LV dyssynchrony, GLS, and RLS calculated by 2D-STE can predict long-term response to CRT in patients with ischemic HF.

  15. 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.

  16. 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...

  17. 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...

  18. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  19. 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...

  20. 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...

  1. 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

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

    PubMed

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

    2011-05-01

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

  3. 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

  4. [Biventricular resynchronization in the management of severe cardiac insufficiency].

    PubMed

    Chine, Samira; Kammoun, Ikram; Ben Halima, Afef; Lefi, Abdelatif; Chaabène, Olfa; Zouaoui, Walid; Essmatt, Wajih; Marrakchi, Sonia; Gargouri, Sami; Keskes, Hend; Kachboura, Salem

    2004-01-01

    Heart failure is a major problem of public health, it represents a frequent status among patients with heart disease, and its implications in term of mortality and cost are high. Non Pharmacological treatment of heart failure most commonly designed as cardiac resynchronization therapy (CRT) has demonstrate efficacy to improve functional class, exertion capacity, left ventricular ejection fraction, reduction of mitral regurgitation, and probably mortality at midterm. The most recent studies emphasize on the role of implantable cardioverter defibrillate or (ICD) combined with CRT to reduce mortality. More trials are needed to valid this concept.

  5. Narrow QRS systolic heart failure: is there a target for cardiac resynchronization?

    PubMed

    Jackson, Tom; Claridge, Simon; Behar, Jonathan; Sammut, Eva; Webb, Jessica; Carr-White, Gerald; Razavi, Reza; Rinaldi, Christopher Aldo

    2015-01-01

    Cardiac resynchronization therapy has revolutionized the management of systolic heart failure in patients with prolonged QRS during the past 20 years. Initially, the use of this treatment in patients with shorter QRS durations showed promising results, which have since been opposed by larger randomized controlled trials. Despite this, some questions remain, such as, whether correction of mechanical dyssynchrony is the therapeutic target by which biventricular pacing may confer benefit in this group, or are there other mechanisms that need consideration? In addition, novel techniques of cardiac resynchronization therapy delivery such as endocardial and multisite pacing may reduce potential detrimental effects of biventricular pacing, thereby improving the benefit/harm balance of this therapy in some patients.

  6. Ventricular assist devices: history, patient selection, and timing of therapy.

    PubMed

    Tang, Daniel G; Oyer, Philip E; Mallidi, Hari R

    2009-06-01

    Timing of therapy and selection of patients in the use of ventricular assist devices (VADs) can be difficult. In general, consideration for VAD implantation is appropriate in patients with endstage heart failure who are failing optimal medical therapy and in whom no alternative traditional surgical treatment options are available. However, identifying when a particular patient has reached this point is not always straightforward. There are a broad range of medical and surgical therapies for patients with overt heart failure, and this armamentarium is constantly expanding. The risks, benefits, and expected outcomes with VAD therapy have also undergone dramatic changes over the last decade. Advances in technology have led to a proliferation of newer generation devices that are smaller, lighter, easier to implant, and more reliable than previous generation devices. This, in turn, has led to a markedly improved risk-benefit ratio, with increased durability and reduced morbidity. The indications for the implantation of ventricular assist devices have also evolved over the last several years, and specific patient presentations and goals of therapy have led to specific indications. Device therapy has traditionally been classified as bridge to recovery, bridge to transplantation, and destination therapy. However, such designations may not be well defined at the time of implantation, and recovery and response following initiation of VAD support may allow patients to change from one classification to another. The current data regarding indications and timing of device implantation are reviewed. PMID:20559983

  7. 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.

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

    PubMed

    Sinner, Barbara; Kirchner, Gabriele I

    2016-09-01

    Liver failure is a disease with a high mortality rate. Often liver transplantation is the sole therapeutic option. On the one hand, liver support systems probably support the liver to allow regeneration, on the other hand they are an option to bridge for transplantation. This article gives an overview on the clinically used liver assist devices (molecular adsorbent recirculating system [MARS], Prometheus system, single-pass albumin dialysis [SPAD], plasmapheresis) and discusses the applications in liver failure. PMID:27631450

  9. 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

  10. 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

  11. 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

  12. 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

  13. Device therapy in the management of congestive heart failure.

    PubMed

    Turer, Aslan T; Rao, Sunil V

    2005-01-01

    Despite significant advancements in the treatment of heart failure over the past 2 decades, this patient population is still subject to considerably high morbidity and mortality rates. In recent years, the field of device therapy as adjunctive treatment to the medical management of congestive heart failure has grown in the wake of the large number of randomized trials that have demonstrated the safety and efficacy of these devices. The implantable defibrillator currently represents the standard of care in certain segments of the heart failure population, even in those without a prior arrhythmic event. Biventricular pacing systems appear to have a role in heart failure patients with prolongation of their QRS duration in improving ventricular performance and symptoms, if not mortality. Last, the shortage of organs available for orthotopic transplant has heightened interest in using ventricular-assist devices as destination therapy, and although there is evidence for the feasibility for this approach at the current time, there is a next generation of devices that appear even more promising.

  14. 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

  15. FDA's perspectives on cardiovascular devices.

    PubMed

    Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

    2009-06-01

    The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

  16. 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

  17. 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

  18. Illumination devices for photodynamic therapy of the oral cavity.

    PubMed

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

    2010-11-23

    Three compact and efficient designs are proposed to deliver an average irradiance of 50 mW/cm(2) with spatial uniformity well above 90% over a 25 mm(2) target area for photodynamic therapy of the oral cavity. The main goal is to produce uniform illumination on the target while limiting irradiation of healthy tissue, thus overcoming the need of shielding the whole oral cavity and greatly simplifying the treatment protocol. The first design proposed consists of a cylindrical diffusing fiber placed in a tailored reflector derived from the edge-ray theorem with dimensions 5.5 × 7.2 × 10 mm(3); the second device combines a fiber illuminator and a lightpipe with dimensions 6.8 × 6.8 × 50 mm(3); the third design, inspired by the tailored reflector, is based on a cylindrical diffusing fiber and a cylinder reflector with dimensions 5 × 10 × 11 mm(3). A prototype for the cylinder reflector was built that provided the required illumination for photodynamic therapy of the oral cavity, producing a spatial uniformity on the target above 94% and an average irradiance of 51 mW/cm(2) for an input power of 70 mW.

  19. Illumination devices for photodynamic therapy of the oral cavity

    PubMed Central

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

    2010-01-01

    Three compact and efficient designs are proposed to deliver an average irradiance of 50 mW/cm2 with spatial uniformity well above 90% over a 25 mm2 target area for photodynamic therapy of the oral cavity. The main goal is to produce uniform illumination on the target while limiting irradiation of healthy tissue, thus overcoming the need of shielding the whole oral cavity and greatly simplifying the treatment protocol. The first design proposed consists of a cylindrical diffusing fiber placed in a tailored reflector derived from the edge-ray theorem with dimensions 5.5 × 7.2 × 10 mm3; the second device combines a fiber illuminator and a lightpipe with dimensions 6.8 × 6.8 × 50 mm3; the third design, inspired by the tailored reflector, is based on a cylindrical diffusing fiber and a cylinder reflector with dimensions 5 × 10 × 11 mm3. A prototype for the cylinder reflector was built that provided the required illumination for photodynamic therapy of the oral cavity, producing a spatial uniformity on the target above 94% and an average irradiance of 51 mW/cm2 for an input power of 70 mW. PMID:21157577

  20. Recovery from disturbance requires resynchronization of ecosystem nutrient cycles.

    PubMed

    Rastetter, E B; Yanai, R D; Thomas, R Q; Vadeboncoeur, M A; Fahey, T J; Fisk, M C; Kwiatkowski, B L; Hamburg, S P

    2013-04-01

    Nitrogen (N) and phosphorus (P) are tightly cycled in most terrestrial ecosystems, with plant uptake more than 10 times higher than the rate of supply from deposition and weathering. This near-total dependence on recycled nutrients and the stoichiometric constraints on resource use by plants and microbes mean that the two cycles have to be synchronized such that the ratio of N:P in plant uptake, litterfall, and net mineralization are nearly the same. Disturbance can disrupt this synchronization if there is a disproportionate loss of one nutrient relative to the other. We model the resynchronization of N and P cycles following harvest of a northern hardwood forest. In our simulations, nutrient loss in the harvest is small relative to postharvest losses. The low N:P ratio of harvest residue results in a preferential release of P and retention of N. The P release is in excess of plant requirements and P is lost from the active ecosystem cycle through secondary mineral formation and leaching early in succession. Because external P inputs are small, the resynchronization of the N and P cycles later in succession is achieved by a commensurate loss of N. Through succession, the ecosystem undergoes alternating periods of N limitation, then P limitation, and eventually co-limitation as the two cycles resynchronize. However, our simulations indicate that the overall rate and extent of recovery is limited by P unless a mechanism exists either to prevent the P loss early in succession (e.g., P sequestration not stoichiometrically constrained by N) or to increase the P supply to the ecosystem later in succession (e.g., biologically enhanced weathering). Our model provides a heuristic perspective from which to assess the resynchronization among tightly cycled nutrients and the effect of that resynchronization on recovery of ecosystems from disturbance.

  1. Ventricular assist devices as destination therapy: psychosocial and ethical implications.

    PubMed

    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

  2. Health economic concerns on cardiac rhythm management devices longevity and how to overcome them.

    PubMed

    Capucci, Alessandro; Luzi, Mario; Cipolletta, Laura; Molini, Silvano

    2016-01-01

    The number of device implantations is in constant increase due to the ageing population, extended indications to implant for preventing sudden cardiac death and treating heart failure. An increase in the number of implants is directly related to a higher number of device replacements and that is one of the most important risk factors for device infection. Therefore, all the above mentioned factors contribute to an increase in the cost for health care system. Currently, several methods help to prolong device battery longevity and consequently reduce the costs, such as: a new battery, drug eluting leads, high impedance leads, algorithm to minimize unnecessary pacing, capture management and correct programming to avoid inappropriate and unnecessary shock in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy devices. Furthermore remote monitoring is very promising to reduce health system costs related to devices. PMID:26778415

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

    PubMed

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

    2016-03-01

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

  4. 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

  5. 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.

  6. Fast and automatic watermark resynchronization based on zernike moments

    NASA Astrophysics Data System (ADS)

    Kang, Xiangui; Liu, Chunhui; Zeng, Wenjun; Huang, Jiwu; Liu, Congbai

    2007-02-01

    In some applications such as real-time video applications, watermark detection needs to be performed in real time. To address image watermark robustness against geometric transformations such as the combination of rotation, scaling, translation and/or cropping (RST), many prior works choose exhaustive search method or template matching method to find the RST distortion parameters, then reverse the distortion to resynchronize the watermark. These methods typically impose huge computation burden because the search space is typically a multiple dimensional space. Some other prior works choose to embed watermarks in an RST invariant domain to meet the real time requirement. But it might be difficult to construct such an RST invariant domain. Zernike moments are useful tools in pattern recognition and image watermarking due to their orthogonality and rotation invariance property. In this paper, we propose a fast watermark resynchronization method based on Zernike moments, which requires only search over scaling factor to combat RST geometric distortion, thus significantly reducing the computation load. We apply the proposed method to circularly symmetric watermarking. According to Plancherel's Theorem and the rotation invariance property of Zernike moments, the rotation estimation only requires performing DFT on Zernike moments correlation value once. Thus for RST attack, we can estimate both rotation angle and scaling factor by searching for the scaling factor to find the overall maximum DFT magnitude mentioned above. With the estimated rotation angle and scaling factor parameters, the watermark can be resynchronized. In watermark detection, the normalized correlation between the watermark and the DFT magnitude of the test image is used. Our experimental results demonstrate the advantage of our proposed method. The watermarking scheme is robust to global RST distortion as well as JPEG compression. In particular, the watermark is robust to print-rescanning and

  7. 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.

  8. 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

  9. 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

  10. Bacterial output from three respiratory therapy humidifying devices.

    PubMed

    Vesley, D; Anderson, J; Halbert, M M; Wyman, L

    1979-03-01

    Three devices used to humidify the air delivered to hospitalized patients were evaluated for their relative hazard as measured by the concentration of bacterial output delivered with the gas. Two of the devices were evaporative types (commonly called "humidifiers"), moisturizing with water vapor, while the third was a nebulizer, delivering water droplets in aerosol form. Reservoirs were seeded with a tracer organism Pseudomonas cepacia (approximately 10(4)/ml) in distilled water. The output gas (approximately 30 1/min) was sampled through an Andersen six-stage bacterial sampler operated at 28.3 1/min. Excess gas was bled off through a Y-tubing. Results indicate that the nebulizer produces heavily contaminated bacterial aerosols (greater than 1000 P cepacia colonies in the 3-minute sampling period) even after a 20-minute warm-up period that raised the reservoir temperature to greater than 45 degrees C. The two evaporative type devices produced virtually no viable organisms even when sampling was initiated with the reservoir at room temperature.

  11. 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

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

    PubMed Central

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

    2012-01-01

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

  13. Intensity modulating and other radiation therapy devices for dose painting.

    PubMed

    Galvin, James M; De Neve, Wilfried

    2007-03-10

    The introduction of intensity-modulated radiation therapy (IMRT) in the early 1990s created the possibility of generating dramatically improved dose distributions that could be tailored to fit a complex geometric arrangement of targets that push against or even surround healthy critical structures. IMRT is a new treatment paradigm that goes beyond the capabilities of the earlier technology called three-dimensional radiation therapy (3DCRT). IMRT took the older approach of using fields that conformed to the silhouette of the target to deliver a relatively homogeneous intensity of radiation and separated the conformal fields into many subfields so that intensity could be varied to better control the final dose distribution. This technique makes it possible to generate radiation dose clouds that have indentations in their surface. Initially, this technology was mainly used to avoid and thus control the dose delivered to critical structures so that they are not seriously damaged in the process of irradiating nearby targets to an appropriately high dose. Avoidance of critical structures allowed homogeneous dose escalation that led to improved local control for small tumors. However, the normal tissue component of large tumors often prohibits homogeneous dose escalation. A newer concept of dose-painting IMRT is aimed at exploiting inhomogeneous dose distributions adapted to tumor heterogeneity. Tumor regions of increased radiation resistance receive escalated dose levels, whereas radiation-sensitive regions receive conventional or even de-escalated dose levels. Dose painting relies on biologic imaging such as positron emission tomography, functional magnetic resonance imaging, and magnetic resonance spectroscopy. This review will describe the competing techologies for dose painting with an emphasis on their commonalities.

  14. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  15. 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.

  16. 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

  17. Design and control of RUPERT: a device for robotic upper extremity repetitive therapy.

    PubMed

    Sugar, Thomas G; He, Jiping; Koeneman, Edward J; Koeneman, James B; Herman, Richard; Huang, H; Schultz, Robert S; Herring, D E; Wanberg, J; Balasubramanian, Sivakumar; Swenson, Pete; Ward, Jeffrey A

    2007-09-01

    The structural design, control system, and integrated biofeedback for a wearable exoskeletal robot for upper extremity stroke rehabilitation are presented. Assisted with clinical evaluation, designers, engineers, and scientists have built a device for robotic assisted upper extremity repetitive therapy (RUPERT). Intense, repetitive physical rehabilitation has been shown to be beneficial overcoming upper extremity deficits, but the therapy is labor intensive and expensive and difficult to evaluate quantitatively and objectively. The RUPERT is developed to provide a low cost, safe and easy-to-use, robotic-device to assist the patient and therapist to achieve more systematic therapy at home or in the clinic. The RUPERT has four actuated degrees-of-freedom driven by compliant and safe pneumatic muscles (PMs) on the shoulder, elbow, and wrist. They are programmed to actuate the device to extend the arm and move the arm in 3-D space. It is very important to note that gravity is not compensated and the daily tasks are practiced in a natural setting. Because the device is wearable and lightweight to increase portability, it can be worn standing or sitting providing therapy tasks that better mimic activities of daily living. The sensors feed back position and force information for quantitative evaluation of task performance. The device can also provide real-time, objective assessment of functional improvement. We have tested the device on stroke survivors performing two critical activities of daily living (ADL): reaching out and self feeding. The future improvement of the device involves increased degrees-of-freedom and interactive control to adapt to a user's physical conditions.

