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Sample records for resynchronization therapy devices

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

    PubMed

    Trupp, Robin J

    2004-01-01

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

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

    PubMed Central

    Daoud, Georges E; Houmsse, Mahmoud

    2016-01-01

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

  3. Mitral Annuloplasty Using a Cardiac Resynchronization Device

    PubMed Central

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

    2010-01-01

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

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

    PubMed

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

    2016-08-15

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

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

    PubMed

    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. 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

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

    PubMed

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

    2016-06-01

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

  8. Recent advances in cardiac resynchronization therapy.

    PubMed

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

    2011-03-01

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

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

    PubMed

    Nayar, Vikrant; Pugh, Peter J

    2010-02-01

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

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

    PubMed

    Smith, Sakima A; Abraham, William T

    2011-01-01

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

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

    PubMed

    Linde, Cecilia; Braunschweig, Frieder

    2015-12-01

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

  12. Cardiac Resynchronization Therapy: An Overview on Guidelines.

    PubMed

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

    2015-12-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

    Bose, Abhishek; Truong, Quynh A.

    2015-01-01

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

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

    PubMed

    Morgan, John M; Delgado, Victoria

    2009-11-01

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

  17. Cardiac Resynchronization Therapy in CKD: A Systematic Review

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2015-12-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2012-05-01

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

  20. 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

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

    PubMed

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

    2016-07-01

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

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

    PubMed

    Sun, Shinning; Joglar, Jose A

    2011-08-01

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

  3. 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.

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

    PubMed

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

    2016-02-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2013-04-01

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

  6. Echocardiographic Predictors of Worse Outcome After Cardiac Resynchronization Therapy

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2011-06-01

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

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

    PubMed

    Corbisiero, Raffaele; Muller, David

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  10. Device therapies: new indications and future directions.

    PubMed

    Kumar, Prabhat; Schwartz, Jennifer D

    2015-01-01

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

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

    PubMed Central

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

    2007-01-01

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

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

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

    2015-09-01

    Congestive heart failure is associated with increased levels of several inflammatory mediators, and animal studies have shown that infusion of a number of cytokines can induce heart failure. However, several drugs with proven efficacy in heart failure have failed to affect inflammatory mediators, and anti-inflammatory therapy in heart failure patients has thus far been disappointing. Hence, to what extent heart failure is caused by or responsible for the increased inflammatory burden in the patient is still unclear. Over the past couple of decades, resynchronization therapy with a biventricular pacemaker has emerged as an effective treatment in a subset of heart failure patients, reducing both morbidity and mortality. Such treatment has also been shown to affect the inflammation associated with heart failure. In this study, we review recent data on the association between heart failure and inflammation, and in particular how resynchronization therapy can affect the inflammatory process. PMID:26099323

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

    NASA Astrophysics Data System (ADS)

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

    2015-11-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-08-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2012-08-01

    Cardiac resynchronization therapy (CRT) has been proven in clinical trials to be a very effective therapy in appropriate patients. However, although the literature has primarily focused on appropriate implanting techniques and inclusion criteria for CRT devices by electrophysiologists, most patients who receive CRT are managed by their primary care providers with the help of general cardiologists and/or heart failure (HF) specialists. As CRT has been more broadly applied over the past decade, the fragmentation and specialization of care in the current health care system have created challenges in optimizing this otherwise invasive but potentially beneficial intervention in the complex HF patient. Furthermore, cost considerations as well as appropriate follow-up care continue to challenge the optimal application of these devices, particularly when evidence to support multidisciplinary approaches is lacking. The challenge begins with identification of appropriate candidates for CRT, which is an evolving concept due to data emerging from new studies with a wide range of inclusion and exclusion criteria coupled with increasing oversight from providers or even logistical hurdles from patients. Postimplant management practices and procedures are still evolving. The important and so-far unresolved concept of the "nonresponder" to CRT remains largely subjective and is variably defined in the literature, and the lack of understanding of the underlying mechanisms of "nonresponse" continues to challenge long-term management of CRT, even given the recent developments in advanced sensor technologies. Therefore, further investigations into HF disease management with a multispecialty approach, pre-CRT and post-CRT, are warranted. PMID:22521929