  18. 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.

  19. 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

  20. Destination therapy with left ventricular assist devices: for whom and when?

    PubMed

    Porepa, Liane F; Starling, Randall C

    2014-03-01

    Historically, cardiac transplantation is the only definitive therapy for mortality reduction, symptom reduction, and improved quality of life in advanced heart failure. Because of improvement in cardiovascular care there is now a growing number of patients such as the elderly and those with abundant comorbidity who are not eligible for cardiac transplant. Durable mechanical circulatory support is the new reality in the treatment of advanced heart failure in this population subset. The left ventricular assist device (LVAD) has evolved from humble origins as a short-term extracorporeal and pulsatile device into a durable intracorporeal continuous flow device capable of providing permanent support in the form of destination therapy (DT) LVAD. Data gathered from original landmark clinical trials including Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH), and the Heart Mate II Trial, and the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) provide insight into the type of patient and the timing in which to consider DT LVAD therapy. There are a number individual patient warning signs and symptoms that predate clinical decline; thus, identifying individuals who might benefit from a DT LVAD strategy. The adverse event burden that accompanies DT LVAD therapy cannot be ignored when considering LVAD as an adjunct to ongoing medical therapy. Trends in patient selection regarding mechanical circulatory support continue to evolve along with the technology. As more clinical outcome data are gathered we will continue to refine our patient selection criteria and timing of implant. PMID:24565254

  1. 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

  2. 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

  3. 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.

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

    PubMed

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

    2011-06-01

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

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

    Raunio, Antti; Sipilä, Kirsi; Raustia, Aune

    2012-01-01

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

  7. 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

  8. Titanium alloys as fixation device material for cranioplasty and its safety in electroconvulsive therapy.

    PubMed

    Kaido, Takanobu; Noda, Takamasa; Otsuki, Taisuke; Kaneko, Yuu; Takahashi, Akio; Nakai, Tetsuji; Nabatame, Maki; Tani, Mariko

    2011-03-01

    Here, we report the case of a patient successfully treated by a series of electroconvulsive therapy (ECT) who had implanted skull fixation devices made of titanium alloy. The patient was a 57-year-old man with bipolar I disorder. He was hospitalized for the treatment of manic symptoms of bipolar I disorder with pharmacotherapy and ECT. He sustained a fall and hit his head hard on the ground. Acute subdural hematoma developed, and emergent surgery to remove the hematoma was carried out. Cranioplasty was performed using fixation devices made of titanium alloy (Ti 6Al-4V). In order to control his manic symptoms, a series of ECT was readministered from 1 week after surgery. No adverse effects occurred. Devices must be investigated and chosen very carefully for permanent implantation, especially in patients during a course of ECT.

  9. A model for prediction of resynchronization after time-zone flights.

    PubMed

    Wegmann, H M; Klein, K E; Conrad, B; Esser, P

    1983-06-01

    Utilizing experimental data from three flight studies, a concept was developed which allows appraising average resynchronization for any day after arrival in a new time-zone. The course of adaptation is nonlinear and can be mathematically represented by an exponential function. The model predicts higher initial resynchronization rates when more time zones are crossed, but total time for complete reentrainment is essentially the same and, thus is independent of the number of time-zones. The equation derived from experimental data is converted into an e-function and the resulting time constants are presented as they evolved for different functions and flight directions.

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

    PubMed

    Neuzner, Jörg

    2015-06-01

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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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.

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

    PubMed

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

    2014-06-01

    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.

  17. 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

  18. 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.

  19. 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

  20. Factors affecting the success of resynchronization protocols with or without progesterone supplementation in dairy cows

    PubMed Central

    Forro, Annette; Beindorff, Nicola; Sharifi, Ahmad Reza; Brozos, Christos; Bollwein, Heinrich

    2015-01-01

    The objective of this study was to investigate factors that influence the success of resynchronization protocols for bovines with and without progesterone supplementation. Cow synchronized and not found pregnant were randomly assigned to two resynchronization protocols: ovsynch without progesterone (P4) supplementation (n = 66) or with exogenous P4 administered from Days 0 to 7 (n = 67). Progesterone levels were measured on Days 0 and 7 of these protocols as well as 4 and 5 days post-insemination. Progesterone supplementation raised the P4 levels on Day 7 (p < 0.05), but had no overall effect on resynchronization rates (RRs) or pregnancy per artificial insemination (P/AI). However, cows with Body Condition Score (BCS) > 3.5 had increased P/AI values while cows with BCS < 2.75 had decreased P/AI rates after P4 supplementation. Primiparous cows had higher P4 values on Day 7 than pluriparous animals (p = 0.04) and tended to have higher RRs (p = 0.06). Results of this study indicate that progesterone supplementation in resynchronization protocols has minimal effects on outcomes. Parity had an effect on the levels of circulating progesterone at initiation of the protocol, which in turn influenced the RR. PMID:25293490

  1. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  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

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

  4. Resynchronization with unknown pregnancy status using progestin-based timed artificial insemination protocol in beef cattle.

    PubMed

    Sá Filho, M F; Marques, M O; Girotto, R; Santos, F A; Sala, R V; Barbuio, J P; Baruselli, P S

    2014-01-15

    Two experiments were designed to evaluate the use of resynchronization (RESYNCH) protocols using a progestin-based timed artificial insemination (TAI) protocol in beef cattle. In experiment 1, 475 cyclic Nelore heifers were resynchronized 22 days after the first TAI using two different inducers of new follicular wave emergence (estradiol benzoate [EB; n = 241] or GnRH [n = 234]) with the insertion of a norgestomet ear implant. At ear implant removal (7 days later), a pregnancy test was performed, and nonpregnant heifers received a dose of prostaglandin plus 0.5 mg of estradiol cypionate, with a timed insemination 48 hours later. The pregnancy rate after the first TAI was similar (P = 0.97) between treatments (EB [41.9%] vs. GnRH [41.5%]). However, EB-treated heifers (49.3%) had a greater (P = 0.04) pregnancy per AI (P/AI) after the resynchronization than the GnRH-treated heifers (37.2%). In experiment 2, the pregnancy loss in 664 zebu females (344 nonlactating cows and 320 cyclic heifers) between 30 and 60 days after resynchronization was evaluated. Females were randomly assigned to one of two groups (RESYNCH 22 days after the first TAI [n = 317] or submitted only to natural mating [NM; n = 347]). Females from the NM group were maintained with bulls from 15 to 30 days after the first TAI. The RESYNC-treated females were resynchronized 22 days after the first TAI using 1 mg of EB on the first day of the resynchronization, similar to experiment 1. No difference was found in P/AI (NM [57.1%] vs. RESYNC [61.5%]; P = 0.32) or pregnancy loss (NM [2.0%] vs. RESYNC [4.1%]; P = 0.21) after the first TAI. Moreover, the overall P/AI after the RESYNCH protocol was 47.5%. Thus, the administration of 1 mg of EB on day 22 after the first TAI, when the pregnancy status was undetermined, promotes a higher P/AI in the resynchronized TAI than the use of GnRH. Also, the administration of 1 mg of EB 22 days after the TAI did not affect the preestablished pregnancy.

  5. 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

  6. Device therapy to modulate the autonomic nervous system to treat heart failure.

    PubMed

    Lopshire, John C; Zipes, Douglas P

    2012-10-01

    Heart failure is the final common pathway in many forms of heart disease, and is associated with excessive morbidity and mortality. Pathophysiologic alterations in the interaction between the heart and the autonomic nervous system in advanced heart failure have been noted for decades. Over the last decade, great advances have been made in the medical and surgical treatment of heart failure - and some of these modalities target the neuro-cardiac axis. Despite these advances, many patients progress to end-stage heart failure and death. Recently, device-based therapy targeting the neuro-cardiac axis with various forms of neuromodulatory stimuli has been shown to improve heart function in experimental heart failure models. These include spinal cord stimulation, vagal nerve stimulation, and baroreflex modulation. Human trials are now underway to evaluate the safety and efficacy of these device-based neuromodulatory modalities in the heart failure population.

  7. 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.

  8. Outcome of patients with ventricular assist devices and acute renal failure requiring renal replacement therapy.

    PubMed

    Kaltenmaier, B; Pommer, W; Kaufmann, F; Hennig, E; Molzahn, M; Hetzer, R

    2000-01-01

    The significance of acute renal failure (ARF) for patients treated with a ventricular assist device (VAD) is uncertain. There is little information on the outcome of patients who require renal replacement therapy during treatment with a VAD. A retrospective review was undertaken to evaluate the impact of renal failure requiring renal replacement therapy on such patients. Studied were 227 patients who were supplied with a VAD at the German Heart Institute Berlin. Fifty-five patients required renal replacement therapy during treatment with a VAD. These were compared with patients not needing renal replacement therapy (ARF and non-ARF groups). Significant differences for the end points of survival, heart transplantation, and discharge from hospital were observed in patients with ARF (p < 0.01). Survival was then analyzed according to indications for treatment with a VAD (bridge to transplantation or cardiac recovery after cardiotomy, transplantation, myocardial infarction, myocarditis, and endocarditis). Survival for bridge-to-transplantation patients was clearly influenced in a negative way by ARF (p < 0.01). For cardiac recovery patients, only a small difference in survival was observed (p = 0.05). We conclude that ARF is a negative predictor for bridge-to-transplantation patients. For cardiac recovery patients the impact of ARF on survival is marginally significant.

  9. 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

  10. 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

  11. 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.

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

    NASA Technical Reports Server (NTRS)

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

    1986-01-01

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

  13. 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.

  14. 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

  15. 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.

  16. 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

  17. Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea

    PubMed Central

    Schwab, Richard J.; Kim, C.; Siegel, Lawrence; Keenan, B.T.; Black, Jed; Farid-Moayer, Mehran; Podmore, Jonathan; Vaska, Matt

    2014-01-01

    Study Objectives: The objective of this study was to explore the mechanism of action of the oral pressure therapy (OPT) device, a new treatment for sleep apnea. Design: Case series. Setting: Academic medical center. Patients: Fifteen subjects with sleep apnea who had been successfully treated (responders) with the OPT device and 4 subjects who were not successfully treated (non-responders) with the OPT device. Interventions: All subjects underwent a MRI (without the device, with the device in place without vacuum and with the device in place with vacuum) to examine the biomechanical changes associated with the OPT device. Measurements and Results: Oral pressure therapy significantly (P = 0.002) increased the size of the retropalatal airway in both the lateral and anterior-posterior dimensions by moving the soft palate anteriorly and superiorly and the anterior-superior segment of the tongue forward, toward the teeth. The percentage and absolute increase in the cross-sectional area of the retropalatal region, the superior movement of the soft palate, and the anterior displacement of the tongue were significantly greater in the responders than in the non-responders. In responders, there were significant increases in the mean (P = 0.002), maximum (P = 0.0002), and minimum (P = 0.04) cross-sectional areas of the retropalatal region with the OPT device. However, in the retroglossal region, airway caliber decreased with the OPT device. Conclusions: In those who responded to oral pressure therapy, it increased airway caliber in the retropalatal region by moving the soft palate anteriorly and superiorly and the anterior-superior segment of the tongue forward. Citation: Schwab RJ, Kim C, Siegel L, Keenan BT, Black J, Farid-Moayer M, Podmore J, Vaska M. Examining the mechanism of action of a new device using oral pressure therapy for the treatment of obstructive sleep apnea. SLEEP 2014;37(7):1237-1247. PMID:25061252

  18. 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

  19. 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.

  20. In vitro biomechanical evaluation of single impulse and repetitive mechanical shockwave devices utilized for spinal manipulative therapy.

    PubMed

    Liebschner, Michael A K; Chun, Kwonsoo; Kim, Namhoon; Ehni, Bruce

    2014-12-01

    Mechanical shockwave therapy devices have been in clinical use for almost 40 years. While most often used to treat back pain, our understanding of their biomechanical performance is very limited. From biomechanical studies we know that biological tissue is viscoelastic and preferably excited around its resonance frequency. Targeting these frequencies has been the focus in extracorporeal shock wave lithotripsy, but these concepts are relatively new in orthopedic and rehabilitation therapies. The exact mechanism by which shockwave therapy acts is not known. Knowledge of the performance characteristics of these devices, correlated with clinical outcome studies, may lead to better patient selection, improvement of device functionality, and knowledge of the underlying working principals of therapy. The objectives of this study were to determine the ability of several commercial shockwave devices to achieve a desired thrust profile in a benchtop setting, determine the thrust profile in a clinical analog, and determine the influence of operator experience level on device performance. We conducted two different types of testing: (1) bench testing to evaluate the devices themselves, and (2) clinical equivalent testing to determine the influence of the operator. The results indicated a significant dependence of thrust output on the compliance of the test media. The Activator V-E device matched the ideal half-sine thrust profile to 94%, followed by the Impulse device (84%), the Activator IV/FS (74%), and the Activator II (48%). While most devices deviated from the ideal profile on the return path, the Impulse device exhibited a secondary peak. Moreover, the Activator V-E device provided evidence that the device performs consistently despite operator experience level. This has been a major concern in manual spinal manipulation. Based on our results, a hyper-flexible spine would receive a lower peak thrust force than a hypo-flexible spine at the same power setting. Furthermore

  1. [Devic syndrome--case report, current principles of diagnosis and therapy].

    PubMed

    Iljicsov, Anna; Barsi, Péter; Várallyay, György; Tátrai, Erika; Somfai, Gábor Márk; Bereczki, Dánieli; Rudas, Gábor; Simó, Magdolna

    2010-09-30

    Neuromyelitis optica (NMO, Devic-syndrome) is a rare, relapsing autoimmune disease of the central nervous system, which is distinguished from other demyelinating disorders by a recently identified, specific autoantibody. By demonstrating the anti-aquaporin-4 IgG in the serum, a heterogenous group of syndromes can be defined, called NMO-spectrum. In the future, optical coherence tomography may support this diagnosis besides the clinical features, imaging examinations and presence of serum antibody. Early recognition and treatment can improve clinical outcome even in serious condition. Long-term immunosuppressive therapy is advised to prevent further relapses and to stabilize or improve clinical status. Hereby, we report a case of a 51-year-old woman, under treatment for one and a half years. We summarize the current knowledge about the pathomechanism, diagnostic strategy and therapy of neuromyelitis optica. We review recent findings and the diagnostic value of a new, non-invasive ophtalmological examination, the optical coherence tomography. According to the first results, this method may be helpful in the early differential diagnosis of optic neuritis.

  2. 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.

  3. 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

  4. [Devic syndrome--case report, current principles of diagnosis and therapy].

    PubMed

    Iljicsov, Anna; Barsi, Péter; Várallyay, György; Tátrai, Erika; Somfai, Gábor Márk; Bereczki, Dánieli; Rudas, Gábor; Simó, Magdolna

    2010-09-30

    Neuromyelitis optica (NMO, Devic-syndrome) is a rare, relapsing autoimmune disease of the central nervous system, which is distinguished from other demyelinating disorders by a recently identified, specific autoantibody. By demonstrating the anti-aquaporin-4 IgG in the serum, a heterogenous group of syndromes can be defined, called NMO-spectrum. In the future, optical coherence tomography may support this diagnosis besides the clinical features, imaging examinations and presence of serum antibody. Early recognition and treatment can improve clinical outcome even in serious condition. Long-term immunosuppressive therapy is advised to prevent further relapses and to stabilize or improve clinical status. Hereby, we report a case of a 51-year-old woman, under treatment for one and a half years. We summarize the current knowledge about the pathomechanism, diagnostic strategy and therapy of neuromyelitis optica. We review recent findings and the diagnostic value of a new, non-invasive ophtalmological examination, the optical coherence tomography. According to the first results, this method may be helpful in the early differential diagnosis of optic neuritis. PMID:21033421

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

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

    PubMed

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

    2016-01-08

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

  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. 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

  15. 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

  16. 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.

  17. A Randomized Controlled Trial of the embrace Advanced Scar Therapy Device to Reduce Incisional Scar Formation

    PubMed Central

    Longaker, Michael T.; Rohrich, Rod J.; Greenberg, Lauren; Furnas, Heather; Wald, Robert; Bansal, Vivek; Seify, Hisham; Tran, Anthony; Weston, Jane; Korman, Joshua M.; Chan, Rodney; Kaufman, David; Dev, Vipul R.; Mele, Joseph A.; Januszyk, Michael; Cowley, Christy; McLaughlin, Peggy; Beasley, Bill; Gurtner, Geoffrey C.; Longaker, Michael T.; Gurtner, Geoffrey C.

    2015-01-01

    Background Scarring represents a significant biomedical burden in clinical medicine. Mechanomodulation has been linked to scarring through inflammation, but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible. Methods The authors conducted a 12-month, prospective, open-label, randomized, multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy device to reduce mechanical forces on healing surgical incisions. Incisions from 65 healthy adult subjects were randomized to receive embrace treatment on one half of an abdominoplasty incision and control treatment (surgeon's optimal care methods) on the other half. The primary endpoint for this study was the difference between assessments of scar appearance for the treated and control sides using the visual analogue scale scar score. Results Final 12-month study photographs were obtained from 36 subjects who completed at least 5 weeks of dressing application. The mean visual analogue scale score for embrace-treated scars (2.90) was significantly improved compared with control-treated scars (3.29) at 12 months (difference, 0.39; 95 percent confidence interval, 0.14 to 0.66; p = 0.027). Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale evaluation (p = 0.02 and p < 0.001, respectively). No serious adverse events were reported. Conclusions These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery. To the authors’ knowledge, this represents the first level I evidence for postoperative scar reduction. PMID:24804638

  18. The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.

    PubMed

    Carroll, John D; Edwards, Fred H; Marinac-Dabic, Danica; Brindis, Ralph G; Grover, Frederick L; Peterson, Eric D; Tuzcu, E Murat; Shahian, David M; Rumsfeld, John S; Shewan, Cynthia M; Hewitt, Kathleen; Holmes, David R; Mack, Michael J

    2013-09-10

    The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) transcatheter valve therapy (TVT) registry is a novel, national registry for all new TVT devices created through a partnership of the STS and the ACC in close collaboration with the Food and Drug Administration, the Center for Medicare and Medicaid Services, and the Duke Clinical Research Institute. The registry will serve as an objective, comprehensive, and scientifically based resource to improve the quality of patient care, to monitor the safety and effectiveness of TVT devices, to serve as an analytic resource for TVT research, and to enhance communication among key stakeholders. PMID:23644082

  19. The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.

    PubMed

    Carroll, John D; Edwards, Fred H; Marinac-Dabic, Danica; Brindis, Ralph G; Grover, Frederick L; Peterson, Eric D; Tuzcu, E Murat; Shahian, David M; Rumsfeld, John S; Shewan, Cynthia M; Hewitt, Kathleen; Holmes, David R; Mack, Michael J

    2013-09-10

    The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) transcatheter valve therapy (TVT) registry is a novel, national registry for all new TVT devices created through a partnership of the STS and the ACC in close collaboration with the Food and Drug Administration, the Center for Medicare and Medicaid Services, and the Duke Clinical Research Institute. The registry will serve as an objective, comprehensive, and scientifically based resource to improve the quality of patient care, to monitor the safety and effectiveness of TVT devices, to serve as an analytic resource for TVT research, and to enhance communication among key stakeholders.

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

    PubMed Central

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

    2016-01-01

    Abstract: 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

  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.

  2. 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

    2013-05-02

    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.

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

    PubMed

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

    2014-10-01

    This retrospective cohort study evaluates the effect of chronic antimicrobial suppression (CAS) therapy on clinical outcomes in patients with continuous-flow left ventricular assist devices (CF-LVADs) and a history of device-related infection. Patients with CF-LVAD implantation between January 2008 and August 2011 who received systemic CAS after index antibiotic treatment of a device-related infection were included. Chronic suppression was defined as continuation of antibiotics for longer than 6 weeks after the index infection. Standard International Society for Heart and Lung Transplantation definitions were used. The primary outcome is failure of CAS, defined as a clinical deterioration resulting in the need for transition from oral to intravenous (IV) therapy or a need to change to a different IV antibiotic, elevation to status 1A on the transplant list as a result of ongoing infection, or device/driveline exchange. Of 140 patients screened, 16 patients were included (69% male, 63% African American, median age 52 years). The driveline was the most common site of infection (69%). Organisms isolated included Gram-positive cocci (n = 7), Gram-negative bacilli (n = 10), and Candida (n = 1). Oral trimethoprim/sulfamethoxazole treatment was most commonly used for suppression (37.5%). Failure of CAS occurred in 5/16 (31%) patients after a mean time of 175 days on therapy (range 10-598). The majority of failures (60%) required device exchanges. Side effects of nausea, vomiting, or diarrhea were reported in three patients; all required changes in oral suppression regimen. Clostridium difficile infection was noted in two patients. These results, which must be confirmed by a larger analysis, suggest that one-third of CF-LVAD patients may develop recurrent infections while on CAS therapy. PMID:24571683

  4. 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.

  5. 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

  6. Drug/device combinations for local drug therapies and infection prophylaxis.

    PubMed

    Wu, Peng; Grainger, David W

    2006-04-01

    Combination devices-those comprising drug releasing components together with functional prosthetic implants-represent a versatile, emerging clinical technology promising to provide functional improvements to implant devices in several classes. Landmark antimicrobial catheters and the drug-eluting stent have heralded the entrance, and significantly, routes to FDA approval, for these devices into clinical practice. This review describes recent strategies creating implantable combination devices. Most prominent are new combination devices representing current orthopedic and cardiovascular implants with new added capabilities from on-board or directly associated drug delivery systems are now under development. Wound coverings and implantable sensors will also benefit from this combination enhancement. Infection mitigation, a common problem with implantable devices, is a current primary focus. On-going progress in cell-based therapeutics, progenitor cell exploitation, growth factor delivery and advanced formulation strategies will provide a more general and versatile basis for advanced combination device strategies. These seek to improve tissue-device integration and functional tissue regeneration. Future combination devices might best be completely re-designed de novo to deliver multiple bioactive agents over several spatial and temporal scales to enhance prosthetic device function, instead of the current 'add-on' approach to existing implant device designs never originally intending to function in tandem with drug delivery systems.

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

    PubMed

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

    2016-01-01

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

  8. Robotic-based carbon ion therapy and patient positioning in 6 degrees of freedom: setup accuracy of two standard immobilization devices used in carbon ion therapy and IMRT

    PubMed Central

    2012-01-01

    Purpose To investigate repositioning accuracy in particle radiotherapy in 6 degrees of freedom (DOF) and intensity-modulated radiotherapy (IMRT, 3 DOF) for two immobilization devices (Scotchcast masks vs thermoplastic head masks) currently in use at our institution for fractionated radiation therapy in head and neck cancer patients. Methods and materials Position verifications in patients treated with carbon ion therapy and IMRT for head and neck malignancies were evaluated. Most patients received combined treatment regimen (IMRT plus carbon ion boost), immobilization was achieved with either Scotchcast or thermoplastic head masks. Position corrections in robotic-based carbon ion therapy allowing 6 DOF were compared to IMRT allowing corrections in 3 DOF for two standard immobilization devices. In total, 838 set-up controls of 38 patients were analyzed. Results Robotic-based position correction including correction of rotations was well tolerated and without discomfort. Standard deviations of translational components were between 0.5 and 0.8 mm for Scotchcast and 0.7 and 1.3 mm for thermoplastic masks in 6 DOF and 1.2 - 1.4 mm and 1.0 - 1.1 mm in 3 DOF respectively. Mean overall displacement vectors were between 2.1 mm (Scotchcast) and 2.9 mm (thermoplastic masks) in 6 DOF and 3.9 - 3.0 mm in 3 DOF respectively. Displacement vectors were lower when correction in 6 DOF was allowed as opposed to 3 DOF only, which was maintained at the traditional action level of > 3 mm for position correction in the pre-on-board imaging era. Conclusion Setup accuracy for both systems was within the expected range. Smaller shifts were required when 6 DOF were available for correction as opposed to 3 DOF. Where highest possible positioning accuracy is required, frequent image guidance is mandatory to achieve best possible plan delivery and maintenance of sharp gradients and optimal normal tissue sparing inherent in carbon ion therapy. PMID:22458824

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

    PubMed

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

    2015-08-01

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

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

    PubMed

    Doty, Diane

    2015-12-01

    Mechanical circulatory support (MCS) devices offer advanced heart failure patients a potential long-term solution. MCS devices implantation is increasing related to the increased volume of heart failure patients, the shortfall of suitable donors, and the advanced technology and smaller size of the devices. To ensure a successful outcome, some key elements must be taken into consideration and managed: patient selection, preoperative preparation, intraoperative care, postoperative care, and posthospital education. The ultimate success of an MCS implantation relies on a multidisciplinary approach and excellent patient/caregiver education in each phase of hospitalization. PMID:26567498

  11. 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.

  12. Treatment Control and Device Optimization of Transurethral Curvilinear Applicators for Prostate Thermal Therapy

    NASA Astrophysics Data System (ADS)

    Sridhar, Mallika; Wootton, Jeffery H.; Juang, Titania; Diederich, Chris J.

    2009-04-01

    Transurethral ultrasound catheter devices in curvilinear configurations are being optimized for improved treatment control and accuracy, reduced treatment times and minimizing surrounding heating of thermally sensitive structures beyond the prostate. A transient acoustic and biothermal model was used to estimate prostate temperature distributions, treatment times and rectal heating for various device configurations and control strategies while accommodating sweeping of curvilinear applicators, power modulation, outer target boundary pilot-point temperature control (sequential rotation) and changes in attenuation with lethal thermal dose. Large prostates can be treated in clinically reasonable times (20-40 min) with low rectal heating if the curvilinear device radius of curvature are increased to 25 mm, device frequency is kept low between 5-6.5 MHz and large device dimensions are chosen (5 X 20 mm) with high maximum allowable temperatures along device length. Pilot-point temperature feedback treatment control can be enhanced with decreased rectal thermal dose by using variable boundary temperatures at the posterior prostate near rectum.

  13. 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

  14. 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

  15. Influence of different atrioventricular and interventricular delays on cardiac output during cardiac resynchronization therapy.

    PubMed

    Riedlbauchová, Lucie; Kautzner, Josef; Frídl, Petr

    2005-01-01

    Restoration of the atrioventricular (AVD) and interventricular (VVD) delays increases the hemodynamic benefit conferred by biventricular (BiV) stimulation. This study compared the effects of different AVD and VVD on cardiac output (CO) during three stimulation modes: BiV-LV = left ventricle (LV) preceding right ventricle (RV) by 4 ms; BiV-RV = RV preceding LV by 4 ms; LVP = single-site LV pacing. We studied 19 patients with chronic heart failure due to ischemic or idiopathic dilated cardiomyopathy, QRS >/= 150 ms, mean LV end-diastolic diameter = 78 +/- 7 mm, and mean LV ejection fraction = 21 +/- 3%. CO was estimated by Doppler echocardiographic velocity time integral formula with sample volume placed in the LV outflow tract. Sets of sensed-AVDs (S-AVD) 90-160 ms, paced-AVDs (P-AVD) 120-160 ms, and VVDs 4-20 ms were used. BiV-RV resulted in lower CO than BiV-LV. S-AVD 120 ms and P-AVD 140 ms caused the most significant increase in CO for all three pacing modes. LVP produced a similar increase in CO as BiV stimulation; however, AV sequential pacing was associated with a nonsignificantly higher CO during LVP than with BiV stimulation. CO during BiV stimulation was the highest when LV preceded RV, and VVD ranged between 4 and 12 ms. The most negative effect on CO was observed when RV preceded LV by 4 ms. Hemodynamic improvement during BiV stimulation was dependent both on optimized AVD and VVD. LV preceding RV by 4-12 ms was the most optimal. Advancement of the RV was not beneficial in the majority of patients.

  16. Association of BNP and Troponin Levels with Outcome among Cardiac Resynchronization Therapy Recipients

    PubMed Central

    Shalaby, Alaa A.; Abraham, William T.; Fonarow, Gregg C.; Bersohn, Malcolm M.; Gorcsan, John; Lee, Li-Yin; Halilovic, Jasmina; Saba, Samir; Maisel, Alan; Singh, Jagmeet P.; Sonel, Ali; Kadish, Alan

    2015-01-01

    Introduction We conducted a prospective multicenter study to assess the prognostic value of combined baseline pre-implant plasma levels of the biomarkers cardiac troponin T (TnT) and BNP among CRT-D recipients. Methods At CRT-D implant, patients were stratified based on detectable TnT (≥0.01 ng/ml) and elevated BNP (predefined as >440 pg/ml) levels. Patients were classified into 3 groups high (both detectable TnT and high BNP), intermediate (either detectable TnT or high BNP), or low (non-detectable TnT and low BNP). Patients were followed for 12 months. Survival curves free from mortality or HFH were assessed. To assess the predictive value of biomarker category, we constructed a multivariate Cox regression model, including the covariates of age, NYHA class, LVEF, and QRS duration. Results A total of 267 patients (age 66 ± 12 years, males 80%, LVEF 25% ± 8%, ischemic CM 52%, QRSd 155 ± 26 ms) were studied. After one year, there were 13 deaths and 25 HFH events. A significant difference in event free survival among the 3 groups was observed, with high and intermediate categories having worse survival than low (log-rank test, p <0.001). In the multivariate model, risk category was a significant predictor of outcome: Hazard ratios were 7.34 (95% CI: 2.48 to 21.69) and 2.50 (95% CI: 1.04 to 6.04) for high and intermediate risk groups respectively (p<0.0001). Conclusion Among CRT-D recipients, baseline TnT and BNP values alone or in combination provide significant prognostic value for the outcome of mortality or HFH. PMID:25677851

  17. 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

  18. 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

  19. 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

  20. 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

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

    PubMed

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

    2014-08-01

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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. Speech--Language Therapy with the Non-Verbal Child Utilizing Assistive Devices.

    ERIC Educational Resources Information Center

    Larkin, Alecia S.

    The paper describes assessment techniques, the process of aid selection, and therapy procedures with young nonverbal handicapped children. Assessment of such children requires an evaluation of the child's present means of communication, hearing, vision, receptive skills, and ability to use language (verbal, gestural, or graphic). Among factors to…

  7. 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

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

    PubMed

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

    2006-01-01

    The examination of the patients exposed to physical factors (magnetotherapy, laser therapy and thermotherapy) has demonstrated that Intramag unit with attachments Intraterm and LAST-02 for local physiotherapy is effective in patients with chronic prostatitis and can be used in urological hospitals and outpatient clinics. PMID:17058682

  9. Relation of optimal lead positioning as defined by three-dimensional echocardiography to long-term benefit of cardiac resynchronization.