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

    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

  20. 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

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

    PubMed Central

    Schuster, Peter; Faerestrand, Svein

    2005-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

    Ingadottir, Brynja; Thylén, Ingela; Jaarsma, Tiny

    2015-01-01

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

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

    PubMed Central

    2011-01-01

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

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

    PubMed

    Auricchio, Angelo; Prinzen, Frits W

    2011-01-01

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

  10. 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

  11. 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

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

    PubMed

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

    2010-05-01

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

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed

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

    2016-05-01

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

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

    Yamada, Satsuki; Terzic, Andre

    2014-01-01

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

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

    PubMed

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

    2013-09-15

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

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

    PubMed

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

    2013-09-01

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

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

    PubMed

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

    2016-08-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2016-07-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

    Fujii, Banyo; Takami, Mistuaki

    2008-06-01

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

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

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

    2008-03-01

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

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

    PubMed

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

    2016-07-01

    Despite extensive studies on clinical indices for the selection of patient candidates for cardiac resynchronization therapy (CRT), approximately 30% of selected patients do not respond to this therapy. Herein, we examined whether CRT simulations based on individualized realistic three-dimensional heart models can predict the therapeutic effect of CRT in a canine model of heart failure with left bundle branch block. In four canine models of failing heart with dyssynchrony, individualized three-dimensional heart models reproducing the electromechanical activity of each animal were created based on the computer tomographic images. CRT simulations were performed for 25 patterns of three ventricular pacing lead positions. Lead positions producing the best and the worst therapeutic effects were selected in each model. The validity of predictions was tested in acute experiments in which hearts were paced from the sites identified by simulations. We found significant correlations between the experimentally observed improvement in ejection fraction (EF) and the predicted improvements in ejection fraction (P<0.01) or the maximum value of the derivative of left ventricular pressure (P<0.01). The optimal lead positions produced better outcomes compared with the worst positioning in all dogs studied, although there were significant variations in responses. Variations in ventricular wall thickness among the dogs may have contributed to these responses. Thus CRT simulations using the individualized three-dimensional heart models can predict acute hemodynamic improvement, and help determine the optimal positions of the pacing lead. PMID:26973218

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-04-01

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

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

    PubMed

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

    2016-07-01

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

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

    PubMed

    Crea, Pasquale; Picciolo, Giuseppe; Luzza, Francesco

    2016-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2014-06-15

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

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

    PubMed Central

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

    2016-01-01

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

  17. 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

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

    PubMed

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

    2016-07-15

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

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

    PubMed Central

    2012-01-01

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

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

    PubMed

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

    2016-02-01

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

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

    PubMed

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

    2016-04-15

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  5. Cardiac Resynchronization Therapy (CRT)

    MedlinePlus

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

    PubMed Central

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

    2016-01-01

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

  7. Devices as destination therapy.

    PubMed

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

    2003-02-01

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

  8. Current Status of Left Ventricular Assist Device Therapy.

    PubMed

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

    2016-07-01

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

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

    PubMed Central

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

    2009-01-01

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

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

    PubMed

    Barold, S Serge; Herweg, Bengt

    2011-01-01

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

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

    PubMed

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

    2016-03-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2010-02-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  15. 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

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

    PubMed

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

    2016-02-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2007-01-01

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

  1. Device-based Therapy for Hypertension.

    PubMed

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

    2016-08-01

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

  2. Diode-laser-based therapy device

    NASA Astrophysics Data System (ADS)

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

    2004-10-01

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

  3. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  4. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  5. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  6. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  9. Arrhythmia management after device removal.

    PubMed

    Nishii, Nobuhiro

    2016-08-01

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

  10. Balloon Devices for Atrial Fibrillation Therapy

    PubMed Central

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

    2015-01-01

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

  11. Balloon Devices for Atrial Fibrillation Therapy.

    PubMed

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

    2015-05-01

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

  12. Implantable drug therapy device: A concept

    NASA Technical Reports Server (NTRS)

    Feldstein, C.