    PubMed

    Becker, Michael; Hoffmann, Rainer; Schmitz, Fabian; Hundemer, Anne; Kühl, Harald; Schauerte, Patrick; Kelm, Malte; Franke, Andreas

    2007-12-01

    We sought to define the impact of echocardiographically defined left ventricular (LV) lead position on the efficacy of cardiac resynchronization therapy (CRT) in a serial study using 3-dimensional echocardiography. Fifty-eight consecutive patients (53+/-9 years of age; 37 men) with heart failure were included in the study. Echocardiograms were obtained before CRT, within 7 days after implantation, and at 12+/-2 months of follow-up using a 3-dimensional digital ultrasound scanner (iE33, Philips, Andover, Massachusetts). Analysis of the temporal course of contraction in 16 LV segments was performed offline using a semiautomatic contour tracing software (LV Analysis, TomTec, Unterschleissheim, Germany). Based on the resulting volume/time curves the segment with the latest minimum of systolic volume in each patient was identified preoperatively (segment A). In addition, the temporal difference between the pre- and postoperative (within 7 days) minimum of systolic volume was determined for each segment. The segment with the longest temporal difference was defined to show the greatest effect of CRT. Location of the LV lead tip was assumed to be within this segment (segment B). LV lead position was defined as optimal when segments A and B were equal and as nonoptimal when they were far from each other. Using this definition, 26 patients had a nonoptimal and 32 patients an optimal LV lead position. Before CRT ejection fraction (32+/-4% vs 31+/-6%), LV end-systolic and end-diastolic volumes (242+/-92 vs 246+/-88 ml, 315+/-82 vs 323+/-90 ml), and peak oxygen consumption (14.3+/-1.4 vs 14.6+/-1.5 ml/min/kg) were equal in the 2 groups. At 12+/-2 months of follow-up, patients with an assumed optimal LV lead position showed greater increases of ejection fraction (10+/-2% vs 6+/-3%) and peak oxygen consumption (2.4+/-0.3 vs 1.5+/-0.4 ml/min/kg) and greater decreases of LV end-systolic (32+/-7 vs 21+/-5 ml) and end-diastolic (20+/-7 vs 13+/-6 ml) volumes. In conclusion

  10. 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

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

    PubMed Central

    Chelu, Mihail Gabriel

    2016-01-01

    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

  12. [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

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

    PubMed

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

    2011-02-01

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

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

    PubMed Central

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

    2013-01-01

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

  15. Partial extracorporeal carbon dioxide removal using a standard continuous renal replacement therapy device: a preliminary study.

    PubMed

    Quintard, Jean-Marie; Barbot, Olivier; Thevenot, Florence; de Matteis, Olivier; Benayoun, Laurent; Leibinger, Frank

    2014-01-01

    To test the feasibility, safety, and efficacy of partial extracorporeal CO2 removal (PECCO2R) using a standard continuous renal replacement (CRRT) device with a pediatric oxygenation membrane introduced into the circuit in a serial manner. In this retrospective single-center study, we have studied mechanically ventilated patients with persistent significant respiratory acidosis and acute renal failure requiring ongoing CRRT. Sixteen patients were treated with our PECCO2R device. PaCO2 and arterial pH were measured before as well as at 6 and 12 hours after PECCO2R implementation. Hemodynamic parameters were continuously monitored. Our PECCO2R system was efficient to significantly reduce PaCO2 and increase arterial pH. The median PaCO2 before treatment was 77 mm Hg (59-112) with a median reduction of 24 mm Hg after 6 hours and 30 mm Hg after 12 hours (31% and 39%, respectively). The median pH increase was 0.16 at 6 hours and 0.23 at 12 hours. Partial extracorporeal CO2 removal treatment had no effect on oxygenation. No complication was observed. Our PECCO2R approach based on the simple introduction of a pediatric extracorporeal membrane oxygenation membrane into the circuit of a standard CRRT device is easy to implement, safe, and efficient to improve respiratory acidosis.

  16. 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

  17. 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.

  18. 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

  19. 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.

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

    PubMed

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

    2014-01-01

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

  1. 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

  2. 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.

  3. Effect of an oxygen pressure injection (OPI) device on the oxygen saturation of patients during dermatological methyl aminolevulinate photodynamic therapy.

    PubMed

    Blake, E; Allen, J; Thorn, C; Shore, A; Curnow, A

    2013-05-01

    Methyl aminolevulinate photodynamic therapy (MAL-PDT) (a topical treatment used for a number of precancerous skin conditions) utilizes the combined interaction of a photosensitizer (protoporphyrin IX (PpIX)), light of the appropriate wavelength, and molecular oxygen to produce singlet oxygen and other reactive oxygen species which induce cell death. During treatment, localized oxygen depletion occurs and is thought to contribute to decreased efficacy. The aim of this study was to investigate whether an oxygen pressure injection (OPI) device had an effect on localized oxygen saturation levels and/or PpIX fluorescence of skin lesions during MAL-PDT. This study employed an OPI device to apply oxygen under pressure to the skin lesions of patients undergoing standard MAL-PDT. Optical reflectance spectrometry and fluorescence imaging were used to noninvasively monitor the localized oxygen saturation and PpIX fluorescence of the treatment area, respectively. No significant changes in oxygen saturation were observed when these data were combined for the group with OPI and compared to the group that received standard MAL-PDT without OPI. Additionally, no significant difference in PpIX photobleaching or clinical outcome at 3 months between the groups of patients was observed, although the group that received standard MAL-PDT demonstrated a significant increase (p<0.05) in PpIX fluorescence initially and both groups produced a significant decrease (p<0.05) after light irradiation. In conclusion, with this sample size, this OPI device was not found to be an effective method with which to improve tissue oxygenation during MAL-PDT. Further investigation is therefore required to find a more effective method of MAL-PDT enhancement.

  4. 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.

  5. 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.

  6. 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.

  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. 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

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

    PubMed Central

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

    2015-01-01

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

  11. 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

  12. Comparison of 2-Year Outcomes of Extended Criteria Cardiac Transplantation Versus Destination Left Ventricular Assist Device Therapy Using Continuous Flow.

    PubMed

    Daneshmand, Mani A; Krishnamoorthy, Arun; Samsky, Marc D; Felker, G Michael; Pura, John A; Lokhnygina, Yuliya; Hernandez, Adrian F; Rosenberg, Paul B; Blue, Laura J; Schroder, Jacob N; Rogers, Joseph G; Milano, Carmelo A; Patel, Chetan B

    2015-08-15

    Alternatives have emerged for patients ineligible for cardiac transplantation under standard criteria. The purpose of our study was to compare outcomes in patients ineligible for cardiac transplantation under standard criteria, treated either with extended criteria cardiac transplantation (ECCT) or a continuous flow destination therapy left ventricular assist device (CF DT-LVAD). From 2005 to 2012, patients treated with either ECCT or CF DT-LVAD at our institution were retrospectively analyzed. In the overall unmatched cohort, we examined mortality and other outcomes, including index hospitalization length of stay, renal function, stroke, and readmission rates. After propensity score (PS) matching, outcomes were compared between ECCT and CF DT-LVAD recipients. Overall, 62 patients underwent ECCT, and 146 patients were treated with CF DT-LVAD. The 2-year mortality estimate for ECCT recipients was 27.3% (95% confidence interval 15.5% to 39.1%) and for CF DT-LVAD recipients was 11.2% (95% confidence interval 4.8% to 17.6%). After PS matching of 39 patients from each treatment group, there was no significant difference in overall survival after 2 years (p = 0.346). In both unmatched and PS-matched analyses, CF DT-LVAD patients compared with ECCT had a significantly higher estimated glomerular filtration rate at 1 year but also had significantly higher hospital readmission rates. Stroke also more commonly occurred after CF DT-LVAD compared with ECCT (17 vs 5, unmatched; and 2 vs 1, PS matched). However, there was no significant difference between PS-matched groups in 2-year stroke-free survival (p = 0.371). In conclusion, ECCT and CF DT-LVAD in select patients are comparable therapies with respect to 2-year survival. PMID:26092273

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

    PubMed

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

    2015-02-01

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

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

    PubMed Central

    2009-01-01

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

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

    PubMed

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

    2013-01-01

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

  17. 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.

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

    PubMed

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

    2015-12-01

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

  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. Extracorporeal shock wave therapy for chronic painful heel syndrome: a prospective, double blind, randomized trial assessing the efficacy of a new electromagnetic shock wave device.

    PubMed

    Gollwitzer, Hans; Diehl, Peter; von Korff, Alexej; Rahlfs, Volker W; Gerdesmeyer, Ludger

    2007-01-01

    Published data describing the efficacy of extracorporeal shock wave therapy for the treatment of plantar heel pain provide conflicting results, and optimal treatment guidelines are yet to be determined. To assess the efficacy and safety of extracorporeal shockwave therapy compared with placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device, we undertook a prospective, double-blind, randomized, placebo-controlled trial conducted among 40 participants who were randomly allocated to either active, focused extracorporeal shockwave therapy (0.25 mJ/mm(2)) or sham shockwave therapy. Both groups received 3 applications of 2000 shockwave impulses, each session 1 week apart. The primary outcome was the change in composite heel pain (morning pain, pain with activities of daily living, and pain upon application of pressure with a focal force meter) as quantified using a visual analog pain scale at 12 weeks after completion of the interventions compared with baseline. Secondary endpoints included changes in morning pain, pain with activities of daily living, and pain upon application of pressure with a focal force meter, as measured on a visual analog pain scale, as well as the change in the Roles and Maudsley score, at 12 weeks after the baseline measurement. Active extracorporeal shockwave therapy resulted in a 73.2% reduction in composite heel pain, and this was a 32.7% greater reduction than that achieved with placebo. The difference was not statistically significant (1-tailed Wilcoxon Mann-Whitney U test, P =.0302), but reached clinical relevance (Mann-Whitney effect size = 0.6737). In regard to the secondary outcomes, active extracorporeal shockwave therapy displayed relative superiority in comparison with the sham intervention. No relevant adverse events occurred in either intervention group. The results of the present study support the use of electromagnetically generated extracorporeal shockwave therapy for the treatment of

  1. Device-Guided Paced Respiration as an Adjunctive Therapy for Hypertension in Obstructive Sleep Apnea: A Pilot Feasibility Study

    PubMed Central

    Bertisch, Suzanne M.; Schomer, Ashley; Kelly, Erin E.; Baloa, Leonardo A.; Hueser, Lauren E.; Pittman, Stephen D.; Malhotra, Atul

    2011-01-01

    Background Data suggest that device-guided paced respiration (<10 breaths/minute) may reduce blood pressure in hypertensive patients. We hypothesized that daily device-guided slow breathing may lower blood pressure in patients with hypertension and obstructive sleep apnea (OSA). Methods In this one-arm pilot study, we enrolled 25 subjects with hypertension and OSA. Subjects were asked to perform device-guided paced respiration 30 minutes a day for 8 weeks. Our primary outcome was change in office systolic and diastolic blood pressures from baseline to 8 weeks. Results Twenty-four subjects completed the study. Mean baseline blood pressure was 140.0 ± 10.2 mmHg systolic and 82.7 ± 8.9 mmHg diastolic. Complete device data were available for 17 subjects. Mean device adherence was 81% ± 24% and 51% achieved a mean breath rate ≤10 breaths/minute over 8 weeks. Three subjects had changes in their anti-hypertensive medications during the study. Among the remaining 21 subjects, mean difference in office blood pressure from baseline to 8 weeks was −9.6 ± 11.8 mmHg systolic (p= < 0.01) and −2.52 ± 8.9 mmHg diastolic (p=0.21). Conclusion Device-guided paced respiration may lower systolic blood pressure in patients with hypertension and OSA; however, our findings need to be confirmed with larger randomized controlled trials. PMID:21523471

  2. 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.

  3. Device-guided paced respiration as an adjunctive therapy for hypertension in obstructive sleep apnea: a pilot feasibility study.

    PubMed

    Bertisch, Suzanne M; Schomer, Ashley; Kelly, Erin E; Baloa, Leonardo A; Hueser, Lauren E; Pittman, Stephen D; Malhotra, Atul

    2011-09-01

    Data suggest that device-guided paced respiration (<10 breaths/min) may reduce blood pressure in hypertensive patients. We hypothesized that daily device-guided slow breathing may lower blood pressure in patients with hypertension and obstructive sleep apnea (OSA). In this one-arm pilot study, we enrolled 25 subjects with hypertension and OSA. Subjects were asked to perform device-guided paced respiration 30 min a day for 8 weeks. Our primary outcome was change in office systolic and diastolic blood pressures from baseline to 8 weeks. Twenty-four subjects completed the study. Mean baseline blood pressure was 140.0 ± 10.2 mmHg systolic and 82.7 ± 8.9 mmHg diastolic. Complete device data were available for 17 subjects. Mean device adherence was 81 ± 24% and 51% achieved a mean breath rate ≤10 breaths/min over 8 weeks. Three subjects had changes in their anti-hypertensive medications during the study. Among the remaining 21 subjects, mean difference in office blood pressure from baseline to 8 weeks was -9.6 ± 11.8 mmHg systolic (p ≤ 0.01) and -2.52 ± 8.9 mmHg diastolic (p = 0.21). Device-guided paced respiration may lower systolic blood pressure in patients with hypertension and OSA; however, our findings need to be confirmed with larger randomized controlled trials.

  4. Implantation of a left ventricular assist device as a destination therapy in Duchenne muscular dystrophy patients with end stage cardiac failure: management and lessons learned.

    PubMed

    Iodice, Francesca; Testa, Giuseppina; Averardi, Marco; Brancaccio, Gianluca; Amodeo, Antonio; Cogo, Paola

    2015-01-01

    Duchenne muscular dystrophy (DMD) is an X-linked recessive disorder, characterized by progressive skeletal muscle weakness, loss of ambulation, and death secondary to cardiac or respiratory failure. End-stage dilated cardiomyopathy (DCM) is a frequent finding in DMD patients, they are rarely candidates for cardiac transplantation. Recently, the use of ventricular assist devices as a destination therapy (DT) as an alternative to cardiac transplantation in DMD patients has been described. Preoperative planning and patient selection play a significant role in the successful postoperative course of these patients. We describe the preoperative, intraoperative and postoperative management of Jarvik 2000 implantation in 4 DMD pediatric (age range 12-17 years) patients. We also describe the complications that may occur. The most frequent were bleeding and difficulty in weaning from mechanical ventilation. Our standard protocol includes: 1) preoperative multidisciplinary evaluation and selection, 2) preoperative and postoperative non-invasive ventilation and cough machine cycles, 3) intraoperative use of near infrared spectroscopy (NIRS) and transesophageal echocardiography, 4) attention on surgical blood loss, use of tranexamic acid and prothrombin complexes, 5) early extubation and 6) avoiding the use of nasogastric feeding tubes and nasal temperature probes. Our case reports describe the use of Jarvik 2000 as a destination therapy in young patients emphasizing the use of ventricular assist devices as a new therapeutic option in DMD. PMID:25444433

  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.

  6. 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.

  7. 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.

  8. Use of a novel hemoadsorption device for cytokine removal as adjuvant therapy in a patient with septic shock with multi-organ dysfunction: A case study.

    PubMed

    Basu, Reshma; Pathak, Sunjay; Goyal, Jyoti; Chaudhry, Rajeev; Goel, Rati B; Barwal, Anil

    2014-12-01

    CytoSorb(®) (CytoSorbents Corporation, USA) is a novel sorbent hemoadsorption device for cytokine removal. The aim of this study was to examine the clinical use of CytoSorb(®) in the management of patient with septic shock. We used this device as an adjuvant to stabilize a young patient with multi-organ failure and severe sepsis with septic shock. A 36-year-old female patient was hospitalized with the complaints of malaise, general body ache, and breathing difficulty and had a medical history of diabetes mellitus type II, hypertension, obstructive sleep apnea, hypothyroidism and morbid obesity. She was diagnosed to have septic shock with multi-organ dysfunction (MODS) and a low perfusion state. CytoSorb(®) hemoadsorption column was used as an attempt at blood purification. Acute physiology and chronic health evaluation score, MODS score, and sequential organ failure assessment score were measured before and after the device application. CytoSorb application as an adjuvant therapy could be considered in septic shock.

  9. 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.

  10. 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

  11. 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

  12. A single implantable cardioverter-defibrillator shock unmasking an electrical storm of 389 ventricular tachycardia episodes triggering device therapies.

    PubMed

    Arias, Miguel A; Valverde, Irene; Puchol, Alberto; Castellanos, Eduardo; Rodríguez-Padial, Luis; Sánchez, Ana M; Alvarez-Temiño, María; Palomino, Miguel

    2008-11-01

    We describe the case of a patient with ischemic cardiomyopathy who presented the first implantable cardioverter-defibrillator (ICD) shock approximately 5 months after implantation. Device interrogation surprisingly revealed the occurrence of 389 ventricular tachyarrhythmia episodes terminated by asymptomatic antitachycardia pacing (ATP) except for the episode requiring shock. The present case of electrical storm highlights how contemporary tiered ATP schemes constitute a valuable but underused form of termination for ventricular tachyarrhythmias in ICD patients, reducing the number of painful shocks and their adverse consequences.

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

    2015-05-12

    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.

  18. 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.

  19. 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

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

    PubMed

    Hurd, Theresa; Trueman, Paul; Rossington, Alan

    2014-03-01

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

  1. Acute resynchronization with inhaled iloprost in a pregnant woman with idiopathic pulmonary artery hypertension.

    PubMed

    Cotrim, Carlos; Simões, Otília; Loureiro, M J; Cordeiro, Pedro; Miranda, Rita; Silva, Cecília; Avillez, Teresa; Carrageta, Manuel

    2006-05-01

    We describe the case of a pregnant woman with idiopathic pulmonary arterial hypertension, a responder in right heart catheterization, followed since the first trimester in outpatient consultations, admitted to hospital at 23 weeks gestation. She was treated with inhaled iloprost until delivery (at 34 weeks gestation) and continuous infusion of iloprost throughout the perioperative period and following days. This line of therapy has proved efficacious in previous cases. The authors present echocardiographic images that document acute changes in ventricular synchrony during inhalation of iloprost.

  2. 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."

  3. Improvement of cardiac sarcoplasmic reticulum calcium cycling in dogs with heart failure following long-term therapy with the Acorn Cardiac Support Device.

    PubMed

    Gupta, Ramesh C; Mishra, Sudhish; Rastogi, Sharad; Sharov, Victor G; Sabbah, Hani N

    2005-06-01

    Abnormal Ca(2+)-homeostasis is a hall-marked characteristic of the failing heart. In the normal myocardium, the sarcoplasmic reticulum (SR) is a principal organelle that controls intracellular Ca(2+) concentration during the cardiac cycle. The SR consists of longitudinal and terminal cisternea regions. The former contains the Ca(2+)-ATPase pump or SERCA-2a whose function is to transport cytosolic Ca(2+) into the lumen of the SR during diastole and whose activity is regulated by reversible phosphorylation of the endogenously SR-bound phospholamban (PLB). The SR's terminal cisternea region contains ryanodine-sensitive Ca(2+)-release channels (RR), the activity of which is regulated by direct and indirect reversible phosphorylation. These channels release the SR-stored Ca(2+) during contraction. We have shown that in left ventricular (LV) myocardium from dogs with coronary microembolization-induced heart failure, ability of the SR to sequester and release Ca(2+) during the cardiac cycles is impaired. This abnormality was associated with reduced expression (protein and mRNA) levels of Ca(2+)-ATPase, PLB, and reduced PLB phosphorylation. Long-term therapy with the Acorn Cardiac Support Device (CSD) is associated with restoration of the ability of the SR to sequester Ca(2+). This improvement in SR function following chronic CSD therapy was due primarily to increased affinity of the SERCA-2a for calcium. The later was associated with (1) increased phosphorylation of PLB at serine 16 and threonine 17, (2) unchanged protein expression of PLB and (3) unchanged protein expression of SERCA-2a in LV myocardium of CSD-treated dogs compared to controls. This review summarizes our current understanding of the role of the CSD in modulating SR calcium cycling in an experimental canine model of chronic heart failure produced by multiple sequential intracoronary microembolizations. PMID:16258722

  4. 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

  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. 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

  7. Evaluation of relative transmitted dose for a step and shoot head and neck intensity modulated radiation therapy using a scanning liquid ionization chamber electronic portal imaging device

    PubMed Central

    Mohammadi, Mohammad; Bezak, Eva

    2012-01-01

    The dose delivery verification for a head and neck static intensity modulated radiation therapy (IMRT) case using a scanning liquid ionization chamber electronic portal imaging device (SLIC-EPID) was investigated. Acquired electronic portal images were firstly converted into transmitted dose maps using an in-house developed method. The dose distributions were then compared with those calculated in a virtual EPID using the Pinnacle3 treatment planning system (TPS). Using gamma evaluation with the ΔDmax and DTA criteria of 3%/2.54 mm, an excellent agreement was observed between transmitted dose measured using SLIC-EPID and that calculated by TPS (gamma score approximately 95%) for large MLC fields. In contrast, for several small subfields, due to SLIC-EPID image blurring, significant disagreement was found in the gamma results. Differences between EPID and TPS dose maps were also observed for several parts of the radiation subfields, when the radiation beam passed through air on the outside of tissue. The transmitted dose distributions measured using portal imagers such as SLIC-EPID can be used to verify the dose delivery to a patient. However, several aspects such as accurate calibration procedure and imager response under different conditions should be taken into the consideration. In addition, SLIC-EPID image blurring is another important issue, which should be considered if the SLIC-EPID is used for clinical dosimetry verification. PMID:22363108

  8. Evaluation of relative transmitted dose for a step and shoot head and neck intensity modulated radiation therapy using a scanning liquid ionization chamber electronic portal imaging device.

    PubMed

    Mohammadi, Mohammad; Bezak, Eva

    2012-01-01

    The dose delivery verification for a head and neck static intensity modulated radiation therapy (IMRT) case using a scanning liquid ionization chamber electronic portal imaging device (SLIC-EPID) was investigated. Acquired electronic portal images were firstly converted into transmitted dose maps using an in-house developed method. The dose distributions were then compared with those calculated in a virtual EPID using the Pinnacle(3) treatment planning system (TPS). Using gamma evaluation with the ΔD(max) and DTA criteria of 3%/2.54 mm, an excellent agreement was observed between transmitted dose measured using SLIC-EPID and that calculated by TPS (gamma score approximately 95%) for large MLC fields. In contrast, for several small subfields, due to SLIC-EPID image blurring, significant disagreement was found in the gamma results. Differences between EPID and TPS dose maps were also observed for several parts of the radiation subfields, when the radiation beam passed through air on the outside of tissue. The transmitted dose distributions measured using portal imagers such as SLIC-EPID can be used to verify the dose delivery to a patient. However, several aspects such as accurate calibration procedure and imager response under different conditions should be taken into the consideration. In addition, SLIC-EPID image blurring is another important issue, which should be considered if the SLIC-EPID is used for clinical dosimetry verification.

  9. 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

  10. Adrenal glucocorticoids have a key role in circadian resynchronization in a mouse model of jet lag.

    PubMed

    Kiessling, Silke; Eichele, Gregor; Oster, Henrik

    2010-07-01

    Jet lag encompasses a range of psycho- and physiopathological symptoms that arise from temporal misalignment of the endogenous circadian clock with external time. Repeated jet lag exposure, encountered by business travelers and airline personnel as well as shift workers, has been correlated with immune deficiency, mood disorders, elevated cancer risk, and anatomical anomalies of the forebrain. Here, we have characterized the molecular response of the mouse circadian system in an established experimental paradigm for jet lag whereby mice entrained to a 12-hour light/12-hour dark cycle undergo light phase advancement by 6 hours. Unexpectedly, strong heterogeneity of entrainment kinetics was found not only between different organs, but also within the molecular clockwork of each tissue. Manipulation of the adrenal circadian clock, in particular phase-shifting of adrenal glucocorticoid rhythms, regulated the speed of behavioral reentrainment. Blocking adrenal corticosterone either prolonged or shortened jet lag, depending on the time of administration. This key role of adrenal glucocorticoid phasing for resetting of the circadian system provides what we believe to be a novel mechanism-based approach for possible therapies for jet lag and jet lag-associated diseases. PMID:20577050

  11. Exercise performance of chronic heart failure patients in the early period of support by an axial-flow left ventricular assist device as destination therapy.

    PubMed

    Compostella, Leonida; Russo, Nicola; Setzu, Tiziana; Compostella, Caterina; Bellotto, Fabio

    2014-05-01

    Axial-flow left ventricular assist devices (LVADs) are increasingly used as destination therapy in end-stage chronic heart failure (CHF), as they improve survival and quality of life. Their effect on exercise tolerance in the early phase after implantation is still unclear. The aim of this study was to evaluate the effect of LVADs on the exercise capacity of a group of CHF patients within 2 months after initiation of circulatory support. Cardiopulmonary exercise test data were collected for 26 consecutive LVAD-implanted CHF patients within 2 months of initiation of assistance; the reference group consisted of 30 CHF patients not supported by LVAD who were evaluated after an episode of acute heart failure. Both LVAD and reference groups showed poor physical performance; LVAD patients achieved lower workload (LVAD: 36.3 ± 9.0 W, reference: 56.6 ± 18.2 W, P < 0.001) but reached a similar peak oxygen uptake (peak VO2 ; LVAD: 12.5 ± 3.0 mL/kg/min, reference: 13.6 ± 2.9 mL/kg/min, P = ns) and similar percentages of predicted peak VO2 (LVAD: 48.8 ± 13.9%, reference: 54.2 ± 15.3%, P = ns). While the values of the O2 uptake efficiency slope were 12% poorer in LVAD patients than in reference patients (1124.2 ± 226.3 vs. 1280.2 ± 391.1; P = ns), the kinetics of VO2 recovery after exercise were slightly better in LVAD patients (LVAD: 212.5 ± 62.5, reference: 261.1 ± 80.2 sec, P < 0.05). In the first 2 months after initiation of circulatory support, axial-flow LVAD patients are able to sustain a low-intensity workload; though some cardiopulmonary exercise test parameters suggest persistence of a marked physical deconditioning, their cardiorespiratory performance is similar to that of less compromised CHF patients, possibly due to positive hemodynamic effects beginning to be produced by the assist device.

  12. 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

  13. 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

  14. 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.

  15. Nano-photosensitizers Engineered to Generate a Tunable Mix of Reactive Oxygen Species, for Optimizing Photodynamic Therapy, Using a Microfluidic Device

    PubMed Central

    Yoon, Hyung Ki; Lou, Xia; Chen, Yu-Chih; Koo Lee, Yong-Eun; Yoon, Euisik; Kopelman, Raoul

    2014-01-01

    This work is aimed at engineering photosensitizer embedded nanoparticles (NPs) that produce optimal amount of reactive oxygen species (ROS) for photodynamic therapy (PDT). A revised synthetic approach, coupled with improved analytical tools, resulted in more efficient PDT. Specifically, methylene blue (MB) conjugated polyacrylamide nanoparticles (PAA NPs), with a polyethylene glycol dimethacrylate (PEGDMA, Mn 550) cross-linker, were synthesized so as to improve the efficacy of cancer PDT. The long cross-linker chain, PEGDMA, increases the distance between the conjugated MB molecules so as to avoid self-quenching of the excited states or species, and also enhances the oxygen permeability of the NP matrix, when compared to the previously used shorter cross-linker. The overall ROS production from the MB–PEGDMA PAA NPs was evaluated using the traditional way of monitoring the oxidation rate kinetics of anthracence-9,10-dipropionic acid (ADPA). We also applied singlet oxygen sensor green (SOSG) so as to selectively derive the singlet oxygen (1O2) production rate. This analysis enabled us to investigate the ROS composition mix based on varied MB loading. To effectively obtain the correlation between the ROS productivity and the cell killing efficacy, a microfluidic chip device was employed to provide homogeneous light illumination from an LED for rapid PDT efficacy tests, enabling simultaneous multiple measurements while using only small amounts of NPs sample. This provided multiplexed, comprehensive PDT efficacy assays, leading to the determination of a near optimal loading of MB in a PAA matrix for high PDT efficacy by measuring the light-dose-dependent cell killing effects of the various MB–PEGDMA PAA NPs using C6 glioma cancer cells. PMID:24701030

  16. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark

    PubMed Central

    Kirkfeldt, Rikke Esberg; Johansen, Jens Brock; Nohr, Ellen Aagaard; Jørgensen, Ole Dan; Nielsen, Jens Cosedis

    2014-01-01

    Aims Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality. Methods and results Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1–1.6), underweight (aRR 1.5; 1.1–2.3), implanted in a centre with an annual volume <750 procedures (0–249 procedures: aRR 1.6; 1.1–2.2, 250–499: aRR 2.0; 1.6–2.7, 500–749: aRR 1.5; 1.2–1.8), received a dual-chamber ICD (aRR 2.0; 1.4–2.7) or CRT-D (aRR 2.6; 1.9–3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0–1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4–2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0–2.3). Conclusion CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment. PMID:24347317

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

    PubMed Central

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

    2016-01-01

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

  18. 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

  19. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... Devices; Classification of Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound... Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure... Apparatus Device Intended for Negative Pressure Wound Therapy.'' The agency is classifying the device...

  20. [Aerosol therapy].

    PubMed

    Wildhaber, J H

    1998-08-15

    Aerosol therapy plays a major role in the diagnosis and treatment of various lung diseases. The aim of inhalation therapy is to deposit a reproducible and adequate dose of a specific drug to the airways, in order to achieve a high, local, clinical effect while avoiding serious systemic side effects. To achieve this goal, it is therefore important to have an efficient inhalation device to deliver different medications. However, the currently available therapeutic inhalation devices (nebuliser, pressurised metered-dose inhaler and dry powder inhaler) are not very efficient in aerosol delivery and have several disadvantages. Inhalation devices can be assessed by in vitro studies, filter studies and radiolabelled deposition studies. Several radiolabelled deposition studies have shown that nebulisers and pressurised metered-dose inhalers are not very efficient in aerosol delivery. In children, before 1997, only 0.5% to 15% of the total nebulised or actuated dose from a nebuliser or pressurised metered-dose inhaler actually reached the lungs. These numbers were somewhat improved in adults, 30% of the total nebulised or actuated dose reaching the airways. Aerosol therapy with dry powder inhalers was the most efficient before 1997, 30% of the total dose being deposited in the lungs of adults and children. In 1997, new developments in pressurised metered-dose inhalers much improved their efficiency in aerosol delivery. Lung deposition can be increased by up to 60% with use of a non-electrostatic holding chamber and/or a pressurised metered-dose inhaler with a hydrofluoroalkane propellant possessing superior aerosol characteristics. Several studies comparing the clinical efficiency of different inhalation devices have shown that the choice of an optimal inhalation device is crucial. In addition to the aerosol characteristics, ventilation parameters and airway morphology have an important bearing on deposition patterns. These parameters may be greatly influenced by the

  1. 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

  2. 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

  3. 21 CFR 892.5750 - Radionuclide radiation therapy system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  4. 21 CFR 892.5300 - Medical neutron radiation therapy system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  5. 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...

  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... (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...

  7. 21 CFR 892.5750 - Radionuclide radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radionuclide radiation therapy system. 892.5750... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5750 Radionuclide radiation therapy system. (a) Identification. A radionuclide radiation therapy system is a device intended to permit...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  10. Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy (ESWT) device: a North American confirmatory study.