    1972-01-01

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

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

    PubMed

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

    2016-07-01

    Fixed-time artificial insemination (FTAI) has been regarded as the most useful method to increase the number of cows inseminated in a given herd. The main treatments for FTAI in beef cattle are based on the use of progesterone-releasing devices and GnRH or estradiol to synchronize follicle wave emergence, with a mean pregnancy per AI (P/AI) around 50%. However, more recent protocols based on GnRH (named 5-day Co-Synch) or estradiol (named J-Synch) that reduce the period of progesterone device insertion and extend the period from device removal to FTAI have been reported to improve P/AI in beef cattle. Furthermore, treatments to resynchronize ovulation for a second FTAI in nonpregnant cows have provided the opportunity to do sequential inseminations and achieve high P/AI in a breeding season, reducing or even eliminating the need for clean-up bulls. In summary, FTAI protocols have facilitated the widespread application of AI in beef cattle, primarily by eliminating the necessity of estrus detection in beef herds. PMID:27180326

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

    PubMed Central

    Parrott, Helen

    2015-01-01

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

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

    PubMed

    Heidbuchel, Hein; Hindricks, Gerhard

    2015-02-01

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

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

    PubMed

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

    2016-01-01

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

  17. Negative pressure wound therapy limits downgrowth in percutaneous devices

    PubMed Central

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

    2016-01-01

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

  18. Acoustic and Cavitation Fields of Shock Wave Therapy Devices

    NASA Astrophysics Data System (ADS)

    Chitnis, Parag V.; Cleveland, Robin O.

    2006-05-01

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

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

    PubMed Central

    Shen, Jing; Chui, Chunghin; Tao, Xiaoming

    2013-01-01

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

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

    PubMed

    Leahy, Robin A; Davenport, Elizabeth E

    2015-01-01

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

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

    PubMed

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

    2008-05-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

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

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

    PubMed Central

    Haennel, Robert G.

    2012-01-01

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

  4. Device Cleaning and Infection Control in Aerosol Therapy.

    PubMed

    O'Malley, Catherine A

    2015-06-01

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

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

    PubMed

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

    2016-06-01

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

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

    PubMed

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

    2013-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    Gura, Melanie T

    2015-01-01

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

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

    PubMed

    Rawe, Ian M

    2014-01-01

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

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

    PubMed Central

    Zivin, Sean P.; Gaba, Ron C.

    2014-01-01

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

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

    PubMed Central

    Abraham, William T.; Smith, Sakima A.

    2013-01-01

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

  12. Method and devices for performing stereotactic microbeam radiation therapy

    DOEpatents

    Dilmanian, F. Avraham

    2010-01-05

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

    Segura, José Adolfo

    2003-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2014-11-01

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

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

    NASA Astrophysics Data System (ADS)

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

    1999-03-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  1. Are Electronic Cardiac Devices Still Evolving?

    PubMed Central

    Mabo, P.

    2014-01-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION... Surgical Devices § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy. (a) Identification. A non-powered suction apparatus device intended for negative pressure...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION... Surgical Devices § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy. (a) Identification. A non-powered suction apparatus device intended for negative pressure...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION... Surgical Devices § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy. (a) Identification. A non-powered suction apparatus device intended for negative pressure...

  5. 21 CFR 878.4683 - Non-Powered suction apparatus device intended for negative pressure wound therapy.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... negative pressure wound therapy. 878.4683 Section 878.4683 Food and Drugs FOOD AND DRUG ADMINISTRATION... Surgical Devices § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy. (a) Identification. A non-powered suction apparatus device intended for negative pressure...

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

    PubMed

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

    2015-09-01

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

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed

    Wilkening, André; Baiden, David; Ivlev, Oleg

    2012-12-01

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

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

    NASA Astrophysics Data System (ADS)

    Maruvada, Subha; Harris, Gerald R.

    2005-04-01

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

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

    PubMed

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

    2016-05-01

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

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

    PubMed

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

    2013-04-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

    Santhanakrishnan, Arvind; Nestle, Trent T; Moore, Brian L; Yoganathan, Ajit P; Paden, Matthew L

    2013-01-01

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

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

    PubMed Central

    2010-01-01

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

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

    PubMed

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

    2014-12-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2015-01-01

    Cell encapsulation holds enormous potential to treat a number of hormone deficient diseases and endocrine disorders. We report a simple and universal approach to fabricate robust, hydrogel-based, nanofiber-enabled encapsulation devices (NEEDs) with macroscopic dimensions. In this design, we take advantage of the well-known capillary action that holds wetting liquid in porous media. By impregnating the highly porous electrospun nanofiber membranes of pre-made tubular or planar devices with hydrogel precursor solutions and subsequent crosslinking, we obtained various nanofiber-enabled hydrogel devices. This approach is broadly applicable and does not alter the water content or the intrinsic chemistry of the hydrogels. The devices retained the properties of both the hydrogel (e.g. the biocompatibility) and the nanofibers (e.g. the mechanical robustness). The facile mass transfer was confirmed by encapsulation and culture of different types of cells. Additional compartmentalization of the devices enabled paracrine cell co-cultures in single implantable devices. Lastly, we provided a proof-of-concept study on potential therapeutic applications of the devices by encapsulating and delivering rat pancreatic islets into chemically-induced diabetic mice. The diabetes was corrected for the duration of the experiment (8 weeks) before the implants were retrieved. The retrieved devices showed minimal fibrosis and as expected, live and functional islets were observed within the devices. This study suggests that the design concept of NEEDs may potentially help to overcome some of the challenges in the cell encapsulation field and therefore contribute to the development of cell therapies in future. PMID:25453936

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

    PubMed

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

    2015-02-24

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

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

    PubMed Central

    2016-01-01

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

  20. 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

  1. 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.

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

    PubMed

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

    2015-02-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2011-10-01

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

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

    NASA Astrophysics Data System (ADS)

    Rockley, Graham J.

    2001-03-01

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

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

    PubMed

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

    2016-05-01

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

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

    PubMed

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

    2015-01-01

    Repeatable head immobilization is important for minimizing positioning error during radiation therapy for veterinary patients with head neoplasms. The purpose of this retrospective cross-sectional study was to describe a novel technique for head immobilization (Device II) and compare this technique with a previously described technique (Device I). Device II provided additional support by incorporating three teeth (vs. two teeth with Device I). Between 2011 and 2013, both devices were applied in clinically affected cats (Device I, n = 17; Device II, n = 11) and dogs (Device I, n = 85; Device II, n = 22) of various breeds and sizes. The following data were recorded for each included patient: variability in the angle of the skull (roll, yaw, and pitch), coordinates of the isocenter, and distance from the reference mark to the tumor. Devices I and II differed for skull angle variability during the treatment of dogs (roll, P = 0.0007; yaw, P = 0.0018; pitch, P = 0.0384) and for yaw of during the treatment of cats (P < 0.0001). In each case, Device II was superior to Device I. The distance from the reference mark to the center of the tumor was significantly decreased for Device II vs. Device I (dogs, P < 0.0001; cats, P = 0.0002). Device II also provided more accurate coordinates for the isocenter. Authors recommend the use of, Device II for future clinical patients. PMID:26202221

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

    NASA Technical Reports Server (NTRS)

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

    1973-01-01

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

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

    SciTech Connect

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

    1986-12-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2006-05-01

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

  10. 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

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

    PubMed

    Nestor, Mark Steven

    2004-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2015-02-01

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

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

    PubMed

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

    2016-01-01

    Alongside the remarkable advances in medical and invasive therapies for the treatment of ischemic heart disease, an increasing number of patients with advanced coronary artery disease unsuitable for revascularization continue to suffer from angina pectoris despite optimal medical therapy. Patients with chronic angina have poor quality of life and increased levels of anxiety and depression. A considerable number of innovative therapeutic modalities for the treatment of chronic angina have been investigated over the years; however, none of these therapeutic options has become a standard of care, and none are widely utilized. Current treatment options for refractory angina focus on medical therapy and secondary risk factor modification. Interventions to create increased pressure in the coronary sinus may alleviate myocardial ischemia by forcing redistribution of coronary blood flow from the less ischemic subepicardium to the more ischemic subendocardium, thus relieving symptoms of ischemia. Percutaneous, transvenous implantation of a balloon expandable, hourglass-shaped, stainless steel mesh in the coronary sinus to create a fixed focal narrowing and to increase backwards pressure, may serve as a new device-based therapy destined for the treatment of refractory angina pectoris. PMID:26886464