    PubMed

    Kudo, Patricia; Dainty, Katie; Clarfield, Michael; Coughlin, Larry; Lavoie, Pauline; Lebrun, Constance

    2006-02-01

    Despite numerous publications and clinical trials, the results of treatment of recalcitrant chronic plantar fasciitis with extracorporeal shockwave therapy (ESWT) still remain equivocal as to whether or not this treatment provides relief from the pain associated with this condition. The objective of this study was to determine whether extracorporeal shock wave therapy can safely and effectively relieve the pain associated with chronic plantar fasciitis compared to placebo treatment, as demonstrated by pain with walking in the morning. This was set in a multicenter, randomized, placebo-controlled, double-blind, confirmatory clinical study undertaken in four outpatient orthopedic clinics. The patients, 114 adult subjects with chronic plantar fasciitis, recalcitrant to conservative therapies for at least 6 months, were randomized to two groups. Treatment consisted of approximately 3,800 total shock waves (+/-10) reaching an approximated total energy delivery of 1,300 mJ/mm(2) (ED+) in a single session versus placebo treatment. This study demonstrated a statistically significant difference between treatment groups in the change from baseline to 3 months in the primary efficacy outcome of pain during the first few minutes of walking measured by a visual analog scale. There was also a statistically significant difference between treatments in the number of participants whose changes in Visual Analog Scale scores met the study definition of success at both 6 weeks and 3 months posttreatment; and between treatment groups in the change from baseline to 3 months posttreatment in the Roles and Maudsley Score. The results of this study confirm that ESWT administered with the Dornier Epos Ultra is a safe and effective treatment for recalcitrant plantar fasciitis.

  11. Central Nervous System Device Infections.

    PubMed

    Hasbun, Rodrigo

    2016-11-01

    Nosocomial meningitis can occur in association with central nervous system (CNS) devices such as cerebrospinal shunts or drains, intrathecal pumps, and deep brain stimulators and carry substantial morbidity and mortality. Diagnosing and treating these infections may be challenging to physicians as cerebrospinal fluid cultures may be negative due to previous antibiotic therapy and cerebrospinal abnormalities may be secondary to the primary neurosurgical issue that prompted the placement of the CNS device (e.g., "chemical meningitis" due to intracranial hemorrhage). Besides antibiotic therapy given intravenously and sometimes intrathecally, removal of the device with repeat cultures prior to re-implantation is key in achieving successful outcomes. PMID:27686676

  12. 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

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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

    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.

  18. Current devices of respiratory physiotherapy

    PubMed Central

    Hristara-Papadopoulou, A; Tsanakas, J; Diomou, G; Papadopoulou, O

    2008-01-01

    In recent years patients with respiratory diseases use various devices, which help the removal of mucus from the airways and the improvement of pulmonary function. The aim of the present study is to determine the effectiveness of the current devices of respiratory physiotherapy, as it comes from the review of literature. The current devices of physiotherapy for patients with respiratory diseases, are presented as an alternative therapy method or a supplemental therapy and they can motivate patients to apply therapy by themselves. These devices seem to increase patients' compliance to daily treatment, because they present many benefits, as independent application, full control of therapy and easy use. These devices are the Positive Expiratory Pressure, the High Frequency Chest Wall Oscillation, the Oral High Frequency Oscillation, the Intrapulmonary Percussive Ventilation, the Incentive Spirometry the Flutter and the Acapella and the Cornet. Current devices seem to be effective in terms of mucus expectoration and pulmonary function improvement, as it is shown by published studies. The choice of the suitable device for each patient is a challenge for the physiotherapist in order to achieve better compliance in daily treatment. More controlled studies are needed due to the fact that the number of published studies is limited. PMID:19158964

  19. 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.

  20. Photovoltaic device

    DOEpatents

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

    2015-09-01

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

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. Sealing device

    DOEpatents

    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.

  8. 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

  9. 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.

  10. 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.

  11. Wireless quantified reflex device

    NASA Astrophysics Data System (ADS)

    Lemoyne, Robert Charles

    The deep tendon reflex is a fundamental aspect of a neurological examination. The two major parameters of the tendon reflex are response and latency, which are presently evaluated qualitatively during a neurological examination. The reflex loop is capable of providing insight for the status and therapy response of both upper and lower motor neuron syndromes. Attempts have been made to ascertain reflex response and latency, however these systems are relatively complex, resource intensive, with issues of consistent and reliable accuracy. The solution presented is a wireless quantified reflex device using tandem three dimensional wireless accelerometers to obtain response based on acceleration waveform amplitude and latency derived from temporal acceleration waveform disparity. Three specific aims have been established for the proposed wireless quantified reflex device: 1. Demonstrate the wireless quantified reflex device is reliably capable of ascertaining quantified reflex response and latency using a quantified input. 2. Evaluate the precision of the device using an artificial reflex system. 3.Conduct a longitudinal study respective of subjects with healthy patellar tendon reflexes, using the wireless quantified reflex evaluation device to obtain quantified reflex response and latency. Aim 1 has led to the steady evolution of the wireless quantified reflex device from a singular two dimensional wireless accelerometer capable of measuring reflex response to a tandem three dimensional wireless accelerometer capable of reliably measuring reflex response and latency. The hypothesis for aim 1 is that a reflex quantification device can be established for reliably measuring reflex response and latency for the patellar tendon reflex, comprised of an integrated system of wireless three dimensional MEMS accelerometers. Aim 2 further emphasized the reliability of the wireless quantified reflex device by evaluating an artificial reflex system. The hypothesis for aim 2 is that

  12. 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)

  13. Candida Infections of Medical Devices

    PubMed Central

    Kojic, Erna M.; Darouiche, Rabih O.

    2004-01-01

    The number of indwelling medical devices is escalating, and an increasing proportion of device-related infections are being caused by Candida spp. Candida spp. produce biofilms on synthetic materials, which facilitates adhesion of the organisms to devices and renders them relatively refractory to medical therapy. Management of device-related Candida infections can be challenging. Removal of the infected device is generally needed to establish cure of Candida infections of medical devices. However, since the pathogenesis of Candida bloodstream infection is complicated, more studies are necessary to determine the role of catheter exchange in patients with both gastrointestinal tract mucositis and indwelling catheters. The medical and economic impact of these infections is enormous. PMID:15084500

  14. 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

  15. 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

  16. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  17. 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...

  18. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  19. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 21 CFR 892.5840 - Radiation therapy simulation system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  1. 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)

  2. 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

  3. [Cardiac contractility modulation. A new form of therapy for patients with heart failure and narrow QRS complex?].

    PubMed

    Kleemann, T

    2015-11-01

    Cardiac contractility modulation (CCM) is a stimulation therapy by an implantable impulse generator, which enhances ventricular contractile performance by delivering CCM impulses to the right ventricle during the absolute refractory period. The CCM signals mediate increased inotropy by prolonging the duration of the action potential, which leads to an enhanced influx of calcium into cardiomyocytes and a greater release of calcium by the sarcoplasmic reticulum. The increase of cardiac contractility is not associated with increased oxygen consumption. Several small studies have shown that CCM therapy can safely improve symptoms of heart failure and peak oxygen consumption in patients with moderate to severe heart failure who are not eligible for resynchronization therapy. Therefore, CCM is a novel potential therapy for patients with heart failure, an ejection fraction ≤ 35 % and a normal QRS duration < 130 ms. However, apart from selecting appropriate patients for CCM therapy there are still unanswered questions, such as the impact of CCM therapy on established clinical endpoints. At present no data are available which have shown that CCM therapy leads to reduction of hospitalization for heart failure or mortality.

  4. 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...

  5. 21 CFR 892.5710 - Radiation therapy beam-shaping block.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiation therapy beam-shaping block. 892.5710... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5710 Radiation therapy beam-shaping block. (a) Identification. A radiation therapy beam-shaping block is a device made of a...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 21 CFR 892.5900 - X-ray radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false X-ray radiation therapy system. 892.5900 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5900 X-ray radiation therapy system. (a) Identification. An x-ray radiation therapy system is a device intended to produce and control...

  14. Sleep apnoea in patients with heart failure: part II: therapy.

    PubMed

    Bordier, Philippe

    2009-10-01

    Nasal continuous positive airway pressure (CPAP) is generally recommended for the treatment of obstructive sleep apnoea. CPAP lowers the cardiovascular morbidity and mortality associated with severe obstructive sleep apnoea. At least 50% of patients presenting with chronic heart failure (HF) have sleep apnoea; a subset of these patients may have obstructive sleep apnoea and may derive a survival benefit from CPAP. However, this population is also prone to developing central sleep apnoea, Cheyne-Stokes respiration or both (CSA/CSR), for which CPAP lowers the apnoea-hypopnoea index only partially and for which the overall effect of CPAP on survival remains to be determined, particularly as it has been observed to increase the mortality rate in subsets of patients. Other treatments may prove effective in patients with chronic HF and CSA/CSR, although none, thus far, has been found to confer a survival benefit. New ventilatory modes include bi-level positive airway pressure and automated adaptive servoventilation, the latter being most effective against CSA/CSR. Measures that can alleviate CSA/CSR indirectly include beta-adrenergic blockers and renin-angiotensin-aldosterone system inhibitors, nocturnal supplemental oxygen and cardiac resynchronization therapy (CRT). The effects of theophylline, acetazolamide and nocturnal CO(2) have also been studied. The second part of this review describes the applications and effects of therapies that are available for sleep apnoea in patients with chronic HF.

  15. 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 ...

  16. Ventricular assist device

    MedlinePlus

    VAD; RVAD; LVAD; BVAD; Right ventricular assist device; Left ventricular assist device; Biventricular assist device; Heart pump; Left ventricular assist system; LVAS; Implantable ventricular assist device

  17. 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.

  18. 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.

  19. 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.

  20. Ventricular assist devices: The future is now.

    PubMed

    Lima, Brian; Mack, Michael; Gonzalez-Stawinski, Gonzalo V

    2015-05-01

    Heart failure has become a global epidemic. For advanced heart failure, a broad assortment of device options have been introduced for both acute and prolonged intervals of hemodynamic assistance. Durable implantable ventricular assist devices (VADs) in particular play a key role in the management of advanced heart failure. This review focuses specifically on the current outcomes with VAD therapy, highlights the results from pivotal clinical trials, and summarizes the various device options on the market and those in preclinical development. PMID:25596799

  1. 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.

  2. 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.

  3. 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.

  4. [Devic disease].

    PubMed

    Papeix, Caroline

    2006-11-01

    Devic disease, also known as neuromyelitis optica, is a severe rare condition characterized clinically by one or more episodes of optical neuritis and myelitis. Pathologically, it is characterized by extensive demyelination associated with axon loss and deposits of complement and immunoglobulins (IgM) within the lesions. Specific antibodies for this disease (IgG NMO) were recently identified. Immunosuppressive treatment is currently the best option for preventing relapse. PMID:17086129

  5. Medical devices regulatory aspects: a special focus on polymeric material based devices.

    PubMed

    Sridhar, Radhakrishnan; Pliszka, Damian; Luo, He-Kuan; Chin Lim, Keith Hsiu; Ramakrishna, Seeram

    2015-01-01

    Medical devices form a broad range of appliances from a basic nanoparticle coating or surgical gloves to a complicated laser therapy device. These devices are designed to support patients, surgeons and healthcare personnel in meeting patients' healthcare needs. Regulatory authorities of each country regulate the process of approval, manufacturing and sales of these medical devices so as to ensure safety and quality to patients or users. Recent recalls of medical devices has increased importance of safety, awareness and regulation of the devices. Singapore and India have strong presence and national priorities in medical devices development and use. Herein we capture the rationale of each of these national regulatory bodies and compare them with the medical devices regulatory practices of USA and European nations. Apart from the comparison of various regulatory aspects, this review will specifically throw light on the polymer material based medical devices and their safety.

  6. Electrooptical devices

    NASA Astrophysics Data System (ADS)

    Hurwitz, C. E.

    1980-03-01

    This report covers work carried out with support of the Department of the Air Force during the period 1 October 1979 through 31 March 1980. A part of this support was provided by the Rome Air Development Center. CW operation at temperatures up to 55 C has been achieved for GaInAsP/InP double-heterostructure (DH) lasers emitting at 1.5 micrometers, which were grown without a GaInAsP buffer layer. These devices are of interest for use as sources in fiber-optics communications systems, since the lowest transmission loss reported for fused-silica optical fibers occurs at 1.55 micrometers. Surface passivation techniques developed for InP and GaInAsP avalanche photodiodes have resulted in reductions of dark current as large as four orders of magnitude, to values as low as .0000016 A/sq cm at 0.9 V(b) where V(b) is the breakdown voltage. Devices consisting entirely of InP have been passivated with plasma-deposited Si3N4, and those with a GaInAsP layer but with the p-n junction in InP have been passivated with polyimide. Neither of these techniques successfully reduces dark currents in devices with the p-n junction in the GaInAsP, but a film of photoresist sprayed with SF6 as the propellant has given excellent results. The electrical characteristics in InP ion implanted with Sn, Ge, Si, and C have been investigated. All of these column IV elements yielded n-type conductivity and Sn, Ge, and Si showed high electrical activation; however, implanted C was found to have a net electrical activation of only about 5 percent.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Biocompatibility of implantable biomedical devices

    NASA Astrophysics Data System (ADS)

    Lyu, Suping

    2008-03-01

    Biomedical devices have been broadly used to treat human disease, especially chronic diseases where pharmaceuticals are less effective. Heart valve and artificial joint are examples. Biomedical devices perform by delivering therapies such as electric stimulations, mechanical supports and biological actions. While the uses of biomedical devices are highly successful they can trigger adverse biological reactions as well. The property that medical devices perform with intended functions but not causing unacceptable adverse effects was called biocompatibility in the early time. As our understanding of biomaterial-biological interactions getting broader, biocompatibility has more meanings. In this talk, I will present some adverse biological reactions observed with implantable biomedical devices. Among them are surface fouling of implantable sensors, calcification with vascular devices, restenosis with stents, foreign particle migration and mechanical fractures of devices due to inflammation reactions. While these effects are repeatable, there are very few quantitative data and theories to define them. The purpose of this presentation is to introduce this biocompatibility concept to biophysicists to stimulate research interests at different angles. An open question is how to quantitatively understand the biocompatibility that, like many other biological processes, has not been quantified experimentally.

  14. Optoelectronic device

    DOEpatents

    Bonekamp, Jeffrey E.; Boven, Michelle L.; Gaston, Ryan S.

    2014-09-09

    The invention is an optoelectronic device comprising an active portion which converts light to electricity or converts electricity to light, the active portion having a front side for the transmittal of the light and a back side opposite from the front side, at least two electrical leads to the active portion to convey electricity to or from the active portion, an enclosure surrounding the active portion and through which the at least two electrical leads pass wherein the hermetically sealed enclosure comprises at the front side of the active portion a barrier material which allows for transmittal of light, one or more getter materials disposed so as to not impede the transmission of light to or from the active portion, and a contiguous gap pathway to the getter material which pathway is disposed between the active portion and the barrier material.

  15. 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.

  16. 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)

  17. 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.

  18. 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...

  19. 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

  20. Integrated device architectures for electrochromic devices

    SciTech Connect

    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.

  1. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  2. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  3. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  4. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  5. 21 CFR 892.5770 - Powered radiation therapy patient support assembly.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered radiation therapy patient support assembly... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Therapeutic Devices § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. A powered radiation therapy patient support...

  6. 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.

  7. 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.

  8. Acute oxygen therapy.

    PubMed

    Akbar, Fazal; Campbell, Ian Allen

    2004-05-01

    Oxygen therapy is a central part of our clinical practice and is widely used in many pulmonary and non-pulmonary conditions worldwide but it is sometimes used unnecessarily and can be harmful. Optimum use is not only important for patient care but is also sound fiscally because of the expense of oxygen and the cost of devices utilised. This article is aimed both at reviewing available research and guidelines for the use of oxygen and providing knowledge of different administering and monitoring devices and equipment. Various hospital based audits have shown oxygen as being poorly prescribed and inappropriately administered and it is important for everyone involved in patient care to understand the basics of oxygen therapy before optimum practice can be implemented and followed. PMID:15225466

  9. Medical devices: US medical device regulation.

    PubMed

    Jarow, Jonathan P; Baxley, John H

    2015-03-01

    Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. It does not regulate the practice of medicine. Devices are classified based on complexity and level of risk, and "pre-1976" devices were allowed to remain on the market after being classified without FDA review. Post-1976 devices of lower complexity and risk that are substantially equivalent to a marketed "predicate" device may be cleared through the 510(k) premarket notification process. Clinical data are typically not needed for 510(k) clearance. In contrast, higher-risk devices typically require premarket approval. Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation.