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

    PubMed

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

    2014-07-01

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

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

    SciTech Connect

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

    2013-11-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Irwin, Marleen E

    2004-01-01

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

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

    PubMed

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

    2016-05-01

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

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

    PubMed

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

    2016-08-01

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

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

    PubMed

    Thai, Nina N

    2012-02-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2010-08-01

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

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

    SciTech Connect

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

    2014-06-01

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

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

    PubMed Central

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

    2016-01-01

    Endoscopic vacuum-assisted closure (VAC) is increasingly being used as a means of managing perforations or anastomotic leaks of the upper gastrointestinal (GI) tract. Published outcomes are favourable, with few mentions of complications or morbidity. We present a case in which the management of a gastric perforation with endoscopic vacuum therapy was complicated by cervical oesophageal perforation. The case highlights the risks of such endoscopic therapeutic procedures and is the first report in the literature to describe significant visceral injury during placement of a VAC device for upper GI perforation. Iatrogenic oesophageal perforation is an inherent risk to upper GI endoscopy and the risk increases in therapeutic endoscopic procedures. Complications may be reduced by management under a multidisciplinary team in a centre with specialist upper GI services. There is no doubt that the endoscopic VAC approach is becoming established practice, and training in its use must reflect its increasingly widespread adoption. PMID:27470015

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

    NASA Astrophysics Data System (ADS)

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

    2016-06-01

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

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

    PubMed

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

    2016-06-01

    Owing to its high carrier mobility, conductivity, flexibility and optical transparency, graphene is a versatile material in micro- and macroelectronics. However, the low density of electrochemically active defects in graphene synthesized by chemical vapour deposition limits its application in biosensing. Here, we show that graphene doped with gold and combined with a gold mesh has improved electrochemical activity over bare graphene, sufficient to form a wearable patch for sweat-based diabetes monitoring and feedback therapy. The stretchable device features a serpentine bilayer of gold mesh and gold-doped graphene that forms an efficient electrochemical interface for the stable transfer of electrical signals. The patch consists of a heater, temperature, humidity, glucose and pH sensors and polymeric microneedles that can be thermally activated to deliver drugs transcutaneously. We show that the patch can be thermally actuated to deliver Metformin and reduce blood glucose levels in diabetic mice. PMID:26999482

  6. 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

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

    PubMed Central

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

    2011-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2015-06-01

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

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

    PubMed

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

    2013-08-01

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

  10. 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

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

    PubMed

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

    2016-08-01

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

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

    PubMed

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

    2016-01-01

    The aim of this study is to develop a new method to align the patient setup lasers in a radiation therapy treatment room and examine its validity and efficiency. The new laser alignment method is realized by a device composed of both a metallic base plate and a few acrylic transparent plates. Except one, every plate has either a crosshair line (CHL) or a single vertical line that is used for alignment. Two holders for radiochromic film insertion are prepared in the device to find a radiation isocenter. The right laser positions can be found optically by matching the shadows of all the CHLs in the gantry head and the device. The reproducibility, accuracy, and efficiency of laser alignment and the dependency on the position error of the light source were evaluated by comparing the means and the standard deviations of the measured laser positions. After the optical alignment of the lasers, the radiation isocenter was found by the gantry and collimator star shots, and then the lasers were translated parallel to the isocenter. In the laser position reproducibility test, the mean and standard deviation on the wall of treatment room were 32.3 ± 0.93 mm for the new method whereas they were 33.4 ± 1.49 mm for the conventional method. The mean alignment accuracy was 1.4 mm for the new method, and 2.1 mm for the conventional method on the walls. In the test of the dependency on the light source position error, the mean laser position was shifted just by a similar amount of the shift of the light source in the new method, but it was greatly magnified in the conventional method. In this study, a new laser alignment method was devised and evaluated successfully. The new method provided more accurate, more reproducible, and faster alignment of the lasers than the conventional method. PMID:26894331

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

    PubMed

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

    2006-04-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Rubio Tabares, Jonathan; Amaya Gonzalez, Pablo Felipe

    2016-09-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2016-04-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2015-06-01

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

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

    PubMed

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

    2007-01-01

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

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

    PubMed

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

    2008-01-01

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

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

    PubMed

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

    2016-03-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed

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

    2013-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2013-05-01

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

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

    PubMed

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

    2013-03-01

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

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

    PubMed

    2015-10-13

    The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device "nonthermal shortwave therapy'' (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices. PMID:26470404

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

    PubMed Central

    Lee, Lawrence S.; Shekar, Prem S.

    2014-01-01

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

  9. 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.

  10. 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

  11. 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

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

    PubMed Central

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

    1997-01-01

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

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

    PubMed 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

  14. 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

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

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  17. 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.

  18. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-03-01

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

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

    PubMed Central

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

    2014-01-01

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

  2. 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

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

    PubMed

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

    2015-11-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2015-05-01

    Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias, device, and lead failure and may also be useful in risk-predicting patient-related outcomes. Financial benefits for patients and healthcare organizations have also been shown. We sought to assess the implementation and funding of RM of CIEDs, including conventional pacemakers (PMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in Europe. Electronic survey from 43 centres in 15 European countries. In the study sample, RM was available in 22% of PM patients, 74% of ICD patients, and 69% of CRT patients. The most significant perceived benefits were the early detection of atrial arrhythmias in pacemaker patients, lead failure in ICD patients, and worsening heart failure in CRT patients. Remote monitoring was reported to lead a reduction of in-office follow-ups for all devices. The most important reported barrier to the implementation of RM for all CIEDs was lack of reimbursement (80% of centres). Physicians regard RM of CIEDs as a clinically useful technology that affords significant benefits for patients and healthcare organizations. Remote monitoring, however, is perceived as increasing workload. Reimbursement for RM is generally perceived as a major barrier to implementation. PMID:25713012

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

    PubMed

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

    2016-05-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-04-01

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

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

    PubMed

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

    2014-07-15

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

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

    PubMed

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

    2016-04-01

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

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

    PubMed

    Ylikorkala, O; Kauppila, A; Siljander, M

    1978-08-19

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

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

    NASA Astrophysics Data System (ADS)

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

    2006-05-01

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

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

    SciTech Connect

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

    2010-02-01

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

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

    PubMed

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

    2016-05-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2016-03-01

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

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

    PubMed

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

    2008-01-01

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

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

    SciTech Connect

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

    2009-10-01

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

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

    PubMed

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

    2013-11-01

    The aim of this European Heart Rhythm Association (EHRA) survey was to assess clinical practice in relation to the tools and techniques used for cardiac implantable electronic devices procedures in the European countries. Responses to the questionnaire were received from 62 members of the EHRA research network. The survey involved high-, medium-, and low-volume implanting centres, performing, respectively, more than 200, 100-199 and under 100 implants per year. The following topics were explored: the side approach for implantation, surgical techniques for pocket incision, first venous access for lead implantation, preference of lead fixation, preferred coil number for implantable cardioverter-defibrillator (ICD) leads, right ventricular pacing site, generator placement site, subcutaneous ICD implantation, specific tools and techniques for cardiac resynchronization therapy (CRT), lead implantation sequence in CRT, coronary sinus cannulation technique, target site for left ventricular lead placement, strategy in left ventricular lead implant failure, mean CRT implantation time, optimization of the atrioventricular (AV) and ventriculo-ventricular intervals, CRT implants in patients with permanent atrial fibrillation, AV node ablation in patients with permanent AF. This panoramic view allows us to find out the operator preferences regarding the techniques and tools for device implantation in Europe. The results showed different practices in all the fields we investigated, nevertheless the survey also outlines a good adherence to the common standards and recommendations. PMID:24170423

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

    PubMed

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

    1998-08-01

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

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

    PubMed

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

    2015-02-01

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

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

    PubMed

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

    2016-07-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2016-06-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed Central

    2010-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    1996-03-01

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