  10. Thermoelectric device for treatment of radiculitis and spinal massage

    NASA Astrophysics Data System (ADS)

    Anatychuk, L. I.; Kobylyansky, R. R.

    2012-06-01

    Results of development of a thermoelectric device that enables controlled cyclic temperature impact on the damaged area of human organism are presented. Unlike the existing medical devices employing direct supply current for thermoelectric module, the present device controls supply current according to time dependence of temperature change assigned by doctor. It is established that such a device is an efficient means of therapy at herniation of intervertebral disks with marked radiculitis and tunicary syndromes, at meningitis, other spinal diseases and back traumas.

  11. [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

  12. 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 ...

  13. 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 ...

  14. Radiation therapy

    MedlinePlus

    ... Because radiation is most harmful to quickly growing cells, radiation therapy damages cancer cells more than normal cells. ... cells from growing and dividing, and leads to cell death. Radiation therapy is used to fight many types of ...

  15. 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 ... in your home. A different kind of oxygen therapy is called hyperbaric oxygen therapy. It uses oxygen ...

  16. 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.

  17. 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.

  18. Play Therapy

    PubMed Central

    Kool, Ritesh

    2010-01-01

    Play therapy represents a unique form of treatment that is not only geared toward young children, but is translated into a language children can comprehend and utilize—the language of play. For the referring provider or practitioner, questions may remain regarding the nature, course, and efficacy of play therapy. This article reviews the theoretical underpinnings of play therapy, some practical considerations, and finally a summary of the current state of research in regard to play therapy. The authors present the practicing psychiatrist with a road map for referring a patient to play therapy or initiating it in appropriate cases. PMID:21103141

  19. Medical Device Safety

    MedlinePlus

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

  20. 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.

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. Active and intelligent inhaler device development.

    PubMed

    Tobyn, Mike; Staniforth, John N; Morton, David; Harmer, Quentin; Newton, Mike E

    2004-06-11

    The dry powder inhaler, which has traditionally relied on the patient's inspiratory force to deaggregate and deliver the active agent to the target region of the lung, has been a successful delivery device for the provision of locally active agents for the treatment of conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, such devices can suffer from poor delivery characteristics and/or poor reproducibility. More recently, drugs for systemic delivery and more high value compounds have been put into DPI devices. Regulatory, dosing, manufacturing and economic concerns have demanded that a more efficient and reproducible performance is achieved by these devices. Recently strategies have been put in place to produce a more efficient DPI device/formulation combination. Using one novel device as an example the paper will examine which features are important in such a device and some of the strategies required to implement these features. All of these technological advances are invisible, and may be irrelevant, to the patient. However, their inability to use an inhaler device properly has significant implications for their therapy. Use of active device mechanisms, which reduce the dependence on patient inspiratory flow, and sensible industrial design, which give the patient the right clues to use, are important determinants of performance here.

  7. Electroconvulsive therapy

    MedlinePlus

    Shock treatment; Shock therapy; ECT; Depression - ECT; Bipolar - ECT ... ECT is a highly effective treatment for depression, most commonly ... who: Are having delusions or other psychotic symptoms with ...

  8. [Development and application of new temperature control moxibustion device].

    PubMed

    Yang, Liu; Jiang, Hao; Wang, Lifang; Ma, Haili

    2015-07-01

    To develop a new temperature control moxibustion device so as to improve the clinical therapeutic effect of moxibustion. According to the thermal effect of moxibustion, with the designs such as the modern electronic equipment (temperature control system) adopted and in combination of smoke filtration device and oxygen mask device, a new temperature control moxibustion device was developed. The new temperature control moxibustion device may achieve the automatic regulation of temperature and distance and avoid the pollution and irritation of smoke and flavor, etc. As a result, the traditional moxibustion therapy can better play its efficacy and display its safety and convenience in practice.

  9. 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…

  10. 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…

  11. 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…

  12. 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

  13. 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.

  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. 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 §...

  16. 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 §...

  17. 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 §...

  18. 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 §...

  19. 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 §...

  20. 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

  1. 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)

  2. Sealed container sampling device

    NASA Technical Reports Server (NTRS)

    Hennigan, T. J.

    1969-01-01

    Sampling device, by means of a tapered needle, pierces a sealed container while maintaining the seal and either evacuates or pressurizes the container. This device has many applications in the chemical, preservative and battery-manufacturing industries.

  3. Image-guided acoustic therapy.

    PubMed

    Vaezy, S; Andrew, M; Kaczkowski, P; Crum, L

    2001-01-01

    The potential role of therapeutic ultrasound in medicine is promising. Currently, medical devices are being developed that utilize high-intensity focused ultrasound as a noninvasive method to treat tumors and to stop bleeding (hemostasis). The primary advantage of ultrasound that lends the technique so readily to use in noninvasive therapy is its ability to penetrate deep into the body and deliver to a specific site thermal or mechanical energy with submillimeter accuracy. Realizing the full potential of acoustic therapy, however, requires precise targeting and monitoring. Fortunately, several imaging modalities can be utilized for this purpose, thus leading to the concept of image-guided acoustic therapy. This article presents a review of high-intensity focused ultrasound therapy, including its mechanisms of action, the imaging modalities used for guidance and monitoring, some current applications, and the requirements and technology associated with this exciting and promising field.

  4. 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.

  5. 76 FR 51876 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... intended for use in the application of localized heat and pressure therapy to the eyelids. The device is... component that is inserted around the eyelids and a component to control the application of heat and... Sterility and Shelf Life Testing. Adverse tissue reaction Biocompatibility. Electrical shock...

  6. 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, ...

  7. 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 ...

  8. 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 ...

  9. Photodynamic Therapy

    NASA Astrophysics Data System (ADS)

    Kaščáková, Slávka; Giuliani, Alexandre; Jamme, Frédéric; Refregiers, Matthieu

    Treatments based on absorption of electromagnetic radiation may be categorized according to the photon wavelength range. On the one hand, radiotherapy is based on X-rays delivery to tissues and is widely spread and recognized for cancer treatment. On the other hand, photodynamic therapy (PDT) involves low energy radiation in the visible and near infrared range in combination with a drug referred to as the photosensitizer. A short overview of conventional radiotherapy and accelerator-based therapy is first presented. Then PDT is introduced and its mechanisms are reviewed along with the factors affecting its outcome. The domains of application of this therapy are presented through a discussion of the most used photosentizers. Finally we present new developments in the field that would permit the combination of potentialized radiotherapy and photodynamic therapy.

  10. 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 ...

  11. Proton therapy

    MedlinePlus

    ... direction of the tumor. A machine called a synchrotron or cyclotron creates and speeds up the protons. ... redness in the radiation area, and temporary hair loss. AFTER THE PROCEDURE Following proton therapy, you should ...

  12. 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.

  13. 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.

  14. 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.

  15. Organic photosensitive devices

    DOEpatents

    Rand, Barry P; Forrest, Stephen R

    2013-11-26

    The present invention generally relates to organic photosensitive optoelectronic devices. More specifically, it is directed to organic photosensitive optoelectronic devices having a photoactive organic region containing encapsulated nanoparticles that exhibit plasmon resonances. An enhancement of the incident optical field is achieved via surface plasmon polariton resonances. This enhancement increases the absorption of incident light, leading to a more efficient device.

  16. Amorphous silicon photovoltaic devices

    DOEpatents

    Carlson, David E.; Lin, Guang H.; Ganguly, Gautam

    2004-08-31

    This invention is a photovoltaic device comprising an intrinsic or i-layer of amorphous silicon and where the photovoltaic device is more efficient at converting light energy to electric energy at high operating temperatures than at low operating temperatures. The photovoltaic devices of this invention are suitable for use in high temperature operating environments.

  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. Laser therapy

    MedlinePlus

    ... of preoperative and operative surgery: surgical devices and energy sources. In: Townsend CM, Beauchamp RD, Evers BM, Mattox KL, eds. Sabiston Textbook of Surgery . 19th ed. Philadelphia, ... technologies: principles and skin interactions. In: Bolognia JL, ...

  19. Update on arrhythmias and cardiac pacing 2013.

    PubMed

    Almendral, Jesús; Pombo, Marta; Martínez-Alday, Jesús; González-Rebollo, José M; Rodríguez-Font, Enrique; Martínez-Ferrer, José; Castellanos, Eduardo; García-Fernández, F Javier; Ruiz-Mateas, Francisco

    2014-04-01

    This report discusses a selection of the most relevant articles on cardiac arrhythmias and pacing published in 2013. The first section discusses arrhythmias, classified as regular paroxysmal supraventricular tachyarrhythmias, atrial fibrillation, and ventricular arrhythmias, together with their treatment by means of an implantable cardioverter defibrillator. The next section reviews cardiac pacing, subdivided into resynchronization therapy, remote monitoring of implantable devices, and pacemakers. The final section discusses syncope.

  20. Update on arrhythmias and cardiac pacing 2013.

    PubMed

    Almendral, Jesús; Pombo, Marta; Martínez-Alday, Jesús; González-Rebollo, José M; Rodríguez-Font, Enrique; Martínez-Ferrer, José; Castellanos, Eduardo; García-Fernández, F Javier; Ruiz-Mateas, Francisco

    2014-04-01

    This report discusses a selection of the most relevant articles on cardiac arrhythmias and pacing published in 2013. The first section discusses arrhythmias, classified as regular paroxysmal supraventricular tachyarrhythmias, atrial fibrillation, and ventricular arrhythmias, together with their treatment by means of an implantable cardioverter defibrillator. The next section reviews cardiac pacing, subdivided into resynchronization therapy, remote monitoring of implantable devices, and pacemakers. The final section discusses syncope. PMID:24774592

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 75 FR 25279 - Device Improvements to Reduce the Number of Under-Doses, Over-Doses, and Misaligned Exposures...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-07

    ... features that manufacturers should incorporate into radiation therapy devices (morning session) and..., radiation therapy treatment planning systems, and radiation therapy simulators to help reduce... attend the public meeting, you must register by e- mail at CDRHRadiationTherapy@fda.hhs.gov or...

  10. Drainage devices in glaucoma surgery.

    PubMed

    Hille, K; Moustafa, B; Hille, A; Ruprecht, K W

    2004-01-01

    Glaucoma drainage devices, also termed aqueous shunts (AS), are widely used in the USA. Indications for AS include excessive conjunctival scarring diminishing the success of another filtration surgeries, abnormalities of the iridocorneal angle, neovascular glaucoma, presence of corneal grafts, and inflammatory glaucoma. Qualified success has been achieved for many years in 50 to 100 % of the treated eyes, depending on the patient selection. An AS consists of a silicone tube that is inserted into the anterior chamber and a plate (explant) made of silicone or polypropylene. The latter is positioned between the recti muscles. Within some weeks the surrounding tissue forms a fibrous bleb around the plate. This serves as a permanent filtration reservoir. The most serious complication is postoperative hypotonia, that can lead to serious choroidal detachment, suprachoroidal hemorrhage, anterior chamber flattening, and corneal decompensation. To avoid this complication some devices, e.g. the Ahmed Glaucoma valve and the Krupin valve, have integrated mechanisms to sustain a residual intraocular pressure. With other devices such as the Molteno and the Baerveldt devices the tube has to be temporarily ligated until a scar area forms around the explant. On the other hand, fibrous infiltration of the wall of the bleb often leads to a reversible rise in intraocular pressure about one to four months after surgery which can be treated by massaging the bulb, needling the bleb, or injection of antimetabolites. There are no obvious differences between the different AS regarding the success of pressure control. With appreciation of indications and therapy of complications, AS are an useful option in the management of complicated glaucoma, where conventional filtration surgery is considered to carry a high risk of failure.

  11. Heat exchange device

    SciTech Connect

    Callison, G.

    1984-01-17

    A heat exchange device is adapted to recover heat from the fire box of a wood burning stove or the like for heating ambient air in a room or other enclosed space. The heat exchange device is adapted to mount in a recess in a stove top in place of a lid which is normally supplied with the stove. The device according to the invention includes heat exchange means which extend into the fire box of the stove below the top surface thereof. The heat from the heat exchange device is transmitted into a main cavity of the device where the heat is transferred to air forced through the main cavity by a blower mounted to an outside surface of the device. Air exit means are provided on a surface opposite to the surface on which the blower is mounted to provide a passage for heated air into the room or other enclosed space to be heated. The device may also include a top mounted isolated handle for ease in handling the device such as for moving from one area to another. In a second embodiment of the device, a high temperature heat exchange glass plate is mounted on the surface of the device which is in contact with the fire box. Heat is transmitted by heat exchange plate to the main cavity of the device where the air is heated and blown into the room as above.

  12. Electrochromic display device

    NASA Astrophysics Data System (ADS)

    Nicholson, M. M.

    1984-07-01

    This invention relates to electrochromic devices. In one aspect it relates to electrically controllable display devices. In another aspect it relates to electrically tunable optical or light filters. In yet another aspect it relates to a chemical sensor device which employs a color changing film. There are many uses for electrically controllable display devices. A number of such devices have been in commercial use for some time. These display devices include liquid crystal displays, light emitting diode displays, plasma displays, and the like. Light emitting diode displays and plasma display panels both suffer from the fact that they are active. Light emissive devices which require substantial power for their operation, In addition, it is difficult to fabricate light emitting diode displays in a manner which renders them easily distinguishable under bright ambient illumination. Liquid crystal displays suffer from the disadvantage that they are operative only over a limited temperature range and have substantially no memory within the liquid crystal material.

  13. Functional PLC devices

    NASA Astrophysics Data System (ADS)

    Takiguchi, Koichi

    2005-01-01

    This paper reports recent advances in photonic functional devices. These devices are being developed for advanced optical networks and are fabricated by using planar lightwave circuit technology. After briefly summarizing the fabrication, properties, and progress of silica based planar lightwave circuits, this work describes lattice-form dynamic devices designed to compensate for unwanted fiber characteristics with respect to high-speed wavelength division multiplexing transmissions. These dynamic devices include adaptive chromatic dispersion, polarization-mode dispersion, and gain non-uniformity compensators. The paper then describes optical signal processing devices for communications use, namely an optical label recognition device, an optical encoder/decoder for time-spreading/wavelength-hopping code division multiple access, and a spectrum synthesis device.

  14. Custom Knee Device for Knee Contractures After Internal Femoral Lengthening.

    PubMed

    Bhave, Anil; Shabtai, Lior; Ong, Peck-Hoon; Standard, Shawn C; Paley, Dror; Herzenberg, John E

    2015-07-01

    The development of knee flexion contractures is among the most common problems and complications associated with lengthening the femur with an internal device or external fixator. Conservative treatment strategies include physical therapy, serial casting, and low-load prolonged stretching with commercially available splinting systems. The authors developed an individually molded, low-cost custom knee device with polyester synthetic conformable casting material to treat knee flexion contractures. The goal of this study was to evaluate the results of treatment with a custom knee device and specialized physical therapy in patients who had knee flexion contracture during femoral lengthening with an intramedullary lengthening femoral nail. This retrospective study included 23 patients (27 limbs) who underwent femoral lengthening with an internal device for the treatment of limb length discrepancy. All patients had a knee flexion contracture raging from 10° to 90° during the lengthening process and were treated with a custom knee device and specialized physical therapy. The average flexion contracture before treatment was 36°. The mean amount of lengthening was 5.4 cm. After an average of 3.8 weeks of use of the custom knee device, only 2 of 27 limbs (7.5%) had not achieved complete resolution of the flexion contracture. The average final extension was 1.4°. Only 7 of 27 limbs (26%) required additional soft tissue release. The custom knee device is an inexpensive and effective method for treating knee flexion contracture after lengthening with an internal device.

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

    DOEpatents

    Cox, Daryl F.; Hochanadel, Charles D.; Haynes, Howard D.

    2010-05-18

    The invention is a human and animal performance data acquisition, analysis, and diagnostic system for fitness and therapy devices having an interface box removably disposed on incoming power wiring to a fitness and therapy device, at least one current transducer removably disposed on said interface box for sensing current signals to said fitness and therapy device, and a means for analyzing, displaying, and reporting said current signals to determine human and animal performance on said device using measurable parameters.

  16. Towards a myocardial contraction force reconstruction technique for heart disease assessment and therapy planning

    NASA Astrophysics Data System (ADS)

    Haddad, Seyyed M. H.; Drangova, Maria; White, James A.; Samani, Abbas

    2014-03-01

    Cardiac ischemic injuries can be classified into two main categories: reversible and irreversible. Treatment of reversible damages is possible through revascularization therapies. Clinically, it is quite vital to determine the reversibility of ischemic injuries and local efficiency using accurate diagnostics techniques. For this purpose, a number of imaging techniques have been developed. To our knowledge, while some of these techniques are capable of assessing tissue viability which is believed to be correlated with ischemic injuries reversibility, none of them are capable of providing information about local myocardial tissue efficiency. Note that this efficiency indicates the local tissue contribution to the overall (global) heart mechanical function which is characterized by parameters such as ejection fraction. While contraction force generation of the myocardium is a reliable and straightforward mechanical measure for the local myocardium functionality, it is also hypothesized that the level of damage reversibility expected from therapy is proportional to the intensity and distribution of these forces. As such this research involves developing a new imaging technique for cardiac contraction force quantification. This work is also geared towards another application, namely Cardiac Resynchronization Therapy (CRT), specifically for electrode leads configuration optimization. The latter has not been tackled through a systematic technique thus far. In the proposed method, contraction force reconstruction is accomplished by an inverse problem algorithm solved through an optimization framework which uses forward mechanical modelling of the myocardium iteratively to obtain the contraction forces field. As a result, the method requires a forward mechanical model of the myocardium which is computationally efficient and robust against divergence. Therefore, we developed such a model which considers all aspects of the myocardial mechanics including hyperelasticity

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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

  2. Biventricular assist devices: a technical review.

    PubMed

    Gregory, Shaun D; Timms, Daniel; Gaddum, Nicholas; Mason, David G; Fraser, John F

    2011-09-01

    The optimal treatment option for end stage heart failure is transplantation; however, the shortage of donor organs necessitates alternative treatment strategies such as mechanical circulatory assistance. Ventricular assist devices (VADs) are employed to support these cases while awaiting cardiac recovery or transplantation, or in some cases as destination therapy. While left ventricular assist device (LVAD) therapy alone is effective in many instances, up to 50% of LVAD recipients demonstrate clinically significant postoperative right ventricular failure and potentially need a biventricular assist device (BiVAD). In these cases, the BiVAD can effectively support both sides of the failing heart. This article presents a technical review of BiVADs, both clinically applied and under development. The BiVADs which have been used clinically are predominantly first generation, pulsatile, and paracorporeal systems that are bulky and prone to device failure, thrombus formation, and infection. While they have saved many lives, they generally necessitate a large external pneumatic driver which inhibits normal movement and quality of life for many patients. In an attempt to alleviate these issues, several smaller, implantable second and third generation devices that use either immersed mechanical blood bearings or hydrodynamic/magnetic levitation systems to support a rotating impeller are under development or in the early stages of clinical use. Although these rotary devices may offer a longer term, completely implantable option for patients with biventricular failure, their control strategies need to be refined to compete with the inherent volume balancing ability of the first generation devices. The BiVAD systems potentially offer an improved quality of life to patients with total heart failure, and thus a viable alternative to heart transplantation is anticipated with continued development. PMID:21739329

  3. Patient selection for left ventricular assist devices.

    PubMed

    Lund, Lars H; Matthews, Jennifer; Aaronson, Keith

    2010-05-01

    Heart transplantation (HTx) improves symptoms and prolongs life in advanced heart failure (HF), but organ supply is limited. In recent years, mechanical circulatory support and specifically implantable left ventricular assist devices (LVADs) have undergone technical improvements, and outcomes have improved dramatically. Left ventricular assist devices are now viable options for patients with severe HF as bridge to transplantation, destination therapy, or as bridge to recovery. Many believe that LVADs may soon provide outcomes similar to, or better than, HTx, launching a new era of end-stage HF management. The key to improving outcomes is patient selection, but the field is changing rapidly and guidelines and consensus are limited. This review summarizes recent reports of predictors of poor outcomes and provides an overview of selection for LVAD therapy. PMID:20172939

  4. [Gene therapy].

    PubMed

    Rodríguez-Fragoso, L

    1997-01-01

    In the last years there has been much progress in our understanding of molecular mechanisms in the pathogenesis of disease. In this review we provide an overview of gene therapy, its most actualized techniques for gene delivery, and we give specific examples of laboratory and clinical achievements to date. The development of methods for delivering genes to mammalian cells has stimulated great interest in the possibility of treating human disease by gene-based therapies. As a result, concepts and methods that would have been considered purely science fiction 50 years ago are now used in the treatment of diseases. The widespread application of gene therapy technology to many diseases is already breaking down the traditional boundaries of modern medicine. However, despite its progress, several key technical drawbacks need to be overcome before gene therapy can be used safely and effectively in clinical settings. Technological developments, particularly in the areas of gene delivery and cell transplantation, will be critical for the successful practice of gene therapy.

  5. MRI for patients with cardiac implantable electrical devices.

    PubMed

    Chow, Grant V; Nazarian, Saman

    2014-05-01

    MRI has become an invaluable tool in the evaluation of soft tissue and bony abnormalities. The presence of a cardiac implantable electrical device (CIED) may complicate matters, however, because these devices are considered a contraindication to MRI scanning. When MRI is performed in patients with a CIED, risks include reed switch activation in older devices, lead heating, system malfunction, and significant radiofrequency noise resulting in inappropriate inhibition of demand pacing, tachycardia therapies, or programming changes. This report reviews indications and risk-benefit evaluation of MRI in patients with CIED and provides a clinical algorithm for performing MRI in patients with implanted devices. PMID:24793805

  6. A suspicious reason for Raynaud's phenomenon: Intrauterine device.

    PubMed

    Diken, Adem I; Yalçınkaya, Adnan; Aksoy, Eray; Yılmaz, Seyhan; Çağlı, Kerim

    2015-06-01

    Primary Raynaud's phenomenon may be insistent in patients under medical therapy, and intrauterine devices may be an unnoticed reason in these patients. Fluctuations in female sex hormone status were reported to be associated with the emergence of primary Raynaud's phenomenon symptoms. The use of intrauterine devices was not reported to be associated with Raynaud's phenomenon previously. Intrauterine device may stimulate vascular hyperactivity regarding hormonal or unknown mechanisms that result in Raynaud's phenomenon. We present a postmenopausal patient who complained of primary Raynaud's phenomenon symptoms and had recovery after the removal of her copper intrauterine device.

  7. 77 FR 24959 - Scientific Information Request on Local Therapies for Unresectable Primary Hepatocellular Carcinoma

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... Therapies for Unresectable Primary Hepatocellular Carcinoma AGENCY: Agency for Healthcare Research and... local, minimally invasive, medical devices for unresectable primary hepatocellular carcinoma (e.g... Comparative Effectiveness Review of Local Therapies for Unresectable Primary Hepatocellular Carcinoma,...

  8. DEVICE CONTROLLER, CAMERA CONTROL

    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

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  14. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  15. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  16. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  17. 21 CFR 892.5050 - Medical charged-particle 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 charged-particle radiation therapy system...-particle radiation therapy system. (a) Identification. A medical charged-particle radiation therapy system...) intended for use in radiation therapy. This generic type of device may include signal analysis and...

  18. [The application of total quality management (TQM) in quality management of radiation therapy].

    PubMed

    Jiang, Rui-yao; Fu, Shen; Li, Bin

    2009-03-01

    The strategies and methods of the total quality management (TQM) need to applied in quality management of radiation therapy. We should improve the level of quality control and quality assurance in radiation therapy. By establishing quality control system in radiation therapy, standardization of radiation therapy workflow, strengthening quality control of devices and physical technique and paying attention to safety protection and staff training.

  19. Animal therapy.

    PubMed

    Willis, D A

    1997-01-01

    This article explores the concept of animal therapy. The discussion includes a brief history of animal therapy, its importance, its relationship to rehabilitation, and its usefulness as a tool to influence adaptation, change, power, communication, advocacy, teaching, accountability, responsibility, and locus of control. This theoretical concept is important because of the joy and unconditional love animals can provide their owners. Relationships with animals can promote feelings of self-worth, help offset loneliness, reduce anxiety, provide contact, comfort, security, and the feeling of being needed. PMID:9110848

  20. Anabolic therapies.

    PubMed

    Lane, Nancy E; Silverman, Stuart L

    2010-03-01

    The striking clinical benefits of intermittent parathyroid hormone in osteoporosis have begun a new era of skeletal anabolic agents. Recombinant human parathyroid hormone (rhPTH) (1-34) is the first US Food and Drug Administration-approved anabolic therapy. Its use has been limited by the need for subcutaneous injection. Newer delivery systems include transdermal and oral preparations. Newer anabolic therapies include monoclonal antibody to sclerostin, a potent inhibitor of osteoblastogenesis; and use of bone morphogenetic proteins and parathyroid hormone-related protein PTHrP, a calcium-regulating hormone similar to PTH. PMID:20425087

  1. Left Atrial Appendage Closure Devices

    PubMed Central

    Romero, Jorge; Perez, Irving E; Krumerman, Andrew; Garcia, Mario J; Lucariello, Richard J

    2014-01-01

    Atrial fibrillation (AF) increases the risk for thromboembolic stroke five-fold. The left atrial appendage (LAA) has been shown to be the main source of thrombus formation in the majority of strokes associated with AF. Oral anticoagulation with warfarin and novel anticoagulants remains the standard of care; however, it has several limitations, including bleeding and poor compliance. Occlusion of the LAA has been shown to be an alternative therapeutic approach to drug therapy. The purpose of this article is to review the different techniques and devices that have emerged for the purpose of occluding this structure, with a particular emphasis on the efficacy and safety studies published to date in the medical literature. PMID:24963274

  2. Combating medical device fouling.

    PubMed

    Harding, Jacqueline L; Reynolds, Melissa M

    2014-03-01

    When interfaced with the biological environment, biomedical devices are prone to surface biofouling due to adhesion of microbial or thrombotic agents as a result of the foreign body response. Surface biofouling of medical devices occurs as a result of nonspecific adhesion of noxious substrates to the surface. Approaches for biofouling-resistant surfaces can be categorized as either the manipulation of surface chemical functionalities or through the incorporation of regulatory biomolecules. This review summarizes current strategies for creating biofouling-resistant surfaces based on surface hydrophilicity and charge, biomolecule functionalization, and drug elution. Reducing the foreign body response and restoring the function of cells around the device minimizes the risk of device rejection and potentially integrates devices with surrounding tissues and fluids. In addition, we discuss the use of peptides and NO as biomolecules that not only inhibit surface fouling, but also promote the integration of medical devices with the biological environment.

  3. Truth therapy/lie therapy.

    PubMed

    Langs, R

    In this paper an attempt is made to conceptualize a basic dimension of various psychotherapeutic treatment modalities, especially psychoanalysis and psychoanalytically oriented psychotherapy. The central variable under consideration is the extent to which each endeavors to approach the truth within both patient and therapist as it exists dynamically in terms of their spiraling unconscious communicative interaction. That treatment modality which takes into account every possible dimension of such truths is termed truth therapy. Treatment modalities that make no attempt to arrive at these truths or that deliberately or inadvertently falsify their nature are termed lie or barrier therapies. Extensive consideration is given to truth therapy and the truth system on which it is based. The basis for the need for lie therapies is explored, and lie systems, which may arise from either patient or therapist, or both, are identified. A classification of common types of lie patients and lie therapists (and their main techniques) is offered. The implications of this delineation for our understanding of the dynamic therapies are discussed, and a number of new clinical issues arising from this perspective are addressed.

  4. 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.

  5. 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.

  6. 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.

  7. [Clinical trials with advanced therapy medicinal products].

    PubMed

    Schüssler-Lenz, M; Schneider, C K

    2010-01-01

    For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as medicinal products or medical devices. Thus, for some products no data from clinical studies are available, e.g., for autologous chondrocyte products. The draft guideline on Good Clinical Practice for clinical trials with advanced therapies describes specific additional requirements, e.g., ensuring traceability. Most clinical studies with advanced therapies in Germany are still in early phase I or II trials with highly divergent types of products and clinical indications. The Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMEA) has been established to meet the scientific and regulatory challenges with advanced therapies.

  8. 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.

  9. 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.

  10. 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.

  11. EVA Exercise Device

    NASA Technical Reports Server (NTRS)

    1990-01-01

    The EVA (Extra Vehicular Activity) Exercise Device for evaluation and effectiveness of weightlessness on astronauts during long duration spaceflights, at the NASA Ames Research Center, Mountain View, California

  12. 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.

  13. 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.

  14. Preloaded latching device

    NASA Technical Reports Server (NTRS)

    Wesselski, Clarence J. (Inventor); Nagy, Kornel (Inventor)

    1992-01-01

    A latching device is disclosed which is lever operated sequentially to actuate a set of collet fingers to provide a radial expansion and to actuate a force mechanism to provide a compressive gripping force for attaching first and second devices to one another. The latching device includes a body member having elongated collet fingers which, in a deactuated condition, is insertable through bores on the first and second devices so that gripping terminal portions on the collet fingers are proximate to the end of the bore of the first device while a spring assembly on the body member is located proximate to the outer surface of a second device. A lever is rotatable through 90 deg to move a latching rod to sequentially actuate and expand collet fingers and to actuate the spring assembly by compressing it. During the first 30 deg of movement of the lever, the collet fingers are actuated by the latching rod to provide a radial expansion and during the last 60 deg of movement of the lever, the spring assembly acts as a force mechanism and is actuated to develop a compressive latching force on the devices. The latching rod and lever are connected by a camming mechanism. The amount of spring force in the spring assembly can be adjusted; the body member can be permanently attached by a telescoping assembly to one of the devices; and the structure can be used as a pulling device for removing annular bearings or the like from blind bores.

  15. 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 ...

  16. Intravenous therapy

    PubMed Central

    Waitt, C; Waitt, P; Pirmohamed, M

    2004-01-01

    Intravenous administration of fluids, drugs, and nutrition is very common in hospitals. Although insertion of peripheral and central cannulae and subsequent intravenous therapy are usually well tolerated, complications that prolong hospitalisation, and in some cases cause death, can arise on occasions. Additionally, many cannulae are inserted unnecessarily. This article seeks to review this area and to outline good medical practice. PMID:14760169

  17. 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…

  18. Pet Therapy.

    ERIC Educational Resources Information Center

    Kavanagh, Kim

    1994-01-01

    This resource guide presents information on a variety of ways that animals can be used as a therapeutic modality with people having disabilities. Aspects addressed include: pet ownership and selection criteria; dogs (including service dogs, hearing/signal dogs, seeing leader dogs, and social/specialty dogs); horseriding for both therapy and fun;…

  19. Constant Therapy.

    PubMed

    2016-09-28

    Designed by scientists at Boston University, this speech therapy app aims to improve everyday skills, such as speech, memory and focus, for patients recovering from a traumatic brain injury or who have aphasia, dementia or a speech-language disorder. PMID:27682560

  20. 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